再生医療の世界市場

【英語タイトル】Global Regenerative Medicine Industry

Global Industry Analystsが出版した調査資料(GIA702037)・商品コード:GIA702037
・発行会社(調査会社):Global Industry Analysts
・発行日:2017年1月
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・レポート言語:英語
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・調査対象地域:グローバル
・産業分野:医療
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【レポートの概要】

This report analyzes the worldwide markets for Regenerative Medicine in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, Asia-Pacific, and Rest of World.
Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

The report profiles 52 companies including many key and niche players such as:
- AlloSource
- Anika Therapeutics, Inc.
- Bioventus LLC
- DePuy Synthes Companies
- Exactech, Inc.

【レポートの目次】

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1 Disclaimers………….. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. OUTLOOK………….. II-1 Regenerative Medicine: A Preface II-1 An Overview of Regenerative Medicine in Bone and Joint Applications………….. II-2 Current and Future Analysis…………..II-2 Developed Markets Dominate, Developing to Drive Growth II-3

2. REGENERATIVE MEDICINE – A MACRO PERSPECTIVE II-4 Regenerative Medicine – Past, Present & Future II-4 Another Revolution in the Making? II-5 Conventional Chemical Medicine Vs Regenerative Medicine II-6 Regenerative Medicine – Bypassing the Ethical Concerns II-6 Regenerative Medicine Throws Up Several New Therapies II-6 Current Global Market for Regenerative Medicine II-7 Market Potential………….. II-7 Therapeutic Companies and Products in Regenerative Medicine – Current Status………….. II-8 Key Statistical Data…………..II-9 Table 1: Global Regenerative Medicines Market by Category (2016E): Percentage Breakdown for Biomaterials, Stem Cell Therapies and Tissue Engineering (includes corresponding Graph/Chart)………….. II-9

Table 2: Global Market for Regenerative Medicines by Therapeutic Area (2015): Percentage Breakdown of Number of Therapies Under Clinical Evaluation (includes corresponding Graph/Chart)………….. II-9

Table 3: Clinical Development Pipeline of Cell and Tissue-Based Therapies by Stage (2015): Percentage Breakdown of Number of Products in Phase I, Phase II and Phase III Trials (includes corresponding Graph/Chart) II-9 List of Major Commercially Available Cell Therapy Products II-10 Select Commercial Regenerative Medicine Products in the Global Market………….. II-11 Select Regenerative Products in Mid-to-Late-Stage Clinical Development………….. II-11 Growth Drivers for Regenerative Medicine II-12 A Combination of Factors to Drive Regenerative Medicine Market II-12 Burgeoning Global Population Offers Significant Growth Opportunities………….. II-12 Table 4: Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (includes corresponding Graph/Chart) II-13 Aging Global Population: Need for New Effective Treatments II-14 Table 5: Global Population Statistics for the 65+ Age Group (2015) (includes corresponding Graph/Chart) II-15

Table 6: Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart) II-16

Table 7: Life Expectancy for Select Countries in Number of Years: 2015E (includes corresponding Graph/Chart) II-17 Increasing Healthcare Spending in Emerging Markets: Opportunities in Store…………..II-18 Table 8: Healthcare Spending as a Percentage of GDP by Region (2016E) (includes corresponding Graph/Chart) II-18

