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Global Regenerative Medicine Industry

  • June 2014
  • -
  • Global Industry Analysts
  • -
  • 320 pages

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 2013 through 2020. Also, a seven-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 46 companies including many key and niche players such as -

AlloSource
Anika Therapeutics, Inc.
Biomet, Inc.
Bioventus LLC
DePuy Synthes Companies

Table Of Contents

Global Regenerative Medicine Industry



I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and 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-3
Developed Markets Dominate, Developing to Drive Growth II-3

2. REGENERATIVE MEDICINE - A MACRO PERSPECTIVE II-4
Regenerative Medicine - The Past, the Present, and the Future II-4
Another Revolution in the Making? II-5
Conventional Chemical Medicine Vs Regenerative Medicine II-6
Regenerative Medicine - The Need of Modern Era 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 Medicine Industry Value by
Activity/Segment (2012): Percentage Breakdown for
Regenerative Therapies, Manufacturing and Services, and Tools and
Non-Therapeutic Products (includes corresponding
Graph/Chart) II-9

Table 2: Global Regenerative Medicines Market by Category
(2012): Percentage Breakdown for Biopharmaceuticals, Cell
and Tissue-Based Therapies, and Regenerative Devices and
Compounds (includes corresponding Graph/Chart) II-9

Table 3: Global Market for Cell and Tissue-based Therapies
(2012): Percentage Breakdown of Number of Therapies Being
Tested or Sold (includes corresponding Graph/Chart) II-9

Table 4: Global Market for Cell and Tissue-based Therapies
(2012): Percentage Breakdown of Number of Commercially
Available Products by Application (includes corresponding
Graph/Chart) II-10

Table 5: Clinical Development Pipeline of Cell and
Tissue-Based Therapies by Stage (2012): Percentage Breakdown
of Number of Products in Phase III or Pivotal Trials, Phase
II Trials, Phase I Trials and Commercially Distributed
(includes corresponding Graph/Chart) II-10
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-12
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-13
Table 6: Top 25 Countries Worldwide in Terms of Population
(2010 and 2013) (includes corresponding Graph/Chart) II-13
Aging Global Population: Need for New Effective Treatments II-14
Table 7: Global Population Statistics for the 65+ Age Group
(2012) (includes corresponding Graph/Chart) II-15

Table 8: Over-65 Years Population as a % of Total Population
(2010 and 2020P) (includes corresponding Graph/Chart) II-16

Table 9: Elderly Population (65+ Years) as a % of Total
Population (2000 and 2025) (includes corresponding
Graph/Chart) II-16
Increasing Healthcare Spending in Emerging Markets:
Opportunities in Store II-16
Table 10: Healthcare Spending as % of GDP in Select
Countries (2011) (includes corresponding Graph/Chart) II-17
Scientific and Technological Advances in Associated Areas II-17
Government Support and Increased Private Sector Participation II-17
Investment and Funding Landscape II-18
Major MandA Activity and Strategic Alliances in Regenerative
Medicine: 2011-2013 II-19
Recent Advancements in the Science of Regenerative Medicine II-19
Advanced Ceramics Gaining Preeminence in Regenerative Medicine
Field II-20
Table 11: Global Medical Ceramics Market (2013): Percentage
Breakdown of Value Sales by Application (includes
corresponding Graph/Chart) II-21
3D Organ and Tissue Printing: Still in Early Stages II-21
Nanotechnology in Regenerative Medicine II-21
Advances in Nanotechnology Assist Regenerative Medicine II-21
Issues to be Sorted Out II-22
Need for New Scientific and Technological Standards II-22
Standardized Guidelines II-22
Clinical Translation - Collaboration of Multidisciplinary
Skills is Essential II-23
The Question of Apt Business Models - The Service and Product
Approach II-23
Autologous or Service Approach Preferred by European Firms II-24
Allogenic or Product Approach - Slow to Develop II-24
Regenerative Medicine Requires Improved Biomaterials II-24
Assessment of Worldwide RandD Activities in the Area of
Biomaterials II-25
Investors Wary of Funding Regenerative Medicine II-25
Regenerative Medicine Field Lags Behind due to Segregated Focus II-26
Challenges Encountered by Regenerative Medicine II-26
Scientific and Technological Challenges II-27
Barriers in Sharing Intellectual Property Rights II-27
Viable Manufacturing Technologies and Skilled Personnel Crucial II-28
Strict Regulations Push up Operational Costs II-28

