For a report overview of this report please contact sara.peerun@visiongainglobal.com
(+44 (0) 20 7336 6100) or refer to our website:
https://www.visiongain.com/Report/1816/Global-Stem-Cell-Technologies-and-Applications-Market-2017-2027
https://www.visiongain.com/
2. www.visiongain.com
Contents
1. Report Overview
1.1 Global Stem Cell Technologies and Applications Market Overview
1.2 Global Stem Cell Technologies and Applications Market Segmentation
1.3 Why You Should Read This Report
1.4 How this Report Delivers
1.5 Key Questions Answered by This Report
1.6 Who is Report for?
1.7 Research and Analysis Methods
1.8 Frequently Asked Questions (FAQ)
1.9 Some Associated Reports
1.10 About Visiongain
2. Introduction to Stem Cell Technologies and Applications
2.1 What are Stem Cells? Defining Characteristics
2.2 Timeline of Stem Cell Research
2.3 Embryonic Stem Cells (ESCs) Enter the Picture
2.4 Classifying Stem Cells by Potency
2.5 The Main Types of Stem Cells and Their Properties
2.6 iPSCs: The Benefits of ESCs, but Without the Downsides?
2.7 Parthenogenetic Stem Cells: Scientific Background
2.8 Autologous Versus Allogeneic Stem Cells
2.9 Phases of Clinical Trials
2.10 Scope of this Report
3. International Developments and Stem Cell Regulatory
Environments
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Contents
3.1 Regulatory Environment in the US
3.1.1 Dynamic Biotechnology Sector and Liberal Stance on Patents
3.1.2 Understanding ‘Homologous’ Use
3.1.3 Controversy Surrounding ESC Research
3.1.4 NIH ESC Stem Cell Registry: Has Made Good Progress, but Not Enough for
its Critics
3.1.5 CIRM and NIH Stem Cell Funding into Various Channels
3.1.6 FDA vs Regenerative Sciences
3.1.7 Are Stem Cells Clinics the ‘Wild West’ of Medicine?
3.1.8 Stem Cell Clinics Using Loopholes to Avoid Oversight?
3.1.9 FDA Releases Three New Draft Guidances, but is it Doing Enough?
3.2 Regulatory Environment in Europe
3.2.1 Unified Overarching System of Regulation Across EU
3.2.2 Difference Between EU Member States Regarding hESC Research
3.2.3 European Court of Justice Performs an U-Turn and Clears Path Towards
Stem Cell Patents
3.2.4 The UK: A Leader in European Stem Cell Research
3.3 Regulatory Environment in Japan
3.3.1 Liberal Stance on hESC but with Excessive Bureaucracy?
3.3.2 Japan: A Pioneer in iPSC Research, Although First In-Human Trial has been
Suspended
3.3.3 The STAP Cell Events: Excitement Dashed
3.3.4 Government Committed to Regenerative Medicines and iPSC Research
3.3.5 Japan Becomes Very Attractive Market for Stem Cell Companies due to
Favourable Regulatory Changes
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3.4 Regulatory Environment in South Korea
