Clinical trial sector to miss target

Industry unlikely to grow to $1.5 bn by 2010 following manpower crunch.

A decade-old clinical trials industry of the country, which was projected to grow to over $1.5 billion by 2010, is likely to miss the target despite annual growth of over 60 per cent in the last few years, according to industry experts.

Industry experts cite a lack of adequate manpower, a dwindling pipeline of global drug companies, regulatory issues (India is yet to allow the first phase of clinical trials) and emergence of competition from countries such as China as reasons for the industry lagging behind its target.

Clinical research is a systematic study of human beings to generate data for discovering or verifying clinical, pharmacological or adverse effects to determine the safety and efficacy of a new drug. The study is conducted in four phases, involving human volunteers, ranging from 20-80 people in the first phase to 1,000-5,000 in the crucial third phase. The cost of conducting clinical trials for a new drug is approximately $200-250 million and it involves many years of development.

The global clinical trial industry was worth $12.3 billion in 2007 and is projected to grow to $23.1 billion by 2011.

“If India earned about $70-80 million in 2001-02, we could grow only to $140 million by 2006 and $200 million by 2007. The revenue growth is not as expected though the industry is growing phenomenally in India,” said Dr S K Gupta, the dean and director-general of the Institute of Clinical Research (India), recently on the sidelines of a Confederation of Indian Industry-sponsored (CII) conference on clinical trials.

According to a McKinsey projection a few years ago, the Indian clinical trials industry was estimated to grow to about $1.5 billion by 2010. Now, the industry estimates the expenditure on clinical trials to be limited to $300-400 million in India.

Despite India’s large patient population, cost advantages and medical infrastructure, which involves over 230 medical colleges annually producing over 22,000 graduates a year and with over 15,000 hospitals with about 9 lakh hospital beds, not many clinical trials are coming to India.

“The leading ten multinational companies conduct 146 clinical trials in India, whereas China is fast catching up with over 100 trials. This is despite the fact that India figures among countries in the world that provide fast regulatory clearances, which is within 4-12 weeks. On the contrary, in China, it takes 36-44 weeks,” noted Venkat Jasti, chairman and managing director, Suven Life Sciences.

Sources pointed out that wide negative media publicity on erring clinical research organisations may have caused apprehensions in the minds of sponsors.

“Non-compliance with international guidelines on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) had caused some issues with a few CROs (clinical research organisations). Manipulation and misrepresentation of data and deviation from ethics of the industry also causes CROs to lose faith and business,” said Dr Arun Bhatt, president, Clininvent.

At present, India has over 150 CROs conducting about 272 clinical trials and a majority of the trials are in the field of infection, oncology, cardiology and psychiatric diseases.