Clinical Trial market

Clinical Research industry revenue is projected to total $40 billion in 2011, representing approximately one-third of total pharma and biotech R&D spending.

According to clinicaltrials.gov, approximately 53% of clinical trials are performed in the United States, 24% in Europe and 23% in Asia, Latin America, Africa and Australia.

The clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31% during 2010-2012. Presently, the market is characterized by the dominance of phase III and phase II trials, which currently hold more than 80% of the market. This scenario is expected to remain intact in future as well.

Worldwide, the average cost of developing one molecule costs about $282 million and takes about seven years to complete. According to industry estimates, the cost of phase I trial is 50% cheaper in India and for phase II it is 60% less.

Clinical Trials market in India has shown significant growth symptoms in the recent past.
Clinical research experienced over 84% growth during 2006-2008 and it has its own merit in regards to further prospect considering global clinical market is growing at 12%. Clinical research industry in India touched US$258 million in 2008, up from US$140 million in 2006. An estimate shows that clinical research in India is expected to be US$320 million by 2009. The cost of conducting clinical trials in India, for instance, is 20 to 60 per cent of the cost in developed countries. Not surprisingly, about 20 to 30 per cent of the clinical development activity is now outsourced to developing countries such as India. Currently, there are more than 150 CROs in India.

According to industry sources, India has about 500 investigators. India has over 572,000 doctors, 43,322 hospitals and dispensaries and about 8.7 lakh beds including both private and public. Majority of the doctors are graduates with little or no knowledge about clinical trials and hence would not qualify as investigators for complex international clinical trials. The situation requires tremendous efforts to attract the medical professionals/specialists to clinical research. Identifying and attracting potential investigators is the biggest challenge, requiring innovative approaches. The current efforts at training are fragmented. The training focus of sponsors and CROs is on the investigators involved in their trials and their own monitors and other professionals. The enormous challenge of large number of quality professionals in medical and clinical research can only be met by cooperative and collaborative efforts between industry, academia and government. Besides the manpower efforts, the training activity will need financial support. In the US, the industry spends over $300 million on training. The funding has to come from all stakeholders, with majority share coming from the major beneficiary, the pharma industry.

Clinical research is losing its attractiveness in the US due to the shortage of investigators. By 2005, there will not be enough clinical investigators to handle the number of drugs in clinical development. Center Watch estimates that against a 2005 demand for 56,000 investigators, only 48,000 will be available, a shortfall of 15 percent.

Around 25 contract research organizations (CROs) and almost all multinational pharmaceuticals companies have started full-fledged clinical trials in India since last three years. Further, the amendment to Schedule Y of the Drugs and Cosmetics Act in February, now allows MNC s to conduct simultaneous trails in India and abroad

The huge and skilled manpower available in India could revolution the clinical trial field. The implementation of the GATT has opened a new opportunities for India to concentrate on the clinical trial market. In India the infrastructure is available for the smooth conduct of clinical trials. The Indian Pharmaceutical Companies with the available resources can successfully accept the challenge of globalization and can play a major role in the clinical trials.