1. Report Overview

1.1 Global Stem Cell Technologies and Applications Market Overview

1.2 Why you should Read This Report

1.3 How this Report Delivers

1.4 Key Questions Answered by This Report

1.5 Who is this Report for?

1.6 Research and Analysis Methods

1.7 Frequently Asked Questions (FAQ)

1.8 Some Associated Reports

1.9 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

2.4.1 Post Fertilisation and Germ Layers

2.5 The Main Types of Stem Cells and Their Properties

2.6 iPSCs: The Benefits of ESCs, but Without the Downsides?

2.6.1 CIRM hPSC Repository Launches 300 iPSC Lines

2.7 Parthenogenetic Stem Cells: Scientific Background

2.7.1 Are they Ethical Alternatives to ESCs? What are the Commercial Applications?

2.8 Autologous Versus Allogeneic Stem Cells

2.8.1 Are Universal Stem Cell Products Possible?

2.9 Phases of Clinical Trials

2.10 Scope of this Report

3. International Developments and Stem Cell Regulatory Environments

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 Vaious 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

3.3.3.1 Riken Concludes Investigation

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

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

3.4.4 New changes a requirement for the current research and development in HESC

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

3.6 Israel Regulatory Environment: A Strong Presence in Stem Cell Research

3.7 Indian Regulatory Environment: Emerging Stem Cell Industry – in Need of more Regulation?

4. Stem Cell Technologies and Applications: World Market 2018-2028

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 2017-2028

4.5 Stem Cell Technologies and Applications Market: Forecast by Segment 2017-2028

4.6 How Will Segmental Market Shares Change to 2028?

4.6.1 Which Segments will Grow the Most?

4.7 Stem Cell Technologies and Applications Market: Drivers and Restraints

5. Stem Cell Cancer Therapeutics Segment 2018-2028

5.1 Stem Cell Cancer Therapeutics: Overview and Current Status

5.2 Stem Cell Cancer Therapeutics: Market Forecast 2018-2028

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?

