Translational regenerative medicine market prospects 2015 2025
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For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com (+44 (0)20 7549 9976) or refer to our website: https://www.visiongain.com/Report/1390/Translational-Regenerative-Medicine-Market-Prospects-2015-2025
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Translational regenerative medicine market prospects 2015 2025
- 2. www.visiongain.com Contents 1. Report Overview 1.1 Global Translational Regenerative Medicine: Market Overview 1.2 Global Translational Regenerative Medicine Market Segmentation 1.3 Why You Should Read This Report 1.4 How This Report Delivers 1.5 Key Questions Answered By This Analytical Report 1.6 Who Is This Report For? 1.7 Methodology 1.8 Frequently Asked Questions (FAQ) 1.9 Associated Reports 1.10 About Visiongain 2.1 What is Regenerative Medicine? 2.1.1 Translational Regenerative Medicine ā From Bench To Bedside 2.2 Translational Regenerative Medicine ā Market Breakdown 2.2.1 Stem Cell Therapy ā Marketable Differentiation And Specialisation 2.2.1.1 How Embryonic Stem Cells (ESCs) Entered The Fray 2.2.1.2 Classifying Stem Cells by Potency 2.2.1.3 Stem Cells Categories: ESCs, SSCs, iPSCs 2.2.1.4 Parthenogenetic Stem Cells: Ethical ESC-Like Cells? 2.2.1.5 Autologous versus Allogeneic Stem Cells: Towards Universal Stem Cell Products? 2.2.2 Tissue Engineering ā Invitro Manipulation For Therapeutic Purposes 2.2.3 Gene Therapies 2.2.3.1 Harnessing Infectivity: Viral Vectors in Gene Therapy 2.3 Other Approaches To Regenerative Medicine 1. Report Overview 2. An Introduction To Translational Regenerative Medicine
- 3. www.visiongain.com Contents 2.3.1 Small Molecules and Proteins ā Scaffold-Based Delivery Of Signalling Molecules 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 The Phases of Clinical Trials 2.6 Market Definition 2.6.1 Products Excluded From The Report 3.1 Global Translational Regenerative Medicine: Market Overview 3.1.1 Segments Within The Global Translational Regenerative Medicine Market 3.2 The Global Translational Regenerative Medicine Market In 2013 And 2014 3.3 Global Translational Regenerative Medicine: Market Forecast 2015-2025 3.3.1 Market Sectors That Will Drive Regenerative Medicine Growth 3.3.2 Global Translational Regenerative Medicine Market - Changing Market Shares By Sector 2015-2025 4.1 The Global Market For Stem Cell Therapies, 2013 And 2014 4.1.1 Stem Cell Therapies: Currently Available Therapies 4.1.2 Haematopoietic Stem Cell Transplantation (HSCT) 4.1.3 Stem Cell Orthobiologics 4.2 Stem Cell Therapies: Global Market Forecast 2015-2025 4.3 AlloStem (AlloSource) 4.4 Osteocel Plus (NuVasive) 4.4.1 Osteocel Plus: Sales Forecast 2015-2025 4.5 Trinity ELITE and Trinity Evolution (Orthofix) 4. Stem Cell Therapies: Leading Applications, 2015-2025 3. Translational Regenerative Medicine Market, 2015-2025
- 4. www.visiongain.com Contents 4.5.1 Trinity ELITE and Trinity Evolution: Sales Forecast, 2015-2025 4.6 PureGen (AlphaTec Spine) 4.7 Other Approved Stem Cell Therapy Products, 2015 4.7.1 Cartistem (Medipost) 4.7.2 Cupistem (Anterogen) 4.7.3 Hearticellgram-AMI (Pharmicell) 4.7.4 Prochymal/ Remestemcel-L (Mesoblast) 4.7.4.1 Prochymal/ Remestemcel-L: Sales Forecast 2015-2025 4.8 Development Pipeline For Stem Cell Therapies, 2015-2025 4.8.1 Late-Stage Pipeline for Stem Cell Therapies, 2015 4.8.1.1 StemEx (Gamida