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Business Models and Value Systems for Regenerative Medicine Therapies: Rationale and Methodology

Tait, J   Bruce, K   Courtenay, A   Gregson, G   Lowrie, H   Mastroeni, M   Mittra, J   Pearson, MA   Robertson, M   Snowden, K

January 2011

Regenerative medicine is one of several developments arising from stem cell research, seen as being capable of revolutionising healthcare and improving human health. The development of tissues (for example heart or liver) differentiated from human embryonic stem cells (HES cells) or induced pluripotent stem cells (iPS cells) is already being used by many pharmaceutical companies for toxicology testing of new drugs, but cell and tissue replacement therapy are expected to deliver the ultimate promise of stem cell biology (McKernan et al., 2010).

PricewaterhouseCoopers (PwC, 2010) have predicted that the first such products will be treatments for wound care, cartilage and bone injury using differentiated stem cells, biomaterials and growth factors (being developed by Apligraf® and ChondroCelect®). The second phase of development will focus on treatments for conditions such as mycocardial infarction and diabetes using iPS cells, involving companies such as Advanced Cell Technology, Bioheart Inc., Cardio3 Biosciences, Cytori Therapeutics Inc. and Gaminda Cell Ltd. The third phase will be treatments for central nervous system diseases using HES cells, for example developed by CellCure, Geron, NeuralStem and International Stem Cell Corporation.

The potential economic impact of RM as a whole is estimated to be between $2 - 5 Billion, and the annual growth of the global stem cell component of this market is forecast to be 29.2%, with sales of $11 billion by 2020 (Regenerative Medicine: Industry Briefing, 2009). Savings in direct health care costs in the USA are projected to be $250 billion per year from chronic diseases such as late-stage Parkinson’s disease, new cases of spinal cord injury, heart failure, stroke, and insulin-dependent diabetes (Mason & Dunnill, 2008).

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