Several top pharmaceutical companies in India are venturing into contract research on a big way as they find it was a potential area for growth in the next few years.
Some of the major pharma companies which have set up their own CROs recently include Wockhardt, Zydus Cadila, Cipla, Sun Pharma, Torrent, Unichem, Alkem, and Intas. Ranbaxy and Nicholas Piramal are already having their CROs namely SRL Ranbaxy and Well Quest.
Most of these CROs have restricted their activities to bioequivalence (BE) and bioavailability (BA) studies. However, a few like Zydus Cadila's CRO, SRL Ranbaxy and Well Quest have extended their work in the area of clinical trials as well.
"Post product patent regime, an Indian company will be at an advantage if it has an independent CRO. Especially, when foreign companies look for alliances, those having facility to conduct BE/BA study will have greater chances to qualify. Besides, a company can use its CRO for its own product launches, which will save a lot of time and cost," said Dr. Dilip Pawar, general manager, Medical Services, Unichem Labs Ltd.
"BE/BA studies in India can be conducted at about one-third costs compared to US or Europe. So, foreign companies could outsource the BE/BA studies to India, considering cost benefits, even if the product is not meant to be marketed in India," said S Krishnakumar, general manager, Business Development, Alkem Labs Ltd.
The current Indian CRO market is estimated at $ 70 to 100 million, which is growing at a rate of 60 per cent annually.
Along with CROs promoted by pharma companies (pharma-CROs), there are independent CROs like Siro Clinpharma, Clininvent Research, Lambda, Synchron, Quintiles, and Covance doing business in the country.
Some analysts believe that the existence of independent CROs like the ones mentioned above could put brakes over the earning potential of CROs floated by pharma companies.
"In some cases pharma companies do not wish to give BE/BA contract to a CRO floated by another pharma company due to competition and confidentiality related factors. They prefer to award the contract to an independent CRO company, which is neutral and not affiliated with any pharma company. In such cases, pharma-CROs tend to be the losers," said a senior official in a leading pharma-CRO.