In the nascent, but rapidly growing field of stem cell therapies, products are a long way from being commercialized. However, the market potential for stem cell therapies products is very large. This report aims to identify those technologies and opportunities in the United States with the greatest future opportunities, the opportunities to develop enabling technologies in the field, and the organizations and laboratories performing current research. In addition, a section is included that covers the legislative, political and social issues surrounding stem cell technology and research. These issues are impacting the development of the technology.
This report is a convenient and comprehensive report on stem cells and the technologies being development. Objectives of the report include the following:
- To describe research activities and potential
- To outline problems involved in developing these technologies and the fairly rigorous regulatory challenges that companies will be facing when licensing these new therapies.
- To provide the kind of current information and analysis the reader will need to make strategic business or investment decisions in the area of stem cell technology.
- To provide in-depth information on most companies, organizations, and research facilities involved in the field.
This report is designed to be used primarily by executives, investors, venture capitalists, and business development managers and analysts involved in the pharmaceutical or biotechnology areas that may have an interest in stem cell technology. Companies and organizations seeking to identify partners with complementary technologies may also find this report valuable.
Stem cell research and the accompanying enabling technologies have virtually exploded since embryonic stem cells were first isolated in 1998. Many of the enabling and complementary technologies impacting stem cells are only now catching up to the rate of research. As such, there is a section on companies supplying the research, including those with cell lines, cell and tissue culture media, and reagents.
The report includes detailed profiles and information on:
- 82 companies involved in the development of stem cell therapeutics, worldwide,
- 57 academic organizations involved in stem cell research in the U.S.,
- 19 laboratories outside the U.S. with advanced research in the field,
- 20 detailed profiles on key companies in the industry,
- 32 suppliers to the Stem Cell Industry, of media, sera, and reagents specifically intended for stem cell research,
- 10 organizations on the NIH list as suppliers having embryonic stem cell lines.
- 149 key researchers at academic organizations worldwide, and
- 11 key researchers at commercial organizations.
Because of the early stages of product development, near-term estimates on products currently in development would be pure speculation. The vast majority of products to be discussed have yet to be developed, and we expect any projections made here would be shown to be inaccurate within 5 years.
Scope And Content Of Report
Stem cell research and the accompanying enabling technologies have virtually
exploded since embryonic stem cells were first isolated in 1998. Many of the enabling
and complementary technologies affecting stem cells are only now catching up to the
rate of research. As such, there is a section on companies that supply the research
companies, including those with cell lines, cell and tissue culture media, and reagents.
The report includes detailed profiles and information on the following:
82 companies involved in the development of stem cell therapeutics, worldwide.
19 laboratories outside the United States with advanced research in the field.
20 detailed profiles on key companies in the industry.
32 suppliers to the Stem Cell Industry of media, sera, and reagents specifically
intended for stem cell research.
10 organizations on the National Institutes of Health list as suppliers of
embryonic stem cell lines.
149 key researchers at academic organizations worldwide.
11 key researchers at commercial organizations.
Because product development is in the early stages, near-term estimates on
products currently in development would be pure speculation. The vast majority of
products discussed in this report have yet to be developed, and we expect that any
projections made here will be shown to be inaccurate within 5 years.
The information in this report was taken from primary industry sources;
interviews with company, government, and academic organization officials; and
company submissions such as 10K reports to the Securities and Exchange
Commission, annual reports, biotechnology analyst reports, trade journals, and
medical literature. The author contacted more than 30 companies and individuals
involved in the development of stem cell products. Research began in the spring of
2001 and was completed by the fall of 2001.
New Study Identifies Global Stem Cell Industry Leaders
New York, February 13, 2002 /PR Newswire — A new study released today identifies 13 companies as being in the best position to capitalize on the emerging potential of stem cell technologies. The new study from Kalorama Information and available through MarketResearch.com found several companies from the United States, the United Kingdom, and Australia to be well positioned to succeed.
According to the study, Geron Corporation is currently the dominant organization in the field of stem cell therapy for regenerative medicine. However, the status of that dominance may depend on factors such as commercial rights to develop the cell lines produced for the company, competitive factors, the effectiveness of Geron's technology platform, and other environmental factors.
