Stem Cells - The Hype & Hope

World Analysis 2009-2024

Publication Date	March 2009
Publisher	Visiongain
Product Type	Report
Pages	155
ISBN Number	not applicable
Product Code	VIS00117

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Summary

Stem cell technologies - changes to US regulations to give exciting new hopes and potentially vast commercial opportunities - brand new in-depth analysis

Stem cells represent one of the most promising medical breakthroughs of all time, as our new market report explains. Currently, in 2009, the new US administration is lifting some major restrictions on stem cells technologies. This developmental obstacle now removed, all types of stem cells are available for expanding the therapeutic and commercial potentials, as our new report Stem Cells - The Hype & Hope - World Analysis 2009-2024 explains. Based upon the cells that create and renew all tissues potentially, stem cell therapies could revolutionise the treatment of disease, especially through tissue and organ replacement. Stem cells could provide revolutionary treatments for conditions from diabetes to multiple sclerosis, and from myocardial infarction to chronic obstructive pulmonary disease, amongst many others. Stem cell lines could also change the way pharmaceutical companies assess new chemical entities during R&D.

A conservative estimate places the potential market value of stem cells at over $150bn by late next decade. But will stem cell products be ready to meet regulatory hurdles and market requirements? Where is stem cell research heading today? What stem cell therapies are likely to hit the market from 2009 onwards? Where does the highest value lie in the short-term? What are the commercial threats there? This new visiongain report answers these and other crucial questions about this important developing field, one with vast commercial potential.

Comprehensive analysis of the global stem cells sector and market

Stem Cells - The Hype & Hope - World Analysis 2009-2024 examines stem cells technology critically. We used a comprehensive review of information sources, including consultations with relevant experts. This report provides detailed sales forecasts, discussions of pipeline developments and analyses of important contemporary issues, especially relevant commercial drivers and restraints. This report also covers regulations and ethics. Sources used include commercial databases, industry news, published reports, policy documents and economic research. Importantly, visiongain applied rigorous
financial forecasting, qualitative analyses and the assessment of unmet needs. The result is a comprehensive market- and industry-centred report with detailed analysis and informed opinion that you will not find elsewhere.

Why you should buy this report:

Key information that you will find in Stem Cells - The Hype & Hope - World Analysis 2009-2024 includes:
Analyses of the existing market value for stem cells Analyses of the

potential market value of stem cell therapies, including detailed revenue forecasts from 2009 to 2024 Forecasts for existing stem cell markets, including private cord blood banks and Osiris Therapeutics and NuVasive's Osteocel Discussions of ethical complications and situations that influence the way stem cell medicine is perceived, researched and conducted
Analyses of key organisations, suppliers and relevant national laws Expert opinions from original research interviews with key opinion leaders in stem cells research and technology Informed analyses of the strengths and weaknesses of the technologies from 2009 onwards
Balanced assessments of commercialdrivers and restraints in the stem cells field.

Visiongain believes that stem cell technologies are progressing rapidly. We
predict that more products will enter the market over the coming 5 years,
changing the commercial landscape for stem cells.

Content

1 Executive Summary
1.1 The Focus of This Report: "Stem Cells Therapy" versus "Regenerative
Medicine"
1.2 Crucial Aspects of the Stem Cell Market
1.2.1 Summary Points
1.2.2 Potential Sales Values
1.3 Aims, Scope and Format of This Report
1.3.1 The Speculative Aspects of Assessing the Stem Cell Field
1.3.2 Chapter Outline
1.4 Research Methods

