At the moment India only accounts for around 2 per cent of the total number of trials carried out around the world, with around 221 trials conducted in the country in 2007, according to RNCOS’ just-published report entitled Booming Clinical Trials Market in India.
This proportion is expected to reach 5 per cent by 2012, thanks to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings that could trim the cost of trials by 50 to 75 per cent.
The driver is offshoring of clinical research by the research-based drug industry, which is seeing a surge in the cost of drug development. RNCOS estimates the cost of developing a new drug at nearly US$1.2bn in 2008, with nearly half of the cost being spent on clinical trials (Phase I-IV).
As a result, nearly all major pharmaceutical/biotech companies and contract research organisations are establishing a presence in India, and the number of clinical trials in the country is expected to grow several fold in the next five years.
Companies can save a substantial amount in India on both staff and utilities, notes the report. For instance, the salary of a clinical research associate is only 13 per cent of that in the US and around 18 per cent of the equivalent in Western Europe. Similar mid-teen ratios apply when employing biostatisticians, it says, and companies can also save substantially on utilities and land while setting up their operations in India.
However, there are some potential brakes on growth, according to RNCOS.
“To achieve its goal of becoming a global hub of clinical trials, [India] has to overcome challenges like unethical trials, delays in trial approval, inappropriate protection of clinical data, and lack of Good Clinical Practice (GCP) certified sites and investigators,” it said.
The report identifies five key players in India’s clinical research arena, namely Syngene International, Quintiles Research (India), Lambda Therapeutic Research, Vimta Labs and Veeda Clinical Research.