Key challenge facing this emerging sector include:
- the segmentation of the market
- ambiguities in the regulatory framework
- cautious investor funding
- ethical considerations concerning the using and sourcing of embryos
- tissue traceability and donor confidentiality
- lack of Information about the origins of stem cell therapy
- intellectual property rights and opportunity costs
- technical problems faced in going from a tissue sample to the derivation and characterisation of stem cells through to a final product, coupled to unrealistic expectations and “hype”
- design of clinical studies
- post-market monitoring
- compensation and liability for injury.
