Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 5 | 5 |
| List of Tables | 9 | 1 |
| List of Figures | 9 | 1 |
| Introduction | 10 | 1 |
| Translational Regenerative Medicine - Market Overview | 11 | 4 |
| Introduction and Background What is Translational Regenerative Medicine? | 11 | 2 |
| Patent Landscape | 13 | 1 |
| Regenerative Therapy in Unregulated Settings | 13 | 1 |
| Currently Marketed Products Overview | 13 | 1 |
| Potential Future Impact on the Pharmaceutical Landscape | 13 | 1 |
| Overcoming Shortfalls in Pharmaceuticals to Treat some Diseases | 13 | 1 |
| New Area for Pharmaceutical Companies to Enter through Licensing Agreements | 13 | 1 |
| Highly Priced Therapies | 14 | 1 |
| Emerging Economies are Embracing Regenerative Medicine | 14 | 1 |
| Academia/Small Biotech Collaborations | 14 | 1 |
| Regenerative Medicine - Stem Cell Therapy | 15 | 24 |
| Overview | 15 | 1 |
| Different Types of Stem Cells | 16 | 1 |
| Embryonic Stem Cells | 16 | 1 |
| Overview | 16 | 1 |
| Issues | 16 | 1 |
| Mesenchymal Stem Cells | 17 | 1 |
| Induced Pluripotent Stem Cells | 17 | 1 |
| Issues | 18 | 1 |
| Very Small Embryonic-Like Stem Cells | 18 | 1 |
| Manufacturing Stem Cells Challenges of Achieving Large-Scale Consistency | 18 | 1 |
| Market Analysis | 19 | 1 |
| Market Prospects | 19 | 1 |
| Reimbursement | 20 | 1 |
| Service Industries around Stem Cell Therapy | 21 | 1 |
| Discontinued Molecules | 21 | 1 |
| Applications | 22 | 1 |
| Applications: Cardiovascular | 23 | 1 |
| Myocardial Infarction | 24 | 2 |
| Heart Failure | 26 | 1 |
| Products in Development | 26 | 1 |
| Congestive Heart Failure | 26 | 1 |
| Critical Limb Ischemia | 27 | 1 |
| Products in Development | 27 | 1 |
| Applications: Central Nervous System Disorders | 27 | 1 |
| Parkinson s Disease | 28 | 1 |
| Products in Development | 28 | 1 |
| Multiple Sclerosis | 28 | 1 |
| Products in Development | 28 | 1 |
| Alzheimer s Disease | 28 | 1 |
| Products in Development | 28 | 1 |
| Amyotrophic Lateral Sclerosis | 28 | 1 |
| Products in Development | 29 | 1 |
| Stroke | 29 | 1 |
| Products in Development | 29 | 1 |
| Spinal Cord Injury | 30 | 1 |
| Products in Development | 30 | 1 |
| Applications: Oncology | 30 | 1 |
| Haematological Malignancies | 31 | 1 |
| Applications: Gastrointestinal | 31 | 1 |
| Crohn s Disease and Perianal Fistulas | 32 | 1 |
| Applications: Musculoskeletal | 32 | 1 |
| Spinal Fusion | 33 | 1 |
| Late-stage Pipeline Products Overview | 33 | 1 |
| Phase III | 33 | 1 |
| Prochymal | 33 | 1 |
| ATIR | 34 | 1 |
| Bone Marrow-Derived Allogeneic MPCs | 34 | 1 |
| C-Cure | 34 | 1 |
| GSK2696273 | 34 | 1 |
| Ixmyelocel T | 34 | 1 |
| MyoCell | 35 | 1 |
| Ontaril + Fibrin Adhesive | 35 | 1 |
| StemEx | 35 | 1 |
| Marketed Products | 36 | 1 |
| Hearticellgram-AMI | 36 | 1 |
| Cartistem | 36 | 1 |
| Cupistem | 36 | 1 |
| Drivers/Barriers | 37 | 1 |
