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Global Markets for Implantable Biomaterials

  • January 2015
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  • BCC Research
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  • 229 pages

This BCC Research report examines the global market for medical biomaterials by geographic region and by market segment, and also provides an in-depth discussion and analysis of the application of biomaterials and a review of new and developing technology platforms.

Use this report to:
- Identify the latest developments into new and innovative implantable biomaterials, their properties, their method of manufacture and intended clinical applications.
- Learn about the main products in each sector and plan a product entry strategy in line with the strengths and weaknesses of the competition.
- Analyze the challenges and potential threats facing the biomaterials industry.

Highlights
- The global market for implantable biomaterials was worth nearly $75.1 billion in 2013. This market is expected to grow at a compound annual growth rate (CAGR) of 6.7% between 2014 and 2019 resulting in $79.1 billion in 2014 and $109.5 billion global market in 2019.
- The North America market totaled $38.3 billion in 2013. This market should increase to about $40.2 billion in 2014 and should reach about $51.8 billion by 2019, demonstrating a CAGR of 5.2% from 2014 to 2019.
- The Latin American market totaled $3.4 billion in 2013. This market should reach almost $3.8 billion in 2014 and $6.8 billion by 2019, a CAGR of 12.6% from 2014 to 2019.

Introduction & Scope

INTRODUCTION
Biomaterials have made a significant contribution in improving the outcomes of patients suffering from the issues associated with long-term chronic conditions as well
as helping to resolve the problems of traumatic injury. It is anticipated that the use of medical biomaterials will continue to expand rapidly through the emergence of new
and innovative technologies as well as the identification of new applications for products based on biomaterial technologies.

By definition, the use of biomaterials covers a broad area of therapeutic use. In fact, any natural or synthetic material that interfaces with living tissue and/or biological
fluids may be classified as a biomaterial. Even common materials such as polyester have shown usefulness in some biomedical applications. However, certain physical,
chemical and mechanical characteristics render some materials more desirable than others for biological application.

To complicate things further, the determination of these desirable traits depends on the material’s intended use in the body. For example, the material for a bone implant
must exhibit great compressive strength, while the material for a ligament replacement must display far more flexibility and tensile strength. In all cases, however,
a biomaterial must perform compatibly with the body. In other words, the biocompatibility and, in some cases, bioactivity, of the material comprise key factors in
determining whether a new graft or implant succeeds in the body. In order to define biocompatibility, it may be easier to define what it is not, rather than what it is. A biocompatible material disrupts normal body functions as little as possible. Therefore, the material causes no thrombogenic, toxic or allergic inflammatory response when the material is placed in vivo. The material must not stimulate changes in plasma proteins and enzymes or cause an immunologic reaction, nor can it instigate carcinogenic, mutagenic or teratogenic (gross tissue change) effects.

Bioactive materials play a more aggressive role in the body. While a biocompatible material should affect the equilibrium of the body as little as possible, a bioactive
material recruits specific interactions between the material and surrounding tissue. For example, a bioactive material can encourage tissue integration to aid in the fixation of
an implant in the body. Many total hip implants operations today rely partially on a porous coating of hydroxyapatite (HA), a normal component of bone, to help permanently stabilize the stem of the implant in the bone. The coating encourages ingrowth from the surrounding tissue that interlocks within the pores, much like the pieces of a jigsaw puzzle lock together. Although many current medical procedures call for inert biocompatible materials, the increasing understanding of tissue interaction promises many more applications for aggressive bioactive materials.

STUDY GOALS AND OBJECTIVES
The aim of this report is to conduct an initial review of the biomaterials currently in use as implantable medical devices and then to further the discussion with a review of
some of the latest developments into new and innovative biomaterials, their properties, their method of manufacture and intended clinical applications.