3.4.1 Highs and Lows with Regard to hESC Research
3.4.2 Regulators are Quick to Approve Therapies, Although this has Drawn
Criticism
3.4.3 Tracheal Transplant Patient Dies
3.5 Chinese Regulatory Environment
3.5.1 Liberal Regulation on Stem Cells and Very High Number of Stem Cell
Clinical Trials Taking Place in the Country
3.5.2 Stem Cell Medical Tourism Very Popular
3.5.3 CFDA Releases New Stem Cell Draft Guidance
4. Stem Cell Technologies and Applications: World Market
2017-2027
4.1 Therapeutic Applications Versus Non-Therapeutic Applications of Stem Cells
4.2 Regional Breakdown of the World Market
4.3 Market Segmentation
4.4 Stem Cell Technologies and Applications Market: Forecast 2016-2027
4.5 Stem Cell Technologies and Applications Market: Forecast by Segment 2016-
2027
4.6 How Will Segmental Market Shares Change to 2027?
4.6.1 Which Segments will grow the Most?
4.7 Stem Cell Technologies and Applications Market: Drivers and Restraints 2016-
2027
5. Stem Cell Cancer Therapeutics Segment 2017-2027
5.1 Stem Cell Cancer Therapeutics: Overview and Current Status
5.2 Stem Cell Cancer Therapeutics: Market Forecast 2016-2027
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Contents
5.3 Haematopoietic Stem Cell Transplantation (HCST)
5.3.1 An Established Treatment for Haematological Cancers
5.3.2 Autologous HSCT: Dominant Form of HSCT
5.3.3 Autologous Versus Allogeneic HSCT: Advantages and Disadvantages
5.3.4 GvHD: The Major Issue for HSCT
5.3.5 Strengths and Weaknesses of the Three Major Sources of HSCs
5.3.6 What is Cord Blood?
5.3.7 Number of HSCT Operations Performed Worldwide, Split by Autologous
Versus Allogeneic HSCT, 2012-2014
5.3.8 HSCT Costs and Medicare Coverage
5.3.9 The Indications which can be treated with HSCT: Haematological
Malignancies are the Major Indications
5.3.10 HSCT has the Potential to Address Multiple Cancers, which represent a
$20bn+ Market
5.4 From Procedures to Products: Cord Blood Stem Cell Approvals
5.4.1 Hemacord (New York Blood Center): The First FDA-Approved Cord Blood
Product
5.4.2 HPC, Cord Blood (ClinImmune Labs / University of Colorado Blood Bank)
5.4.3 Ducord (Duke University School of Medicine)
5.4.4 Allocord (SSM Cardinal Glennon Children’s Medical Center)
5.4.5 HPC, Cord Blood BLA 125432 (LifeSouth Community Blood Centers)
5.4.6 CLEVECORD, HPC
5.4.7 HPC, Cord Blood (BLA 125585)
5.5 Stem Cell Cancer Therapeutics Pipeline
5.5.1 Agenmestencel-T (Apceth)
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5.5.2 CLT-008 and CLT-009 (Cellerant Therapeutics): Company Receives $47.5m
Grant from US Government
5.5.3 ProHema (Fate Therapeutics)
5.5.4 StemEx and NiCord (Gamida Cell)
5.5.5 MSC-100-IV (Previously Known as Prochymal) and Unnamed MPC-
Expanded Cord Blood Product (Mesoblast)
5.5.6 HSC835 (Novartis)
5.5.7 Ancillary Products for the HSCT Setting
5.5.8 Targeting of Cancer Stem Cells (CSCs)
5.6 Stem Cell Cancer Therapeutics: Drivers and Restraints 2016-2027
6. Stem Cell Cardiovascular Therapeutics Segment 2017-
2027
6.1 Stem Cell Cardiovascular Therapeutics: Overview and Current Status
6.2 Stem Cell Cardiovascular Therapeutics: Market Forecast 2016-2027
6.3 Cardiovascular Diseases Make up a Large part of the Global Pharmaceutical
Market
6.3.1 Stem Cell Treatments for Stroke: Touched Upon in This Chapter but mainly
Covered under Central Nervous System Therapeutics
6.3.2 Cardiovascular and Cerebrovascular Conditions are the World’s Most Fatal
Diseases
6.3.3 AMI, CLI and Stroke: Major Ischemic Disease Targets
6.4 The State of Stem Cell Research for Cardiovascular Diseases
6.4.1 Practical Advantages to Choosing the Heart as a Target for Stem Cell R&D
6.4.2 Defining Cardiovascular Stem Cells: Scientific Context
6.5 The Mysterious Effects of Stem Cells in the Heart
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Contents
6.5.1 MSCs in the Heart: Evidence to Support their Use, as well as Doubts over
their Efficacy
6.5.2 Cardiosphere-Derived Cells, hESC-Derived Cardiomyocytes and C-kit Cells
6.6 Stem Cell Cardiovascular Therapeutics on the Market
6.6.1 Hearticellgram-AMI (Pharmicell)
6.6.2 CardioRel (Reliance Life Sciences)
6.7 Stem Cell Cardiovascular Therapeutics Pipeline
6.7.1 Ixmyelocel-T (Vericel Corporation)
6.7.2 Alecmestencel-T (Apceth)
6.7.3 Arteriocyte: Using its ‘Magellan System’ to Treat CLI
6.7.4 MultiStem (Athersys) for Myocardial Infarction and Stroke
6.7.5 Baxter: Phase 3 CD34+ Stem Cell Therapy for Refractory Angina
6.7.6 CardiAMP (BioCardia) for Heart Failure: Scheduled to Finally Begin Phase 3
in January 2017
6.7.7 MyoCell (U.S. Stem Cell, Inc. – Formerly Bioheart): Autologous ‘Muscle
Stem Cell’ Therapy
6.7.8 CAP-1001 and CAP-1002 (Carpricor): Cardiospehere-Derived Cells for
Heart Repair
6.7.9 Ceylad (Formerly Cardio3): Proprietary Cardiopoiesis Technology Platform -
Can be Applied to Various Stem Cell Sources
6.7.10 Mesoblast: Mesenchymal Precursor Cells for Heart Failure and Myocardial
Infarction
6.7.11 Caladrius Biosciences: Will not Continue Development of CLBS10, the
Company’s Former Lead Candidate
6.7.12 Stemedica Cell Technologies: ‘Ischaemic-Tolerant’ Stem Cell Platform
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Contents
6.7.13 Gemacell and Cryocell (Human Stem Cells Institute): Awaiting Important
Russian Legislation to be Passed before Development Can Continue
6.8 Stem Cell Cardiovascular Therapeutics: Drivers and Restraints 2016-2027
7. Stem Cell Central Nervous System Therapeutics Segment
2017-2027
7.1 Stem Cell Central Nervous System Therapeutics: Overview and Current
Status
7.2 Stem Cell Central Nervous System Therapeutics: Market Forecast 2016-2027
7.3 The State of Stem Cell Research in CNS Diseases
7.3.1 Stem Cells are the Best Hope for Many Serious CNS Conditions
7.3.2 Awaiting a First Breakthrough Approval
7.3.3 Human Neural Stem Cells (NSCs) Successfully Isolated
7.3.4 NSCs Reach the Clinic Without Serious Controversy
7.3.5 CNS Disorders are a Major Focus for ESC Research
7.3.6 MSCs: Can Glial Cell and Astrocyte Formation Help Neurological
Conditions?