3. BONE AND JOINT REGENERATIVE MEDICINE - AN OVERVIEW II-29
Bone Regenerative Medicine Presents Need for Advanced Therapies II-29
Limitations and Drawbacks for Different Bone Grafts II-30
Key Growth Drivers II-30
Rising Incidences of Degenerative Intervertebral Disc Diseases II-30
Table 12: % of Women Affected by Osteoporosis (includes
corresponding Graph/Chart) II-31
Increase in Prevalence of Arthritis and Other Orthopedic
Disorders II-31
Rise in Revision Orthopedic Surgeries II-31
Increase in Spinal Fusions in Private Healthcare II-31
Bone Grafts Market Maintains Positive Momentum II-32
Applications of Bone Grafts: A Review II-32
Spine Fusion - The Largest Bone Graft Indication II-33
Dental Bone Grafting - A High Potential Market II-33
Table 13: Global Dental Regeneration Market (2013E):
Percentage Breakdown of Value Sales for Bone Allografts,
Membranes, Tissue Regeneration (includes corresponding
Graph/Chart) II-34
What Drives Physicians' Choice of Bone Grafts? II-34
Patient Safety Emerges as a Top Priority II-34
Bone Graft Substitutes (BGSs) Market: Showing Promising
Potential II-35
Commercially Available Bone Graft Substitutes II-36
Growing Clinical Use of Bone Graft Substitutes in Surgical
Procedures II-38
Synthetic Bone Graft Substitutes to Replace Traditional
Autografts and Allografts II-39
Select Synthetic Products in Orthobiologics II-40
Orthobiologics Gain Traction in the Bone Grafts Market II-40
Table 14: Global Orthobiologics Market (2012): Percentage
Breakdown of Value Sales for Allograft and DBM, Blood and
Marrow-based Products, Growth Factors, Hemostasis, Synthetic
Bone Graft Substitutes and Viscosupplements (includes
corresponding Graph/Chart) II-41

Table 15: Leading Players in the Global Orthobiologics
Market (2013): Percentage Breakdown of Value Sales for
Baxter, JandJ/ Synthes, Medtronic, Sanofi, Stryker and Others
(includes corresponding Graph/Chart) II-41

