Stem Cell Therapies and Regenerative Medicine: Current Applications and Future Possibilities
The worldwide market for stem cell, cytokine and growth factor therapies is estimated at $12.7 billion in 2005 and, rising at an average annual growth rate (AAGR) of 10.3%, is expected to reach $20.7 billion in 2010.
Nearly 98% of the market is consumed by blood and immune system treatments, a figure that will shrink slightly to 95% in 2010.
Revenues worldwide for stem cell, cytokine and growth factor therapies for all other bodily systems are expected to rise at an AAGR of 26.4% to just over $1 billion in 2010.
The first off-the-shelf cell therapy approved by the FDA was for wound treatment. Recently, a bone morphogenic protein (BMP) has been approved for the acceleration of spinal fusions.
In March 2002, BCC published its first study focused on stem cells and progenitor cell therapy. Since that time, stem cell and regenerative companies have had a difficult time because of a shortage of funding. However, new companies have sprung up, as new research prompts new avenues of exploration.
The political climate for embryonic stem cells has changed. The Bush Administration maintains a ban in the U.S. on federal funding for research using newly established lines. However, California and Illinois have begun funding this research and others seem likely to follow. The House of Representatives has passed a bill reversing Bush's ban, and the Senate is likely to pass it. Meanwhile, other countries are making embryonic stem cell research a priority. For most of 2005, for instance, it seemed as if South Korean scientists had surpassed the rest of the world in the ability to generate patient-specific embryonic stem cells through nuclear transfer. It now appears that these results were fabricated; respectable peer-reviewed journals were taken in by the hoax because the achievements described were quite feasible, given similar results acheived in animal studies.
Given these many changes taking place in regenerative medicine, it seems a good time to renew our study of this field. This comprehensive and cohesive technical market research report from BCC is set within the existing regulatory framework and takes into account not only technical accomplishments but also political and financial realities. The study, therefore, establishes the necessary context from which to make rational decisions regarding decisions in this expanding field.
SCOPE OF STUDY
The report contains:
- An overview that introduces the various kinds of stem cells, gives definitions, and discusses political, regulatory aspects, and the major developments of 2005 including the retraction of previously published South Korean stem cell research results
- Analysis of applications including current and potential cytokine and cell therapies with forecasts through 2010
- A discussion of current products as well as many that are still in clinical trials
- An industry structure analysis including companies in the field and their focus
- Profiles of individual companies, and includes the names of key officers.
METHODOLOGY AND INFORMATION SOURCES
The information reported herein has been gathered from a variety of industry and other sources. The 10K forms and other SEC filings from public companies have been examined along with annual reports, catalogues, and press releases. The World Wide Web is a rich source of information, as almost every commercial concern now has its own Web page. Where appropriate, medical literature and scientific literature have served as a research source.
We have also gathered statistical information from the U.S. government, the World Health Organization, and private foundations. Armed with the industry and statistical information garnered all of these sources, market participants were interviewed to fill in the gaps.
The author of this report, Steven Edwards, Ph.D., has a broad background in the biological and health sciences, and is well acquainted with advanced technology. He received his doctorate in biology from the University of California, San Diego. His thesis work centered on the expression of murine leukemia virus genes, and he was awarded a National Institutes of Health (NIH) postdoctoral fellowship to study neuroendocrinology at the Salk Institute. Subsequently, Dr. Edwards was a Research Associate at La Jolla Cancer Research Foundation (now Burnham Institute), where he studied developmental regulation of gene transcription in teratocarcinoma cells (cells similar to embryonic stem cells). Later, he was appointed assistant professor in the biochemistry department of Meharry Medical College (Nashville, TN). There he directed a research laboratory studying transcriptional regulation, supported by grants from the American Heart Association and the NIH.
Dr. Edwards is now a medical industry analyst, and science writer and editor. He has been the editor of several BCC newsletters: Applied Genetics News, Drug Discovery/Technology News, Cell Therapy News, and Nano/Bio Convergence News, and is now editor of Biomolecular Diagnostic News. His journalistic work has also appeared in Massachusetts Institute of Technology's (MIT's) Technology Review, Diabetes Forecast, Genetic Engineering News, and other publications. He is a frequent contributor to RedzoneProfits (Website: www.redzoneprofits.com), an Internet-based investment newsletter that focuses on emerging technology companies.
Dr. Edwards was the project analyst responsible for the BCC reports B-119 Cell Therapy and Tissue Engineering, Emerging Products (1998); B-127 Microelectronic Medical Implants, Products, Technology and Opportunity (1999); B-143 Bones and Joints: Drugs, Devices, and Regenerative Technologies (2000); Progenitor and Stem Cell Therapy: Current Uses and Future Possibilities (2002); B-162 Biomedical Applications of Nanoscale Devices (2003); and B-192 Beyond Chemotherapy: Battling Cancer with Biotechnology (2004). He is also the author of The Nanotech Pioneers: Where are they taking us?, a book due to be published by Wiley-VCH Verlag GmbH & Co. in January 2006.
Dr. Edwards has served as vice president for technologies for Phaelixe, Inc., a consulting firm in Denver, CO. He has also consulted for a venture capital company, and has served as program chairman for several nanotech and nanobiotech conferences hosted by BCC. .
Hematopoietic stem cell therapies are still the most widely used and generate the most revenue, as can be seen in the table below. We project this will remain the case through 2007, by which time over $1.3 billion in revenues will be generated by the purchase of products and services in support of these therapies. The average annual growth rate for these products, from 2001 to 2007 is expected to be 29.2%. These revenue projections, like all others in this report, exclude fees charged by physicians for their services and general hospital costs.
Skin, bone, and cartilage are largely derived from mesenchymal stem cells, as are tendons, ligaments, and fat cells (the epidermal layer of skin, however, comes from the ectoderm). Skin replacement to treat ulcers, burns, and surgical wounds was the first "off-the-shelf" living cell therapy to be approved. The progenitor cells for these products are fibroblasts and keratinocytes from newborn human foreskin. Chondrocytes (cartilage producing cells) are used to repair articular cartilage after knee injuries, with additional applications on the way. Combined cell and tissue engineering approaches for repairing bone fractures are being developed. In 2001, we estimate that progenitor cell therapies to replace skin, bone, or cartilage will generate about $43 million in revenues. By 2007, we expect this category to grow ten-fold to $457 million, as indicated above, for an AAGR of 48.1%.