Worldwide Medical Ceramics Sample Nano 873

n-tech Research Report

Worldwide Medical Ceramics Markets:

2016-2025

Issue date: April 2016

Report number: Nano-873

n-tech Research PO Box 3840 Glen Allen, VA 23058

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Worldwide Medical Ceramics Markets: 2016-2025

Report Description

This report analyzes the market for medical ceramics, a business that n-tech believes will major opportunity for both materials firms and medical device manufacturers in the coming decade. It examines the latest products, with a

special focus on product releases in the past year, as well as the recent technical developments in the medical ceramics space. It also discusses the hurdles that

medical ceramic products must overcome to achieve market acceptance, including the demands made by regulatory regimes in leading national and regional markets.

Medical ceramics is already established for orthopedic and dental implants; areas in

which they provide patients with metals-free solutions. This report shows how the revenue generation for medical ceramics can be extended to newer areas such the as healing of long segmental bone defects and to scaffold-guided bone

replacements.

This report also provides n-tech’s assessments of the strategies of leading firms active in medical and dental ceramics space. In addition, the report contains

granular ten-year forecasts of medical/dental ceramic shipments in volume and value terms, with breakouts by application, type of material and geographical region.

Materials covered include alumina, zirconia, silicon ceramics, hydroxyapatite,

bioglass, piezoceramics, nanoceramics, and other materials. Applications discussed in this report include, hip and knee implants; crowns, bridges and other dental

implants; surgical and diagnostic tools, implantable electronic implants, and regenerative medicine. Ceramics are an ideal material in these applications

because of their wear resistance, inherent stability and excellent electrical properties.

Major firms that are discussed in the report include: 3M, Advanced BioHealing, Amedica, Bioengineering Laboratories, Bonesupport, CeramTec, CoorsTek Medical,

Cytophil, Danaher, Dentsply-Sirona, DiscGenics, RegenScientific, DePuy Synthes, Heraeus Johnson & Johnson, Kinetic Concepts, MicroPort Orthopedics, Morgan

Technical Ceramics, Straumann, Stryker and Zimmer Biomet.

Table of Contents

Executive Summary

E.1 Opportunities in the Medical Device and Implant Segment

E.1.1 Opportunities for Ceramics in the Prostheses and Bone Replacement Markets

E.1.2 New Production Methods Improve the Scope of Medical Ceramic Applications: An

Emerging Role for Additive Manufacturing


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E.1.3 Strong Potential Continues for Bioactive Ceramic Coatings and Related Composites

E.1.4 Development of Piezoceramics and Nanoceramics in medical applications

E.2 Opportunities for the Healthcare Segment

E.2.1 Ceramics in Orthopedics and Dentistry as an Opportunity

E.2.2 Bone Regeneration Market and Scaffold-Guided Tissue Engineering: Latest

Developments

E.2.3 Injectable Ceramics Expanding the Regenerative Market for Medical Ceramics

E.2.4 Device Makers Need to Prepare for Move to Increased Outpatient Procedures

E.3 Opportunities for Materials Firms

E.3.1 Cost-effective Large-Scale Production of High Quality Materials Is the Key to Success

E.3.2 Others Factors Affecting Medical Ceramic Manufacturers

E.4 Some Firms to Watch in Medical Ceramics

E.4.1 Orthopedic Implant Manufacturers

E.4.2 Dental Implant Manufacturers

E.4.3 Medical Ceramic Materials Manufacturers and Injectable Ceramic Solution Providers