Cell) 4.8.1.2 Mesenchymal Precursor Cell Therapies (Mesoblast) 4.8.1.3 Adult Autologous CD34+ Cells (Baxter) 4.8.1.4 MyoCell (Bioheart) 4.8.1.5 Cx601 (TiGenix) 4.8.1.6 Adipose-Derived Stem Cells (Cytori Therapeutics) 4.8.1.7 Stempeucel (Stempeutics Research) 4.8.1.8 C-Cure (Cardio3 BioSciences) 4.8.1.9 Other Late-Stage Stem Cell Therapies 4.8.2 Diabetes And Stem Cell Therapy 4.8.2.1 Mesenchymal Precursor Cells (Mesoblast) 4.8.2.2 VC-01 (ViaCyte Inc) 4.8.2.2.1 Clinical Development Efforts For VC-01 For The Treatment Of Diabetes 4.8.3 Cardiovascular Disease And Stem Cell Therapy 4.8.3.1 Endometrial Regenerative Cells (MediStem, Intrexon) 4.8.3.2 AMR-001 (NeoStem) 4.8.3.3 CAP-1002 (Capricor) 4.8.4 Stem Cell Therapy in Cancer 4.8.4.1 CLT-008 (Cellerant Therapeutics)
- 5. www.visiongain.com Contents 4.8.4.2 OncoCyte/BioTime ā Targeting Cancer With Gene And Stem Cell Therapy 4.8.5 Stem Cell Therapy For Central Nervous System (CNS) Conditions 4.8.5.1 NurOwn (BrainStorm Cell Therapeutics) 4.8.5.1.1 Clinical Development Efforts for NorOwn, 2015 4.8.5.2 NSI-566 (Neuralstem) 4.8.5.3 MultiStem (Athersys) 4.8.5.4 PDA-001 (Cenplacel-L, Celgene) 4.8.5.5 ALD-401 (Cytomedix) 4.8.5.6 ReN001 (ReNeuron) 4.8.6 Stem Cell Therapy for Eye Diseases 4.8.6.1 MA09-hRPE (Advanced Cell Technology) 4.8.6.2 HuCNS-SC (StemCells Inc.) 4.8.6.3 Collaboration And License Agreement Between Pfizer And The London Project to Cure Blindness 4.9 Stem Cells Therapy Market: Drivers and Restraints 2015-2025 5.1 The Global Market For Tissue Engineered Therapies, 2013 And 2014 5.1.1 Tissue Engineering Therapies: Currently Available Therapies 5.2 Tissue Engineering Therapies: Global Market Forecast 2015-2025 5.3 Tissue Engineering In Wound Repair And Healing 5.3.1 Apligraf (Organogenesis) 5.3.1.1 Apligraf: Historical Sales Analysis 5.3.1.2 Apligraf: Sales Forecast 2015-2025 5.3.2 BioDfence and BioDfactor (BioD) 5.3.3 CureXcell (MacroCure) 5.3.4 Dermagraft (Organogenesis) 5.3.4.1 Dermagraft (Shire): Sales Forecast 2015-2025 5.3.5 Epicel (Aastrom) 5. Tissue Engineering Therapies: Leading Applications, 2015-2025
- 6. www.visiongain.com Contents 5.3.6 Grafix (Osiris Therapeutics) 5.3.7 MySkin and CyroSkin (Regenerys) 5.3.8 ReCell (Avita Medical) 5.3.8.1 ReCell (Avita Medical): Sales Forecast 2015-2025 5.4 Tissue Engineering for Cartilage Repair 5.4.1 Autologous Chondrocyte Implantation (ACI) 5.4.2 Carticel (Aastrom Biosciences) 5.4.3 ChondroCelect (TiGenix, Sobi Partners) 5.4.4 DeNovo NT (Zimmer) 5.4.5 MACI (Aastrom Biosciences) 5.5 Other Available Tissue Engineering Therapies 5.5.1 Autologous Cultured Cell and Tissue Products (Japan Tissue Engineering Co.) 5.5.2 Gintuit (Organogenesis) 5.5.3 LAVIV (azficel-T), (Fibrocell Science) 5.5.4 Acellular Tissue Engineering Products 5.6 Tissue Engineering: Development Pipeline, 2015-2025 5.6.1 Pipeline Products For Autologous Chondrocyte Implantation 5.6.2 Tissue Engineering For Skin 5.6.3 Tissue Engineering for Liver Diseases 5.6.3.1 Extracorporeal Bio-Artificial Liver Therapy (Vital Therapies) 5.6.4 Tissue Engineering for Cardiovascular Disease 5.6.5 Tissue Engineering for Eye Diseases 5.7 Future Prospects for Organ Transplantation and Tissue Engineering 5.8 Tissue Engineered Products Market: Drivers and Restraints 2015-2025 6.1 The Global Market For Gene Therapies, 2013 And 2014 6.2 Gene Therapies: Global Market Forecast 2015-2025 6.3 Currently Available Gene Therapy Products 6. Gene Therapies: Leading Applications, 2015-2025
