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, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. A six-year historic analysis is also provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain. The report profiles 119 companies including many key and niche players such as -

BioVest International, Inc.
Curis, Inc.
Cytori Therapeutics, Inc.
Evotec AG
Forticell Bioscience, Inc.
Geron Corporation


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Code : MCP-1241
Price : $4950
Companies : 119
Pages : 562
Date : November 2012
Market Data Tables : 165

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 TABLE OF CONTENTS


 
   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
  
   A Primer.....II-1
Current and Future Analysis.....II-1
1$100
   Current Global Market for Regenerative Medicine.....II-2
Therapeutic Companies and Products in Regenerative Medicine – Current Status.....II-2
1$100
   Select Therapeutic Regenerative Medicine Products in the Global Market.....II-3
Market Potential.....II-3
2$125
   An Overview of Regenerative Medicine in Bone and Joint Applications.....II-5
Bone Graft Substitutes – Penetration in Foot and Ankle Surgeries.....II-5
Repair of Non-Healing Bones – High Market Potential.....II-5
1$100
   Market Potential of Bone Graft Substitutes (BGSs).....II-6
Table 1: Global Bone Graft Substitute Market (2010): Percentage Share Breakdown of Sales for DePuy, OrthoVita, ApaTech/Baxter, Wright Medical, Medtronic/RTI, Biomet, and Others (includes corresponding Graph/Chart).....II-6
Synthetic Bone Graft Substitutes to Replace Traditional Autografts and
  Allografts.....II-6
1$350
   Select Synthetic Products in Orthobiologics.....II-7
Bone Morphogenic Proteins (BMPs) Gaining Popularity.....II-7
Bone Morphogenic Protein products in Orthobiology.....II-7
Table 2: Global Bone Morphogenic Protein Market (2010): Percentage Share Breakdown of Sales for Medtronic/RTI, and Stryker (includes corresponding Graph/Chart).....II-7
1$350
   Demineralized Bone Matrices (DBMs) Market Getting Crowded.....II-8
Table 3: Global Demineralized Bone Matrix Market (2011): Percentage Share Breakdown of Value Sales for Medtronic/RTI, Synthes/MTF, Integra LifeSciences, Altiva, Bacterin, and Others (includes corresponding Graph/Chart).....II-8
Select DBM products in Orthobiologics market.....II-8
Biomaterials Market – Promising Opportunities for Cost-Effective Products.....II-8
1$350
   Existing Bone Graft Procedures – Limitations and Concerns.....II-9
Autograft Procedures.....II-9
Allograft – DBM and Other Allografts.....II-9
BMPs and Other Synthetic Growth Factors.....II-9
1$100
   Medical Devices and Implants for Orthopedics.....II-10
Expanding Opportunities in Hip and Knee Market.....II-10
Extremity Reconstruction – A Growing Market.....II-10
1$100
   Tissue Engineered Cartilage Market – An Overview.....II-11
Tissue Engineered Cartilages – A Promising Solution for Cartilage Repair.....II-11
Market Potential of Tissue Engineered Cartilage Products.....II-11
Potential Applications of Tissue Engineered Cartilage Products.....II-11
1$100
   Commercially Available tissue engineered cartilage products.....II-121$100
   Challenges in Clinical Application of Tissue Engineered Cartilage Products.....II-13
Bone Marrow Transplants (BMTs).....II-13
1$100
   Market Potential for BMTs.....II-14
Companies Engaged in CBSC Research for BMTs.....II-14
Table 4: Global Orthobiologics Market (2010): Percentage Share Breakdown of Value Sales for Medtronic/RTI, Synthes/MTF, DePuy, Osteotech, Orthofix, and Others (includes corresponding Graph/Chart).....II-14
1$350
   Table 5: Global Orthobiologics Market (2010): Percentage Share Breakdown of Value Sales by Product Type for Growth Factors, Synthetics, DMBs, Allografts, and Stem Cells (includes corresponding Graph/Chart).....II-15

Table 6: Global Machined Bone and Allograft Market (2010): Percentage Share Breakdown of Value Sales for Synthes/MTF, DePuy, Medtronic/RTI, Osteotech, RTIX, and Others (includes corresponding Graph/Chart).....II-15

Table 7: Global Stem Cell Orthobiologics Market (2010): Percentage Share Breakdown of Value Sales for Nuvasive, and Otrhofix includes corresponding Graph/Chart).....II-15
1$350
   Table 8: Global Bone Growth Stimulation Market (2010): Percentage Share Breakdown of Value Sales for Orthofix, Biomet, DJO and Smith & Nephew (includes corresponding Graph/Chart).....II-16