The key objective was also to conduct and provide an analysis of the market value, growth rates, market shares and market development, as well as examine the market
dynamics and market factors influencing the growth and development of this market. This report also looks at the challenges and potential threats facing the industry, and
the factors influencing the market shares of the major market suppliers as well as smaller indigenous manufacturers in local markets. The emphasis of this report is to provide the reader with:
- A detailed analysis of the revenues and forecasts for the global implantable biomaterials market, with a more detailed analysis and forecast of the revenues for the global market subdivided by major market subsegments by geographic region and finally by selected country.
- A detailed analysis of the global market share, together with a more detailed analysis of the market share by geographic regions and finally by selected country.
In addition, this analysis provides a:
- Detailed review of the current products and product specifications that are available for all the market segments identified.
- Profile of the individual market subsegments within the major market segments analyzed.
- Review of the major market opportunities through the recognition of specific high-growth and emerging market opportunities.
- Brief description of the historical development for each of the major market segments.
- Profile of the leading suppliers of implantable biomaterials together with related information about specific products.

The study will allow the reader to:
- Evaluate the effect of strategic factors such as technology-driven change and industry consolidation.
- Investigate the current market dynamics driving change in the implantable biomaterials market.
- Assess future growth opportunities in the implantable biomaterials market.
- Review the main products in each sector and plan a product entry strategy in line with the strengths and weaknesses of the competition.
- Utilize the report to help realize an individual company’s position in the marketplace and to provide insight into the future of the market and the opportunities that exist.

SCOPE OF THE REPORT
This market research report focuses on the global market for medical biomaterials by geographic region and by market segment, and also provides an in-depth discussion
and analysis of the application of biomaterials and a review of new and developing technology platforms. This report also examines companies that are actively developing and marketing medical biomaterials around the world. Detailed tables and charts with sales forecasts and market share data are also included.

Products that are used as biomaterials can be segmented by the materials from which they are made; for example:
- Metallic.
- Ceramic.
- Polymeric.
- Natural.
- Composites.

In addition to the segmentation by material type, medical biomaterials can also be examined by application/therapeutic area as follows:
- Orthopedic.
- Cardiovascular.
- Dental.
- Immunology and infection.
- Pulmonary/respiratory disease.
- Plastic surgery.
- Urology/gynecology.
- Endocrinology and metabolic diseases.
- Ophthalmology.
- Oncology.
- Dermatology and wound care.
- Gastroenterology.
- Neurology.
- Oto-Rhino-Laryngology (ORL).

The global market for medical biomaterials has been estimated at $48 billion in 2013, and is expected to more than double by 2019, reaching $102.5 billion. The growth
represents a compound annual growth rate (CAGR) of by the end of the forecast period. In 2013, the cardiovascular biomaterial segment represented the largest single market
segment, accounting for 34.5% of the global biomaterial market, followed by the orthopedic segment. Plastic surgery and wound healing applications are expected to
experience the highest growth in the coming years.

North America is the largest market for biomaterials and is expected to grow at CAGR of 5.2% from 2014 to 2019 due to an increase in the aging population. Due to rising
awareness of biomaterial products in Asia, and increased partnerships and collaborations, the Asian market is expected to grow at a CAGR of 21.5% from 2014 to 2019.