E.5 Summary of Ten-Year Forecasts of Medical Ceramics

Chapter One: Introduction

1.1 Background to this Report

1.1.1 Medical Ceramics: Two Key Markets

1.1.2 Bioceramics: Tooth and Bone Replacements Dominate Market

1.1.3 Wide Use of Ceramics In Biomedical Equipment

1.1.4 Opportunities for Implantable Bioceramics

1.1.5 Nanoceramic Composites: Promising but Risky

1.2 Objectives and Scope of This Report

1.3 Information Sources and Methodology for This Report

1.4 Plan of This Report

Chapter Two: Medical Ceramics: Current Use and Major Technology Trends

2.1 Ceramic Composites as Dental and Orthopedic Implants: Key Medical-Related Trends

2.1.1 Ceramic Compositions

2.1.2 New Production Methods for Orthopedic and Dental Implants Using Ceramics

2.1.3 Ceramic Injection Molding Produces Small, High-Precision and Intricate Implants

2.1.4 Calcium Phosphate Coatings

2.1.5 Hydroxyapatite (HA) Coatings

2.1.6 Glass Ceramic Coatings

2.1.7 Diamond-Like Carbon Coatings

2.2 Alumina- and Zirconia-based Medical Ceramics

2.3 Predominantly Glass and Partially Filled Glass Ceramics

2.4 Future Markets for Piezoceramics and Sensors

2.4.1 Medical Imaging

2.5 Current and Future Applications of Medical Nanoceramics


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2.5.1 Companies and Products

2.6 Key Points Made in this Chapter

Chapter Three: Application and Markets for Medical Ceramics

3.1 Major Factors Impacting the Medical Ceramics Market

3.1.1 The Impact of Clinical Trials

3.1.2 Environmental Regulations and Standards: ISO 13485

3.1.3 Intellectual Property Issues

3.1.4 Research and Development

3.2 Medical Ceramics in Orthopedics

3.2.1 Total Hip and Joint Replacements

3.2.2 Artificial Joints and Bioglass Implants

3.2.3 Scaffold-Guided Tissue Engineering

3.2.4 Other Orthopedic Applications

3.2.5 Pricing and Forecast Assumptions

3.2.6 Ten-Year Forecast of Medical Ceramics in Orthopedics, by Material and Medical

Procedure

3.2.7 Notable Companies and Other Organizations Influencing the Use of Ceramics in

Orthopedics

3.3 Medical Ceramics for Dentistry

3.3.1 Main Applications for Medical Ceramics in Dentistry

3.3.2 Ten-Year Forecast of Medical Ceramics in Dentistry by Material and Dental Procedure


Dentistry

3.4 Medical Ceramics in Medical Equipment

3.4.1 Ceramics for Surgical Equipment

3.4.2 Diagnostic Equipment: Piezoceramics

3.4.3 Ceramics in Implantable Electronic Devices

3.4.4 Ten-Year Forecast of Medical Equipment by Material and Equipment Type


Medical Equipment

3.5 Injectable Ceramics and Ceramic Composites for In-Vivo Regeneration of Hard and Soft

Tissues

3.5.1 Ten-Year Forecast of Medical Ceramics in Regeneration Procedures


Regeneration Procedures

Chapter Four: Summary of Forecasts and Geographical Analysis

4.1 Summary of Ten-Year Market Forecasts

4.1.1 Summary Forecast by Procedure

4.1.2 Summary Forecast by Type of Equipment/Implant

4.1.3 Summary Forecast by Type of Medical Ceramic Material

4.2 Market for Medical Ceramics in the U.S.


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4.2.1 Regulatory Environment

4.2.2 Trends and Opportunities

4.2.3 Ten-Year Forecast of the U.S. Medical Ceramic Market

4.3 Market for Medical Ceramics in Europe



4.3.3 Ten-Year Forecast of the European Market for Medical Ceramics

4.4 Market for Medical Ceramics in Japan



4.4.3 Ten-Year Forecasts of Markets for Medical Ceramics in Japan

4.5 Market for Medical Ceramics in China



4.5.3 Ten-Year Forecast of the Medical Ceramic Market in China

4.6 Other Notable National and Regional Markets for Medical Ceramics

4.6.1 Canada

4.6.2 Australia

4.6.1 Ten-Year Forecast of the Medical Ceramic Market in Other Parts of the World

Acronyms and Abbreviations Used In this Report

About the Authors

List of Exhibits

Exhibit E-1: Ten-Year Forecast of the Medical Ceramics Market (Global)--US$ Millions

