For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website: http://www.visiongain.com/Report/1159/Translational-Regenerative-Medicine-Market-Prospects-2014-2024

1. Translational Regenerative Medicine:
Market Prospects 2014-2024
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2. Contents
1.1. Executive Summary
Executive Summary
1.1 Overview of Findings
1.2 Structure of the Report
1.3 Research and Analysis Methods
1.4 Glossary of Terms in this Report
2.2. Introduction to Translational Regenerative Medicine
Introduction to Translational Regenerative Medicine
2.1 What is Translational Regenerative Medicine?
2.2 Translational Regenerative Medicine: Market Segmentation
2.2.1 Stem Cell Therapy
2.2.1.1 Classifying Stem Cells by Potency
2.2.1.2 Categories of Stem Cells
2.2.1.3 Autologous versus Allogeneic Stem Cells: Towards Universal Stem Cell Products?
2.2.1.4 Stem Cell Therapeutic Applications
2.2.2 Tissue Engineering
2.2.3 Gene Therapy
2.2.3.1 Harnessing Infectivity: Viral Vectors in Gene Therapy
2.3 Other Areas of Regenerative Medicine
2.3.1 Small Molecules and Proteins – Enhancing Regenerative Medicine
2.3.2 Cosmetic Applications of Regenerative Medicine
2.4 Regulation of Regenerative Medicine
2.4.1 Regulation of Regenerative Medicine Products in Europe
2.4.2 Regulation of Regenerative Medicine Products in the US
2.5 Phases of Clinical Trials
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3. Contents
2.6 Scope of this Report
2.6.1 Products Excluded from this Report
3.3. Regenerative Medicine: World Market 2014-2024
Regenerative Medicine: World Market 2014-2024
3.1 The World Regenerative Medicine Market in 2012 and 2013
3.2 Leading Regenerative Medicine Products
3.3 Leading Companies in the Regenerative Medicine Market
3.4 World Regenerative Medicine Market: Sales Forecast 2014-2024
3.4.1 Regenerative Medicine Market Segments: Sales Forecasts 2014-2024
3.4.2 Regenerative Medicine: CAGRs by Segment 2014-2024
3.4.3 Changing Market Shares by Segment 2014-2024
3.5 Stem Cell Therapies Lead the Regenerative Medicine Market
3.5.1 Stem Cells Therapy Market: Drivers and Restraints 2014-2024
3.6 Tissue Engineered Products Will Continue Strong Growth
3.6.1 Tissue Engineered Products Market: Drivers and Restraints 2014-2024
3.7 Gene Therapies Show High Growth Potential
3.7.1 Gene Therapy Market: Drivers and Restraints 2014-2024
4.4. Leading National Markets 2014-2024
Leading National Markets 2014-2024
4.1 Regional Breakdown of the World Regenerative Medicine Market
4.2 World Regenerative Medicine Market: Regional Forecast 2014-2024
4.2.1 Regenerative Medicine: CAGRs by Regional Market 2014-2024
4.2.2 How Will Regional Market Shares Change to 2024?
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4. Contents
4.3 The US Regenerative Medicine Market 2014-2024
4.3.1 US Regenerative Medicine Market: Drivers and Restraints
4.3.2 US Market Overview: The Leading Regenerative Medicine Market
4.3.2.1 Regulation of Regenerative Medicine in the US
4.3.2.2 Embryonic Stem Cell Research Remains Controversial
4.3.2.3 An End to Patents on Human Genes?
4.4 The European Regenerative Medicine Market 2014-2024
4.4.1 European Regenerative Medicine Market: Drivers and Restraints
4.4.2 European Market Overview: A Strong Science Base
4.4.2.1 On the Brink of a Unitary European Patent System
4.4.2.2 Regulation of Regenerative Medicine in Europe
4.4.2.3 European REMEDiE Project
4.4.2.4 A UK Perspective on the Regenerative Medicine Market
4.4.2.5 Developments in the Russian Regenerative Medicine Market
4.5 The Asia-Pacific Regenerative Medicine Market 2014-2024
4.5.1 Asia-Pacific Regenerative Medicine Market: Drivers and Restraints
4.5.2 Asia-Pacific Market Overview: Towards Rapid Commercialisation
4.5.2.1 Japan: Transforming the Regulatory Landscape
4.5.2.2 China: Encouraging Stem Cell R&D
4.5.2.3 India: An Emerging RM Industry
4.5.2.4 South Korea: First to Approve Stem Cell Treatments
4.5.2.5 Australia: Encouraging Translational Regenerative Medicine
4.6 The Regenerative Medicine Market in the Rest of the World 2014-2024
4.6.1 Brazil – An Emerging Market in South America
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5. Contents
5.5. Leading Companies in the Regenerative Medicine Market
Leading Companies in the Regenerative Medicine Market
5.1 Aastrom Biosciences: Developing Cardiovascular Stem Cell Therapies
5.1.1 Aastrom Biosciences: Clinical Trials