5.3.6.1 Cord Blood Use is Rising in HSCT

5.3.7 Number of HSCT Operations Performed Worldwide, Split by Autologous Versus Allogeneic HSCT, 2015-2017

5.3.7.1 Numbers of HSCT Operations Performed in Europe, Split by Donor Type, 2011-2017

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

5.4.1.1 Hemacord Awarded Prix Galien ‘Best Biotechnology Product’ Award

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

5.4.7 HPC, Cord Blood (BLA 125585)

5.5 Stem Cell Cancer Therapeutics Pipeline

5.5.1 Agenmestencel-T (Apceth)

5.5.2 CLT-008 and CLT-009 (Cellerant Therapeutics): Company Receives $47.5m Grant from US Government

5.5.3 ProHema (Fate Therapeutics)

5.5.3.1 ProTmune

5.5.4 StemEx and NiCord (Gamida Cell)

5.5.4.1 StemEx Shows Improved Survival at 100 Days – but FDA Wants Another Clinical Trial

5.5.4.2 Copper Chelator Based Technology

5.5.4.3 NiCord

5.5.4.4 NiCord: The Company Aiming for a “Paradigm Shift” in Treatment Practice, Receives Orphan Drug Designation

5.5.4.5 NiCord: Gamida Cell Reaches Agreement on Phase 3 Design Outline with the FDA and EMA

5.5.4.6 NAM Technology Platform

5.5.4.7 Novartis Chooses not to buy Gamida Cell

5.5.5 MSC-100-IV (Previously Known as Prochymal) and Unnamed MPC-Expanded Cord Blood Product (Mesoblast)

5.5.5.1 MSC-100-IV: World’s First Approved Stem Cell Drug Outside of South Korea

5.5.5.2 MSC-100-IV: Culture Expanded and Able to Treat GvHD

5.5.5.3 An Important Role to Play in the Future of HSCT

5.5.5.4 Wins Approval in Japan, through Partner JCR Pharmaceuticals, and Phase 3 Trial will Support US BLA

5.5.5.5 MSC-100-IV / Temcell HS Injection Revenue Forecast 2017-2028

5.5.5.6 MPC-Expanded Cord Blood Product in a Phase 3 Trial for Haematological Malignancies

5.5.6 HSC835 (Novartis)

5.5.6.1 Novartis Enters Partnership Agreement with Regenerex to Develop Novel Cell-Based Therapies

5.5.6.2 Collaborations with Intellia Therapeutics and Caribou for CRISPR and HSCs

5.5.6.3 Collaborations with Gamida Cell, Israel

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 2018-2028

6. Stem Cell Cardiovascular Therapeutics Segment 2018-2028

6.1 Stem Cell Cardiovascular Therapeutics: Overview and Current Status

6.2 Stem Cell Cardiovascular Therapeutics: Market Forecast 2017-2028

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

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)

6.6.1.1 One of the First Approved Cardiovascular Stem Cell Treatments in the World

6.6.1.2 Hearticellgram-AMI Sales Estimates 2014-2017

6.6.1.3 Will Have Difficulty Getting Approved in Markets Outside of South Korea

6.6.1.4 Hearticellgram-AMI Revenue Forecast 2018-2028

6.6.2 CardioRel (Reliance Life Sciences)

6.6.2.1 Available on the Indian Market, but Does Data Back it up?

6.6.2.2 CardioRel Revenue Forecast 2018-2028

6.7 Stem Cell Cardiovascular Therapeutics Pipeline

6.7.1 Ixmyelocel-T (Vericel Corporation)

6.7.1.1 Vericel Shifts Focus Away from CLI and Towards DCM

6.7.1.2 Currently it has met Phase 2b endpoint, with a Possible Launch in 2019

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

6.7.4.1 Updates from Athersys Regarding Trial Status: Did MultiStem Fail in Stroke, or was it just Being Assessed in the Wrong Treatment Window?

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

6.7.7.1 MyoCell: Is the Company Still Trying to Secure Funds to Restart the Phase 2/3 MARVEL Trial?

6.7.7.2 MyoCell: MIRROR Trial on Hold

6.7.7.3 MyoCell SDF-1: Improved Version of MyoCell

6.7.7.4 MyoCell SDF-1 Phase 1 Trial (Regen): Another Trial Put on Hold

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

6.7.9.1 C-Cure: Stem Cell Therapy for the Treatment of Heart Failure

6.7.9.2 C-Cure: Two Phase 3 Trials Under Way

6.7.10 Mesoblast: Mesenchymal Precursor Cells for Heart Failure and Myocardial Infarction

6.7.10.1 Rexlemestrocel-L for Congestive Heart Failure (CHF), Chief Executive Provides Update

6.7.10.2 CEP-41750: Promising Phase 2 Results, More Effective in a Particular Subset of Heart Failure Patients?

6.7.10.3 Phase 2 Trial of MPCs in Acute Myocardial Infarction

6.7.11 Caladrius Biosciences: Will not Continue Development of CLBS10, the Company’s Former Lead Candidate

6.7.11.1 CLBS12 for CLI: Due to Start Phase 2 in Japan in January 2016

6.7.12 Stemedica Cell Technologies: ‘Ischaemic-Tolerant’ Stem Cell Platform

6.7.12.1 Trials in Myocardial Infarction and Stroke

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 2017-2028

7. Stem Cell Central Nervous System Therapeutics Segment 2018-2028

7.1 Stem Cell Central Nervous System Therapeutics: Overview and Current Status

7.2 Stem Cell Central Nervous System Therapeutics: Market Forecast 2018-2028

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?