Table 16: Global Stem Cell Orthobiologics Market (2012):
Percentage Breakdown of Value Sales for Alphatec, Nuvasive
and Otrhofix (includes corresponding Graph/Chart) II-42
Increasing Visibility of Orthobiological Products to Spur
Grafting Options II-42
Autograft: Gold Standard for Bone Grafting Procedures II-42
Allograft: Leading the Race over Autografts II-43
Commercially Available Allograft and Xenograft Bone Products II-43
Advanced Allografts Encroaching into the Use of Autografts in
Surgical Procedures II-44
Technological Advancements Drive the Market for Bone Grafts II-44
Foot and Extremity Reconstruction - Promising Market for Bone
Grafts II-44
Precision Machined Allograft Gain Surgeon Preference II-45
Unmet Clinical Needs to Foster RandD Engine II-45
Biological Solutions in Sports Medicine - Beyond Bone Grafting II-45
What Ails the Market? II-45
Disease Transmission through Bone Grafts - A Major Safety
Concern II-45
Lack of Standards in Bone Graft Substitute Market II-46
Reimbursement Issues Continue to Haunt Bone Grafts Market II-46
Table 17: Payer Mix in Orthopedic-driven Surgeries
Worldwide (2012) (includes corresponding Graph/Chart) II-46
Regional Regulations and Religious Beliefs Hamper Bone Graft
Substitutes Market II-47
Synthetic Bone Grafts - Solution for Halal Bone Graft
Implantation II-47
Bone Glue - A Potential Threat to the Bone Graft Market II-47
Alliances with Organ Procurement Organizations: A Shot in
the Arm II-47
Aging Baby Boomers Render a Decreased Donor Pool II-48
Limited Availability of Donor Tissues II-48
Intense Competition from Alternative Tissue Repair Therapies II-48
Substitute Technologies Threaten to Replace Spinal Fusions II-49
Bone Grafts Termed as Tissues Suffer From Inconsistent
Patient Outcomes II-49
BMPs and Other Synthetic Growth Factors II-49
Bone Morphogenic Proteins (BMPs): Safety Concerns Led to
Downfall II-50
Bone Morphogenic Protein Products in Orthobiology II-50
Demineralized Bone Matrices (DBMs) Market: Strong Growth but
Tough Competition II-50
Table 18: 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-51
Commercially Available Demineralized Bone Matrix Products II-51
Biomaterials Market - Promising Opportunities for Cost-
Effective Products II-52
Tissue Engineered Cartilage Market - An Overview II-52
Tissue Engineered Cartilages - A Promising Solution for
Cartilage Repair II-52
Stem Cells to Support Tissue Engineering II-54
Market Potential of Tissue Engineered Cartilage Products II-54
Potential Applications of Tissue Engineered Cartilage Products II-54
Commercially Available tissue engineered cartilage products II-55
Challenges in Clinical Application of Tissue Engineered
Cartilage Products II-55
Bone Marrow Transplants (BMTs) II-56
Market Potential for BMTs II-56
Companies Engaged in CBSC Research for BMTs II-57
Stem Cell Research - Not Just Another Medical Advancement II-57
Sources of Stem Cells II-58
Stem Cell Based Bone Grafts - Fastest Growing Bone Graft
Substitute Segment II-58
Commercially Available Cell Therapy Products for Orthopedic
Applications II-59
Regenerative Stem Cell Products for Spine and Orthopedics in
Clinical Development II-59
Progenitor Cell Therapy to Witness No Holds Barred Growth II-60
Stem Cell Market on the Verge of Rapid Growth II-60
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-63
Mesenchymal Stem Cells for Regenerative Medicine II-64
MSC based Models for Orthopedic Repair II-64
Delivery of MSCs to Regions Requiring Therapy II-65
MSCs in the Treatment of Osteoarthritis II-65
MSCs in the Treatment of Rheumatoid Arthritis II-66
Scientific and Technological Challenges in Orthopedic
Regenerative Market II-66
Bone Regeneration II-66
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 19: Global Bone Growth Stimulation Market (2012):
Percentage Breakdown of Value Sales for Biomet, Bioventus,
DJO and Orthofix (includes corresponding Graph/Chart) II-69

5. REGENERATIVE MEDICINE IN OTHER AREAS II-70
Wound Healing - The Second Largest Segment II-70
Tissue Engineered Skin Substitutes: Potential Substitutes for
Skin grafts II-70
Commercially Available Tissue Engineered Skin Substitutes II-71
Cardiology - Promising Opportunities II-71
Select Stem Cell Products in the Development for CV Indications II-71
Diabetes - Highly Effective Innovative Treatments II-72
Regenerative Medicine Products in Development Pipeline for
Diabetes II-73
Neurodegenerative Diseases - Great Potential II-73
Body Sculpting/Cosmetics - High Potential II-73
Platelet Rich Plasma Treatment Gains Popularity II-73
Genetic Disorders II-74
Osteoarthritis II-74
Orthopedic Oncology II-74
What's in Store? II-74
Regenerative Medicine to Arrest Ageing? II-74
Thriving on an Aging World Population II-75
Faster Healing Process II-75
Regenerative Medicine to Overcome Donor Organs Shortage II-76
Possible Scenarios II-76

