August 19, 2008
High Growth Reported for the Stakeholder Opinions: Novel Therapeutic Approaches in Cardiovascular Medicine
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Stakeholder Opinions: Novel Therapeutic Approaches in Cardiovascular Medicine - Lack of market prospects for biologics expose an opportunity for cell and gene therapieshttp://www.reportlinker.com/p091762/Stakeholder-Opinions-Novel-Therapeutic-Approaches-in-Cardiovascular-Medicine---Lack-of-market-prospects-for-biologics-expose-an-opportunity-for-cell-and-gene-therapies.html
At the forefront of novel technologies; momentum is steadily building for the development of stem cell products to address cardiovascular disease. The most active areas are those with high clinical unmet need heart failure, cardiomyopathy and ishemic heart disease.
-Analysis of the current unmet needs in cardiovascular disease markets
-Opinion leader commentary on key clinical trials and market landscape
-Review of the clinical and commercial status of stem cell therapy for cardiovascular disease
-Review of the clinical and commercial status of gene therapy for cardiovascular disease
Datamonitor's analysis demonstrates how the most innovative drugs offer the greatest growth potential for their respective markets. In the mature cardiovascular market, commercial success must be derived from innovative approaches with unique clinical benefits.
The array of innovative gene and cell products emerging from young companies exposes investment opportunities for venture capitalists, Big Pharma, as well as partnering opportunities for technology companies that can offer compatible catheters, or cell delivery devices.
There awaits an outstanding commercial opportunity for innovators who address clinical unmet need in this market, as a number of companies will see their key revenue generators melt away as they lose patent protection.
Reasons to Purchase
-Understand the need for innovation in the cardiovascular market.
-Up to date insight into the commercial and clinical status of cardiovascular gene and cell therapies
-Understand the barriers to commercialization of novel therapies, with expert commentary
ABOUT DATAMONITOR HEALTHCARE 2 About the Cardiovascular and Diabetes pharmaceutical analysis team: 2 CHAPTER 1 EXECUTIVE SUMMARY 3 Objective of the analysis 3 Datamonitor Key insights 3 Related reports 5 Acknowledgements 5 CHAPTER 2 BACKGROUND 8 Business Implications 8 Introduction 8 Scope 9 Definition of unmet needs 10 Clinical unmet needs in cardiovascular markets 10 Commercial Unmet Needs in cardiovascular markets 16 Commercial opportunities across cardiovascular indications 19 Response to the unmet need 22 Summary 23 CHAPTER 3 NOVEL DRUG TARGETS IN CV MEDICINE 24 Business Implications 24 Introduction 24 Bridging the "innovation gap" 25 Cardiovascular drug targets 25 New technologies allow expansion into novel targets 27 A lack of commercially viable drug targets 28 Biologics drive market growth 29 Monoclonal antibodies (MAbs) 30 Application of MAbs in cardiovascular disease 30 ReoPro (abciximab) profile 30 MAbs in the cardiovascular pipeline 31 BI-204 for atherosclerosis 31 TB-402 for thrombosis 33 Therapeutic vaccines 34 The need for therapeutic vaccines for chronic cardiovascular disease 34 Angiotensin vaccines for hypertension 34 Protherics's Angiotensin Therapeutic Vaccine 36 Cytos Biotechnology's CYT006-AngQ 36 Outlook for angiotensin vaccines 37 CHAPTER 4 STEM CELLS FOR USE IN CV MEDICINE 39 Business Implications 39 Introduction 39 The biology of stem cells 40 Derivation 41 Embryonic stem cells (ESCs) 42 Adult stem cells (ASCs) 42 The use of embryonic versus adult stem cells 43 Proliferation 43 Differentiation and pluripotency 44 Allogeneic versus autologous stem cells 44 The development timeline for stem cell technology 46 The exploitation of stem cells 47 Stem cell therapy 47 Use in regenerative medicine and tissue engineering 47 Stem cell transplantation 47 Stem cells for use in drug discovery 48 Screening arrays of compounds 48 Predictive toxicology 48 Stem cell therapy in cardiovascular medicine 48 Current status 48 The need for cardiovascular regeneration 49 Myocardial infarction and myocardial ischemia 49 Heart failure 50 Stem cell suitability for cardiovascular regeneration 50 Embryonic stem cells (ESCs) 51 Adult stem cells (ASCs) 51 Clinical development of stem cells for cardiovascular disease 54 Current clinical trial focus 54 Clinical trial results 57 Summary and future focus 66 Future clinical trial focus 67 Commercial landscape 69 International markets 70 Key players and products 70 Company Profiles 83 Aastrom Biosciences 83 Advanced Cell Technology 86 Angioblast Systems 88 Athersys 89 BioHeart 91 Cardio3BioSciences 93 Osiris Therapeutics 94 Development hurdles for stem cell therapy 96 Commercial risk associated with small companies 97 Research capacity 97 Regulation 100 Ethics and the perception of stem cells 101 Reimbursement 102 Intellectual property 102 CHAPTER 5 GENE THERAPY FOR USE IN CV MEDICINE 105 Business Implications 