2 Stem Cells: Types and Sources
2.1 Defining Characteristics
2.1.1 Multipotency vs. Pluripotency
2.1.2 Germ Layers and Multipotent Cells
2.2 Embryonic Stem Cells
2.2.1 Abortion Debates, IVF, and Embryonic Stem Cells
2.2.2 Harvesting Human Eggs
2.3 Cybrids: Controversial Animal-Human Hybrids
2.3.1 "Disease in a Dish" Models Using Cybrids
2.3.2 Cybrids and Therapeutic Cloning
2.3.3 Animal or Human?
2.4 Adult Stem Cells
2.4.1 Tissue / Body Part Sources of Adult Stem Cells
2.5 Cord Blood: The "Natural" Source of Embryonic Stem Cells
2.5.1 "Cord-Blood-Derived Embryonic-Like Stem Cells" (CBE)
2.5.2 CBEs: Ethical and Available
2.5.3 Cord Blood Proven to Cure
2.5.4 The Odds of Needing a Blood Stem Cell Transplant
2.5.5 Cord Blood: Private Hope or Public Salvation?
2.5.5.1 Tissue Matching Can be Less Precise with Cord Blood
2.5.5.2 Extra-Familial Tissue Matching
2.5.5.3 Private Cord Blood Banking: Biological Insurance
2.5.5.3.1 Regional Rules on Private Cord Blood Banking
2.5.5.3.2 US Oversight of Cord Blood Stem Cells
2.6 Commercial Potential of Cord Blood Banks: Market Forecast
2.6.1 86% of Banks Established post-2000
2.6.2 Banks' Added Value
2.7 Do Stem Cells Cause Cancer?
2.7.1 Cancer Metastasisation Caused by Rogue Stem Cells?
2.7.2 Potency Re-programming Requires Insertion of Cancerous Gene
2.7.3 Will Stem Cell Treatments Cause Cancer?

3 Established Stem Cell Treatments
3.1 Bone Marrow Transplants: 40+ Years of Success
3.2 Peripheral Blood Stem Cells: Gaining Ground
3.3 Cord Blood Stem Cells
3.4 Graft-Versus-Tumour Effect: Donated Cells Kill Host's Cancer Cells
3.4.1 Allogenic Transplants are Better for Killing Cancer
3.5 Graft-Versus-Host Disease: When Host and Transplant Do Not Mesh
3.5.1 Prochymal: Treatment for GvHD
3.6 Host-Versus-Graft: When Stem Cells are Rejected
3.7 "Saviour-Siblings": Stem Cells from a Sibling, Created or Chosen to be a Saviour
3.7.1 UK Cases and Rules on Saviour Siblings
3.7.2 Regardless of the Ethics, Saviour Sibling Stem Cells Work

4 Emerging Stem Cell Treatments
4.1 Prochymal - Poised to be the First Revolutionary Stem Cell Treatment
4.1.1 Market Value of Prochymal Indications
4.1.2 Crohn's Disease
4.1.3 Chronic Obstructive Pulmonary Disease
4.1.4 Diabetes and Prochymal
4.1.5 Cardiac Indications
4.1.6 Graft-Versus-Host Disease
4.1.7 Prochymal and Acute Radiation Syndrome
4.1.7.1 Proof-of-Concept for Prochymal for ARS
4.2 Osteocel Market Forecast: Osiris's First Marketed Product, Now Sold by NuVasive
4.2.1 Osteocel: The Only Marketed Product with Viable Stem Cells
4.2.2 Osteocel XC
4.3 Other Wound Healing / Surgical Healing
4.4 Heart and Artery Repair
4.5 Autoimmune Diseases
4.5.1 Crohn's Disease
4.5.2 Diabetes Types 1 and 2
4.5.3 Multiple Sclerosis
4.6 Reducing Rejection: Addressing Graft-Versus-Host Disease
4.7 Paralysis Treatments: Geron's GRNOPC1. (The First Embryonic Stem Cell Clinical Trial)
4.7.1 How Much GRNOPC1 Can Geron Make?
4.8 Therapeutic Cloning / Somatic Cell Nuclear Transfer
4.8.1 Organ Transplants: Can Therapeutic Cloning Make Them Obsolete?
4.8.2 Growing Organs
4.8.3 Somatic Cell Nuclear Transfer for Disease Models

5 Leading Stem Cell Therapy Companies
5.1 Osiris: First to Market with Stem Cells
5.1.1 Prochymal and 2008
5.1.2 Osiris and NuVasive
5.1.3 Osteocel Sales Forecast
5.1.4 Osiris and Genzyme Marketing Agreement
5.1.5 Osiris and Boston Scientific: Partnership Ended 2008
5.2 Genzyme
5.3 Geron: First Embryonic Stem Cell Trial
5.4 Novocell: Looking to Follow Geron in Embryonic Stem Cell Trials
5.4.1 Johnson & Johnson and Novocell
5.4.2 Pfizer and Novocell
5.5 Pfizer and Induced Pluripotent Stem Cells (iPS)
5.6 Novartis: The Genomics Institute of the Novartis Research Foundation (GNF)
5.7 MediStem, Inc. (MediStem Laboratories, Inc.)
5.8 Regenetech
5.8.1 Biogenea-CellGenea
5.9 Neuralstem, Inc.
5.10 Advanced Cell Technology (ACT)
5.10.1 ACT and Transition Holdings, Inc.
5.10.2 ACT and CHA Biotech Co., Ltd.
5.10.3 ACT Acquired Mytogen, Inc.
5.11 Garnet BioTherapeutics / Neuronyx
5.12 Pluristem Therapeutics, Inc.
5.13 BrainStorm Cell Therapeutics
5.14 Cellerix: Ontari has EMA Orphan Drug Status
5.15 ReNeuron
5.16 CellCure Neurosciences, Ltd.
5.17 Athersys
5.18 Royan Institute (Tehran)
5.19 Reliance Life Sciences, India
5.20 Cytori Therapeutics

