Lack of legislation and awareness coupled with quality and ethical issues have deterred the growth of stem cell therapy business in India,where the biotech market is expected to reach USD 8 billion by 2015,according to a report by YES Bank.
Special provisions such as 10-year tax benefits,duty exemptions,fast tracking the approval process by giving it a status of orphan drug (as done in the US) are some measures which could be very helpful to become leaders in this sector,the report ‘Stem Cells–an emerging Bio-sector’ suggested.
“The legislation for this sector still is at the draft stage. A regulatory framework governing the sector,instead of the guidelines existing at present is essential for the proper growth of stem cell research and applications in India.
“There are also no guidelines regarding pricing which results in certain unproven injections being sold for around Rs 80,000,” the report said.
Several companies are taking advantage of the lack of laws governing the stem cell segment and advertise their therapies and clinical trials as ICMR approved.
However,given the multi-tiered system of registration and approvals recommended in the ICMR’s guidelines,some of these are based on fraudulent or exaggerated claims. Further,there are also ethical worries on the side-effects of such treatment,it further said.
In India,there are very few players in the stem cell sector and these are all in very nascent stages and industry consolidation with global players entering into the market through mergers and acquisition route could propel industry growth,it opined.
Developing countries such as India and China are emerging as leading Biotechnology markets in Asia. Indian Biotech market has in fact tripled over the last five years,and is projected to grow at a CAGR of over 20 per cent to achieve a market size of USD 8 billion by 2015. The Stem Cell segment is an emerging sub-segment of the Biotechnology industry,the report added.
Quoting Axis Research Mind,a reputed market forecast organisation,the report also said that the global stem cell therapy market was pegged at USD 21 Billion in 2010 and is expected to cross USD 60 Billion by 2015,tripling in size.