India's CRO industry doubling each year
million (€83 million) and is almost doubling each year, reflecting
the shifting focus of the pharmaceutical outsourcing industry to
Asia.
The findings are published in a recent report analyzing the clinical research industry and 33 leading contract research organizations (CROs) in India, put together by US pharmaceutical consulting firm Proximare.
With current estimates of bringing one new molecule into the market amounting to at least $800 million, pharmaceutical companies looking for effective solutions are turning their attention to outsourcing to low-cost, developing countries rather than persisting with expensive R&D efforts.
One of the biggest and costliest challenges facing the biotech and pharmaceutical companies is clinical trials, due to rapidly rising costs of trials, lack of qualified, scientific human capital, subject recruiting problems and increasing complexities of protocols.
This has led to the growth in clinical research outsourcing and off-shoring to countries like India.
According to the report, India's value proposition in clinical research is compelling for many reasons, including its large patient population, large pool of English-speaking scientific and healthcare personnel, abundance of healthcare facilities and significantly lower costs of conducting trials.
Another added attraction is that India is now improving its previously sub-standard international property laws and research standards to meet international levels.
A previous barrier to outsourcing to India has been that companies are worried about probable loss of control in processes and proprietary knowledge and delays due to regulatory hold-ups.
Recent amendments to Schedule Y of Drugs and Cosmetics Rules of India, 1945, signify a progressive attitude on the part of the Indian Government, clarifying the environment for clinical research in the country.
Executives at large and small pharmaceutical and biotech companies are increasingly becoming intrigued about India and how they can leverage it to launch high quality products in a quicker and more cost-effective manner. Venture capital firms and institutional investors are also now rushing to invest in this arena, said Proximare.
"Companies like Pfizer, Lilly, AstraZeneca, Bausch & Lomb and others are already leveraging the Indian clinical research industry for conducting trials as well as data management. In addition, leading CROs like Quintiles have set up extensive operations in India," said Nailesh Bhatt, managing director of Proximare.Proximare's report can be purchased on the company's >website.