5.1.2 Aastrom Biosciences: Products in Development
5.1.2.1 Ixmyelocel-T: Autologous Mesenchymal Stem Cell Therapy
5.2 Advanced Cell Technology: Stem Cells for Eye Diseases
5.2.1 Advanced Cell Technology: Clinical Trials
5.2.2 Advanced Cell Technology: Products in Development
5.2.2.1 Retinal Pigment Epithelial Cell Therapy
5.2.2.2 iPSC-derived Platelets
5.2.2.3 Hemangioblast Program
5.2.2.4 Mesenchymal Stem Cell Program
5.2.2.5 Other Products
5.3 Alphatec Spine: Bone Allgrafts
5.3.1 Alphatec Spine: Clinical Trials
5.3.2 Alphatec Spine: Products in Development
5.4 Anterogen: South Korean Stem Cell Company
5.4.1 Anterogen: Clinical Trials
5.4.2 Anterogen: Products in Development
5.5 Athersys: Developing Allogeneic Progenitor Cell Therapy
5.5.1 Athersys: Clinical Trials
5.5.2 Athersys: Products in Development
5.5.2.1 MultiStem: Allogeneic Multipotent Adult Progenitor Cells
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6. Contents
5.5.2.2 Serotonin Receptor Agonists
5.6 Avita Medical: Spray-On Skin Cell Therapy
5.6.1 Avita Medical: Clinical Trials
5.7 AxoGen: Nerve Regeneration Products
5.7.1 AxoGen: Clinical Trials
5.7.2 AxoGen: Products in Development
5.8 Genzyme (acquired by Sanofi): A Leader in Regenerative Medicine
5.8.1 Genzyme: Clinical Trials
5.8.2 Genzyme: Products in Development
5.9 Medipost: Cartilage Repair with Cartistem
5.9.1 Medipost: Clinical Trials
5.9.2 Medipost: Products in Development
5.10 Mesoblast: An Australian RM Leader
5.10.1 Mesoblast : Clinical Trials
5.10.2 Mesoblast: Products in Development
5.10.2.1 NeoFuse
5.10.2.2 Prochymal
5.10.2.3 Chondrogen
5.10.2.4 Mesenchymal Precursor Cells in Congestive Heart Failure
5.10.2.5 Other Pipeline Products
5.11 NuVasive: Spinal Surgery Bone Allografts
5.11.1 NuVasive: Clinical Trials
5.11.2 NuVasive: Products in Development
5.12 Organogenesis: a Tissue Engineering Pioneer
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7. Contents
5.12.1 Organogenesis: Clinical Trials
5.12.2 Organogenesis: Products in Development
5.13 Osiris Therapeutics: a Leading Stem Cell Company
5.13.1 Osiris Therapeutics: Clinical Trials
5.13.2 Osiris Therapeutics: Products in Development
5.14 Pharmicell: South Korean Stem Cell Leader
5.14.1 Pharmicell: Clinical Trials
5.14.2 Pharmicell: Products in Development
5.15 Regenerys: Manufacturing Skin Substitutes
5.15.1 Regenerys: Clinical Trials
5.15.2 Regenerys: Products in Development
5.16 Shire Regenerative Medicine: Entering the RM Market
5.16.1 Shire: Clinical Trials
5.16.2 Shire: Products in Development
5.16.2.1 Vascugel
5.17 TiGenix: European Cell Therapy Leader
5.17.1 TiGenix: Clinical Trials
5.17.2 TiGenix: Products in Development
5.18 UniQure: First Gene Therapy Approved in Europe
5.18.1 UniQure: Clinical Trials
5.18.2 UniQure: Products in Development
6.6. Stem Cell Therapy: Leading Applications 2014-2024
Stem Cell Therapy: Leading Applications 2014-2024
6.1 Stem Cell Therapy: Currently Available Therapies
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8. Contents
6.1.1 Haematopoietic Stem Cell Transplantation (HSCT)
6.1.2 Stem Cell Orthobiologics
6.1.2.1 Osteocel Plus (NuVasive): Sales Forecast 2014-2024
6.1.2.2 Trinity ELITE and Trinity Evolution (Orthofix): Sales Forecast 2014-2024
6.1.2.3 LiquidGen (Skye Orthobiologics)
6.1.2.4 AlloStem (AlloSource)
6.1.2.5 PureGen (AlphaTec Spine)
6.1.3 Other Approved Stem Cell Therapy Products
6.1.3.1 Prochymal (remestemcel-L, Osiris Therapeutics/Mesoblast): Sales Forecast 20142024
6.1.3.2 Hearticellgram-AMI (Pharmicell)
6.1.3.3 Cupistem (Anterogen)
6.1.3.4 Cartistem (Medipost)
6.2 Stem Cell Therapy Pipeline to 2024
6.2.1 Late-Stage Pipeline for Stem Cell Therapies
6.2.1.1 StemEx (carlecortemcel-L, Gamida Cell)
6.2.1.2 Mesenchymal Precursor Cell Therapies (Mesoblast)
6.2.1.3 Adult Autologous CD34+ Cells (Baxter)
6.2.1.4 MyoCell (Bioheart)
6.2.1.5 Cx601 (TiGenix)
6.2.1.6 Adipose-Derived Stem Cells (Cytori Therapeutics)
6.2.1.7 Stempeucel (Stempeutics Research)
6.2.1.8 C-Cure (Cardio3 BioSciences)
6.2.1.9 Other Late-Stage Stem Cell Therapies
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9. Contents
6.2.2 Diabetes and Stem Cell Therapy
6.2.2.1 Mesenchymal Precursor Cells (Mesoblast)
6.2.2.2 VC-01 (ViaCyte)
6.2.3 Cardiovascular Disease and Stem Cell Therapy
6.2.3.1 Endometrial Regenerative Cells (Medistem)
6.2.3.2 AMR-001 (NeoStem)
6.2.3.3 CAP-1002 (Capricor)
6.2.4 Stem Cell Therapy in Cancer
