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From Technologies to Market
Point-of-Need Testing: Application of
Microfluidic Technologies
2016 reportSample
Sample© 2016
2©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
Abaxis, Abbott Point of Care, Accriva Diagnostics, Achira, AgPlus Diagnostics, Akonni Biosystems, Alere (Abbott), Ativa Medical, Atlas Genetics, Atonomics, BD Diagnostics, BioCartis, Biodetection Instruments, Biofire
(bioMérieux), BioSensia, Biosurfit, Carbo Analytics, Carclo Diagnostic Solutions, Cepheid, Coris BioConcept, Daktari Diagnostics, DNA electronics, Dolomite Microfluidics, Enigma Diagnostics, Etta Healthcare (OvaGene
Oncology), Fast-track Diagnostics, F Cubed, FluimediX, Focus diagnostics (DiaSorin Group), Genalyte, GeneFluidics, GenePOC, Great Basin, HemoCue (Radiometer, Danaher), Ikerlan, INO, Instant Labs, Iquum (Roche),
Lacrisciences, LeukoDx, Luminex, Medimate, Mesa Biotech, Micronics (Sony), Molbio Diagnostics Pvt. Ltd, Nanomix, Nanosphere, NetBio, OndaVia, OPKO Diagnostics, Oxford Nanopore, Pall Corporation, PathSensors, Patterson, Philips, POC Medical Systems, PositiveID, QuantuMDx, Radiometer (Danaher), Radisens Diagnostics,
Rheonix, Roche, Samsung, Sandstone Diagnostics, Sanwa Biotech, Schlumberger, SMB (Zoetis), Sony DADC (Stratec), Spartan Bioscience, Sphere Medical, SpinChip Diagnostics AS, StableLab, STMicroelectronics, TearLab,
Tecil, Ubiquitome, Vista Therapeutics, Wako Diagnostics…
LIST OF COMPANIES MENTIONED IN THIS REPORT
3©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
CONTENT OF THE REPORT
The report provides:
• An introduction to Point-of-Need testing, our definitions and why it is used
• What can microfluidic technology bring to PoN testing?
• What happened in the industry since 2014, what are the new trends?
• What is the state of the art in each application? What are the characteristics for each of them and the related business models?
• A revision of our PoN market segmentation with technical and economical requirements per segment, examples of products, key players and market forecasts
• Market data 2015 and forecasts 2016-2021
• A focus on molecular diagnostics and assay multiplexing
• A detailed chapter dealing with regulations and reimbursement for several applications (human diagnostics, veterinary diagnostics, agro-food).
4©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
OBJECTIVES OF THE REPORT
• This report provides a complete update of the market data and drivers, key technical,economic requirements and prospects of microfluidic technologies for Point of Needdiagnostics
• It provides an analysis of relation between the potential PON applications, the emergingtechnologies and the assets of microfluidics
Applications
•Market requirements
•Market drivers
•Health system drivers and constrains
Technologies, Systems
•System requirements
•Sample injection, preparation
•Volume of sample
•Systems requirements (economic, technical)
Microfluidics
•Microfluidic Device
•Detection technology
•Fluid handling, mixing
•Manufacturing and materials
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 5
WHO SHOULD BE INTERESTED IN THIS REPORT?
