While regenerative medicine could dramatically impact healthcare in the mid-to-long term as these novel therapies go through clinical trials, a new breed of regenerative medicine is already practiced in the EU and emerging economies.
In those areas, clinics offering regenerative (mostly cell-based) therapy claim to provide a wide range of medical solutions for chronic conditions such as cardiac disease, Alzheimer and Parkinson diseases, and diabetes. Most of these clinics have created their own home-brew systems for harvesting, culturing, processing, and (re)introducing cells to patients, despite limited clinical data supporting the efficacy or safety of the treatments.
This home-brew segment, which generally operates below the radar of regulatory authorities, demonstrates that there is a significant demand for regenerative medicine—regardless of whether the therapies have been scientifically shown to work.
Scientia’s research indicates that these clinics will see higher levels of regulatory scrutiny over time and will be required to submit clinical evidence of efficacy and safety for their therapeutic approaches.
In May of 2009, the Chinese Ministry of Health placed legal curbs on stem-cell treatments in the country. Its new approval process requires companies to submit clinical data in order to offer service. However, enforcement will likely be an issue, given the number of hospitals and clinics offering these services and China’s large size. In addition, the penalties are relatively light (suspension of medical license and fines), which means current practitioners may have little motivation to discontinue operations.
Still, the popularity of these home-brew therapies and individuals’ willingness to pay for them show significant demand for regenerative medicine on a global basis.
The regenerative medicine field reverberates with potential implications for various stakeholders in the pharma/biotech and medical-device markets. It presents a challenge to the status quo and could well alter current competitive market dynamics.
Many regenerative medicine players are emerging from unexpected fields and have limited background or competence in either pharma or medical devices. This new breed of players is creating new markets and using novel go-to-market approaches and business models.
In order to remain competitive, these companies must view regenerative medicine from a strategic perspective. It is imperative that they prepare for the changes likely to occur over the next 10+ years as many of these therapies hit the market.