6.2.4.1 CLT-008 (Cellerant Therapeutics)
6.2.4.2 OncoCyte/BioTime – Targeting Cancer with Gene and Stem Cell Therapy
6.2.5 Stem Cell Therapy for CNS Conditions
6.2.5.1 NurOwn (BrainStorm Cell Therapeutics)
6.2.5.2 NSI-566 (Neuralstem)
6.2.5.3 MultiStem (Athersys)
6.2.5.4 PDA-001 (cenplacel-L, Celgene)
6.2.5.5 ALD-401 (Cytomedix)
6.2.5.6 ReN001 (ReNeuron)
6.2.6 Stem Cell Therapy for Eye Diseases
6.2.6.1 MA09-hRPE (Advanced Cell Technology)
6.2.6.2 HuCNS-SC (StemCells, Inc.)
6.2.6.3 EC200 (EyeCyte)
6.2.6.4 Pfizer’s Collaboration with The London Project to Cure Blindness
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10. Contents
7.7. Tissue Engineering: Leading Applications 2014-2024
Tissue Engineering: Leading Applications 2014-2024
7.1 Tissue Engineering: Currently Available Therapies
7.1.1 Tissue Engineering for Wound Repair
7.1.1.1 Apligraf (Organogenesis): Sales Forecast 2014-2024
7.1.1.2 BioDfence and BioDfactor (BioD)
7.1.1.3 CureXcell (MacroCure)
7.1.1.4 Dermagraft (Shire): Sales Forecast 2014-2024
7.1.1.5 Epicel (Sanofi)
7.1.1.6 Grafix (Osiris Therapeutics)
7.1.1.7 MySkin and CyroSkin (Regenerys)
7.1.1.8 ReCell (Avita Medical): Sales Forecast 2014-2024
7.1.2 Tissue Engineering for Cartilage Repair: Autologous Chondrocyte Implantation
7.1.2.1 Carticel (Sanofi)
7.1.2.2 ChondroCelect (TiGenix)
7.1.2.3 DeNovo NT (Zimmer)
7.1.2.4 MACI (Sanofi)
7.1.3 Other Available Tissue Engineering Therapies
7.1.3.1 Autologous Cultured Cell and Tissue Products (Japan Tissue Engineering Co.)
7.1.3.2 Gintuit (Organogenesis)
7.1.3.3 LAVIV (azficel-T, Fibrocell Science)
7.1.3.4 Acellular Tissue Engineering Products
7.2 Tissue Engineering Pipeline to 2024
7.2.1 Autologous Chondrocyte Implantation Pipeline
7.2.2 Tissue Engineering for Skin
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11. Contents
7.2.3 Tissue Engineering for Liver Disease
7.2.3.1 Extracorporeal Bio-Artificial Liver Therapy (Vital Therapies)
7.2.4 Tissue Engineering for Cardiovascular Disease
7.2.5 Tissue Engineering for Eye Diseases
7.2.6 Prospects for Organ Transplantation
8.8. Gene Therapy: Leading Applications 2014-2024
Gene Therapy: Leading Applications 2014-2024
8.1 Gene Therapy: Currently Available Therapies
8.1.1 Gendicine (Benda Pharmaceutical)
8.1.2 Oncorine (Shanghai Sunway Biotech)
8.1.3 Neovasculgen (Human Stem Cells Institute)
8.1.4 Neovasculgen (HSCI): Sales Forecast 2014-2024
8.1.5 Glybera (UniQure)
8.2 Withdrawn From Sale: Rexin-G (Epeius Biotechnologies)
8.3 Gene Therapy Pipeline to 2024
8.3.1 Late-Stage Gene Therapy Pipeline
8.3.1.1 Collategene (beperminogene perplasmid, AnGes MG/Vical)
8.3.1.2 ProstAtak (AdV-tk, Advantagene)
8.3.1.3 Trinam (taberminogene vadenovec, Ark Therapeutics)
8.3.1.4 TVEC (talimogene laherparepvec, Amgen)
8.3.1.5 AAV2-hRPE65v2 (Spark Therapeutics)
8.3.1.6 CG0070 (Cold Genesys)
8.3.2 Gene Therapy for Diabetes
8.3.3 Gene Therapy for Cancer
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12. Contents
8.3.4 Gene Therapy for Neurological Diseases
8.3.5 Gene Therapy for Haemophilia B
9.9. Qualitative Analysis of the Regenerative Medicine Market 2014Qualitative Analysis of the Regenerative Medicine Market 2014-2024
2024
9.1 SWOT Analysis of the Regenerative Medicine Market
9.2 Strengths
9.2.1 Incremental Progress in Research
9.2.2 Regulatory Frameworks Improving
9.2.3 An Established Route to Market
9.2.4 Strong Support from National Governments
9.3 Weaknesses
9.3.1 Lack of Venture Capital
9.3.2 High Costs of RM Therapies
9.3.3 Commercialisation Requires New Business Models
9.3.4 Lack of Standardisation
9.4 Opportunities
9.4.1 Disruptive RM Therapies Can Create New Markets
9.4.2 3D Bioprinting and Other Technologies May Enable Rapid Scale-Up
9.4.3 Increasing Burden of Chronic Disease
9.4.4 Medical Tourism Can Drive the Market
9.5 Threats
9.5.1 Restraints on Reimbursement
9.5.2 Difficulty Establishing an Evidence Base
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13. Contents
9.5.3 Ethical Concerns Limiting R&D
9.5.4 Progress May be Slow
9.6 Porter’s Five Forces Analysis of the Regenerative Medicine Market
9.6.1 Rivalry Among Competitors [Medium]
9.6.2 Threat of New Entrants [Medium]
9.6.3 Power of Suppliers [Low]
9.6.4 Power of Buyers [Low]
9.6.5 Threat of Substitutes [High]
10. Research Interviews
10. Research Interviews
10.1 Interview with Dr Alan Trounson, President, California Institute for Regenerative Medicine
(CIRM)
