Opportunities in Stem Cell Research and Commercialization: Technology Advances, Regulatory Impact and Key Players
Business Insights
March 6, 2006 207 Pages - SKU: RET1270913
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Stem cell transplants are routinely used to treat patients with cancers and other disorders of the blood and the immune system and may hold the key to repairing or replacing tissue cells damaged in many devastating diseases. Thus, proven and potential clinical benefit underpins the vast interest in stem cell research. Stem cells have both the capacity to self-renew (by cell division) and differentiate into mature, specialized cells. Differentiation describes a process of development with an increase in the level of organisation or complexity of a cell, accompanied with a more specialized function. During differentiation, certain genes become activated and other genes become inactivated in an intricately regulated fashion. As a result, a differentiated cell develops specific structures and performs certain functions.
Key features:
- Growth forecasts for stem cell market sub-sectors to 2010.
- An examination of proprietary technologies and company strategies shaping the market for adult, embryonic and fetal stem cell products.
- Assessment of the therapeutic potential of human stem cells for tissue repair and regeneration.
- Analysis of global regulatory issues which are dictating where and how embryonic stem cell research is being done.
Key findings:
- The market for stem cell products and services (including cytokines) is forecast to grow almost three-fold from $24.6 billion in 2005 to $68.9 billion in 2010.
- During the years 1980-2005, over 2,000 US patents claiming stem cell technologies and applications relevant to healthcare were published; the annual publication rate accelerated sharply in 2002.
- The majority of adult stem cell R&D is conducted in the US, while most embryonic stem cell research is conducted outside the US due to a restrictive legislative environment.
- In 2005, the first commercial product containing adult stem cells was launched in the US - Osiris Therapeutics Osteocel.
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- Executive Summary
- Introduction to stem cells
- Regulatory and ethical issues
- Technologies and strategies
- Market analysis
- Adult stem cell programs
- Embryonic and fetal stem cell programs
- Patents in stem cell research
- Trends and opportunities
- Chapter 1 Introduction to stem cells
- Summary
- Introduction
- Stem cell types
- Differentiated cell types
- Major milestones in stem cell research
- Characteristics of embryonic and adult stem cells
- Current uses of stem cells
- Potential uses of stem cells
- Chapter 2 Regulatory and ethical issues
- Summary
- Introduction
- Regulation of cell and tissue therapies (USA)
- Ethical issues in embryonic stem cell research
- Global embryonic stem cell policies
- USA
- Europe
- Israel, Russian Federation and Asian nations
- Canada and Australia
- Chapter 3 Technologies and strategies
- Summary
- Introduction
- Culture of adult stem cells
- Isolation and identification of stem cells
- Ex vivo expansion
- Prevention of differentiation in culture
- Preservation and scale-up
- Examples of adult stem cell cultures
- Hematopoietic stem cells
- Mesenchymal stem cells
- Neural stem cells
- Culture of mouse ESCs
- Culture of human ESCs
- Single cell cloning
- Challenges
- Tissue engineering
- Chapter 4 Market analysis
- Summary
- Introduction
- The regulation of cellular therapy
- Human embryonic stem cells (hESCs)
- Human mesenchymal stem cells (MSCs)
- Human hematopoietic stem cells (HSCs)
- Stem cell mobilization
- Stem cell expansion
- Stem cell therapy and tissue engineering products
- Commercial applications
- Bone/cartilage regeneration
- Myocardial and vascular regeneration
- Pancreatic beta-cell regeneration
- Neuronal regeneration
- Skin replacement and wound healing
- Drug screening
- Embryonic and fetal stem cell programs
- Potential markets
- Overview of stem cell market forecasts
- The stem cell market, 2005-2010
- Preliminary observations
- Quantitative forecasts
- Stem cell competitive landscape
- Therapeutic stem cells and research/services
- Cord blood banks
- Cytokines
- Chapter 5 Adult stem cell programs
- Summary
- Introduction
- Hematopoietic stem cell (HSC) transplantation
- Established clinical applications