7.4 Progress in Specific CNS Conditions
7.4.1 HSCT in MS: Could ‘Resetting’ the Immune System Treat MS?
7.4.2 ALS: Could this Rare Disease be the First Neurodegenerative Condition for
Stem Cell Treatment?
7.4.3 Parkinson’s Disease: Field Recovering after Voluntary Moratorium on Stem
Cell Research by Many Western Nations Ends
7.4.4 Dry Age-Related Macular Degeneration: A Major Unmet Need
7.5 Several Multi-Billion Dollar Markets are Open to Stem Cell Developers if they
can Translate the Potential of Stem Cells into Therapies
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7.6 Stem Cell Central Nervous System Therapeutics Pipeline
7.6.1 MA09-hRPE (Ocata Therapeutics): Stem Cells for Eye Diseases
7.6.2 NurOwn (BrainStorm Cell Therapeutics): Neurotrophic Factor -Releasing
Stem Cells for ALS
7.6.3 International Stem Cell Corporation: Company Signals Intent to Start Phase
1/2a Study in PD Soon
7.6.4 Neuralstem: Allogeneic NSCs for Synaptic Repair and Neuroprotection
7.6.5 PF-05206388 (Pfizer and the London Project to Cure Blindness): Finally
Begins Phase 1Trial, with first Successful Surgery
7.6.6 Q-Cells (Q Therapeutics): Phase 1/2 Trial Begins
7.6.7 ReNeuron: CTX Neural Cell Line and its Advantages
7.6.8 SB623 (SanBio): Enters Phase 2 for Stroke, as well as for Traumatic Brain
Injury
7.6.9 StemCells, Inc: A Leader in Neural Stem Cells
7.7 Stem Cell Central Nervous System Therapeutics: Drivers and Restraints 2016-
2027
8. Stem Cell Therapeutics in Other Disease Areas 2017-2027
8.1 Stem Cell Therapeutics in Other Disease Areas: Overview and Current Status
8.2 Stem Cell Therapeutics in Other Disease Areas: Market Forecast 2016-2027
8.3 Stem Cell Therapeutics in Other Disease Areas: Therapies on the Market
8.3.1 Osteocel Plus (NuVasive)
8.3.2 Trinity Evolution and Trinity Elite (Orthofix): Stem Cell Orthobiologics
8.3.3 CARTISTEM (MEDIPOST)
8.3.4 Allostem (Allosource)
8.3.5 Map3 (RTI Surgical)
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8.3.6 ReliNethra for Ocular Surface Damage (Reliance Life Sciences)
8.3.7 Cupistem (Anterogen)
8.4 Stem Cell Therapeutics for Other Diseases: Research Areas
8.4.1 HSCT for Orphan Diseases
8.4.2 Potential for Genetically Modified Stem Cells for HIV and Other Diseases?
8.4.3 Stem Cells Contribute to the Osteogenesis Process in Bone Repair
8.4.4 Stem Cells Gaining Increasing Importance in Bone Graft Market, but whether
these are True ‘Stem Cell Products’ is Debatable
8.4.5 Stem Cells also have Potential in Autoimmune Disorders
8.4.6 Potential Cure for Diabetes?
8.4.7 Stem Cells in Active Liver Repair
8.4.8 Long-Term Possibilities
8.5 Stem Cell Therapeutics in Other Disease Areas: Pipeline
8.5.1 ALLO-ASC and ALLO-ASC-DFU (Anterogen)
8.5.2 MultiStem (Athersys): Fails Phase 2 Ulcerative Colitis, Still Undergoing
Phase 1 as Immunomodulation Therapy after Liver Transplantation
8.5.3 BioTime: Multiple Subsidiaries Focused on Regenerative Medicine
8.5.4 Calimmune: Dual Anti-HIV Gene Therapy via Stem Cells
8.5.5 (PDA-001 and PDA-002) Celgene Corporation
8.5.6 ReJoin (Cellular Biomedicine Group): Interim Results from the MSCs for
Knee Osteoarthritis
8.5.7 PNEUMOSTEM (MEDIPOST)
8.5.8 Translational Biosciences: Set Up for the Sole Purpose of Conduction Stem
Cell Clinical Trials, Five Phase 1/2 Trials Ongoing
8.5.9 Mesoblast: MPCs for Various Indications
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8.5.10 Pluristem Therapeutics: Uses PLX Cells to Secrete Therapeutic Proteins in