10.1.1 Improved Funding in the Stem Cells Field
10.1.2 MSCs: Major Potential or Merely a Placeholder?
10.1.3 CIRM Investment Strategies
10.1.4 The Changing Regulatory Environment Worldwide
10.1.5 Key Trends for the Next Five to Ten Years
10.2 Interview with Professor Francois Berthiaume, Associate Professor of Biomedical
Engineering, Rutgers University, New Jersey
10.2.1 On the Regenerative Medicine Market
10.2.2 On the Future of Stem Cell Therapies
10.2.3 Challenges in the Tissue Engineering Market
10.2.4 Thoughts on Future Developments
10.3 Interview with Dr William Dolphin, CEO, Avita Medical, UK
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14. Contents
10.3.1 Future Prospects for the Regenerative Medicine Market
10.3.2 Is Regenerative Medicine Ready For Commercialisation?
10.3.3 On Emerging Regenerative Medicine Markets
10.3.4 Future Therapeutic Areas
10.3.5 Barriers to Developing Regenerative Medicine?
10.3.6 Thoughts on Future Developments
11. Conclusions
11. Conclusions
11.1 The World Regenerative Medicine Market in 2012 and 2013
11.1.1 Current Leading Regenerative Medicine Segments
11.1.2 Leading Regenerative Medicine Products
11.1.3 Leading Regenerative Medicine Companies
11.1.4 Leading Regional Markets
11.2 World Regenerative Medicine Market Forecast 2014-2024
11.3 Regenerative Medicine Late-Stage Pipeline
11.4 The Future of the Regenerative Medicine Market?
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15. Contents
List of Tables
Table 1.1 Currency Exchange Rates, 2012
Table 2.1 European Union Definitions of Regenerative Medicine Products, 2013
Table 2.2 Potency and Source of Stem Cells, 2013
Table 2.3 Germ Layers and Their Associated Cells, Tissues and Organs, 2013
Table 2.4 Stem Cell Categories, 2013
Table 2.5 Stem Cell Donor Terminology, 2013
Table 2.6 Clinical Trial Phases
Table 3.1 World Regenerative Medicine Market: Revenues ($m) and Market Shares (%) by
Segment, 2012
Table 3.2 Leading Regenerative Medicine Products: Revenues ($m), 2012
Table 3.3 Leading Companies in the Regenerative Medicine Market: Leading Products and Net
Revenues ($m), 2012
Table 3.4 World Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR (%),
2012-2024
Table 3.5 World Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR (%)
by Segment, 2012-2018
Table 3.6 World Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR (%)
by Segment, 2018-2024
Table 3.7 World Regenerative Medicine Market: CAGR (%) by Segment, 2012-2018, 2018-2024
and 2012-2024
Table 3.8 Market Shares (%) of the Regenerative Medicine Market by Segment, 2012, 2018 and
2024
Table 3.9 Stem Cell Market: Revenues ($m) and Market Shares (%) by Subsegment, 2012
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16. Contents
Table 3.10 Stem Cell Therapy Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2024
Table 3.11 Tissue Engineered Products Market Forecast: Revenues ($m), AGR (%), CAGR (%),
2012-2024
Table 3.12 Gene Therapy Market: Commercial-Stage Products, 2013
Table 3.13 Gene Therapy Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2024
Table 3.14 Gene Therapy Market Forecast: Revenues ($m), AGR (%), CAGR (%) by Product,
2012-2024
Table 4.1 World Regenerative Medicine Market: Revenues ($m) and Market Shares (%) by
Region, 2012
Table 4.2 World Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR (%)
by Region, 2012-2018
Table 4.3 World Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR (%)
by Region, 2018-2024
Table 4.4 World Regenerative Medicine Market: CAGR (%) by Region, 2012-2018, 2018-2024
and 2012-2024
Table 4.5 Market Shares (%) of the Regenerative Medicine Market by Region in 2012, 2018 and
2024
Table 4.6 US Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR (%),
2012-2024
Table 4.7 European Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR
(%), 2012-2024
Table 4.8 Asia-Pacific Regenerative Medicine Market Forecast: Revenues ($m), AGR (%), CAGR
(%), 2012-2024
Table 4.9 Rest of the World Regenerative Medicine Market Forecast: Revenues ($m), AGR (%),
CAGR (%), 2012-2024
Table 5.1 Aastrom Biosciences: Regenerative Medicine Clinical Trials, 2013
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17. Contents
Table 5.2 Advanced Cell Technology: Regenerative Medicine Clinical Trials, 2013
Table 5.3 AlphaTec Spine: Regenerative Medicine Clinical Trials, 2013