- 7. www.visiongain.com Contents 6.3.1 Gendicine (Benda Pharmaceutical) 6.3.2 Oncorine (Shanghai Sunway Biotech) 6.3.3 Neovasculgen (Human Stem Cells Institute) 6.3.3.1 Neovasculgen (HSCI): Sales Forecast 2015-2025 6.3.4 Glybera (UniQure) 6.3.4.1 Glybera: Sales Forecast 2015-2025 6.4 Development Pipeline For Gene Therapies, 2015-2025 6.4.1 Late-Stage Pipeline Gene Therapies, 2015 6.4.1.1 Collategene (beperminogene perplasmid) - (AnGes MG/Vical) 6.4.1.2 ProstAtak (AdV-tk) - (Advantagene) 6.4.1.3 Trinam (taberminogene vadenovec) ā (Ark Therapeutics) 6.4.1.4 T-VEC (talimogene laherparepvec) ā (Amgen) 6.4.1.4.1 Clinical Trials And Development Efforts For T-Vec 6.4.1.4.2 Talimogene Laherparepvec (T-Vec) ā Sales Forecast 2015-2025 6.4.1.5 AAV2-hRPE65v2 (Spark Therapeutics) 6.4.1.6 CG0070 (Cold Genesys) 6.4.2 Gene Therapy For Use In The Treatment Of Diabetes 6.4.3 Gene Therapy Directed At Oncology Indications 6.4.4 Gene Therapy Directed At Neurological Diseases 6.4.5 Gene Therapy Directed At Tackling Haemophilia B 6.5 Gene Therapy Market: Drivers and Restraints 2015-2025 7.1 The Translational Regenerative Medicine Market By Region 7.1.1 The Global Distribution of Translational Regenerative Medicine In 2013 And 2014 7.2 Leading National Markets: Forecast 2015-2025 7.2.1 Changing Market Shares By Region, 2015-2025 7.3 Regional Translational Regenerative Medicine Markets: Analysis And Forecasts, 2015-2025 7. Leading National Markets for Translational Regenerative Medicine, 2015-2025
- 8. www.visiongain.com Contents 7.4 United States: The Largest Translational Regenerative Medicine Market 7.4.1 US Translational Regenerative Medicine Market: Market Drivers And Restraints, 2015-2025 7.4.2 US Translational Regenerative Medicine Market: Market Forecast 2015-2025 7.4.3 The Regulatory Framework For Regenerative Medicine In The US 7.4.4 The Impact Of Ethical And Regulatory Reluctance To Embryonic Stem Cell Research And Its Impact On Funding 7.4.5 How Is The Ending Of Patenting For Human Gene Products Affecting The Regenerative Medicine Market In The US? 7.5 Europe: A Fragmented Regenerative Medicine Market 7.5.1 European Regenerative Medicine Market: Market Drivers and Restraints, 2015-2025 7.5.2 European Regenerative Medicine Market: Market Forecast 2015-2025 7.5.3 Europeās Unitary Patent System And Its Impact On The Future Of Regenerative Medicine In The Region 7.5.4 Regulation Of Regenerative Medicine In The European Union 7.5.5 UK: A Leading Research Centre For Regenerative Medicine In Europe 7.5.5.1 Regulation of Stem Cell Research In The UK 7.5.6 Russia: Rising Interest In Regenerative Medicine Research 7.6 Asia-Pacific: Accommodating Regulatory Landscape Aiding Rapid Product Commercialisation 7.6.1 Asia-Pacific Regenerative Medicine Market: Market Drivers and Restraints, 2015- 2025 7.6.2 Asia-Pacific Regenerative Medicine Market: Market Forecast 2015-2025 7.6.3 Australia: Encouraging Translational Regenerative Medicine 7.6.4 China: Encouraging Stem Cell R&D 7.6.4.1 Government Intervention Into RM Research In China 7.6.4.2 Regulation Of Stem Cell Research In China 7.6.4.3 Commercialisation Of Gene Therapy And Tissue Engineering Products In China 7.6.4.4 Medical Tourism Impacting Market Growth For Regenerative Medicine In China