Kalorama’s analysts based their conclusions about the industry leaders on considerations such as progress in stem cell research and development to date, actual revenue as well as revenue potential, product pipeline, intellectual property, key strategic alliances, quality of management and personnel, key acquisitions and agreements, marketing considerations, and manufacturing and regulatory factors.
“Many of the companies active in the field are also active in other therapeutic areas that can generate revenue while stem cell therapies remain in development,” notes Eric Langer, the author of the study. “Given the long development cycle for stem cell products and the associated costs involved, these are the companies that will be most able to realize commercial success with stem cells.”
The study culminated in an exhaustive 400-page report entitled Opportunities in Stem Cell Technology, reviewing all the strategic challenges for this nascent but highly promising field. Technologies, funding (governmental and private), regulation, ethics, licensing and partnership deals, key support technologies, research facilities, and profiles of all the major competitors are included.
Scope and Content of Report
Chapter One: Introduction
What Exactly Is a Stem Cell?
History of the Technology
Corporate Development of Stem Cell Technologies
When Will There Be Payoff?
Stem Cell Background
- Stem Cell Terminology
- Stem Cell Medical Science
Challenges in Stem Cell Research
- Immune Response
- Can Stem Cells Be Effective in Regenerating Tissues?
Technical Challenges in Stem Cell Research
- Embryonic Stem Cells
- Adult Stem Cells
Comparisons of Embryonic and Adult Stem Cells
- Similarities: Adult and Embryonic Stem Cells
- Differences: Adult and Embryonic Stem Cells
- What Is Known About Human Pluripotent Stem Cells?
Adult Stem Cells
- What Is Known About Adult Stem Cells?
NIH Funding for Stem Cell Research
Chapter Two: Demographics and Disease Modalities
Potential Disease Modalities
Summary of Important Similarities and Differences Between Adult and Embryonic Stem Cells
Actual and Potential Uses of Human Adult Stem Cells
- Potential Uses of Human ES Cells (Plus Certain Nonhematopoietic Uses of Adult Stem Cells)
- Using Human Embryonic Stem Cells for Therapeutic Transplants
- Special Considerations Regarding the Therapeutic Application of Human ES Cells
- Other Potential Uses of Human Embryonic Stem Cells
Chapter Three: Stem Cell Products In Research And Development
The Potential for Stem Cell Products
Areas of Product Development
Neural, Brain, and Spinal Stem Cell Applications
Liver Stem Cell Applications
Pancreas Stem Cell Applications
Cardiac Stem Cell Applications
Renal Stem Cell Applications
Blood Stem Cell Applications
Retinal Stem Cell Applications
Diabetes—Stem Cell Applications
Orthopedics—Stem Cell Applications
Other Stem Cell Applications
Chapter Four: Stem Cell Companies
- Companies Involved in Stem Cell Product Development
- Source and Type of Stem Cells
- Therapeutic Area Targeted by Stem Cell Technology
- Safety Issues and Cellular Therapies
Select Stem Cell Company Profiles
- Aastrom Biosciences, Inc.
- Bioheart, Inc.
- BioTransplant, Inc.
- Cell Based Delivery, Inc.
- Diacrin, Inc.
- Geron Corporation, Inc.
- ImClone Systems Incorporated
- Incara Pharmaceuticals, Inc.
- Islet Technology
- MorphoGen Pharmaceuticals, Inc.
- NeoTherapeutics, Inc.
- NeuralStem Biopharmaceuticals, Ltd.
- Nexell Therapeutics, Inc.
- Osiris Therapeutics, Inc.
- ReNeuron, Inc.
- SELECT Therapeutics, Inc./Cell Science Therapeutics, Inc.
- Stem Cell Pharmaceuticals Inc.
- StemCells, Inc.
- Titan Pharmaceuticals, Inc.