Table 9: Per-Capita Healthcare Expenditure in US$ for Select Countries/Regions (2014) (includes corresponding Graph/Chart)………….. II-19 Government Support and Increased Private Sector Participation II-19 Investment and Funding Landscape II-19 Major M&A Activity and Strategic Alliances in Regenerative Medicine: 2011-2016…………..II-20 Recent Advancements in the Science of Regenerative Medicine II-21 Advanced Ceramics Gaining Preeminence in Regenerative Medicine Field………….. II-21 Table 10: Global Medical Ceramics Market (2015 & 2020): Percentage Breakdown of Value Sales by Application (includes corresponding Graph/Chart)…………..II-22 3D Organ & Tissue Printing: Still in Early Stages II-23 Nanotechnology in Regenerative Medicine II-23 Advances in Nanotechnology Assist Regenerative Medicine II-23 Issues to be Sorted Out…………..II-23 Need for New Scientific and Technological Standards II-23 Standardized Guidelines…………..II-24 Clinical Translation – Collaboration of Multidisciplinary Skills is Essential…………..II-24 The Question of Apt Business Models – The Service and Product Approach………….. II-25 Autologous or Service Approach Preferred by European Firms II-25 Allogenic or Product Approach – Slow to Develop II-26 Regenerative Medicine Requires Improved Biomaterials II-26 Assessment of Worldwide R&D Activities in the Area of Biomaterials………….. II-27 Investors Wary of Funding Regenerative Medicine II-27 Regenerative Medicine Field Lags Behind Due to Segregated Focus II-27 Challenges Encountered by Regenerative Medicine II-28 Scientific and Technological Challenges II-28 Barriers in Sharing Intellectual Property Rights II-29 Viable Manufacturing Technologies and Skilled Personnel Crucial II-29 Strict Regulations Push up Operational Costs II-29 Challenges Facing Autologous Cell Therapies II-30

3. BONE AND JOINT REGENERATIVE MEDICINE – AN OVERVIEW II-31 Bone Regenerative Medicine Presents Need for Advanced Therapies II-31 Limitations and Drawbacks for Different Bone Grafts II-32 Key Growth Drivers…………..II-32 Rising Incidences of Degenerative Intervertebral Disc Diseases II-32 Table 11: Global Osteoporosis Prevalence by Country/Region (2012 & 2022P): Number of People with Osteoporosis in Millions for US, EU, Japan, China and India (includes corresponding Graph/Chart)…………..II-33 Table 12: % of Women Affected by Osteoporosis (includes corresponding Graph/Chart)…………..II-33 Increase in Prevalence of Arthritis and Other Orthopedic Disorders………….. II-33 Rise in Revision Orthopedic Surgeries II-33 Increase in Spinal Fusions in Private Healthcare II-34 Bone Grafts Market Maintains Positive Momentum II-34 Applications of Bone Grafts: A Review II-35 Spine Fusion – The Largest Bone Graft Indication II-35 Dental Bone Grafting – A High Potential Market II-36 Table 13: Global Dental Regeneration Market (2013): Percentage Breakdown of Value Sales for Bone Allografts, Membranes, Tissue Regeneration (includes corresponding Graph/Chart)………….. II-36 What Drives Physicians’ Choice of Bone Grafts? II-36 Patient Safety Emerges as a Top Priority II-37 Bone Graft Substitutes (BGSs) Market: Showing Promising Potential………….. II-37 Commercially Available Bone Graft Substitutes II-38 Growing Clinical Use of Bone Graft Substitutes in Surgical Procedures………….. II-40 Synthetic Bone Graft Substitutes to Replace Traditional Autografts and Allografts…………..II-40 Select Synthetic Products in Orthobiologics II-41 Orthobiologics Gain Traction in the Bone Grafts Market II-41 Table 14: Leading Players in the Global Orthobiologics Market (2016E): Percentage Breakdown of Value Sales for AlloSource, DePuy, Integra, Medtronic, MTF, RTI Biologics, Sanofi, Sekagaku, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart) II-43 Histroical Data for Additional Perspective II-43 Table 15: Global Orthobiologics Market (2012): Percentage Breakdown of Value Sales for Allograft & DBM, Blood & Marrow-based Products, Growth Factors, Hemostasis, Synthetic Bone Graft Substitutes and Viscosupplements (includes corresponding Graph/Chart)…………..II-43