Table 5.4 Anterogen: Regenerative Medicine Clinical Trials, 2013
Table 5.5 Athersys: Regenerative Medicine Clinical Trials, 2013
Table 5.6 Avita Medical: Regenerative Medicine Clinical Trials, 2013
Table 5.7 AxoGen: Regenerative Medicine Clinical Trials, 2013
Table 5.8 Genzyme: Products in the US Market, 2013
Table 5.9 Genzyme: Regenerative Medicine Clinical Trials, 2013
Table 5.10 Medipost: Regenerative Medicine Clinical Trials, 2013
Table 5.11 Mesoblast: Regenerative Medicine Clinical Trials, 2013
Table 5.12 NuVasive: Regenerative Medicine Clinical Trials, 2013
Table 5.13 Organogenesis: Regenerative Medicine Clinical Trials, 2013
Table 5.14 Osiris Therapeutics: Regenerative Medicine Clinical Trials, 2013
Table 5.15 Pharmicell: Regenerative Medicine Clinical Trials, 2013
Table 5.16 Regenerys: Regenerative Medicine Clinical Trials, 2013
Table 5.17 Shire: Regenerative Medicine Clinical Trials, 2013
Table 5.18 TiGenix: Regenerative Medicine Clinical Trials, 2013
Table 5.19 UniQure: Regenerative Medicine Clinical Trials, 2013
Table 6.1 Selected Currently Available Stem Cell Products, 2013
Table 6.2 FDA-Approved Cord Blood-Derived Stem Cell Products for HSCT, 2013
Table 6.3 Stages of Osteogenesis, 2013
Table 6.4 NuVasive: Osteocel Plus Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
Table 6.5 Orthofix: Trinity ELITE Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
Table 6.6 Mesoblast: Prochymal Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
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18. Contents
Table 6.7 Stem Cell Therapy Pipeline: Therapies in Late-Stage Clinical Trials, 2013
Table 7.1 Selected Currently Available Tissue Engineering Products, 2013
Table 7.2 Organogenesis: Apligraf Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
Table 7.3 Shire: Dermagraft Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
Table 7.4 Avita Medical: ReCell Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
Table 7.5 Vital Therapies: Extracorporeal Bio-Artificial Liver Therapy Clinical Trials, 2013
Table 8.1 Currently Available Gene Therapies, 2013
Table 8.2 Benda Pharmaceutical: Gendicine Clinical Trials, 2013
Table 8.3 Human Stem Cells Institute: Neovasculgen Revenue Forecast ($m), AGR (%),
CAGR(%), 2012-2024
Table 8.4 UniQure: Glybera Revenue Forecast ($m), AGR (%), CAGR(%), 2012-2024
Table 8.5 Gene Therapy Pipeline: Therapies in Late-Stage Clinical Trials, 2013
Table 8.6 Advantagene: Gene Therapy Clinical Trials, 2013
Table 8.7 Amgen: TVEC Clinical Trials, 2013
Table 8.8 Spark Therapeutics: AAV2-hRPE65v2 Clinical Trials, 2013
Table 9.1 SWOT Analysis of the Regenerative Medicine Market, 2014-2024
Table 9.2 World 65+ Population Forecast: Size (m), AGR (%), CAGR (%), 2013-2024
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19. Contents
List of Figures
Figure 2.1 Brief History of Stem Cell Research, 1900-2000
Figure 2.2 Brief History of Tissue Engineering, 1900-2013
Figure 2.3 Examples of FDA-Approved Tissue Engineered Products
Figure 2.4 Brief History of Gene Therapy, 1970-2013
Figure 3.1 World Regenerative Medicine Market: Market Shares (%) by Segment, 2012
Figure 3.2 Leading Regenerative Medicine Products: Market Shares (%), 2012
Figure 3.3 World Regenerative Medicine Market Forecast: Revenues ($m), 2012-2024
Figure 3.4 World Regenerative Medicine Market Forecast: Revenues ($m) by Segment, 20122024
Figure 3.5 World Regenerative Medicine Market Forecast: CAGR (%) by Segment, 2012-2018
Figure 3.6 World Regenerative Medicine Market Forecast: CAGR (%) by Segment, 2018-2024
Figure 3.7 World Regenerative Medicine Market Forecast: CAGR (%) by Segment, 2012-2024
Figure 3.8 World Regenerative Medicine Market: Market Shares (%) by Segment, 2018
Figure 3.9 World Regenerative Medicine Market: Market Shares (%) by Segment, 2024
Figure 3.10 Stem Cell Market: Market Shares (%) by Subsegment, 2012
Figure 3.11 Stem Cell Therapy Market Forecast: Revenues ($m), 2012-2024
Figure 3.12 Stem Cell Therapy Market: Drivers and Restraints, 2014-2024
Figure 3.13 Tissue Engineered Products Market Forecast: Revenues ($m), 2012-2024
Figure 3.14 Tissue Engineered Products Market: Drivers and Restraints, 2014-2024
Figure 3.15 Gene Therapy Market Forecast: Revenues ($m), 2012-2024
Figure 3.16 Gene Therapy Market: Market Shares (%) by Product, 2012
Figure 3.17 Gene Therapy Market: Market Shares (%) by Product, 2018
