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Stem Cell Markets

A stem cell is an extraordinary type of cell that has the ability to self-renew for long periods of time and to differentiate into specialized cells under appropriate physiological or experimental conditions. Traditionally, stem cells have been classified as either embryonic, adult (tissue-specific or cord blood) stem cells. Recent understanding of stem cell biology may provide new approaches for the treatment of a number of diseases as well as tissue/organ injuries, including cardiovascular disease, neurological disease, musculoskeletal disease, diabetes and hematopoietic disorders. Stem cell fate is determined by both intrinsic regulators and the extra-cellular environment (niche), and their expansion and differentiation ex vivo are generally controlled by growing them in a specific configuration (monolayer or three-dimensional culture). This process, which is vital to enable stem cells to be used for therapeutic purposes, is called differentiation. Differentiation is a process involving unspecialized cells progressing to become specialized cells with restricted developmental potential.The purpose of this TriMark Publications report is to describe the specific market segments of the medical research space using stem cells for research and development (R&D) purposes. This study reviews all of the generally accepted analytical methods that are currently in use today for preparing and using stem cells. It examines the use of stem cells in developing new therapies for disease.

Table of Contents

• 1.Overview3
  • 1.1Statement of Report3
  • 1.2Scope of the Report4
  • 1.3Methodology4
  • 1.4Executive Summary4
  
  
• 2.Biology of Stem Cells6
  • 2.1Scope of this Chapter6
  • 2.2Basic Properties of Stem Cells and Their Classification6
  • 2.3Differentiation of Stem Cells9
    • 2.3.1Neural and Neuronal Differentiation9
    • 2.3.2Cardiomyogenic Differentiation of ESCs9
    • 2.3.3Differentiation of Mesenchymal Stem/Progenitor Cells10
  • 2.4Self Renewal of Stem Cells10
  • 2.5Dedifferentiation and Nuclear Reprogramming11
  • 2.6Functional Proliferation of Adult Mature Cells12
  • 2.7Nanog Promotes Transfer of Pluripotency after Cell Fusion12
  • 2.8MicroRNAs in Stem Cell Development13
  • 2.9Stem Cell Therapy13
  
  
• 3.Market Analysis of the Stem Cells Space14
  • 3.1Scope of this Chapter14
  • 3.2The Overall Market Opportunity and Segmentation of the Total Stem Cells Marketplace14
  • 3.3Potential Stem Cell Commercial Applications17
    • 3.3.1Cord Blood Stem Cells and Cord Blood Stem Cell Banking: Current Market Environment and Opportunity17
  • 3.4Results of Primary Market Survey to Characterize Qualitative and Quantitative Trends in the Stem Cells Space19
    • 3.4.1Characteristics of the Respondent Pool20
    • 3.4.2Utilization of the Different Classes of Stem Cells22
    • 3.4.3Quantitative Metrics of the Stem Cell Research Marketplace: Number of Experiments Performed, Research23
    • 3.4.4Evolution of Research Activities with the Different Types of Stem Cells: Current Usage Trends and Usage in 12 to 18 Months27
    • 3.4.5Types of Research Activities the End-User Community Performing with the Different Types of Stem Cells29
    • 3.4.6Challenges Facing Stem Cell Researchers32
    • 3.4.7Market Drivers and Research Questions Being Addressed in the Stem Cells Space36
    • 3.4.8Summary of Challenges and Opportunities in the Stem Cells Space Based on TriMark's Analysis37
    • 3.4.9Unmet Product Needs in the Stem Cells Research Space and Licensing/IP Constraints38
  • 3.5Competitive Landscape of the Stem Cells Marketplace40
    • 3.5.1SWOT Analysis of the Major Stem Cell Market Segments46
  • 3.6Market Size and Forecasts49
  
  
• 4.Worldwide Landscape of Stem Cell Research53
  • 4.1Scope of this Chapter53
  • 4.2Global Embryonic Stem Cell Research53
    • 4.2.1Top Research Institutions Worldwide in the Stem Cells Space and Global "Hot Spots" for Research and Therapeutics54
  • 4.3Stem Cell Research in the U.S.56
    • 4.3.1Proposition 71 in the State of California57
  • 4.4Intellectual Property (IP) Landscape Surrounding Stem Cells58
  • 4.5Who Will Finance Stem Cell Research?60
    • 4.5.1U.S. Government Policy on Stem Cell Research61
    • 4.5.2Current Federal Policy63
      • 4.5.2.1Moral Issues Affecting the Policy64
      • 4.5.2.2Significance and Requirement of Federal Funding66
      • 4.5.2.3Implementing the Current Policy68
    • 4.5.3International Law70
      • 4.5.3.1Australia70
      • 4.5.3.2U.K.70
      • 4.5.3.3Canada70
      • 4.5.3.4China70
      • 4.5.3.5Germany71
      • 4.5.3.6Switzerland72
      • 4.5.3.7Japan72
      • 4.5.3.8Israel72
      • 4.5.3.9Singapore72
    • 4.5.4Technological and Economical Disadvantage for U.S.72
    
    
• 5.Therapeutic Areas and Research Programs in the Stem Cells Space74
  • 5.1Scope of this Chapter74
  • 5.2Therapeutic and Other Markets Addressed by Stem Cells74
    • 5.2.1Hematopoietic Stem Cells (HSCs)75
    • 5.2.2Stem Cell Therapeutics for Cardiac and Ischemic Diseases78
    • 5.2.3Stem Cell Therapeutics for Type I Diabetes80
    • 5.2.4Stem Cell Therapeutics for Orthopedic Diseases81
    • 5.2.5Stem Cell Therapeutics for Neurological Disease81
  • 5.3Off-the-Shelf Stem Cells Being Developed82
  
