- BioServices segment clocked sales of 3,245.97 crore registering
a growth of 23 percent for FY 2010-11
- MNCs continue to dominate the market
- Total number of clinical trials stood at 1,584 in 2011
- Indian CROs aggressively looking at expansion to South East Asian
- Sector to grow at 20-30 percent over the next three years
The bioServices sector clocked total revenues of
3,245.97 crore in
2010-11, registering a growth of 23 percent over last year’s (2009-10)
total segment revenue of
2,639 crore. This constitutes about 19
percent of the total biotech industry revenue for the fiscal.
Compared to the previous two fiscals, where the CRO industry was hard
hit by the global downturn in particular, fiscal 2010-11 saw some
positive developments in this segment. Companies as well as the Indian
government (the DCGI in particular) authorities were proactive in
creating a favorable environment for clinical trials. Consolidation in
the global landscape, in the form of mergers and acquisitions, had its
cascade effect on the Indian CRO industry. However, in spite of the
fall in the number of global clinical trials, the clinical research
sector witnessed a growth of 23 percent over last year as the country
saw a rise in the number of local clinical trials.
A good number of global companies are now looking at India to conduct
large scale global trials. While low costs and large patient pool still
remain the crucial deciding factors for attracting these companies,
skilled investigators and emphasis on quality are some of the rising
factors contributing to the segment’s growth. Above all, India is
gradually emerging as a drug discovery destination rather than a mere
drug development destination, as more companies are looking at
innovative and novel products. In terms of key therapeutic areas, the
CROs are focusing on oncology, neurology, respiratory, diabetes,
anti-infective, psychiatry, endocrinology, central nervous system,
cardiovascular system. Diabetes takes the top spot due to the large
population suffering from diabetes.
Players operating in the Indian segment include multinational CROs,
Indian CROs, multinational pharmaceutical companies and Indian
pharmaceutical companies. While the first three categories of companies
are into global trials, Indian pharma companies usually look at
conducting primarily local trials. The Indian market is still dominated
by multinational CROs. Major global players include Quintiles, PPD,
Parexel, ICON, Pharmanet, Kendle, i3 InVentiv, Omnicare Clinical
Research, Inveresk Research, MDS and SCIREX Corporation.
Major Indian players include Siro Clinpharm, GVK Bio, Clininvent, Ecron
Acunova, CliniRx, Asian Clinical Trials, Jubilant Clinsys, Vimta Labs,
Lotus, Lambda Therapeutics, Clinigene, Max Neeman Medical and
International, Synchron Research, iGate (now Diagnosearch Life
Sciences), Veeda Clinical Research and Actimus Biosciences.
According to estimates, there are around 30 CROs conducting BA/BE
trials, 50 CROs looking at phase I-IV trials. Major companies looking
at BA/BE studies include Lambda Synchron, BA Research, Veeda Clinical
Research, Vimta, Bioserve, Accutest, Accunova and Lotus Labs. In India,
there are only a few companies into phase I trials (due to issues of
large scale investments in infrastructure).
The much favored business model followed by most of the homegrown CROs
is to commence their business with a focus on BA/BE studies and then
gradually move up the value chain, once they develop their competency.
This model is an emerging trend and will stay so for some years.
Since June 2009, the DCGI made it mandatory that all clinical trials
have to be registered with the Clinical Trials Registry of India (CTRI)
before a single subject is recruited for the study. As of January 2011,
according to the CTRI, the total number of trials stood at 1,584 as
against 806 trials between January-December 2010. Quintiles India
conducts the largest number of trials in the country.
There are a total of 2,000 investigators overseeing clinical trials
across various sites in India. India still faces the challenge of a
dire paucity of investigators as well as lack of sites. Estimates point
out that India requires an additional 25-30 percent more investigators.
Industry experts opine that this shortage can be overcome by by tapping
tier II and III cities and towns and by constant training on GCP and
GLP to these investigators.
Homegrown CROs are also aggressively looking at expanding to other
markets of the world, the South East Asian markets in particular. A
direct presence in these countries will give Indian CROs the advantage
of close proximity to their clients. Other upcoming destinations
include Eastern Europe and Africa. East Europe offers advantages like
large patient pool, low cost and proximity to multinational companies
present in West and Central Europe.
About two-three CROs are doing phase I trial, 15-20 CROs are involved
in phase II trials, 12-15 CROs are involved in phase III and 20-25 CROs
are doing Bio Avaibility /Bio Equivalence (BA/BE) studies. In India,
most clinical CROs carry out phase II-IV studies. Very few CROs carry
out phase I studies. The number of BA/BE CROs would be around 100.
Siro Clinpharm, in early 2011, announced the start of their operations
in Malaysia thus expanding reach in the Asian continent. They already
have consolidated their position in Western as well as Eastern Europe.
Veeda Clinical Research again, towards May 2011, announced from its
Ahmedabad headquarters, that the final steps had been put in place for
the commissioning of its CRC Veeda (Malaysia) phase I unit in the
Ampang Hospital in Kuala Lumpur in Malaysia, most likely to be called
‘CVM’. Having established a presence in Thailand, Synchron Research is
looking at tapping the growing South East Asian market, with Vietnam
being the favoured destination.This is due to the rise of the
pharmaceutical sector in this region, coupled with the influx of a
large number of multinational companies into this region.
Looking into the future, the CRO industry will continue to grow at a
rate of 20-30 percent in the next three years. The segment will also
see the entry of a number of small-sized homegrown CROs into the market
looking at BA/BE studies. Also, being on the growth mode, Indian CROs
will look at outbound acquisitions both big and small. Mandatory
resgistration of all clincial trials in India has brought about the
much-needed transparency into the system and this in turn will lead to
a rise in the number of global companies outsourcing clinical trials to