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20. Contents
Figure 3.18 Gene Therapy Market: Market Shares (%) by Product, 2024
Figure 3.19 Gene Therapy Market: Drivers and Restraints, 2014-2024
Figure 4.1 World Regenerative Medicine Market: Revenues ($m) by Region, 2012
Figure 4.2 World Regenerative Medicine Market: Market Shares (%) by Region, 2012
Figure 4.3 World Regenerative Medicine Market Forecast: Revenues ($m) by Region, 2012-2024
Figure 4.4 World Regenerative Medicine Market Forecast: CAGR (%) by Region, 2012-2018
Figure 4.5 World Regenerative Medicine Market Forecast: CAGR (%) by Region, 2018-2024
Figure 4.6 World Regenerative Medicine Market Forecast: CAGR (%) by Region, 2012-2024
Figure 4.7 World Regenerative Medicine Market: Market Shares (%) by Region, 2018
Figure 4.8 World Regenerative Medicine Market: Market Shares (%) by Region, 2024
Figure 4.9 US Regenerative Medicine Market Forecast: Revenues ($m), 2012-2024
Figure 4.10 US Regenerative Medicine Market: Drivers and Restraints, 2014-2024
Figure 4.11 European Regenerative Medicine Market Forecast: Revenues ($m), 2012-2024
Figure 4.12 European Regenerative Medicine Market: Drivers and Restraints, 2014-2024
Figure 4.13 Asia-Pacific Regenerative Medicine Market Forecast: Revenues ($m), 2012-2024
Figure 4.14 Asia-Pacific Regenerative Medicine Market: Drivers and Restraints, 2014-2024
Figure 4.15 Rest of the World Regenerative Medicine Market Forecast: Revenues ($m), 20122024
Figure 6.1 NuVasive: Osteocel Plus Revenue Forecast ($m), 2012-2024
Figure 6.2 Orthofix: Trinity ELITE Revenue Forecast ($m), 2012-2024
Figure 6.3 Mesoblast: Prochymal Revenue Forecast ($m), 2012-2024
Figure 7.1 Organogenesis: Apligraf Revenue Forecast ($m), 2012-2024
Figure 7.2 Shire: Dermagraft Revenue Forecast ($m), 2012-2024
Figure 7.3 Avita Medical: ReCell Revenue Forecast ($m), 2012-2024
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21. Contents
Figure 8.1 Human Stem Cells Institute: Neovasculgen Revenue Forecast ($m), 2012-2024
Figure 8.2 UniQure: Glybera Revenue Forecast ($m), 2012-2024
Figure 9.1 World 65+ Population Forecast: Size (m), 2013-2024
Figure 9.2 Porter’s Five Forces Analysis of the Regenerative Medicine Market, 2014-2024
Figure 11.1 World Regenerative Medicine Market: Revenues ($m) by Segment, 2012
Figure 11.2 World Regenerative Medicine Market: Revenues ($m) by Region, 2012
Figure 11.3 World Regenerative Medicine Market Forecast: Revenues ($m), 2012-2024
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22. Contents
Companies Listed
Aastrom Biosciences
Adiposet Ltd (merged into Regenerys)
Advanced BioHealing (acquired by Shire)
Advanced Cell Technology (ACT)
Advanced Tissue Sciences (ATS)
Advantagene
Allosource
AlphaTec Spine
Altrika (acquired by Regenerys)
Amedica
Amgen
Amorcyte (acquired by NeoStem)
Amorepacific Corporation
Amsterdam Molecular Therapeutics (predecessor of UniQure)
AnGes MG
Angioblast Systems (acquired by Mesoblast)
Anika Therapeutics
AnorMED (acquired by Genzyme)
Anterogen (subsidiary of Bukwang Pharm Co Ltd)
Arcarios B.V.
Ark Therapeutics
Arteriocyte
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23. Contents
Athersys
Avita Medical
AxoGen
AxoGen Corporation (merged into AxoGen)
Baxter International
Beike Biotechnology
Benda Pharmaceutical
BioD
Bioheart
BioMed Realty Trust, Inc.
BioSante Pharmaceuticals
BioTime
BioTissue
BioVex Group (acquired by Amgen)
Blackstone Medical (acquired by Orthofix)
Bluebird Bio
BrainStorm Cell Therapeutics Inc.
Bukwang Pharm Co Ltd
California Stem Cell
Capricor
Cardio3 BioSciences
CDI
Celgene
Cell Targeting
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24. Contents
CellCoTec
Cellerant Therapeutics
Cellerix (merged into TiGenix)
Cephalon
Ceregene
CHA Biotech
Chiesi Farmaceutici SpA
Cipla
Clinical Cell Culture (C3) (merged into Avita Medical)
Clinimmune Labs
co.don
Cold Genesys
Cook Biotech Incorporated
CryoCenter Saint-Petersburg
CytoMedix
Cytori Therapeutics
Daiichi Sankyo
Dendreon
DePuy Mitek (subsidiary of Johnson & Johnson)
Epeius Biotechnologies
EyeCyte
Fibrocell Science
Gamida Cell Ltd
Gemabank
www.visiongain.com

25. Contents
Genpharm
Genzyme (subsidiary of Sanofi)
Geron
Histogenics
Humacyte
Human Stem Cells Institute
Insulete Inc
Introgen Therapeutics
ISTO Technologies
Japan Tissue Engineering Co. (J-TEC)
JCR Pharmaceuticals Co.
