Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features Innovative Stem Cell and Gene Therapy Applications



Summary



GBI Research, the leading business intelligence provider, has released its latest research, “Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features Innovative Stem Cell and Gene Therapy Applications”, which provides insights into the global regenerative medicine therapeutics market. The report provides an in-depth analysis of regenerative medicine and the challenges in translating it into clinical practice, with a focus on stem cell research, gene therapy and tissue engineering. The report also includes insights into the late-stage R&D pipeline for regenerative medicine and the indications of particular interest in terms of development. Some of the countries focusing on regenerative medicine are looked at for their regulatory and research environment. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

GBI Research has found that the regenerative medicine market has significant potential for growth, despite the low number of currently approved molecules. Regenerative medicine offers a chance to find curative therapies for disease areas with significant unmet need, including orphan diseases and diseases with a high burden globally, such as cancer and diabetes. In addition, the growth of the elderly population offers a large patient base for regenerative therapies. However, translating regenerative medicine from basic research and preclinical work to clinical trials in humans and then into medical practice is a challenging process and many applications are as yet unapproved. Some areas, such as wound healing, have seen some success, but gene therapy and many stem cell applications are as yet in their infancy. The direction of the market and the potential for success are examined in this report, along with an analysis of the currently marketed therapies and promising applications being studied in the pipeline.



Scope


- An overview of stem cell therapy, gene therapy and tissue engineering and the current market situation.
- An examination of the current state of research in each of the areas, by therapy area and indication.
- An examination of the late-stage pipeline for stem cell therapy, gene therapy and tissue engineering.
- Key drivers and restraints that have had a significant impact on the market and on each indication.
- Profiles of the regulatory landscape in key countries globally.
- The competitive landscape of the regenerative medicine market, with key companies profiled.



Reasons to buy


- Align your product portfolio to markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the potential regions and regenerative medicine markets poised for strong growth.
- Create a more tailored national strategy through the understanding of key drivers and barriers of the global regenerative medicine market.
- Develop key strategic initiatives by understanding the key focus areas and top selling therapeutics of leading companies.
- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.