- 9. www.visiongain.com Contents 7.6.5 Japan: Difficulty In Translating Research Into Commercialisation 7.6.5.1 Research Funding: A Major Determinant Of Growth In Japanās Regenerative Medicine 7.6.5.2 Government Interventions In Promoting Stem Cell Research In Japan 7.6.5.3 Regulation of Regenerative Medicine In Japan 7.6.6 India: An Emerging Market For Regenerative Medicine 7.6.6.1 Efforts In Stem Cell Research In India 7.6.6.2 Unclear Guidelines Hindering Progression Of Gene Therapy Research In India 7.6.7 South Korea: First to Approve Stem Cell Treatments 7.6.7.1 A Regeneration In South Koreaās Stem Cell Research Efforts 7.7 Rest of the World: Regenerative Medicine Conquering New Territories And Booming 7.7.1 Rest of the World Regenerative Medicine Market: Market Forecast 2015-2025 8.1 Translational Regenerative Medicine: A Hotbed For Innovation 8.2 Aastrom Biosciences 8.2.1 Aastromās Acquisition Of Sanofiās Regenerative Medicine Business 8.2.2 Aastrom: Historical Financial And Performance Analysis, 2011-2013 8.2.3 Aastrom Regenerative Medicine Portfolio, 2015 8.2.4 Aastrom: Pipeline Analysis, 2015 8.3 Alphatec Spine 8.3.1 Alphatec Spine: Financial And Performance Analysis, 2009-2013 8.3.2 Alphatec Spineās Shifting Focus From Regenerative Medicine To Medical Devices 8.4 Anterogen 8.4.1 Anterogen: Pipeline Analysis, 2015 8.5 Athersys 8.5.1 Athersys: Financial And Performance Analysis, 2010-2013 8. Leading Companies In The Translational Regenerative Medicine Market, 2015-2025
- 10. www.visiongain.com Contents 8.5.2 Athersys: Pipeline Analysis, 2015 8.5.2.1 MultiStem Technology ā Potential Treatment For A Range Of Diseases 8.6 Avita Medical 8.6.1 Avita Medical: Historical Financial And Performance Analysis, 2013-2014 8.6.2 Avita Medical: Regenerative Medicine Portfolio, 2015 8.6.3 Avita Medical: Pipeline Analysis, 2015 8.7 AxoGen 8.7.1 AxoGen: Historical Financial And Performance Analysis, 2010-2013 8.7.2 AxoGen: Regenerative Medicine Portfolio, 2015 8.7.3 AxoGen: Pipeline Analysis, 2015 8.8 Medipost 8.8.1 Medipost: Historical Financial And Performance Analysis, 2011-2013 8.8.2 Medipost: Regenerative Medicine Portfolio, 2015 8.8.3 Medipost: Pipeline Analysis, 2015 8.9 Mesoblast 8.9.1 Mesoblast Product Portfolio, 2015 8.9.2 Mesoblast: Historical Financial And Performance Analysis, 2011-2014 8.9.3 Mesoblast: Pipeline Analysis, 2015 8.9.3.1 NeoFuse 8.9.3.2 Chondrogen 8.9.3.3 Prochymal 8.9.3.4 Other Recent Pipeline Acquisitions By Mesoblast 8.10 NuVasive 8.10.1 NuVasive Product Portfolio, 2015 8.10.2 NuVasive: Historical Financial And Performance Analysis, 2009-2013 8.10.3 NuVasive: Pipeline Analysis, 2015 8.11 Ocata Therapeutics 8.11.1 Ocata Therapeutics: Historical Financial And Performance Analysis, 2009-2013 8.11.2 Ocata Therapeutics: Pipeline Analysis, 2015 8.11.2.1 Retinal Pigment Epithelial Cell Therapy
- 11. www.visiongain.com Contents 8.11.2.2 Research Around iPSC-derived Platelets 8.11.2.3 Hemangioblast As A Treatment for Blood And Cardiovascular Diseases 8.11.2.4 Mesenchymal Stem Cell Program ā Tissue Repair Functionalities 8.11.3 Ocataās Other Therapeutic Platforms 8.12 Organogenesis 8.12.1 Organogenesis RM Portfolio, 2015 8.12.2 Organogenesis: Pipeline Analysis, 2015 8.13 Osiris Therapeutics 8.13.1 Osiris Therapeutics: RM Portfolio, 2015 8.13.2 Osiris Therapeutics: Historical Financial And Performance Analysis, 2010-2013 8.13.3 Osiris Therapeutics: Pipeline Analysis, 2015 8.14 Pharmicell 8.14.1 Pharmicell: Historical Financial And Performance Analysis, 2011-2013 8.14.2 Pharmicell: Pipeline Analysis, 2015 8.15 Regenerys 8.15.1 Regenerys: RM Portfolio, 2015 8.15.2 Regenerys: Pipeline Analysis, 2015 8.16 Shire 8.16.1 Shire: RM Portfolio, 2015 8.16.2 Shire: Historical Financial And Performance Analysis, 2010-2013 8.16.3 Shire: Pipeline Analysis, 2015 8.16.3.1 Vascugel 8.17 TiGenix 8.17.1 TiGenix: Historical Financial And Performance Analysis, 2011-2013 8.17.2 TiGenix: Pipeline Analysis, 2015 8.18 UniQure 8.18.1 UniQure: Pipeline Analysis, 2015
