China continues to outpace India as a spearhead for outsourcing of clinical trials to Asia, a new report suggests.

In April, the Indian Planning Commission claimed there were 139 clinical trials outsourced to India by pharmaceutical multinationals at that time, while only 98 trials had gone to China.

But the new report from PricewaterhouseCoopers (PwC) notes that, as of June 2008, China had 428 trials registered as underway on Clinicaltrials.gov, the website maintained by the US National Institutes of Health (NIH), giving a total of 870 completed or ongoing studies compared with 737 in India.

The data from Clinicaltrials.gov provide only a snapshot of global trends in study placement. While the NIH website represents by far the largest publicly available registry of clinical trials in the world, only federally and privately funded studies of experimental treatments for “serious or life-threatening diseases and conditions” have to be lodged there. Registration of any other trials is voluntary.

Nonetheless, the figures cited by PwC do accord with indications last autumn that China was pulling ahead of India as a preferred location for clinical studies. At that stage, the registry included 287 clinical trials currently ongoing – either recruiting patients or not yet recruiting – in China, compared with 270 studies in India. In terms of clinical trials that had been completed, terminated or withdrawn, 148 were listed for China and 123 for India.

Cost critical

There is little doubt, though, that both territories have been prime beneficiaries of the outsourcing trend in clinical research. Cost has been a critical factor, alongside recent moves to strengthen laws in intellectual property protection, observes the PwC report, The changing dynamics of pharma outsourcing in Asia: are you re-adjusting your sights?.

It also points to the size of the patient pool in these countries. Asia accounts for more than 60% of the world’s population and around one third of this population lives in China and India alone. “The population base for clinical trials is vast and has the advantage of being relatively ‘treatment naïve’,” PwC comments. “Locating clinical trials in lower-cost territories such as China and India can potentially save up to 60% on costs and reduce patient enrolment time by as much as 30%.”

Another important plus in some Asian markets is that many hospitals or doctors are serving large numbers of patients, the report notes. This enables trial sponsors to recruit more quickly from a smaller number of sites. The average number of patients per clinical trial site in India is 50, five times higher than in the US.

These advantages may be offset, though, by regulatory barriers such as significant delays in getting clinical trials off the ground, PwC warns. Delays of up to 12 months are “not uncommon” in China and, despite recent moves to streamline approval processes, nine-month waits are “typical” in India.

Currently Singapore offers the shortest time to approval for new trials – two to three months – in the region. As the report observes, Singapore has been the focal point for the development of Good Clinical Practice in Asia, steering a number of initiatives such as training clinical research personnel and creating a conducive environment for multisite trials. On the downside, Singapore’s population base is very small (albeit ethnically diverse) and generally has access to good medical facilities, meaning there are fewer opportunities for treatment-naïve studies.

Another caveat is that labour costs are starting to converge as national economies take off in Asia, just as rising incomes, urbanisation and changing lifestyles are reducing divergence in East/West disease profiles.

In Singapore, for example, labour costs are already comparable to those in developed Western markets and are significantly higher than in India and China, PwC says. Wage costs in the Indian drug industry are still at 30% of European and 20% of US levels but the country is having problems recruiting in some areas, such as clinical research professionals.

Future growth

According to PwC, the market for contract research organisations (CROs) in India was worth around US$323 million last year and is expected to show a compound annual growth rate (CAGR) of about 49% to 2010. “Government support and funding are being extended to improve the segment’s potential and serviceability,” it adds.

CROs in India “have been successfully adhering to quality standards and the output is similar to that of developed markets”, the report observes. India also has very strong data management and information technology capabilities.

The Chinese CRO market has expanded rapidly over the last few years, with growth rates of 52% and 38% in 2006 and 2007 respectively. Last year the market was estimated at US$186 million. The CRO market in China is expected to generate a CAGR of 33% over the next five years to reach US$791 million in 2012, by which time Chinese CROs will account for 2-3% of the global market for contract research, PwC says.

Almost all of the foreign CROs operating in China are providing clinical trial services and some domestic players have started offering biology and chemistry as well as preclinical and clinical trial capabilities, it points out.