Table 9: Global Spinal Stimulation Market (2010): Percentage Share Breakdown of Value Sales for Orthofix, Biomet and DJO (includes corresponding Graph/Chart).....II-16

Table 10: Global Long Bone Stimulation Market (2010): Percentage Share Breakdown of Value Sales for Smith& Nephew, DJO, Biomet and Orthofix (includes corresponding Graph/Chart).....II-16
Regenerative Medicine in Other Areas.....II-16
Wound Healing – The Second Largest Segment.....II-16
1$350
   Cardiology – Promising Opportunities.....II-17
Diabetes – Highly Effective Innovative Treatments.....II-17
Neurodegenerative Diseases – Great Potential.....II-17
1$100
   Body Sculpting/Cosmetics – High Potential.....II-18
Table 11: Global Market for Regenerative Medicine in Body Reconstruction and Cosmetics (2014): Value Sales by Target Area (in US$ Million) (includes corresponding Graph/Chart).....II-18
Regenerative Medicine – the Past, the Present, & the Future.....II-18
2$350
   Another Revolution in the Making?.....II-20
Conventional Chemical Medicine Vs Regenerative Medicine.....II-20
1$100
   Regenerative Medicine – The Need of Modern Era.....II-21
Regenerative Medicine Throws in Several New Therapies.....II-21
What’s in Store?.....II-21
Regenerative Medicine to Arrest Ageing?.....II-21
1$100
   Thriving on an Aging World Population.....II-22
Faster Healing Process.....II-22
1$100
   Regenerative Medicine to Overcome Donor Organs Shortage.....II-23
Possible Scenarios.....II-23
Stem Cell Research – Not Just Another Medical Advancement.....II-23
1$100
   Sources of Stem Cells.....II-24
Japanese Technology in the Area of Stem Cells.....II-24
1$100
   Progenitor Cell Therapy to Witness No Holds Barred Growth.....II-25
Key Issues at Play.....II-25
Ethical Angle of Embryonic Stem Cell Research.....II-25
1$100
   Growth Drivers for Regenerative Medicine.....II-26
A Combination of Factors to Drive Regenerative Medicine Market.....II-26
Aging Population Provides a Ready Market for Innovative Therapies.....II-26
Scientific and Technological Advances in Associated Areas.....II-26
Government Support and Increased Private Sector Participation.....II-26
1$100
   Investment and Funding Landscape.....II-271$100
   A Promising Outlook.....II-28
Increased Activity in the Field of Regenerative Medicine.....II-28
Recent Advancements in the Science of Regenerative Medicine.....II-28
1$100
   Nanotechnology in Regenerative Medicine.....II-29
Advances in Nanotechnology Assist Regenerative Medicine.....II-29
1$100
   Players Embrace Automation in Production Facilities.....II-30
Contract Manufacturing – A Growing Sector.....II-30
Issues to be Sorted Out.....II-30
Need for New Scientific and Technological Standards.....II-30
1$100
   Standardized Guidelines.....II-31
Clinical Translation – Collaboration of Multidisciplinary Skills is Essential.....II-31
1$100
   The Question of Apt Business Models – The Service and Product Approach.....II-32
Table 12: Percentage Breakdown of Autologous and Allogeneic Approach by Therapeutic Firms Across Select Countries (2011) (includes corresponding Graph/Chart).....II-32
1$350
   Autologous or Service Approach Preferred by European Firms.....II-33
Allogeneic or Product Approach – Slow to Develop.....II-33
Regenerative Medicine Requires Improved Biomaterials.....II-33
1$100
   Assessment of Worldwide R&D Activities in the Area of Biomaterials.....II-34
Investors Wary of Funding Regenerative Medicine.....II-34
1$100
   Regenerative Medicine Field Lags Behind due to Segregated Focus.....II-35
Challenges Encountered by Regenerative Medicine.....II-35
Scientific and Technological Challenges.....II-35
1$100
   Barriers in Sharing Intellectual Property Rights.....II-36