6. REGULATORY ENVIRONMENT II-77
Global Regulatory Landscape II-77
US II-77
FDA Classification of Bone Products II-77
Human Cells, Tissues and Cellular and Tissue-Based Products
(HCT/Ps) II-78
Good Tissue Practices II-78
DBM-based Products in US II-78
Synthetic Bone Graft Substitutes II-79
Tissue Banking Regulation II-79
FDA Regulations on Xenograft II-79
EU II-79
Japan II-79
Regulatory Norms Governing Embryonic Stem Cell Research II-80
Human Embryonic Stem Cell Regulation in Select Countries
Worldwide II-80
The IP Scenario in the Embryonic Stem Cells Research II-81
Diversity in Patent Regimes Pose Tremendous Challenges II-81
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 20: Fractures by Age Group (2012): Percentage Breakdown
of Number of Fractures by Age Group (includes corresponding
Graph/Chart) II-83

Table 21: Global Orthopedic Market by Segment (2013E):
Percentage Breakdown of Value Sales for Extremities, Hips,
Knees, Orthobiologics, Spice, 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 22: Worldwide Orthopedic Market (2013E): Percentage
Breakdown of Value Sales by Company for DePuy Synthes,
Medtronic, Smith and Nephew, Stryker, Zimmer and Others
(includes corresponding Graph/Chart) II-86

Table 23: Worldwide Market for Orthopedic Implants in Spinal
Procedures (2013E): Percentage Breakdown of Value Sales by
Company for JandJ, Medtronic and Others (includes corresponding
Graph/Chart) II-86

Table 24: Worldwide Market for Orthopedic Implants for
Reconstructive Procedures (2013E): Percentage Breakdown of
Value Sales by Company for Biomet, Jand J, Smith and Nephew,
Stryker, Zimmer and Others (includes corresponding
Graph/Chart) II-87

Table 25: Worldwide Market for Orthopedic Implants for Trauma
Procedures (2013E): Percentage Breakdown of Value Sales by
Company for Biomet, JandJ, Smith and Nephew, Stryker, Zimmer and
Others (includes corresponding Graph/Chart) II-87

Table 26: Global Joint Replacement Market (2013E): Percentage
Breakdown of Sales for Biomet, DePuy Synthes, Smith and Nephew,
Stryker, Zimmer and Others (includes corresponding
Graph/Chart) II-87
Bone Grafts and Joint Revision Arthroplasty II-88
Table 27: Worldwide Orthopedic Large Joint Market by Segment
(2013E): Percentage Breakdown of Value Sales for Hip, Knee
and Spine (includes corresponding Graph/Chart) II-88

Table 28: Worldwide Orthopedic Extremities Market by Segment
(2013E): Percentage Breakdown of Value Sales for Foot/Ankle,
Shoulder, Wrist/Finger and Elbow (includes corresponding
Graph/Chart) II-88

8. RESEARCH AND DEVELOPMENT II-89
Tissue Engineers Found New Biomaterial for Stimulating
Cartilage Growth II-89
Chrysalis Develops Chrysalin® Drug for Stimulating Tissue Growth II-89
Innovative Artificial Implants Hold Promise for Bone Injuries II-89
Bone Marrow Grafts Exhibit Promise for Low-Back Pain Patients II-90
Charged Nanoparticles Hold Potential to Heal Cracked Bones II-90
Silk Scaffolds with Excellent Mechanical Properties to
Facilitate Bone Formation II-91
New Fusion Protein to Stimulate Bone Tissue Regeneration II-91
Researchers Develop Human Heart Tissues with Autonomous Beating II-91
Scientists at Free University of Brussels Develop Thyroid
Cells of Mice II-92
Scientists Demonstrate New Source of Skin for Reconstructive
Procedures II-92
Instron TGT Bioreactor Stimulates Cell Growth by Applying
Hydrostatic Pressure II-93
New Ways of Fixing Broken Bones II-93
BoneCure Sleeve - Heading Towards the Human Market II-93
Bioactive Glass - Suitable for Weight Bearing Portion II-93
Neural Stem Cell to Restore Memory Functioning II-94
Pancreatic Islet Cells to Control Blood Sugar in Diabetics II-94
Therapeutic Cloning to Cure Parkinson's II-94