6 Major Stem Cell Suppliers
6.1 StemCell Technologies
6.1.1 Geron and StemCell Technologies
6.2 ES Cell International, Singapore: Aiming for the First Marketed Product Including Embryonic Stem Cells
6.3 Stemride International Limited (SIL) and Reproductive Genetics Institute, Chicago: Normal and Abnormal Cell Lines
6.4 Merck / Calibochem
6.4.1 Stem Cell Sciences and Merck
6.5 Cellular Dynamics International (CDI)
6.5.1 Roche and Cellular Dynamics: Pioneering Toxicity Assays
6.6 HyClone / Thermo Fisher Scientific
6.7 Stemgent
6.8 Stem Cell Innovations (SCI)
6.9 Axiogenesis (Germany)
6.9.1 Roche and Axiogenesis
6.10 StemLifeLine: Embryonic Stem Cells Without Embryo Destruction?

7 Overview of Regional Embryonic Stem Cell Regulations and Funding Bodies
7.1 Pan-Europe: Roche, GlaxoSmithKline and AstraZeneca
7.2 United States
7.2.1 California Stem Cell Research and Cures Initiative (Proposition 71) and The California Institute for Regenerative Medicines
7.2.1.1 Stanford University Received $75 Million for Stem Cell Research
7.2.1.2 UC Irvine Received $27 Million for Stem Cell Research Center
7.3 United Kingdom
7.3.1 The London Regenerative Medicine Network (LRMN)
7.4 Sweden
7.5 Switzerland
7.6 Belgium
7.7 France: Reassessing Embryonic Research in 2009
7.8 Less-Permissive European Countries for Stem Cells
7.8.1 Germany
7.8.2 Norway
7.8.3 Italy
7.9 Canada
7.10 Russia
7.11 Israel: At the Forefront of Research; Reproductive Cloning Ban Up for Reassessment in 2009
7.12 Gulf Countries: Funding Biotechnology, Funding Stem Cell Research
7.13 Singapore: Advanced and Prominent in Stem Cells
7.14 China: Open to the Potential of Stem Cell Technologies
7.15 India: First Stem Cells Facility Due to Open in 2009
7.16 Australia and the Australian Stem Cell Centre
7.17 Japan
7.18 South Korea
7.19 South Africa