Table Of Contents

Global Markets for Implantable Biomaterials
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 3
SCOPE OF THE REPORT 4
INFORMATION SOURCES 5
ANALYST'S CREDENTIALS 6
RELATED BCC RESEARCH REPORTS 6
BCC RESEARCH WEBSITE 7
DISCLAIMER 7
CHAPTER 2 SUMMARY 9
SUMMARY TABLE GLOBAL REVENUE FORECASTS FOR IMPLANTABLE BIOMATERIALS
BY REGION, THROUGH 2019 ($ MILLIONS) 10
SUMMARY FIGURE GLOBAL REVENUE FORECASTS FOR IMPLANTABLE
BIOMATERIALS, 2010-2019 ($ MILLIONS) 10
CHAPTER 3 OVERVIEW 12
CLASSIFICATION OF BIOMATERIALS USED IN MEDICINE 13
FIGURE 1 CLASSIFICATION OF BIOMATERIALS 13
NATURAL BIOMATERIALS 13
SYNTHETIC BIOMATERIALS 13
COMBINED BIOMATERIALS 13
SYNTHETIC BIOMATERIALS 14
POLYMER BIOMATERIALS 14
Synthetic Polymeric Materials 15
TABLE 1 FDA LIST OF THERMOPLASTIC, THERMOSET/ELASTOMER AND
ABSORBABLE BIOMATERIALS 15
Synthetic Non-Biodegradable Polymers 16
TABLE 2 FDA LIST OF ADHESIVE AND FLUID BIOMATERIALS 16
Ultra-high-Molecular-Weight Polyethylene 16
Polyetheretherketone (PEEK) 17
Polymethyl Methacrylate 18
TABLE 3 BONE CEMENT COMPONENTS 18
METALLIC BIOMATERIAL ALLOYS AND TECHNOLOGIES 22
TABLE 4 FDA GENERAL CLASSIFICATION OF METALLIC BIOMATERIALS
COMPENDIUM 22
CERAMIC BIOMATERIALS 28
TABLE 5 FDA GENERAL CLASSIFICATION OF CERAMIC AND COMPOSITE CERAMIC
BIOMATERIALS COMPENDIUM 28
Bioinert Ceramics 29
Bioactive Ceramics 30
Hydroxylapatite 30
Tricalcium Phosphate (TCP) 30
Ceramic on Ceramic Bearings 31
COMPOSITE BIOMATERIALS 31
TABLE 6 FDA GENERAL CLASSIFICATION OF COMPOSITE BIOMATERIALS
COMPENDIUM 32
BIOMATERIALS OF BIOLOGICAL ORIGIN 33
FIGURE 7 GLOBAL REVENUE SHARES OF ORTHOPEDICS BIOMATERIALS BY REGION,
2013 (%) 34
HISTORICAL DEVELOPMENT OF BIOMATERIALS 34
BIOMATERIALS MARKET EVOLUTION 35
FIGURE 2 CLASSIFICATION OF BIOMATERIALS 35
HISTORY AND DEVELOPMENT OF ABSORBABLE AND ERODIBLE WOUND
CLOSURE BIOMATERIALS 36
Sutures 36
FIGURE 3 MARKET DYNAMICS BY THERAPEUTIC AREA 36
Surgical Glues 37
HISTORY AND DEVELOPMENT OF ABSORBABLE AND ERODIBLE
ORTHOPEDIC BIOMATERIALS 38
RECENT DEVELOPMENTS AND TECHNOLOGICAL ADVANCES IN ABSORBABLE
AND ERODIBLE BIOMATERIALS 40
ABSORBABLE AND ERODIBLE WOUND CLOSURE BIOMATERIALS 40
Developments into Control of Absorption or Degradation Rates for
Absorbable Sutures 40
Development of Second-Generation Fibrin Sealants 41
Research into and Development of Bioabsorbables for Reduction of
Post-Operative Adhesions 41
ABSORBABLE AND ERODIBLE ORTHOPEDIC BIOMATERIALS 42
Continued RandD into Recombinant Human Osteogenic Protein-1
(rhOP-1) 42
ONGOING AND FUTURE DEVELOPMENTS IN BIOMATERIAL TECHNOLOGIES 43
DEVELOPMENTS IN FIBER-BASED TISSUE ENGINEERING TECHNOLOGIES
(FBTE) 43
Electrospinning Nanofibers 43
Thermally Induced Phase Separation 44
3-D Fiber-Deposited Scaffolds for Tissue Engineering and Organ
Printing 45
Self-Assembling Tissue Engineering Systems 45
"SUPERFINISHING" OF IMPLANT SURFACES USING MMP 46
ELECTROPHORETIC DEPOSITION OF HYDROXYAPATITE OR BIOACTIVE
GLASS 46
METALLIC ALLOYS AND TECHNOLOGIES 46
STEM CELL TECHNOLOGIES AND NANOENGINEERED BIOMATERIALS 47
DEVELOPMENTS IN CERAMIC TECHNOLOGIES 47
