India tipped for 15% share of clinical sector by 2011

By Phil Taylor

- Last updated on GMT

Related tags: Clinical research, Clinical trial

Shifting clinical trial operations from Western markets to India can reap substantial benefits for sponsors in saved costs and time, according to KPMG’s just-published report India Pharma Inc.

And while the operating environment for Indian clinical research organisations (CROs) is very competitive, particularly from other emerging markets such as Eastern Europe and China, the country has the potential to “emerge as the foremost destination for outsourcing of this integral R&D function​.”

The Indian market for clinical research outsourcing was valued at around $200m in 2007, according to KPMG, nearly three times its value in 2001-02. It is predicted to reach a value of $500-$600m by 2010, with a 15 per cent share of the global clinical trials market in the following year.

That growth trend is expected to continue thanks to the fact that India is among the least expensive of all the other emerging markets, roughly on a par with Russia, and can command the highest patient recruitment rates, says KPMG, citing data from this year’s World Economic Forum Annual Meeting.

It’s of particular benefit that a high proportion of India’s patient population has disease association with urban lifestyles, while patient recruitment tends to be very fast, trials are efficient and patient return rates are high compared to Western countries. As with most other emerging markets the country’s patient pool is also generally treatment-naïve.

India also ranks highly in terms of its facilities and pool of clinical investigators, behind Russia but ahead of China, though has a less favourable regulatory environment and less trial experience than Eastern Europe, according to the WEF data. For example, the country current has around 1,000 Good Clinical Practice (GCP) trained investigators, but will need to hike that to 3,000-6,000 by 2010 if it is to meet its growth projections.

The regulatory environment, however, is showing signs of improving. Strengthened intellectual property legislation, plus the revision of the Schedule Y Drugs and Cosmetics Rules in 2005 have all played a part.

For example, prior to 2005 it was not possible to carry out Phase II and II trials in India unless those phases had already been conducted elsewhere. The change was made possible after sweeping changes to the legislation built a framework for trial approvals and set out transparent standards and responsibilities for trial sponsors, investigators and ethics committees.

In July last year, India was the first Asian country to launch a Clinical Trial Registry, and the fact that the US Food and Drug Administration has also started auditing Indian trials “is a sign of this industry maturing in our country​,” commented Dr Ferzaan Engineer, CEO of Quintiles Research (India).

Overall, the cost of conducting clinical trials in the US is around 2.5 times that in India, says KPMG. Around 100 CROs have already set up shop there, with a mixture of multinationals such as Quintiles and Parexel, joint venture partners such as Aptuit and Synergy Research, and home-grown firms.

According to KPMG, Indian CROs “are on the lookout for acquiring attractive foreign targets to build operational capabilities and a global client base​.”

Janmejay R. Vyas, found and managing director of Dishman Pharmaceuticals and Chemicals, is particularly bullish about India’s future potential as an outsourcing superpower, both in clinical research and more generally.

India is the only logical place, because if you look at the entire arena, South America is not respecting IP protection. Western countries are rising in cost. Korea and Japan have good chemistry, but they are already very expensive,” says Vyas.

“ Countries other than India such as Bangladesh, Malaysia, and Thailand have no chemistry and are way behind us. Africa and Middle East countries are not at all in chemistry​,” he continues.

So if I am a western manufacturer where can I go other than India?​”

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