Table 16: Global Stem Cell Orthobiologics Market (2012): Percentage Breakdown of Value Sales for Alphatec, NuVasive and Orthofix (includes corresponding Graph/Chart) II-44 Increasing Visibility of Orthobiological Products to Spur Grafting Options…………..II-44 Autograft: Gold Standard for Bone Grafting Procedures II-44 Allograft: Leading the Race over Autografts II-45 Commercially Available Allograft and Xenograft Bone Products II-45 Allografts Encroach into the Use of Autografts in Surgical Procedures………….. II-46 Technological Advancements Drive the Market for Bone Grafts II-46 Foot and Extremity Reconstruction – Promising Market for Bone Grafts………….. II-46 Precision Machined Allograft Gain Surgeon Preference II-47 Unmet Clinical Needs to Foster R&D Engine II-47 Biological Solutions in Sports Medicine – Beyond Bone Grafting II-47 What Ails the Market?…………..II-47 Disease Transmission through Bone Grafts – A Major Safety Concern………….. II-47 Lack of Standards in Bone Graft Substitute Market II-48 Reimbursement Issues Continue to Haunt Bone Grafts Market II-48 Regional Regulations & Religious Beliefs Hamper Bone Graft Substitutes Market…………..II-48 Synthetic Bone Grafts – Solution for Halal Bone Graft Implantation………….. II-49 Bone Glue – A Potential Threat to the Bone Graft Market II-49 Alliances with Organ Procurement Organizations: A Shot in the Arm………….. II-49 Aging Baby Boomers Render a Decreased Donor Pool II-49 Limited Availability of Donor Tissues II-50 Intense Competition from Alternative Tissue Repair Therapies II-50 Substitute Technologies Threaten to Replace Spinal Fusions II-50 Bone Grafts Termed as Tissues Suffer From Inconsistent Patient Outcomes………….. II-51 BMPs and Other Synthetic Growth Factors II-51 Bone Morphogenic Proteins (BMPs): Safety Concerns Led to Downfall………….. II-51 Bone Morphogenic Protein Products in Orthobiology II-52 Demineralized Bone Matrices (DBMs) Market: Strong Growth but Tough Competition………….. II-52 Table 17: Global Demineralized Bone Matrix Market (2012): Percentage Breakdown of Value Sales for Altiva, Bacterin, Integra LifeSciences, Medtronic, Synthes/MTF and Others (includes corresponding Graph/Chart) II-53 Commercially Available Demineralized Bone Matrix Products II-53 Biomaterials Market – Promising Opportunities for Cost- Effective Products………….. II-54 Tissue Engineered Cartilage Market – An Overview II-54 Tissue Engineered Cartilages – A Promising Solution for Cartilage Repair………….. II-54 Stem Cells to Support Tissue Engineering II-55 Market Potential of Tissue Engineered Cartilage Products II-55 Potential Applications of Tissue Engineered Cartilage Products II-56 Challenges in Clinical Application of Tissue Engineered Cartilage Products………….. II-56 Bone Marrow Transplants (BMTs) II-57 Companies Engaged in CBSC Research for BMTs II-57 Stem Cell Research – Not Just Another Medical Advancement II-58 Sources of Stem Cells…………..II-58 Stem Cell Based Bone Grafts – Fastest Growing Bone Graft Substitute Segment…………..II-59 Commercially Available Cell Therapy Products for Orthopedic Applications………….. II-60 Regenerative Stem Cell Products for Spine and Orthopedics in Clinical Development…………..II-60 Progenitor Cell Therapy to Witness No Holds Barred Growth II-60 Stem Cell Market on the Verge of Rapid Growth II-61 Clinical Development in Adult stem cells Moves Ahead, Lurches in hESCs………….. II-61 Adult Stem Cell Research Eludes Ethical Dispute II-62 Teratomas – No Longer an Impediment to Stem Cell Therapy Development………….. II-62 Induced Pluripotent – A Potential Competitor to hESCs? II-63 Intricate Differences Exist between hESC and iPS Cells II-63 Use of iPS for Regenerative Medicine II-64 Mesenchymal Stem Cells for Regenerative Medicine II-64 MSC based Models for Orthopedic Repair II-65 Delivery of MSCs to Regions Requiring Therapy II-65 MSCs in the Treatment of Osteoarthritis II-66 MSCs in the Treatment of Rheumatoid Arthritis II-66 Scientific and Technological Challenges in Orthopedic Regenerative Market…………..II-67 Bone Regeneration…………..II-67 Clinical Approaches in Bone Regeneration and Their Limitations II-67

4. COMPETITIVE LANDSCAPE…………..II-68 Bone Grafts: A Highly Fragmented Market II-68 Bone Growth Stimulation Market II-69 Table 18: Global Bone Growth Stimulation Market (2016): Percentage Breakdown of Value Sales for Bioventus, DJO, Orthofix and Zimmer Biomet (includes corresponding Graph/Chart)………….. II-69 Medtronic’s Infuse BMP Lands into Controversy II-69