Damaged Tissues
8.5.11 Regeneus: Adipose Derived MSC Therapies
8.5.12 S-Evans Biosciences: Menstrual Stem Cells
8.5.13 TiGenix: Expanded Adipose-Derived Stem Cell Therapies
8.5.14 VC-01 (ViaCyte)
8.6 Genetically Modified Stem Cell Therapies
8.6.1 BluebirdBio: Gene-Modified HSCs for Orphan Diseases
8.6.2 GSK: Stem Cell Gene Therapies for Rare Diseases, Including one which has
been Submitted for Approval in Europe
9. Stem Cell Non-Therapeutic Applications 2017-2027
9.1 Stem Cell Non-Therapeutic Applications: Overview and Current Status
9.2 Stem Cell Non-Therapeutic Applications: Market Forecast 2016-2027
9.3 Stem Cell Banking: Growing Demand Worldwide
9.3.1 Impact of the current epidemic of Zika Virus and HIV in cord cell banking
9.3.2 Is there a Need for Stem Cell Banking as a Form of ‘Health Insurance’?
9.3.3 Stem Cell Banking Companies in the US and Around the World
9.3.4 Dental Stem Cell Banking: An Alternative to Cord Blood Banks?
9.4 Stem Cell Supply and Processing: iPSCs are the New Driver
9.4.1 Stem Cell Supply and Processing Companies
9.5 Stem Cell-Based Assays: Major Potential for Preclinical Screens
9.5.1 Advantages of Stem Cell-Based Assays
9.5.2 Stem Cell-Based Assay Companies
9.6 Research, Reagents, and Other Non-Therapeutic Stem Cell Activities
9.7 Drivers and Restraints
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Contents
10. Qualitative Analysis of the Stem Cell Technologies and
Applications Market 2017-2027
10.1 SWOT Analysis of the Stem Cell Technologies and Applications Market
10.2 Strengths
10.2.1 HSCT is already an Established Procedure
10.2.2 Approvals for Stem Cell Therapies
10.2.3 Relaxation of Regulatory Barriers
10.3 Weaknesses
10.3.1 Uncertain Mechanisms of Action in Stem Cell Therapies
10.3.2 Phase 3 Trials only make up a Small Fraction of the Currently Ongoing
Clinical Trials
10.3.3 Regulatory and Reimbursement Concerns
10.3.4 The scare of a possible immune rejection after a stem cell transplant
10.4 Opportunities
10.4.1 Huge Potential in Unmet Clinical Needs
10.4.2 Opportunities in the Non-Therapeutic Uses of Stem Cells, including Cord
Blood Banking and Cell-Based Assays
10.4.3 Interactions with Related Technologies will Offer new Opportunities
10.4.4 Genetic Modification of Stem Cells
10.5 Threats
10.5.1 Financial Risks and Under-Capitalisation of the Stem Cells Sector
10.5.2 Threat of Pipeline Failures
10.5.3 Long-Term Safety Concerns
10.6 STEP Analysis of the Stem Cell Technologies and Applications Market
10.7 Social Factors
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10.7.1 Increasing Burden of Disease as World Population Ages
10.7.2 Biological Insurance through Stem Cell Banking
10.7.3 Stem Cell Tourism: Both an Opportunity and Threat to the Market
10.8 fTechnological Factors
10.8.1 Increasing Research Output
10.8.2 IPSC Advances
10.8.3 Greater Understanding of Stem Cell Differentiation
10.8.4 Interactions with Other Technologies
10.8.5 CRISPR: A Breakthrough in Genome Editing
10.9 Economic Factors
10.9.1 Grey Market for Stem Cell Therapies
10.9.2 Broad Changes in Pharma / Healthcare Markets
10.9.3 New Business Models are required due to the Unique Challenges Posed by
these Non-Traditional Therapies
10.10 Political Factors
10.10.1 Controversies over Embryonic Stem Cell Research
10.10.2 Support from National Governments
10.10.3 Patient Pressure to Deregulate the Stem Cell Therapies Market
11. Conclusions
11.1 Stem Cell Technologies and Applications: An Emerging Market
11.2 Current Leading Segments and Regional Markets
11.3 World Stem cell Technologies and Applications Market Forecast 2016-2027
11.4 The Future of the Stem Cell Market
11.5 Concluding Remarks
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Contents
List of Tables
Table 2.1 Classifying Stem Cells by Potency
Table 2.2 The Different Germ Layers and Their Associated Types of Cells and
Organs
Table 2.3 Main Types of Stem Cells and Their Properties
Table 2.4 Stem Cell Donor Terminology
Table 2.5 The Different Phases of Clinical Trials
Table 3.1 NIH Embryonic Stem Cell Registry: Stem Cell Lines by Status, 2015 and
2016
Table 3.2 New FDA Draft Guidances, 2016
Table 3.3 StemGen’s Classifications of European Nations by Level of
Permissiveness towards hESC research
Table 4.1 Stem Cell Technologies and Applications Market by Region: Revenues
($m), Market Shares (%), 2016
Table 4.2 Stem Cell Technologies and Applications Market by Segment:
Revenues ($m), Market Shares (%), 2016
Table 4.3 Stem Cell Technologies and Applications Market Forecast: Revenues
($m), AGR (%), CAGR (%), 2016-2020
Table 4.4 Stem Cell Technologies and Applications Market Forecast: Revenues
($m), AGR (%), CAGR (%), 2021-2027