| Manufacturing Cells Faces Problems in Terms of Achieving Large-Scale Consistency | 37 | 1 |
| The Formation of Tumors from Stem Cells is an Ongoing Issue that Must be Overcome | 37 | 1 |
| Ethical Issues Delay Research | 37 | 1 |
| Stem Cell Tourism Decreases Confidence in Stem Cell Therapy and Overshadows Genuine Research | 38 | 1 |
| Many Stem Cell Therapies are Minimally Invasive | 38 | 1 |
| Regenerative Medicine - Gene Therapy | 39 | 16 |
| Overview | 39 | 1 |
| Gene Therapy Delivery Mechanisms | 39 | 2 |
| Market Analysis | 41 | 1 |
| Applications | 42 | 1 |
| Oncology | 42 | 1 |
| Prostate Cancer | 43 | 1 |
| Melanoma | 43 | 1 |
| CNS | 44 | 1 |
| Parkinson s Disease | 45 | 1 |
| Cardiovascular | 46 | 1 |
| Peripheral Arterial Disease | 47 | 1 |
| Heart Failure | 47 | 1 |
| Currently Marketed Products | 48 | 1 |
| Gendicine | 48 | 1 |
| Mechanism of Action | 48 | 1 |
| Clinical Trial Details | 48 | 1 |
| Safety | 48 | 1 |
| Market | 49 | 1 |
| Oncorine | 49 | 1 |
| Rexin-G | 49 | 1 |
| Mechanism of Action | 49 | 1 |
| Pipeline Prospects | 50 | 1 |
| Phase III and NDA Filing | 50 | 1 |
| Mipomersen (Kynamro) | 50 | 1 |
| Alipogene Tiparvovec (AMT-011), Human LPL [S447X] + Mycophenolate Mofetil + Cyclosporine + Methylprednisolone | 50 | 1 |
| Allovectin-7 | 50 | 1 |
| Collategene | 51 | 1 |
| GS-101 | 51 | 1 |
| GSK2402968 | 51 | 1 |
| GSK2696273 | 51 | 1 |
| Lenti-D | 51 | 1 |
| Rexin-G | 51 | 1 |
| Trabedersen | 51 | 1 |
| TV-1011 | 51 | 1 |
| Setbacks with Late-Stage Pipeline Products | 51 | 1 |
| Glybera | 51 | 1 |
| Overview | 51 | 1 |
| Mechanism of Action | 52 | 1 |
| Cerepro | 52 | 1 |
| Overview | 52 | 1 |
| Mechanism of Action | 52 | 1 |
| Drivers/Barriers | 53 | 1 |
| High Profile Deaths Reduce Confidence in the Field among Companies, Regulatory Authorities and Patients | 53 | 1 |
| Safety Issues with Use of Viral Vectors | 53 | 1 |
| Ensuring a Long-term Therapeutic Benefit from Gene Therapy is Difficult | 53 | 1 |
| Scientific Hurdles to Overcome are Still Numerous | 54 | 1 |
| Approvals in China have been Criticized as Being too Hasty | 54 | 1 |
| Regenerative Medicine - Tissue Engineering | 55 | 8 |
| Overview | 55 | 1 |
| Types of Scaffold | 56 | 1 |
| Market Analysis | 57 | 1 |
| Applications | 57 | 1 |
| Organ Transplantation | 57 | 1 |
| Wound Management | 58 | 1 |
| Orthopedics | 59 | 1 |
| Cardiovascular | 59 | 1 |
| Marketed Products | 60 | 1 |
| Apligraf | 60 | 1 |
| Clinical Trials Venous Leg Ulcers | 60 | 1 |
| Clinical Trials Diabetic Foot Ulcers | 60 | 1 |
| Drivers/Barriers | 61 | 1 |
| Drivers | 61 | 1 |
| High demand for Organ Transplants | 61 | 1 |
| Increase in Diseases such as Diabetes Creates the Need for Skin Grafts for Ulcers | 61 | 1 |
| Barriers | 62 | 1 |
| Science is not yet Sufficiently Advanced for More Complex Procedures | 62 | 1 |
| The Use of Human Embryonic Stem Cells Creates Issues in Regulation and Ethics | 62 | 1 |
