Product Code: GDHCHT006
Regenerative medicine could potentially cure diseases and may replace palliative treatments for chronic diseases. Stem cells in particular have been studied for their regenerative properties: their potential to repair or replace damaged or diseased human cells or tissues to restore normal function. Stem cells are able to develop into different cell types in the body during early the early stages of life and growth. They have a role in repairing many types of damaged tissue.
The FDA has put out a comprehensive policy framework for the development and oversight of regenerative medicine products through the 21st Century Cures Act, legislation for an expedited approval path for cellular medicines designated as regenerative medicine advanced therapies (RMATs) to patients who need them faster and more efficiently.
Studies of stem cell therapies targeting cardiovascular indications such as heart failure (HF), myocardial infarction (MI), cardiomyopathy (CM), and left ventricular dysfunction (LVD) aim to demonstrate that stem cells injected into the circulation or directly into the injured heart tissue improve cardiac function and/or induce the formation of new capillaries.
The majority of CVMD pipeline candidates are in preclinical development, with ~73% of CVMD stem cell pipeline therapies specifically targeting cardiovascular indications. Representative stem cell types that are being investigated in clinical trials towards CV indications include mesenchymal precursor, ischemia-tolerant mesenchymal, myoblast, immunomodulatory progenitor, and heart-derived stem cells.
Currently, there is an absence of big pharma investment in cardiovascular stem cell therapy clinical development, with the majority of the R&D efforts in this space being undertaken by small biotech companies.
The report "Stem Cell Therapies in CVMD", provides an assessment of the pipeline, clinical, and commercial landscape of stem cell therapies in CVMD. Overall, it is expected that new stem cell therapy approvals will drive CVMD market growth from 2018-2025.
Companies Mentioned: Mesoblast, U.S. Stemcell, Celixir, Capricor, Stemedica, Healios, Athersys, SanBio.
Components of the slide deck include -
- Overview of CVMD and Stem Cells: epidemiology and regulatory oversight
- Pipeline Assessment: regional breakdown, promising late-stage products, early-stage pipeline by molecule type
- Clinical Trials Assessment: trial breakdown by phase, leading industry and non-industry sponsors
- Market Access: considerations for reimbursement, pricing, and unmet needs
- Market Outlook: competitive assessment and key market events (2018-2025).
Reasons to buy
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global CVMD stem cell therapy market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CVMD stem cell therapy market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
Table of Contents
- 1.1 Related Reports 5
- 1.2 Upcoming Related Reports 6
2. Executive Summary 7
- 2.1 Key Findings 8
- 2.2 CVMD Stem Cell Therapy Competitive Landscape Insights 9
3. Overview - Stem Cells, CVMD, Epidemiology 10
- 3.1 Regenerative Medicine 12
- 3.2 Stem Cells and Cardiovascular Disease 13
- 3.3 Stem Cell Therapies 15
- 3.4 Overview of Heart Disease and Epidemiology 16
- 3.5 Overview of Other CV Indications and Epidemiology 22
- 3.6 Overview of Metabolic Disorders and Epidemiology 26
4. Regulatory Oversight of Stem Cell Therapies 30
- 4.1 Regulatory Agencies in the US and EU 32
- 4.2 The FDA and Stem Cell Therapy 33
- 4.3 Oversight of Stem Cell Therapy in Japan and China 34
- 4.4 Marketed Heart Failure Therapy in Japan 35
5. Pipeline Assessment, Profiled Stem Cell Therapies 36
- 5.1 Pipeline Stem Cell Therapies Targeting CVMD 38
- 5.2 Stem Cell Therapies for Heart Failure 39
- 5.3 HF Pipeline: Mesoblast's Revascor 40
- 5.4 HF Pipeline: U.S. Stemcell's MyoCell 41
- 5.5 HF Pipeline: Celixir's Heartcel 42
- 5.6 HF Pipeline: Capricor's CAP-1002 43
- 5.7 HF Pipeline: Stemedica's Stemedyne-MSC 44
- 5.8 Stroke Pipeline: Healios'/Athersys' Multistem 45
- 5.9 Stroke Pipeline: SanBio's SB623 46
6. Clinical Trials and Key Developers 47
- 6.1 Overview of Clinical Trials 49
- 6.2 CVMD Stem Cell Therapy Development 50
- 6.3 Clinical Trial Mapping 51
- 6.4 Key Players 52
7. Market Access: Reimbursement, Pricing, Unmet Need 53
- 7.1 Market Access 55
- 7.2 Stem Cell Therapy Reimbursement 56
- 7.3 Unmet Need within CVD 57
- 7.4 CVD Stem Cell Therapy Reimbursement and Pricing 58
- 7.5 Reimbursement for HF Stem Cell Pipeline Therapies 59
- 7.6 Reimbursement for Stroke Stem Cell Pipeline Therapies 60
- 7.7 MD (Diabetes) Stem Cell Therapy Reimbursement 61
8. Market Outlook 62
- 8.1 Market Outlook for Mesoblast's Revascor 64
- 8.2 Market Outlook for U.S. StemCell's MyoCell 65
- 8.3 Market Outlook for Celixir's Heartcel 66
- 8.4 Market Outlook for Capricor's CAP-1002 67
- 8.5 Market Outlook for Stemedica's Stemedyne-MSC 68
- 8.6 Market Outlook for Healios'/Athersys' Multistem 69
- 8.7 Market Outlook for SanBio's SB623 70
- 8.8 Anticipated Key Events for Stem Cell Therapies in CVD 71
9. Appendix 72
- 9.1 Sources 73
- 9.2 Methodology 74
- 9.3 Primary Research 75
- 9.4 About the Authors 76
- 9.5 About GlobalData 78
- 9.6 Contact Us 79
- 9.7 Disclaimer 80