OBJECTIVES: Recent advances in embryonic stem cell based therapies are moving regenerative medicine based products into clinical trials and closer to entering the pharmaceutical arena. As these therapies edge closer to entering the market, it is important that appropriate health technology assessments are in place to deal with these new market entrants. Both autologous and allogenic products are under development, however, this analysis will focus on allogenic products and the challenges they will face. Allogenic products are derived from cells or tissues and likely to be marketed “off the shelf,” similar to conventional biopharmaceutical products. While regulatory pathways for biopharmaceuticals are well established, it is only in the past decade that regulatory development has evolved to secure guidelines and controls for stem cell based therapies, creating evaluation challenges for payers as these agents enter the market. METHODS: Conventional pharmaceuticals are generally assessed using a “value based” approach, in which their value is assessed by evaluating the positive and negative differentiation from established references. As no true direct reference will be available for allogenic products, potential references will be identified to support the “value based” approach and identify market access challenges. RESULTS: Skin replacement therapies are the only commercialized allogenic products to date (e.g. TransCyte and Apligraf), and serve as interesting case studies to evaluate how these types of therapies may be valued. Biologic agents faced a similar dilemma when first launched and demonstrated the importance of identifying appropriate indirect references to support these novel drugs. CONCLUSIONS: In the evolving regulatory and P&R environment, a greater unknown in regenerative based medicine surrounds the process of pricing and market access. Learning from biologics and skin replacement therapies can infer challenges and opportunities for these new therapies.