Market Challenges

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.
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