- 12. www.visiongain.com Contents 9.1 Market Factors Influencing The Translational Regenerative Medicine Market 9.2 SWOT Analysis Of The Translation Market, 2015-2025 9.2.1 Strengths 9.2.1.1 Improvements In Regulatory Frameworks 9.2.1.2 Advancements In General Cellular And Tissue Research Aiding Regenerative Medicine 9.2.1.3 Strong Support From Governments In Multiple Regions 9.2.1.4 Increasing Ease Of Product Commercialisation And Market Access 9.2.2 Weaknesses 9.2.2.1 The High Price Of Regenerative Medicine Products May Restrain Market Growth 9.2.2.2 Lack Of Funding From Venture Capital 9.2.2.3 The Intrinsic Lack Of Standardisation Is A Burden To Scaling Up Manufacturing 9.2.2.4 Successful Commercialisation Of RM Products Requires New Business Models 9.2.3 Opportunities 9.2.3.1 3D Bioprinting And Other Technologies May Enable Rapid Scale-Up 9.2.3.2 Medical Tourism May Stimulate Standardisation And Drive Market Growth 9.2.3.3 Disruptive Regenerative Medicine Therapies Can Create New Markets 9.2.4 Threats 9.2.4.1 Ethical Concerns Limiting R&D In Regenerative Medicine 9.2.4.2 Difficulty Establishing An Evidence Base For Long-Term Efficacy Of RM Therapies 9.2.4.3 Rate Of Scientific Progress ā A Major Determinant Of RM Market Growth 9.2.4.4 Restraints On Reimbursement May Slow Growth 9. Qualitative Analysis for the Global Translational Regenerative Medicine Market, 2015-2025
- 13. www.visiongain.com Contents 9.3 Porterās Five Force Analysis Of The Translational Regenerative Medicine Market, 2015-2025 9.3.1 Threat Of New Entrants 9.3.2 Threat Of Substitutes 9.3.3 Power Of Suppliers 9.3.4 Power Of Buyers 9.3.5 Rivalry Among Competitors 10.1 Interview With Antonio S J Lee Ph.D, CEO & Managing Director For MEDIPOST America Inc. 10.1.1 MEDIPOST And Recent Developments In Regenerative Medicine 10.1.2 The Transition From Mid- To Late-Stage Clinical Trials In The RM Market And Its Likely Implications 10.1.3 CARTISTEMĀ®, PNEUMOSTEMĀ®, NEUROSTEMĀ® - Medipostās Development Plans In Regenerative Medicine 10.1.4 Cord Blood Banking And Koreaās Role In Its Advancement 10.1.5 The Role Of R&D Strategies And Long-Term Efficacy Data In The Future Success Of Regenerative Medicine 10.1.6 The Role Of Big-Pharma Companies In Regenerative Medicine And The Need For Regulatory Harmonisation 10.1.7 On The Unmet Needs For Regenerative Medicine To Target 10.1.8 On The Future Developments To Expect In The Market For Regenerative Medicine Over The Next Decade 11.1 Overview Of Current Market Conditions And Market Forecast, 2013-2025 11.2 Leading Regenerative Medicine Segments In 2013 11.3 Leading Regions In The Translational Regenerative Medicine Market In 2013 And 2014 11.4 Future Outlook For The Various Sectors Within TRM, 2015-2025 10. Expert Opinions from Our Primary Research 11. Conclusions
- 14. www.visiongain.com Contents 11.5 R&D Pipeline Products Crucial To Future Market Growth 11.6 What Does The Future Hold For Regenerative Medicine?