Table 4.5 Stem Cell Technologies and Applications Market Forecast by Segment:
Revenues ($m), AGR (%), CAGR (%), 2016-2020
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Table 4.6 Stem Cell Technologies and Applications Market Forecast by Segment:
Revenues ($m), AGR (%), CAGR (%), 2021-2027
Table 4.7 Stem Cell Technologies and Applications Market by Segment:
Revenues ($m), Market Share (%), 2021 and 2027
Table 5.1 Stem Cell Cancer Therapeutics Market Forecast: Revenues ($m), AGR
(%), CAGR (%), 2016-2020
Table 5.2 Stem Cell Cancer Therapeutics Market Forecast: Revenues ($m), AGR
(%), CAGR (%), 2021-2027
Table 5.3 Comparison of Bone Marrow, Peripheral Blood and Cord Blood for
HSCT
Table 5.4 Estimated Number of HSCT Operations Performed Globally, by Donor
Type: AGR (%), CAGR (%), 2012-2014
Table 5.5 European HSCT Operations: Number of Operations by Donor Type,
2003-2012
Table 5.6 Indications with Medicare Coverage for HSCT (both Autologous and
Allogeneic)
Table 5.7 Malignancies and Other Haematological Diseases which may be
Treated with HSCT
Table 5.8 HSCT-Addressable Cancers: Estimated Combined Incidence in the US,
Japan and Western Europe (Number of Cases), CAGR (%), 2012-2024
Table 5.9 FDA-Approved Cord Blood-Derived Stem Cell Products for HSCT, 2016
Table 5.10 Past and Present ProHema (Fate Therapeutics) Clinical Trials, 2016
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Table 9.5 Select Stem Cell Supply and Processing Companies, 2016
Table 9.6 Select Companies with Involvement in Stem Cell-Based Assays, 2016
Table 10.1 World 65+ Population Forecast: Population (m), CAGR (%), 2015-
2050
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Contents
List of Figures
Figure 1.1 Global Stem Cell Technologies and Applications Market Segmentation
Overview, 2017
Figure 2.1 Timeline of Stem Cell Research
Figure 3.1 NIH Embryonic Stem Cell Registry: Stem Cell Lines by Status, 2016
Figure 3.2 NIH Spending for stem cell research by year (in USD billions)
Figure 3.3 CIRM Funding by Disease Area, Percentage (%), 2015
Figure 4.1 Therapeutic Applications of Stem Cells vs Non-Therapeutic
Applications: Market Shares (%), 2016
Figure 4.2 Therapeutic Applications of Stem Cells vs Non-Therapeutic
Applications: Market Shares (%), 2027
Figure 4.3 Stem Cell Technologies and Applications Market by Region: Market
Shares (%), 2016
Figure 4.4 Stem Cell Technologies and Applications Market by Segment: Market
Shares (%), 2016
Figure 4.5 Stem Cell Technologies and Applications Market Forecast: Revenues
($m), 2016-2027
Figure 4.6 Stem Cell Technologies and Applications Market Forecast by
Segment: Revenue ($m), 2016-2027
Figure 4.7 Stem Cell Technologies and Applications Market Forecast by Segment,
2016-2027
Figure 4.8 Stem Cell Technologies and Applications Market: Market Shares (%) by
Segment, 2021
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Figure 4.9 Stem Cell Technologies and Applications Market: Market Shares (%) by
Segment, 2027
Figure 4.10 Stem Cell Technologies and Applications Market: Drivers and
Restraints, 2016-2027
Figure 5.1 Stem Cell Cancer Therapeutics Market Forecast: Revenue ($m), 2016-
2027
Figure 5.2 Estimated Proportions of Global HSCT Operations by Donor Type,
2016
Figure 5.3 European HSCT Operations by Donor Type, 2003-2012
Figure 5.4 European HSCT Operations: Number of Operations by Donor Type,
2003-2012
Figure 5.5. Estimated New Cases of Leukemia, Lymphoma and Myeloma in 2016
Figure 5.6. Estimated new cases of leukemia diagnosed in 2016
Figure 5.7 HSCT-Addressable Cancers: Estimated Combined Incidence in the
US, Japan and Western Europe (Number of Cases), 2012-2024
Figure 5.8 Most Common Diseases Treated by Cord Blood from LifeCord:
Percentage (%) 2016
Figure 5.9 MSC-100-IV / Temcell HS Forecast (Mesoblast / JCR
Pharmaceuticals): Revenue ($m), 2016-2027
Figure 5.10 Stem Cell Cancer Therapeutics Market: Drivers and Restraints, 2016-
2027
Figure 6.1 Stem Cell Cardiovascular Therapeutics Market Forecast: Revenue
($m), 2016-2027
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Figure 6.2 Global Cardiovascular Disease Market by Drug Class: Market Shares
(%), 2016
Figure 6.3 Projected Global Deaths from Ischaemic Heart Disease and Stroke
(millions ), 2015 and 2030
Figure 6.4 Hearticellgram-AMI (Pharmicell) Sales Estimates: Revenue ($m), 2012-
2016
Figure 6.5 Hearticellgram-AMI (Pharmicell) Forecast: Revenue ($m), 2016-2027
Figure 6.6 CardioRel (Reliance Life Sciences) Forecast: Revenue ($m), 2016-
2027
Figure 6.7 Stem Cell Cardiovascular Therapeutics Market: Drivers and Restraints,
2016-2027
Figure 7.1 Stem Cell CNS Therapeutics Market Forecast: Revenue ($m), 2014-
2026