5. REGENERATIVE MEDICINE IN OTHER AREAS II-71 Wound Healing – The Second Largest Segment II-71 Tissue Engineered Skin Substitutes: Potential Substitutes for Skin grafts………….. II-71 Commercially Available Tissue Engineered Skin Substitutes II-72 Cardiology – Promising Opportunities II-72 Select Stem Cell Products in the Development for CV Indications II-73 Diabetes – Highly Effective Innovative Treatments II-74 Regenerative Medicine Products in Development Pipeline for Diabetes………….. II-74 Neurodegenerative Diseases – Great Potential II-74 Body Sculpting/Cosmetics – High Potential II-75 Platelet Rich Plasma Treatment Gains Popularity II-75 Genetic Disorders………….. II-75 Osteoarthritis………….. II-75 Orthopedic Oncology………….. II-76 What’s in Store?………….. II-76 Regenerative Medicine to Arrest Ageing? II-76 Thriving on an Aging World Population II-76 Faster Healing Process…………..II-77 Regenerative Medicine to Overcome Donor Organs Shortage II-77 Possible Scenarios………….. II-77

6. REGULATORY ENVIRONMENT…………..II-78 Global Regulatory Landscape…………..II-78 US………….. II-78 FDA Classification of Bone Products II-78 Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)………….. II-78 Good Tissue Practices…………..II-79 DBM-based Products in US…………..II-79 Synthetic Bone Graft Substitutes II-79 Tissue Banking Regulation…………..II-80 FDA Regulations on Xenograft…………..II-80 EU………….. II-80 Japan………….. II-80 Regulatory Norms Governing Embryonic Stem Cell Research II-81 Human Embryonic Stem Cell Regulation in Select Countries Worldwide………….. II-81 The IP Scenario in the Embryonic Stem Cells Research II-81 Diversity in Patent Regimes Pose Tremendous Challenges II-82 International Divide on Patenting Dents hESC Research II-82

7. A PEEK INTO THE GLOBAL ORTHOPEDIC INDUSTRY II-83 Orthopedic Industry: An Overview II-83 Table 19: Incidence of Fractures by Age Group (2014): Percentage Breakdown of Number of Fractures for Below 45 Years, 45 to 64 Years, and Above 65 Years (includes corresponding Graph/Chart)…………..II-83

Table 20: Global Orthopedic Market by Segment (2015E): Percentage Breakdown of Value Sales for Extremities, Hips, Knees, Orthobiologics, Spine, Trauma and Others (includes corresponding Graph/Chart)…………..II-84 Medical Devices and Implants for Orthopedics II-84 Expanding Opportunities in Hip and Knee Market II-85 Extremity Reconstruction – A Growing Market II-85 Is Consolidation Blowing in the Wind? II-85 Product Mix of Reconstructive Devices Companies II-86 Key Statistics in Global Orthopedics Industry II-86 Table 21: Leading Companies in the Global Orthopedic Market (2016E): Percentage Breakdown of Value Sales for DePuy Synthes, Medtronic, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart) II-86

Table 22: Global Orthopedic Market by Application (2016E): Percentage Breakdown of Value Sales for Arthroscopy, Joint Reconstruction, Orthobiologics, Spine, Trauma and Others (includes corresponding Graph/Chart) II-87

Table 23: Leading Players in the Global Trauma and Extremity Products Market (2016E): Percentage Breakdown of Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart) II-87 Bone Grafts & Joint Revision Arthroplasty II-87 Table 24: Leading Players in the Global Hip and Knee Replacement Market (2016): Percentage Breakdown of Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart) II-88

Table 25: Leading Players in Worldwide Knee Replacement Market (2016): Percentage Breakdown by Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart) II-88

Table 26: Leading Players in Worldwide Hip Replacement Market (2016): Percentage Breakdown by Value Sales for DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and Others (includes corresponding Graph/Chart) II-88