Exhibit 2-1: Biomedical Applications for Bioceramics

Exhibit 2-2: Factors Favoring the Global Medical Ceramics Industry

Exhibit 2-3: Key Bioceramic Coatings and their Future Potential

Exhibit 3-1: Clinical Trials and Their Impact on Ceramics

Exhibit 3-2: Key Intellectual Property Issues

Exhibit 3-3: Major Medical Ceramics Manufacturers and their Key Strengths

Exhibit 3-4: Key Medical Ceramics for Orthopedic Applications, Major Benefits, and Future

Outlook

Exhibit 3-5: Ceramic Material Pricing Assumptions

Exhibit 3-6: End-Product Cost and Medical Ceramic Content Estimates

Exhibit 3-7: Approximate Share of the Market for Different Ceramic Materials in Each

Application

Exhibit 3-8: Ten-Year Forecast of Ceramics in Conventional Hip Implants, by Ceramic and

Implant Type

Exhibit 3-9: Ten-Year Forecast of Ceramics in Conventional Knee Implants, by Ceramic and

Implant Type

Exhibit 3-10: Ten-Year Forecast of Ceramics in Crowns and Bridges, by Material and

Equipment Type


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Exhibit 3-11: Ten-Year Forecast of Ceramics in Dental Implants, by Material

Exhibit 3-12: Key Piezoceramic-based Diagnostic Equipment and Their Potential Benefits

Exhibit 3-13: Ten-Year Forecast of Ceramics in Surgical Equipment, by Equipment Type

Exhibit 3-14: Ten-Year Forecast of Piezoceramics in Diagnostic Equipment, by Equipment

Type

Exhibit 3-15: Ten-Year Forecast of Ceramics in Implantable Electronic Devices, by

Equipment Type

Exhibit 3-16: Ten-Year Forecast of Ceramics in Regenerative Applications

Exhibit 4-1: Ten-Year Revenue Forecast for Medical Ceramics by Procedure (Global)

Exhibit 4-2: Ten-Year Revenue Forecast for Medical Ceramics by Equipment/Implant Type

(US$ Millions)

Exhibit 4-3: Global Ten-Year Revenue Forecast for Medical Ceramics by Material Type

(US$ Millions)

Exhibit 4-4: Global Ten-Year Volume Forecast for Medical Ceramics by Material Type (Metric

Tons)

Exhibit 4-5: Recent Launches of Ceramic-based Medical Devices in the U.S.

Exhibit 4-6: Ten-Year Forecast for Medical Ceramics in the U.S. (US$ Millions)

Exhibit 4-7: Ceramic-based Medical Devices in Europe

Exhibit 4-8: Ten-Year Forecast for Medical Ceramics in Europe (US$ Millions)

Exhibit 4-10: Recent Launches of Ceramic-based Medical Devices in the Asian Region

Exhibit 4-11: Ten-Year Forecast for Medical Ceramics in China (US$ Millions)

Exhibit 4-12: Ten-Year Forecast of the Medical Ceramics Market in the Rest of the World

(US$ Millions)

Exhibit 4-13: Ten-Year Medical Ceramics Summary Revenue Forecast by County/Region

(US$ Millions)

Related Reports

Worldwide Medical Polymer Markets: 2013-2020

Worldwide Medical Ceramics Markets: 2013

Worldwide Medical Polymer Markets: 2016-2025

http://ntechresearch.com/market_reports/worldwide_medical_polymer_markets_2013_2020

http://ntechresearch.com/market_reports/worldwide_medical_ceramics_markets_2013

http://ntechresearch.com/market_reports/worldwide-medical-polymer-markets-2016-2025


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Chapter One: Introduction

1.1 Background to this Report

1.1.1 Medical Ceramics: Two Key Markets

In the past, medical ceramics were represented by ceramic and clay implants that

remained inert in the host and acted as scaffolds or supports. Today, the scenario has

changed remarkably due to the introduction of an entirely new generation of

bioceramics. These implants are, amazingly, structurally and functionally compatible

with living tissue in the human body and contribute to the development of new tissue.

Over the past two decades, there has been tremendous improvement in the

performance of these bioceramics, and technology advances have created a very huge

market for ceramics in the medical sector.