Figure 7.2 Stem Cell CNS Therapeutics Market: Drivers and Restraints, 2016-
2027
Figure 8.1 Stem Cell Therapeutics in Other Disease Areas Market Forecast:
Revenues ($m), 2016-2027
Figure 8.2 Osteocel Plus (NuVasive) Forecast: Revenue ($m), 2016-2027
Figure 8.3 Trinity Evolution and Elite (Orthofix): Revenue ($m), 2010-2014
Figure 8.4 Trinity Evolution and Elite (Orthofix): Revenue ($m), 2016-2027
Figure 8.5 CARTISTEM (MEDIPOST) Forecast: Revenues ($m) 2016-2027
Figure 9.1 Stem Cell Non-Therapeutic Applications Market Forecast: Revenue
($m), 2016-2027
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Figure 9.2 Stem Cell Non-Therapeutic Applications Market: Drivers and
Restraints, 2016-2027
Figure 10.1 SWOT Analysis of the Stem Cell Technologies and Applications
Market, 2016-2027
Figure 10.2 STEP Analysis of the Stem Cell Technologies and Applications Market
2016-2027
Figure 10.3 World 65+ Population Forecast: Population (m), 2015-2050
Figure 11.1 Stem Cell Technologies and Applications Market Forecast, split by
Therapeutic vs Non-Therapeutic Applications: Revenue ($m), 2016-2027
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Contents
List of Companies and Organizations Mentioned in the Report
Aastrom Biosciences
Advanced Cell Technology
Alder Biopharmaceuticals
Alkems
AllCells
Allergan
AlloSource
American Academy of Neurology
American Academy of Pediatrics (AAP)
American Neurological Associates Annual Meeting
American Society of Blood and Marrow Transplantation.
Americas Committee for Treatment and Research in Multiple Sclerosis
Americord
Amgen
Angiocrine Bioscience
Anterogen
Arteriocyte
Associated Press
Asterias Biotherapeutics
Athersys
Auriga Ventures
Axiogenesis
Baxter Healthcare
BaYi Brain Hospital
BioCardia
BioE
BioEden
Biogenea-Cellgenea
Bioheart, Inc
Biologic Therapies
BioMet Orthopedics
BioTime
BioTime Asia
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Blackstone Medical
Bluebird Bio
BMJ (The British Medical Journal)
Boston Children’s Hospital
BrainStorm Cell Therapeutics
Caladrius Biosciences
California Institute for Regenerative Medicine (CIRM)
Calimmune
Capricor
Cardio3
Caribou
Carolinas Cord Blood Bank (CCBB)
Casey Eye Institute
Cedars-Sinai Heart Institute
Cell Cure Neurosciences
Cell Therapy Catapult
CellCentric
Cellectis
Cellerant Therapeutics
Cellerix
CELLTREE
Cellular Biomedicine Group (CBMG)
Cellular Dynamics International
Center for International Blood and Marrow Transplant Research (CIBMTR)
Centers for Medicare & Medicaid Services
Cephalon
Cesca Therapeutics
Ceylad
Cha General Hospital
China Cord Blood Corporation
China Food and Drug Administration (CFDA)
Chinese Academy of Sciences
Chinese Ministry of Health
Chinese Ministry of Science and Technology
CJ CheilJedang
Clal Biotechnologies Industries
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Cleveland Biolabs
Clinicaltrials.gov
ClinImmune Labs
Cochrane
Cognate BioServices
Committee for Medicinal Products for Human Use (CHMP)
Consortium of Multiple Sclerosis Centers
Cook General BioTechnology
Cord Blood America
Cord Blood Registry Systems
Cordlife Group
CRISPR Therapeutics
Cryo-Cell International
CryoCord
Cryonix CJSC
Cryo-Save
CXR Biosciences
Cytori Therapeutics
Data Safety Monitoring Board (DSMB)
Denali Ventures
Dendreon
Dong-A Pharmaceuticals Co
Drugs and Cell Therapies in Haematology (Journal)
Duke University School of Medicine
Elbit Imaging
Elbit Medical Technologies
Eli Lilly
Elsevier
EMA
EMA Committee for Orphan Medicinal Products
EpiStem
ESI Bio
European Court of Human Rights
European Court of Justice
European Group for Blood and Marrow Transplantation (EBMT)
European Haematology Association
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EuroStemCell
Fate Therapeutics
FDS Pharma
Federal D.C. Court of Appeals
Fondazione Centro San Raffaele
Fondazione Telethon
Forbion Capital Partners
Forticell Bioscience
Gamida Cell
Gemabank
Gene Therapy Advisory Committee
Genetico
Genetrix Group
Geron
Gilead
GlobalStem
Globocan
GSK
Harvard Apparatus Regenerative Technology
Harvard Business School
Harvard Stem Cell Institute
Harvard University
Howard Hughes Medical Institute
Human Fertilisation and Embryology Authority (HFEA)
Human Stem Cells Institute
Human Tissue Authority
ImmunoCellular Therapeutics
Immunovative Therapies
Indian Department of Biotechnology
Insception Biosciences
Intellia Therapeutics
IntelliCell Biosciences
International Society for Stem Cell Research (ISSCR)
International Stem Cell Corporation (ISCO)
International Stemcell Services
IPS Academia Japan
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Isar Medical Centre
Israel Healthcare Venture
Israel Stem Cell Society
Japan Institute of Biomedical Research.
