REGENERATIVE MEDICINE - A GLOBAL STRATEGIC BUSINESS REPORT   

Research Abstract

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


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Code: MCP-1241
Price: $4950
Companies: 46
Pages: 320
Date: June 2014
Market Data Tables: 62
Status: * New Report

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 TABLE OF CONTENTS


 
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   Regenerative Medicine: A Preface.....II-11$100
   An Overview of Regenerative Medicine in Bone and Joint Applications.....II-21$100
   Current and Future Analysis.....II-3
Developed Markets Dominate, Developing to Drive Growth.....II-3
1$100
   Regenerative Medicine – The Past, the Present, & the Future.....II-41$100
   Another Revolution in the Making?.....II-51$100
   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
1$100
   Current Global Market for Regenerative Medicine.....II-7
Market Potential.....II-7
1$100
   Therapeutic Companies and Products in Regenerative Medicine – Current Status.....II-81$100
   Key Statistical Data.....II-9
Table 1: Global Regenerative Medicine Industry Value by Activity/Segment (2012): Percentage Breakdown for Regenerative Therapies, Manufacturing & Services, and Tools & 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 & 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
1$350
   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
1$350
   Select Commercial Regenerative Medicine Products in the Global Market.....II-111$100
   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
1$100
   Burgeoning Global Population Offers Significant Growth Opportunities.....II-13
Table 6: Top 25 Countries Worldwide in Terms of Population (2010 & 2013) (includes corresponding Graph/Chart).....II-13
1$350
   Aging Global Population: Need for New Effective Treatments.....II-14 1$100
   Table 7: Global Population Statistics for the 65+ Age Group (2012) (includes corresponding Graph/Chart).....II-151$350
   Table 8: Over-65 Years Population as a % of Total Population (2010 & 2020P) (includes corresponding Graph/Chart).....II-16

Table 9: Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart).....II-16
Increasing Healthcare Spending in Emerging Markets: Opportunities in Store.....II-16
1$350
   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
1$350
   Investment and Funding Landscape.....II-181$100
   Major M&A Activity and Strategic Alliances in Regenerative Medicine:
  2011-2013.....II-19
Recent Advancements in the Science of Regenerative Medicine.....II-19
1$100
   Advanced Ceramics Gaining Preeminence in Regenerative Medicine Field.....II-20 1$100
   Table 11: Global Medical Ceramics Market (2013): Percentage Breakdown of Value Sales by Application (includes corresponding Graph/Chart).....II-21
3D Organ & Tissue Printing: Still in Early Stages.....II-21
Nanotechnology in Regenerative Medicine.....II-21
Advances in Nanotechnology Assist Regenerative Medicine.....II-21
1$350
   Issues to be Sorted Out.....II-22
Need for New Scientific and Technological Standards.....II-22
Standardized Guidelines.....II-22
1$100
   Clinical Translation – Collaboration of Multidisciplinary Skills is Essential.....II-23
The Question of Apt Business Models – The Service and Product Approach.....II-23
1$100
   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
1$100
   Assessment of Worldwide R&D Activities in the Area of Biomaterials.....II-25
Investors Wary of Funding Regenerative Medicine.....II-25
1$100
   Regenerative Medicine Field Lags Behind due to Segregated Focus.....II-26
Challenges Encountered by Regenerative Medicine.....II-26
1$100
   Scientific and Technological Challenges.....II-27
Barriers in Sharing Intellectual Property Rights.....II-27
1$100
   Viable Manufacturing Technologies and Skilled Personnel Crucial.....II-28
Strict Regulations Push up Operational Costs.....II-28
1$100
   Bone Regenerative Medicine Presents Need for Advanced Therapies.....II-291$100
   Limitations and Drawbacks for Different Bone Grafts.....II-30
Key Growth Drivers.....II-30
Rising Incidences of Degenerative Intervertebral Disc Diseases.....II-30
1$100
   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
1$350
   Bone Grafts Market Maintains Positive Momentum.....II-32
Applications of Bone Grafts: A Review.....II-32
1$100
   Spine Fusion – The Largest Bone Graft Indication.....II-33
Dental Bone Grafting – A High Potential Market.....II-33
1$100
   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
1$350
   Bone Graft Substitutes (BGSs) Market: Showing Promising Potential.....II-351$100
   Commercially Available Bone Graft Substitutes.....II-362$200
   Growing Clinical Use of Bone Graft Substitutes in Surgical Procedures.....II-381$100
   Synthetic Bone Graft Substitutes to Replace Traditional Autografts and
  Allografts.....II-39
1$100
   Select Synthetic Products in Orthobiologics.....II-40
Orthobiologics Gain Traction in the Bone Grafts Market.....II-40
1$100
   Table 14: 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-41

