New applications in drug discovery platforms are set to fuel advances in stem cell therapies, but a raft of ethical, clinical and commercial issues will need to be navigated before the market's full potential can be unleashed, according to a new study.
Stem cells offer exciting potential in regenerative medicine and are likely to be widely used by mid-2017, says the study, published by Frost & Sullivan.
Pharmaceutical, biotechnology and medical device companies are all showing increased interest in stem cell research, notes the report, and it forecasts that growth in the market will be driven by stem cell applications in drug discovery platforms and by successful academia/commercial drug company partnership models.
"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," comments Vinod Jyothikumar, consulting analyst at F&S. "Previously, animal cell lines, tumours or genetic transformation have been the traditional platform for testing drug candidates. However, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies," he points out.
Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research, and this will provide impetus to the emergence of novel cell-based therapies, according to the study.
However, it adds, there are key challenges to the market's development relating to reimbursement, ethics and the complexity of clinical trials.
For example, while securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success, stem cell therapies are likely to be expensive, and insurers may therefore be unwilling to pay for them. At the same time, patients are unlikely to be able to afford such treatments.
"The use of embryonic stem cells raises a host of thorny ethical, legal and social issues. As a result, market prices for various products may be affected,” Mr Jyothikumar cautions.
Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues, and these are hindering the overall research process for several companies working in collaboration with these institutes, he notes.
"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies. Possibly low return on investment is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapies,” he warns.
To push through policy or regulatory reforms, the technology platform and geographical location of stem cell companies should complement the terms laid down by the European Medicines Agency (EMA), Mr Jyothikumar advises.
"The methodology for cell expansion and synchronisation must be optimised to acquire a large population of the desired cell at the right differentiation point," he goes on, adding: "more research is needed in human pluripotent and multi-potent stem cell as it differs from mice to humans. Completion of clinical trials will be essential to ensure the safety and efficacy of the stem cell therapy.”