9. PRODUCT OVERVIEW II-95
Regenerative Medicine - An Introduction II-95
Bone Replacements/Grafting: Introduction II-95
Bone Grafts: A Peek into their Mechanism of Action II-95
Types of Bone Grafts II-96
Scoring of Osteoconduction, Osteoinduction, and Osteogenesis
Properties of Bone Grafts by Type II-96
Autografts II-96
Standard Allografts II-97
Machined Bone Allografts II-97
Demineralized Bone Matrix II-98
Bone Morphogenetic Proteins (BMPs) II-98
Basic Functions of TGF-Beta II-99
Synthetic Bone Grafts II-99
Collagen-based Matrices II-99
Ceramic: A Material of Choice II-99
Hydroxyapatite: A Major Calcium Phosphate Based Ceramic II-100
Calcium Sulfate II-100
Polymer Based Bone Grafts II-100
Coral: A Valuable Synthetic Graft Material II-100
Electrical Bone Growth Stimulators II-101
Internal Bone Growth Stimulators II-101
External Bone Growth Stimulators II-101
Cell and Tissue-based Therpies II-102
Stem Cells-Based Therapies II-102
Bone Tissue Engineering II-102
Hybrid Materials II-103
Osteoinductive Materials II-103
Immuno-modulatory Biomaterials II-104
Advanced Hydrogels II-104
Biodegradable Scaffolds II-104

10. PRODUCT INNOVATIONS/INTRODUCTIONS II-105
AlloSource Introduces AlloMendâ„¢ II-105
Orthofix Launches Trinity® ELITE™ II-105
Synergy Biomedical to Introduce Biosphere Putty II-105
K2M Launches VENADO Bone Graft Systems II-105
K2M Introduces Vesuvius DBM Putty II-105
The Center for Regenerative Medicine Rolls Out Genorthix System II-105
RTI Surgical Introduces BioReadyâ„¢ DBM Putty II-105
K2M Rolls Out VESUVIUS Osteobiologic Systems II-106
BioHorizons Introduces MinerOss® Cancellous II-106
Amedica Introduces Dynamic Bone II-106
Orthogen Introduces NanoGen II-106
SIRAKOSS Introduces MaxSi II-106
BioMimetic Therapeutics to Launch Augmatrixâ„¢ Biocomposite Bone
Graft II-106
Orthofix International Introduces Collageâ„¢ Osteoconductive
Scaffold II-106
TGA Clears BioMimetic's Augment® Bone Graft for
Commercialization in Australia II-106
Medtronic Launches ARTISANâ„¢ Space Maintenance System II-107
NovaBone Adds MacroPor-Si+ to its Portfolio II-107
RTI Surgical Announces First Implantation of map3â„¢ II-107
Integra Receives FDA Clearance for Accell Evo3 II-107
RTI Surgical Introduces BioAdaptâ„¢ DBM Foam II-107
Integra Unveils Trel-Xpressâ„¢ Demineralized Bone Matrix II-107
Keystone Dental Introduces DynaMatrixâ„¢ Plus II-107
Wright Introduces FUSIONFLEXâ„¢ Demineralized Moldable Scaffold II-108
Micromedics Launches OsteoXpress 15cc Bone Graft Delivery Device II-108
Bacterin Unveils OsteoSponge®SC II-108