Table 15: Leading Players in the Global Orthobiologics Market (2013): Percentage Breakdown of Value Sales for Baxter, J&J/ Synthes, Medtronic, Sanofi, Stryker and Others (includes corresponding Graph/Chart).....II-41
1$350
   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
1$350
   Allograft: Leading the Race over Autografts.....II-43
Commercially Available Allograft and Xenograft Bone Products.....II-43
1$100
   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
1$100
   Precision Machined Allograft Gain Surgeon Preference.....II-45
Unmet Clinical Needs to Foster R&D 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
1$100
   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
1$350
   Regional Regulations & 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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$350
   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
2$200
   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
1$100
   Commercially Available tissue engineered cartilage products.....II-55
Challenges in Clinical Application of Tissue Engineered Cartilage Products.....II-55
1$100
   Bone Marrow Transplants (BMTs).....II-56
Market Potential for BMTs.....II-56
1$100
   Companies Engaged in CBSC Research for BMTs.....II-57
Stem Cell Research – Not Just Another Medical Advancement.....II-57
1$100
   Sources of Stem Cells.....II-58
Stem Cell Based Bone Grafts – Fastest Growing Bone Graft Substitute Segment.....II-58
1$100
   Commercially Available Cell Therapy Products for Orthopedic Applications.....II-59
Regenerative Stem Cell Products for Spine and Orthopedics in Clinical
  Development.....II-59
1$100
   Progenitor Cell Therapy to Witness No Holds Barred Growth.....II-60
Stem Cell Market on the Verge of Rapid Growth.....II-60
1$100
   Clinical Development in Adult stem cells Moves Ahead, Lurches in hESCs.....II-611$100
   Adult Stem Cell Research Eludes Ethical Dispute.....II-62
Teratomas – No Longer an Impediment to Stem Cell Therapy Development.....II-62
1$100
   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
1$100
   Mesenchymal Stem Cells for Regenerative Medicine.....II-64
MSC based Models for Orthopedic Repair.....II-64
1$100
   Delivery of MSCs to Regions Requiring Therapy.....II-65
MSCs in the Treatment of Osteoarthritis.....II-65
1$100
   MSCs in the Treatment of Rheumatoid Arthritis.....II-66
Scientific and Technological Challenges in Orthopedic Regenerative Market.....II-66
Bone Regeneration.....II-66
1$100
   Clinical Approaches in Bone Regeneration and Their Limitations.....II-671$100
   Bone Grafts: A Highly Fragmented Market.....II-681$100
   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
1$350
   Wound Healing – The Second Largest Segment.....II-70
Tissue Engineered Skin Substitutes: Potential Substitutes for Skin grafts.....II-70
1$100
   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
1$100
   Diabetes – Highly Effective Innovative Treatments.....II-721$100
   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
1$100
   Genetic Disorders.....II-74
Osteoarthritis.....II-74
Orthopedic Oncology.....II-74
What’s in Store?.....II-74
Regenerative Medicine to Arrest Ageing?.....II-74
1$100
   Thriving on an Aging World Population.....II-75
Faster Healing Process.....II-75
1$100
   Regenerative Medicine to Overcome Donor Organs Shortage.....II-76
Possible Scenarios.....II-76
1$100
   Global Regulatory Landscape.....II-77
US.....II-77
FDA Classification of Bone Products.....II-77
1$100
   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
1$100
   Synthetic Bone Graft Substitutes.....II-79
Tissue Banking Regulation.....II-79
FDA Regulations on Xenograft.....II-79
EU.....II-79
Japan.....II-79
1$100
   Regulatory Norms Governing Embryonic Stem Cell Research.....II-80
Human Embryonic Stem Cell Regulation in Select Countries Worldwide.....II-80
1$100
   The IP Scenario in the Embryonic Stem Cells Research.....II-81
Diversity in Patent Regimes Pose Tremendous Challenges.....II-81
1$100
   International Divide on Patenting Dents hESC Research.....II-821$100
   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
1$350
   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
1$350
   Expanding Opportunities in Hip and Knee Market.....II-85
Extremity Reconstruction – A Growing Market.....II-85
Is Consolidation Blowing in the Wind?.....II-85
1$100
   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 & 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 J&J, Medtronic and Others (includes corresponding Graph/Chart).....II-86
1$350
   Table 24: Worldwide Market for Orthopedic Implants for Reconstructive Procedures (2013E): Percentage Breakdown of Value Sales by Company for Biomet, J& J, Smith & 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, J&J, Smith & 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 & Nephew, Stryker, Zimmer and Others (includes corresponding Graph/Chart).....II-87
1$350
   Bone Grafts & 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
1$350
   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
1$100
   Bone Marrow Grafts Exhibit Promise for Low-Back Pain Patients.....II-90
Charged Nanoparticles Hold Potential to Heal Cracked Bones.....II-90
1$100
   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
1$100
   Scientists at Free University of Brussels Develop Thyroid Cells of Mice.....II-92