Viable Manufacturing Technologies and Skilled Personnel Crucial.....II-36
1$100
   Strict Regulations Push up Operational Costs.....II-37
Scientific and Technological Challenges in Orthopedics.....II-37
Bone Regeneration.....II-37
Clinical Approaches in Bone Regeneration and Their Limitations.....II-37
2$125
   Regenerative Medicine Advances in Four Phases.....II-39
Human Substances.....II-39
Tissue Engineering.....II-39
Therapeutic Cloning.....II-39
Nanotechnology-Driven Biomaterials.....II-39
1$100
   Types of Regenerative Medicine.....II-40
Type I – Regenerative Medicine.....II-40
Human Proteins and Genes are Drugs in Regenerative Medicine.....II-40
Type-2 Regenerative Medicine.....II-40
Therapies Based on Human Cells and Tissues.....II-40
2$125
   Type-3 Regenerative Medicine.....II-42
Based on Embryonic Stem Cells.....II-42
1$100
   The Opponents of the ESC Theory.....II-43
Embryonic Stem Cells – Shortcomings.....II-43
1$100
   Type-4 Regenerative Medicine.....II-44
Based on Novel Materials / Material Science Advancements.....II-44
1$100
   Overview of Major Regenerative Medicine Techniques.....II-45
Natural Regenerative Proteins.....II-45
Tissue Engineering Capable of Culturing Replacement Organs.....II-45
1$100
   All About Stem Cells.....II-46
Adult Stem Cells.....II-46
Adult Stem Cell Research Eludes Ethical Dispute.....II-46
1$100
   hESC – Highly Capable of Differentiating and Multiplying.....II-47
Stem Cell Research in Development of Regenerative Medicine.....II-47
Neural Stem Cell to Restore Memory Functioning.....II-47
1$100
   Pancreatic Islet Cells to Control Blood Sugar in Diabetics.....II-48
Therapeutic Cloning to Cure Parkinson’s.....II-48
1$100
   Global Regulatory Landscape.....II-49
US.....II-49
EU.....II-49
Japan.....II-49
1$100
   Regulatory Norms Governing ES Cell Research.....II-50
Milestones in the Human Embryonic Stem Cell Research: 2001.....II-50
Legality of ES Cell Use in Major Developed Nations.....II-50
1$100
   BioMimetic Therapeutics to Launch Augmatrix™ Biocomposite Bone Graft.....II-51
TEI Biosciences Introduces PriMatrix™ Ag Antimicrobial Dermal Repair Scaffold.....II-51
1$100
   SANUWAVE Health Introduces orthoPACE™ in Europe.....II-52
Kensey Nash’s Medeor ECM Receives Approval from US FDA.....II-52
Celling Technologies Unveils Res-Q Device.....II-52
1$100
   Kinetic Wins FDA Approval for LifeCell Tissue Matrix.....II-531$100
   BioMimetic Therapeutics Secures CE Mark Approval for GEM 21S® in EU.....II-54
WFIRM and Nantong University Set-up China-US Regenerative and Translational Medicine
  Research Center.....II-54
EMD Millipore Collaborates with Centre for Commercialization of Regenerative
  Medicine.....II-54
1$100
   American CryoStem Associates with Alliance for Regenerative Medicine.....II-55
TAP Biosystems Collaborates with a leading Regenerative Medicine Company.....II-55
Cytomedix Acquires Aldagen.....II-55
1$100
   Centre for Commercialization of Regenerative Medicine Sets Up Industry
  Consortium.....II-56
Tengion Conducts Preclinical Study for Small Intestine Regeneration.....II-56
TiGenix Inks Agreement with Cellerix for Combining Business Operations.....II-56
1$100
   La Jolla Pharmaceutical Acquire Rights to Regenerative Immunophilin Ligands from
  GliaMed.....II-57
Medtronic Acquires Minority Stake in Tengion.....II-57
1$100
   ImageIQ to Enter into Partnership with CCBC, NCRM and Cleveland Clinic.....II-58
Centre for Commercialization of Regenerative Medicine Collaborates with McEwen Centre
  for Regenerative Medicine.....II-58
1$100
   LifeNet Health Sets Up Institute of Regenerative Medicine.....II-59
UK Government Sets Out Plan for Regenerative Medicine.....II-59