o Diagnostics companies:
• To have a broad overview of all Point-of-Needtesting applications and markets
• To identify new markets and the associatedrequirements
• To monitor and benchmark potentialcompetitors
• To understand behavior evolution
o Industrial & Services companies:• To understand what is the state of the art and
which solutions could bring operational benefits
o Financial & Strategic investors:
• To understand the potential for Point-of-Needtesting
• To know the latest moves within the industry
• To get a list of PoN players and their activities
• To understand which are the sweet spots and thepromising applications
o R&D players:
• To understand new challenges in PoN testing andmicrofluidics
• To address the right market with the righttechnology
o Microfluidic foundries and device makers:
• To understand technical requirements depending onthe applications
• To identify business opportunities and prospects
o Healthcare & Governmental organizations:
• To evaluate benefits of using PoN testing
• To identify relevant companies
o Electronics, MEMS and optics companies:
• To understand the challenges and requirements inmicrofluidics, biology and healthcare
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 6
TABLE OF CONTENTS
1/2
• Introduction
• What happened since 2014?– Mergers and acquisition analysis
– Collaborations
– Fundraising
– New products launched on the market
– Statistical analysis (application covered, type of sample used…)
• Market data and forecasts– Our definitions and Market segmentation
– Point of need tests market data and forecast in volume
– Point of need tests market data and forecast in value
– Related Microfluidic device market for point of need testing in
volume and value
– Microfluidics contribution in the final selling price of a test
– Microfluidic based PoN tests market growth per segments
• Market segmentation– Methodology
– Segments descriptionso S1: Emergency testing
o S2: Third-world infections: remote areas testing
o S3: Home tests, Doctor’s office screening,
Decentralized hospital tests
o S4: Genetic testing, companion diagnostics, forensics
o S5: Veterinary testing
o S6: Environmental and Industrial testing
o S7:Agro-food testing
• Focus on molecular diagnostics– Sample preparation challenges
– Who’s the next PoC giant?
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 7
TABLE OF CONTENTS
2/2
• Assay menus and multiplexing– Which company is providing which assay menu?
– Focus on cardiac biomarkers
– High-plex vs. Low-plex
• Regulatory & market access for Point-of-Care testing– Regulatory requirement per countries (USA, Europe, China)
– Focus on the new IVD Directive arriving in Europe
• Reimbursement landscape for Point-of-Care testing– Reimbursement landscape in USA
– Reimbursement landscape in France, Germany, UK
• Regulations for veterinary diagnostics
• Regulations for agro-food industry
• Supply Chain
• Conclusions
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 8
REPORT METHODOLOGY
Market forecast methodology
Yole’s analysis
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 9
REPORT METHODOLOGY
Technology analysis methodology Information collection
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 10
DEFINITION
• This year, we decided to change the title of our report from « Point-of-Care » to « Point-of-Need ». Indeed, Point-of-Carerefers to human testing whereas we discuss a much larger scope:
• Human testing
• Veterinary testing
• Industrial testing (oil & gas, chemicals…)
• Agro-food testing (dairy, food, beverage, crops…)
• Environmental testing (water quality monitoring and bacteria detection…)
• Forensics
• …
• What is Point-of-Need testing? Several criteria can be discussed: portability, out-of-the-lab, ease of use…
• We define as Point-of-Need testing any diagnostic test performed out of reference laboratories: at home, at the patient’s bed, inICUs (Intensive Care Units), at the physician’s office, near a production line, etc.
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 11
SCOPE OF THE REPORT
• This report will focus on tests to be performed at the point of need (= decentralized testing), already commercialized or indevelopment, based on microfluidic technology.
• Microfluidic technology can be used both in the cartridge/chip and in the system reader.
• Simple tests such as lateral flow analysis and tests done on strips (dedicated for Drugs of abuse tests, Fertility tests, Respiratorydisease tests...) are not included in the scope of this report.
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 12
UPDATED MARKET SEGMENTATION
We updated our market segmentation, accordingly with the market evolution, and explain which
market segments are likely to appear in the next few years.
For each segment, a detailed description is given along with the technical and economic
requiremends, examples of products, market data and forecasts, examples of players…
13
MARKET DATA AND FORECASTS
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
Market data and forecasts are provided and explained per segment and sub-segments, along with an
analysis of the value chain (microfluidic device/reagents/margin…)
14
MARKET SHARES PER PLAYER AND PER SEGMENT
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
Market share estimations are provided per segment
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 15
MARKET ANALYSIS
Which are the recent strategic moves? How much money has been raised?
What are the advantages and limits of the business models adopted by Point-of-Need players?
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies 16
TECHNOLOGY ANALYSIS
What are the recent technology improvements? What are technology developers now focusing on?
Are there major trends on the technical side?