105 Introduction 106 Key definitions 106 Genomics 106 Gene therapy 107 The evolution of gene therapy 108 Discovery timeline 108 Approaches to gene therapy 110 In vivo versus ex vivo gene therapy 110 Gene delivery strategies 112 The use of vectors 112 Vector types 112 Delivery modalities 115 Systemic delivery 115 Non-systemic delivery 116 Disease targets for gene therapy 116 Research activity by indication 117 Cancer 117 Inherited diseases 118 Other targets 119 Gene therapy targets in cardiovascular disease 119 Therapeutic angiogenesis 124 Coronary artery disease (CAD) and myocardial ischemia 124 Peripheral arterial disease (PAD) 125 Heart failure 125 The beta-adrenergic (beta-AR) receptor signaling pathway 125 SERCA2a 126 Hypertension 127 ACE gene linked to high blood pressure in men 127 Targets in dyslipidemia 128 LDL-cholesterol and triglycerides 128 HDL-cholesterol 130 Other dyslipidemic targets 131 Gene therapies in the drug development pipeline 132 Current status 132 Current status of clinical trials of gene therapy 133 Gene therapy for coronary artery disease 133 Gene therapy for peripheral arterial disease 137 Gene therapy for heart failure 140 The beta-adrenergic receptor (beta-AR) signaling pathway 140 SERCA2a 140 Gene therapy for dyslipidemia 141 Gene therapy for hypertension 141 Future perspectives in gene therapy 142 Summary of preclinical and clinical research 142 Restenosis 142 Commercial landscape 143 International markets 143 Key players and products 144 Cardium Therapeutics 146 Development hurdles for gene therapy 148 Research and informatics 148 APPENDIX 150 Bibliography 150 About Datamonitor 154 About Datamonitor Healthcare 154 About the Cardiovascular Disease analysis team 155 Report methodology 155 Disclaimer 156 List of Tables Table 1: Summary of clinical unmet needs across the main cardiovascular indications, 2008 12 Table 2: Family classification of drug targets 26 Table 3: ReoPro: Overview 31 Table 4: Key clinical trials using stem cells in acute myocardial infarction, 2008 58 Table 5: Key clinical trials using stem cells in heart failure, 2008 63 Table 6: Key unknowns in cardiovascular stem cell therapy 69 Table 7: Stem cell products currently in development for cardiovascular indications, 2008 72 Table 8: Stem cell companies developing products for cardiovascular indications (Listed) 77 Table 9: Stem cell companies developing products for cardiovascular indications (Non-listed) 81 Table 10: Comparison of different gene vectors used for gene transfer 113 Table 11: Potential delivery methods for different vectors in cardiovascular disease 116 Table 12: Genetic targets in cardiovascular disease 121 Table 13: Effects of overexpressing SR Ca2+ pump in myocytes isolated from failing human hearts 127 Table 14: Key clinical trials in gene therapy for CAD 134 Table 15: Key clinical trials in gene therapy for PAD 138 List of Figures Figure 1: Chapter 2 - Business Implications 8 Figure 2: The $ sales plateau in the cardiovascular market, 2006-2016 17 Figure 3: US patent expiries of the top 10 cardiovascular brands, 2006-2016 18 Figure 4: Summary of unmet needs in cardiovascular indications, 2008 23 Figure 5: Chapter 3 - Business Implications 24 Figure 6: Technological advances expand the conceptual 'druggable' space 27 Figure 7: Key characteristics influencing pharmaceutical commercial attractiveness 29 Figure 8: The mechanism through which the renin-angiotensin-aldosterone system induces systemic hypertension 35 Figure 9: Chapter 4 - Business Implications 39 Figure 10: Definition of terms in the stem cell differentiation process 41 Figure 11: US and UK milestones in the development of stem cell technology, 1950-2008 46 Figure 12: Summary of current focus of stem cell technology in cardiovascular disease, 2008 49 Figure 13: Expert comment: maximizing useful progenitor cells per sample volume is an important consideration 54 Figure 14: Development hurdles for embryonic stem cells 56 Figure 15: Expert comment: future clinical trial focus for stem cell therapy in cardiovascular disease 68 Figure 16: Cardiovascular stem cell therapies in clinical development, 2008 71 Figure 17: Proposed research, development and marketing protocol for stem cell therapies 99 Figure 18: Chapter 5 - Business Implications 105 Figure 19: Timeline of key developments in gene therapy 109 Figure 20: In vivo versus ex vivo gene transfer 111Figure 21: Reserch activity in gene therapy, according to number of clinical trials, by indication 119 Figure 22: Summary of current focus of gene therapy research in cardiovascular disease, 2008 132 Figure 23: Reserch activity in gene therapy, according to number of clinical trials, by location 144 Figure 24: Cardiovascular stem cell therapies in clinical development, 2008 145
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Stakeholder Opinions: Novel Therapeutic Approaches in Cardiovascular Medicine - Lack of market prospects for biologics expose an opportunity for cell and gene therapies
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