The global market for tissue engineering and cell therapy products is set to more than quadruple from 2009 to 2018. Products in cell therapy and tissue engineering include includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies.
The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.
Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, fluctuating industry investment and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. The reversal of the U.S. government's ban on federal funding for embryonic stem cell research has given researchers sponsored with federal funding increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.
Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.
Meanwhile, tighter regulatory environments in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a healthy 20%.
Meanwhile, growth rates in Europe and other areas outside the United States and Asia/Pacific (rest of world or ROW) are expected to be roughly to growth of the market in Asia. This reflects the fact that European and developing market regulatory requirements allow products to be commercialized more rapidly in those regions. While the rate of growth in the United States for this time period is expected to be slower, this is only due to its larger size and its position ahead of other markets on the classic market growth curve. Nonetheless, some in Europe worry that research in the United States will accelerate at a more rapid pace now that U.S. researchers have access to additional lines of stem cells. The fear is that this will allow development in regenerative medicine technologies to threaten an eclipse of the gains made in Europe in the past several years.
See Report #S520.