| Translational Regenerative Medicine to 2018 - Geographical Landscape | 63 | 10 |
| The US | 63 | 1 |
| Regulatory Overview | 63 | 1 |
| Current Legislation and Regulatory Framework | 63 | 1 |
| Probable Future Developments | 64 | 1 |
| The EU | 64 | 1 |
| The UK | 65 | 1 |
| Regulation | 65 | 1 |
| Funding | 65 | 1 |
| France | 66 | 1 |
| Germany | 67 | 1 |
| Italy | 67 | 1 |
| Japan | 68 | 1 |
| Other Economies | 69 | 1 |
| China | 69 | 1 |
| South Korea | 70 | 1 |
| Israel | 70 | 1 |
| Singapore | 71 | 1 |
| Australia | 72 | 1 |
| Canada | 72 | 1 |
| Translational Regenerative Medicine to 2018: Opportunities and Challenges | 73 | 4 |
| Opportunities | 74 | 1 |
| An Increasingly Elderly Population Increases the Number of Patients that Could Benefit from Regenerative Therapies | 74 | 1 |
| Regenerative Medicine Targets Diseases with High Unmet Need | 74 | 1 |
| There are Many Organizations Providing Funding, Including Private, Government and Public Bodies | 74 | 1 |
| High Treatment Costs | 74 | 1 |
| Many Countries have Permissive Laws Designed to Encourage Regenerative Medicine Innovation | 74 | 1 |
| Challenges | 75 | 1 |
| High Costs will Cause Problems with Reimbursement | 75 | 1 |
| There are High Risks to Investment | 75 | 1 |
| One to Many or One to One Approach to Regenerative Therapy? | 75 | 1 |
| European Court of Justice Ruled that Patents Cannot Apply to the Products of Research Involving the Destruction of Human Embryos | 76 | 1 |
| The Regulatory Landscape is Young and Requires Further Formalization | 76 | 1 |
| There are Still Many Scientific and Technical Hurdles to Overcome | 76 | 1 |
| Unregulated Use of Regenerative Medicine Harms the Research Landscape | 76 | 1 |
| Translational Regenerative Medicine to 2018 - Competitive Landscape | 77 | 9 |
| Companies Overview | 77 | 1 |
| Company Profiles | 77 | 1 |
| Ark Therapeutics | 77 | 1 |
| Organogenesis | 78 | 1 |
| SWOT | 79 | 1 |
| Tengion | 79 | 1 |
| SWOT | 79 | 1 |
| Advanced BioHealing | 80 | 1 |
| SWOT | 80 | 1 |
| AMT | 80 | 1 |
| SWOT | 81 | 1 |
| GSK | 81 | 1 |
| Epeius | 82 | 1 |
| Osiris | 82 | 1 |
| Cardio3 | 82 | 1 |
| CorMatrix Cardiovascular | 83 | 1 |
| Aastrom | 83 | 1 |
| BioHeart | 83 | 1 |
| Cytori | 84 | 1 |
| Mesoblast | 84 | 1 |
| Geron | 84 | 1 |
| ReNeuron | 85 | 1 |
| Appendix | 86 | 10 |
| Market Definitions | 86 | 1 |
| Abbreviations | 86 | 2 |
| Sources | 88 | 1 |
| Research Methodology | 89 | 2 |
| Coverage | 89 | 1 |
| Secondary Research | 90 | 1 |
| Primary Research | 90 | 1 |
| Therapeutic Landscape | 91 | 3 |
| Epidemiology-based Forecasting | 91 | 2 |
| Market Size by Geography | 93 | 1 |
| Geographical Landscape | 94 | 1 |
| Pipeline Analysis | 94 | 1 |
| Competitive Landscape | 94 | 1 |
| Expert Panel Validation | 94 | 1 |
| Contact Us | 94 | 1 |
| Disclaimer | 94 | 1 |
| Disclaimer | 95 | 1 |
