The rising cost of healthcare has been a cause of concern around the globe. The global economic crisis has seen governments such as the US and Japan attempting to minimise the cost of state-funded healthcare.
The increased prevalence of cardiovascular disorders, metabolic diseases, cancer, etc coupled with the emergence of more virulent forms of existing diseases poses a challenge for current medical therapies.
India is already seen as the world’s low-cost pharmacy as far as conventional therapies are concerned. And the recent economic and epidemiological changes present a lucrative opportunity for the Indian biotech industry to replicate this success in the field of innovative healthcare therapies that include biopharmaceuticals, vaccines, regenerative medicine, etc.
The Indian biotech industry registered a compounded annual growth rate (CAGR) of 20% in the past decade. While biosimilars generic versions of biologic drugs currently make the most significant contribution to the top-line, another promising field is regenerative medicine. This is a novel multi-disciplinary field that relies on cell therapeutics and bio-engineering techniques to enhance the functionality of organs and tissues.
With stem cell products being rolled out in various parts of the world, the global stem cell market is poised to grow at a rate of 30% from 2010 to 2012 and projected to be around $1.2 billion by 2012 and expected to reach around $16 billion in 2017.
However, the stem cell market in India is still underdeveloped. In the next few years, the field of stem cell biology and regenerative medicine is likely to move towards translational research and eventually to clinical practice in India.
According to the GBI Research report, the stem cell market in India is estimated to touch $600 million by 2017. The Indian Council of Medical Research(ICMR), the apex body for the regulation of medical research in India and the Department of Biotechnology (DBT) have until now only approved indications for stem cell therapies in bone marrow transplantation, labelling all other procedures as experimental and it needs to be conducted only in the form of clinical trials.
However, stem cells have been used to restore vision in patients who have suffered corneal damage due to chemical injuries or burns. Therapies involving stem cells are also being offered as treatments for spinal cord injuries, heart ailments and Parkinson’s disease. Worldwide, scientists have even used stem cells to generate cartilage and insulin producing cells in the pancreas.
Stem cell technology seems to have huge health benefits and business potential; but it is essential to develop a framework to tap into this immense potential in a planned manner.
The government has drafted guidelines for stem cell R&D, but a definitive law is yet to be formulated. This has led to expensive procedural delays of 12-18 months that effectively drive investors away to destinations such as Malaysia that have a clear policy and decision within 90 days.
Another problem arising from the lack of regulation is that some companies have been advertising fraudulent claims and selling unapproved treatment options at exorbitant prices.
India represents a growing market for regenerative medicines and stem cell therapies. This further highlights the need to take immediate steps to develop strong regulatory policies so that the country does not miss out on this opportunity to provide cheap and innovative healthcare solutions.
India has the potential to become a leading global player for stem cell products and services. So, the government must act fast in implementing a clear policy for cell therapy.
While the stem cell market is emerging in India, recent approval of clinical trials of stem cell-based products by DCGI has created immense interest among global players and Big Pharmas to collaborate and co-develop stem cell products in India.
The initiative taken by DBT in creating a world-class stem cell research centre in Bangalore is a positive step in nurturing valueadded stem cell research in India. We can leverage availability of rich talent pool in stem cells field.