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© Copyright EU Gateway | Business Avenues
The information and views set out in this study are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. The contents of this publication are the sole responsibility of EU Gateway | Business Avenues and can in no way be taken to reflect the views of the European Union. The purpose of this report is to give European companies selected for participation in the EU Gateway | Business Avenues Programme an introductory understanding of the target markets countries and support them in defining their strategy towards those markets. For more information, visit www.eu-gateway.eu.
Healthcare & Medical Technologies – Japan Market Study - Page 3 of 121
EU Gateway to Japan
Central Management Unit
Japan Market Study
JANUARY 2018
Submitted to the European Commission on 10 January 2018
Healthcare & Medical Technologies – Japan Market Study - Page 4 of 121
Table of Contents
TABLE OF FIGURES .................................................................................................................................................. 7
LIST OF ABBREVIATIONS ........................................................................................................................................ 9
1. EXECUTIVE SUMMARY HEALTHCARE & MEDICAL TECHNOLOGIES .......................................................... 11
1.1. JAPANESE MARKET AND THE EU ........................................................................................................... 11
1.2. HEALTHCARE MARKET IN JAPAN ............................................................................................................ 12
1.3. MARKET TRENDS HEALTHCARE & MEDICAL TECHNOLOGIES ................................................................... 13
1.4. ASSISTIVE TECHNOLOGIES ..................................................................................................................... 15
1.5. MEDICAL EQUIPMENT ............................................................................................................................ 15
1.6. ICT FOR HEALTHCARE & MEDICAL TECHNOLOGIES ................................................................................ 16
1.7. TELEMEDICINE AND REMOTE HEALTH MONITORING ................................................................................. 17
1.8. NANOTECHNOLOGY FOR HEALTHCARE & MEDICAL TECHNOLOGIES ........................................................ 17
1.9. BIOTECHNOLOGY FOR HEALTHCARE & MEDICAL TECHNOLOGIES ............................................................ 18
1.10. DENTAL PRODUCTS AND TECHNOLOGIES ............................................................................................. 18
1.11. HEALTHCARE & MEDICAL TECHNOLOGIES REGULATIONS ..................................................................... 19
2. WHAT ARE THE CHARACTERISTICS OF JAPAN? .......................................................................................... 23
2.1. POLITICAL OVERVIEW ............................................................................................................................ 25
2.2. ECONOMIC OVERVIEW ........................................................................................................................... 25
2.3. TRADE OVERVIEW BETWEEN EU AND JAPAN .......................................................................................... 28
3. HEALTHCARE & MEDICAL TECHNOLOGIES MARKET OVERVIEW AND EU ENTRY OPPORTUNITIES .......... 32
3.1. JAPANESE HEALTHCARE & MEDICAL TECHNOLOGIES MARKET ............................................................... 32
3.1.1. Short Historic Healthcare & Medical Technologies Market Overview ........................................... 32
3.1.2. Market Overview Healthcare & Medical Technologies .................................................................. 33
3.1.3. Market Trends Healthcare & Medical Technologies ...................................................................... 40
3.1.4. Import Market of Healthcare & Medical Technologies ................................................................... 42
3.2. ASSISTIVE TECHNOLOGIES ..................................................................................................................... 43
3.2.1. Market Overview Assistive Technologies ...................................................................................... 43
3.2.2. EU Entry Opportunities Assistive Technologies ............................................................................ 47
3.2.3. Japanese Market Players .............................................................................................................. 55
3.3. MEDICAL EQUIPMENT ............................................................................................................................ 58
3.3.1. Market Overview Medical Equipment ............................................................................................ 58
3.3.2. Trends in Medical Device Market .................................................................................................. 62
3.3.3. EU Entry Opportunities Medical Equipment .................................................................................. 63
3.4. ICT FOR HEALTHCARE & MEDICAL TECHNOLOGIES ................................................................................ 66
Healthcare & Medical Technologies – Japan Market Study - Page 5 of 121
3.4.1. Market Overview ICT for Healthcare & Medical Technologies ...................................................... 66
3.4.2. Market Trends ICT for Healthcare & Medical Technologies .......................................................... 67
3.4.3. EU Entry Opportunities for ICT in Healthcare & Medical Technologies ........................................ 69
3.5. TELEMEDICINE AND REMOTE HEALTH MONITORING ................................................................................. 73
3.5.1. Market Overview Telemedicine and Remote Health Monitoring ................................................... 73
3.5.2. Market Trends Telemedicine and Remote Health Monitoring ....................................................... 76
3.5.3. EU Entry Opportunities Telemedicine and Remote Health Monitoring ......................................... 76
3.6. NANOTECHNOLOGY HEALTHCARE .......................................................................................................... 77
3.6.1. Market Overview Nanotechnology Healthcare .............................................................................. 77
3.6.2. Market Trends Nanotechnology Healthcare .................................................................................. 78
3.6.3. EU Entry Opportunities Nanotechnology Healthcare .................................................................... 80
3.7. LIFE SCIENCE / BIOTECHNOLOGY FOR HEALTHCARE ............................................................................... 81
3.7.1. Market Overview Life Science / Biotechnology for Healthcare ...................................................... 81
3.7.2. Market Trends Life Science / Biotechnology for Healthcare ......................................................... 82
3.7.3. EU Entry Opportunities Life Science / Biotechnology for Health ................................................... 83
3.8. DENTAL PRODUCTS AND TECHNOLOGIES ............................................................................................... 85
3.8.1 Market Overview Dental Products .................................................................................................. 85
3.8.2. Market Trends Dental Products ..................................................................................................... 87
3.8.3. EU Entry Opportunities Dental Products ....................................................................................... 88
4. HEALTHCARE & MEDICAL TECHNOLOGIES REGULATIONS ....................................................................... 91
4.1. HEALTHCARE & MEDICAL TECHNOLOGIES REGULATIONS ....................................................................... 91
4.1.1. Pharmaceuticals and Medical Device Act (PMD Act) .................................................................... 91
4.1.2. Application and Approval ............................................................................................................... 92
4.1.3. Long-Term Care Insurance (LCTI) system .................................................................................. 100
4.1.4. Medical Fees and Insurance Reimbursement ............................................................................. 103
4.1.5. Other Regulations ........................................................................................................................ 104
5. ANNEXES............................................................................................................................................................ 106
5.1. HEALTHCARE & MEDICAL TECHNOLOGIES INDUSTRY ASSOCIATIONS ..................................................... 106
5.2. HEALTHCARE & MEDICAL TECHNOLOGIES TRADE FAIRS ....................................................................... 108
5.3. LIST OF HEALTHCARE & MEDICAL TECHNOLOGIES COMPANIES IN JAPAN .............................................. 110
5.3.1. Terumo Corporation ..................................................................................................................... 110
5.3.2. Olympus Corporation ................................................................................................................... 110
5.3.3. Nipro Corporation ........................................................................................................................ 111
5.3.4. Hitachi Healthcare Manufacturing ............................................................................................... 111
5.3.5. Fukuda Denshi ............................................................................................................................. 112
5.3.6. Nihon Kohden .............................................................................................................................. 112
Healthcare & Medical Technologies – Japan Market Study - Page 6 of 121
5.4. EUROPEAN HMT COMPANIES IN JAPAN ................................................................................................ 113
5.4.1. Philips Electronics Japan ............................................................................................................. 113
5.4.2. LivaNova ...................................................................................................................................... 113
5.5. BIBLIOGRAPHY AND REFERENCES ........................................................................................................ 116
Healthcare & Medical Technologies – Japan Market Study - Page 7 of 121
Table of Figures
Figure 1: Various sources, total market value approx. 6.76 trillion JPY in FY2014, Telemedicine is below 1% market share..................................................................... 13
Figure 2: various sources ........................................................................................................... 15
Figure 3: Pharmaceuticals and Medical Devices Agency, https://www.pmda.go.jp/english/review-services/outline/0001.html ............................ 21
Figure 4: Japan Factsheet, several sources .............................................................................. 23
Figure 5: © Abenomics, Cabinet of the Prime Minister website .................................................. 26
Figure 6: EU-Japan Trade Relationship-Facts and Figures, European Commission, 2017 ....... 28
Figure 7: The EU-Japan EPA in 60 seconds, European Commission, Trade, 2017 .................. 29
Figure 8: Eurostat, European Commission, Directorate-General for Trade, May 2017 .............. 29
Figure 9: © Cabinet Public Relations Office, July 2017............................................................... 30
Figure 10: © Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future challenges, Japanese Society of Medical Sciences, Yasuki KOBAYASHI ..... 32
Figure 11: various online resources ........................................................................................... 34
Figure 12: Overview of National Medical Expenditures for 2013, Ministry of Health Labour and Welfare (MLHW) ................................................................................................ 34
Figure 13: United Nations, World Population Prospects, the 2015 Revision .............................. 35
Figure 14: The World Pharmaceutical Markets Fact Book 2014, Espicom ................................ 36
Figure 15: © Basic Review Process for Drug of Medical Device Application, Pharmaceutical and Medical Devices Agency (PMDA) ...................................................................... 37
Figure 16: © Supply Chain of Medical Devices in Japan, Pharmaceutical and Medical Devices Agency (PMDA) .......................................................................................... 37
Figure 17: © Demystifying Device Reimbursement in Japan-Device Talk, EMERGO, 2017 ...... 39
Figure 18: Compiled by JETRO based on the “International Comparison of Regulations for Regenerative Medicine and Cell Therapy 2013” by the National Institute of Health Sciences ................................................................................................................... 40
Figure 19: JETRO, Attractive Sectors: Life Science, 2016 ......................................................... 42
Figure 20: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016 .................................................................................................................. 44
Figure 21: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016 .................................................................................................................. 45
Figure 22: Services available under Long-Term Care Insurance (LTCI) .................................... 46
Figure 23: Assistive Devices available for Rental Services ........................................................ 48
Figure 24: Commercialised Products developed by NRDPMWA ............................................... 50
Figure 25: © Healthcare Support System to Remotely Monitor the Elderly, Fujitsu Journal Online, 2014 .......................................................................................................................... 52
Figure 26: TrendForce, May 2015 .............................................................................................. 54
Figure 27: © AFP/GETTY and © Professor SANKAI, University of Tsukuba/Cyberdyne: Cyberdyne employees wearing a HAL robot-suit walking in Tokyo .......................... 55
Healthcare & Medical Technologies – Japan Market Study - Page 8 of 121
Figure 28: © RIKEN-TRI Collaboration Centre for Human-Interactive Robot Research. RIBA uses two arms to lift a person lying in bed or sitting on a wheelchair, moves and sets the person down ............................................................................. 56
Figure 29: © Robot Seal PARO, Tom Battey .............................................................................. 57
Figure 30: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW ....................................................................................................................... 59
Figure 31: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW ....................................................................................................................... 60
Figure 32: Gyokai Search, FY2015 Medical Device Industry Sales Ranking, 2016 ................... 61
Figure 33: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW ....................................................................................................................... 62
Figure 34: ICT in Healthcare Questionnaire, Ministry of Internal Affairs and Communications, 2016 .......................................................................................................................... 67
Figure 35: © ICT Trends in Japan’s Healthcare Policy, Fujitsu Science Technology, July 2015 .................................................................................................................. 68
Figure 36: © Global Wearable Device Market: Key Research Findings 2016, Yano Research Institute, 2016 ........................................................................................................... 72
Figure 37: © The Japan Times: Prime Minister Shinzo Abe tries out a telemedicine system offered by the city of Minamisoma in Fukushima Prefecture, 2017........................... 74
Figure 38: © Nano Bio First, Kazunori KATAOKA, Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST), 2012 .................................... 79
Figure 39: Nanotechnology Products Database, www.statnano.com ........................................ 80
Figure 40: Attractive Sectors-Biotechnology, JETRO, 2007 ....................................................... 84
Figure 41: Figure 36: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA), 2017 ............................................ 85
Figure 42: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA), 2017 ..................................................................... 87
Figure 43: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA), 2017 ..................................................................... 88
Figure 44: Websites MHLW, MIC and others, 2017 ................................................................... 89
Figure 45: © Japan: The Regulatory Process for Medical Devices, Emergo, 2017 .................... 94
Figure 46: © Japan: The Time, Cost and Complexity of Registration, Emergo, 2017 ................. 97
Figure 47: Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013) ................................................................................................... 98
Figure 48: Overview LTCI, MHLW 2016 .................................................................................. 100
Figure 49: Overview LTCI, MHLW 2016 .................................................................................. 101
Figure 50: Overview LTCI, MHLW 2016 .................................................................................. 102
Figure 51: Overview LTCI, MHLW 2016 .................................................................................. 103
Figure 52: New Orange Plan, LTCI, MHLW, 2016 ................................................................... 104
Healthcare & Medical Technologies – Japan Market Study - Page 9 of 121
List of Abbreviations
ADEM Agency for Medical Research and Development
AI Artificial Intelligence
AIST National Institute of Advanced Industrial Science and Technology
app(s) Application(s)
ASEAN Association of Southeast Asian Nations
b billion
CAGR Compound Annual Growth Rate
CE Conformité Européene
CT Computed Tomography
DDS Drug Delivery Systems
DPJ Democratic Party of Japan
EHR Electronic Health Record
EPA Economic Partnership Agreement
EU European Union
EUR Euro
FDA Food and Drug Administration
FDI Foreign Direct Investment
FFOPs Follow-On Protein Products
FY Fiscal Year
GDP Gross Domestic Product
HAL Hybrid Assistive Limbo
HHC Home Health Care
HI Health Insurance
IBM International Business Machines
ICT Information and Communication Technology
IoT Internet of Things
iPS Induced Pluripotent Stem
iPSC Induced Pluripotent Stem Cells
IT Information Technology
JASPA Japan Assistive Products Association
JBA Japan Bioindustry Association
JDA Japan Dental Association
JETRO Japan External Trade Organisation
JMDN Japanese Medical Device Nomenclature
JPY Japanese Yen
k thousand
Healthcare & Medical Technologies – Japan Market Study - Page 10 of 121
LDP Liberal Democratic Party
LTCI Long-term Care Insurance
m million
METI Ministry of Economy, Trade and Industry
MEXT Ministry of Education, Culture, Sports, Science and Technology
MHLW Ministry of Health Labour and Welfare
MIC Ministry of Internal Affairs and Communications
MRI Magnetic Resonance Imaging
NHI National Health Insurance
NRDPMWA National Research and Development Program for the Medical and Welfare Apparatus
OECD Organisation for Economic Co-operation and Development
PAL Pharmaceutical Affairs Law
PHR Personal Health Record
PMD Act Pharmaceutical and Medical Device Act
PMDA Pharmaceuticals and Medical Devices Agency
QMS Quality Management Systems
R&D Research and Development
RHS Remote Healthcare Systems
RIBA Robot for Interactive Body Assistance
t trillion
US United States of America
USB Universal Serial Bus
WHO World Health Organisation
Healthcare & Medical Technologies – Japan Market Study - Page 11 of 121
1. Executive Summary Healthcare & Medical Technologies
1.1. Japanese Market and the EU
Japan remains the third largest global economic powerhouse, following the US and China. It aims
to achieve a Gross Domestic Product (GDP) of JPY 600 trillion (EUR 5 trillion) by FY2020, when
the Olympics will be hosted in Tokyo. Prime Minister Shinzo ABE and his cabinet hope to reach
this milestone goal based on his Abenomics strategy containing 3 main “arrows” of boosting the
economy, energising corporate activities and driving innovation and trade.
One of the main steps to reaching this GDP goal is the principal platform for the Economic
Partnership Agreement (EPA) between the EU and Japan. This EPA was signed in Brussels on
6 July 2017 during the 24th EU-Japan Summit in the presence of Prime Minister Abe, European
Commission President Juncker and European Council President Tusk, after nearly five years of
negotiations. The final approval is expected by mid-2018.
The EU currently exports on an annual basis goods worth EUR 58 billion and services valued at
EUR 28 billion to Japan. The EPA predicts an average 20% growth of EU exports, pushing up the
nominal GDP by 1% and possible creation of 420,000 new jobs.1
In 2015, 8.1% of total EU healthcare and medical device exports were to Japan. For European
companies, the EPA will further reduce costs for export certifications of medical devices, following
Japan’s joining International Standards on Quality Management Systems (QMS) in 2014.
1 Eurostat, European Commission, Directorate-General for Trade, May 2017
Healthcare & Medical Technologies – Japan Market Study - Page 12 of 121
1.2. Healthcare Market in Japan
In 1922, Japan launched its Health Insurance (HI) for industrial workers, followed in 1938 with the
voluntary National Health Insurance (NHI), to additionally include farmers and self-employed
people. From 1961, Japan had implemented a universal health insurance system that covered
nearly all citizens. The last major addition to the system was the Long-Term Care Insurance for
the Elderly, implemented from 2000.2
The public healthcare system is supported by working contributors via a 30% co-payment, but for
older patients this co-payment can vary from 10 to 20% depending upon their income.
Currently and following the 15 September 2017 announcements by the Ministry of Internal Affairs
and Communications (MIC), the Japanese population aged over 65 represents 27.7% of the total
population, equal to 35.14 million inhabitants. Additionally, for the first time, more that 2 million
people are over 90 years old. The average male life expectancy is almost 80 years, while women
average around 86 years. By FY2050, it is estimated that almost 40% of the population will be
over 65, ranking Japan as the highest in the world.