8. PRODUCT OVERVIEW………….. II-89 Regenerative Medicine – An Introduction II-89 Bone Replacements/Grafting: Introduction II-89 Bone Grafts: A Peek into their Mechanism of Action II-89 Types of Bone Grafts…………..II-90 Scoring of Osteoconduction, Osteoinduction, and Osteogenesis Properties of Bone Grafts by Type II-90 Autografts………….. II-90 Standard Allografts…………..II-91 Machined Bone Allografts…………..II-91 Demineralized Bone Matrix…………..II-92 Bone Morphogenetic Proteins (BMPs) II-92 Basic Functions of TGF-Beta…………..II-93 Synthetic Bone Grafts…………..II-93 Collagen-based Matrices…………..II-93 Ceramic: A Material of Choice…………..II-93 Hydroxyapatite: A Major Calcium Phosphate Based Ceramic II-94 Calcium Sulfate………….. II-94 Polymer Based Bone Grafts…………..II-94 Coral: A Valuable Synthetic Graft Material II-95 Electrical Bone Growth Stimulators II-95 Internal Bone Growth Stimulators II-95 External Bone Growth Stimulators II-95 Cell and Tissue-based Therapies…………..II-96 Stem Cells-Based Therapies…………..II-96 Bone Tissue Engineering…………..II-96 Hybrid Materials…………..II-97 Osteoinductive Materials…………..II-97 Immuno-modulatory Biomaterials II-98 Advanced Hydrogels…………..II-98 Biodegradable Scaffolds…………..II-98

9. PRODUCT INNOVATIONS/INTRODUCTIONS II-99 Orthofix’s New Bone Growth Stimulators Obtain FDA and CE Approvals………….. II-99 Anika Therapeutics Obtains CE Approval for ORTHOVISC®-T II-99 Zimmer Biomet Rolls Out Bone Allograft PrimaGen II-99 Novastep Introduces biofit™ Wedge System II-99 Stryker Launches New Hand-held Bone Graft Material Delivery Device………….. II-99 Glidewell Unveils New Range of Dental Bone Grafting Products II-99 AlloSource Launches Two New Demineralized Cortical Fiber Allografts………….. II-100 Exactech Launches Acapella® One Cervical Spacer System II-100 Anika Therapeutics Rolls Out Viscosupplement CINGAL in the EU II-100 NuVasive Launches AttraX® Putty…………..II-100 Integra LifeSciences to Launch Omnigraft™ Dermal Regeneration Matrix………….. II-100 Anika Therapeutics Secures Approval for Cingal® for Treatment of Osteoarthritic Knee Pain…………..II-100 Bioventus Launches SIGNAFUSE™ Bioactive Bonegraft Putty II-100 AlloSource Rolls Out ProChondrix® Cartilage Restoration Matrix II-101 MIS Implants Releases 4MATRIX Bone Graft Cement II-101 Citagenix Launches PentOS OI™ Putty II-101 Medtronic’s Infuse® Bone Graft Receives Approval for New Indications………….. II-101 Nordson Introduces Bone Graft Delivery System II-101 AmnioLife to Launch New DBM Product Range II-101 BioMimetic Secures FDA Approval for AUGMENT® Bone Graft II-101

10. RECENT INDUSTRY ACTIVITY…………..II-102 TheraCell to Secure Patent for DBF™ Technology II-102 Derma Sciences Acquires BioD…………..II-102 Histogenics Buys Japanese Developmental and Commercialization Rights to NeoCart…………..II-102 Integra LifeSciences Inks Deal with AlloSource II-102 AlloSource Obtains Patent for ProChondrix® Cartilage Restoration Matrix………….. II-102 Exactech Divests Dental Biologics Business to Salvin II-102 AlloSource Secures Patent for Acellular Human Dermal Matrix II-103 AlloSource’s AlloStem® Cellular Bone Allograft Obtains Patent in the US………….. II-103 Bioventus Takes Over BioStructures II-103 Wright Medical Group Merges with Tornier II-103 Ortho RTi to Acquire Technology from Gestion Univalor and Polytechnique Montréal…………..II-103 Fujifilm Takes Over Cellular Dynamics II-103 Anika Therapeutics Files for IDE for Hyalofast II-103 Zimmer Takes Over ETEX Holdings…………..II-104 Aastrom Biosciences Acquires Cell Therapy and Regenerative Medicine Business of Sanofi…………..II-104 Olympus to Sell the OP-1 Plant II-104 Wright Medical Group Divests OrthoRecon Business II-104