Scientists Demonstrate New Source of Skin for Reconstructive Procedures.....II-92
1$100
   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
1$100
   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
1$100
   Regenerative Medicine – An Introduction.....II-95
Bone Replacements/Grafting: Introduction.....II-95
Bone Grafts: A Peek into their Mechanism of Action.....II-95
1$100
   Types of Bone Grafts.....II-96
Scoring of Osteoconduction, Osteoinduction, and Osteogenesis Properties of Bone
  Grafts by Type.....II-96
Autografts.....II-96
1$100
   Standard Allografts.....II-97
Machined Bone Allografts.....II-97
1$100
   Demineralized Bone Matrix.....II-98
Bone Morphogenetic Proteins (BMPs).....II-98
1$100
   Basic Functions of TGF-Beta.....II-99
Synthetic Bone Grafts.....II-99
Collagen-based Matrices.....II-99
Ceramic: A Material of Choice.....II-99
1$100
   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
1$100
   Electrical Bone Growth Stimulators.....II-101
Internal Bone Growth Stimulators.....II-101
External Bone Growth Stimulators.....II-101
1$100
   Cell and Tissue-based Therpies.....II-102
Stem Cells-Based Therapies.....II-102
Bone Tissue Engineering.....II-102
1$100
   Hybrid Materials.....II-103
Osteoinductive Materials.....II-103
1$100
   Immuno-modulatory Biomaterials.....II-104
Advanced Hydrogels.....II-104
Biodegradable Scaffolds.....II-104
1$100
   AlloSource Introduces AlloMend™.....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 BioReady™ DBM Putty.....II-105
1$100
   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 Augmatrix™ Biocomposite Bone Graft.....II-106
Orthofix International Introduces Collage™ Osteoconductive Scaffold.....II-106
TGA Clears BioMimetic’s Augment® Bone Graft for Commercialization in
  Australia.....II-106
1$100
   Medtronic Launches ARTISAN™ Space Maintenance System.....II-107
NovaBone Adds MacroPor-Si+ to its Portfolio.....II-107
RTI Surgical Announces First Implantation of map3™.....II-107
Integra Receives FDA Clearance for Accell Evo3.....II-107
RTI Surgical Introduces BioAdapt™ DBM Foam.....II-107
Integra Unveils Trel-Xpress™ Demineralized Bone Matrix.....II-107
Keystone Dental Introduces DynaMatrix™ Plus.....II-107
1$100
   Wright Introduces FUSIONFLEX™ Demineralized Moldable Scaffold.....II-108
Micromedics Launches OsteoXpress 15cc Bone Graft Delivery Device.....II-108
Bacterin Unveils OsteoSponge®SC.....II-108
1$100
   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
1$100
   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
1$100
   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
1$100
   Essex Woodlands Launches Bioventus.....II-112
J&J 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
1$100
   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
1$100
   AlloSource (US).....II-114
Anika Therapeutics, Inc. (US).....II-114
1$100
   Biomet, Inc. (US).....II-1151$100
   Bioventus LLC (US).....II-116
DePuy Synthes Companies (US).....II-116
DePuy Spine, Inc. (US).....II-116
1$100
   Exactech, Inc. (US).....II-117
Histogenics Corp. (US).....II-117
Integra LifeSciences Holdings Corp (US).....II-117
1$100
   LifeCell Corporation (US).....II-118
LifeNet Health, Inc. (US).....II-118
1$100
   Medtronic, Inc. (US).....II-119
NovaBone Products LLC (US).....II-119
1$100
   NuVasive, Inc. (US).....II-120
Orthofix International N.V. (Netherlands).....II-120
1$100
   Osiris Therapeutics, Inc. (US).....II-121
Smith & Nephew Plc (UK).....II-121
1$100
   Stryker Corporation (US).....II-1221$100
   TiGenix N.V. (Belgium).....II-1231$100
   Wright Medical Technology, Inc. (US).....II-124
BioMimetic Therapeutics LLC (US).....II-124
1$100
   Zimmer Holdings, Inc. (US).....II-1251$100
   Table 29: World Recent Past, Current & Future Market Analysis for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - US, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....II-1261$350
   Table 30: World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - US, Japan, Europe, Asia-Pacific and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....II-1271$350
   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 & 2020 (includes corresponding Graph/Chart).....II-1281$350
   Regenerative Medicine Market by Segment.....II-129
Table 32: World Recent Past, Current & Future Market Analysis for Regenerative Medicine Products for Bone and Joint Applications by Segment - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....II-129
1$350
   Table 33: World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Segment - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....II-1301$350
   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 & 2020 (includes corresponding Graph/Chart).....II-1311$350
   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
1$75
   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
1$75
   Regenerative Therapy – Best Fit for Joint Problems.....III-3
Bone Grafts Market – An Insight.....III-3
1$75
   Bone Graft Substitutes Market: Opportunities for Growth.....III-4
Aging Population: A Strong Demographic Driver.....III-4
1$75
   Table 35: North American Elderly Population by Age Group (1975-2050) (includes corresponding Graph/Chart).....III-51$200
   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
1$200
   Arthritis.....III-7
Table 37: % of Population Diagnosed with Arthritis by Age Group (includes corresponding Graph/Chart).....III-7