17
SUPPLY CHAIN ANALYSIS
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
Supply chain analysis is provided, along with examples of collaborations per segment
18
REGULATORY, REIMBURSEMENT AND MARKET ACCESS LANDSCAPE
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
Deep investigation has been carried out concerning the regulations, market access and
reimbursement landscape for several markets (medical, veterinary, agro-food) and geographic areas
(Europe, USA, China)
19
Biography & contact
THE AUTHORS
Sébastien ClercMarket & Technology AnalystMedical Technologies
He is a Medical Technologies Analyst at Yole Développement, the “More than Moore” market research and strategy consulting company. Aftergraduating from Grenoble INP with a Biomedical Technologies Master degree, he completed his training with a Master degree in Innovation andTechnology Management, during which he oversaw strategy and marketing..
Contact: [email protected]
Benjamin Roussel, PharmDActivity LeaderMedical Technologies
He is leading the MedTech activity (microfluidic and medical technologies) at Yole Développement, the “More than Moore” market research andstrategy consulting company. He holds a pharmacy diploma from the University Claude Bernard Lyon, complemented by a master degree inTechnology and Innovation Management from EM Lyon Business School.
Contact: [email protected]
©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
20
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Founded in 1998, Yole Développement has grown to become a group of companies providing marketing, technology and strategy consulting, media in addition to corporate finance services. With a strong focus on emerging applications using silicon and/or micro manufacturing (technology or process), Yole Développement group has expanded to include more than 50 associates worldwide covering MEMS, Compound Semiconductors, LED, Image Sensors, Optoelectronics, Microfluidics & Medical, Photovoltaics, Advanced Packaging, Manufacturing, Nanomaterials and Power Electronics. The group supports industrial companies, investors and R&D organizations worldwide to help them understand markets and follow technology trends to develop their business.
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©2016 | www.yole.fr | Point-of-Need Testing: Application of Microfluidic Technologies
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OUR 2016 REPORTS PLANNING (1/2)
MARKET AND TECHNOLOGY REPORTS
by Yole Développement
o MEMS & SENSORS
− Gas Sensor Technology and Market 2016
− Status of the MEMS Industry 2016*
− Sensors for Cellphones and Tablets 2016
− Market and Technology Trends of Inkjet Printheads: Towards New Printing
Opportunities 2016…
− Sensors for Biometry and Recognition 2016
− Finger Print Sensors Market and Technologies 2016
− 3D Imaging & Sensing 2016**
− Silicon Photonics 2016
− Emerging Non Volatile Memories 2016*
o IMAGING & OPTOELECTRONICS
− Sensors for Drones and Robots: Market Opportunities and Technology Revolution
2016
− Status of the CMOS Image Sensor Industry 2016*
− Uncooled Infrared Imaging Technology & Market Trends 2016*
− Imaging Technologies for Automotive 2016
− 3D Imaging & Sensing 2016**
− Silicon Photonics 2016
o MEDTECH
− BioMEMS: Microsystems for Healthcare Applications 2016
− Point of Need Testing 2016: Application of Microfluidic Technologies
o ADVANCED PACKAGING
− FanOut WLP: Technology Trends and Business Update 2016*
− Embedded Die Packaging: Technology and Markets Trends 2016*
− 2.5D & 3D IC Business Update 2016
− Status of the Advanced Packaging Industry 2016*
− Advanced Packaging in Emerging Markets: China 2016
o MANUFACTURING
− Inspection and Metrology Technology and Applications Trends in Advanced Packaging
2016**
− Equipment and Materials for Fan Out Technology (Wafer vs Panel)
− Equipment and Materials for Advanced Substrates
− Equipment and Materials for 3D T(X)V Technology
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CMOS 2016
**To be confirmed
32
OUR 2016 REPORTS PLANNING (2/2)
o COMPOUND SEMICONDUCTORS
− GaN RF Devices Market: Applications, Players, Technology, and Substrates 2016 – 2022