11. RECENT INDUSTRY ACTIVITY II-109
Aastrom Biosciences Acquires Cell Therapy and Regenerative
Medicine Business of Sanofi II-109
Olympus to Sell the OP-1 Plant II-109
Wright Medical Group Divests OrthoRecon Business II-109
RTI Biologics Acquires Pioneer Surgical Technology II-109
Bioventus and Pfizer Enter into Agreement II-109
AlloSource Enters into Partnership with Humacyte II-109
Wright Medical Group Acquires BioMimetic Therapeutics II-110
BioTime Inks Definitive Deal with Geron for Stem Cell Assets II-110
Histogen Establishes PUR Biologics Joint Venture to Develop
Biologic Products II-110
Vitro Diagnostics to Acquire and Merge with Neuromics II-110
Mesoblast Group Takes Over Osiris' Culture- Expanded
Mesenchymal Stem Cell Business II-110
ThermoGenesis and TotipotentRx Enter into Definitive Merger
Agreement II-110
KCI and LifeCell Merge II-110
Sistemic and Roslin Cells Collaborate with Scottish
Development International II-110
360ip and CCRM Join Forces II-111
Olympus Biotech and BonAlive Enter into Multi-Year Exclusive
Distribution Agreement II-111
Mesoblast's Singapore Unit Obtains the US FDA Approval for
Production of MPCs II-111
Cellectis bioresearch Inks Collaboration Agreement with Stemgent II-111
Bonesupport Receives CE Mark Approval for Cerament|G resorbable II-111
Dainippon Sumitomo Pharma Establishes Regenerative and
Cellular Medicine Office II-111
StemCells Partners with R Biomedical II-111
Essex Woodlands Launches Bioventus II-112
JandJ Takes Over Synthes II-112
EastBridge Merges with Cellular Biomedicine II-112
Baxter Acquires Synovis II-112
Cytomedix Acquires Aldagen II-112
BioMimetic Therapeutics Secures CE Mark Approval for GEM 21S®
in EU II-112
EMD Millipore Collaborates with Centre for Commercialization
of Regenerative Medicine II-112
American CryoStem Associates with Alliance for Regenerative
Medicine II-113
Stryker Acquires Orthovita II-113
Zimmer Dental and Curasan Enter into Distribution Agreement II-113
NuVasive Signs Licensing Agreement with AlloSource II-113
Histogenics Takes Over ProChon Biotech II-113

12. FOCUS ON SELECT PLAYERS II-114
AlloSource (US) II-114
Anika Therapeutics, Inc. (US) II-114
Biomet, Inc. (US) II-115
Bioventus LLC (US) II-116
DePuy Synthes Companies (US) II-116
DePuy Spine, Inc. (US) II-116
Exactech, Inc. (US) II-117
Histogenics Corp. (US) II-117
Integra LifeSciences Holdings Corp (US) II-117
LifeCell Corporation (US) II-118
LifeNet Health, Inc. (US) II-118
Medtronic, Inc. (US) II-119
NovaBone Products LLC (US) II-119
NuVasive, Inc. (US) II-120
Orthofix International N.V. (Netherlands) II-120
Osiris Therapeutics, Inc. (US) II-121
Smith and Nephew Plc (UK) II-121
Stryker Corporation (US) II-122
TiGenix N.V. (Belgium) II-123
Wright Medical Technology, Inc. (US) II-124
BioMimetic Therapeutics LLC (US) II-124
Zimmer Holdings, Inc. (US) II-125

13. GLOBAL MARKET PERSPECTIVE II-126
Table 29: World Recent Past, Current and Future Market 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 2013
through 2020 (includes corresponding Graph/Chart) II-126

Table 30: 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 2006 through 2012 (includes corresponding
Graph/Chart) II-127

Table 31: World 15-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 2006, 2014 and
2020 (includes corresponding Graph/Chart) II-128
Regenerative Medicine Market by Segment II-129
Table 32: World Recent Past, Current and Future Market 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 2013 through
2020 (includes corresponding Graph/Chart) II-129

Table 33: 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 2006 through 2012 (includes
corresponding Graph/Chart) II-130

Table 34: World 15-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
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-131


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
High Potential for Regenerative Medicine in Orthopedics III-2
Regenerative Medicine in Bone and Joint Applications III-2
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 35: North American Elderly Population by Age Group
(1975-2050) (includes corresponding Graph/Chart) III-5
Table 36: US Population Breakdown by Age Group (2012)
(includes corresponding Graph/Chart) III-6
Rising Incidence of Degenerative Intervertebral Disc
Diseases III-6
Back Pain III-6
Arthritis III-7
Table 37: % of Population Diagnosed with Arthritis by
Age Group (includes corresponding Graph/Chart) III-7
Osteoporosis III-7
Table 38: Osteoporosis Population in the US: 2002, 2005,
2008 and 2012 (includes corresponding Graph/Chart) III-8

Table 39: 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-9
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-10
Orthopedic Biomaterials Market - An Overview III-10
Regulatory Challenges Limit Growth in the US Orthopedic
Biomaterials Market III-10
Orthobiologics Market - Overview III-11
Adequate Reimbursement: An Impetus for Growth and Profitability III-11
Table 40: Payer Mix for Spinal (Cervical) Fusion
Procedures in the US (includes corresponding Graph/Chart) III-11