  
• 6.Company Profiles85

Appendix 1.Glossary of Terms in Stem Cell Biology97

INDEX OF FIGURES

Figure 2.1: Derivation of Embryonic Stem Cells (ESCs) from the Inner Cell Mass of Blastocysts7

Figure 2.2: Classification of Stem Cells: Embryonic Stem Cells versus Adult Stem Cells8

Figure 2.3: Somatic Cell Nuclear Transfer (SCNT)11

Figure 3.1: Segmentation of the Stem Cells Marketplace Based Upon Commercial Offerings-Products and Services16

Figure 3.2: Geographical Breakout of Stem Cell End-User Survey Respondents20

Figure 3.3: Affiliation (Pharma, Biotech, Academic/University) of Stem Cell End-user Survey Respondents20

Figure 3.4: Most of the Survey Respondents are Studying Stem Cells or Using Stem Cells in their Research21

Figure 3.5: Length of Time our Survey Respondent Pool has been Studying Stem Cells or Using Stem Cells in their Research Activities21

Figure 3.6: Utilization/Research with Different Stem Cell types22

Figure 3.7: Range of Number of Experiments Involving Stem Cells Conducted Per Week23

Figure 3.8: Differences with Respect to Usage of Stem Cell Types24

Figure 3.9: How Much Research Dollars are Spent Monthly on Research/Studies with Different Stem Cell Types25

Figure 3.10: Growth of Research Spending in Various Segments of the Stem Cells Space (Defined by Stem Cell Type)26

Figure 3.11: Growth in End-User Utilization of the Various Different Stem Cell Types26

Figure 3.12: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells28

Figure 3.13: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months28

Figure 3.14: Broad Classification of Research Activities Being Performed with Stem Cells by Researchers29

Figure 3.15: Current End-User Utilization Category of Adult Stem Cells (ASCs)30

Figure 3.16: Current End-User Utilization Category of Human Embryonic Stem Cells (hESCs)30

Figure 3.17: Current End-User Utilization Category of Human Cord Blood Stem Cells30

Figure 3.18: Current End-User Utilization Category of Animal Stem Cells31

Figure 3.19: Current End-User Utilization Category of Cancer Stem Cells31

Figure 3.20: Challenges in the Study or Utilization of Adult Stem Cells (ASCs)33

Figure 3.21: Challenges in the Study or Utilization of Human Embryonic Stem Cells (hESCs)33

Figure 3.22: Challenges in the Study or Utilization of Human Cord Blood Stem Cells34

Figure 3.23: Challenges in the Study or Utilization of Animal Stem Cells34

Figure 3.24: Challenges in the Study or Utilization of Cancer Stem Cells35

Figure 3.25: Top Unmet Needs in Commercial Products in the Stem Cells Research Space38

Figure 3.26: Stem Cells Research Market, 2006-201151

Figure 4.1: Stem Cell Research Worldwide55

INDEX OF TABLES

Table 2.1: The Different Types of Stem Cells and their Properties8

Table 2.2: Adult Stem Cell (ASC) Differentiation Properties9

Table 3.1: Characteristics of Different Stem Cell Types and Associated Market Opportunity15

Table 3.2: Segmentation of the Stem Cell Market by Type/Lineage of Stem Cell16

Table 3.3: Selected Cord Blood Banks in the U.S.18

Table 3.4: Selected Companies in the Cord Blood Stem Cell Technology and Therapeutics Development Space19

Table 3.5: Breakout of the Stem Cell Research Market: Current Research Efforts with Different Types of Stem Cells27

Table 3.6: Breakout of the Stem Cell Research Market: Research Efforts with Different Types of Stem Cells in 12 to 18 Months27

Table 3.7: Market Shares of Companies/Institutions Offering Different Stem Cells to Researchers41

Table 3.8: Market Shares of Companies/Institutions Offering Reagents for Stem Cell Research42

Table 3.9: The Stem Cells Research Market Forecast, 2006-201150

Table 3.10: The World Market for Stem Cell Products and Services, 2005-201252

Table 4.1: Major Milestones in Stem Cell Research and Associated Timeline, 1981-200654

Table 4.2: Selected Stem Cell Hot Spots Worldwide Administering Non-FDA Approved Stem Cell Therapeutic Regimens56

Table 4.3: NIH Funding of Stem Cell Research in the U.S., 2002-200657

Table 4.4: Snapshot of the Current Key Stem Cell Patents59

Table 4.5: Stem Cell Derivations68

Table 5.1: Estimate of Potential Market Opportunity for Stem Cell-based Therapeutics74

Table 5.2: Autologous Versus Allogeneic Cell Therapy75

Table 5.3: Diseases Treated with HSC Transplantation Today76

Table 5.4: HSC Sources and their Properties77

Table 5.5: Stem Cell Therapeutics for Hematological Diseases in Development78

Table 5.6: Stem Cell-based Therapeutics for Cardiac and Ischemic Diseases in Development79

Table 5.7: Stem Cell-based Therapeutics for Vascular Diseases in Development80

Table 5.8: Stem Cell Therapeutics for Type I Diabetes in Development80

Table 5.9: Stem Cell Therapeutics for Orthopedic Disease in Development81

Table 5.10: Stem Cell Therapeutics for Neurological Disease in Development82

Table 5.11: Segmentation of the Allogeneic Cell Therapy Market84

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