Monday, February 23, 2009

6 insights on clinical R&D in India

We at STINSON Brand Innovation continue to view India as an emerging strategic market – including as a location for pharmaceutical and biotech clinical research and development. Working closely with our partner agency BrandCare in Mumbai, we’re staying up to date on relevant developments there.

In our fact-finding, we’ve gathered these six insights from Max Neeman International, a leading Contract Research Organization based out of India. This CRO provides full range of clinical research services to global pharmaceutical, biotech and devices companies.

1. Emerging markets shine as mature markets stagnate

During 2007, the Asia-Pacific markets grew collectively by 13.3% (excluding Japan) and now represent 11% of the total global market, which during the same period grew 6.4% to reach $712bn.

The removal of service tax for CROs and customs duty on all imported drugs used in clinical trials has and will continue to help give the India based CRO industry a boost and compete even better on a cost basis, to other emerging countries.

"Robust economic growth and expansion of access to healthcare remains the primary driver of these markets," said the market intelligence firm report.

2. India tapped for 15% share of clinical sector by 2011

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% 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.

3. India winning race with China for Asia's top clinical spot

At present India appears to be beating China in the race for Asia's top clinical spot, according to new figures published by India's Planning Commission.

As it continues to attract new business from large pharma players, the market value of India's clinical research organization (CRO) industry is blossoming - currently estimated at $300m and projected to rocket to $1.5b-$2bn by 2010.

"India has a vibrant pharmaceutical market and with patient protection in place since 2005", and this effectively means that companies can introduce drugs in India at the same time as other countries, said chairman of India's Institute of Clinical Research, S. R. Dugal, adding that compared with China, India "strictly follows" ethical guidelines.

4. Asian CROs poised for substantial growth in specific therapeutic areas

Over the next two years, urology and musculoskeletal/arthritis are expected to be the most outsourced researched areas.

While cardiovascular, central nervous system (CNS) and metabolic diseases are the research areas that are currently the most outsourced, oncology is likely to show an increase in outsourcing in the next two years, predicted Research and Markets.

5. Phase I outsourcing to India by 2010?

The outsourcing of Phase I trials to India may be allowed by 2009-10 after the Central Drugs Standard Control Organization (CDSCO) said it is considering changing its stance.

Currently Phase I trials are only allowed if the compound was discovered in India or if data from other markets is submitted, which has restricted the outsourcing of early stage research in India.

The CDSCO's proposals would overturn this and also allow foreign companies to conduct Phase 0 and 1 trials in India.

6. Growth continues for Indian CMOs

India's contract manufacturing market is expected to rocket forward over the next couple of years to reach a value of $2.46bn in 2010, according to a just-released report from KPMG.

That represents an annual growth rate of more than 40 percent, according to the figures, which come from Cygnus Industry InSight.

With 75 facilities inspected by the US FDA, the highest number of any country outside the US, the country now accounts for 46% of all the drug master files (DMF's) submitted to the agency.

Here are some highlights of Max Neeman capabilities:

- Its MD and PhD trained teams maintain the expertise to assist the pharmaceutical, biotech and device industries in conducting complex clinical trials
- Able to serve the needs of 'Top 10' pharmaceutical firms, as well as small to midsize biotechnology and device companies.
- Based out of 5 regional offices, with access to hospitals and health care facilities across India.
- Operational since 2001, awarded 126 trials for global sponsors across wide range of therapeutic areas.
- Received ISO 9001:2000 certification by United Kingdom Accreditation Service (UKAS) for Site Management, Monitoring and Data Management.
- Active in 102 sites in 22 cities with access to 800 ICH-GCP trained Investigators.
- Maintains a patient retention rate between 98.1 to 98.4% across different therapeutic areas.
- Successfully completed 4 US FDA GCP Audits for highest enrollment globally.

To learn more about its experience in clinical research. visit

And for brand strategies to enter the dynamic market of India, contact me at

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