In FY2015, Japan ranked third on the Health Spending Index of the Organisation for Economic
Co-operation and Development (OECD) with 11.2% of its GDP, just behind the US and
Switzerland. Total social security costs, including pensions, healthcare and welfare, stands at
around 23% of the GDP.
This demographic situation creates interesting business opportunities for EU companies in the
Healthcare & Medical Technologies market that wish to increase or begin exports to Japan.
The FY2014 revision of the former Pharmaceuticals Affairs Law (PAL) into the Pharmaceutical
and Medical Device Act (PMD Act) will support future HMT sector growth at an annual rate of 3%.
Japan holds about 10% of the global HMT market share for both drugs and medical devices.
2 Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future challenges, Japanese Society of Medical Sciences,
Yasuki KOBAYASHI
Healthcare & Medical Technologies – Japan Market Study - Page 13 of 121
Market Share Healthcare & Medical Technologies Sub-Sectors in Japan
Figure 1: Various sources, total market value approx. 6.76 trillion JPY in FY2014, Telemedicine is below 1% market share
1.3. Market Trends Healthcare & Medical Technologies
In addition to changing demographic trends in Japan, drastic reformation of the healthcare market
in general is among the key policies of the Abe cabinet. It aims to achieve this through high quality
Research and Development (R&D) and manufacturing of medical devices, together with innovative
healthcare services supported by strong ICT infrastructure. Customised medical care, based upon
Personal Health Records and anonymous cloud-based big data are another key priority. Approval
processes for both new drugs and medical devices will also be shortened substantially.
The total market value for medical devices was JPY 2.68 trillion (EUR 22.3 billion) in FY2013.
This was JPY 1.375 trillion (EUR 11.458 billion) of domestically manufactured medical devices
and JPY 1.30 trillion (EUR 10.84 billion) of imported medical devices, commanding 49% market
Assistive Technologies
21%
Medical Equipment 40%
ICT Healthcare5%
Nanotechnology4%
Biotechnology26%
Dental Equipment4%
Healthcare & Medical Technologies – Japan Market Study - Page 14 of 121
share.3 The revised PMD Act should be a big push due to eased import regulations, which will
drive continued growth of imported medical devices.
Concrete export business opportunities for European companies to Japan, can be found in the
following summary.
Healthcare & Medical Technology Sector Business Opportunities
Assistive Technologies ▪ Continued strong demand for railings, silver cars, walking devices,
walkers and walking assistants following enclosing into long-term rental systems by local governments
▪ Nursing Robot Market to increase to JPY 1.5 trillion (EUR 12.45 billion) by FY2020 (15-fold from FY2015)
▪ Orthopaedic Devices and Surgical Implants demand as Japan’s demand alone is +50% of all Asian-Pacific market
Medical Equipment ▪ Almost 50% of all medical equipment is imported
▪ Future growth potential for endoscopic surgery equipment
▪ Replacement demand of existing MRI equipment
ICT for Healthcare & Medical Technologies
▪ Electronic Medical Record Systems: +23% by FY2020
▪ Community Healthcare Coordination Systems: +66% by FY2020
▪ IoT Technologies: +20% annually between FY2015-2020
Telemedicine and Remote Health Monitoring
▪ Remote monitoring service market to grow to JPY 13.9 billion (EUR 115.83 million) by FY 2025 (almost 50% increase versus FY2016)
▪ Following FY2015 deregulations, telemedicine demand will be brisk for Remote Nursing Care and Remote Healthcare Systems (RHS)
Nanotechnology ▪ Market to triple in value by FY2020 to EUR 94.4 billion
▪ Nanotech applications in Dentistry and Sanitary sectors
▪ Medical equipment with nanotechnology for less invasive surgeries
Life Science / Biotechnology ▪ Market to 10-fold in value by FY2030 to EUR 166 billion
▪ Business potential in participation and collaboration with biotechnology clusters nationwide
Dental Products and Technologies ▪ Dental examination equipment and dental laboratory equipment
(high import ratio)
3 JETRO, Attractive Sectors: Life Science, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 15 of 121
Healthcare & Medical Technology Sector Business Opportunities
▪ CAD/CAM devices for dentistry, dental implant materials, dental impression and reproduction materials, total and partial floor denture materials (+80% import ratio)
Figure 2: various sources
1.4. Assistive Technologies
In Japan, assistive devices and technologies are part of the welfare segment that includes nursing
care, rehabilitation and the home care sector. In FY2014, the Japanese market for the welfare
equipment industry was JPY 1.4 trillion 4 (EUR 11.65 billion) and it is forecasted to reach
JPY 4,5 trillion (EUR 37.5 billion) by FY2025.5
Responding to this trend and driven by the scheduled revision of the Long-Term Nursing Care
Insurance system in FY2018, new business opportunities for European manufacturers in this sub-
sector are emerging.
The market will show especially strong demand for advanced and innovative assistive devices
that meet the needs of Japan’s rapidly ageing population particularly in areas such as mobility
impairment equipment, home care devices and nursing homes, remote monitoring services,
orthopaedic devices and surgical implants.
Further, nursing care robots will play a very significant role, not only in the nursing care sector but
also in the medical sector from general to rehabilitation uses.
1.5. Medical Equipment
The Japanese medical equipment and materials market is the third largest in the world, and it is
expected to grow further as Japan’s ageing population rapidly increases. By FY2050, Japan is
expected to be a “super-aged” society with 40% of its population over 65 years.
4 Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016 5 Current Situation and Outlook of the Welfare Market in 2017, Fuji Keizai Group, Japanese, 2017
Healthcare & Medical Technologies – Japan Market Study - Page 16 of 121
Almost 50% or JPY 1.37 trillion (EUR 11.37 billion) of Japan’s medical device and materials
market consists of imported products, particularly sophisticated medical technologies.6
European companies might find it difficult to compete with domestic manufacturers in
e.g. diagnostic imaging, therapeutic and surgical equipment, and biophenomena measuring and
monitoring systems. However, thanks to the amended Pharmaceutical and Medical Device (PMD)
Act, the import market is expected to continue expanding. Business opportunities for European
healthcare manufacturers lie in innovative technologies like cardiology equipment, pacemakers,
orthopaedic implants and medical devices that alleviate pain in general and improve the quality
of life for patients. Furthermore, given Japan's ageing population and the increasing number of
patients with chronic and life-style diseases, the markets for in-home care devices, technologies,
and health ICT related products is expected to grow accordingly.
1.6. ICT for Healthcare & Medical Technologies
At the end of FY2013, the ICT healthcare market was an estimated JPY 374.3 billion
(EUR 3.11 billion), but is predicted to grow to JPY 420.4 billion (EUR 3.5 billion) by FY2020.7
Areas like Electronical Medical Records like Electronic Health Records (EHR) and Personal
Health Records (PHR), Supplier Information Sharing and Remote Safety Check and Confirmation
Systems, Remote Diagnostic Imaging Systems and Internet of Things (IoT) devices are expected
to show double-digit growth on an annual basis8 through FY2020.
Also, wearable devices with healthcare applications, including Smart Watches and Smart Bands,
are estimated to exceed 11 million devices by FY2020 from 3.5 million devices in FY2016.9
Currently, nearly 30% of the Japanese population is aged over 65 years, there will be stronger
demand to alleviate the burden on nursing care workers. This is the opportunity for Robotic
6 Annual Report on Statistics of Production by Pharmaceutical Industry in 2013, Ministry of Health, Labour and Welfare (MHLW) 7 Invest in Tokyo website, 2016 8 ICT in Healthcare Questionnaire, MIC, 2016 9 Global Wearable Device Market: Key Research Findings 2016, Yano Research Institute, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 17 of 121
Devices to emerge. This specific market segment is predicted to grow from JPY 16.7 billion
(EUR 139.15 million) in FY2015 to JPY 404.3 billion (EUR 3.36 billion) by FY2035.10
1.7. Telemedicine and Remote Health Monitoring
Closely linked to the ICT Healthcare market segment, this niche market is still small but is expected
to grow by 30% to JPY 13.2 billion (EUR 110 million) by FY2020. Further growth aims to enhance
nationwide coverage of rural and remote areas mainly occupied by the elderly at present. Sub-
sectors like remote medical/nursing care and remote healthcare systems (RHS) look promising but
attention is currently focused on the telemedicine subsector, given the deregulatory measurements
taken by the Abe government in 2017. New inroads into telemedicine is not limited to customised
telemedicine software as some hospitals and doctors already provide similar services with existing
platforms like Skype, Facebook Messenger and iPhone FaceTime video.
1.8. Nanotechnology for Healthcare & Medical Technologies
Within the nanotechnology field in Japan, healthcare is taking the biggest share at nearly 50%.
The market is predicted to grow to EUR 95 billion by FY2020 and up to EUR 189 billion by
FY2030.11
Currently, R&D and manufacturing is done mainly between universities, research centres and
private companies, with applications focusing on nanomedicines, dentistry, tissue engineering
and medical supplies. Like global trends, Japan is also working rapidly on creating a pinpoint
Nano-Drug Delivery System (DDS) for cancer imaging and target therapy.12
In this phase, cooperation among private Japanese companies like Unicharm and Tokuyama
Dental, or leading academic and research institutes like Kyoto University, Tokyo Institute of
Technology or National Institute for Materials Science, seem to be the most efficient market
10 5-year Plan for Development of Robotic Devices for Nursing Care, METI, 2014 11 Nanotech Cluster and Industry Landscape in Japan, Andrej Zagar, EU-Japan Centre for Industrial Cooperation, 2014 12 Nano Bio First, Kazunori KATAOKA, Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST), 2012
Healthcare & Medical Technologies – Japan Market Study - Page 18 of 121
entrance strategies for EU companies specialising in nanotechnology applications for healthcare
and medical equipment.
1.9. Biotechnology for Healthcare & Medical Technologies
Very closely related to the nanotechnology sector, defined broadly in Japan as life science, this
is one of the Abe cabinet priorities given Japan’s rapidly ageing society and resulting medical
healthcare expenditures.
In FY2015, the Japanese biotech market was JPY 3.11 trillion (EUR 25.91 billion)13 of which 55%
was directly linked to the healthcare and medical industry and valued at JPY 1.74 trillion
(EUR 14.5 billion). The Ministry of Economy, Industry and Trade (METI) also announced its
intention to grow the Japanese biotech market to JPY 20 trillion (EUR 166 billion) by FY2030.14
The Government of Japan also established the Agency for Medical Research and Development
(ADEM) with JPY 126.5 billion (EUR 1.05 billion) budgeted for FY2016 to focus on stem cells,
pharma and medical device cooperation among all market players.
Participation and collaboration in clusters focusing on biotechnology as well as collaboration
projects between private companies and research institutes (eg. NIPRO and Kyoto University on
iCeMS) are likely the best ways to enter the Japanese market for European companies.
1.10. Dental Products and Technologies
Japan’s ageing population has dramatic impact on the nation’s healthcare system in general, and
oral healthcare and dentistry specifically. It has been widely recognised that oral health is
fundamental to general health and the relationship between the medical and dental fields is
starting to further mature and expand.
13 Nikkei Biotechnology and Business, 2015 14 METI Policy announcement to 6-fold bio market to JPY 20 trillion by FY2030, Nikkei, 2015
Healthcare & Medical Technologies – Japan Market Study - Page 19 of 121
Globally, Japan is the second largest dental market with dental examination medical expenditures
of JPY 380 billion (EUR 3.16 billion) in FY2014. Japan imported dental x-ray equipment, dental
equipment and dental materials valued at JPY 60.1 billion (EUR 500 million) in FY2015.15
Japan has a very low percentage of edentulousness because dental professionals practise under
a “treat the original teeth as much as possible” policy. Although often neglected in the past,
patients are now focusing more and more on oral health and aesthetic (cosmetic) dental services.
This has led to increased demand for dental services such as teeth straightening, overbite
correction and bad breath prevention.
Emerging opportunities exist for European manufacturers in advanced dental examination and
diagnostic technologies, preventive technologies, CAD/CAM devices, materials for dental implants,
dental reproduction materials about preventive dental care and modern dental treatment.
1.11. Healthcare & Medical Technologies Regulations
At the end of 2014, the Abe cabinet drastically revised the strict Pharmaceutical Affairs Law (PAL)
and renamed it the Pharmaceutical Medical Device Act (PMD Act) which created eased import
regulations, reduced costs for obtaining certifications and faster review approvals.
Medical devices are now separated from drugs with their own Marketing Authorisation and
Manufacturing License. Also, private third parties can now provide certification services for
Specially Controlled Medical Devices if the established standards and procedures are followed.
The permission system for Manufacturing Licenses of Medical Devices is now simplified to
registration. Lastly, the Standards Compliance Investigation for manufacturing and quality of
medical devices has been rationalised. With the implementation of these deregulations, Japan
aims to create a registration and approval process that is faster than that of the Food and Drug
Administration (FDA) in the US.
15 New Dental Medical Equipment and Dental Medical Technology Industry Vision, JDA, 2017
Healthcare & Medical Technologies – Japan Market Study - Page 20 of 121
The Pharmaceuticals and Medical Devices Agency (PMDA), an independent entity under
jurisdiction of the Ministry of Health, Labour and Welfare (MHLW), is the responsible body for
evaluations and approvals of both domestic and imported medical devices. Japan does not levy
any custom duties on imported medical devices.
Japan’s medical device classification system is based on four risk level classes as defined by the
Japanese Medical Device Nomenclature (JMDN) codes, which are different from US and
European classifications.
Class I (lowest risk to the human body) is defined as general medical devices (e.g., scalpels,
x-ray film, items for dental techniques…)
Class II (relatively low risk) is defined as controlled medical devices (e.g., MRI equipment,
catheters, dental alloys…)
Class III (relatively high risk) is defined as having a relatively high risk to the human body in
case of failure (e.g., dialyzers, artificial bones, artificial respirators…)
Class IV (highest risk) is defined as specifically controlled devices (e.g., pace makers,
artificial heart valves, stent grafts…)
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Regulatory Review Process Medical Equipment
Figure 3: Pharmaceuticals and Medical Devices Agency, https://www.pmda.go.jp/english/review-services/outline/0001.html
Notably, Japan does not currently accept the CE mark or an FDA certificate, but the principal
agreement on the EPA in 2017 should eliminate this hurdle in the future.
For European companies, to fully understand future business potential of the healthcare and
medical device market in Japan, an important law is the Long-Term Care Insurance (LCTI) for the
Healthcare & Medical Technologies – Japan Market Study - Page 22 of 121
elderly, originally issued in April 2000. This law aims to resolve issues facing its rapidly ageing
society, namely, support in the best way possible independent living and a customer-oriented,
user chosen approach to medical and welfare services, all backed by a robust social insurance
system with clear benefits and burdens. The next major revision of the LCTI is planned for FY2018
will further address these issues and opportunities.
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2. What are the Characteristics of Japan?
Japan Factsheet
Population (last census FY2014) 127,220,000 inhabitants
Land Area 377,962 km2
Capital Tokyo
Currency Japanese Yen (JPY)
Gross Domestic Product (GDP) FY2017 (est.) JPY 554 trillion16 (EUR 4.616 trillion)
Sovereign Debt FY2016 (247% of GDP) JPY 1,371 trillion17 (EUR 11.43 trillion)
Foreign Direct Investment (FDI) FY2016 JPY 27.8 trillion18 (EUR 231 billion)
Country Competitiveness Index FY2016 Global Rank19: 8th
Tax Revenues FY2016 JPY 57.6 trillion20 (EUR 480 billion)
Consumption Tax (Value Added Tax) 8%
Unemployment Rate 2017 2.8%21
Life Expectancy (Men) 80 years
Life Expectancy (Women) 87 years
Figure 4: Japan Factsheet, several sources
It is well known that Japan rapidly strengthened its position in the global economy during the post-
war period. Historically, the primary drivers of Japan’s strong economic growth have been high
rates of investment in production plants and equipment, applications of industrial efficiency, high
education standards, good relations between labour and management, ready access to leading
technologies with significant investments in research and development, increasingly open world
16 www.japan.go.jp/abenomics/index.html 17 www.reuters.com/article/markets-debt-global-idUSL8N1G95BD 18 www.japan.go.jp/abenomics/index.html 19 Top 10 Most Competitive Global Economies, The Global Competitiveness Report 2016-2017 20 www.japan.go.jp/abenomics/index.html 21 www.japan.go.jp/abenomics/index.html
Healthcare & Medical Technologies – Japan Market Study - Page 24 of 121
trade framework and a large domestic market of discerning consumers – all of which have given
Japanese businesses an advantage in scale and operations effectiveness.
At the same time, the rapid ageing of the population has created tremendous structural
implications on the future workforce, the savings rate of the working population, and hence, the
government tax revenue budget.
From a global point of view, in FY2014, Japan was the 2nd biggest Medical Device Market with a
market share of 9.1%, behind the US with 39.3% but ahead of Germany with a share of 7.9%.22
The market share of imported medical devices has historically been hovering just below the 50%
line, but following the enactment of the revised and liberalised PMD Act in FY2014, it is expected
that the import share from overseas medical devices will exceed the 50% threshold from now on.
On average, the device market itself grows at a CAGR of 3% per annum.23
The medical device market is divided between generic domestic manufacturers like Olympus
Medical Systems, Hitachi Medical, Toshiba Medical Systems and foreign capital players like
GE Healthcare Japan, Philips Medical Japan, Siemens Japan and Stryker Japan. Promising
business areas for overseas manufacturers are related to endoscopic surgery, surgical support
robots and image diagnosis equipment like MRI and CT scanners.