Japan’s Ministry of Economy, Trade and Industry (METI)
Japanese Health Ministry
Japanese Ministry of Labour and Welfare (MHLW)
Japanese Pharmaceuticals and Medical Devices Agency
JCR Pharmaceuticals
JingYuan Bio
Johnson & Johnson
Karolinska Institute
Korean Food and Drug Administration
Korean MFDS (Ministry of Food and Drug Safety)
Lifebank Cryogenics
LifebankUSA
LifeMap Sciences
LifeMap Solutions
LifeSouth Community Blood Centers Inc
Lonza
Massachusetts General Hospital
Maxcyte
Mayo Clinic
McMaster University
MedCell Bioscience
MEDIPOST
Medistem Panama
Medtronic
Mesoblast
Miltenyi Biotec
Musculoskeletal Transplant Foundation (MTF)
National Dental Pulp Laboratory
Nature (journal)
Nature Biotechnology (Journal)
30. www.visiongain.com
Contents
NeoStem
Neuralstem
New England Journal of Medicine
New York Blood Center
New York Blood Center’s Milstein National Cord Blood Program (NCBP)
New York Heart Association
NHS Blood and Transplant Authority
Northwestern University
Novartis
Novartis Research Foundation
NurOwn
Nuvasive
Ocata Therapeutics
OncoCyte
Opexa Therapeutics
Oregon Health and Science University
OrLife Bio
Orthofix
Osiris Therapeutics
Pahrump Valley Times
Pfizer
Pharmicell
Pharmsynthez
Plasticell
Pluristem
Polyphor
Prix Galien
Q Therapeutics
Queen Mary University of London
Quest Biomedical
ReCyte
Regenerative Sciences
Regenerex
31. www.visiongain.com
Contents
Regeneron
Regeneus
Reliance Group
Reliance Life Sciences
ReNeuron
RepliCel Life Sciences
Reprobank
ReproCELL
RIKEN Center for Developmental Biology
Roche
Roslin Cellab
RTI Biologics
RTI Surgical
RUSNANO Corporation
RVC OJSC
SanBio
Sangamo BioSciences
Sanofi
Science (journal)
S-Evans Biosciences
Spinesmith Partners
SSM Cardinal Glennon Children's Medical Center
Stem Cell Bank
Stemcell Technologies
StemCells
StemCore
StemCyte
Stemedica Cell Technologies
StemGen
Stemina Biomarker Discovery
SynBio
TAP Biosystems (Sartorius Stedim Biotech
Tel Aviv University
32. www.visiongain.com
Contents
Teva
The Committee for Advanced Therapies (CAT)
The European Commission
The Lancet
The London Project to Cure Blindness
The Marcus Foundation
The Zon Laboratory
Therapeutic Goods Administration
TiGenix
Tong Yuan Stem Cell
TrakCel
Translational Biosciences
U.S. Stem Cell, Inc
UCL Business PLC
UCL Institute of Ophthalmology
UCLA
UK Care Quality Commission
UK Department of Health
UK Department of Health and the Medical Research Council
UK Home Office
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
UK National Institute for Health Research
UK Regenerative Medicine Platform
uniQure
United Nation’s Department of Economic and Social Affairs
University of California
University of Colorado Anschutz Medical Campus (AMC)
University of Colorado Cord Blood Bank
University of Kyoto
University of Massachusetts
University of Washington
University of Western Ontario
University of Wisconsin Alumni Research Foundation
33. www.visiongain.com
Contents
US Congress
US District Court for the District of Columbia
US FDA
US National Cord Blood Program
US National Institute of Allergy and Infectious Diseases (NIAID)
US National Institute of Health (NIH)
US National Marrow Donor Program
US National Marrow Donor Program (NMDP)
US Patent and Trademark Office
US Supreme Court
Valeant
Vericel Corporation
Vesta Therapeutics
ViaCord
ViaCyte
ViroMed
Vitro Biopharma
WA Optimum Health Care
WHO
Yale University
34. 1.1 www.visiongain.com Page 74
Stem Cell Technologies and Applications Market
2017-2027: Cancer, Cardiovascular, CNS, Other
Disease Areas and Non-Therapeutic Applications
4.3 Market Segmentation
Visiongain divides the stem cell technologies and applications market into five segments:
• Stem cell cancer therapeutics
• Stem cell cardiovascular therapeutics
• Stem cell central nervous system (CNS) therapeutics
• Stem cell therapeutics in other disease areas
• Stem cell non-therapeutic applications.