7.4.1.1 Clinical Trials Involving HSCT in MS

7.4.1.2 Barriers to Overcome Before HSCT Could Become an Established Therapy for 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

7.6 Stem Cell Central Nervous System Therapeutics Pipeline

7.6.1 MA09-hRPE (Ocata Therapeutics): Stem Cells for Eye Diseases

7.6.1.1 Orphan Drug Status in both the US and EU

7.6.1.2 Current Clinical Trials in SMD

7.6.1.3 Early Signs of Efficacy

7.6.1.4 Has Moved into Phase 2 in AMD

7.6.2 NurOwn (BrainStorm Cell Therapeutics): Neurotrophic Factor -Releasing Stem Cells for ALS

7.6.2.1 Phase 2 Trial in 48 ALS Patients Underway

7.6.2.2 Phase 2a Results Demonstrate “Statistically Significant Effect”

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

7.6.4.1 NSI-566 in ALS

7.6.4.2 NSI-566 in ALS: Encouraging Data from Completed Phase 2 Trial

7.6.4.3 NSI-566 for Chronic Spinal Cord Injury: Phase 1 Top-Line Data Expected Q4 2015

7.6.4.4 NSI-566 for Ischaemic Stroke: Phase 1/2 Trials Underway in China

7.6.4.5 Preclinical Investigation in 11 Other Indications

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

7.6.7.1 CTX for Stroke

7.6.7.2 CTX for Stroke: Long-Term PISCES Study Shows Promising Results

7.6.7.3 CTX for Stroke: Undergoing Phase 2, Using Highest Cell Dose from PISCES Study

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

7.6.9.1 HuCNS-SC for Pelizaeus-Merzbacher Disease: Undergoing Second Phase 1 Trial

7.6.9.2 HuCNS-SC for NCL: Second Phase 1 Trial Withdrawn

7.6.9.3 HuCNS-SC for Spinal Cord Injury: Phase 2

7.6.9.4 HuCNS-SC for AMD: Top-Line Phase 1/2 Results Released

7.7 Stem Cell Central Nervous System Therapeutics: Drivers and Restraints 2018-2028

8. Stem Cell Therapeutics in Other Disease Areas 2018-2028

8.1 Stem Cell Therapeutics in Other Disease Areas: Overview and Current Status

8.2 Stem Cell Therapeutics in Other Disease Areas: Market Forecast 2017-2028

8.3 Stem Cell Therapeutics in Other Disease Areas: Therapies on the Market

8.3.1 Osteocel Plus (NuVasive)

8.3.1.1 Osteocel to Osteocel Plus: Passing Through Different Companies and Patent Disputes

8.3.1.2 The Leading Stem Cell Orthobiologic

8.3.1.3 Is it Better than Autograft?

8.3.1.4 Osteocel Plus Revenue Forecast 2017-2028

8.3.2 Trinity Evolution and Trinity Elite (Orthofix): Stem Cell Orthobiologics

8.3.2.1 Positive Results from New Trial in Foot and Ankle Procedures

8.3.2.2 Trinity Evolution and Elite Revenue 2010-2014

8.3.2.3 Trinity Evolution and Elite Revenue Forecast 2016-2027

8.3.3 CARTISTEM (MEDIPOST)

8.3.3.1 CARTISTEM: The World’s First Allogeneic Stem Cell Drug

8.3.3.2 CARTISTEM: Latest Updates Includes Results from Phase 3 Trial, Initiation of Phase 1/2 Trial in the US

8.3.3.3 CARTISTEM: Revenues 2013 – H1 2015

8.3.3.4 CARTISTEM Revenue Forecast 2017-2028

8.3.4 Allostem (Allosource)

8.3.5 Map3 (RTI Surgical)

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?