DEVELOPMENTS IN SMART POLYMERS AS BIOMATERIALS 48
EXAMPLES OF PROPRIETARY BIOMATERIAL TECHNOLOGIES 48
CHAPTER 4 GLOBAL IMPLANTABLE BIOMATERIALS MARKET 51
INTRODUCTION 51
MARKET REVENUE ANALYSIS 51
GLOBAL MARKET REVENUE ANALYSIS 51
TABLE 8 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS,
THROUGH 2019 ($ MILLIONS) 52
FIGURE 4 GLOBAL MARKET FOR IMPLANTABLE BIOMATERIALS, 2010-2019 ($
MILLIONS) 52
Global Market Revenue Analysis by Region 53
FIGURE 5 GLOBAL REVENUES FOR IMPLANTABLE BIOMATERIALS BY REGION, 2014
(%) 53
Global Market Revenue Analysis by Market Segment 54
TABLE 9 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
SEGMENT, THROUGH 2019 ($ MILLIONS) 54
FIGURE 6 GLOBAL REVENUES FOR IMPLANTABLE BIOMATERIALS BY INDIVIDUAL
SEGMENT, 2013 ($ MILLIONS) 55
TABLE 10 GLOBAL REVENUE FORECAST FOR BIOMATERIALS USED IN
ORTHOPEDICS AND CARDIOVASCULAR APPLICATIONS, THROUGH 2019 ($
MILLIONS) 55
FIGURE 7 GLOBAL REVENUE SHARES OF ORTHOPEDICS BIOMATERIALS BY REGION,
2013 (%) 55
FIGURE 8 GLOBAL REVENUES FOR CARDIOVASCULAR BIOMATERIALS BY REGION,
2013 (%) 56
TABLE 11 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED IN
DENTAL SURGERY AND IMMUNOLOGY APPLICATIONS, THROUGH 2019 ($ MILLIONS) 57
TABLE 12 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED IN
PULMONARY AND PLASTIC SURGERY APPLICATIONS, THROUGH 2019 ($ MILLIONS) 58
TABLE 13 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
UROLOGY/GYNECOLOGY AND ENDOCRINOLOGY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 58
TABLE 14 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED IN
OPHTHALMICS AND ONCOLOGY APPLICATIONS, THROUGH 2019 ($ MILLIONS) 59
TABLE 15 GLOBAL REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED IN
DERMATOLOGY AND OTHER SURGICAL APPLICATIONS, THROUGH 2019 ($
MILLIONS) 59
CHAPTER 5 NORTH AMERICAN MARKET FOR IMPLANTABLE BIOMATERIALS 61
REGULATORY AND LEGISLATIVE REQUIREMENTS 61
UNITED STATES 61
FDA Medical Device Regulations 61
Regulatory Approval Process for Biomaterials 63
Centers for Medicare and Medicaid Services 64
The 2010 Affordable Care Act 65
Private Insurance 65
Traditional Fee-for-Service Health Insurance Plans 65
Health Maintenance Organizations (HMOs) 65
Preferred Provider Organizations (PPOs) 66
FIGURE 9 PRIVATE HEALTH INSURANCE COVERAGE IN THE U.S. AMONG PERSONS
UNDER AGE 65, 2007-2011 (MILLION/%) 66
TABLE 16 PERSONAL HEALTHCARE EXPENDITURES; AGGREGATE AND PER CAPITA
AMOUNTS, PERCENT DISTRIBUTION AND ANNUAL PERCENTAGE CHANGE BY
SOURCE OF FUNDS, 2006-2018 ($ BILLIONS) 67
CANADA 68
MARKET DYNAMICS 68
MARKET DRIVERS 68
MARKET RESTRAINTS 70
MARKET REVENUE ANALYSIS 72
NORTH AMERICAN MARKET REVENUE ANALYSIS 72
North American Market Revenue Analysis 72
TABLE 17 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS, THROUGH 2019 ($ MILLIONS) 72
FIGURE 10 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS, 2010-2019 ($ MILLIONS) 73
TABLE 18 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS BY COUNTRY, THROUGH 2019 ($ MILLIONS) 74
TABLE 19 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS BY SEGMENT, THROUGH 2019 ($ MILLIONS) 74
