The Hindu Business Line : Clinical trial market to fall short of billion-dollar projection

Mumbai, Oct. 13 Despite having conducted over 700 clinical trials in the country, it increasingly looks like the Indian clinical trial segment may not get to that often-touted benchmark of $1.5 billion by 2010.

A recent presentation by the Drug Controller-General of India said that the market value for clinical trials outsourced to India was around $300 million, up 65 per cent from 2006, and was expected to be between $1.5 billion and $2 billion by 2010.

But industry stake-holders point out that though the number of clinical trials done in the country are increasing every year, ground realities reflect it is far from reaching the billion-plus mark bandied about by the Government and consultant companies.

Lack of sites

There are not enough investigation sites that do clinical research in the country, and doctors too are not inclined towards research due to lack of awareness or fear of getting into legal tangles, observes Dr Arun Bhatt, President of clinical research organisation (CRO) ClinInvent, a part of The Chatterjee Group.

If the local clinical trial market was indeed progressing towards the billion-plus projection, that means at least three lakh patients should have participated in trails till date, he said. But actual numbers are about 30,000, he added. Similarly, there are about 1,000 sites undertaking such trials, when at least 10,000 sites are needed to touch the projected benchmark, he said.

Research-inclined officials of drug companies and CRO representatives estimate that the clinical trial market in 2010 would stand between $400 million and $600 million.

Infrastructure bottleneck

The Associate Director of PricewaterhouseCoopers, Mr Sujay Shetty, has similar misgivings on the billion-dollar projections for the local clinical trial market. It is not that the local market lacks opportunity, it does not have clinical infrastructure with the required scalability, he observes. Only a small part of global trials are coming to India and the nature of the work is also limited, he said.

Norms governing the segment to ensure standardised procedures are still pending, and they are required to bring more quality players on board, he said.

Echoing the concerns of CRO representatives, he said, there is a shortage of site and site investigators. And despite courses trying to address the shortage of clinicians, he said their “employability” is low, especially in managerial positions.

More clinical research is being channelled into India from big pharma like Pfizer, GlaxoSmithKline, Novartis and Bristol Myers Squibb, but the entire clinical machinery needs to be cranked up further if performance has to match the latent potential of the segment, say industry representatives.

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