Table Of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 9
2 Introduction 10
3 Translational Regenerative Medicine - Market Overview 11
3.1 Introduction and Background - What is Translational Regenerative Medicine? 11
3.1.1 Patent Landscape 13
3.1.2 Regenerative Therapy in Unregulated Settings 13
3.1.3 Currently Marketed Products - Overview 13
3.2 Potential Future Impact on the Pharmaceutical Landscape 13
3.2.1 Overcoming Shortfalls in Pharmaceuticals to Treat some Diseases 13
3.2.2 New Area for Pharmaceutical Companies to Enter through Licensing Agreements 13
3.2.3 Highly Priced Therapies 14
3.2.4 Emerging Economies are Embracing Regenerative Medicine 14
3.2.5 Academia/Small Biotech Collaborations 14
4 Regenerative Medicine - Stem Cell Therapy 15
4.1 Overview 15
4.2 Different Types of Stem Cells 16
4.2.1 Embryonic Stem Cells 16
4.2.2 Mesenchymal Stem Cells 17
4.2.3 Induced Pluripotent Stem Cells 17
4.2.4 Very Small Embryonic-Like Stem Cells 18
4.3 Manufacturing Stem Cells - Challenges of Achieving Large-Scale Consistency 18
4.4 Market Analysis 19
4.4.1 Market Prospects 19
4.4.2 Reimbursement 20
4.4.3 Service Industries around Stem Cell Therapy 21
4.5 Discontinued Molecules 21
4.6 Applications 22
4.7 Applications: Cardiovascular 23
4.7.1 Myocardial Infarction 24
4.7.2 Heart Failure 26
4.7.3 Congestive Heart Failure 26
4.7.4 Critical Limb Ischemia 27
4.8 Applications: Central Nervous System Disorders 27
4.8.1 Parkinson’s Disease 28
4.8.2 Multiple Sclerosis 28
4.8.3 Alzheimer’s Disease 28
4.8.4 Amyotrophic Lateral Sclerosis 28
4.8.5 Stroke 29
4.8.6 Spinal Cord Injury 30
4.9 Applications: Oncology 30
4.9.1 Haematological Malignancies 31
4.10 Applications: Gastrointestinal 31
4.10.1 Crohn’s Disease and Perianal Fistulas 32
4.11 Applications: Musculoskeletal 32
4.11.1 Spinal Fusion 33
4.12 Late-stage Pipeline Products Overview 33
4.12.1 Phase III 33
4.13 Marketed Products 36
4.13.1 Hearticellgram-AMI 36
4.13.2 Cartistem 36
4.13.3 Cupistem 36
4.14 Drivers/Barriers 37
4.14.1 Manufacturing Cells Faces Problems in Terms of Achieving Large-Scale Consistency 37
4.14.2 The Formation of Tumors from Stem Cells is an Ongoing Issue that Must be Overcome 37
4.14.3 Ethical Issues Delay Research 37
4.14.4 Stem Cell Tourism Decreases Confidence in Stem Cell Therapy and Overshadows Genuine Research 38
4.14.5 Many Stem Cell Therapies are Minimally Invasive 38
5 Regenerative Medicine - Gene Therapy 39
5.1 Overview 39
5.2 Gene Therapy Delivery Mechanisms 39
5.3 Market Analysis 41
5.4 Applications 42
5.4.1 Oncology 42
5.4.2 CNS 44
5.4.3 Cardiovascular 46
5.5 Currently Marketed Products 48
5.5.1 Gendicine 48
5.5.2 Oncorine 49
5.5.3 Rexin-G 49
5.6 Pipeline Prospects 50
5.6.1 Phase III and NDA Filing 50
5.7 Setbacks with Late-Stage Pipeline Products 51
5.7.1 Glybera 51
5.7.2 Cerepro 52
5.8 Drivers/Barriers 53
5.8.1 High Profile Deaths Reduce Confidence in the Field among Companies, Regulatory Authorities and Patients 53
5.8.2 Safety Issues with Use of Viral Vectors 53
5.8.3 Ensuring a Long-term Therapeutic Benefit from Gene Therapy is Difficult 53
5.8.4 Scientific Hurdles to Overcome are Still Numerous 54
5.8.5 Approvals in China have been Criticized as Being too Hasty 54
6 Regenerative Medicine - Tissue Engineering 55
6.1 Overview 55
6.2 Types of Scaffold 56
6.3 Market Analysis 57
6.4 Applications 57
6.4.1 Organ Transplantation 57
6.4.2 Wound Management 58
6.4.3 Orthopedics 59
6.4.4 Cardiovascular 59
6.5 Marketed Products 60
6.5.1 Apligraf 60
6.6 Drivers/Barriers 61
6.6.1 Drivers 61
6.6.2 Barriers 62
7 Translational Regenerative Medicine to 2018 - Geographical Landscape 63
7.1 The US 63
7.1.1 Regulatory Overview 63
7.1.2 Current Legislation and Regulatory Framework 63
7.1.3 Probable Future Developments 64
7.2 The EU 64
7.2.1 The UK 65
7.2.2 France 66
7.2.3 Germany 67
7.2.4 Italy 67
7.3 Japan 68
7.4 Other Economies 69
7.4.1 China 69
7.4.2 South Korea 70
7.4.3 Israel 70
7.4.4 Singapore 71
7.4.5 Australia 72
7.4.6 Canada 72
8 Translational Regenerative Medicine to 2018: Opportunities and Challenges 73
8.1 Opportunities 74
8.1.1 An Increasingly Elderly Population Increases the Number of Patients that Could Benefit from Regenerative Therapies 74
8.1.2 Regenerative Medicine Targets Diseases with High Unmet Need 74
8.1.3 There are Many Organizations Providing Funding, Including Private, Government and Public Bodies 74
8.1.4 High Treatment Costs 74
8.1.5 Many Countries have Permissive Laws Designed to Encourage Regenerative Medicine Innovation 74
8.2 Challenges 75
8.2.1 High Costs will Cause Problems with Reimbursement 75
8.2.2 There are High Risks to Investment 75
8.2.3 “One to Many” or “One to One” Approach to Regenerative Therapy? 75
8.2.4 European Court of Justice Ruled that Patents Cannot Apply to the Products of Research Involving the Destruction of Human Embryos 76
8.2.5 The Regulatory Landscape is Young and Requires Further Formalization 76
8.2.6 There are Still Many Scientific and Technical Hurdles to Overcome 76
8.2.7 Unregulated Use of Regenerative Medicine Harms the Research Landscape 76
9 Translational Regenerative Medicine to 2018 - Competitive Landscape 77
9.1 Companies Overview 77
9.2 Company Profiles 77
9.2.1 Ark Therapeutics 77
9.2.2 Organogenesis 78
9.2.3 Tengion 79
9.2.4 Advanced BioHealing 80
9.2.5 AMT 80
9.2.6 GSK 81
9.2.7 Epeius 82
9.2.8 Osiris 82
9.2.9 Cardio3 82
9.2.10 CorMatrix Cardiovascular 83
9.2.11 Aastrom 83
9.2.12 BioHeart 83
9.2.13 Cytori 84
9.2.14 Mesoblast 84
9.2.15 Geron 84
9.2.16 ReNeuron 85
10 Appendix 86
10.1 Market Definitions 86
10.2 Abbreviations 86
10.3 Sources 88
10.4 Research Methodology 89
10.4.1 Coverage 89
10.4.2 Secondary Research 90
10.4.3 Primary Research 90
10.5 Therapeutic Landscape 91
10.5.1 Epidemiology-based Forecasting 91
10.5.2 Market Size by Geography 93
10.6 Geographical Landscape 94
10.7 Pipeline Analysis 94
10.8 Competitive Landscape 94
10.8.1 Expert Panel Validation 94
10.9 Contact Us 94
10.10 Disclaimer 94
10.11 Disclaimer 95