8.4.6.1 Clinical Stage Programmes in 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

8.5.3.1 AST-OPC1 and AST-VAC2 (Asterias Biotherapeutics)

8.5.3.2 OpRegen (Cell Cure Neurosciences)

8.5.3.3 Other BioTime Subsidiaries Related to Stem Cells: OncoCyte, ReCyte, ESI Bio, LifeMap Sciences Etc.

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)

8.5.7.1 NEUROSTEM (MEDIPOST): Undergoing Phase 1/2 Trial and Obtains Patents Around the Globe

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

8.5.9.1 MPC-300-IV in Diabetes

8.5.9.2 MPC-300-IV in Rheumatoid Arthritis

8.5.9.3 MPC-06-ID in Chronic Back Pain, Enters Phase 3

8.5.10 Pluristem Therapeutics: Uses PLX Cells to Secrete Therapeutic Proteins in Damaged Tissues

8.5.10.1 PLX-PAD: Phase 2 for Intermittent Claudication

8.5.10.2 PLX-PAD: Completes Phase 1/2 for Injured Gluteal Muscle

8.5.10.3 PLX-R18: In Preclinical Development for ARS

8.5.11 Regeneus: Adipose Derived MSC Therapies

8.5.11.1 Progenza Undergoing Phase 1 Trial

8.5.12 S-Evans Biosciences: Menstrual Stem Cells

8.5.13 TiGenix: Expanded Adipose-Derived Stem Cell Therapies

8.5.13.1 EASC Technology Platform

8.5.13.2 Cx601: Meets Primary Endpoint in Phase 3 Trial

8.5.13.3 The Road to Approval for Cx601 in Europe and the US

8.5.13.4 Cx611 for Rheumatoid Arthritis and also Severe Sepsis

8.5.13.5 Cx621 – Positive Results from Phase 1 Trial, but Development on Hold

8.5.13.6 ChondroCelect Already on the Market – Although is More of a Cell Therapy Rather than a Stem Cell Therapy

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 2018-2028

9.1 Stem Cell Non-Therapeutic Applications: Overview and Current Status

9.2 Stem Cell Non-Therapeutic Applications: Market Forecast 2017-2028

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

10. Qualitative Analysis of the Stem Cell Technologies and Applications Market 2018-2028

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 Phase 3 Trials only make up a Small Fraction of the Currently Ongoing Clinical Trials

10.3.2 Uncertain Mechanisms of Action in Stem Cell Therapies

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

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 Technological 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 2017-2028

11.4 The Future of the Stem Cell Market

11.5 Concluding Remarks

Appendices

Glossary

Some Associated Reports

Visiongain Report Sales Order Form

About Visiongain

Visiongain report evaluation form

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, 2016 and 2017

Table 3.2 Estimated and expected NIH spending in Stem cell research from 2013-2018(expected) (in million USD)

Table 3.3 New FDA Draft Guidance’s

Table 3.4 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 (%), 2017

Table 4.2 Stem Cell Technologies and Applications Market by Segment: Revenues ($m), Market Shares (%), 2017

Table 4.3 Stem Cell Technologies and Applications Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2016-2022

Table 4.4 Stem Cell Technologies and Applications Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 4.5 Stem Cell Technologies and Applications Market Forecast by Segment: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 4.6 Stem Cell Technologies and Applications Market Forecast by Segment: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 4.7 Stem Cell Technologies and Applications Market by Segment: Revenues ($m), Market Share (%), 2022 and 2028

Table 5.1 Stem Cell Cancer Therapeutics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 5.2 Stem Cell Cancer Therapeutics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2021-2026

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 (%), 2015-2017

Table 5.5 European HSCT Operations: Number of Operations by Donor Type, 2011-2017

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, 2018

Table 5.10 Past and Present ProHema (Fate Therapeutics) Clinical Trials

Table 5.11 MSC-100-IV / Temcell HS Forecast (Mesoblast / JCR Pharmaceuticals): Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 5.12 MSC-100-IV / Temcell HS Forecast (Mesoblast / JCR Pharmaceuticals): Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 5.13 HSC835 (Novartis) Ongoing Clinical Trials, 2017