FIGURE 11 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS BY SEGMENT, 2013 ($ MILLIONS) 75
TABLE 20 NORTH AMERICAN REVENUE FORECAST FOR ORTHOPEDICS AND
CARDIOVASCULAR BIOMATERIALS, THROUGH 2019 ($ MILLIONS) 75
TABLE 21 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN DENTAL SURGERY AND IMMUNOLOGY APPLICATIONS,
THROUGH 2019 ($ MILLIONS) 76
TABLE 22 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN PULMONARY AND PLASTIC SURGERY APPLICATIONS,
THROUGH 2019 ($ MILLIONS) 76
TABLE 23 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN UROLOGY/GYNECOLOGY AND ENDOCRINOLOGY
APPLICATIONS, THROUGH 2019 ($ MILLIONS) 78
TABLE 24 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN OPHTHALMICS AND ONCOLOGY APPLICATIONS, THROUGH
2019 ($ MILLIONS) 78
TABLE 25 NORTH AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN DERMATOLOGY AND OTHER SURGICAL APPLICATIONS,
THROUGH 2019 ($ MILLIONS) 79
MARKET SHARE ANALYSIS 80
NORTH AMERICAN MARKET SHARE ANALYSIS BY MARKET SEGMENT 80
TABLE 26 NORTH AMERICAN MARKET SHARE ANALYSIS OF IMPLANTABLE
BIOMATERIALS BY COMPANY, 2013 ($ MILLIONS/%) 80
TABLE 27 NORTH AMERICAN MARKET SHARE ANALYSIS OF ORTHOPEDIC
BIOMATERIALS BY COMPANY, 2013 81
TABLE 28 NORTH AMERICAN MARKET SHARE ANALYSIS OF CARDIOVASCULAR
BIOMATERIALS BY COMPANY, 2013 ($ MILLIONS/%) 82
CHAPTER 6 EUROPEAN MARKET FOR IMPLANTABLE BIOMATERIALS 84
REGULATORY AND LEGISLATIVE REQUIREMENTS 84
(GENERAL) MEDICAL DEVICE DIRECTIVE, MDD (93/42/EEC) 84
ACTIVE IMPLANTABLE MEDICAL DEVICE DIRECTIVE, AIMDD (90/383/EEC) 85
IN VITRO DIAGNOSTIC MEDICAL DEVICE DIRECTIVE, IVDMDD (98/79/EC) 85
PIP Breast Implants 86
MoM Hip Implants 87
PROPOSAL FOR CHANGES TO THE MEDICAL DEVICE DIRECTIVE, MDD
(93/42/EEC) 87
THE RUSSIAN FEDERATION 89
MARKET DYNAMICS 90
MARKET DRIVERS 90
MARKET RESTRAINTS 92
MARKET REVENUE ANALYSIS 93
EUROPEAN MARKET REVENUE ANALYSIS 93
TABLE 29 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS,
THROUGH 2019 ($ MILLIONS) 93
FIGURE 12 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS,
2010-2019 ($ MILLIONS) 93
European Market Revenue Analysis by Country 94
TABLE 30 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY, THROUGH 2019 ($ MILLIONS) 95
TABLE 31 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY (FRANCE AND GERMANY), THROUGH 2019 ($ MILLIONS) 95
TABLE 32 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY (ITALY AND SPAIN), THROUGH 2019 ($ MILLIONS) 96
TABLE 33 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY (UNITED KINGDOM AND BENELUX), THROUGH 2019 ($ MILLIONS) 96
European Market Revenue Analysis by Market Segment 97
TABLE 34 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
SEGMENT, THROUGH 2019 ($ MILLIONS) 97
FIGURE 13 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
SEGMENT, 2013 ($ MILLIONS) 98
TABLE 35 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED
IN ORTHOPEDICS AND CARDIOVASCULAR APPLICATIONS, THROUGH 2019 ($
MILLIONS) 99
TABLE 36 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED
IN DENTAL SURGERY AND IMMUNOLOGY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 100
TABLE 37 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED
IN PULMONARY AND PLASTIC SURGERY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 101
TABLE 38 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED
IN UROLOGY/GYNECOLOGY AND ENDOCRINOLOGY APPLICATIONS, THROUGH 2019
($ MILLIONS) 101
TABLE 39 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED
IN OPHTHALMICS AND ONCOLOGY APPLICATIONS, THROUGH 2019 ($ MILLIONS) 102
TABLE 40 EUROPEAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS USED
IN DERMATOLOGY AND OTHER SURGICAL APPLICATIONS, THROUGH 2019 ($
MILLIONS) 103
MARKET SHARE ANALYSIS 104
EUROPEAN MARKET SHARE ANALYSIS BY MARKET SEGMENT 104
TABLE 41 EUROPEAN MARKET SHARES OF IMPLANTABLE BIOMATERIALS BY
COMPANY, 2013 ($ MILLIONS/%) 104
TABLE 42 EUROPEAN MARKET SHARES OF IMPLANTABLE BIOMATERIALS USED IN
ORTHOPEDICS BY COMPANY, 2013 105
TABLE 43 EUROPEAN MARKET SHARES OF IMPLANTABLE BIOMATERIALS USED IN
CARDIOVASCULAR APPLICATIONS BY COMPANY, 2013 ($ MILLIONS/%) 106
CHAPTER 7 ASIA-PACIFIC MARKET FOR IMPLANTABLE BIOMATERIALS 108
JAPAN 108
REGULATORY AND LEGISLATIVE REQUIREMENTS 108
TABLE 44 OVERVIEW OF PHARMACEUTICAL AFFAIRS LAW (PAL) AND JAPANESE
MEDICAL DEVICES NOMENCLATURE (JMDN) CODES AND RELATED CODES
ACCORDING TO THE EU MDD 109
Marketing Authorization System 109
TABLE 45 REIMBURSEMENT CATEGORIES IN JAPAN 111
CHINA 111
OVERVIEW OF THE HEALTHCARE SYSTEM 112
FIGURE 14 THE CHINESE HEALTHCARE SYSTEM 112
HEALTHCARE REFORMS 113
HEALTHCARE INSTITUTIONS 113
TABLE 46 NUMBER OF HEALTHCARE INSTITUTIONS, ACCORDING TO OWNERSHIP
IN CHINA, 2010 (NUMBER) 114
HOSPITAL RESOURCES 114
TABLE 47 TOTAL NUMBER OF HOSPITALS IN CHINA BY RANKING, 2010 115
INDIA 117
OVERVIEW OF THE HEALTHCARE SYSTEM 117
TABLE 48 OVERVIEW OF HEALTHCARE IN INDIA 119
HOSPITAL RESOURCES 120
POPULATION STATISTICS 121
SOUTH KOREA 122
MARKET DYNAMICS 124
MARKET DRIVERS 124
MARKET RESTRAINTS 127
MARKET REVENUE ANALYSIS 129
ASIA-PACIFIC: MARKET REVENUE ANALYSIS 129
TABLE 49 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS,
THROUGH 2019 ($ MILLIONS) 130
FIGURE 15 ASIA-PACIFIC REVENUE FORECASTS FOR IMPLANTABLE BIOMATERIALS,
2010-2019 ($ MILLIONS) 130
Asia-Pacific: Market Revenue Analysis by Country 130
TABLE 50 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY, THROUGH 2019 ($ MILLIONS) 131
TABLE 51 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY (CHINA AND JAPAN), THROUGH 2019 ($ MILLIONS) 132
TABLE 52 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
COUNTRY (INDIA AND SOUTH KOREA), THROUGH 2019 ($ MILLIONS) 133
Asia-Pacific: Market Revenue Analysis by Market Segment 134
TABLE 53 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS BY
SEGMENT, THROUGH 2019 ($ MILLIONS) 134
FIGURE 16 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
BY INDIVIDUAL SEGMENT, 2013 ($ MILLIONS) 135
TABLE 54 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN ORTHOPEDICS AND CARDIOVASCULAR APPLICATIONS, THROUGH 2019 ($
MILLIONS) 135