- 15. Page 79www.visiongain.com Translational Regenerative Medicine: Market Prospects 2015-2025 in GvHD failed to show the drugās efficacy. In February 2012, Sanofi ended its collaboration with Osiris (via Sanofiās Genzyme subsidiary) to market Prochymal outside the US and Canada. 4.7.4.1 Prochymal/ Remestemcel-L: Sales Forecast 2015-2025 In April 2014, Mesoblast provided updates on its clinical programs designed to get Prochymal approved in the US. The product is currently designated by the FDA as an Orphan Drug and a Fast Track product. Table 4.6 Prochymal: Sales Forecast ($m, AGR%, CAGR%), 2013-2025 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Prochymal($m) 0 0 6 13 26 44 69 90 106 115 122 128 131 AGR (%) - - - 122.6 91.7 73.4 54.3 31.6 17.1 8.9 6.4 4.5 2.3 CAGR (%) 2015-19 CAGR (%) 2015-25 83.8 2019-25 11.4 36.1 Figure 4.4 Prochymal: Sales Forecast ($m, AGR%), 2013-2025 0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 140 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 AGR(%) Revenue($m) Year Revenue ($m) AGR (%) Source: Visiongain 2015 Source: Visiongain 2015
- 16. Page 134www.visiongain.com Translational Regenerative Medicine: Market Prospects 2015-2025 6.6). If successful, ProstAtak would be the first therapy to prevent the recurrence of a cancer, and despite being a gene therapy, it is being described by the company as a āvaccineā for cancer. Table 6.6 Advantegene: Gene Therapy Clinical Trials, 2015 Identifier Start and End Dates Intervention Indication Phase NCT00751270 Nov 2005 - Dec 2013 AdV-tk plus valacyclovir Malignant glioma, glioblastoma multiforme, anaplastic astrocytoma I NCT00589875 Mar 2007 - Dec 2014 AdV-tk plus valacyclovir Malignant glioma, glioblastoma multiforme, anaplastic astrocytoma II NCT00638612 Nov 2007 - May 2013 AdV-tk plus valacyclovir Pancreatic adenocarcinoma I NCT00634231 Apr 2010 - Dec 2014 AdV-tk plus valacyclovir and radiotherapy Malignant glioma, recurrent ependymoma I NCT01436968 Sep 2011 - Sep 2017 AdV-tk plus valacyclovir Prostate cancer III NCT01997190 Oct 2013 - Oct 2015 AdV-tk plus valacyclovir Malignant pleura effusion, lung cancer, mesothelioma, breast cancer, ovarian cancer I 6.4.1.3 Trinam (taberminogene vadenovec) ā (Ark Therapeutics) Ark Therapeuticsā Trinam is a gene therapy designed to prevent the blockage of blood vessels (stenosis) following vascular surgery in dialysis patients. Trinam consists of a vascular endothelial growth factor (VEGF) gene delivered using an adenoviral vector, Ad 5 (adenovirus type 5), and a biodegradable delivery device made from collagen. At the end of access graft surgery, the device is fitted around the outside of the patientās vein. The adenoviral vector carrying the VEGF gene is then injected into the space between the device and the blood vessel. The locally transfected VEGF gene promotes muscle cells in the blood vessel to secrete VEGF. This promotes the release of beneficial nitric oxide and prostacyclin, which help protect the blood vessel. Phase II clinical trial results, released in March 2007, showed that, as well as having a good safety profile, Trinam helped keep access grafts for dialysis functional for three times longer than in Source: Advantegene 2014; Visiongain 2015; World Health Organization: International Clinical Trials Registry Platform