8 Visiongain Interviews with Stem Cell Experts
8.1 Dr. Johan Luthman, PhD., Global Head of Exploratory Medicine (Neurology, Autoimmune & Inflammatory Diseases), Merck Serono (a division of Merck KGaA)
8.1.1 On the Difficulties of Translational Medicine
8.1.2 On the Differences Between Technology and Media Perceptions
8.1.3 On Confusion in the Media
8.1.4 On Stem Cells and Neurologic Disorders
8.1.4.1 On Which Neurological Disorders will be Treated First
8.1.4.2 On Multiple Sclerosis
8.1.5 On Why Stem Cell Results Take a Long Time
8.1.6 On When Stem Cell Therapies Will Reach the Market
8.1.7 On the Distinction between Regenerative Medicine and Stem Cell Therapies
8.2 Dr Stephen Minger, Senior Lecturer and Director of King's College London's Stem Cell Biology Laboratory (Wolfson Centre for Age-Related Diseases)
8.2.1 On Whether Adult or Embryonic Stem Cells Should Receive More Funding/Support
8.2.2 On Cord Blood and Embryonic Stem Cells
8.2.3 On the Need for More Immunological Assays
8.2.4 On How Long Until There are Human Stem Cell Therapies
8.2.5 On Cord Blood as a Source of Stem Cells
8.2.6 On Private Cord Blood Banking
8.2.7 On Therapeutic Cloning
8.2.7.1 On Therapeutic Cloning and Tissue Type Cell Lines
8.2.8 On the Promising and Unusual Immunological Properties of Embryonic Stem Cells
8.2.9 On Mesenchymal Stem Cells and Inflammation 8.2.10 On the Suggestive Use of Foreskin Fibroblasts
8.3 Gregory Bonfiglio, Proteus Venture Partners
8.3.1 On the Terms "Stem Cell Therapy" and "Regenerative Medicine"
8.3.2 On "Near Term" Applications
8.3.3 On the Value-Creation Curve for Venture Capital in Stem Cells
8.3.4 On There Being No Known Limits for Stem Cell Possibilities
8.3.5 On Stem Cells in 25 Years
8.3.6 On Funding as a Primary Limitation
8.3.7 On Stem Cells in Multiple Sclerosis and Diabetes Type 1
8.3.8 On Cord Blood
8.3.9 On Extracellular Matrixes
8.3.10 On Disease-Specific Cell Lines
8.3.11 On Adult vs. Embryonic Stem Cells
8.3.12 On Where There is Capital for Stem Cell and Regenerative Medicine Research
8.4 Josephine Quintavalle, Founder of Comment on Reproductive Ethics (CORE)
8.4.1 On Embryonic Stem Cells and Dehumanisation
8.4.2 On HFEA Regulation for Embryo Destruction
8.4.3 On Economics and Scientific Effectiveness
8.4.4 On Cord Blood
8.4.5 On Adult Stem Cell Therapies and the Economics of Therapy
8.4.6 On Public, Private and Private/Public Cord Blood Banks
8.4.7 On International Studies and International Communication

9 Market Value Potentials and Projections
9.1 Visiongain's Stem Cells Market Projection
9.1.1 Complexities of Analysis
9.1.2 Bases for Visiongain's Market Projection
9.2 Forecast by Market Subdivision
9.2.1 Laboratory Supplies
9.2.2 Bone Marrow Transplants
9.2.3 Organs and Tissues

10 SWOT Analysis
10.1 Strengths and Weaknesses
10.1.1 Strength in Numbers
10.1.2 Weakness in Fragmentation
10.1.3 Weakness in Funding Uncertainties
10.2 Opportunities and Threats
10.2.1 Opportunities Abound
10.2.2 The Constant Threat of Politics

11 Conclusions
11.1 The Hope
11.2 The Hype
11.3 The Short-Term Future
11.4 The Long-Term Future

Appendix: Religious Perspectives on (Embryonic) Stem Cells
1 Catholicism
2 Protestantism
3 Judaism
4 Islam
5 Hinduism

List of Tables
Table 2.1 Types of Cellular Potency and Sources of Cells

Table 2.2 Germ Layers and Associated Cells/Organs

Table 2.3 Adult Stem Cell Sources

Table 2.4 Private / Family Cord Blood Banks Sales Forecast, 2009-2024

Table 4.1 Market Value of Selected Prochymal Future Indications, Based Upon Sales Through Q3 2008

Table 4.2 Osteocel Sales Forecast, 2009-2024 (including Osteocel XC)

Table 4.3 Clinical Trials of Stem Cell Studies for Surgical or Injury Healing, Phases I-III, 2009

Table 4.4 Stem Cell Heart Repair Clinical Trials, Phases III-IV, 2009

Table 4.5 Clinical Trials for Autoimmune Diseases (non-Prochymal), Phases I-III, 2009

Table 4.6 Clinical Trials for Graft-Versus-Host Disease, Phase II-III, 2009

Table 4.7 Countries' Donor Systems (Opt-in vs. Opt-out), 2009

Table 5.1 Osteocel Sales Forecast, 2009-2024

Table 9.1 Stem Cells Sales Forecasts, Total Market and by Sub-Market, 2009-2024

Table 10.1 Strengths and Weaknesses in the Stem Cells Market, 2009-2024

Table 10.2 Opportunities and Threats in the Stem Cells Market, 2009-2024

List of Figures
Figure 2.1 Private / Family Cord Blood Banks Sales Forecast, 2009-2024
Figure 4.1 Market Value of Selected Prochymal Future Indications, Based Upon Sales Through Q3 2008

Figure 4.2 Osteocel Sales Forecast, 2009-2024

Figure 5.1 Osteocel Sales Forecast, 2009-2024

Figure 9.1 Stem Cells Total Market Sales Forecast, 2009-2024

Figure 9.2 Stem Cells Sales Forecasts by Sub-Market, 2009-2024