Indian clinical research organisations (CROs) do not see any near-term impact of recession as large pharma customers such as

AstraZeneca and Glaxo continue to send more work to India, where these trials could be conducted at one-fifth of the US cost.

The $200-million Indian clinical research outsourcing market will reach up to $600 million by 2010, according to a joint study done by research firm KPMG and the Confederation of Indian Industry (CII) in September this year. “Credit restrictions will prompt global biotech companies to see greater favour in outsourcing clinical trials to India,” Partner- Healthsciences Practice, Ernst & Young India, Ajit Mahadevan said.

While the cost of clinical trials vary on the basis of complexity and disease segment, a simple trial in India can cost 15-20% of the US price, while a more sophisticated trial—involving imaging systems—may be 50-60% of the US price. Studies suggest that R&D expenditure is increasing by 15% per year, making global biopharmaceutical companies look for cheaper options. India scores high due to faster enrollments, speed of completion, large and diverse patient pool as well as increasing private healthcare network.

“Biopharmaceutical discovery generally involves a commitment of $350-400 million till the pre-clinical phase, writing it off will not be easy. This will put pressure on companies to continue trials,” said Institute of Clinical Research (India) chairman Shiv Raman Dugal.

With many bio-pharmaceutical companies’ clinical trials already in the pipeline, and with patent expiry dates remaining constant, Indian CROs working for them are somewhat insulated from any slump so far.

Experts such as Dr Vasadeo Ginde, who is the president and managing director of iGate Clinical Research, believe that while work coming from smaller biotech companies might get affected in the long-term, bigger biotech companies will increasingly seek to leverage India’s cost advantages. “Moreover, since they manage their own CROs, impact will be neutral to positive. India currently has about 360 trials underway, including phaseI to phase IV studies,” he added.

Meanwhile, companies such as Biocon’s Clinigene continue to see more trials coming their way.

“It is possible that the slowdown could mean a significant increase in revenues over the next year,” said Biocon CRO unit COO Dr Arvind Atignal.