The $42 billion global clinical trials and data management market seems to be accelerating its move to India. As the US participation in clinical trials wanes, there has been a surge in clinical trials and data management work coming to Indian shores. During the past couple of months, many big and medium-sized pharmaceutical and biotech companies such as Pfizer, GlaxoSmithKline, Johnson & Johnson, Sanofi-Aventis, Eli Lilly, Merck, Sharp & Dohme Corp (MSD), Bayer, Biogen Idec and Amgen have transferred a significant chunk of their clinical trials work to India. They are undertaking trials for six therapy areas?oncology, central nervous system, respiratory, endocrinology, cardiovascular and infectious diseases.
There are 475 to 480 trials going on in the country, up from 350 in 2008 and 170 in 2006. India now participates in 7% of global phase III and 3.2% of phase II trials. Industry-sponsored trials make up for 90% of the overall clinical trials market and have grown at a spectacular 39% CAGR between 2004 and 2008. .
The US Food and Drug Administration (USFDA) has deployed dedicated personnel in India so that pharmaceutical companies comply with the FDA regulations. Drug companies like GSK, Wyeth and Amgen have ramped up the staff strength at their India dedicated centres for clinical trials data management work.
Global pharmaceutical companies are also relocating their clinical trials to India as they are keen on tapping the $8 billion domestic pharmaceuticals market. ?Indian CRO industry is dominated by large global and mid-sized CROs and some of the local Indian CROs,? says Pfizer director of medical and regulatory affairs, Chandrashekhar Potkar.
?Action in the clinical trials landscape is hectic and exciting. We have definitely noticed a significant surge in the volume of clinical trials work coming to India,? says Dr Lal Pathlabs chairman, Arvind Lal. Elaborating, he explains that the global financial crisis has severely affected the liquidity of pharmaceutical and biotech companies. ?They have had to look at their business models and evaluate more cost efficient operating models. As a result, the industry has moved into a faster trajectory of outsourcing clinical trials and data management work to India,? he adds.
Not only trials conducted in India meet the same safety and quality standards, they can reduce development time by half. A case in point: Phase III cancer trials are reported to have been conducted three times as fast if both the US and global sites such as those in India are used, compared to the US-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented in a place like India, reveals the Institute of Clinical Research India (ICRI) chairman, Shiv Raman Dugal. ?We can certainly expect the number of registered clinical trials in the country to touch a new high this year,? he stresses.
In 2008, the global pharmaceuticals market has grown at the slowest rate in this decade and is expected to slow down further. The market reached $773 billion at a growth rate of 4.8% in 2008. During the eight year period between 2000 and 2008, while the total R&D spend of pharmaceutical companies has increased from $53 billion to $129 billion, the number of drugs approved has declined. This decreased R&D productivity is due to the increased failure rate in trials and higher cost of developing new drugs due to stricter regulatory requirements. An increasing number of clinical trials projects are being terminated at the phase III stage.
?In such depressed market conditions, pharmaceutical companies are becoming more risk-averse. They are becoming choosey and getting fewer drugs into the clinical trials stage,? says Lal. A Tufts Centre for the Study of Drug Development analysis of 1,572 filings with the USFDA indicates that the share of investigator filings from the US has declined from 86% in 1997 to 57% in 2007.
This shift can be attributed to emerging economies such as Eastern Europe, Korea, Brazil, Russia and India. In terms of industry sponsored sites, India is ranked third among emerging markets after Russia and Poland and is growing fastest in terms of industry sponsored Phase II-III sites, says a recent Ernst & Young study.
Key attractiveness of the Indian market is that it has one of the fastest subject recruitment rates globally?ranging from two to eight times that of global average. This is bolstered by lower screen failure rates and drop-out rates.
For example, there is screen failure rate of 35% in India for a diabetes phase III study compared to over 51% globally.
There are more than 2,500 industry-sponsored phase II-III clinical trial study sites that are carrying out clinical trial activity across the top 15 cities in the country.
The number of phase II-III study sites has grown by 116% over the last 15 months. India ranks second in Asia after Japan in its number of industry-sponsored phase II-III clinical trial study sites and accounts for nearly 20% of all Asian study sites.
?These sites are able to recruit more patients compared to their global counterparts, thereby leading to an overall reduction in timelines owing to the reduced complexity of managing the same quantum of data from fewer sites,? says Muralidharan Nair, partner, health sciences advisory practice, Ernst & Young.
For instance, the number of active patients per site compared across multiple countries for a mid-sized European global pharma company was 10.1 per site in the US and 4.7 per site in UK compared to 16.1 in India. No wonder, almost all of big pharmaceutical companies and an increasing proportion of small biotech companies are conducting trials here.
Indian CROs are providing services to sponsors at 50-60% of the cost incurred through global CROs. Given the innate advantage of higher recruitment speed in India, Indian as well as global CROs are able to reduce enrolment times for trials for sponsors.
In addition, Indian CROs being smaller in scale may occasionally have the advantage of being more nimble compared to their global counterparts. Owing to this, small pharma and biotech companies are beginning to look at outsourcing trials to smaller Indian CROs compared to the larger global providers as they are perceived to have better response times, informs Nair. As the India experience of these companies? increases, there will be more work on the offer for Indian CROs which are hitherto smaller in size.
Global trials enable pharmaceutical companies to bring medicines to market more quickly and cost-effectively. And India is meeting this demand. Healthcare analysts inform that India could participate in 4% of global clinical trials by 2012. However, India?s contribution to the volume of global trials is expected to be higher for phase III trials ranging from 14% to 23%. This certainly is an exciting testing time.