Table 6.1 Stem Cell Cardiovascular Therapeutics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 6.2 Stem Cell Cardiovascular Therapeutics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 6.3 Global Cardiovascular Disease Market by Drug Class: Revenue ($bn), 2017

Table 6.4 Projected Global Deaths from Ischaemic Heart Disease and Stroke (millions), % of Total Deaths, Deaths per 100,000 Population, 2015 and 2030

Table 6.5 Advantages, disadvantages and different clinical trials that are ongoing

Table 6.6 Hearticellgram-AMI (Pharmicell) Sales Estimates: Revenue ($m), AGR (%), 2014-2017

Table 6.7 Hearticellgram-AMI Forecast (Pharmicell): Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 6.8 Hearticellgram-AMI Forecast (Pharmicell): Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 6.9 CardioRel (Reliance Life Sciences) Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 6.10 CardioRel (Reliance Life Sciences) Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 6.11 Past and Present MultiStem (Athersys) Clinical Trials, 2018

Table 6.12 Ongoing Stemedica Cell Technologies Clinical Trials in Cardiovascular Indications, 2018

Table 7.1 Stem Cell CNS Therapeutics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2018-2022

Table 7.2 Stem Cell CNS Therapeutics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 7.3 Ongoing MA09-hRPE (Ocata Therapeutics) Clinical Trials in SMD, 2018

Table 7.4 Ongoing MA09-hRPE (Ocata Therapeutics) Clinical Trials in AMD, 2015

Table 8.1 Stem Cell Therapeutics in Other Disease Areas Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 8.2 Stem Cell Therapeutics in Other Disease Areas Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 8.3 Osteocel Plus Forecast (NuVasive): Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 8.4 Osteocel Plus Forecast (NuVasive): Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 8.5 Trinity Evolution and Elite (Orthofix): Revenues ($m), AGR (%), CAGR (%), 2010-2014

Table 8.6 Trinity Evolution and Elite (Orthofix) Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 8.7 Trinity Evolution and Elite (Orthofix) Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 8.8 CARTISTEM Revenues: Revenue ($m), AGR (%), 2013-H1 2015

Table 8.9 CARTISTEM (MEDIPOST) Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 8.10 CARTISTEM (MEDIPOST) Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 8.11 Non-Oncologic Diseases which can be Treated with HSCT

Table 8.12 Processes and Mechanisms of Bone Repair

Table 8.13 Anterogen Clinical Trials, 2018

Table 8.14 PDA-002 (Celgene Corporation) Current Clinical Trials

Table 8.15 PNEUMOSTEM (MEDIPOST) Past and Present Clinical Trials

Table 8.16 Translational Biosciences Currently Open Clinical Trials, 2015

Table 8.17 S-Evans Biosciences Clinical Trials, 2015

Table 9.1 Stem Cell Non-Therapeutic Applications Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2017-2022

Table 9.2 Stem Cell Non-Therapeutic Applications Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2023-2028

Table 9.3 Selected US Stem Cell Banks, 2018

Table 9.4 Selected Non-US Stem Cell Banks, 2017

Table 9.5. Prominent Dental Stem cell banks globally

Table 9.6 Selected Stem Cell Supply and Processing Companies

Table 9.7 Selected Companies with Involvement in Stem Cell-Based Assays, 2017

Table 10.1 World 65+ Population Forecast: Population (m), 2015-2050

List of Figures

Figure 1.1 Global Stem Cell Technologies and Applications Market Segmentation Overview, 2018

Figure 2.1 Timeline of Stem Cell Research

Figure 3.1 NIH Embryonic Stem Cell Registry: Stem Cell Lines by Status, 2017

Figure 3.2 NIH Spending for stem cell research by year (in USD billions)

Figure 3.3 CIRM Funding by Disease Area, Percentage (%), 2017

Figure 4.1 Therapeutic Applications of Stem Cells vs Non-Therapeutic Applications: Market Shares (%), 2017

Figure 4.2 Therapeutic Applications of Stem Cells vs Non-Therapeutic Applications: Market Shares (%), 2028