11. FOCUS ON SELECT PLAYERS…………..II-105 AlloSource (US)………….. II-105 Anika Therapeutics, Inc. (US)…………..II-105 Bioventus LLC (US)…………..II-106 DePuy Synthes Companies (US)…………..II-106 DePuy Synthes Spine, Inc. (US)…………..II-106 Exactech, Inc. (US)………….. II-107 Integra LifeSciences Holdings Corp. (US) II-107 LifeNet Health, Inc. (US)…………..II-108 Medtronic, plc (Ireland)…………..II-108 NovaBone Products LLC (US)…………..II-108 NuVasive, Inc. (US)………….. II-109 Orthofix International N.V. (Netherlands) II-109 Osiris Therapeutics, Inc. (US) II-110 Smith & Nephew plc (UK)…………..II-110 Stryker Corporation (US)…………..II-111 Wright Medical Technology, Inc. (US) II-112 Zimmer Biomet Holdings, Inc. (US) II-112

12. GLOBAL MARKET PERSPECTIVE…………..II-114 Table 27: World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region – US, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)…………..II-114

Table 28: World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region – US, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)………….. II-115

Table 29: World 14-Year Perspective for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region – Percentage Breakdown of Dollar Sales for US, Japan, Europe, Asia-Pacific and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) II-116 Regenerative Medicine Market by Segment II-117 Table 30: World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications by Segment – Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)…………..II-117

Table 31: World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Segment - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)..............II-118

Table 32: World 14-Year Perspective for Regenerative Medicine Products for Bone and Joint Applications by Segment - Percentage Breakdown of Dollar Sales for Bone Replacements, Bone Stimulators, and Tissue Replacements Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) II-119

III. MARKET

1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 Current and Future Analysis..............III-1 US to Retain Leadership Position III-1 The Strength of US in Regenerative Medicine - A Glance III-1 Factors Driving the US Market of Regenerative Medicine III-2 Regenerative Medicine in Bone and Joint Applications III-2 High Potential for Regenerative Medicine in Orthopedics III-3 Regenerative Therapy - Best Fit for Joint Problems III-3 Bone Grafts Market - An Insight III-3 Bone Graft Substitutes Market: Opportunities for Growth III-4 Aging Population: A Strong Demographic Driver III-4 Table 33: North American Elderly Population by Age Group (1975-2050) (includes corresponding Graph/Chart) III-5 Rising Incidence of Degenerative Intervertebral Disc Diseases.............. III-6 Back Pain.............. III-6 Arthritis.............. III-6 Table 34: % of Population Diagnosed with Arthritis by Age Group (includes corresponding Graph/Chart) III-7 Osteoporosis..............III-7 Table 35: Osteoporosis and Low Bone Mass Population in the US: 2010 & 2020 (includes corresponding Graph/Chart).............. III-8 Table 36: Breakdown of Osteoporotic Fractures by Site in the US (includes corresponding Graph/Chart) III-8 Rise in Revision Orthopedic Surgeries Boosts Demand III-8 Increasing Visibility of Orthobiological Products to Spur Grafting Options..............III-8 Synthetic Bone Grafts to Fan Growth III-9 Spinal Surgery Market: Opportunity for Bone Grafts Market III-9 Dental Bone Graft Substitutes Market: An Overview III-9 Orthopedic Biomaterials Market - An Overview III-10 Regulatory Challenges Limit Growth in the US Orthopedic Biomaterials Market..............III-10 Orthobiologics Market - Overview III-10 Adequate Reimbursement: An Impetus for Growth & Profitability III-11 Table 37: Payer Mix for Spinal (Cervical) Fusion Procedures in the US (includes corresponding Graph/Chart) III-11

Table 38: Payer Mix for Spinal (Lumbar) Fusion Procedures in the US (includes corresponding Graph/Chart) III-11 Competitive Scenario..............III-12 Standard Bone Allografts..............III-12 Table 39: US Market for Standard Bone Allografts (2012): Percentage Market Share Breakdown of Leading Tissue Processors (includes corresponding Graph/Chart) III-12 Demineralized Bone Matrix (DBM) III-13 Table 40: Leading Players in the US DBM Market (2015): Percentage Breakdown of Sales for DePuy Synthes, Interga, Medtronic and Others (includes corresponding Graph/Chart) III-13 Machined Bone Allografts..............III-13 Table 41: US Market for Machined Bone Allografts (2012): Percentage Share Breakdown of Leading Tissue Processors (includes corresponding Graph/Chart) III-14