1$100
   Healthpoint Acquires Cell-based Technologies and Allied Assets from Intercytex.....II-60
Astellas Pharma to Acquire Equity Stake in Cytori Therapeutics.....II-60
1$100
   Cephalon Enters into Partnership with Mesoblast.....II-61
BioTime and California Institute for Regenerative Medicine Ink Agreement.....II-61
The Automation Partnership Extends Partnership with EPSRC Centre for Innovative
  Manufacturing in Regenerative Medicine.....II-61
1$100
   The Alliance for Regenerative Medicine Introduces Regenerative Medicine Promotion
  Act.....II-62
Power3 Medical Inks Definitive Agreement to Acquire StemTroniX.....II-62
Healthpoint Acquires CYZACT™ and ICX-SKN Technologies from Intercytex.....II-62
1$100
   Stem Cell Therapy International Merges with Histostem.....II-63
TiGenix Acquires Orthomimetics.....II-63
Integra Inks Licensing Deal with Organogenesis.....II-63
DePuy Spine Collaborates with ATRM.....II-63
Epistem Enters into Partnership with Novartis.....II-63
1$100
   Athersys Inks Agreement with Pfizer.....II-64
Beike Biotechnology Signs Investment Agreement with Biomaster.....II-64
Fujifilm Establishes New Drug Discovery Labs.....II-64
1$100
   BioVest International, Inc. (US).....II-65
Curis, Inc. (US).....II-65
1$100
   Cytori Therapeutics, Inc. (US).....II-661$100
   Evotec AG (Germany).....II-67
Forticell Bioscience, Inc. (US).....II-67
1$100
   Geron Corporation (US).....II-68
Integra LifeSciences Corporation (US).....II-68
1$100
   LifeCell Corporation (US).....II-69
Osiris Therapeutics, Inc. (US).....II-69
1$100
   Tengion, Inc. (US).....II-70
Tepha Inc. (US).....II-70
1$100
   TiGenix N.V. (Belgium).....II-712$125
   Table 13: World Recent Past, Current & Future Market Analysis for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....II-731$350
   Table 14: World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....II-741$350
   Table 15: World 15-Year Perspective for Regenerative Medicine Products for Bone and Joint Applications by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for Years 2004, 2011 & 2018 (includes corresponding Graph/Chart).....II-751$350
   Regenerative Medicine Market by Application.....II-76
Table 16: World Recent Past, Current & Future Market Analysis for Regenerative Medicine Products for Bone and Joint Applications by Application - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....II-76
1$350
   Table 17: World Historic Review for Regenerative Medicine Products for Bone and Joint Applications by Application - Bone Replacements, Bone Stimulators, and Tissue Replacements Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....II-771$350
   Table 18: World 15-Year Perspective for Regenerative Medicine Products for Bone and Joint Applications by Application - Percentage Breakdown of Dollar Sales for Bone Replacements, Bone Stimulators, and Tissue Replacements Markets for Years 2004, 2011 & 2018 (includes corresponding Graph/Chart).....II-781$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
Millions of American Patients Put their Hope in Stem Cell Research.....III-2
1$75
   Table 19: Prevalence of Various Diseases in the US (includes corresponding Graph/Chart).....III-3
High Potential for Regenerative Medicine in Orthopedics.....III-3
Regenerative Medicine in Bone and Joint Applications.....III-3
1$200
   Regenerative Therapy – Best Fit for Joint Problems.....III-4 1$75
   Table 20: US Market for Regenerative Medicine Products for Bone and Joint Applications (2011, 2015 & 2018): Percentage Breakdown of Value Sales for Bone Replacement Grafting, Bone Growth Stimulators, and Tissue Engineering Cartilage (includes corresponding Graph/Chart).....III-5