− SiC Modules, Devices and Substrates for Power Electronics 2016*
− GaN Modules, Devices and Substrates for Power Electronics 2016*
− Sapphire Applications & Market 2016: from LED to Consumer Electronics*
o LED
− Automotive Lighting: Technology, Industry, and Market Trends 2016
− OLED for Lighting - Technology, Industry and Market Trends 2016
− Sapphire Applications and Market 2016: From LED to Consumer Electronics*
− LED Packaging 2016
− Microdisplays and MicroLEDs
− UV LED Technology, Manufacturing and Applications Trends 2016*
o POWER ELECTRONICS
− Power Electronics for EV/HEV 2016: Market, Innovations and Trends
− GaN RF Devices Market: Applications, Players, Technology, and Substrates 2016 – 2022
− Opportunities for Power Electronics in Renewable Electricity Generation 2016
− Status of Power Electronics Industry 2016*
− Passive Components Technologies and Market Trends for Power Electronics 2016
− SiC Modules, Devices and Substrates for Power Electronics 2016*
− GaN Modules, Devices and Substrates for Power Electronics 2016*
− Inverter Technologies Trends & Market Expectations 2016
− Thermal Management for LED and Power 2016
o BATTERY
− Market Trends and Technologies in Battery Pack and Assembly 2016
− Innovative and Emerging Technologies in Energy Storage Market 2016
**To be confirmed
PATENT ANALYSIS by Knowmadeo Patent Infringement (crossed analysis based on Knowmade and System Plus Analysis
expertise)
o Patent Investigation (crossed analysis based on Knowmade & Yole Développement
expertise)
o Patent Landscape
TEARDOWN & REVERSE COSTING by System Plus ConsultingMore than 30 teardowns and reverse costing analysis and cost simulation tools to be
published in 2016.
33
OUR 2015 PUBLISHED REPORTS LIST
o MEMS & SENSORS
− Sensors and Data Management for Autonomous Vehicles
− Sensors for Wearable Electronics And Mobile Healthcare
− Status of the MEMS Industry
− Uncooled Infrared Imaging Technology & Market Trends
− Infrared Detector Technology & Market Trends
− High-End Gyroscopes, Accelerometers and IMUs for Defense, Aerospace & Industrial
− Emerging Non Volatile Memory (NVM) Technology & Market Trends
o IMAGING & OPTOELECTRONICS
− Camera Module Industry
− Uncooled Infrared Imaging Technology & Market Trends
− Status of the CMOS Image Sensors
− Infrared Detector Technology & Market Trends
o MEDTECH
− Sample Preparation Automation Through Emerging Microfluidic Technologies
− 2015 Microfluidic Applications in the Pharmaceutical, Life Sciences, In-Vitro Diagnostic, and
Medical Device Markets
− Sensors for Wearable Electronics And Mobile Healthcare
o COMPOUND SEMICONDUCTORS
− Sapphire Applications & Market 2015: from LED to Consumer Electronics
− SiC, GaN, and other Wide Band Gap (WBG) materials for power electronics applications
− GaN and SiC Devices for Power Electronics Applications
o LED
− LED Lighting Module Technology, Industry and Market Trends 2015
− UV LED - Technology, Manufacturing and Application Trends
− Phosphors & Quantum Dots 2015: LED Downconverters for Lighting & Displays
− Sapphire Applications & Market 2015: from LED to Consumer Electronics
o POWER ELECTRONICS
− Power Packaging Technology Trends and Market Expectations
− Energy Management for Smart Grid, Cities and Buildings: Opportunities for Battery
Electricity Storage Solutions
− Status of Chinese Power Electronics Industry
− New Technologies and Architectures for Efficient Data Center
− IGBT Market and Technology Trends
− Status of Power Electronics Industry
− SiC, GaN, and other Wide Band Gap (WBG) materials for power electronics applications
− GaN and SiC Devices for Power Electronics Applications
o ADVANCED PACKAGING
− Status of the Advanced Packaging Industry
− Supply Chain Readiness for Panel Manufacturing in Packaging
− Fan-in Wafer Level Packaging: Market and Technology Trends
− Flip Chip: Technologies and Markets Trends
− Fan-Out and Embedded Die: Technologies & Market Trends
o MANUFACTURING
− Photolithography Equipment and Materials for Advanced Packaging, MEMS and LED
Applications
− Emerging Non Volatile Memory (NVM) Technology & Market Trends
34
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