Osteoporosis.....III-7
1$200
   Table 38: Osteoporosis Population in the US: 2002, 2005, 2008 & 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
1$200
   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
1$75
   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
1$75
   Orthobiologics Market – Overview.....III-11
Adequate Reimbursement: An Impetus for Growth & Profitability.....III-11
Table 40: Payer Mix for Spinal (Cervical) Fusion Procedures in the US (includes corresponding Graph/Chart).....III-11
1$200
   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
1$200
   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
1$200
   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, J&J, Stryker, Wright Medical and Others (includes corresponding Graph/Chart).....III-14
Stem Cell Market Outlook.....III-14
1$200
   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
1$75
   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
1$75
   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
1$75
   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
1$75
   Scientific and Technological Challenges to be Tackled.....III-19
Dominant Patents a Cause of Concern.....III-19
1$75
   Product Innovations/Introductions.....III-203$225
   Strategic Corporate Developments.....III-233$225
   Key Players.....III-2611$595
   B. Market Analytics.....III-37
Table 46: US Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-37
1$200
   Table 47: US Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-381$200
   A. Market Analysis.....III-39
Current and Future Analysis.....III-39
Market Overview.....III-39
The Discovery of iPS Cells Lends Traction.....III-39
1$75
   Drug Development – A Major Application for iPS.....III-40
Use of iPS for Regenerative Medicine.....III-40
1$75
   Intractable and Congenital Disease Treatments.....III-41
Research & Development Rife in iPS Cells Space.....III-41
Japan Gears Up to Devise Standards for Regenerative Medicine Products.....III-41
1$75
   Japan Revises the Pharmaceutical Affairs Law.....III-42
General Trends in Regenerative Medicine Industry.....III-42
Research Activity in Regenerative Medicine Field.....III-42
1$75
   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
1$75
   Science Ministry Rolls Out Regenerative Medicine Project.....III-44
Regenerative Medicine Exempted from Ban on Human Cloning.....III-44
1$75
   Strategic Corporate Development.....III-45
B. Market Analytics.....III-45
Table 48: Japanese Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-45
1$200
   Table 49: Japanese Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-461$200
   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
1$75
   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
1$200
   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
1$75
   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
1$200
   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
1$200
   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
1$75
   Need for Harmonized Clinical Trial Regulation.....III-53
International Alliances – Outsourcing Options with Developing Countries.....III-53
1$75
   Patenting Issues in hESC Research.....III-54
Ageing Population to Drive Demand for MSC based Therapies.....III-54
1$75
   Table 55: Population Breakup by Age Group for Select European Countries: 2012 (as a Percentage of Total Population) (includes corresponding Graph/Chart).....III-551$200
   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
1$75
   Barriers to Commercialization.....III-571$75
   Product Launches.....III-58
Strategic Corporate Developments.....III-58
1$75
   Key Players.....III-592$150
   B. Market Analytics.....III-61
Table 56: European Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-61
1$200
   Table 57: European Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-621$200
   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
1$200
   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
1$75
   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
1$75
   South Korea.....III-66
Malaysia.....III-66
Singapore.....III-66
Product Innovations/Introduction.....III-66
1$75
   Strategic Corporate Development.....III-67
B. Market Analytics.....III-67
Table 59: Asia-Pacific Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-67
1$200
   Table 60: Asia-Pacific Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-681$200
   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
1$75
   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
1$75
   Overview of Brazilian Orthopedic Devices Market.....III-71
Middle East.....III-71
Israel.....III-71
Stem Cell Research in Full Swing.....III-71
2$150
   Strategic Corporate Developments.....III-73
B. Market Analytics.....III-73
Table 61: Rest of World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2013 through 2020 (includes corresponding Graph/Chart).....III-73
1$200
   Table 62: Rest of World Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market - Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2012 (includes corresponding Graph/Chart).....III-741$200
  
Total Companies Profiled: 46 (including Divisions/Subsidiaries - 51)

Region/Country Players

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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