Table 42: US Market for Synthetic Bone Graft Substitutes (2012): Percentage Share Breakdown of Value Sales by Company for Biomet, J&J, Stryker, Wright Medical and Others (includes corresponding Graph/Chart) III-14 Stem Cell Market Outlook..............III-15 Millions of American Patients Put their Hope in Stem Cell Research.............. III-15 Rapidly Ageing Population Also Spurs Demand for MSC based Therapies.............. III-15 Regenerative Medicine - Other Areas of Application III-16 Regenerative Medicine - Face of Future Revolution in Cardiology.............. III-16 Regenerative Medicine in Wound Healing - The Most Widespread Application..............III-16 Regenerative Medicine in Diabetes - A Number of Emerging Applications.............. III-16 Regenerative Medicine - A Ray of Hope for Neurodegenerative Disease Patients..............III-17 Implantable Regenerative Products Take Over Sports Medicine III-17 Challenges in the Area of Product Development III-17 Process of Integration Continues III-17 Scientific and Technological Challenges to be Tackled III-18 Dominant Patents a Cause of Concern III-18 Product Approvals/Launches..............III-19 Strategic Corporate Developments III-21 Key Players.............. III-23 B.Market Analytics..............III-30 Table 43: US Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-30

Table 44: US Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-31

2. JAPAN.............. III-32 A.Market Analysis.............. III-32 Current and Future Analysis..............III-32 A Peek into Current State of Affairs III-32 Regenerative Medicine to Become A Cost Saving Tool III-32 Japan Takes Steps to Push Forward its RM Science III-33 The Discovery of iPS Cells Lends Traction III-34 Drug Development - A Major Application for iPS III-34 Use of iPS for Regenerative Medicine III-35 Intractable and Congenital Disease Treatments III-35 Research & Development Rife in iPS Cells Space III-35 General Trends in Regenerative Medicine Industry III-36 Research Activity in Regenerative Medicine Field III-36 More Companies Eye the Regenerative Medicine Potential III-36 Competition Heats up Behind Closed Doors III-37 Japanese Firms Need to Catch Up with US and European Competitors.............. III-37 Science Ministry Rolls Out Regenerative Medicine Project III-38 Regenerative Medicine Exempted from Ban on Human Cloning III-38 Regenerative Medicine - Regulatory Overview in Japan III-38 The RM Act.............. III-39 Japanese Pharma Seeks Regenerative Medicine to Gain Competitive Advantage..............III-39 Strategic Corporate Development III-40 B.Market Analytics..............III-40 Table 45: Japanese Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-40

Table 46: Japanese Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-41

3. EUROPE.............. III-42 A.Market Analysis.............. III-42 Current and Future Analysis..............III-42 Great Potential for Regenerative Medicine III-42 Challenges Faced by European Regenerative Medicine Industry III-42 Orthopedic Biomaterials Market - An Overview III-42 Synthetic Bone Graft Market Drives the BGS Market III-43 Dental Biomaterials Market in Europe: An Insight III-43 Key Historical Statistical Data for Additional Perspective III-44 Table 47: European Bone Graft Substitutes Market by Type (2012): Percentage Share Breakdown of Value Sales for Allograft, DBM and Synthetic (includes corresponding Graph/Chart).............. III-44

Table 48: European Market for Standard Bone Allografts by Leading Companies/ Organizations (2012): Percentage Share Breakdown of Value Sales for LifeNet Health, Medtronic, Musculoskeletal Transplant Foundation, RTI Surgical and Others (includes corresponding Graph/Chart) III-44

Table 49: European Market for Machined Bone Allografts by Leading Companies/ Organizations (2012): Percentage Share Breakdown of Value Sales for Medtronic, Musculoskeletal Transplant Foundation, RTI Surgical and Others (includes corresponding Graph/Chart)..............III-45