Chapter Five: Academic Organizations In Stem Cell Research Activities
Highlights of Recent Academic Research Activities
Academic and Government Organizations Listed by Area of Activity
Literature Review of Academic and Non-Commercial Organizations Involved with Stem Cells
- Hematopoietic Stem Cell Transplantation: mostly stem cell support institutions that published clinical trials or research involving stem cells (2000-2001)
Chapter Six: Stem Cell Research Suppliers and Enabling Technologies
Stem Cell Supply Research Activity
Effectiveness of Research Products
Challenges to the Supply Industry
Activities of Suppliers in the Field
Media Development Support for Stem Cell Research
Companies on the NIH Stem Cell Registry
- Sixty-Four Stem-Cell Lines Eligible for Funding
Concerns about Competence of Approved Cell Lines
Organization Profiles: Organizations with NIH-Listed Stem Cell Lines
Stem Cell Products Background
- Bone Marrow Stroma
- Mesenchymal Stem Cells
- Stem Cell Factor
- CFU Assays
- Liquid Cell Culture Media
- Isolation of Stem Cells
- Clonogenic Progenitor Assays, In Vitro Tests
Chapter Seven: Legislative, Social, and Political Issues
Concerns Regarding Origins of Stem Cells
- Human Face to the Debates
- Political Rulings
Potential for Irresponsible Research
- Human Cloning
- Scientists Create Human Embryos to Harvest Stem Cells
- Risks Associated with Stem Cells in Clinical Applications
- Risks Associated with Human Cloning
- Private Sector Cloning
Impact of Restrictions on Embryonic Stem Cells
Alternative Sources of Stem Cells
- Sources of Human Embryonic Stem Cells
- Sources of Other Human Stem Cells
- Limitations of Adult Stem Cells
Events in Stem Cell Legislation and Ethics
- Public Opinion on Stem Cell Issues
- Moral Issues—Opposing Views
- Summary of NBAC Review: Ethical Issues Associated with Human Stem Cell
- National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells
- August 2001 Bush Administration Federal Funding Limitations
International Stem Cell Rules and Legislation
- European Group on Ethics in Science and New Technologies
- Country-Specific Legislation and Guidelines
Chapter Eight: Strategic Issues
The Investment Climate
- Funding to Survive Clinical Trials
- Licensing Stem Cell Technologies
- Technology Partnerships
- Stem Cell Licensing Issues
US Regulatory Issues
- Federal Agencies Involved in Stem Cell Regulation
- FDA Regulatory Overview
- Cell and Tissue Regulations
- Implementation of the New Regulations
- Standard Methods
- FDA Market Approvals
- Process for Approval of Drugs and Biologics
- Process for Approval of Medical Devices
- Regulatory Issues Specific to Stem Cell Products
Regulatory Issues in Europe and Japan
- Marketing Outside the United States
- Growing or Culturing Stem Cells
- Patents and Stem Cells
Appendix A: Stem Cells: A Primer
National Institutes of Health
- What is a Stem Cell?
- How are pluripotent stem cells derived?
- Potential Applications of Pluripotent Stem Cells
- Adult Stem Cells
Appendix B: Stem Cell Researchers and Links
Coalition for the Advancement of Medical Research
Appendix C: Stem Cell Glossary
Key Terms in Stem Cell Technology
List of Exhibits
Table 1-1: Timeline of Human Embryonic Stem Cell Research
Table 2-1: Diseases for Which Unrelated Marrow Donor Transplants Have Been Performed
Table 4-1: Companies, Contact Details, and Descriptions
Table 4-2: Cord blood and Therapeutic Stem Cell Services Companies
Table 5-1. Stem Cells Academic/Government Organizations
Table 6-1: Companies and Research Laboratories with Stem Cell Lines
Table 6-2. Select Organizations Providing Cell Lines
Table 6-3. Cell Culture Systems: Media, Sera and Cell Growth Systems for Stem Cell Reagents: Stem Cell Factors/Cytokines, Antibodies, Conjugates, Growth Factors, Kits, Services
Table 7-1: Events in Stem Cell Policy and Ethics
Table 7-2: Results of Poll asking "Do You Support Federal Funding for Stem-Cell Research?"
Table 7-3: Organizations Involved in Bioethics
Table 7-4: Summary of September 1999 NBAC Recommendations on Stem Cell Research
Table B-1: Academic and Government Laboratories Involved in Stem Cell Research Sorted by Organization
Table B-2: Researchers at Commercial Stem Cell Organizations Contributing to 7/01 NIH Report
Table B-3: Stem Cell Web Links