The two key markets for medical ceramics are:

Implantable bioceramics, which consist of medical devices and implants that are

on the market as tooth and bone replacements. Bone and joint replacements are

essentially metal and ceramic composites, whereas dental implants are mostly

made of all-ceramic systems. Bioceramics are a huge success as implantable

materials because they are bioactive in their natural compositions and can be

fabricated into various composites with metals, both natural and synthetic

polymers, carbon fibers, and most recently, carbon nanotubes.

Medical equipment, including analytical and scientific instrumentation; ceramics

are primarily used in analytical, diagnostic, vision, and therapy systems.

Although there are a few risks and ambiguities regarding the use of implants and

medical devices based on ceramics, n-tech certainly believes that the market for

implantable bioceramics will continue to grow in the future. This growth can possibly be

converted into profitable businesses by the companies manufacturing the medical

ceramic devices and the firms that supply the necessary raw materials.

1.1.2 Bioceramics: Tooth and Bone Replacements Dominate Market

Biocompatibility and resistance to wear have made ceramic materials ideal for a range

of medical applications, from artificial joints to electronic sensors, stimulators, and drug

delivery devices. Alumina and zirconia, among other ceramics, have been successful in

withstanding the hostile environment of the human body. The implantable bioceramics

market primarily consists of two segments: tooth and bone replacements.


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Dental implants: The dental consumables segment includes crowns/bridges, implants,

orthodontics, impressive materials, composites, endodontics, adhesives, and cements,

while the dental equipment segment is composed of large equipment, such as

autoclaves, sterilizers, chairs, communication systems, compressors, cuspidors, and

digital imaging systems. Small equipment, including amalgam removal systems,

amalgamators, hand piece cleaners, lab equipment, duplicators, and ultrasonic

cleaners, also fall into this product segment.

The leading multinational manufacturers account for approximately two-thirds of the

global implant market and pursue premium strategies. The remainder of the market is

very fragmented, consisting of several hundred competitors, the majority of which have

a local country or regional focus.

The competition in the global dental implant market is intense, with only a few large

players the likes of Straumann, Dentsply Sirino, Danaher, 3M, Zimmer Biomet. The

main drivers of the global dental market include low dental implant penetration rates and

an increasing worldwide elderly population. Another factor that drives the dental market

is longer life expectancies, because an increase in life expectancy results in a more

elderly population. Increasing consumer incomes and increasing urban populations are

other major factors that are boosting the dental market.

UT Dentistry first U.S. practice to offer new FDA-approved ceramic implants:

Patients who need dental implants but have thin gums or are allergic to titanium may

benefit from a new, stronger ceramic dental implant just approved by the U.S. Food and

Drug Administration. The new implant is available through UT Dentistry, the clinical

practice of the School of Dentistry at the University of Texas Health Science Center San

Antonio.

Already used for some time in Europe, the implant was approved by the FDA in January

2016 for use in the United States. The ceramic implant is placed with a protective cap to

allow for the three- to four-month healing phase before the tooth can be used for

chewing. Although the ceramic implant is available to all implant patients, the cost is

higher than titanium implants.

World's First FDA Approved Two-Piece and Tapered All-Zirconia Zirkolith Dental

Implants: With more than a decade of clinical experience in Europe, Swiss-based Z-

Systems is a leader in solutions for naturally white, metal-free zirconia dental implants.

In 2015, the FDA approved Zirkolith implants that are manufactured in a proprietary

process from high quality zirconia, a material successfully used for medical devices like

hip replacements since the 1980s. While most dental implants are today still made of


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gray titanium, Zirkolith implants overcome the aesthetic limitations and combine

biocompatibility with excellent osseointegration and reliability.

With the latest FDA approved Z-Systems generation implants, the Z5cTwo-Piece

Zirconia Implant, offers excellent osseointegration, similar benefits as today's 2 piece

systems, no grey shin through, low plaque adhesion, and achieve an industry-leading

98 percent-plus implant survival rate.

Bone implants: Alumina and zirconia are the main ceramic materials for bone implants,

largely due to their mechanical strength and chemical inertness. Morgan Technical

Ceramics is one of the globally known medical ceramic manufacturers that has

substantial experience in developing clinically proven ceramic joints using alumina and

zirconia.