In the healthcare service market, Japan expects this segment to grow from JPY 4 trillion
(EUR 33 billion) in FY2013 to JPY 10 trillion (EUR 83 billion) by FY2020. Specifically, promising
sub-segments include nursing care ICT, self-care health equipment and community care systems.
Domestic players include Cyberdyne, Fuji Machine Manufacturing, Panasonic, Omron
Healthcare, Terumo, Fujitsu, NEC and Konica Minolta but showing growth potential for
EU companies that can provide localised Japanese language ICT solutions with maintenance
services after delivery and installation.24
22 Worldwide Medical Market Forecasts to 2019, Espicom, 2014 23 Annual Report on Statistics of Production by the Pharmaceutical Industry, Yano Research Institute, 2014 24 Attractive Sectors: Life Science, JETRO-Invest in Japan, July 2016
Healthcare & Medical Technologies – Japan Market Study - Page 25 of 121
2.1. Political Overview
Japan is a constitutional monarchy, with the Emperor as the symbolic head of state. The system
is a parliamentary democracy with the National Diet as the sole legislative body. The Diet is
composed of an Upper House (House of Councillors) and a Lower House (House of
Representatives), and a Prime Minister, chosen by a Diet ballot, who appoints a cabinet, with a
majority required to be Diet members.
Japan’s voting system is non-obligatory, and the voting age was lowered from 20 to 18 years in
2015, resulting in 104 million eligible voters.
The Liberal Democratic Party (LDP) has governed Japan for most of the last 70 years, and was
only out of power briefly in 1993-1994 and in 2009 when the Democratic Party of Japan (DPJ),
led by Yukio Hatoyama, secured a historical victory that put the DPJ into governing powers.
Since then, following a landslide election victory by the Liberal Democratic Party (LDP), Prime
Minister Shinzo Abe took office as Japan’s 97th re-elected Prime Minister in 2014. Since
August 2016, Abe’s Cabinet has 20 ministers, including the Prime Minister himself. As a result,
Japan’s economic and financial situations have undergone noticeable changes.
2.2. Economic Overview
Today, aiming for a future GDP of JPY 600 trillion (EUR 5 trillion), Japan is still the 3rd largest
global economy, after the US and China. Japan’s main industries are automotive, consumer
electronics, computers, other electronics and pharmaceuticals. Services represent 75% of the
GDP, industrial activities 23.5% and agriculture 1.5%.
Following the financial and real estate bubble bursting in the early 1990’s, and after more than
two decades of economic stagnation, Prime Minister Shinzo Abe and his Cabinet unveiled a
comprehensive economic policy package to revive and sustain the Japanese economy while
maintaining fiscal discipline. This programme became known as Abenomics.
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The centrepiece of Abenomics is the “Three Arrow Policy” targeted at an active monetary policy,
a flexible and stimulant fiscal policy and a sustainable long-term growth strategy - all carried out
through structural reforms to encourage private investments. The economic parameters focus
mainly on boosting productivity, driving innovation and trade, and stimulating corporate activity.
Figure 5: © Abenomics, Cabinet of the Prime Minister website
Internationally, the Brexit (UK) in July 201625 and the inauguration of US President Donald Trump
in early 2017 had strong but temporary impact on the exchange rates between the JPY and the
Euro. Since the middle of 2017, the rate is back to usual trade levels and has been hovering
around JPY 130 for EUR 1.
Given the long-term low and negative interest rates by the Central Bank of Japan, it is believed
that the Japanese Yen will remain relatively strong for the near future against other global
currencies, including the Euro, thus creating export business opportunities for overseas
manufacturers and suppliers.
25 http://www.reuters.com/article/us-global-forex/yen-advances-on-brexit-impact-fears-pound-plunges-to-31-year-low-idUSKCN0ZM00T
Healthcare & Medical Technologies – Japan Market Study - Page 27 of 121
In recent years, multinationals like Apple (US), Nokia (Finland), Continental (Germany) and BASF
(Germany), have created major Research and Development (R&D) centres in Japan. Internet
companies like Facebook, Google and Amazon (all US) have also had presence in the country
for some time now. Recently, however, newer internet companies like TripAdvisor, Airbnb, Uber,
Netflix, Hulu and Spotify also have established representative offices in Japan. For FY2020,
Japan is targeting JPY 35 trillion (EUR 291 billion) of inbound Foreign Direct Investment (FDI).
Tokyo is and continues to be the favourite city to establish a presence (35%) in Japan, while Osaka
represents 16% of total FDI value. Nagoya remains a popular destination for automotive
manufacturing and related businesses, given Toyota Motors has its global headquarters there.
Yokohama is especially popular for larger scaled R&D centres. Both cities have an FDI share of 11%
each. These four major cities combined represent almost 75% of total FDI value in Japan. Across all
foreign direct investments in Japan, Asia represents 40%, Europe 31% and the USA 29%.26
Since Prime Minister Abe took office in 2012, annual corporate profits have increased to
JPY 68.2 trillion (EUR 568 billion) in May 2017. As an indicator, the Nikkei Index has remained in
the JPY 19,000 range since the beginning of 2017. These results were mainly obtained through
large-scale monetary easing policies, consecutive tax reforms (corporate tax ratio was 37% in
2013 and Abe’s cabinet is aiming for 29.74% by 2018).
26 JETRO, Invest Japan Report 2016
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2.3. Trade Overview between EU and Japan
2.3.1 Japan and EU business in Figures
EPA Facts and Figures Infographic
Figure 6: EU-Japan Trade Relationship-Facts and Figures, European Commission, 2017
Healthcare & Medical Technologies – Japan Market Study - Page 29 of 121
Exports of EU Goods & Services to Japan 2016:
Figure 7: The EU-Japan EPA in 60 seconds, European Commission, Trade, 2017
In 2015, EU medical device manufacturers exported 8.1% of their medical devices to Japan, while
imports from Japan stood at 6.1%.27
The graph below shows the Total Goods: EU Trade Flows and Balance, Annual Data 2006-2016
Figure 8: Eurostat, European Commission, Directorate-General for Trade, May 2017
27 EU Export and Import Destinations: EDMA- European IVD Market Statistics Report 2015
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2.3.2 EU-Japan Economic Partnership Agreement (EPA)
The EU and Japan together account for 33% of the world’s GDP and have a combined population
of 632 million people. On 6 July 2017, during the 24th EU-Japan Summit held in Brussels, the
President of the European Commission Jean-Claude Juncker, the President of the European
Council Donald Tusk and the Prime Minister of Japan Shinzo Abe announced the principle
agreement of the Economic Partnership Agreement between the EU and Japan.
Figure 9: © Cabinet Public Relations Office, July 2017
Negotiations between both parties started back in 2013 and took in total 18 rounds on technical
and political levels to conclude the most important bilateral trade deal ever. Upon ratification of
the agreement, predictions are that EU exports to Japan could increase by 33% while Japan’s
exports to the EU are expected to grow 24%. The EPA is said to boost trade in goods and
services, with an estimated GDP growth up to 0.8% for the EU and up to 1% for Japan, while
creating investment opportunities for both economic blocks that might result in 420,000 new jobs.
It also includes the protection of EU standards and will further eliminate trade barriers and ease
regulatory standards over the next decade. In addition, the EU will gain improved access to
Japan’s public procurement systems at both government and private enterprise levels. In return,
Japan will gain eased market entrance for automotive, pharmaceutical and home electronics
industries.
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Final agreement and approval of the EPA is expected by mid-2018 with full implementation
targeted for early 2019.
Concretely, for European Healthcare & Medical Technologies companies, this EPA will mean
profoundly reduced costs for certifications of exported medical devices following the adaptation
of the International Standards on Quality Management Systems (QMS) by Japan in 2014.
Healthcare & Medical Technologies – Japan Market Study - Page 32 of 121
3. Healthcare & Medical Technologies Market Overview and EU Entry Opportunities
3.1. Japanese Healthcare & Medical Technologies Market
3.1.1. Short Historic Healthcare & Medical Technologies Market Overview
As early as 1922, the Japanese government launched the Health Insurance (HI) (Kenko Hoken
in Japanese) covering industrial workers in its first phase. Just before World War II in 1938,
the government added the voluntary National Health Insurance (NHI) (Kokumin Kenko Hoken in
Japanese) to the health insurance system, aiming to also cover farmers and self-employed people
with this new nationwide system.
From 1958 on, following a major revision of the National Health Insurance Law, the NHI became
mandatory. Three years later, in 1961, Japan established a universal health insurance system
covering all Japanese citizens.
Brief history of Japan’s Health Insurance System
1922 Introduction of Health Insurance (HI)
1927 Nationwide Enforcement of HI
1938 Introduction of National Health Insurance (NHI)
1950s Encouragement of the Merger of Towns and Villages
1958 Revision of NHI
1961 Establishment of Universal Coverage
1983 Introduction of Health Services Law for the Aged
2000 Introduction of Long-term Care Insurance for the Elderly
2008 Introduction of Health Care Program for the Elderly aged 75 and over
Figure 10: ©Five Decades of Universal Health Insurance Coverage in Japan: Lessons and future challenges, Japanese Society of Medical Sciences, Yasuki KOBAYASHI
Healthcare & Medical Technologies – Japan Market Study - Page 33 of 121
In 1961, the timing for the introduction of a universal health insurance system was perfect given
the costs of health care at that moment were low, Japan’s economy was growing quickly and
there was a strong feeling of solidarity amongst its people.
At the end of FY2014, Japan had a total of almost 177,500 medical care institutions of which
roughly 8,500 are hospitals, 100,500 are medical clinics and 68,500 are dental clinics, which are
operated by 104,000 dentists. About 2,150 hospitals have 50 to 99 beds, giving them the biggest
share at 25%. The specialty of Internal Medicine practice is offered by 6,838 hospitals and almost
64,000 medical clinics. Other specialties include cardiovascular, gastroenterological and
respiratory medicine.28
In the same period, the total number of beds was 1,681,000, while general beds have been
decreasing over the past 2 decades, the beds for long-term care have been increasing, keeping
the total number almost stable.
At present, Japan has 13.4 hospital beds per 1,000 people, making it rank 1st among OECD
countries and its ratio of nurse to physicians is ranked 2nd.29
3.1.2. Market Overview Healthcare & Medical Technologies
Key Market Indicators for the Healthcare & Medical Technology Sector
Average Life Expectancy Male: 79.55 years
Female: 86.30 years
+65 years old 27.7% (35.14 million persons) of total population; 49% of medical costs
+90 years old 2.06 million persons
+65 years old by 2050 38.8%, highest in the world
Causes of Death for +65 years 1. Osteo Arthritis & Rheumatoid Arthritis: 24% 2. Dementia: 24%
3. Cancer: 23%
Low Birth rate Low birth rate of 1.37 births/couple for FY2009
28 Survey of Medical Institutions, MHLW, 2015 29 OECD Factbook, OECD, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 34 of 121
Key Market Indicators for the Healthcare & Medical Technology Sector
Infant Mortality 1/1,000 new born
Market Growth 2.2% annual growth expected till at least FY2018
Public Healthcare System Privately supported via co-payment by patient at 30%
Co-payments by elder patients vary from 10-20%
Healthcare Costs 11.2% of Japan’s GDP in FY2015
Total Social Security Costs (Pensions, Healthcare, Welfare ...)
Approximately 23% of GDP
Figure 11: various online resources
According to the Organisation for Economic Co-operation and Development (OECD) Health
Statistics released in June 2016, Japan’s total health spending accounted for 11.2% of its Gross
Domestic Product (GDP) in FY2015. Japan is ranked third out of 35 OECD member states, trailing
only the US (16.9%) and Switzerland (11.5%).
Figure 12: Overview of National Medical Expenditures for 2013, Ministry of Health Labour and Welfare (MLHW)
Healthcare & Medical Technologies – Japan Market Study - Page 35 of 121
Percentage of Population over Age 65 by 2050
Figure 13: United Nations, World Population Prospects, the 2015 Revision
As for the domestic market size of medical devices, it was JPY 2.675 trillion (EUR 22.2 billion) for
FY2013, representing a growth rate of +3% in FY2012. The market is expected to continue
expanding at a similar rate for the immediate future, following the enactment of the
Pharmaceutical and Medical Device (PMD) Act in FY2014 and the continuous, rapidly ageing
population. At present, Japan is and remains the second-largest global market after the US and
it holds an approximate 10% global market share.
Healthcare & Medical Technologies – Japan Market Study - Page 36 of 121
Global Medical Device Market: Share by Country 2014
Figure 14: The World Pharmaceutical Markets Fact Book 2014, Espicom
Contrary to most business segments in Japan, the medical devices and technologies sector is one
of the few market segments where Japan imports more than it exports – this clearly shows both the
present market size and the future growth potential for European companies in this segment.
Presently, the Pharmaceuticals and Medical Devices Agency (PMDA) is in charge of reviewing
applications for domestically manufactured and imported medical devices, through using
transparent methods bearing in mind quality, safety and efficacy through experts, while promoting
international harmonisation between existing quality and approval standards.
USA39%
Japan9%
Germany8%
China6%
France4%
UK3%
Italy3%
Canada2%
Russia2%
Others24%
Global Medical Device Market
USA Japan Germany China France UK Italy Canada Russia Others
Healthcare & Medical Technologies – Japan Market Study - Page 37 of 121
Basic Review Process of Medical Device Application in Japan30
Figure 15: © Basic Review Process for Drug of Medical Device Application, Pharmaceutical and Medical Devices Agency (PMDA)
Standard Supply Chain Flow of Medical Devices in Japan31
Figure 16: © Supply Chain of Medical Devices in Japan, Pharmaceutical and Medical Devices Agency (PMDA)
30 http://www.pmda.go.jp/english/review-services/reviews/0001.html 31 QMS for Medical Device in Japan, PMDA, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 38 of 121
Marketing approval in Japan is required for any new medical devices, prior to domestic distribution
and sales, and can be obtained by the following bodies:
Marketing Authorisation Holder (MAH): Japanese organisation who obtains the marketing
approval. MAH needs to comply with Japanese Quality Manufacturing Standards (QMS) and
released medical devices need to meet Japan’s approved specifications
Foreign Restrictive Authorisation Holder (FRAH): Foreign organisation who obtains the
marketing approval but will need to designate a MAH in Japan
Designated MAH: Japanese organisation designated by FRAH to conduct manufacturing
and quality control duties in Japan. Needs to take necessary measures to prevent public
health hazards
The basic document flow for marketing approval of medical devices is straightforward, especially
since the PMD Act revision in FY2014, but specific device and equipment related questions and
extra document requests can be expected.
Pre-Market Submission (Todokede in Japanese): This is a pre-market notification request for
General Medical Devices (Class I) to the PDMA but no actual reviews or assessments will
be conducted by the PMDA for Class I devices
Pre-Market Certification (Ninsho in Japanese): Class II (and a limited number of Class III)
medical devices, with an associated certification standard like Japan Industrial Standards
(JIS), often based upon existing ISO/IEC standards, are subject to pre-market certification.
MAH will file the application with a Registered Certification Body (RCB), comparable with
European CE Marking process where reviews are also handled by external third parties
Pre-Market Approval (Shonin in Japanese): Class II and III devices without a specific
certification standard are subject to the pre-market approval process, and it is the same for
Healthcare & Medical Technologies – Japan Market Study - Page 39 of 121
all Class IV medical devices. MAH needs to file a pre-market approval application with the
PMDA and ultimately obtain approval from the MHLW.32
Reimbursement Categories of Medical Devices in Japan
Figure 17: © Demystifying Device Reimbursement in Japan-Device Talk, EMERGO, 2017
For pricing of medical devices, usually Japanese companies have their standard price list but the
actual sales prices are not really known, as this depends on typical commercial talks between
manufacturer and final customer. The final sales price varies in relation to ordered quantities,
required delivery terms, agreed payment terms, past business volume and price quotes of
competitors, too name only a few.
The market shows a trend of more direct business transactions between manufacturer and
customer, especially in the segment of large and expensive medical devices. For consumables
32 PMDA Medical Device Registration Approval Process, Emergo, 2017
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and high-volume equipment, the final customer tends to procure through major wholesalers
specialised in medical equipment and devices.
3.1.3. Market Trends Healthcare & Medical Technologies
Continuous improvements and adaptations to the national healthcare system are an important
cornerstone within the Abenomics Revival Strategy. The focus is to create a flexible regulatory
framework with both a fast R&D process and license approval system for regenerative medicines.
This should allow Japan to become a central hub for regenerative medicines, with an estimated
market value of JPY 26 trillion (EUR 216 billion) by FY2020.