Johnson & Johnson
Kinetic Concepts Inc. (merging into KCI)
LecTec Corporation (merged into AxoGen)
LifeCell (merging into KCI)
Lincoln Park Capital
Lonza
MacroCure
Medipost
Medistem (formerly Medistem Laboratories)
Medtronic
Mesoblast
Mitsubishi Tanabe
Musculoskeletal Transplant Foundation (MTF)
www.visiongain.com

26. Contents
Myriad Genetics
Mytogen
National Marrow Donor Program (NMDP) (US)
NeoStem
Neuralstem
New York Blood Center
Nippon Zoki Pharmaceutical
NuVasive
OncoCyte (subsidiary of BioTime)
Organogenesis
Organovo
Oristem
Orthofix
Orthomimetics Ltd (acquired by TiGenix)
Osiris Theraeutics
Oxford BioMedica
Parcell Laboratories
Pervasis Therapeutics (acquired by Shire)
Pfizer
Pharmacells
Pharmicell (formerly FCB-Pharmicell)
Progenitor Cell Therapy (part of NeoStem)
Protek Group
Regenerys
www.visiongain.com

27. Contents
Reliance Life Sciences
ReNeuron
Reprobank
Roslin Cellab
RTI Surgical
Rusnano
Sangamo
Sanofi
Shanghai Qisheng
Shanghai Sunway Biotech
Shenzhen SiBiono GeneTech
Shire
Shire Regenerative Medicine (subsidiary of Shire)
Skye Orthobiologics
Sotex PharmFirm (subsidiary of Protek Group)
Spark Therapeutics
StemCells, Inc.
Stempeutics Research
Stratatech Corporation
Systagenix (merging into KCI)
TCA Cellular Therapy
Tengion
Teva Pharmaceutical Industries (Teva)
TiGenix
www.visiongain.com

28. Contents
UniQure
University of Colorado Cord Blood Bank
ViaCyte (formerly NovoCell)
Vical
Vindon Scientific
Visiomed Group (merged into Avita Medical)
Vital Therapies, Inc.
WKD Holding Oy
Xcellerex
Xenetic Biosciences
Zentrales Knochenmarkspender-Register Deutschland (German National Registry of Blood Stem
Cell Donors) (ZKRD)
Zimmer
www.visiongain.com

29. Contents
Other Organisations Mentioned in This Report
Arthritis Research UK
Associazione Infermieristica per lo Studio delle Lesioni Cutanee (Nursing Association for the
Study of Cutaneous Wounds) (AISLeC) (Italy)
Australian Regenerative Medicine Institute
Australian Research Council
Beijing Cancer Hospital
Boston University
British Heart Foundation
California Institute of Regenerative Medicine (CIRM)
Cambridge Stem Cell Biology Institute.
Care Quality Commission (CQC) (UK)
Catalan Institution for Research and Advanced Studies
Cha General Hospital (Seoul, South Korea)
Children's Hospital of Philadelphia
China Food and Drug Administration (CFDA, formerly SFDA)
Chinese Academy of Sciences
Department of Biotechnology (India)
Department of Health (UK)
Duke University School of Medicine
European Medicines Agency (EMA)
European Patent Office
Finnish Red Cross Blood Service
Food and Drug Administration of the Philippines
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30. Contents
Harvard Medical School
Haute Autorité de santé (HAS) (French National Authority for Health)
Health Canada
Heriot-Watt University
Human Fertilisation and Embryology Authorityy (HFEA) (UK)
Institute for Regenerative Medicine, Wake Forest University Baptist Medical Center
Institute of Biomedical Research and Innovation Hospital (Kobe, Japan)
International Society for Stem Cell Research
Internet Archive
Japan Patent Office
Japanese Society for Regenerative Medicine
Karolinska Institute
King Fahad Medical City (Saudi Arabia)
LifeSouth Community Blood Centers
London Project to Cure Blindness
Mayo Clinic
Medical Research Council (UK)
Medicines and Healthcare products Regulatory Agency (MHRA) (UK)
Ministry of Economy, Trade and Industry (METI) (Japan)
Ministry of Food and Drug Safety (MFDS, formerly KFDA) (South Korea)
Ministry of Health (China)
Ministry of Health, Labour and Welfare (MHLW) (Japan)
Ministry of Science and Technology (China)
Monash University
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31. Contents
Moorfields Eye Hospital
National Health and Medical Research Council (Australia)
National Institutes of Health (US)
National Tissue Engineering Center (NTEC) (China)
Northeast ALS consortium
Pharmaceuticals and Medical Devices Agency (PMDA) (Japan)
Riken Center for Developmental Biology
Russian Ministry of Healthcare and Social Development
Rutgers University
Saudi Food and Drug Authority
Scottish Centre for Regenerative Medicine
Singapore General Hospital
SSM Cardinal Glennon Children's Medical Center
St. Jude's Children Research Hospital
StemGen
SUNY Upstate Medical University
UCL Institute of Ophthalmology
United Nations' Department of Economic and Social Affairs
United States Food and Drug Administration (FDA)
Universitat Autònoma de Barcelona
University College London
University of Edinburgh MRC Centre for Regenerative Medicine
University of Michigan
University of Modena Centre for Regenerative Medicine
www.visiongain.com

32. Contents
University of Wisconsin
US Department of Defense
VA Northern California Health Care System
Weizmann Institute of Science (Rehovot, Israel)
Wellcome Trust
World Health Organization
www.visiongain.com

33. Translational Regenerative Medicine:
Market Prospects 2014-2024
A large proportion of cell therapy trials being based in the US.
•
The main restraints on growth are:
Stringent restrictions on human embryonic stem cell research and difficulties with funding,
•
despite recent improvements under the Obama administration; research involving the
destruction of embryos remains a significant moral issue in the US
Concerns among investors due to long and uncertain development times, in a market
•
which is relatively dependent on venture capital to fund product development
Falling R&D productivity and decreasing expenditure on scientific research in the US
•
compared to Europe and the Asia-Pacific regions.