MTC's Vitox AMC alumina matrix composite bioceramic material used in hip joints has

been shown to have exceptionally low wear rates compared with alternative materials. It

is therefore a dependable solution that does not have the potential health risks

associated with metal hip joints, and it is longer lasting, thus enabling patients to

continue to lead active lifestyles.

Medical-grade silicon nitride ceramics of U.S.-based Amedica have good potential to

find applicability in the spinal and arthroplasty segments. The Valeo IITM AL interbody

fusion device is made of micro-composite ceramic silicon nitride biomaterial, which is

believed to help promote bone growth and also has anti-infective properties. The silicon

nitride biomaterial is semi-radiolucent and compatible with all imaging modalities with

clearly visible boundaries in X-rays and produces no artifacts under magnetic

resonance imaging or computed tomography. Amedica has patented this technology for

the use in medical devices to produce an implant designed for the posterior lumbar

interbody procedure to restore disc height.

In 2016, Amedica, a company that develops and commercializes silicon nitride ceramics

as a biomaterial platform, collaborated with Celling Biosciences, a leader in autologous

cellular therapy technologies, to research and develop biologically enhanced implants.

Results from a recent in-vivo scientific study show that Amedica’s proprietary silicon

nitride composition significantly outperformed PEEK in attachment testing of

mesenchymal stem cells. Amedica’s silicon nitride biomaterial contains natural nano-

surface topography and chemistry that play an active role in implant integration, which

current trends in surface modification efforts have not replicated. The results of the

study suggest the microenvironment of silicon nitride promotes better cell adhesion and

compatibility with five times greater cell adhesion as compared to the PEEK material

used.


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Ceramics are also used in bone tissue engineering because of their osteoinductive and

biocompatible properties. Scaffolds that typically act as engineered bone grafts can be

used in several specialty applications, such as bone regeneration and wound healing.

1.1.3 Wide Use of Ceramics In Biomedical Equipment

Ceramics are widely used in biomedical equipment, such as ultrasound machines,

point-of-care systems, medical test equipment, and imaging instruments. MTC has, for

example, launched its piezoceramic objective focusing device that provides the

millisecond responsiveness essential for DNA research. Piezoceramics have become

the premium choice for medical device manufacturers for the execution of accurate

positioning and precise movements.

Because the number of people who need implants is always on the rise, demand for

implantable bioceramics and composites continues to increase, while the number of

ceramic parts used in biomedical equipment depends on the number of pieces of

equipment manufactured and their utility. Thus, n-tech Research believes that the

demand for implantable bioceramics materials will be higher than that for ceramic

components used in medical equipment.

1.1.4 Opportunities for Implantable Bioceramics

Dental consumables represent the largest segment of the dental care industry, followed

by dental equipment. In other words, implantable bioceramics consisting of tooth and

bone replacements are in great demand and account for most of the market, while the

tools and instruments used during implantation account for just a small part of the

overall market.

The scenario described above suggests that not only the number of small implants used

by the global population is growing and likely to continue to grow, but also the

magnitude of sales are steadily increasing. Due to this steady growth in the small

implants market, we expect the bioceramics materials market to continue to grow over

the next eight years.

In this growing market, bioceramic materials suppliers will have expanded opportunities

to generate new business revenues from both natural substrates and composites and

novel manufacturing technologies, such as injection molding and electro-spinning.

However, the significant contributors to clinical success will be materials that are

bioactive, improve lifetimes, and reduce manufacturing costs.

The implant manufacturing giants like Straumann, Dentsply Sirino, Danaher, 3M,

Zimmer Biomet offer end-to-end solutions to patients that receive bone and joint

replacements, from computed tomography (CT) scans to the actual devices. More than

20 percent of all of the prosthetic elements (tooth-based and implant-based) were


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produced using CAD/CAM in 2012. Although the majority of prosthetic elements are still

made by hand, the share of dentists using CAD/CAM prosthetic elements continues to

increase.

1.1.5 Nanoceramic Composites: Promising but Risky

Ceramic materials fabricated in the form of nano-sized particles show excellent promise

in bone tissue regeneration applications. In fact many in vitro studies have proved

beyond a doubt that bone-forming cells called osteoblasts have proliferated on

substrates with nanoceramic particles and coatings.

