With the government moving to tighten up regulations and quell concerns about quality, credibility and reliability, the market for clinical research organisations (CROs) in India is growing at a rate of 11-13% per annum and should cross the US$1 billion mark by 2016, a new report says.

A large, easy-to-access and treatment-naive population, coupled with an already improved regulatory environment and a potential cost advantage of up to 30-50% compared with US norms, are “driving the Indian clinical research organisation market forward”, notes Frost & Sullivan.

The company’s Strategic Analysis of the Clinical Research Organization Market in India puts earned revenues from the Indian market at US$485 million in 2010-11. By 2016 those revenues will be worth more than US$1.0 billion, Frost & Sullivan predicts.

Variety, credibility

The variety of therapeutic areas served by clinical research in India should help to draw in more studies, as should emerging categories such as diagnostics research, the report suggests.

At the same time, better regulations backed up by stringent enforcement laws should bring more credibility to the sector, it says.

The report does, however, cite quality concerns and lack of quality infrastructure in smaller, second-tier trials among the factors that impede the growth of India’s CRO market.

“Reliability and consumer confidence in Indian clinical trials data is lacking, greatly impacting the CRO market,” Frost & Sullivan comments.

“This is the result of a number of small-scale CROs having compromised on the standard of their studies in their bid to compete.”

Single-window clearance

As more established CROs continue to develop, building up reliable data and a stable clientele, the impact of these restraints should diminish, the report says.

“Developing a single-window clearance for clinical trials as well as clear guidelines on the types of international/global trials that can be performed on the Indian population will shore up CRO market growth,” Frost & Sullivan believes.