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The emerging CROs
The Indian CRO sector registered 70 percent growth in 2006-07 over the
previous year's revenues of Rs 425 crore with exports dominating the sector.
Datamonitor's R&D Strategies 2007 report points out
that the drug developers have become increasingly dependent on CROs, which
themselves have become increasingly globalized. This is being driven by both the
rise in the number of CROs in emerging markets and the increasing
internationalization of western CROs. Most global CROs are present in India or
have formed alliances there: seven out of the top 10 CROs have local offices in
India with leading companies such as Quintiles, Chiltern, ICON Clinical Research
building up a significant India presence. Meanwhile, local CROs are picking up
pace, and there is likely to be a period of consolidation in this sector. The
Indian CRO sector is growing at nearly 70 percent over the previous year's
revenues of Rs 425 crore with exports dominating the sector. There are over 40
companies active in this space. Most of these are actively involved in doing
bioavailability/bioequivalence (BA/BE) studies with a handful of them into
clinical trials (Phase I–IV). Considering the potential of doing business in
India, many leading CROs of the world who are looking at both India and China as
potential markets of investments, are entering India. Given the two countries'
low cost base and huge potential patient populations, both the countries are
offering services in abundance.
Considering the advantages India has and its offerings to the
sponsors, McKinsey has estimated that the size of the clinical research market
in India will be close to $1.5 billion by 2010. At present the market is just
$160 million. As of today, India has witnessed different types of players
venturing into the clinical trial data management business, some of them are
full fledged CROs starting separate data management units, some of them are IT
and ITES companies diversifying to data management business and some are
pharmaceutical companies setting up biometrics and data management operations
solely on their own or through partnership.
Dr Chetan Tamhankar, chief operating officer, SIRO
Clinpharm
In India there are two aspects -- companies are on
the move to develop new molecules and they have been needing services
from CRO providers for helping them deliver both within India as well
as other geographies. Moreover, there is a lot of pressure now on the
supply side of aspects like getting enough CRAs, doctors and putting
data management systems in place will be a challenge for the industry
for at least the next 3-4 years.
India's story is very credible. It may not
support on a shorter term a really larger growth - like globalization
for instance, if we need to become global players, it is imperative
that when we go to a customer, we do our studies in India and other
countries and that is also one reason why Indian CROs are expanding to
other geographies. To have this global delivery, we at SIRO are trying
to emerge as a multinational CRO by extending to non-traditional
countries like Central and Eastern Europe and other parts of Asia like
Philippine, Singapore, China, Korea, Thailand and Malaysia. To have
this global desirability, we need to have seamless operations
In fact the main demand for Indian CRO industry is
that that it should not be foreign CROs coming to India but Indians on
the basis of their credibility going to other countries as a global
MNC. That will happen in the near future and SIRO at the moment is
targeting countries with Europe from that perspective and in the
domestic market we are going to tier 2 and tier 3 cities and tying up
with Centers of Excellence (CoEs) for clinical research
Nilesh Nayak, senior executive, business and
development, Rubicon Research, Mumbai
CROs have been the backbone of the Indian biotech
industry. The biotech industry is resource-intensive and has a high
gestation period for any biotech product to come out. CROs in India
have augmented their progress because they have taken off or shared
the burden of innovation by providing the requisite infrastructure and
with increasing cost, they have also shared the cost with these
companies for these trials.
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CROs in India
Cintec International, the global CRO have been successful in
entering into a co-development with Dr. Reddy's Laboratories some time back
and is also looking in the area of biotechnology particularly developing new
cancer drugs. Quintiles in Bangalore is expanding the data management team by
moving work to India and has hired 187 people in data management. SIRO Clinpharm
has a full fledged data management unit and is also working with Pfizer on a
retained FTE model providing contract staffing operations. ICON Clinical
Research has acquired a Chennai-based data management company, Biomines Research
Solutions which will focus on data management and biometrics services. Mumbai-based
Wellquest CRO, the clinical outsourcing division of India pharmaceutical company
Nicholas Piramal, opened a 30,000 square foot research facility in Hyderabad and
has conducted about 100 pivotal trials and 40 pilot studies. Bangalore based
Acunova, an offshoot of Manipal group of hospitals has expertise in
bioinformatics and medical software and offers clinical data management and
biostatistics services to Pharma companies, besides the site management and
contract research capabilities. Synchron, a local CRO offers complete clinical
data management services for data processing, analysis and management from their
Bangalore facilities. Besides these many clinical trial CROs including Covance,
Parexel, Chiltern, PRA International, MDS, Lambda, etc. are exploring the
possibility of setting up clinical trial data management and biostatistics in
India.
IT-biopharma ventures
There has also been the involvement of IT companies like
Wipro, Intel, Satyam, Cognizant, IBM, Oracle and TCS in their bio-IT initiatives
in India. While some of them have actively started the clinical data management
initiatives, others are planning to venture into IT solutions. Satyam Computers
has recently launched the Satyam LifeSciences Center of Excellence. The LS CoE
is a hub for knowledge proliferation, cross leverage of customer experience,
domain competence and virtually demonstrable solutions. In-house IT
solutions have been developed in the area of drug accountability, drug
counterfeiting, cell line management systems, high throughput analyzers,
clinical development, bioinformatics, and sales and marketing solutions in CRM,
Key Opinion Leader portals etc.
Although there has been a number of local and multinational
players in this segment but the ones meeting the industry expectations, with
high global standards, regulatory compliances and the pressures of cost and
cycle time reductions in drug development, with an efficient data management
system will survive.
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