- 17. Page 171www.visiongain.com Translational Regenerative Medicine: Market Prospects 2015-2025 7.6.4.4 Medical Tourism Impacting Market Growth For Regenerative Medicine In China Medical tourism is a big industry in China, with treatments being cheaper there than they are in developed markets such as the US and EU. Stem cells are no different, with thousands of foreign patients visiting clinics in China to have treatments unavailable in other markets. In May 2009, the Ministry of Science and Technology and the Ministry of Health released new guidelines for clinics offering stem cell therapy. Clinics must now be able to show the appropriate levels of expertise, as well as the capacity to perform the treatments. Clinics applying to conduct stem cell treatment need to show that they have performed clinical trials demonstrating the safety and efficacy of the therapy. 7.6.5 Japan: Difficulty In Translating Research Into Commercialisation In recent years, Japan has contributed significantly to research in regenerative medicine. The country is reported to setting safety standards for commercialising regenerative medicine products amid stiff competition from the US and countries in Europe. Analysis by the Japan Patent Office (JPO) in 2009 showed that regenerative medicine research papers produced by Japan accounted for 14% of the global total between 2004 and 2007, while in October 2012, Japanese scientist Shinya Yamanaka shared the Nobel prize for Physiology or Medicine with Professor John Gurdon of the UK, for work on reprogramming cells to become induced pluripotent stem cells. Despite this strong science base, only one regenerative medicine product had been approved in Japan: Japanese Tissue Engineering Co.ās JACE (autologous cultured epidermis). 7.6.5.1 Research Funding: A Major Determinant Of Growth In Japanās Regenerative Medicine The need for the provision of venture capital is a factor which has impacted the regenerative medicine market in various regions around the globe. This, coupled with the little to no link between academia and industry, has been known to act as restraining factors to growth in the TRM market. In Japan, no stem cell products have yet been approved, although some are currently in development with a look to getting launched. An example is the deal signed between Nippon Zoki Pharmaceuticals and South Koreaās Anterogen, in which Nippon Zoki will market Anterogenās stem cell treatment, AdipoPlus, in Japan. AdipoPlus is an adipose-derived stem cell treatment for anal
- 18. Page 187www.visiongain.com Translational Regenerative Medicine: Market Prospects 2015-2025 Figure 8.3 Athersys: Historical Sales ($m) 2010-2013 8.5.2 Athersys: Pipeline Analysis, 2015 8.5.2.1 MultiStem Technology ā Potential Treatment For A Range Of Diseases Athersys announced interim eight-week results from the Phase 2 clinical study with its Partner ā Pfizer ā in April 2014. This study involved the administration of MultiStem cells to patients suffering from treatment refractory ulcerative colitis. Results from the study is said to have demonstrated favourable safety and tolerability for MultiStem treatment, but failed to show significant improvement compared to placebo in primary efficacy endpoints. There are also plans in place for a Phase 2 study for the use of MultiStem in the treatment of myocardial infarction. The company states that MultiStem can be isolated from a suitable donor, scaled up and frozen, enabling the production of millions of doses of the product without genetic modification. MultiStem cells are said to express factors and form multiple cell types with a range of possible therapeutic effects, and have a ādrug-likeā profile ā after performing their therapeutic effects, they are subsequently cleared from the patientās body. 0 1 2 3 4 5 6 7 8 9 10 2010 2011 2012 2013 Sales$m) Year Revenue from licence fees, contracts, and milestone payments ($m) Revenue from Grants ($m) Source: Athersys 2014; Visiongain 2015