Worldwide sales of cell therapy and tissue engineering products eclipsed $6.9 billion in 2009 on pace to reach $32 billion by 2018. This figure 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, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Specifically, President Obama’s repeal of a Presidential Executive Order 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, stricter regulations 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% (CAGR 2009–2018), as shown below.
The first annual Translational Regenerative Medicine Forum that was held April 6-10, 2010, and sponsored by the Regenerative Medicine Foundation highlighted the future promise and needs in this field encompassing succinctly:
replacement tissues and organs
cell therapies to restore function
Other issues addressed include the perennial discussion of policy, funding and the challenges of stem cells, both for embryonic and pluripotent stem cells.
The specific applications discussed at the forum included:
regeneration of the pancreas' islet cells to restore insulin production for diabetics
application of regenerative medicine to treatment of battlefield injuries
cell applications to degenerative retinal disease
outpatient procedure to regenerate disc tissue
injectable therapy to treat heart tissue after heart attack
Given the thrust of the forum, as a forward-looking event that looked at challenges of the field, the promise of new developments and the needs of regenerative medicine, there is a tendency to underestimate the extent the current successful status of regenerative medicine. (Of course, the forum did include presentations by 18 regenerative medicine technologies seeking potential investment from VC groups like DeNovo Ventures, Excel Venture Management, InterSouth Partners, Livingston Securities, Proteus Ventures, and Quaker BioVentures.) As much as the forum focused on the great potential of regenerative medicine market and the challenges it faces, one might say that the forum could not possibly represent the extent to which regenerative medicine promises have already been realized. Here are some examples:
The global market for cell therapy and tissue engineering technologies is currently $6.9 billion per year, growing at an aggregate 18%.
The global market includes $4.35 billion from orthopedics and musculoskeletal applications, $679 million from skin/integumentary applications, $374 million from dental/oral surgery applications and $468 million from cardiology applications.
There are currently hundreds of active companies in this global market.
The top five major medtech companies account for a total of $4.3 billion in regenerative medicine revenues annually.
Indeed, the discussion of promise in the field of regenerative medicine — from the standpoint of patients treated, clinical problems solved, future market realized and all of the above — remains huge and, to a great and practical extent, very much within reach. By our projections, the advances in approved products, clinical applications and resulting market for regenerative medicine will reach $32 billion annually by 2018.