Figure 4.3 Stem Cell Technologies and Applications Market by Region: Market Shares (%), 2017

Figure 4.4 Stem Cell Technologies and Applications Market by Segment: Market Shares (%), 2017

Figure 4.5 Stem Cell Technologies and Applications Market Forecast: Revenues ($m), 2017-2028

Figure 4.6 Stem Cell Technologies and Applications Market Forecast by Segment: Revenue ($m), 2017-2028

Figure 4.7 Stem Cell Technologies and Applications Market Forecast by Segment, 2017-2028

Figure 4.8 Stem Cell Technologies and Applications Market: Market Shares (%) by Segment, 2022

Figure 4.9 Stem Cell Technologies and Applications Market: Market Shares (%) by Segment, 2028

Figure 4.10 Stem Cell Technologies and Applications Market: Drivers and Restraints

Figure 5.1 Stem Cell Cancer Therapeutics Market Forecast: Revenue ($m), 2017-2028

Figure 5.2 Estimated Proportions of Global HSCT Operations by Donor Type, 2017

Figure 5.3 European HSCT Operations by Donor Type, 2011-2017

Figure 5.4. Estimated New Cases of Leukemia, Lymphoma and Myeloma in 2017

Figure 5.5. Estimated new cases of leukemia diagnosed in 2017

Figure 5.6 HSCT-Addressable Cancers: Estimated Combined Incidence in the US, Japan and Western Europe (Number of Cases), 2012-2024

Figure 5.7 Most Common Diseases Treated by Cord Blood from LifeCord: Percentage (%) 2017

Figure 5.8 MSC-100-IV / Temcell HS Forecast (Mesoblast / JCR Pharmaceuticals): Revenue ($m), 2017-2028

Figure 5.9 Stem Cell Cancer Therapeutics Market: Drivers and Restraints

Figure 6.1 Stem Cell Cardiovascular Therapeutics Market Forecast: Revenue ($m), 2016-2028

Figure 6.2 Global Cardiovascular Disease Market by Drug Class: Market Shares (%), 2017

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), 2014-2017

Figure 6.5 Hearticellgram-AMI (Pharmicell) Forecast: Revenue ($m), 2017-2028

Figure 6.6 CardioRel (Reliance Life Sciences) Forecast: Revenue ($m), 2017-2028

Figure 6.7 Stem Cell Cardiovascular Therapeutics Market: Drivers and Restraints, 2016-2027

Figure 7.1 Stem Cell CNS Therapeutics Market Forecast: Revenue ($m), 2017-2028

Figure 7.2 Stem Cell CNS Therapeutics Market: Drivers and Restraints,

Figure 8.1 Stem Cell Therapeutics in Other Disease Areas Market Forecast: Revenues ($m) 2018-2028

Figure 8.2 Osteocel Plus (NuVasive) Forecast: Revenue ($m), 2018-2028

Figure 8.3 Trinity Evolution and Elite (Orthofix): Revenue ($m), 2010-2014

Figure 8.4 Trinity Evolution and Elite (Orthofix): Revenue ($m), 2018-2028

Figure 8.5 CARTISTEM (MEDIPOST) Forecast: Revenues ($m) 2017-2028

Figure 9.1 Stem Cell Non-Therapeutic Applications Market Forecast: Revenue ($m), 2017-2028

Figure 9.2 Stem Cell Non-Therapeutic Applications Market: Drivers and Restraints

Figure 10.1 SWOT Analysis of the Stem Cell Technologies and Applications Market

Figure 10.2 STEP Analysis of the Stem Cell Technologies and Applications Market

Figure 10.3 World 65+ Population Forecast: Population (m), 2015-2050

Figure 12.1 Stem Cell Technologies and Applications Market Forecast, split by Therapeutic vs Non-Therapeutic Applications: Revenue ($m), 2017-2028