The estimated revenues and market shares for these segments for 2016 are provided in Table 4.2
and Figure 4.4. As stated earlier, we believe non-therapeutic applications currently represent a
majority of the total market. We estimate that therapeutic applications represent 42.7% of the
market’s total value in 2016 - the oncology therapeutic area alone represents 36.7%. These
revenues derive from the use of stem cells in hematopoietic stem cell transplantation (HSCT), also
called bone marrow transplantation (BMT). HSCT is integral to the treatment of many hematological
cancers, as discussed in Chapter 5.
35.7
26.8
17.2
20.3
US
Europe
Asia-Pacific
Rest of the World
Figure 4.3 Stem Cell Technologies and Applications Market by
Region: Market Shares (%), 2016
Source: visiongain 2017
35. 1.1 www.visiongain.com Page 111
Stem Cell Technologies and Applications Market
2017-2027: Cancer, Cardiovascular, CNS, Other
Disease Areas and Non-Therapeutic Applications
5.5.5 MSC-100-IV (Previously Known as Prochymal) and
Unnamed MPC-Expanded Cord Blood Product (Mesoblast)
Based in Melbourne and founded in 2004, Mesoblast is developing multiple stem cell therapeutic
platforms, which have the potential to deliver a diverse portfolio of products. In October 2013, Osiris
sold its culture-expanded MSC business, including Prochymal, to Mesoblast, in a transaction worth
up to $100m.
Since December 2010, Cephalon (now part of Teva) owns a 20% stake in Mesoblast and is investing
in the development and commercialisation of cardiovascular and CNS stem cell treatments.
Mesoblast also has a strategic alliance with Lonza, a manufacturer of biological drugs, for long-term
commercial manufacture of stem cell products.
5.5.5.1 MSC-100-IV: World’s First Approved Stem Cell Drug Outside
of South Korea
In May 2012, Prochymal (which Mesoblast now refers to as MSC-100-IV, and will be referred to as
such from here on within this report), became the world’s first stem cell drug to gain regulatory
approval outside of South Korea, when Canada awarded the drug a Notice of Compliance with
conditions (i.e., an authorisation conditional on the manufacturer undertaking follow-up studies once
the therapy reached the market, in order to confirm its clinical benefit).
In June 2012, New Zealand’s regulators also approved MSC-100-IV. In both Canada and New
Zealand, the therapy’s label covers acute paediatric GvHD only. Despite these approvals, the
therapy has yet to be launched commercially.
5.5.5.2 MSC-100-IV: Culture Expanded and Able to Treat GvHD
MSC-100-IV is a preparation of human MSCs obtained from the bone marrow of healthy young
adults. These cells are “culture-expanded” (isolated and grown in cell culture) so that one bone
marrow donation is enough to manufacture 10,000 doses. The therapy is being developed for the
treatment of GvHD, and its activity against GvHD is due to the immunomodulatory properties of the
MSCs, which counteracts T-cell mediated inflammatory processes. They do this by down-regulating
the production of pro-inflammatory cytokines, TNF-a and interferon-gamma.
5.5.5.3 An Important Role to Play in the Future of HSCT
As a treatment for acute paediatric GvHD, MSC-100-IV is effectively an adjunct to HSCT; which is
itself an adjunct to myeloablation with chemotherapy or radiotherapy in the treatment of cancer.
However, it is clearly relevant to the oncology sector (since HSCT in children is primarily used in the
36. 1.1 www.visiongain.com Page 227
Stem Cell Technologies and Applications Market
2017-2027: Cancer, Cardiovascular, CNS, Other
Disease Areas and Non-Therapeutic Applications
Figure 9.2 Stem Cell Non-Therapeutic Applications Market:
Drivers and Restraints, 2016-2027
• Increased uptake of cord
blood banking, especially in
developing markets
• Increasing demand for stem
cell-based assays for in
vitro disease modelling
• Greater research focus on
iPSCs in recent years
• Development of new stem
cell therapies
Drivers Restraints
• Cell-based assays in
general are still only a small
component of the
preclinical drug
development market
• Lack of scientific support for
private stem cell banking
• Slow pace of development
of new stem cell therapies
Source: visiongain 2017