Seamless connection from R&D to commercialisation for the manufacturing of world's
top-class medical services
Promotion and development of innovative health care services for medical treatment,
nursing care, health promotion, disease prevention and daily life support
Realising efficient and high-quality medical services by ICT
Figure 18: Compiled by JETRO based on the “International Comparison of Regulations for Regenerative Medicine and Cell Therapy 2013” by the National Institute of Health Sciences
Healthcare & Medical Technologies – Japan Market Study - Page 41 of 121
Separate from the aforesaid main policies, Japan is also optimising and liberalising the following
healthcare regulations that will determine the future trends in the domestic market for healthcare
and medical devices:
Further amendments of the Pharmaceutical Affairs Law (PAL)
Enforcement of the New Act for Regenerative Medicines
Creation of a faster R&D process in regenerative medicine
Promotion of R&D of orphan drugs fulfilling unmet medical needs
Establishment of laws for medical treatment of patients with intractable diseases
Establishment of government policies for drug prices
Lower premium drug prices with generic drugs
Establishment of policies for promoting usage of generic drugs
Promotion of market entries from overseas healthcare and medical device companies
Enhancement of nursing care by optimal ICT implementation
Promotion of self-care health equipment and related service markets
Enhancement of remote and preventive medical care services and face-to-face medical
examinations (effects to be evaluated based on a FY2018 revision of medical service fees)
Integration and storage of personal medical information using big data to provide customised
medical care by FY2020
Analysis of aggregated anonymous medical records to advance medical research
Creation of National Strategic Special Zones as hubs for cardiac, neurologic and ophthalmic
treatment
Acceleration of development of Advanced Heart Failure treatment, such as myoblast
cell-sheet and cardiomyocyte sheet transplantation therapy
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Enhancement of world-class R&D on iPS like the world’s first successful iPS origin retinal
cell transplant operation for age-related macular degeneration
3.1.4. Import Market of Healthcare & Medical Technologies
The total market value for medical devices is JPY 2.676 trillion (EUR 22.3 billion), representing a
combined value of JPY 1.375 trillion (EUR 11.458 billion) of domestic production and
JPY1.301 trillion (EUR 10.84 billion), equal to almost 49% market share, of imported medical
devices and equipment in FY2013.33
Figure 19: JETRO, Attractive Sectors: Life Science, 2016
33 JETRO, Attractive Sectors: Life Science, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 43 of 121
3.2. Assistive Technologies
3.2.1. Market Overview Assistive Technologies
According to World Health Organisation (WHO), assistive devices and technologies are those
whose primary purpose is to maintain or improve an individual’s functioning and independence to
facilitate participation and to enhance overall well-being. They can also help prevent impairments
and secondary health conditions. Examples of assistive devices and technologies include
wheelchairs, prostheses, hearing aids, visual aids, and specialised computer software and
hardware that increases, respectively, mobility, hearing, vision, or communication capacities.
In Japan, slightly different from Europe, assistive devices and technologies are part of the welfare
segment that also includes nursing care, rehabilitation and the home-care sector. The Japan
Assistive Products Association (JASPA) has assistive/welfare devices defined as follows.34
Assistive devices that support autonomy and nursing care for elderly and disabled persons
in daily life, regardless of home or facility, and assistive devices that improve the living
environment
Assistive devices (including computer systems and assistive technologies) that are used in
care facilities to improve services for elderly and/or disabled people, and contribute to
labour-saving within the facilities. Devices and technologies that support independence of
residents, nursing care support, and improvement of the environment, different from the
above-mentioned definition
Welfare equipment, devices and social infrastructures that support the actions of elderly
and/or disabled people in public places like elevators in public buildings (train stations being
most common), braille blocks, and audio signals for the visually impaired, amongst others
34 Ageing Population, National Health Insurance, Japanese, March 2017
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Categories and Examples of Assistive Devices and Technologies in Japan
Products covered by care insurance Electric bed for medical care or nursing care, manual wheelchair, electric wheelchair, bedsore prevention mat, handrail, silver car (walker for an aged or disabled person), wandering sensing equipment for people with dementia and elderly people, walking aid cane, slope, automatic excretion treatment device, transfer devices (patient lifts for vertical transfer), bathing assistant, toilet seat, simple bathtub
Nursing care and disposable products Adult disposable diapers, urine leakage pants, elderly underwear, shoes for the elderly, waterproof sheets, wet tissues for nursing care, oral wet tissues for nursing care, mouth sponge brush for nursing care, mouth moisturizing agent, cleanser, nursing gloves
Nursing devices and instruments Special bathing equipment, rehabilitation equipment for exercise therapy, evaluation measuring equipment for rehabilitation, radio paging equipment for home, care robot, communication robot
Systems and services Senior citizen home delivery service, housekeeping substitution for the elderly, emergency response system, sensor type home safety confirmation, infrastructure monitoring, dialogue confirmation, support for nursing care and welfare facilities, school lunch for nursing care and welfare facilities, linen for hospitals/nursing care/welfare facilities, security for nursing care and welfare facilities, prevention of long-term care and rehabilitation, dispensing pharmacies for nursing care and welfare facilities, collaboration support for long-term care
Figure 20: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016
The global assistive technology market is estimated at EUR 17 billion in 2015, with a Compound
Annual Growth Rate (CAGR) of 6% during the period from 2015 to 2020.
The market size of the Japanese welfare equipment industry in FY2014 totalled JPY 1.399 trillion
(EUR 11.65 billion), up 3.8% from the previous year. The overall market size has shown steady
growth since FY2009. Looking at specific products per category, we see that general products
such as wigs, dentures, hot water washing toilet seats, seat shifts for cars, home elevators,
glasses and hearing aids were up 3.9% compared to the previous year FY2013.35 Materials and
devices subject to the nursing-care insurance are showing a recovering trend up 7.4% in FY2014.
35 Market Size of Welfare Equipment, Japan Assistive Products Association (JASPA), 2014
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Market Size in Japan of Assistive Devices and Technologies
FY2010 (JPY/EUR) FY2014 (JPY/EUR)
Total Assistive Devices & Technologies 1,165b/9.7b 1,399b/11.65b
Assistive Devices & Technologies (Total Type A) 1,123b/9.35b 1,340b/11.16b
Home Treatment Equipment (Type A) 73.9b/615m 70.3b/585m
Prostheses and Braces (Type A) 171.3b/1.42b 222.4b/1.85b
Personal Care related products (Type A) 334.6b/2.78b 427.5b/3.56b
Moving Equipment and related products (Type A) 97.5b/812m 128.8b/1.07b
Furniture & Fixtures (Type A) 78.8b/656m 102.3b/852m
Communication Equipment (Type A) 325.5b/2.71b 346b/2.88b
Home Nursing Equipment and related products (Type A) 40.3b/335m 40.9b/340m
Miscellaneous (Type A) 2b/16.6m 2b/16.6m
Nursing Home Equipment and Systems (Type B) 4b/33.3m 6.7b/55.8m
Support and Assistive Devices for return to Society (Type C) 37.3b/310m 44.6b/371m
Assistive Devices covered by Long-term care insurance 218.7b/1.82b 286.2b/2.38b
Figure 21: Japan’s Welfare Equipment and Daily Life Support Equipment, Japanese, July 2016
According to the above table, the market size of welfare equipment in FY2014 is about
JPY 1.4 trillion (EUR 11.65 billion), and home treatment equipment, prostheses and braces, and
personal care-related products have the biggest share in the market.
The main driver is the scheduled revision by Abe’s Cabinet of the current long-term nursing care
insurance system in FY2018. The study also foresees a strong need for convenient purchasing
of lower-priced assistive devices and technology products. Additionally, Japan will need to
formulate an adequate response to the needs of almost 80% of the elderly population who do not
Healthcare & Medical Technologies – Japan Market Study - Page 46 of 121
require special nursing care but do want to enjoy an active retirement, often referred to in Japan
as “Silver Life.”
Figure 22: Services available under Long-Term Care Insurance (LTCI)
Purchase Conditions for above Assistive Devices under LTCI:
Purchasing Limit: Maximum JPY 100,000 (EUR 833) total per fiscal year
Users pay 10% or 20% of the total cost
Same products can only be purchased once per year to receive eligible support
Conditions for Home Renovation under LTCI:
Purchasing Limit: Maximum JPY 200,000 (EUR 1,666) total per fiscal year
Users pay 10% or 20% of the total cost
Total amount of JPY 200,000 can be spread out over several renovations
Products: Handrail installations; step elimination; resurfacing floors to prevent slipping; replacing
hinged doors with sliding doors; replacing Japanese-style toilets with Western-style toilets
Healthcare & Medical Technologies – Japan Market Study - Page 47 of 121
The recent study "Current Situation and Outlook of the Welfare Market in 2017," published by the
Fuji Keizai Group, states that many new assistive products and services will find their way into
the Japanese welfare market.
The same research paper predicts the total market value of assistive devices and technologies
to reach almost JPY 4.5 trillion (EUR 37.5 billion) by FY2025 with a breakdown of almost 40% of
all care products covered by health insurance, approximately 50% for care products and
disposables not covered by the aforementioned insurance, and the remaining 10% for nursing
devices and equipment.36
3.2.2. EU Entry Opportunities Assistive Technologies
For FY2017, the market is expected to expand following new market development by wholesalers
and rental companies of assistive devices now that the personal liability of people with mild
cognitive impairment has been abandoned.
The market will show particularly strong demand for railings, silver cars, walking devices, walkers
and walking assistants as these are also a necessity for elderly people who prefer to maintain
independent living and care prevention. Furthermore, local government services are expected to
purchase these products of durable quality for long-term use for their rental systems, thereby
creating promising business opportunities for European manufacturers.
36 Current Situation and Outlook of the Welfare Market in 2017, Fuji Keizai Group, Japanese, June 2016
Healthcare & Medical Technologies – Japan Market Study - Page 48 of 121
Figure 23: Assistive Devices available for Rental Services
Healthcare & Medical Technologies – Japan Market Study - Page 49 of 121
Long-term market expansion is also expected for nursing care equipment and devices in general.
At present, the market share of special bathing equipment and exercise therapy rehabilitation
equipment is growing annually.
For the near future, growth in the nursing robots market segment looks especially promising. Data
released in a market survey by Yano Economic Research Institute forecasts the domestic care
robot market to reach JPY 1.5 trillion (EUR 12.45 billion) by FY2020. This represents a 15-fold
increase of the domestic care robot market from FY2015, also creating new business
opportunities for EU companies active in this specific segment.37
Japan also successfully introduces continuously innovative healthcare and medical technology
devices to the market through the National Research and Development Program for the Medical
and Welfare Apparatus (NRDPMWA) support system.38
Healthcare Products Developed by NRDPMWA
Project Equipment Manufacturer
Modulated motorised wheelchair Motorised wheelchair Suzuki Motor
Braille duplicating system Braille master Matsushita Electric Industries
Foam ink Toppan Printing
Gait pattern analyser for the disabled Position sensitive detector; position sensor system
Hamamatsu Photonics
Force plate Kyowa Electronic Instruments
Multifunctional bed for the bedridden Separated urinal; motorised, patient-controlled bed with toilet
Paramount Bed
Vocal and speech training device Vocal and speech training device Matsushita Communication Industries
Position sensor Rion
Three-dimensional working chair Three-dimensional working chair Imasen Engineering Corporation
Automatic body temperature adjuster Cool best Phoenix
37 Current Situation and Outlook of Welfare Device Rental Market, Yano Research Institute, Japanese, June 2017 38 Commercialised Products developed by NRDPMWA
Healthcare & Medical Technologies – Japan Market Study - Page 50 of 121
Healthcare Products Developed by NRDPMWA
Middle ear implant Middle ear implant Rion
Figure 24: Commercialised Products developed by NRDPMWA
Lastly, any kind of advanced and innovative assistive device that meets the needs of Japan’s
rapidly ageing population will continue to see increasing demand over the next several decades.
A brief overview of promising assistive device and technology market segments that are
interesting for European manufacturers is described below.
3.2.2.1. Orthopaedic Devices & Surgical Implants
As Japan has one of the oldest populations globally, the country has seen a high prevalence of
osteoarthritis, driving the demand for joint replacement devices. The extensive joint reconstruction
and replacement market ranges from large to small devices, and covers shoulder reconstruction
devices, elbow reconstruction devices, knee and hip implants, hand and wrist devices and foot
and ankle devices, amongst others.
The total market value for these devices was estimated to be approximately JPY 157.5 billion
(EUR 1.31 billion) in FY2015. The market is expected to maintain robust growth for the next
decade, and in terms of revenue, Japan already accounts for approximately 50% of the complete
Asia-Pacific orthopaedic device market.
According to several iData Research market reports, the largest segment of the Japanese small
bone and joint orthopaedic device market is the hand and wrist devices segment, which
represents over 70% of the total market. This segment is expected to exceed JPY 12.5 billion
(EUR 104 million) by FY2022, increasing from JPY 10 billion (EUR 83 million) in FY2015. Another
promising growing sub-sector for imports is the shoulder reconstruction market, following its
approval by the Japanese Ministry of Health, Labour, and Welfare (MHLW) in FY2014.39
39 Japan Market Report for Small Bone and Joint Orthopaedic Devices 2016, iData Research, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 51 of 121
Other surgical implantable devices that meet the needs of the elderly, such as cochlear and vision
correction implants, are also seeing increasing demand in Japan, since Abbott’s implantable
Tecnis lenses for cataract patients were approved in FY2013.
Prominent Japanese orthopaedic device industry players include Japan MDM, Kyocera
Corporation, Seikagaku Corporation and Teijin Nakashima Medical.
3.2.2.2. Home care devices and nursing homes
The Japanese tradition of elderly parents moving in with their children has been declining
continuously over the past decades. In 1960, about 80% of elders were living with their children
but this figure has dropped by roughly half to approximately 40% at present. Hence the number
of private, semi-public and public nursing homes has exploded, growing more than 450% over
the past ten years. Presently, the waiting list of people wishing to enter nursing homes exceeds
400,000.40
Also, the number of home healthcare service providers has grown by 400% over the past
15 years. The market for medical devices, portable elder care devices such as respiratory
equipment (global market share of Japan is approximately 8% but expected CAGR of 9.2% by
FY202741) and hemodialysis systems (the Japanese market has been growing on average 3%
on an annual basis since 201342) that can be used in both home healthcare and nursing homes
is showing continued robust growth.
Due to demographic challenges, the Japanese government has also been promoting advanced
technology for elder care like assistive robots that can help with tasks like lifting or placing elderly
patients in/out of bed or bath.
40 Bold steps: Japan’s remedy for a rapidly ageing society, The Globe and Mail online, 2015 41 Global Respiratory Devices Market Share, Future Market Insights, 2017 42 Global Hemodialysis Industry Report 2013-2016, ResearchMoz, 2015
Healthcare & Medical Technologies – Japan Market Study - Page 52 of 121
3.2.2.3. Remote Monitoring Service
The total market size for remote monitoring services was estimated at JPY 9.8 billion
(EUR 81.6 million) in FY2016 and is expected to increase 46.3% to JPY 13.9 billion
(EUR 115.83 million) by FY2025.
Emergency response systems, sensor-type home security confirmation systems, infrastructure
monitoring systems, and interactive confirmation systems currently hold the biggest market share.
Demand is increasing annually given the heightened awareness of family environment and elderly
safety.
At present, the largest market share is for emergency response systems, given brisk demand by
elderly people living by themselves and those afraid of sudden attacks. An increase in demand is
also visible for sensor-type home safety confirmation products for people concerned about
sudden changes in physical condition or those with dementia.
One well-known example is Fujitsu’s remote system for checking the status of patients in bed.
Figure 25: © Healthcare Support System to Remotely Monitor the Elderly, Fujitsu Journal Online, 2014
Healthcare & Medical Technologies – Japan Market Study - Page 53 of 121
3.2.2.4. Nursing care Robots (Hi-tech Devices)
Japan is a global leading country when it comes to robotics. Long used in industrial settings,
Japanese researchers and manufacturers are now looking at whether robots can help as the
country ages, from robot suits that help rehabilitation to fully functional humanoid robots.
For physical disabilities, affecting around 3.94 million Japanese in FY2014 (1 out of 32 people in
Japan), there are diverse needs that can be positively impacted by the use of robot assistants.
Patients with impairments or disabilities in the lower limbs, for example, benefit particularly from
therapy with walking assistance robots, walking frames or exoskeletons.
The planned revision of the nursing care insurance system planned for FY2018 will lead to a
growing demand of nursing care robots. Also, the Ministry of Economy, Trade and Industry (METI)
and Ministry of Health, Labour and Welfare (MHLW) announced its “New Strategy for Robots”
Plan in 2015.
Under this five-year plan, the government plans to support the use of robots in different sectors
of the economy, such as manufacturing, infrastructure, and other industries. The government has
set the biggest share of the programme’s budget to the nursing and medical sector, amounting to
nearly JPY 5.3 billion (EUR 44.16 million). Japan has forecasted that the market for “care service”
robots will rise to JPY 370 billion (EUR 3.07 billion) within 20 years. Currently, the market value
is estimated to be JPY 15.5 billion (EUR 129 million).43
Transfer Aids: Wearable transfer devices that are worn by the caregiver, using robot
technologies to provide powered assistance to alleviate the physical workload of the
caregiver. Also, non-wearable transfer aids powering assistance to the caregiver in
performing lifting motions, such as when transferring an individual from bed to wheelchair
Mobility Aids: Including mobile support equipment and motorised walking support devices, in
addition to walking support equipment that helps the elderly move around, stand up, and sit
down indoors, go to and return from the restroom
43 http://www.meti.go.jp/english/press/2015/pdf/0123_01b.pdf
Healthcare & Medical Technologies – Japan Market Study - Page 54 of 121
Toilet Aids: Installation of adjustable restrooms that use robot technology for excretion that is
movable and can be placed anywhere in a room
Bath Aids: Uses robot technologies to support elderly people in a series of motions required
for getting in and out of bathtubs, and are usable by a single person with or without the help
of an assistant
Monitoring Systems: Including equipment and platforms that use sensors and external
communication functions to support the monitoring of the elderly in long-term care facilities
as well as in private homes
Major Developers and Manufacturers of Nursing Care Robots in Japan
Bed Assistance (wearable) Cyberdyne, Kikuchi Seisakusho, Toshiba
Bed Assistance (non-wearable) Panasonic, Yasakawa Electric Corporation, Fuji Machine, Toyota
Mobility Assistance Azbil, Nabtesco, Yasakawa Electric Corporation
Bath and Toilet Assistance Toto
Meal Assistance Secom
Support for Alzheimer Patients Sumitomo Riko, Clarion
Figure 26: TrendForce, May 2015
Healthcare & Medical Technologies – Japan Market Study - Page 55 of 121
3.2.3. Japanese Market Players
3.2.3.1. Cyberdyne
Cyberdyne focuses on the development and manufacturing of medical robot bionic suits and
home-health aides to be used in rehabilitation and elderly care. Cyberdyne’s exoskeleton is
already used in more than 160 hospitals and nursing homes all over Japan. Other Japanese
companies, like Toyota and Honda, also develop mobility assistive robots.