Table 41: Payer Mix for Spinal (Lumbar) Fusion Procedures
in the US (includes corresponding Graph/Chart) III-12
Competitive Scenario III-12
Standard Bone Allografts III-12
Table 42: US Market for Standard Bone Allografts (2012):
Percentage Market Share Breakdown of Leading Tissue
Processors (includes corresponding Graph/Chart) III-12
Machined Bone Allografts III-13
Table 43: US Market for Machined Bone Allografts (2012):
Percentage Market Share Breakdown of Leading Tissue
Processors (includes corresponding Graph/Chart) III-13
Demineralized Bone Matrix (DBM) III-13
Table 44: Leading Players in the US DBM Market (2012):
Percentage Breakdown of Sales for Bacterin, Exactech,
Integra, Medtronic, RTI Surgical, Stryker, Synthes/ DePuy
Spine, Wright Medical and Others (includes corresponding
Graph/Chart) III-14
Synthetic Bone Graft Substitutes III-14
Table 45: US Market for Synthetic Bone Graft Substitutes
(2012): Percentage Share Breakdown of Value Sales by
Company for Biomet, JandJ, Stryker, Wright Medical and
Others (includes corresponding Graph/Chart) III-14
Stem Cell Market Outlook III-14
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
Rising Governmental Investments in Stem Cell Therapies - A
Growth Booster 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
CBI's Human Tissue Products for Treating Liver Failure and
Diabetes III-17
Market for Liver and Pancreas Transplantation III-18
Implantable Regenerative Products Take Over Sports Medicine III-18
Challenges in the Area of Product Development III-18
Process of Integration Continues III-18
Scientific and Technological Challenges to be Tackled III-19
Dominant Patents a Cause of Concern III-19
Product Innovations/Introductions III-20
Strategic Corporate Developments III-23
Key Players III-26
B.Market Analytics III-37
Table 46: US Recent Past, Current and Future Analysis for
Regenerative Medicine Products for Bone and Joint
Applications Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-37

Table 47: US Historic Review for Regenerative Medicine
Products for Bone and Joint Applications Market - Analyzed
with Annual Sales Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-38

2. JAPAN III-39
A.Market Analysis III-39
Current and Future Analysis III-39
Market Overview III-39
The Discovery of iPS Cells Lends Traction III-39
Drug Development - A Major Application for iPS III-40
Use of iPS for Regenerative Medicine III-40
Intractable and Congenital Disease Treatments III-41
Research and Development Rife in iPS Cells Space III-41
Japan Gears Up to Devise Standards for Regenerative Medicine
Products III-41
Japan Revises the Pharmaceutical Affairs Law III-42
General Trends in Regenerative Medicine Industry III-42
Research Activity in Regenerative Medicine Field III-42
More Companies Eye the Regenerative Medicine Potential III-43
Competition Heats up Behind Closed Doors III-43
Japanese Firms Need to Catch Up with US and European
Competitors III-43
Science Ministry Rolls Out Regenerative Medicine Project III-44
Regenerative Medicine Exempted from Ban on Human Cloning III-44
Strategic Corporate Development III-45
B.Market Analytics III-45
Table 48: Japanese Recent Past, Current and Future Analysis
for Regenerative Medicine Products for Bone and Joint
Applications Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-45

Table 49: Japanese Historic Review for Regenerative Medicine
Products for Bone and Joint Applications Market - Analyzed
with Annual Sales Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-46

3. EUROPE III-47
A.Market Analysis III-47
Current and Future Analysis III-47
Great Potential for Regenerative Medicine III-47
Challenges Faced by European Regenerative Medicine Industry III-47
Financial Viability - A Growing Concern in the Backdrop of
Euro Crisis III-48
Recession Drubs Orthopedic Biomaterials Market III-48
Table 50: European Bone Graft Substitutes Market by Type
(2012): Percentage Share Breakdown of Value Sales for
Allograft, DBM and Synthetic (includes corresponding
Graph/Chart) III-48
Synthetic Bone Graft Market Drives the BGS Market III-49
Bone Morphogenetic Protein (BMP) Market III-49
Dental Biomaterials Market in Europe: An Insight III-49
Key Statistical Data III-50
Table 51: 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-50

