Allogeneic Versus Autologous Stem-Cell Therapy

The author discusses potential manufacturing costs and commercialization challenges of allogeneic and autologous stem-cell therapy.
Jul 01, 2012
Volume 25, Issue 7

Rapid progress is being made in stem-cell research and increasing numbers of therapies are expected to reach the market in the future. Stem cells are undifferentiated cells capable of undergoing self-renewal and differentiation into specific cell types (1). Their function is to replace tissue in response to normal cellular turnover or trauma (1). Harnessing the potential of stem cells can help combat many serious diseases with a high unmet medical need, including cardiac, neurological, and metabolic disorders (2–4). In the future, most cell-based therapies are likely to be:

  • Autologous, with stem-cell expansion, where stem cells are harvested from a patient and culture expanded ex vivo to large quantities over many weeks and then returned to the patient
  • Allogeneic, with stem-cell expansion, where culture expanded stem-cells originating from a single donor provide treatments to large numbers of patients.

The nature of a medical condition may dictate whether autologous or allogeneic therapy is most appropriate. For instance, allogeneic therapy may be the only option when emergency care is required because of the time needed to produce autologous therapy. However, there are many diseases where both autologous and allogeneic therapies are being considered.

Cell-based therapies are likely to be significantly more expensive to produce than small molecule and biological drugs due to the complexity of their manufacturing process. Given that profit is equal to retail price minus costs, whether a stem-cell therapy is commercially successful will be heavily influenced by its manufacturing cost. Understanding how manufacturing costs and processes are likely to differ between allogeneic and autologous therapies will allow an informed decision to be made by companies regarding which therapeutic type to pursue to produce a commercially attractive product. It is also essential to recognize that healthcare payers are evermore scrutinizing the cost effectiveness of treatments when making reimbursement decisions, so simply setting a high product retail price to attain a certain level of profit when faced with high manufacturing costs is not a realistic option. Having detailed data about manufacturing costs will also help companies optimize their manufacturing process to reduce production costs for autologous and allogeneic therapies.

To the author's knowledge, no data exists in the public domain about the cost differential to manufacture allogeneic and autologous therapy. The author sought to address this by determining the cost to manufacture one dose of allogeneic therapy with stem-cell expansion and one dose of autologous therapy with stem-cell expansion. The assumption was made that both allogeneic and autologous therapy had already been approved by regulatory authorities for an unspecified medical condition and shown to be equally safe and effective. The analysis focused purely on manufacturing costs and did not take into account any other costs such as R&D or product marketing. The analysis is timely as, up until recently, stem-cell research was focused almost exclusively on elucidating the science underpinning the discipline. However, companies have now begun to assess how to actually commercialize therapies (5, 6).

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