1.1 List of Tables

Table 1: Cystic Fibrosis Therapeutics Market, Global, Phase III Pipeline, 2011 78
Table 2: Organogenesis Products, 2011 78

1.2 List of Figures

Figure 1: Regenerative Medicine, Global, Main Branches, 2009 11
Figure 2: Stem Cell Therapy, Global, Types of Stem Cell, 2012 16
Figure 3: Stem Cell Therapy, Global, Historic Revenue, $m, 2005-2010 19
Figure 4: Stem Cell Therapy, Global, Pipeline by Therapy Area, 2011 22
Figure 5: Stem Cell Therapy, Global, Cardiovascular Pipeline by Phase, 2012 23
Figure 6: Stem Cell Therapy, Global, CNS Pipeline by Phase, 2012 27
Figure 7: Stem Cell Therapy, Global, Oncology Pipeline by Phase, 2012 30
Figure 8: Stem Cell Therapy, Global, Gastrointestinal Pipeline by Phase, 2012 31
Figure 9: Stem Cell Therapy, Global, Musculoskeletal Pipeline by Phase, 2012 32
Figure 10: Stem Cell Therapy, Global, Drivers and Barriers, 2012 37
Figure 11: Gene Therapy, Delivery Mechanisms Overview, 2012 39
Figure 12: Gene Therapy, Global, Pipeline by Therapy Area, 2012 42
Figure 13: Gene Therapy, Global, Oncology Pipeline by Phase, 2012 42
Figure 14: Gene Therapy, Global, CNS Pipeline by Phase, 2012 44
Figure 15: Gene Therapy, Global, Cardiovascular Pipeline by Phase, 2012 46
Figure 16: Gene Therapy, Global, Drivers and Barriers, 2012 53
Figure 17: Tissue Engineering, Scaffold Types, 2012 56
Figure 18: Tissue Engineering, Global, Drivers and Barriers, 2012 61
Figure 19: Translational Regenerative Medicine, Global, Drivers and Barriers, 2012 73
Figure 20: Ark Therapeutics, SWOT, 2011 77
Figure 21: Organogenesis, SWOT, 2011 79
Figure 22: Tengion, SWOT, 2011 79
Figure 23: Advanced Biohealing, SWOT, 2011 80
Figure 24: AMT, SWOT, 2011 81
Figure 25: GBI Research Market Forecasting Model 93

Companies Mentioned
Ark Therapeutics
Organogenesis
Tengion
Advanced BioHealing
AMT
GSK
Epeius
Osiris
Cardio3
CorMatrix Cardiovascular
Aastrom
BioHeart
Cytori
Mesoblast
Geron
ReNeuron

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