Figure 27: © AFP/GETTY and © Professor SANKAI, University of Tsukuba/Cyberdyne: Cyberdyne employees wearing a HAL
robot-suit walking in Tokyo
Robot Suit Hybrid Assistive Limbo® (HAL), is a robot system for walking support, co-developed
by Professor Yoshiyuki SANKAI of the University of Tsukuba and Cyberdyne. The robot suit
comes with a pair of limb frames made of fibre-reinforced plastic. They cover the outside of a
person's limbs, from the waist to both feet and are a substitute for a person's impaired legs or
weakened leg muscles, helping the user overcome walking difficulties by detecting bioelectric
signals sent from the brain to relevant parts of the body and activating power units attached to
the robot's joints.
Healthcare & Medical Technologies – Japan Market Study - Page 56 of 121
3.2.3.2 Panasonic
Panasonic also develops care robots that work in pharmacies, hospitals and personal homes.
One robot model splits in half to transform from a bed into a wheelchair. This robot eliminates the
risk of injury to the patient and caregiver during the transfer of the patient from their bed to a
wheelchair.
3.2.3.3. Riken-Tri: Robot for Interactive Body Assistance (RIBA)
The Robot for Interactive Body Assistance (RIBA) is developed by RIKEN-TRI Collaboration
Centre for Human-Interactive Robot Research and is a nursing care assistance robot specifically
developed to move a person from the bed to other places. The newest RIBA II is humanoid in
appearance, stands tall at 137cm by 82cm across, and can lift a person weighing up to 80 kg.
Figure 28: © RIKEN-TRI Collaboration Centre for Human-Interactive Robot Research. RIBA uses two arms to lift a person lying in bed or sitting on a wheelchair, moves and sets the person down
Healthcare & Medical Technologies – Japan Market Study - Page 57 of 121
3.2.3.4. National Institute of Advanced Industrial Science and Technology: PARO
Communication robots are mainly developed for mental care patients. PARO is a seal-shaped
robot, also sometimes referred to as "mental commitment robot" or “therapeutic seal robot,” giving
joy and comfort to people who play with it. It measures 57 cm, weighs 2.7 kg and is covered with
artificial fur for a pleasant touch. PARO was developed by The National Institute of Advanced
Industrial Science and Technology (AIST) in Japan.
When the patient caresses or speaks to PARO, the robot seal responds as if it were alive including
movement nuances as blinking, moving limbs and tilting its head. PARO understands basic
greetings and words of praise, and responds accordingly with a body movement or a trill.
Figure 29: © Robot Seal PARO, Tom Battey
Healthcare & Medical Technologies – Japan Market Study - Page 58 of 121
3.3. Medical Equipment
3.3.1. Market Overview Medical Equipment
The global market of medical equipment is estimated to grow at a CAGR of 7.2% from 2016 to
2021.44 The Japanese medical equipment and materials market is the 3rd largest in the world after
the US and the EU. Moreover, the market is expected to further grow due to the rapidly increasing
rate of Japan’s ageing population. The percentage of +65 seniors will rise from 27% in FY2015
to 40% by FY2050. This increase will drive continued demand for advanced medical technologies,
in combination with expansions and new openings of both hospitals and nursing homes.
Following the FY2016 revision of medical fee remuneration and hospital capital investment
regulations, the market is expected to increase 1.6% reaching JPY 2.73 trillion
(EUR 22.75 billion). Based on the growth rate of medical expenses additional growth of 2.9% is
expected for FY2017. With the advance of the ageing Japanese society, demand for medical
equipment will remain strong but the pace might slow slightly over the next couple of years given
the government's suppression of medical expenses and maturity of existing medical equipment.
In general, the Japanese medical equipment market consists 1/3 of insurance-covered Medical
Materials like catheters, artificial joints and pacemakers. The remaining 2/3 are high valued
medical devices like Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and
electrocardiographs.
In Japan, medical devices are usually categorised as follows:
Treatment Devices (catheters, artificial joints, pacemakers, syringes, artificial heart
beat systems)
Diagnostic Devices (endoscope, PET/PET-CT systems, MRI, ultrasonic wave devices,
X-ray films, thermometers, sphygmomanometers, electrocardiograph meters)
Others (dental devices, surgical gloves, contact lenses, home massage chairs)
44 Global Medical Device Technologies Market Growth, Trends & Forecasts 2014 – 2020, Mordor Intelligence
Healthcare & Medical Technologies – Japan Market Study - Page 59 of 121
The Japanese medical device and materials market relies heavily on imported products,
particularly for sophisticated medical technologies. According to the latest official figures of the
Annual Report of the Pharmaceutical Industry Productions, released by the Ministry of Health,
Labour and Welfare (MHLW), the domestic market for medical devices and materials in FY2014
was JPY 2,786 billion (EURO 23.21 billion), of which 49% or JPY 1,365 billion
(EUR 11.37 billion) was imported medical equipment.45
Figure 30: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW
45 http://www.mhlw.go.jp/topics/yakuji/2013/nenpo/dl/insathu_e.pdf
Healthcare & Medical Technologies – Japan Market Study - Page 60 of 121
Domestic Production by Medical Device Type
Figure 31: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW
Top Japanese medical device companies, in terms of sales, include Olympus Medical Systems,
Terumo, NIPRO, Sysmex, Nihon Koden Kogyo, Fukuda Denshi, Omron, Menicon, Shimadzu and
JMS amongst others. Their sales and market share are listed in the table below:
Sales Ranking of Japanese Manufacturers of Medical Devices and Equipment FY2015
Company Name Sales JPY/EUR in billions Market Share
1. Olympus Medical Systems JPY 608.9 (EUR 5.074) 22.9%
2. Terumo JPY 525 (EUR 4.375) 19.7%
3. Nipro JPY 366.6 (EUR 3.055) 13.8%
4. Sysmex JPY 253.1 (EUR 2.109) 9.5%
5. Nihon Koden Kogyo JPY 165.5 (EUR 1.379) 6.2%
6. Fukuda Denshi JPY 117.2 (EUR 0.976) 4.4%
Healthcare & Medical Technologies – Japan Market Study - Page 61 of 121
Sales Ranking of Japanese Manufacturers of Medical Devices and Equipment FY2015
Company Name Sales JPY/EUR in billions Market Share
7. Omron JPY 108.4 (EUR 0.903) 4.1%
8. Menicon JPY 67.3 (EUR 0.560) 2.5%
9. Shimadzu JPY 64.5 (EUR 0.537) 2.4%
10. JMS JPY 57.6 (EUR 0.480) 2.2%
Figure 32: Gyokai Search, FY2015 Medical Device Industry Sales Ranking, 2016
Japanese medical device manufacturers hold a high market share in the following product
segments but among them, the competition is fierce for both price setting and market share.
diagnostic imaging equipment
therapeutic and surgical equipment
biophenomena measuring and monitoring systems
home therapeutic equipment
dialysers
endoscopes
Currently, both domestically-manufactured and imported medical devices are regulated under the
Pharmaceutical and Medical Device Law (PMDL or PMD Act) in Japan, but since the medical
industry is one of the priority business sectors for the Japanese Government, numerous actions
are being taken resulting in overall reform of the sector.
On November 2015, the former strict Pharmaceutical Affairs Law (PAL) was amended and
renamed to the PMDL. The PMDL will enable further improvements to the regulatory review
process, including the establishment of a device-specific regulatory framework in addition to
increasing reviewers from 34 to 105, introduction of a three-track evaluation system and
clarification of the evaluation criteria. Finally, a pre-application evaluation system for new medical
Healthcare & Medical Technologies – Japan Market Study - Page 62 of 121
devices will be launched aiming to shorten the current approval time to 19 months within the
coming years.
The import market of medical devices is expected to continue to expand thanks to this enactment
of the Pharmaceutical and Medical Device (PMD) Act.
Figure 33: © Annual Report on the Survey of Pharmaceutical Industry Productions 2014, MHLW
3.3.2. Market Trends in Medical Device Market
Both imports and exports of medical devices have been increasing since FY2012, but the growth
rate of imports is exceeding that of exports. Hence, Japan's reliance on imported medical devices
and technologies is expected to continue to be strong for the foreseeable future.
It is important to bear in mind that 15~20% of all imported medical products are consumables like
diapers and general-purpose goods like catheters manufactured by Japanese pharmaceutical
plants in low-cost ASEAN (Association of South East Asian Nations) countries and then
re-imported into Japan. Many types of artificial joints are often manufactured by foreign-affiliated
companies’ active in the Japanese healthcare market.
Healthcare & Medical Technologies – Japan Market Study - Page 63 of 121
This current trend is expected to continue in the medium to long term, and forecasts are that the
imports of medical devices will increase annually at a CAGR of 4.4% through FY2021.46
As mentioned before, given Japan's ageing population and the increasing number of patients with
chronic and lifestyle diseases, the markets for in-home care devices, technologies, and health-
related ICT products are expected to grow accordingly. Other promising growth areas include
self-care and preventive care medical devices and products.
As the Japanese health care system increasingly emphasises improved treatment and health
maintenance, it will generate future business opportunities for European healthcare
manufacturers with innovative technologies like cardiology equipment, pacemakers, orthopaedic
implants and medical devices that alleviate pain in general, to improve the quality of life of elderly
and patients.
Furthermore, Prime Minister Abe’s growth strategy calls for promotion of the pharmaceutical,
medical device and biotechnology industries. Although these policy programs are basically
targeted to enhance the international competitiveness of Japanese pharmaceutical and medical
equipment industries, these programmes will also be beneficial to European medical companies
that can offer innovative medical products to Japanese patients.
Another part of this strategy, is the revision of the formerly known Pharmaceutical Affairs Law
(PAL) by the Diet in 2014, to reflect the characteristics of medical devices separately from
pharmaceuticals. The medical review process is expected to be further improved through the new
PDM Act and related regulations.
3.3.3. EU Entry Opportunities Medical Equipment
The Japan External Trade Organisation (JETRO), through their Invest in Japan division, has been
highlighting both the current situation, trends and business opportunities of the medical device
market in Japan as described below.47
46 Pharmaceutical Industry Production Statistics, by Mizuho Bank Industry Research Department for Ministry of Health, Labour and Welfare 47 JETRO, Invest in Japan website
Healthcare & Medical Technologies – Japan Market Study - Page 64 of 121
3.3.3.1. Medical devices for endoscopic surgery
Robust demand for medical equipment and devices for endoscopic surgery is expected, being
favoured nowadays as an innovative surgery system given the limited physical burden on the
patients.
The market was worth JPY 24.5 billion (EUR 204 million) in FY2014, a 5.4% increase over the
previous year. The Yano Research Institute predicts that the market will keep expanding to reach
JPY 27.6 billion (EUR 230 million) by FY2018.
Market players that supply a full line of devices and equipment in this market segment include
Olympus Medical Systems, MC Medical (importer and distributor of Karl Storz products in the
Japanese market) and Stryker Japan.
3.3.3.2. Surgical support robots
The most common surgical support robot in the market is currently deployed in endoscopic
surgery. Especially university hospitals in Japan are increasingly introducing surgical support
robots into their surgery rooms, and it is estimated that at least 200 units48 have been installed in
Japan to date.
Olympus Medical Systems is tepidly developing intelligent surgical support robots for thoracic
surgery. This often happens in collaboration with renowned medical institutions of higher learning,
including Tokyo University, amongst others.
3.3.3.3. Image diagnosis devices (MRI equipment)
Japan has the largest per capita number of MRI devices in the world. Although the number of MRI
devices installed is lower than that of X-ray CT scanners, the market size in value of MRI devices
was JPY 53.1 billion (EUR 442.5 million) for FY2014. Replacement of older existing devices will
48 JETRO, Attractive Sectors: Life Science, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 65 of 121
lead future demand, and Yano Research Institute estimates the market to grow to JPY 54.7 billion
(EUR 455.83 million) by FY2018.
The MRI market in Japan is dominated by major companies Hitachi Medical, Toshiba Medical
Systems, GE Healthcare Japan, Philips Healthcare Japan and Siemens Healthineers Japan.
Espicom Business Intelligence picks orthopaedics and prosthetics (4.7% CAGR in local currency
terms) and diagnostic imaging (3.9%) as top growth performers until FY2018 given the rapidly
ageing population of Japan. At the end of FY2015, the total market value was estimated to be
JPY 157.5 billion (EUR 1.31 billion).
Healthcare & Medical Technologies – Japan Market Study - Page 66 of 121
3.4. ICT for Healthcare & Medical Technologies
3.4.1. Market Overview ICT for Healthcare & Medical Technologies
The total ICT Healthcare market size was valued at JPY 374.3 billion (EUR 3.11 billion) in
FY2013, while forecasts see the market grow to JPY 420.4 billion (EUR 3.5 billion) by FY2020,
representing a 12.3% increase compared to FY2013.49
ICT Systems in Medical and Nursing Care (n=733)
Currently
Implemented (%)
Future
Implementation (%)
Radiological image diagnosis/remote diagnosis 14.2 7.8
Remote emergency medical care 5.0 8.1
Electronic medical records 11.3 13.3
Remote meeting systems for doctors 8.3 4.7
Remote diagnosis at home 1.4 7.0
Visiting nurse support 3.7 6.5
Home care support 2.3 5.2
Medical regional information cooperation 5.2 7.6
Health promotion information 3.7 4.9
ICT Systems in Welfare (n=733)
Currently
Implemented (%)
Future
Implementation (%)
Provide child-rearing support information 29.7 9.3
Electronic maternity child notebook 0.9 2.9
Barrier-free information 11.0 4.7
Supplier information sharing 20.0 12.3
49 Invest in Tokyo website, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 67 of 121
ICT Systems in Medical and Nursing Care (n=733)
Remote safety check and confirmation system 16.6 10.6
Life support system 4.1 6.4
Figure 34: ICT in Healthcare Questionnaire, Ministry of Internal Affairs and Communications, 2016
Currently, several innovative ICT pilot projects are promoted by local and rural municipalities.
Often these pilots are collaborations between academic institutes and private companies.
Other hot key words in the ICT Healthcare sub-sector in Japan, like global trends, are optimisation
of services via big data, artificial intelligence (AI) and Internet of Things (IoT) devices.
3.4.2. Market Trends ICT for Healthcare & Medical Technologies
On a macro-level, the Japanese Government is mainly focusing on the following fields to
invigorate rapid applications of ICT systems in the healthcare and medical technologies market
in Japan:
Efficient and high-quality medical services by utilizing information and communication
technology (ICT)
Data sharing among medical health care providers: Sharing patient data among all medical
professionals and care providers through an electronic medical record keeping system and
other medical data storage systems
ICT for improvement of operational efficiency: Systems to help improve the efficiency of
administrative operations for home healthcare service providers
Expand use of electronic medical records in 90% of large hospitals to prevent duplication of
inspection and administration of medications (by FY2020)
Expand the regional healthcare information collaboration network nationwide for sharing
patient information among medical institutions (by FY2018)
Healthcare & Medical Technologies – Japan Market Study - Page 68 of 121
Use personal number cards as health insurance certificates from FY2017 on and promote
the use of electronic medicine record notebooks across the nation by FY2018.50
Digitisation and ICT use in healthcare, medical care and nursing care fields
Figure 35: © ICT Trends in Japan’s Healthcare Policy, Fujitsu Science Technology, July 2015
At Level 1 of the figure above, Japan aims to digitise systems at medical, nursing and healthcare
sites. Level 2 allows the construction of an overall digital infrastructure for the same markets.
Finally, Level 3 aims to apply the information from this digital infrastructure to optimise and
streamline healthcare expenditures.
ICT and Robotic Devices in Nursing Care
In the home nursing care field, robotic devices for nursing care are expected to be used broadly
onsite to solve the current labour shortage in combination to prevent backaches nursing care
workers are liable to suffer.
50 Note: aforesaid healthcare fields include nursing care ICT, tailor-made medicine and self-care health promotion devices
Healthcare & Medical Technologies – Japan Market Study - Page 69 of 121
Currently, the market size of robotic devices for nursing care is projected to expand from
JPY 16.7 billion (EUR 139.16 million) in FY2015 to JPY 404.3 billion (EUR 3.36 billion) by
FY2035.
