Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Cardiovascular and Diabetes pharmaceutical analysis team:
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor Key insights
- Related reports
- Acknowledgements
- CHAPTER 2 BACKGROUND
- Business Implications
- Introduction
- Scope
- Definition of unmet needs
- Clinical unmet needs in cardiovascular markets
- Commercial Unmet Needs in cardiovascular markets
- Commercial opportunities across cardiovascular indications
- Response to the unmet need
- Summary
- CHAPTER 3 NOVEL DRUG TARGETS IN CV MEDICINE
- Business Implications
- Introduction
- Bridging the "innovation gap"
- Cardiovascular drug targets
- New technologies allow expansion into novel targets
- A lack of commercially viable drug targets
- Biologics drive market growth
- Monoclonal antibodies (MAbs)
- Application of MAbs in cardiovascular disease
- ReoPro (abciximab) profile
- MAbs in the cardiovascular pipeline
- BI-204 for atherosclerosis
- TB-402 for thrombosis
- Therapeutic vaccines
- The need for therapeutic vaccines for chronic cardiovascular disease
- Angiotensin vaccines for hypertension
- Protherics' s Angiotensin Therapeutic Vaccine
- Cytos Biotechnology' s CYT006-AngQ
- Outlook for angiotensin vaccines
- CHAPTER 4 STEM CELLS FOR USE IN CV MEDICINE
- Business Implications
- Introduction
- The biology of stem cells
- Derivation
- Embryonic stem cells (ESCs)
- Adult stem cells (ASCs)
- The use of embryonic versus adult stem cells
- Proliferation
- Differentiation and pluripotency
- Allogeneic versus autologous stem cells
- The development timeline for stem cell technology
- The exploitation of stem cells
- Stem cell therapy
- Use in regenerative medicine and tissue engineering
- Stem cell transplantation
- Stem cells for use in drug discovery
- Screening arrays of compounds
- Predictive toxicology
- Stem cell therapy in cardiovascular medicine
- Current status
- The need for cardiovascular regeneration
- Myocardial infarction and myocardial ischemia
- Heart failure
- Stem cell suitability for cardiovascular regeneration
- Embryonic stem cells (ESCs)
- Adult stem cells (ASCs)
- Clinical development of stem cells for cardiovascular disease
- Current clinical trial focus
- Clinical trial results
- Summary and future focus
- Future clinical trial focus
- Commercial landscape
- International markets
- Key players and products
- Company Profiles
- Aastrom Biosciences
- Advanced Cell Technology
- Angioblast Systems
- Athersys
- BioHeart
- Cardio3BioSciences
- Osiris Therapeutics
- Development hurdles for stem cell therapy
- Commercial risk associated with small companies
- Research capacity
- Regulation
- Ethics and the perception of stem cells
- Reimbursement
- Intellectual property
- CHAPTER 5 GENE THERAPY FOR USE IN CV MEDICINE
- Business Implications
- Introduction
- Key definitions
- The evolution of gene therapy
- Discovery timeline
- Approaches to gene therapy
- In vivo versus ex vivo gene therapy
- Gene delivery strategies
- The use of vectors
- Delivery modalities
- Systemic delivery
- Non-systemic delivery
- Disease targets for gene therapy
- Research activity by indication
- Cancer
- Inherited diseases
- Other targets
- Gene therapy targets in cardiovascular disease
- Therapeutic angiogenesis
- Coronary artery disease (CAD) and myocardial ischemia
- Peripheral arterial disease (PAD)
- Heart failure
- The beta-adrenergic (beta-AR) receptor signaling pathway
- SERCA2a
- Hypertension
- ACE gene linked to high blood pressure in men
- Targets in dyslipidemia
- LDL-cholesterol and triglycerides
- HDL-cholesterol
- Other dyslipidemic targets
- Gene therapies in the drug development pipeline
- Current status
- Current status of clinical trials of gene therapy
- Gene therapy for coronary artery disease
- Gene therapy for peripheral arterial disease
- Gene therapy for heart failure
- The beta-adrenergic receptor (beta-AR) signaling pathway
- SERCA2a
- Gene therapy for dyslipidemia
- Gene therapy for hypertension
- Future perspectives in gene therapy
- Summary of preclinical and clinical research
- Restenosis
- Commercial landscape
- International markets
- Key players and products
- Development hurdles for gene therapy
- APPENDIX
- Bibliography
- About Datamonitor
- About Datamonitor Healthcare
- About the Cardiovascular Disease analysis team
- Report methodology
- Disclaimer
- List of Tables
- Table 1: Summary of clinical unmet needs across the main cardiovascular
indications, 2008
- Table 2: Family classification of drug targets
- Table 3: ReoPro: Overview
- Table 4: Key clinical trials using stem cells in acute myocardial
infarction, 2008
- Table 5: Key clinical trials using stem cells in heart failure, 2008
- Table 6: Key unknowns in cardiovascular stem cell therapy
- Table 7: Stem cell products currently in development for cardiovascular
indications, 2008
- Table 8: Stem cell companies developing products for cardiovascular
indications (Listed)
- Table 9: Stem cell companies developing products for cardiovascular
indications (Non-listed)
- Table 10: Comparison of different gene vectors used for gene transfer
- Table 11: Potential delivery methods for different vectors in
cardiovascular disease
- Table 12: Genetic targets in cardiovascular disease
- Table 13: Effects of overexpressing SR Ca2+ pump in myocytes isolated
from failing human hearts
- Table 14: Key clinical trials in gene therapy for CAD
- Table 15: Key clinical trials in gene therapy for PAD
- List of Figures
- Figure 1: Chapter 2 - Business Implications
- Figure 2: The $ sales plateau in the cardiovascular market, 2006-2016
- Figure 3: US patent expiries of the top 10 cardiovascular brands,
2006-2016
- Figure 4: Summary of unmet needs in cardiovascular indications, 2008
- Figure 5: Chapter 3 - Business Implications
- Figure 6: Technological advances expand the conceptual ' druggable' space
- Figure 7: Key characteristics influencing pharmaceutical commercial
attractiveness
- Figure 8: The mechanism through which the renin-angiotensin-aldosterone
system induces systemic hypertension
- Figure 9: Chapter 4 - Business Implications
- Figure 10: Definition of terms in the stem cell differentiation process
- Figure 11: US and UK milestones in the development of stem cell
technology, 1950-2008
- Figure 12: Summary of current focus of stem cell technology in
cardiovascular disease, 2008
- Figure 13: Expert comment: maximizing useful progenitor cells per sample
volume is an important consideration
- Figure 14: Development hurdles for embryonic stem cells
- Figure 15: Expert comment: future clinical trial focus for stem cell
therapy in cardiovascular disease
- Figure 16: Cardiovascular stem cell therapies in clinical development,
2008
- Figure 17: Proposed research, development and marketing protocol for
stem cell therapies
- Figure 18: Chapter 5 - Business Implications
- Figure 19: Timeline of key developments in gene therapy
- Figure 20: In vivo versus ex vivo gene transfer
- Figure 21: Reserch activity in gene therapy, according to number of
clinical trials, by indication
- Figure 22: Summary of current focus of gene therapy research in
cardiovascular disease, 2008
- Figure 23: Reserch activity in gene therapy, according to number of
clinical trials, by location
- Figure 24: Cardiovascular stem cell therapies in clinical development,
2008
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