Todd McAllister, Ph.D., CEO of Cytograft Tissue Engineering, notes that the annual sales figure in excess of $1.3 billion cited by Dr. Lysaght et al. in the 2008 report for the aggregate field comprising TE, regenerative medicine, and stem cell therapeutics was largely dominated by Medtronic’s product Infuse® Bone Graft, comprised of recombinant human bone morphogenetic protein (rhBMP-2).
In the breakdown of the $1.3 billion sales total, the authors reported the following: “Three areas predominate: sales of Medtronic’s Infuse Bone Graft products are approaching $700 million, the aggregate volume of private sector cord banking of adult stem cells now exceeds $270 million, and sales of biomaterials with a propensity for tissue regeneration, including small intestine submucosa (SIS), now exceeds $240 million.”
While some definitions of the TE and stem cells industry have expanded to include recombinant proteins, extracellular matrices, and other types of products such as SIS, in Dr. McAllister’s view, these entities—while used for regenerative medicine applications—are not technically tissue engineering products and are certainly not cell-based therapeutics that have been grown in a laboratory in tissue culture processes.
The more focused definition of the field he prefers would exclude a number of commercial products, greatly reduce revenue figures, and dramatically diminish both Dr. Lysaght’s and now Dr. Langer’s numbers.
Despite this cautionary perspective, even if one defines the field more narrowly as cell-based therapeutics, “there is no question that sales are ramping up,” there are likely many more companies in existence at present than there were four years ago, and “there is significant growth and cause for celebration,” says Dr. McAllister.
“Recently we have seen a strong increase in the number of clinical trials with cell-based therapies,” he adds, noting that a search of the ongoing clinical trials would likely yield more than 1,000 unique clinical studies of cell-based therapies.
“To me, clinical success will drive commercial success, as you have to make a product that works first; and numbers of products in clinical testing will drive clinical success. The dramatic increase in the number of cell-based therapies being used in the clinic I think is the single most critical indicator of success of the field and of the impending commercial success,” he says.
Viable Business Models
Other signs of strong growth described in the 2012 report were the 7,710 jobs created by the industry during the four-year study period—a 2.3-fold increase compared to the 2008 industry analysis—and the rise in total number of companies from 171 to 202, at all stages, “indicating that the field is not only progressing but also sustaining itself,” stated the authors.
“It took the field 18–20 years or more to get its footing with regard to the complexities of product design and development, regulatory throughput, and distribution, clinical acceptance, and reimbursement,” says Peter Johnson, M.D., co-editor in chief of Tissue Engineering, president and CEO, Scintellix, and vp R&D, Avery Dennison Medical Solutions.
All of those issues “appear to have been surmounted by more than one company with more than one type of product, and that suggests to me that we have at least the beginning of an understanding and acceptance by the FDA on the clinical side and the business savvy, and that business models are now beginning to align with the realities of these types of products.”
Tempering his optimism with the recognition that the industry is still in the early stages, Dr. Johnson states that “the signs point toward a day when we will begin to understand the immunology and cell sourcing so much better that common manufacturing techniques can be used that are accepted by the FDA.”
The industry will then be a step closer to realizing the fundamental value of the potential for tissue-engineered, cell-based products to integrate with the body and yield long-term cures with a single treatment.
“From a business perspective we are absolutely seeing that people can make and sell efficacious products and sell them at a profit. It is a viable business model,” says Dr. McAllister. “In 2008, when the last paper was published, I would argue that you couldn’t have said that for a cell-based therapy.”
What could dramatically accelerate the pace of industry growth or derail its current trajectory in Dr. Langer’s view? A “huge new success” such as a product to regenerate heart muscle, cartilage, or bone, could result in large amounts of new funding and resources being pumped into the industry, or a major discovery on a par with the development of induced pluripotent (iPS) stem cells, for example.
In contrast, a significant negative outcome, whether due to the unexpected behavior of certain cells, less than careful work, or an insurmountable technical hurdle could slow growth and development.