- HSC mobilization products
- Emerging clinical applications
- Purification of HSCs for transplantation
- Harvesting of HSCs from cord blood
- HSC-based gene therapy
- Ex vivo expansion systems
- Mesenchymal stem cells for GvHD
- In vivo stem cell activation
- Stem cells for tissue repair/regeneration
- Tissue repair products
- Bone/cartilage regeneration
- Myocardial and vascular regeneration
- Beta-cell regeneration
- Neuronal regeneration
- Skin replacement and wound healing
- Other applications
- Novel approaches
- Stem cells for drug testing applications
- Chapter 6 Embryonic and fetal stem cell programs
- Summary
- Introduction
- Human embryonic stem cell (hESC) lines
- hESC lines derived from blastocyst embryos
- Other approaches to derivation of hESC lines
- Somatic cell nuclear transfer
- Fusion technologies
- Single-cell embryo biopsy
- Other approaches
- Harnessing the power of ESCs
- Tissue repair/regeneration
- Initial challenges
- Directed differentiation of ESCs
- Nascent therapies
- Drug screening and discovery
- Miscellaneous applications
- Human fetal stem cell therapies
- Chapter 7 Patents in stem cell research
- Summary
- Introduction
- Patent systems in Europe and the US
- Overview
- Post-issue challenges to patent validity
- Patent litigation
- Patenting of stem cells
- Survey of US stem cell patents
- Methodology
- Patent activity analysis
- Competitive analysis
- Most frequently cited patents
- Most prolific patent assignees
- Chapter 8 Trends and opportunities
- Summary
- Slow beginnings, big promise
- Ensuring a strong proprietary position
- Exploiting accessible sources of adult stem cells
- Regenerative medicine takes shape
- Commercializing stem cells for drug screening
- Embracing embryonic stem cell research
- Chapter 9 Appendix
- Specialist stem cell companies
- Companies with adult stem cell programs
- Companies with fetal and embryonic stem cell programs
- Cord blood banks around the world
- The top 30 stem cell patent citations
- Abbreviations
- Technical Terms
- Regulatory Terms
- Index
- List of Figures
- Figure 1.1: History of stem cell research
- Figure 4.2: Commercial focus of 106 stem cell companies by type of stem cell program
- Figure 4.3: Geographic location of 106 specialized stem cell companies
- Figure 4.4: Ownership status of 106 specialized stem cell companies
- Figure 4.5: Cord blood banks by region
- Figure 7.6: US stem cell patents, filed 1980-2005
- Figure 7.7: Patent activity analysis for types of Stem cells, filed 1980-2005
- Figure 7.8: Top 30 US stem cell patents: types of stem cell and technology areas
- Figure 7.9: Top 30 US stem cell patents: therapy area
- Figure 7.10: Top 30 US stem cell patents by FCN, filed 1980-2005
- List of Tables
- Table 4.1: Potential US patient populations for cell-based therapies, 2005
- Table 4.2: Annual direct expenditures in the US for selected diseases, 2005
- Table 4.3: Stem cell market forecasts by technology and product type, 2005-2010
- Table 4.4: Stem cell market forecasts by region, 2005-2010
- Table 7.5: Top 30 stem cell patents by forward citations (US filings), 1980-2005
- Table 7.6: Top 30 assignees for US stem cell patents (US filings 1980-2005)
- Table 8.7: Specialist companies with proprietary adult stem cells or proprietary technogies
- Table 8.8: Specialist companies developing autologous and allogeneic therapies for tissue
- regeneration/repair
- Table 9.9: 106 specialist stem cell companies
- Table 9.10: 106 specialist stem cell companies (cont.)
- Table 9.11: Commercial exploitation of adult stem cells for blood cancers and other blood diseases
- Table 9.12: Commercial exploitation of adult stem cells for tissue repair/regeneration
- Table 9.13: Commercial exploitation of adult stem cells for tissue repair/regeneration (cont.)
- Table 9.14: Commercial exploitation of adult stem cells: miscellaneous research/services
- Table 9.15: Programs utilizing human fetal stem cells
- Table 9.16: Programs utilizing human embryonic stem cells
- Table 9.17: Programs utilizing animal embryonic stem cells
- Table 9.18: Cord Blood Banks in the US and Canada
- Table 9.19: Cord Blood Banks in Mexico, Central and South America
- Table 9.20: Cord Blood Banks in the UK and rest of Europe
- Table 9.21: Cord Blood Banks in the Middle East, Asia, Africa, Australia and New Zealand
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