Since FY2014, with the aim of the rapid and widespread use of robotic devices for nursing care,
the Ministry of Economy, Trade and Industry (METI) and the Ministry of Health, Labour and
Welfare (MHLW) has implemented a “5-year Plan for Development of Robotic Devices for Nursing
Care” which promotes the development of economical and practical robotic devices such as for
lifting aids, mobility aids and monitoring system for people with senile dementia, through a public
contest. Past winners included companies such as Kikuchi Seisakusho, Cyberdyne, Fuji Machine
Manufacturing and Panasonic.
The MHLW is aiming to realise an integrated, community comprehensive care system by FY2025
that provides sufficient housing, medical care, nursing care, prevention services, and living
assistance, so that people will be able to live out their lives as they wish in familiar locations, even
if they eventually require intensive nursing care. Making this integrated community care system a
reality requires cooperation and information-sharing through ICT. Collaboration between the
healthcare, IT and robotics manufacturing sectors is currently under way.
The bigger players like Fujitsu, NEC and Konica-Minolta are especially active in this market of
Medical Information Platforms and Cloud Services.
3.4.3. EU Entry Opportunities for ICT in Healthcare & Medical Technologies
The opportunities for European companies to enter the Japanese market in this sub-sector are
diverse, with growth expected in several key product areas:
Electronic Medical Record Systems: Projected growth of 23.2% from FY2013 to
JPY 149 billion (EUR 1.24 billion). Expected strong in smaller hospitals with 300 beds or
less, for low initial cost and user-friendly cloud services demand should be especially strong
Healthcare & Medical Technologies – Japan Market Study - Page 70 of 121
Community Healthcare Coordination Systems: Market is estimated to expand by 66.7% from
FY2013 to JPY 5 billion (EUR 41.6 million) by FY2020 with rural areas looking especially
promising
Remote Diagnostic Imaging Systems: Estimated five-fold growth from FY2013 to
JPY 38.5 billion (EUR 320 million) by FY202051
ICT Home Health Care (HHC) Market:52 Market is expected to double from JPY 11.8 billion
(EUR 98.33 million) in FY2012 to JPY 26 billion (EUR 216 million) in FY2020. Backed by
government support, numerous domestic and overseas players are entering the healthcare
market with innovative ICT home health care services and devices
HHC patient data sharing:
FY 2013: JPY 3 billion (EUR 25 million); FY2020: JPY 10.4 billion (EUR 86 million)
HHC improving operation efficiency:
FY 2013: JPY 1.66 billion (EUR 13.8 million); FY2020: JPY 1.75 billion (EUR 14.5 million)
HHC remote elderly activity monitoring:
FY 2013: JPY 11.52 billion (EUR 96 million); FY2020: JPY 13.23 billion
(EUR 110.2 million)
HHC remote medical/nursing care:
FY 2013: JPY 100 million (EUR 833,000); FY2020: JPY 550 million (EUR 4.58 million)
Internet of Things (IoT) devices in healthcare: Expected annual growth rate of 20% between
FY2015-2020.53
Continuously increased implementation of digital Electronic Health Record (EHR) and
Personal Health Record (PHR) systems nationwide for medical and nursing care
51 Market Report Medical Devices and Welfare Equipment 2021 Forecast, Fuji Keizai Marketing Research & Consulting Group, 2016, Japanese 52 ICT in Home Health Care in Japan, Ministerie van Buitenlandse Zaken, 2013 53 Ministry of Internal Affairs and Communications, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 71 of 121
Mobile Carriers enhancing mobile cloud applications: NTT DoCoMo with MyMove; KDDI (au)
with Karada Manager; and Softbank Mobile with Softbank Healthcare App
New or improved equipment for enhanced healthcare: Miniaturised and cheaper electronics
and sensors, high-density memory, micro-electromechanically systems and novel
combinations of existing devices
ICT for more Efficient Health Management: Market is projected to expand moderately from
JPY 1.6 billion (EUR 13.3 million) in FY2012 to JPY 1.75 billion (EUR 14.5 million) by
FY2020.54
Innovative ICT applications in the medical field will continue to save considerable amounts of time
spent on administrative work for doctors, nurses and hospital staff. To further improve daily
operation efficiency, particular expertise and know-how in home healthcare should be built into
the systems and devices.
Separate from the aforesaid, the Japanese market has also seen strongly increased imports and
sales of health and sports related wearables with USB (Universal Serial Bus), apps and cloud service
connectivity in recent years. This trend will also continue to be strong over the next few years.
The graph on the next page shows the transition and forecast of the Domestic Market Size of
Wearable Devices:
54 ICT in Home Health Care in Japan, Ministerie van Buitenlandse Zaken, 2013
Healthcare & Medical Technologies – Japan Market Study - Page 72 of 121
Figure 36: © Global Wearable Device Market: Key Research Findings 2016, Yano Research Institute, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 73 of 121
3.5. Telemedicine and Remote Health Monitoring
3.5.1. Market Overview Telemedicine and Remote Health Monitoring
3.5.1.1. Remote activity monitoring of the elderly
The remote activity market is growing steadily each year as more Japanese elderly tend to live
alone if their health allows it. In FY2012, the market was worth approximately JPY 10.1 billion
(EUR 84.16 million) and it is expected to grow by 30% to JPY 13.2 billion (EUR 110 million) by
FY2020. Key innovative and unique selling points will be a necessity for new market entrants as
well as for existing players. Some of the services assure speedy contacts with doctors or
hospitals, while others offer ambulance services to take the patients to hospitals for proper
medical treatment in case of emergency.
3.5.1.2. Remote medical/nursing care
Numerous pilot projects to test the feasibility of remote medicine are being carried out by the
relevant ministries such as Ministry of Internal Affairs and Communications (MIC), MHLW and
Ministry of Education, Culture, Sports, Science and Technology (MEXT). The market in FY2015
stood at JPY100 million (EUR 832,000) and is estimated to increase fivefold to JPY 550 million
(EUR 4.16 million) by FY2020.55
3.5.1.3. Remote Healthcare Systems (RHS)
RHS are anticipated to be employed in healthcare environments requiring high precision, such as
instructing surgical procedures in remote rural areas where often a large part of the population is
+65 years old. One of the main reasons why demand of Remote Healthcare Systems will be
strong over the next decade is due to lacking specialists living in remote communities.
55 ICT in Home Health Care in Japan, Ministerie van Buitenlandse Zaken, 2013
Healthcare & Medical Technologies – Japan Market Study - Page 74 of 121
3.5.1.4. Telemedicine
Figure 37: © The Japan Times: Prime Minister Shinzo Abe tries out a telemedicine system offered by the city of Minamisoma in
Fukushima Prefecture, 2017
However, the telemedicine market is expected to grow rapidly from the current levels following
deregulation and liberalisation by the government in 2017.
Healthcare & Medical Technologies – Japan Market Study - Page 75 of 121
3.5.1.5. Japanese Market Players Telemedicine and Remote Health Monitoring
Fukuda Denshi: http://fukuda.com
Nichii Gakkan: http://www.nichiigakkan.co.jp
Omron Healthcare: http://www.healthcare.omron.co.jp
Philips Healthcare: https://www.philips.co.jp/healthcare
SBS Information Systems: http://www.sbs-infosys.co.jp
Secom: https://www.secom.co.jp
Asahi Kasei Corporation: http://www.asahi-kasei.co.jp
Hitachi Medical Corporation: http://www.hitachi.com/businesses/healthcare/
NTT Group: http://www.ntt.co.jp/index_e.html
Teijin: https://www.teijin.com
Toshiba Corporation: www.toshiba.co.jp
Fujitsu: http://www.fujitsu.com/global
NTT East Corporation: https://www.ntt-east.co.jp/en
Panasonic: http://www.panasonic.com/global/home.html
Sony Corporation: https://www.sony.net
Yuyama: http://www.yuyama.co.jp
Healthcare & Medical Technologies – Japan Market Study - Page 76 of 121
3.5.2. Market Trends Telemedicine and Remote Health Monitoring
Following the MHLW deregulations issued in August 2015, telemedicine really started to gain
momentum. The first phase focused on big metropolitan areas. Currently many hospitals provide
an online consultation option for busy workers, patients having difficulties reaching the hospital
due to physical disabilities, and patients that are receiving recurring check-ups and treatments.
The first appointment conventionally remains face-to-face with the doctor in charge.
Some doctors provide telemedicine services via an iPhone video app that allows patients to make
appointments and chat with them, while others also connect with their patients via existing generic
communication platforms like Skype or Facebook messenger and even email.
One of the major university hospitals, Juntendo, announced in July 2017 that it will start providing
telemedicine services to Parkinson’s patients. Juntendo University Hospital decided to work with
IBM’s telemedicine applications, although patients will need to have an iPad. The hospital aims
to reach 10% of its 3,000 patients in the short term.56
3.5.3. EU Entry Opportunities Telemedicine and Remote Health Monitoring
European companies offering home care, telecommunication networks, radiographs and
pathology freeze frames are looking forward to a bright future of exports to Japan. Also,
manufacturers of examination, observation and patient treatment systems, combined with
personnel training on how to use these telemedicine communications systems, will have good
business opportunities in the Japanese market.
56 The Japan Times: Once sceptical Japan embraces telemedicine as regulatory hurdles fall, 2017
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3.6. Nanotechnology Healthcare
3.6.1. Market Overview Nanotechnology Healthcare
The global market for nanotechnology in healthcare and medicines was estimated at almost
USD 30 billion in FY2014 and is forecast to grow USD 80 billion by FY2019, with a Compound
Annual Growth Rate (CAGR) of 22%. The future growth of the subsector Drug Delivery Systems
(DDS) is particularly promising. In addition, fields like in vivo imaging, in-vitro diagnostics,
biomaterials and active materials are promising sectors globally.57
Market size of the Japanese nanotech sector reached EUR 29.6 billion in
FY2010 and is projected to grow extensively in the future reaching EUR
94.4 billion in FY2020 and should be worth EUR 188.9 billion in FY2030.58
Together with the US and the EU, Japan is one of the world’s leaders in nanotechnology. This is
done by fostering collaboration between private companies and universities or research centres,
while the government is launching development platforms for nanotechnology clusters amongst
various market players. Most relevant examples are the Development of MicroRNA liquid biopsy
for early detection of cancer, led by the National Cancer Center Research Institute, and the
ImPACT Research Center for Advanced Nanobiodevices by the University of Nagoya.59
Nowadays nanotechnology and medical robotics are becoming a key factor in daily life, and this is an
area where Japan is one of the most advanced countries. However, legal and ethical guidelines on
nanotechnology and robotics have not been sufficiently implemented in Japan to date.60
At present, nanotechnology and materials are regulated by the Science and Technology Basic
Law, which promotes Life Science, IT, Environment and Nanotechnology and Materials.
Nanomedicines are regulated within the PMD Act on a product-by-product basis and similar to
normal drugs, without specific nanomedicine regulations.
57 BCC Research, www.bccresearch.com, 2014 58 Nanotech Cluster and Industry Landscape in Japan, Andrej Zagar, EU-Japan Centre for Industrial Cooperation, 2014 59 Special Symposium Life Nanotechnology, Nano Tech Expo 2017, 2017 60 Nanotechnology and Medical Robotics; Legal and Ethical Responsibility, Katsunori KAI, Waseda University, 2014
Healthcare & Medical Technologies – Japan Market Study - Page 78 of 121
3.6.2. Market Trends Nanotechnology Healthcare
Currently, Japan has 41 nanotechnology healthcare products made by seven companies, of which
32 are in dentistry, seven in tissue engineering and two in medical supplies, as shown below:61
Disinfectant: Miracle Titanium MVX Antimicrobial surface coating, Maeda Kogyo
Sanitary Napkin: Sofy Antibacteria, Unicharm
Dentistry: Contra Angle (various models), Nakanishi
Dentistry: Various Products, Yamamoto Precious Metal
Dentistry: Various Products, Tokuyama Dental
Dentistry: Various Products, Sangi
Tissue Engineering: Various Products, Organogenix
Examples of Nanomedicines approved in the past in Japan (classified based upon actual
measurements of the medicines classified as Nanomedicine):62
Lipid microspheres (Palux, Liple, Limethason, Diprivan, Popion)
Liposomes (AmBisome, Doxil, Visudyne)
Polymer-conjugated proteins (Smancs, Pegasys, PegIntron, Somavert)
Antibody-conjugated drugs (Mylotarg, Zevalin)
Nanocrystal drug (Emend)
Imaging agent (Resovist)
61 Nanotechnology Products Database, www.statnano.com 62 Current Initiatives in Japan for Nanomedicines, MHLW,
Healthcare & Medical Technologies – Japan Market Study - Page 79 of 121
Examples of Nanotechnology applied in Healthcare & Medical Technologies:
Creation of Nano-Diagnosis System: Rapid
and Handy Nano-Device for Ultra Early
Cancer Detection
Creation of Nano-Reconstruction System:
Reconstruction of Regeneration-Inducing
Implant Device
Creation of Nano-Drug Delivery System
(Nano-DDS): Pinpoint DDS for Cancer
Imaging and Target Therapy
Creation of Minimally Invasive Nano-Treatment
System: Minimally Invasive Surgery by Nano
Bio Technology
Figure 38: © Nano Bio First, Kazunori KATAOKA, Funding Program for World-Leading Innovative R&D on Science and
Technology (FIRST), 2012
Healthcare & Medical Technologies – Japan Market Study - Page 80 of 121
3.6.3. EU Entry Opportunities Nanotechnology Healthcare
Opportunities exist for European Companies in cooperation with the aforementioned private
companies, but also with nanotechnology research institutions or major universities.
The universities and institutes mentioned below could be the channels for the fastest and easiest
market access for applied nanotechnology in the healthcare sector in Japan.
Universities and Research Centres for Nanotechnology
Name (2016) h-index Number of Articles
National Institute for Materials Science 16 691
Kyoto University 12 614
Tokyo Institute of Technology 9 441
Hokkaido University 9 378
Nagoya University 8 337
Riken 8 270
University of Tsukuba 7 227
Tokyo University of Science 7 177
Keio University 6 143
Hiroshima University 5 122
Figure 39: Nanotechnology Products Database, www.statnano.com
Healthcare & Medical Technologies – Japan Market Study - Page 81 of 121
3.7. Life Science / Biotechnology for Healthcare
3.7.1. Market Overview Life Science / Biotechnology for Healthcare
Global biotech drugs (vaccines, biologics) continue to gain traction in the life sciences sector.
Of the top 10 pharma products by sales in 2014, the majority of them were biotech drugs,
including monoclonal antibodies and recombinant products.
Treatments for rheumatoid arthritis, Hepatitis C, and cancer figure most prominently in the list of
the most sales-generating drugs. Biotech drug sales were an estimated USD 289 billion in 2014
and are projected to grow to USD 445 billion by 2019.63
In Japan, biotech is an integral part of the Abe Administration’s growth strategy and an area which
could offer substantial opportunities for EU exports of biotech products, technologies, and
services.
In 2015, the estimated size of the market was JPY 3.11 trillion (EUR 25.91 billion) (versus
FY2010: JPY 2.4 trillion / EUR 20 billion), according to Nikkei Biotechnology &
Business. Approximately 2/3 of this market is focused on the healthcare and medical industry.
Antibody drugs and Fc fusion protein drugs have been and will to be the two largest growth drivers
here. Healthcare and Medical have a combined share of 56%, JPY 1.74 trillion (EUR 14.5 billion)
with the total biotechnology industry sector. The METI announced in FY2015, to further develop
the Japanese Biotech Market to JPY 20 trillion (EUR 166 billion) by FY2030.64
Also expected to grow further are biosimilar/FOPPs (follow-on protein products) under the Abe
Administration’s “Basic Policy on Economic and Fiscal Management and Reform 2015.”
Innovation in the healthcare sector is a key priority for the present Government of Japan. It has
established the Agency for Medical Research and Development (ADEM), which will support and
fund new product development in both the pharma and medical device sectors.
63 Global Life Sciences Outlook, Deloitte, 2016 64 METI Policy announcement to 6-fold bio market to JPY 20 trillion by FY2030, Nikkei, 2015
Healthcare & Medical Technologies – Japan Market Study - Page 82 of 121
AMED will receive budgetary funding of JPY 126.5 billion in FY2016 (up 1.3% from
JPY 124.8 billion from FY2015). The MHLW has launched a forum in the form of a private panel
for the health minister to promote healthcare start-ups in the country.
3.7.2. Market Trends Life Science / Biotechnology for Healthcare
The Japan Bioindustry Association (JBA) mentions the following ongoing biotechnology research
in healthcare in their FY2015 activity report:65
Development of cell manufacturing and processing systems for the industrialisation of
regenerative medicine, for regenerative medicine products derived from human pluripotent
stem cells (cardiac, nerve, retinal pigment epithelium, liver cells) and for regenerative
medicine products derived from human mesenchymal stem cells
Development of a basic technology for the creation of next-generation pharmaceuticals for
individualised and customised medicine. This project is usually referred to as the
“Technology for the Manufacturing of Next-Generation Therapeutic Antibodies in
Accordance with International Standards”.
In FY2014, the Abe government budgeted JPY 17.2 billion (EUR 143.33 million) for cancer
treatment initiatives involving 3 agencies, with the main recipient being the in April 2015 newly
established Japan Agency for Medical Research and Development (AMED) following the
establishment of the Office for Healthcare Policy in FY2013 and the Act on Promotion of
Healthcare Policy in FY2014. The AMED focuses on integrated medical research from clinical
trials to actual application, amongst which cancer research is featured, but AMED also contributes
to the development of innovative medical devices. 66 Abe’s government also allocated
JPY 4.5 billion (EUR 37.5 million) in the same fiscal year to a consortium of 24 companies and
two universities, which formed a pilot platform for biologic drugs at the end of FY2013.