TABLE 55 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN DENTAL SURGERY AND IMMUNOLOGY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 136
TABLE 56 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN PULMONARY AND PLASTIC SURGERY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 137
TABLE 57 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN UROLOGY/GYNECOLOGY AND ENDOCRINOLOGY APPLICATIONS, THROUGH
2019 ($ MILLIONS) 137
TABLE 58 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN OPHTHALMICS AND ONCOLOGY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 138
TABLE 59 ASIA-PACIFIC REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN DERMATOLOGY AND OTHER SURGICAL APPLICATIONS, THROUGH 2019 ($
MILLIONS) 139
MARKET SHARE ANALYSIS 139
ASIA-PACIFIC MARKET SHARE ANALYSIS BY MARKET SEGMENT 139
TABLE 60 ASIA-PACIFIC MARKET SHARES OF IMPLANTABLE BIOMATERIALS BY
COMPANY, 2013 140
TABLE 61 ASIA-PACIFIC MARKET SHARES OF IMPLANTABLE BIOMATERIALS USED IN
ORTHOPEDICS APPLICATIONS BY COMPANY, 2013 ($ MILLIONS/%) 140
TABLE 62 ASIA-PACIFIC MARKET SHARES OF IMPLANTABLE BIOMATERIALS USED IN
CARDIOVASCULAR APPLICATIONS BY COMPANY, 2013 ($ BILLIONS/%) 142
CHAPTER 8 LATIN AMERICAN MARKET FOR IMPLANTABLE BIOMATERIALS 144
BRAZIL 144
ARGENTINA 147
MEXICO 151
MARKET DYNAMICS 153
MARKET DRIVERS 153
MARKET RESTRAINTS 155
MARKET REVENUE ANALYSIS 157
LATIN AMERICAN MARKET REVENUE ANALYSIS 157
TABLE 63 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS,
THROUGH 2019 ($ MILLIONS) 157
FIGURE 17 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS, 2010-2029 ($ MILLIONS) 158
TABLE 64 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
BY COUNTRY, THROUGH 2019 ($ MILLIONS) 158
TABLE 65 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
BY COUNTRY (ARGENTINA AND BRAZIL), THROUGH 2019 ($ MILLIONS) 159
TABLE 66 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
BY COUNTRY (CHILE AND MEXICO), THROUGH 2019 ($ MILLIONS) 159
TABLE 67 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
BY SEGMENT, THROUGH 2019 ($ MILLIONS) 160
FIGURE 18 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS BY SEGMENT, 2013 ($ MILLIONS) 160
TABLE 68 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN ORTHOPEDICS AND CARDIOVASCULAR APPLICATIONS, THROUGH 2019 ($
MILLIONS) 161
TABLE 69 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN DENTAL SURGERY AND IMMUNOLOGY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 162
TABLE 70 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN PULMONARY AND PLASTIC SURGERY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 163
TABLE 71 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN UROLOGY/GYNECOLOGY AND ENDOCRINOLOGY APPLICATIONS, THROUGH
2019 ($ MILLIONS) 164
TABLE 72 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN OPHTHALMICS AND ONCOLOGY APPLICATIONS, THROUGH 2019 ($
MILLIONS) 164
TABLE 73 LATIN AMERICAN REVENUE FORECAST FOR IMPLANTABLE BIOMATERIALS
USED IN DERMATOLOGY AND OTHER SURGICAL APPLICATIONS, THROUGH 2019 ($
MILLIONS) 165
MARKET SHARE ANALYSIS 166
LATIN AMERICAN MARKET SHARE ANALYSIS BY MARKET SEGMENT 166