Table 21: US Demineralized Bone Matrices Market (2011): Percentage Share Breakdown of Value Sales for Leading Players (includes corresponding Graph/Chart).....III-5
1$200
   Table 22: US Cartilage Procedure Market by Volume: 2012-2018 (in Million Procedures) (includes corresponding Graph/Chart).....III-6
Regenerative Medicine – Other Areas of Application.....III-6
Regenerative Medicine – Face of Future Revolution in Cardiology.....III-6
Regenerative Medicine in Wound Healing – The Most Widespread Application.....III-6
1$200
   Regenerative Medicine in Diabetes – A Number of Emerging Applications.....III-7
Regenerative Medicine – A Ray of Hope for Neurodegenerative Disease
  Patients.....III-7
Major Scientific Breakthroughs and Developments in Regenerative Medicine.....III-7
1$75
   CBI’s Human Tissue Products for Treating Liver Failure and Diabetes.....III-8
Market for Liver and Pancreas Transplantation.....III-8
Implantable Regenerative Products Take Over Sports Medicine.....III-8
1$75
   Challenges in the Area of Product Development.....III-9
Process of Integration Continues.....III-9
Legal Entangles in the Field of Regenerative Medicine – Cause for Concern.....III-9
1$75
   Scientific and Technological Challenges to be Tackled.....III-10
Dominant Patents a Cause of Concern.....III-10
1$75
   Technological Innovations/Breakthroughs.....III-111$75
   Strategic Corporate Developments.....III-121$75
   Key Players.....III-138$225
   B. Market Analytics.....III-21
Table 23: US Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-21
1$200
   Table 24: US Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-221$200
   A. Market Analysis.....III-23
Current and Future Analysis.....III-23
Great Potential for Regenerative Medicine.....III-23
Challenges Faced by European Regenerative Medicine Industry.....III-23
1$75
   Financial Viability – A Growing Concern in the Backdrop of Euro Crisis.....III-24
The Need to Embrace Newer Technologies.....III-24
Complex Regulatory Scenario with Multi-tier Governance System.....III-24
Need for More Integration.....III-24
1$75
   Policies Regarding Egg Procurement Weigh Down Research Progress.....III-25
Need for Harmonized Clinical Trial Regulation.....III-25
1$75
   International Alliances – Outsourcing Options with Developing Countries.....III-26
Patenting Issues in hESC Research.....III-26
1$75
   Oral Tissue Regeneration.....III-27
Table 25: European Oral Tissue Regeneration Market (2011): Percentage Breakdown of Value Sales for Bone Graft Material, Membranes, and Tissue Regeneration (includes corresponding Graph/Chart).....III-27
Overview of select regional markets.....III-27
Germany.....III-27
United Kingdom.....III-27
1$200
   UK Government Sets Out Plan for Regenerative Medicine.....III-28
Barriers to Commercialization.....III-28
Strategic Corporate Developments.....III-28
2$125
   Key players.....III-301$75
   B. Market Analytics.....III-31
Table 26: European Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-31
1$200
   Table 27: European Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-321$200
   A. Market Analysis.....III-33
Current and Future Analysis.....III-33
Canada.....III-33
A Significant Player in the Field of Regenerative Medicine.....III-33
Regulatory and Legislative Scenario.....III-33
1$75
   University of Toronto – Spearheading Regenerative Medicine Research.....III-34
Asia-Pacific.....III-34
Japan.....III-34
Growth Drivers.....III-34
1$75
   Regenerative Medicine Market for Bone and Joint Applications.....III-35
The Expanding RM market for Cartilage Grafts.....III-35
Regenerative Bone Grafts – Slow Progress of Research a Concern.....III-35
Other Areas in Regenerative Medicine.....III-35
Skin Transplantation.....III-35
Pancreas & Liver Transplantation.....III-35
Research Activity in Regenerative Medicine Field.....III-35
1$75
   More Companies Eye the Regenerative Medicine Potential.....III-36
Competition Heats up Behind Closed Doors.....III-36
1$75
   Japanese Firms Need to Catch Up with US and European Competitors.....III-37
Science Ministry Rolls Out Regenerative Medicine Project.....III-37
Regenerative Medicine Exempted from Ban on Human Cloning.....III-37
1$75
   Issues and Concerns.....III-38
Regulatory Issues – Need for Faster Approvals.....III-38
1$75
   Need for Participation in International Standardization.....III-39
China.....III-39
Substantial Government Support.....III-39
India.....III-39
CSIR- Leading the way in Regenerative Medicine Research.....III-39
High Growth Opportunities.....III-39
1$75
   South Korea.....III-40
Malaysia.....III-40
Singapore.....III-40
1$75
   Latin America.....III-41
Argentina.....III-41
Brazil.....III-41
Highly Promising but Challenges Remain.....III-41
1$75
   Inconsistent Government Funding Poses Hurdles for Long-Term Research.....III-42
Import Costs and Delays – An Impediment for the RM Sector.....III-42
Underestimation of Brazilian Innovation – A Concern.....III-42
1$75
   Greater Integration Needed the Need of the Hour.....III-43
Lack of Interest in IP Protection Results in Lesser Patents.....III-43
Africa.....III-43
South Africa.....III-43
1$75
   Strategic Corporate Developments.....III-441$75
   Key players.....III-451$75
   B. Market Analytics.....III-46
Table 28: Rest of World Recent Past, Current & Future Analysis for Regenerative Medicine Products for Bone and Joint Applications Market with Annual Sales Figures in US$ Million for Years 2010 through 2018 (includes corresponding Graph/Chart).....III-46
1$200
   Table 29: Rest of World Historic Review for Regenerative Medicine Products for Bone and Joint Applications Market with Annual Sales Figures in US$ Million for Years 2004 through 2009 (includes corresponding Graph/Chart).....III-471$200
  
Total Companies Profiled: 119 (including Divisions/Subsidiaries - 124)

Region/Country Players

The United States 74 Canada 1 Japan 13 Europe 20 Germany 5 The United Kingdom 9 Rest of Europe 6 Asia-Pacific (Excluding Japan) 12 Latin America 1 Africa 1 Middle-East 1
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