Tissue engineering and cell therapy comprise a market for regenerative products that is expected to grow worldwide from $6.9 billion in 2009 to almost $32 billion by 2018. This market spans many specialties, the biggest of which is therapies for degenerative and traumatic orthopedic and spine applications. Other disorders that will benefit from cell therapies include cardiac and vascular disease, a wide range of neurological disorders, diabetes, inflammatory diseases, and dental decay and/or injury. Key factors expected to influence the market for regenerative medicine are continued political actions, government funding, clinical trials results, industry investments, and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications.
There are key market drivers affecting the relative growth of cell therapy and tissue engineering in specific regions or countries. One historical driver has been the dynamics of stem cell research in the United States. The unavailability of additional stem cells due to President Bush’s Presidential Executive Order in 2001 (since rescinded in 2009 by President Obama) had the affect of decelerating the number of new embryonic stem cell research projects launched, thus postponing the optimistic timeline anticipated by some researchers. This directly delayed the commercialization of products based on embryonic stem cell research, which had the effect of dampening the overall U.S. market. Simultaneously, this also drove increased research and development of the science (if not technologies as well) in areas outside the U.S., especially in the EU. While this distinction between the U.S. and Europe does not account for all the market size and growth differences, it is a distinct, identifiable cause. (The U.S. also has in many respects a more mature — or at least more penetrated cell/tissue market — and the EU is simply catching up.)
Below for comparison is the relative U.S. and European share of the cell therapy and tissue engineering market in 2009 and 2019.
Source: MedMarket Diligence, LLC; Report #S520.