However, when the ceramics are formed into composites with carbon nanotubes

(CNTs), cytotoxicity has been observed in some experiments. In addition, nanoceramic

polymer composites with amine and amide groups may lead to the accumulation of toxic

debris that can evoke inflammatory and/or immune responses and ultimately lead to the

rejection of the composite when implanted in a human host. Moreover, the rejection of

the implant sometimes can lead to sepsis or septic shock.

Therefore, while nanoceramic composites have great potential in the future as implants

and medical devices, n-tech believes that key questions about their biocompatibility and

bioactive properties must first be addressed before that potential can be realized.

Major implant manufacturers must conduct thorough research studies and, more

importantly, appropriate clinical trials before implants and prostheses containing

nanoceramic composites are released to the market.

In addition, n-tech has observed that the number of companies offering nanoceramics is

growing. Therefore, firms that simply offer acceptable clinical solutions, and not clinically

significant advantages, will only be able to compete on price. However, if there is a price

advantage, because most clinicians are price sensitive, they may gravitate to the newer

lower-cost substitute implants.

1.2 Objectives and Scope of This Report

This report is the latest n-tech Research report on opportunities in the medical ceramics

markets. n-tech has been providing comprehensive industry analysis of the medical

ceramics markets for several years, and this report presents information on the existing

markets and emerging opportunities in the field. Thus, the goal of this report is to

analyze and forecast the prospects for bioceramic materials and implants in the coming

ten years.

We have extensively studied the market dynamics in the medical ceramics materials

sector and analyzed what we perceive to be the different opportunities that are

emerging for materials used in both implantable bioceramics and ceramics. These


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opportunities are summarized in detailed forecasts both in revenue and volume terms

for all of the predominantly used materials in medical ceramics, as well as the latest

substrates and composites.

1.3 Information Sources and Methodology for This Report

n-tech has conducted industry research on medical ceramics and bioceramic materials,

and this report is written on the basis of ongoing discussions with key players

throughout the industrial community. In addition, a cumulative analysis of the industry,

including the strengths and weaknesses of the major players, was considered when

drafting this report.

Additional information for this report was drawn from the Internet, commercial

databases, trade press articles, press releases, industry reports and market updates,

and corporate literature in order to further understand the activity that is taking place in

the medical ceramics market space.

In addition, this report is entirely international in scope. We have conducted interviews

worldwide in order to collect information for the report and arrived at the worldwide

forecasts without focusing on any specific geographic areas.

The medical ceramics market forecasts presented in this report are drawn from our

estimates of both material shipments and manufacturing capacities. We also consider

the success rates of the implants and estimate the needs of major medical ceramics

producers with respect to their materials suppliers. The materials forecasts are broken

down by material type and functionality and fabrication process. The forecasting

methods followed and assumptions used when preparing the forecasts in this report are

explained in more detail in Chapter Four.

1.4 Plan of This Report

Chapter Two discusses the major ceramics technologies and the various current

applications for bioceramics. An explanation of the existing market status with a few

insights into the changes that should occur in the market in order to make it more

dynamic and profitable is also provided. This analysis forms the basis for our forecasts,

which are presented later in Chapter Four of the report.

Chapter Three examines the applications for medical ceramics and reviews the major

factors influencing the medical ceramics market with a focus on recent developments in

intellectual property, acquisitions, and consolidation. In this chapter, we analyze the

R&D strategies of some of the major players in this space with respect to ceramics for

use in implants, injectable ceramics, and scaffold-guided bone tissue engineering on

bioceramic scaffolds.


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We also provide a comprehensive account of notable companies and other

organizations influencing the use of ceramics in implants, regenerative medicine, and

medical equipment and present our detailed Ten-year forecasts of implantable

bioceramics and ceramics used in medical instrumentation. The forecasts are organized

primarily by application and functionality.

In Chapter Four, we provide summary ten-year forecasts of the bioceramics materials

sector based on application, functionality, and type of material, with considerable focus

on the processing and fabrication technologies. We also present our ten-year forecasts

for key geographies, including the U.S., Europe, Japan, China, and the rest of the world.