TABLE 74 LATIN AMERICAN MARKET SHARES OF IMPLANTABLE BIOMATERIALS BY
COMPANY, 2013 ($ MILLIONS/%) 166
TABLE 75 LATIN AMERICAN MARKET SHARES OF IMPLANTABLE BIOMATERIALS
USED IN ORTHOPEDIC APPLICATIONS BY COMPANY, 2013 ($ MILLIONS/%) 167
TABLE 76 LATIN AMERICAN MARKET SHARES OF IMPLANTABLE BIOMATERIALS
USED IN CARDIOVASCULAR APPLICATIONS BY COMPANY, 2013 ($ MILLIONS/%) 167
CHAPTER 9 MIDDLE EASTERN/AFRICAN MARKET FOR IMPLANTABLE BIOMATERIALS 170
INTRODUCTION 170
SOUTH AFRICA 170
REGIONAL REGULATIONS, LEGISLATION AND REIMBURSEMENT: MIDDLE
EAST/AFRICA 170
SOUTH AFRICAN MEDICAL DEVICE REGULATORY REQUIREMENTS 170
HEALTH INSURANCE STRUCTURE: SOUTH AFRICA 172
REIMBURSEMENT OF MEDICAL DEVICES: SOUTH AFRICA 172
SAUDI ARABIA 173
PUBLIC HEALTHCARE SYSTEM 173
Primary Healthcare Services 174
Secondary and Tertiary Healthcare Services 174
FIGURE 19 STRUCTURE OF THE HEALTHCARE SECTOR IN SAUDI ARABIA, 2012 174
FIGURE 20 NUMBER OF HOSPITALS IN SAUDI ARABIA BY SUPPLIER, 2012 175
MARKET DYNAMICS 178
MARKET DRIVERS 178
MARKET RESTRAINTS 179
MARKET REVENUE ANALYSIS 181
MIDDLE/EAST AFRICAN MARKET REVENUE ANALYSIS 181
TABLE 77 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS, THROUGH 2019 ($ MILLIONS) 182
FIGURE 21 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS, 2010-2019 ($ MILLIONS) 182
Middle East/African Market Revenue Analysis by Country 182
TABLE 78 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS BY COUNTRY, THROUGH 2019 ($ MILLIONS) 183
TABLE 79 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS BY COUNTRY, THROUGH 2019 ($ MILLIONS) 183
Middle East/African Market Revenue Analysis by Market Segment 183
TABLE 80 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN ORTHOPEDICS AND CARDIOVASCULAR APPLICATIONS,
THROUGH 2019 ($ MILLIONS) 184
TABLE 81 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN DENTAL SURGERY AND IMMUNOLOGY APPLICATIONS,
THROUGH 2019 ($ MILLIONS) 185
TABLE 82 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS, THROUGH 2019 ($ MILLIONS) 185
TABLE 83 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN UROLOGY/GYNECOLOGY AND ENDOCRINOLOGY
APPLICATIONS, THROUGH 2019 ($ MILLIONS) 186
TABLE 84 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN OPHTHALMICS AND ONCOLOGY APPLICATIONS, THROUGH
2019 ($ MILLIONS) 186
TABLE 85 MIDDLE EAST/AFRICAN REVENUE FORECAST FOR IMPLANTABLE
BIOMATERIALS USED IN DERMATOLOGY AND OTHER SURGICAL APPLICATIONS,
THROUGH 2019 ($ MILLIONS) 187
MARKET SHARE ANALYSIS 187
MIDDLE EAST/AFRICAN MARKET SHARE ANALYSIS BY MARKET SEGMENT 187
TABLE 86 MIDDLE EAST/AFRICAN MARKET SHARE ANALYSIS OF IMPLANTABLE
BIOMATERIALS BY COMPANY, 2013 187
TABLE 87 MIDDLE EAST/AFRICAN MARKET SHARES OF IMPLANTABLE
BIOMATERIALS USED IN ORTHOPEDIC APPLICATIONS BY COMPANY, 2013 188
TABLE 88 MIDDLE EAST/AFRICA MARKET SHARES OF IMPLANTABLE BIOMATERIALS
USED IN CARDIOVASCULAR APPLICATIONS BY COMPANY, 2013 189
CHAPTER 10 COMPANY PROFILES 191
CHAPTER 11 APPENDIX A: COMPANY CONTACT DETAILS 228
CHAPTER 12 APPENDIX B: ACRONYMS 239

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