Table 52: 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-50

Table 53: 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-51

Table 54: 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-51
The Need to Embrace Newer Technologies III-51
Complex Regulatory Scenario with Multi-tier Governance System III-52
Need for More Integration III-52
Policies Regarding Egg Procurement Weigh Down Research Progress III-52
Need for Harmonized Clinical Trial Regulation III-53
International Alliances - Outsourcing Options with
Developing Countries III-53
Patenting Issues in hESC Research III-54
Ageing Population to Drive Demand for MSC based Therapies III-54
Table 55: Population Breakup by Age Group for Select
European Countries: 2012 (as a Percentage of Total
Population) (includes corresponding Graph/Chart) III-55
Overview of Select Regional Markets III-56
Germany III-56
United Kingdom III-56
Research Councils Announce Ambitious Project to Support
Regenerative Medicine III-56
Barriers to Commercialization III-57
Product Launches III-58
Strategic Corporate Developments III-58
Key Players III-59
B.Market Analytics III-61
Table 56: European Recent Past, Current and Future Analysis
for Regenerative Medicine Products for Bone and Joint
Applications Market - Analyzed with Annual Sales Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-61

Table 57: European Historic Review for Regenerative Medicine
Products for Bone and Joint Applications Market - Analyzed
with Annual Sales Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-62

4. ASIA-PACIFIC III-63
A.Market Analysis III-63
Current and Future Analysis III-63
Dental Bone Graft Substitutes and Biomaterials Market - An
Overview III-63
Table 58: Over 65 Years Individuals as % of Total
Population in Select Asian Countries (includes
corresponding Graph/Chart) III-63
Overview of Select Regional Markets III-64
China III-64
Substantial Government Support III-64
Orthopedic Biomaterials Market Poised for Robust Growth III-64
India III-64
High Growth Opportunities III-64
Orthopedic Biomaterials and Dental Bone Grafts Market - An
Insight III-65
Rise in Medical Tourism Drives Bone Grafts Market III-65
Adult Stem Cells - A Highly Money-Spinning Market III-65
South Korea III-66
Malaysia III-66
Singapore III-66
Product Innovations/Introduction III-66
Strategic Corporate Development III-67
B.Market Analytics III-67
Table 59: Asia-Pacific Recent Past, Current and Future
Analysis for Regenerative Medicine Products for Bone and
Joint Applications Market - Analyzed with Annual Sales
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-67

Table 60: Asia-Pacific Historic Review for Regenerative
Medicine Products for Bone and Joint Applications Market -
Analyzed with Annual Sales Figures in US$ Million for Years
2006 through 2012 (includes corresponding Graph/Chart) III-68

5. REST OF WORLD III-69
A.Market Analysis III-69
Current and Future Analysis III-69
Overview of Select Regional Markets III-69
Canada III-69
A Significant Player in the Field of Regenerative Medicine III-69
Favorable Growth Prospects in Bone Graft Substitutes Market III-69
University of Toronto - Spearheading Regenerative Medicine
Research III-70
Latin America III-70
Argentina III-70
Brazil III-70
Highly Promising but Challenges Remain III-70
Overview of Brazilian Orthopedic Devices Market III-71
Middle East III-71
Israel III-71
Stem Cell Research in Full Swing III-71
Strategic Corporate Developments III-73
B.Market Analytics III-73
Table 61: Rest of World Recent Past, Current and Future
Analysis for Regenerative Medicine Products for Bone and
Joint Applications Market - Analyzed with Annual Sales
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-73

Table 62: 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
2006 through 2012 (includes corresponding Graph/Chart) III-74


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 46 (including Divisions/Subsidiaries - 51)

The United States (38)
Europe (11)
- Germany (2)
- The United Kingdom (2)
- Rest of Europe (7)
Asia-Pacific (Excluding Japan) (1)
Africa (1)

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