Figure 4.10 summarises the drivers and restraints of the US regenerative medicine market from
2012 to 2024.
Figure 4.10 US Regenerative Medicine Market: Drivers and Restraints, 2014-2024
Restraints
Drivers
•
Increasing demand for treatments for
degenerative and chronic diseases
•
Restrictive environment for human
embryonic stem cell research
•
High concentration of biotech and
life-science funding available
•
Investors deterred by long and
uncertain product development
•
Large proportion of clinical trials
based in the US
•
Falling R&D productivity and
research expenditure
•
Regulatory processes improving
Source: visiongain 2013
4.3.2 US Market Overview: The Leading Regenerative Medicine Market
As the leading market in regenerative medicine by virtue of the number of companies, clinical trials
and product approvals and the funding available for companies and research, US dominance is set
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34. Translational Regenerative Medicine:
Market Prospects 2014-2024
Table 5.17 Shire: Regenerative Medicine Clinical Trials, 2013
Start and
Intervention
End Dates
Sep 1994 NCT01181440
Dermagraft
Jan 1997
Dec 1998 NCT01181453
Dermagraft
Mar 2000
Celaderm (frozen
Jan 2007 NCT00399308
cultured epidermal
Apr 2008
allograft)
Jun 2009 NCT00909870
Dermagraft
Aug 2011
Apr 2010 NCT01099215
PVS-10200
Oct 2012
May 2010 NCT01891760
Dermagraft
Jun 2012
Oct 2011 - Dermagraft or Oasis
NCT01450943
Oct 2014
versus standard care
Identifier
Indication
Diabetic foot ulcer
III
Diabetic foot ulcer
III
Leg ulcer, varicose ulcer
I/II
Venous leg ulcer
III
Peripheral artery disease
I/II
Venous leg ulcer
III
Diabetic foot ulcer
(comparative
efficacy)
Dec 2012 NCT01749306 Dec 2013
Dermagraft (ABH001) Epidermolysis bullosa
(terminated)
Mar 2013 Vascugel (SRM003)
Aug 2014
Mar 2013 NCT01806584
Vascugel (SRM003)
Aug 2015
NCT01806545
Phase
III
Arteriovenous fistula
II
Arteriovenous graft
II
Source: visiongain 2013; ClinicalTrials.gov
5.16.2 Shire: Products in Development
5.16.2.1 Vascugel
In April 2012, Shire acquired Pervasis Therapeutics, obtaining the rights to the company’s cell
therapy, Vascugel (SHP613, formerly SRM003). Vascugel consists of allogeneic human aortic
endothelial cells cultured in a gelatine matrix (Gelfoam). The product is intended to facilitate the
vascular access surgery that patients with end-stage kidney disease undergo so that they can
receive haemodialysis. After this surgery, patients must wait several months on average for the
access site to ‘mature’ and even after maturation there is a high risk that vascular access will fail –
Shire claims that 60% fail within one year. Vascugel is placed outside the blood vessel at a
vascular access site during surgery to promote maturation of the access site and reduce the risk of
failure. The product has received Orphan Product and Fast Track designation from the FDA and
Orphan Product designation from the European Medicines Agency. Phase II clinical trials of
Vascugel are ongoing.
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35. Translational Regenerative Medicine:
Market Prospects 2014-2024
Table 7.1 Selected Currently Available Tissue Engineering Products, 2013
Company
Avita Medical
Intervention
ReCell
Description
Autologous cell treatment
Human allograft derived from
amniotic tissue, morselised
Human allograft derived from
amniotic tissue, patch
Indication
Wound repair
BioD
BioDfactor
BioD
BioDfence
FibroCell Science
LAVIV
Autologous fibroblasts
Japan Tissue
Engineering Co.
(various tissue
products)
MacroCure
CureXcell
Organogenesis
Apligraf
Autologous cultured epidermis,
cartilage and corneal epithelium
Activated allogeneic white blood
cells
Living bi-layered skin substitute
Organogenesis
Gintuit
Allogeneic cultured keratinocytes Regeneration of
and fibroblasts in bovine collagen gum tissue
Osiris Therapeutics
Grafix
Allograft cellular matrix
Diabetic foot
ulcers, burns,
wound repair
Regenerys
CryoSkin
Monolayer of undifferentiated
allogeneic keratinocytes
Burns, ulcers, nonhealing wounds
Regenerys
MySkin
Cultured autologous epidermal
substitute
Burns, ulcers, nonhealing wounds
Sanofi
Carticel
Autologous chondrocyte
implantation
Cartilage repair
Sanofi
Epicel
Cultured epidermal autograft
Sanofi
MACI
Matrix-induced autologous
chondrocyte implantation
Shire
Dermagraft
Fibroblast-derived skin substitute
TiGenix
ChondroCelect
Autologous chondrocyte
implantation
Zimmer
DeNovo NT
Juvenile cartilage allograft tissue
Wound repair
Wound repair
Nasolabial fold
wrinkles
(various)
Wound repair
Wound repair
Wound repair in
severe burns
Cartilage repair
Diabetic foot
ulcers
Cartilage repair
Repair of focal
cartilage defects
Source: visiongain 2013; company reports
The gold standard of wound care remains the use of autologous skin grafts. This technique
requires removal of healthy skin from one area of the patient to implant in another. The clear
limitation of this treatment is the availability of healthy donor skin. For example, in burns victims, a
large amount of donor skin is often required as burns can cover large areas.
www.visiongain.com
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