65 A New Age of Bio-Business: Toward the Creation of New Industry Clusters, JBA, 2015 66 Japan’s Healthcare in 2030, Nomura Research Institute, 2015, Japanese
Healthcare & Medical Technologies – Japan Market Study - Page 83 of 121
Separately, the government also committed JPY 110 billion (EUR 916 million), spread out over
ten years, towards increased research of Induced Pluripotent Stem Cells (iPSCs), building further
on the research by Kyoto University researcher and 2012 Nobel laureate Professor Shinya
Yamanaka, who announced plans to establish an international iPSC bank involving more than
ten countries, including the US and UK.67
Another key trend in the Japanese Pharmaceutical sector is related to the patent expirations of
well-known, long and best-selling drugs in the domestic market. This trend will result in enhanced
nano- and biotechnology R&D and commercial applications given the strong promotion by the
present Japanese government. It is still too early to judge how the government-pushed generic
drug and personalised drug policy will evolve in relation to patent expiration of brand drugs.
3.7.3. EU Entry Opportunities Life Science / Biotechnology for Health
Following the Industrial Cluster Plan, launched in April 2001 to strengthen the capabilities of
regional areas for developing innovative technologies and products, Japan now has nationwide
biotech clusters to foster the growth of business ventures and start-ups. These centres are
frequently procuring biotechnology related devices like fully closed automatic cultivation devices,
flow cytometers and incubators.
The Japanese Government also launched the “Pharmaceutical Industry Vision” policy by the
MHLW to open these markets to innovative international pharmaceutical and medical companies
to further enhance Japan’s international competitiveness in the pharmaceutical industry. It aims
to strengthen R&D and commercialisation of products, regardless of whether they were funded
with international or domestic capital.
Participation and collaboration in clusters focusing on biotechnology as well as collaboration
projects between private companies and research institutes (eg. NIPRO and Kyoto University on
iCeMS) are likely the best market entrance for European companies wishing to enter Japan.
67 Japan Moves to Regain Prominence in Biotech, GEN, 2014
Healthcare & Medical Technologies – Japan Market Study - Page 84 of 121
Figure 40: Attractive Sectors-Biotechnology, JETRO, 2007
Healthcare & Medical Technologies – Japan Market Study - Page 85 of 121
3.8. Dental Products and Technologies
3.8.1 Market Overview Dental Products
Total dental examination medical expenditures stood at about JPY 380 billion (EUR 3.16 billion)
in FY2014, making Japan the number two dental market globally, after the US. Japan imported
dental x-ray equipment, dental equipment and dental materials of value JPY 60.1 billion
(EUR 500 million) as opposed to an export value of JPY 31.6 billion (EUR 263 million) in
FY2015.68 For FY2015, imports increased by 6.6% and exports grew by 5.7% compared to
FY2014. During the period 2016-2020, a CAGR of 6.75% market growth is estimated.69
Currently, Japan has almost 70,000 dental clinics providing dental care to the public nationwide.
Export-Import Ratio of Dental Equipment FY2015
+80% export ratio Drive unit for inside tooth; Hand pieces
High export ratio Equipment for endodontic treatment; Diagnostic imaging system for dentistry; Dental units and related products; Adhesive fillers
Similar export-import ratio Dental ceramics; Small crack dental closure material; Orthodontic equipment and related products
High import ratio Equipment for dental examination; Dental laboratory equipment (except CAD/CAM)
+80% import ratio CAD/CAM devices for dentistry; Materials for dental implants; Dental model material; Dental impression material and reproduction impression material; Total dentures and partial floor denture materials
Figure 41: Figure 36: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association
(JDA), 2017
Dental Computed Tomography (CT) devices and laser devices, which have become quite popular
in recent years, are not included in the description. It is also important to note that devices like
dental computers do not fall under the definition of medical devices in the present Pharmaceutical
and Medical Device Act (PMD Act).
Dental care costs are handled differently depending on factors like cavity development, cavity
numbers and patients covered or not by a health insurance program. All surgical and conservative
68 New Dental Medical Equipment and Dental Medical Technology Industry Vision, JDA, 2017 69 Japan Dental Devices Market, Growth, Trends and Forecasts 2016-2020, Mordor Intelligence, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 86 of 121
treatments and even certain prosthetic treatments are included in the scope of benefits under the
National Health Insurance programme. Certain prosthetic, aesthetic implants such as ceramic,
hybrid ceramic and Gold fillings and crowns; orthodontic treatments like braces, mouth pieces
and back teeth correction are not covered.
The top three Japanese dental equipment manufacturers, with a combined market share of 68.8%
are Yoshida with 27%, J. Morita with 25.8% and Takara Belmont with a 16% market share.
Other key dental equipment market players are GC Corporation, Shofu, 3M Health Care,
Dentsply-Sankin, Kuraray Noritake Dental, Nisshin Japan, Ishifuku Metal Industry, Yamamoto
Precious Metal, Tokuriki Honten, Ohura Precious Metal Industry, IDS and Heraeus Kulzer Japan.
3.8.1.1. 8020 Campaign
The most commonly used international measure for oral health is the prevalence of
edentulousness, or the percentage of people with no teeth. In Japan, the ratio of edentulousness
in the age group 65 to 74 years old is 10%, much lower than all other Organisation for Economic
Co-operation and Development (OECD) countries. For comparison, in Europe and the US, this
percentage is between 25–30% for the same demographic bracket.
This is in part thanks to safe and reliable dental treatment using the highest standards of
technology and state-of-the-art equipment and materials, both domestically manufactured and
imported. In general, Japanese dentists practice under a "treating the original teeth as much as
possible" policy which further sustains this low percentage of edentulousness.
To further promote oral and dental healthcare, the Japan Dental Association (JDA), together with
the MHWL, started the 8020 (Hachimaru Nimaru in Japanese, or ‘Eighty Twenty’) campaign in
1989. The main and simple objective was for elderly “to keep 20 or more of their own healthy
teeth until the age of 80."
Healthcare & Medical Technologies – Japan Market Study - Page 87 of 121
In 1989, the average life expectancy of females surpassed 80 years, and at the age of 80 then,
only 7% had 20 or more healthy teeth. A follow-up survey in FY2016 showed a record high of
more than 50% of Japanese achieved the goal set out by the campaign.
Changes in Percentage of Persons Having 20 or More Teeth by Age Group
Figure 42: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA),
2017
3.8.2. Market Trends Dental Products
Domestic production or imported dental medical instruments are shipped from the manufacturing
and sales business and are offered to dental clinics and dental laboratories throughout the country
by distribution organisations consisting of primary wholesalers and secondary wholesalers
(retailers).
As Japanese elderly value their dental care, even when they are no longer able to visit their usual
dentist, one can expect robust demand for mobile dental equipment that can be used during visits
to patients’ homes.
Healthcare & Medical Technologies – Japan Market Study - Page 88 of 121
Figure 43: New Dental Medical Equipment and Dental Medical Technology Industry Vision, Japan Dental Association (JDA),
2017
3.8.3. EU Entry Opportunities Dental Products
As mentioned above, for European Dental Products and Technologies like dental examination,
dental equipment, CAD/CAM devices, materials for dental implants, dental reproduction materials
and denture materials for total and partial dentures, future export opportunities will be strong as
import volumes will remain high for many years.
The growth in imports in general (as seen in Figure 44) suggests that the opportunities for dental
products from foreign sources is substantial.
Healthcare & Medical Technologies – Japan Market Study - Page 89 of 121
Japan Market Size for Growing Dental Materials and Equipment (unit: JPY 1 million)
FY2014 FY2015 FY2016
Dental X-Ray Equipment 3,216 3,156 4,260
Dental General X-ray Equipment 1,164 1,224 1,236
Dental Use Special X-ray Equipment 2,052 1,932 3,024
Moisture-proof Materials 73.2 92.4 99.6
Dental Electrical Diagnostic Equipment 624 576 852
Dental Suction Device 2,244 2,436 3,156
Orthodontic Equipment 6,636 5,472 6,420
Other Orthodontic Instruments 16.8 33.6 60.0
Ligation or Band Environment Pressure 144 168 228
Dental Laboratory Rotary Equipment 1,800 1,872 2,004
Other Tooth Crown Materials 864 1,188 1,932
Bandage Materials 1.2 28.8 46.8
Dental Root Canal Filling Materials 1,524 1,536 1,716
Dental Model Materials 2,592 2,748 2,880
Dental Diamond Abrasives 252 300 360
Dental Gloves 660 732 1,128
Figure 44: Websites MHLW, MIC and others, 2017
Other dental products related to diagnostic technologies, preventive technologies, oral hard tissue
disease treatment technologies, regenerative medical technologies and dental laboratory
technologies in general will continue to see high demand.70
An example of a successful entrant into the dental market in Japan is Dentsply Sirona, a German
manufacturer that has specialised in dental equipment for over 130 years. As a leader in dental
70 Global Dental Market to Expand at a CAGR of 5.6% in the 2016~2021 article, Trendforce, 2017
Healthcare & Medical Technologies – Japan Market Study - Page 90 of 121
technological innovation, Sirona invented the first electric dental drill in 1887. Sirona established
its Japanese subsidiary in 2004. Sirona Japan expanded rapidly and successfully embedded the
Sirona brand deeply in this sub-sector in Japan. At present, Sirona Japan employs 180 people at
11 locations in the country.
The Sirona CAD/CAM restoration system is now installed in over than 5,700 Sirona treatment
centres and 1,700 Japanese dentists.
On 17 March 2017, Dentsply Sirona and Kuraray Noritake Dental concluded a material
partnership for CAD/CAM blocks business in Japan. Based on this partnership, Dentsply Sirona
will offer professional dental laboratory dedicated and optimised milling strategies for use with
Kuraray Noritake Dental multi-layered zirconia discs.71
71 10 Years of Sirona Japan: A Success Story, https://blog.dentsplysirona.com/en/10-years-sirona-japan-success-story/
Healthcare & Medical Technologies – Japan Market Study - Page 91 of 121
4. Healthcare & Medical Technologies Regulations
4.1. Healthcare & Medical Technologies Regulations
4.1.1. Pharmaceuticals and Medical Device Act (PMD Act)
On 25 November 2014, the Japanese Pharmaceutical Affairs (PAL) Law, long known for its
strictness, was completely revised by the Abe Government under a renaming to “Act on Securing
Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular
Therapy Products, Gene Therapy Products, and Cosmetics” or “Pharmaceuticals and Medical
Device Act” (PMD Act) in short.
The current PMD Act separates medical devices from pharmaceutical products in its technical
treatment, which were handled in the same way in the former PAL. As a result, medical device
regulations have eased, thus leading to reduced development costs and faster approval reviews.
Furthermore, to respond to progress in medical technologies, including reinforcement of safety
measures for pharmaceutical products and medical devices and the creation of an approval
system toward earlier commercialisation of regenerative medicine, the Act was revised with the
aim of quickening the practical application process for technologies while ensuring safety.
The amended Law brought five main changes to secure a safe and expedited supply of medicinal
products and medical devices:
A charter for Marketing Authorisation License and Manufacturing License of medical devices
stated separately from that of pharmaceutical products, quasi-drugs and cosmetics
Private third parties can now also offer certification services for Specially Controlled Medical
Devices, following the newly established standards
Monolithic programme for diagnoses is handled as medical devices so it can be subject to
approval or certification of the Marketing Authorisation License (In PAL, it was not
considered for approval or certification). Standalone software became a Class II device
Healthcare & Medical Technologies – Japan Market Study - Page 92 of 121
The approval system for attaining a Manufacturing License of medical devices was simplified
to a registration system. This also allowed quality inspections to be conducted for product
groupings as opposed to individual products
Standards compliance investigation into manufacturing and quality control of medical
devices was rationalised
In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA), an independent
administrative agency under the jurisdiction of the MHLW, is responsible for implementing
evaluations for approval of pharmaceutical products and medical devices.
As a member of the International Medical Device Regulators Forum (IMDRF), Japan is also doing
serious efforts to harmonise with international standards of the global healthcare market. In
FY2016, the MHLW adapted the local regulations on quality management for medical devices to
conform with the global ISO standard (ISO13485:2016).
4.1.2. Application and Approval
Japan’s medical device classification system is based on the Japanese Medical Device
Nomenclature (JMDN) codes, and are different from US and European classifications. The review
processes for medical devices also differ depending on classification.
Medical devices are classified into 4 classes (Class I, Class II, Class III and Class IV) designating
risk level.
Class I (lowest risk to the human body) is defined as general medical devices
Class II (relatively low risk) is defined as controlled medical devices
Class III (relatively high risk) is defined as having a relatively high risk to the human body in
case of failure
Class IV (highest risk) is defined as specifically controlled devices
Healthcare & Medical Technologies – Japan Market Study - Page 93 of 121
The aforesaid PMD Act revision in FY2014, has profoundly eased applications and approvals of
imported medical devices and equipment but it is important to not lose sight of the former strict
PAL mindset, when exporting to Japan, especially for the first time.
To date, calculating sufficient approval time and financial resources for market entrance and
approval are necessary. Potential Japanese business partners will take a long-term stance and
research if similar devices are already available in Japan or not. Also, the business partner will
perform a profound background check to see if all necessary regulations and rules are cleared or
not, as they need to assure extremely short delivery times once an order has been issued by their
domestic healthcare customers.
In general, the higher the hazard class to which the imported medical device belongs to,
the longer the approval process will take, as it gets more complex. Hence, the cost will also
increase. For devices belonging to the aforesaid Class III and IV, approval fees to the regulators
will vary between EUR 50 to EUR 100,000, not including any consulting fees of external parties.
The complete approval process will take at least 1.5 years from original application.
Also, it is important to bear in mind that almost all regulations and documents are published
exclusively in Japanese and that the PMD Act imposes strict requirements and clinical standards
for foreign manufacturers, hence an experienced regulatory partner with a presence in Japan is
quite essential for business success in the long term.
Finally, overseas manufacturers of high-end and innovative medical equipment should expect
fierce competition from Japanese healthcare manufacturers, especially in promising business
areas like diagnostic imaging, surgical equipment, monitoring systems, dialysers and
endoscopes.
The chart below explains in detail the necessary approval process, step-by-step, per specific
hazard Class, in accordance with the new and simplified PMD Act.
Healthcare & Medical Technologies – Japan Market Study - Page 94 of 121
Regulatory Process for Medical Devices in Japan72
Figure 45: © Japan: The Regulatory Process for Medical Devices, Emergo, 2017
72 https://www.emergogroup.com/resources/japan-process-chart
Healthcare & Medical Technologies – Japan Market Study - Page 95 of 121
“The Regulatory Process for Medical devices in Japan
Step 1: Determine classification of your device according to the Pharmaceuticals and Medical
Devices Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes.
There are 5 classes of increasing risk:
• Class I - General medical devices
• Class II - Specified Controlled medical devices
• Class II - Controlled medical devices
• Class III73 - Highly Controlled medical devices
• Class IV - Highly Controlled medical devices
Step 2: For Class I devices, appoint an MAH in Japan. For all other classes, Appoint Marketing
Authorisation Holder (MAH or D-MAH) to manage your device registration in Japan.
Your MAH or D-MAH will control your device registration.
Step 3: All classes: Japanese manufacturers must register domestic facilities with local
prefectural authorities. Foreign manufacturers must submit a Foreign Manufacturer
Registration (FMR) application to the Pharmaceuticals and Medical Devices Agency
(PMDA).
Step 4: All classes: Implement Quality Management System (QMS) that complies with the PMD
Act and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169. Ordinance
#169 is based on ISO 13485.
Step 5: For Class I devices, submit Pre-Market Submission to Pharmaceutical and Medical
Devices Agency (PMDA). All documents must be in Japanese.
For Class II (Specified Controlled) devices, submit Pre-Market Certification application
to a Registered Certified Body (RCB) authorised to issue certifications. All documents
must be in Japanese.
73 Some Class III medical devices are considered “Specified Highly Controlled” devices and follow the same approval route as Class II
"Specified Controlled" devices
Healthcare & Medical Technologies – Japan Market Study - Page 96 of 121
For Class II (Controlled) through IV devices, prepare Pre-Market Approval application
as well as registration dossier in Summary Technical Document (STED) format. Submit
documents to PMDA. All documents must be in Japanese
Step 6: Most74 Class I devices do not require QMS conformity assessment.
For Class II (Specified Controlled) devices, QMS audit by Registered Certification Body
(RCB).
For Class II (Controlled) through IV devices, QMS audit by PMDA. On-site audits are
typically required for “New” devices with no existing JMDN code, Class IV devices, and
those requiring clinical investigations.
Step 7: For all Class II through IV devices, your QMS certificate will be issued by the PMDA or
your Registered Certification Body.
Step 8: For Class II (Specified Controlled) devices, Pre-Market Certificate issued by RCB.
For Class II (Controlled) through Class IV devices, Pre-Market Approval certificate
issued by MHLW.
Step 9: For all devices, a reimbursement application should be filed with Economic Affairs
Division of MHLW if applicable.