Table 50: European Market for Demineralized Bone Matrix by Leading Companies/ Organizations (2012): Percentage Market Share Breakdown of Value Sales for Medtronic, Musculoskeletal Transplant Foundation, RTI Surgical, Wright Medical Technology and Others (includes corresponding Graph/Chart).............. III-45

Table 51: European Market for Bone Graft Substitutes by Leading Players (2012): Percentage Share Breakdown of Value Sales for Biomet, Medtronic, Stryker, Wright Medical Technology, Zimmer and Others (includes corresponding Graph/Chart).............. III-46 The Need to Embrace Newer Technologies III-46 Complex Regulatory Scenario with Multi-tier Governance System III-46 Need for More Integration..............III-47 Policies Regarding Egg Procurement Weigh Down Research Progress III-47 Need for Harmonized Clinical Trial Regulation III-48 International Alliances - Outsourcing Options with Developing Countries..............III-48 Patenting Issues in hESC Research III-48 Ageing Population to Drive Demand for MSC based Therapies III-49 Table 52: Population Breakup by Age Group for Select EU-28 Countries: 2015 (as a Percentage of Total Population) (includes corresponding Graph/Chart) III-50 Overview of Select Regional Markets III-51 Germany.............. III-51 United Kingdom.............. III-51 Overview.............. III-51 Research Councils Announce Ambitious Project to Support Regenerative Medicine..............III-51 Barriers to Commercialization III-52 Product Approvals/Launches..............III-53 Strategic Corporate Developments III-54 Key Players.............. III-54 B.Market Analytics..............III-56 Table 53: European Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-56

Table 54: European Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-57

4. ASIA-PACIFIC.............. III-58 A.Market Analysis.............. III-58 Current and Future Analysis..............III-58 State of Regenerative Medicine in Asia - An Overview III-58 Dental Bone Graft Substitutes and Biomaterials Market - An Overview.............. III-59 Table 55: Over 65 Years Individuals as % of Total Population in Select Asian Countries: 2015 (includes corresponding Graph/Chart)..............III-59 Overview of Select Regional Markets III-60 China.............. III-60 Substantial Government Support III-60 A Note on Approved Products..............III-60 Orthopedic Biomaterials Market Poised for Robust Growth III-60 India.............. III-61 High Growth Opportunities..............III-61 Orthopedic Biomaterials and Dental Bone Grafts Market - An Insight.............. III-61 Rise in Medical Tourism Drives Bone Grafts Market III-62 Adult Stem Cells - A Highly Money- Spinning Market III-62 Government Takes Steps to Foster Advances in Stem Cell Research.............. III-62 South Korea.............. III-63 Overview.............. III-63 Select Products on the Market III-63 New Council for RM to Encourage Development III-63 Malaysia.............. III-64 Singapore.............. III-64 New Zealand.............. III-64 Regulatory Developments in the Region III-65 B.Market Analytics..............III-66 Table 56: Asia-Pacific Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-66

Table 57: Asia-Pacific Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-67

5. REST OF WORLD.............. III-68 A.Market Analysis.............. III-68 Current and Future Analysis..............III-68 Overview of Select Regional Markets III-68 Canada.............. III-68 A Significant Player in the Field of Regenerative Medicine III-68 Favorable Growth Prospects in Bone Graft Substitutes Market III-68 University of Toronto - Spearheading Regenerative Medicine Research.............. III-69 BridGE@CCRM - Aims High on RM Commercialization III-69 Latin America.............. III-69 Argentina.............. III-69 Brazil.............. III-70 Market is Highly Promising but Challenges Remain III-70 Overview of Brazilian Orthopedic Devices Market III-70 Middle East.............. III-71 Israel.............. III-71 Stem Cell Research in Full Swing III-71 Product Launch.............. III-72 Strategic Corporate Development III-72 B.Market Analytics..............III-73 Table 58: Rest of World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-73

Table 59: Rest of World Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-74

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 52 (including Divisions/Subsidiaries - 54)

The United States (37) Canada (3) Japan (1) Europe (10) - Germany (2) - The United Kingdom (2) - Rest of Europe (6) Asia-Pacific (Excluding Japan) (1) Middle East (1) Africa (1)

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