Stem Cells - The Hype & Hope - World Analysis 2009-2024

Table of Contents

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