Step 10: You may now begin marketing your device in Japan. Approvals do not expire.75
This is a simplified overview of the process. The PMDA may choose to audit your
submission and request more documents, which will add time to your approval.”76
74 MHLW Ordinance #169 documentation is not required for most Class I device applications. However, some Class I device manufacturers do
require QMS certification, including Class I NEW devices (i.e., no JMDN code) 75 Device registrations do not expire. However, QMS certificates are valid for five years and must be renewed six months prior to expiration. Pre-
Market Certification applications may also be subject to annual surveillance audits. The schedule will be determined by the RCB or PMDA 76 https://www.emergogroup.com/resources/japan-process-chart
Healthcare & Medical Technologies – Japan Market Study - Page 97 of 121
Estimated Time, Cost and Complexity of Registration77
Figure 46: © Japan: The Time, Cost and Complexity of Registration, Emergo, 2017
The company Emergo, part of the UL Group with an office in Tokyo, specialises in Device
Classification support, PMDA Registration and Foreign Manufacturer Registration. Till date, they
have executed +770 projects in de Medical Device sector in Japan for numerous global healthcare
and medical device manufacturers.78
General and initial inquiries about medical devices in regard to marketing approval can also be
directed to the Pharmaceuticals and Medical Devices Agency (PMDA).79
77 https://www.emergogroup.com/resources/japan-process-chart 78 https://www.emergogroup.com/resources/japan/all/all 79 http://www.pmda.go.jp/english/index.html
Healthcare & Medical Technologies – Japan Market Study - Page 98 of 121
Classification of Exemplary Medical Devices in Japan
Figure 47: Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013)
General medical devices can be marketed by submitting a notification to the Pharmaceutical
and Medical Device Agency (PMDA). Controlled medical devices, with established certification
standards, can be reviewed by Certified Third-Party bodies. Controlled medical devices without
certification standards and specifically controlled devices must be reviewed by the PMDA and
approved by the MHLW.
Japan does not levy customs duties on imported medical devices. However, medical devices are
heavily regulated under the Pharmaceutical and Medical Device Act (PMD Act). The PMD Act will
enable further improvements to the regulatory review process, including the establishment of a
device-specific regulatory framework.
Japan’s medical device market authorisation process has long been considered one of the most
rigorous, lengthy, and intensive in the world; however, PMD Act greatly streamlined these
regulatory requirements. Although regulations are still stringent, the final aim is to make the
Healthcare & Medical Technologies – Japan Market Study - Page 99 of 121
registration and approval process faster than that of the Food and Drug Administration (FDA) in
the US.
Currently, Japan does not accept CE (Conformité Européene) marking and/or an FDA certificate,
although European and US approval does help speed up the review process. However, the
principle agreement on the Economic Partnership Agreement (EPA) between EU and Japan from
July 2017 will most likely accelerate or completely remove approvals if standards are harmonised
internationally. It is also expected that the recently established Japan Agency for Medical
Research and Development (AMED) will facilitate in the harmonisation between Japanese,
global, and aforementioned recognised medical device standards.
Healthcare & Medical Technologies – Japan Market Study - Page 100 of 121
4.1.3. Long-Term Care Insurance (LCTI) system
Figure 48: Overview LTCI, MHLW 2016
In April 2000, the Japanese government launched its fifth social insurance scheme, the Long-
term Care Insurance, as a mechanism to enable society to provide long-term care to the elderly.
Healthcare & Medical Technologies – Japan Market Study - Page 101 of 121
The ultimate purpose stated in the LTCI Act is to help individuals in need of LTC “to maintain
dignity and an independent daily life routine according to each person’s level of abilities.” To do
so, the government set up three goals when it established the LTCI program.
These three goals are:
Support for independence: The LTCI System aims to support the independence of elderly
people, rather than simply providing personal care
User-oriented: A system in which users, based on their own choice, can receive integrated
services of health, medicine, and welfare from diverse agents
Social insurance system: Adoption of a social insurance system where the relationship
between benefits and burdens is clear
Figure 49: Overview LTCI, MHLW 2016
Healthcare & Medical Technologies – Japan Market Study - Page 102 of 121
Supporting benefits from nursing-care insurance is not limited to nursing care services, but it also
covers welfare equipment that supports the lives of elderly people requiring long-term care,
including canes, wheelchairs and bathing equipment used at nursing facilities.
This furthermore includes equipment and technologies that are used in nursing-care facilities by
caretakers: Equipment used for rehabilitation, training, and tools for users to lead a self-reliant
daily life in their residence. These are subject to insurance benefits for things that help to make
the LTCI objectives possible. Specific target items are announced by the MHLW.
Long-term care insurance services are provided when people aged 65 or over require care or
support for whatever reason, and when people aged 40-64 develop age-related diseases, such
as terminal cancer or rheumatoid arthritis. Initially, co-payment by patients was set as 10%
regardless of income, but as of August 2015, this was increased to 20% for persons with income
above certain level.
Figure 50: Overview LTCI, MHLW 2016
Healthcare & Medical Technologies – Japan Market Study - Page 103 of 121
The next revision of the LTCI System is planned for FY2018 as Japan continues to work towards
a Community-based Integrated Care System by FY2025.
4.1.4. Medical Fees and Insurance Reimbursement
Figure 51: Overview LTCI, MHLW 2016
Healthcare & Medical Technologies – Japan Market Study - Page 104 of 121
4.1.5. Other Regulations
The Japanese government of Prime Minister Abe has both launched and reinforced also other
Healthcare Sector Policies in recent years:
Establishment of Japan Agency for Medical Research and Development (AMED) in 2015 to
streamline a global and integrated medical R&D strategy, including medical device
development, from clinical trials till actual application
Barrier-Free Act: Originally issued in 2006 aiming to promote easy mobility and accessibility
for the elderly and disabled in public spaces like dedicated parking spots, building entrance
approaches, stairs with handrails, wheelchair spots, elevators and multi-purpose toilets
amongst others
Regenerative Medicine Law
The Orange Plan FY2013: Co-housing with dementia patients instead of nursing care
facilities
Figure 52: New Orange Plan, LTCI, MHLW, 2016
Healthcare & Medical Technologies – Japan Market Study - Page 105 of 121
The PMDL will enable further improvements to the regulatory review process, including the
establishment of a new product category for regenerative medicine products. Regenerative
medicine is a branch of medical research in tissue engineering and molecular biology which deals
with replacing, engineering or regenerating human cells, tissues or organs to restore or establish
normal function. The rapid approval system on regenerative medical products was introduced
with the enforcement of the law, which raised Japan to the forefront of regenerative medicine.
Healthcare & Medical Technologies – Japan Market Study - Page 106 of 121
5. Annexes
5.1. Healthcare & Medical Technologies Industry Associations
Japan Medical Industry Association (JMIA):
http://www.med.or.jp/
Medical Technology Association of Japan (MTJAPAN):
www.mtjapan.or.jp
Japan Association of Medical Devices Industries (JAMDI):
http://www.jfmda.gr.jp/
Japanese Surgical Society (JSS):
http://www.jssoc.or.jp/
Japan Association of Health Industry Distributors (JAHID):
http://www.jahid.gr.jp/
Japan Analytical Instruments Manufacturers' Association (JAIMA):
http://www.jaima.or.jp/
Japan Dental Trade Association (JDTA):
http://www.jdta.org/
Japan Home Health Care Association (JHHC):
http://www.jhhc.jp/
Japan Hearing Instruments Manufacturers Association (JHIMA):
http://www.hochouki.com/
Japan Hygiene Products Industry Association (JHPIA):
http://www.jhpia.or.jp/
Healthcare & Medical Technologies – Japan Market Study - Page 107 of 121
Japan Industries Association of Physical Therapy Devices (JIPT):
http://nichirikiko.gr.jp/
Japan Medical Imaging and Radiological Systems Industries Association (JIRA):
http://www.jira-net.or.jp/
Japan Medical-Optical Equipment Industrial Association (JMOIA):
http://www.jmoia.jp/
Japan Ophthalmic Instruments Association (JOIA):
https://www.joia.or.jp/
Japan Contact Lens Association (JCLA):
http://www.jcla.gr.jp/
Healthcare & Medical Technologies – Japan Market Study - Page 108 of 121
5.2. Health and Medical Technology Trade Fairs
2nd CareTEX 2016 (March, Tokyo)
http://caretex.jp/
34th Health Expo 2016 (March, Tokyo)
http://www.this.ne.jp/
16th Japan Drugstore Show (March, Chiba)
http://www.drugstoreshow2016.jp/
37th Kansai Health Industry Fair (April, Osaka)
http://www.newmagazine.jp/
2016 International Exhibition of Medical Imaging (ITEM 2016) (April, Yokohama)
http://www.jira-net.or.jp/event/event_088.html
CPhI Japan 2016 (International Pharma Ingredient Fair) (April, Tokyo)
http://www.cphijapan.com/
P-MEC Japan 2016 (Medicine Ingredients, Devices) (April, Tokyo)
http://www.cphijapan.com/
MEDTEC Japan 2016 (April, Tokyo)
http://www.medtecjapan.com/
22nd Barrier Free 2016 (April, Osaka)
http://www.tvoe.co.jp/bmk/
15th BIO-tech 2016 (May, Tokyo)
http://www.bio-t.jp/
Medical & Imaging Expo 2016 (May, Yokohama)
http://www.opie.jp/mi/index.php
Healthcare & Medical Technologies – Japan Market Study - Page 109 of 121
19th International Welfare & Health Industry Expo (June, Nagoya)
http://www.nagoya-trade-expo.jp/welfare/
7th Medical Device, Development and Manufacturing Fair (June, Tokyo)
http://www.medix-tokyo.jp/
91st Medical Show & Business Expo 2016 (June, Osaka)
http://www.jsmi.gr.jp/connection/
10th in-PHARMA Japan (International Medicine Ingredients) (June, Tokyo)
http://www.pijapan.jp/
29th Interphex Japan (Medicine, Cosmetics R&D and Manufacturing International Expo)
(July, Tokyo)
http://www.interphex.jp/
RE-CARE Japan 2016 (Rehabilitation and Nursing Care Industry Expo) (August, Tokyo)
http://www.re-care.jp/
BioOpto Japan 2016 (September, Yokohama)
http://www.optojapan.jp/bio/
JACLaS EXPO 2016 (Clinical Testing Devices, Reagents and Systems) (September,
Yokohama)
http://jaclas.or.jp/exhibitions/index.html
43rd International Welfare Equipment Expo 2016 (October, Tokyo)
http://www.hcr.or.jp/
HealthCare IT 2018 (April, Tokyo)
http://www.healthcarejapan.com/information/en-index.html
Healthcare & Medical Technologies – Japan Market Study - Page 110 of 121
5.3. List of Healthcare Medical Technology Companies in Japan
5.3.1. Terumo Corporation
http://www.terumo.co.jp/
Terumo Corporation was founded in 1921 as Sekisen Ken-onki Corporation by a group of medical
scientists. The company's first product was "Jintan Taionkei", the first Japanese-made
thermometer available for sale, and it has since expanded into a medical devices manufacturer,
producing medical disposables, cardiovascular systems and diabetes care products.
In 1971, Terumo opened its first overseas office in the United States. Since then, the company
has established subsidiaries in Europe (1971), South America, China, India, Philippines, Vietnam,
Thailand and Australia. The company later expanded its product range to include coronary stents
and catheters, and acquired, among others, the cardiovascular specialty companies Vascutek
and Microvention in 2002 and 2006 respectively.
5.3.2. Olympus Corporation
https://www.olympus.co.jp/product/medical/
Olympus Corporation is a Japanese manufacturer of optics and reprography products. Olympus
was established on 12 October 1919, initially specializing in microscope and thermometer
businesses. Olympus manufactures endoscopic, ultrasound, electrocautery, endotherapy, and
cleaning and disinfection equipment. The first flexible Endoscope in the world was co-developed
and manufactured by Olympus in Tokyo. Through its comprehensive product range and its
reactivity to market innovations, Olympus enjoys a virtual stranglehold of the world market in
gastro-intestinal endoscopes. It has roughly 70% share of the global market whose estimated
value is US$ 2.5 billion. On 28 September 2012, Olympus and Sony announced a joint venture
to develop new surgical endoscopes with 4K resolution (or higher) and 3D capability.
Healthcare & Medical Technologies – Japan Market Study - Page 111 of 121
5.3.3. Nipro Corporation
http://www.nipro.co.jp/en/
Nipro Corporation is a Japanese medical equipment manufacturing company specializing in
medical, pharmaceutical and glass products. Founded in 1954, the company is headquartered in
Osaka and is listed on the Tokyo Stock Exchange and the Osaka Securities Exchange. As of
2013 the company has 58 subsidiaries in Japan, Asia, North and South America and Europe.
5.3.4. Hitachi Healthcare Manufacturing
http://www.hitachi.co.jp/
Hitachi Healthcare Manufacturing, Ltd. engages in the development, manufacturing, sale,
installation, and maintenance of medical equipment, medical information systems, general
purpose analysers, and medical analysers. Its medical equipment includes MRI systems,
CT systems, diagnostic ultrasound systems, digital radiography and fluoroscopy systems with
FPDs/image intensifiers, general radiography systems, X-ray and mobile X-ray systems, optical
topography systems, bone densitometry systems, nuclear medicine systems, and radiotherapy
systems.
The company’s medical information systems comprise medical administration systems, hospital
information systems, medical image management systems, and comprehensive medical checkup
systems; general analysis systems include radiation measuring and control instruments; and
medical analysis systems consist of laboratory test systems and pipettors. It serves National and
other public hospitals, university hospitals, general hospitals, private hospitals and clinics, etc. in
Japan and internationally. Hitachi Healthcare Manufacturing, Ltd. was formerly known as Hitachi
Medical Corporation and changed its name to Hitachi Healthcare Manufacturing, Ltd. in April
2016. The company was founded in 1949 and is headquartered in Tokyo, Japan with various
branch, sales, and service offices in Japan.
Healthcare & Medical Technologies – Japan Market Study - Page 112 of 121
5.3.5. Fukuda Denshi
http://www.fukuda.co.jp/
Fukuda Denshi Co., Ltd. develops, manufactures, and sells medical electronic equipment
worldwide. It provides resting electrocardiograph products; data management software; stress
test products; Holter products and software; and patient monitoring systems, including central and
bedside monitors, digital transmitters, and central viewer workstations. The company also offers
defibrillator monitors; ultrasound scanners; and vascular screening systems. Fukuda Denshi Co.,
Ltd. was founded in 1948 and is based in Tokyo, Japan.
5.3.6. Nihon Kohden
http://www.nihonkohden.co.jp/
Nihon Kohden Corporation is a Tokyo-based leading manufacturer, developer and distributor of
medical electronic equipment, which include EEGs, EMG measuring systems, ECGs, patient
monitors and clinical information systems, with subsidiaries in the US, Europe and Asia.
The company's products are now used in more than 120 countries, and it is the largest supplier
of EEG products worldwide.
In 1972, Takuo Aoyagi, a researcher at the company, invented and patented the basic principles
of pulse oximetry. Two years later he developed the world's first pulse oximeter, which has helped
improve patient safety during anaesthesia.
Healthcare & Medical Technologies – Japan Market Study - Page 113 of 121
5.4. European HMT Companies in Japan
5.4.1. Philips Electronics Japan
Philips Electronics Japan, Ltd. imports, distributes, and markets electronic equipment for
healthcare, lighting, and consumer lifestyle markets. The company offers medical devices
including imaging systems, acute and critical care equipment, ultrasound equipment, clinical
informatics, patient monitoring systems, emergency care products, ventilators, airway
management systems, asthma, allergy, and respiratory management products, home oxygen
equipment, sleep and breathing disorder management systems, home monitoring products,
medical alerts, and anaesthesia machines for hospitals and home health care applications.
It provides domestic appliances and personal care consumer products including shavers, electric
toothbrushes, and oral healthcare.
www.philips.co.jp
5.4.2. LivaNova
Livanova Co., Ltd. imports and sells LivaNova's main products such as artificial lungs, artificial
heart-lung machines, other extracorporeal circulation systems and autologous blood collection
devices.
LivaNova PLC, headquartered in London, UK, is a global medical technology company formed
by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and
Cyberonics Inc., a medical device company with core expertise in neuromodulation.
LivaNova, PLC has received approval from Japan’s Pharmaceutical and Medical Devices Agency
(PMDA) for its Solo Smart stentless tissue valve, the only valve designed to provide superior
hemodynamics with the ease of a stented bioprosthesis implantation.
https://www.livanova.co.jp/company/about/
Healthcare & Medical Technologies – Japan Market Study - Page 114 of 121
Air Liquide Japan
B. Braun Aesculap Japan Co
Biotronik Japan
Coloplast
Dornier MedTech Japan
Draeger Medical Japan
Edaptechnomed
Elekta
Hollister
Integral Corporation
Intuitive Surgical
Japan Lifeline
Japan MDC
JIMRO
Laerdal Medical Japan
Lima Japan
Medis Medical Imaging Systems
Molnlycke Health Care
Nippon Becton Dickinson
Nippon BXI
Nobel Biocare Japan
Novocure
Otto Bock Japan
Healthcare & Medical Technologies – Japan Market Study - Page 115 of 121
Philips Electronics Japan
Radiometer
Siemens Healthcare
Smith & Nephew Wound Management
Sorin Group Japan
TKB Corporation
Vorpal Technologies
Roche Diagnostics
SML (Sceti Medical Labo)
Sysmex bioMerieux
Healthcare & Medical Technologies – Japan Market Study - Page 116 of 121
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