2011 has been a roller coaster ride for the Indian
clinical research industry.
The excitement of seeing India
grow in importance for the global biopharmaceutical industry and the emergence
of a strong innovation-led local industry was offset by a slowdown in the
regulatory environment (for a better part of the year) and media reports that
painted an unfavourable image of the industry. On the positive side, these
challenges galvanised the industry into action and acted as a catalyst for the
industry, regulatory bodies and other key stakeholders to come together on a
common platform to discuss issues important to the industry. This kind of
collaborative effort augurs well for us as we go into 2012 and I am optimistic
about the year ahead.
The potential for our industry
in India is tremendous and presents an attractive opportunity spectrum for
contract research organisations. The clinical trials industry in India was
estimated at $485 million in 2010 by Frost & Sullivan and is projected to
grow at 17 per cent CAGR from 2009-15, remaining the largest clinical trial
market in Asia after Japan. This growth is being fuelled not just by the global
majors, but also by the innovative and generic domestic companies who have
witnessed rapid growth over the past three years. Global biopharma companies
accounted for 90 per cent of Quintiles’ clients in Asia only three years ago
but today the split between global and local clients is closer to 50:50.
As the indigenous pharma
industry in Asia grows and globalises, Indian pharma companies are expected to
lead the region, contributing to a significant proportion of growth of the
regional market for contract research through the development of biosimilars,
therapeutic equivalents, medical devices, and a growing number of NCEs and
NBEs. These regional innovation efforts are underpinned by large investments in
R&D during the past four to five years. some of which have already begin to
yield, for the first time, new chemical entities from the region. These
companies are likely to favour the home country as a location for clinical
development activities.
The need for big pharma
subsidiaries in India to engage in clinical research is also likely to grow as
these companies focus on increasing market share in our fast-evolving market,
whether through new patented product introductions or product life-cycle
management initiatives. India has emerged as a key to the development of
products for the prevention and treatment of high-burden tropical diseases and
pandemics, and investments by global foundations and not-for-profit entities in
large trials for the development of vaccines and therapeutics is expected to
continue to grow rapidly. We will see more initiatives by the Indian
government, not-for-profit funds and biopharma industry to develop new
therapies for diseases that are endemic to India and the developing world.
A big area of growth is that of
the biosimilar industry where a lot of exciting research and development is going
on in India. The potential demand for biosimilars creates an enormous
opportunity for biopharma companies. But unlike the development of progenitor
biologics—or generic versions of chemical-based medications—biosimilar
development and commercialisation is a uniquely difficult endeavour requiring
precision, stepwise planning to ensure timely regulatory approval and optimal
market access. Clinical development strategies must focus on patient selection
and appropriate clinical endpoints, an opportunity for Contract Research
Organisations (CROs) to partner with biopharma companies and help them navigate
the complexities of the industry. We are already beginning to see partnerships
being forged in India between international CROs and domestic pharma players in
the biosim space and this will grow significantly in 2012.
Another growing opportunity for
India is in data-driven healthcare services such as data management,
biostatistics, medical writing and pharmacovigilance. IT capabilities and the
ability to process and make sense of data via analytics are both crucial in
modern clinical trials. The challenges of today’s biopharma industry are
driving organisations to evaluate their product portfolios, operational
delivery and resources and find smarter, faster and more cost-efficient ways to
work. Most large pharma companies have either developed captive centres in
India or have outsourced these services at scale, taking advantage of the
highly skilled workforce and efficiencies in driving these businesses from India.
The work being outsourced is moving up the value chain as customers see the
incremental benefits in outsourcing these services. Customer engagement models
are also changing and becoming far more strategic and transformational. 2012
will continue to see Indian’s dominance in data-driven healthcare services.
Those that succeed will be organisations that are able to combine deep domain
expertise with data management process expertise. More and more biopharma
companies are beginning to recognise the value of this integration.
The course is not without its
obstacles and the industry has had its challenges. 2011 saw some uncertainty on
the regulatory front. Over the last couple of months however, we have been
encouraged by the initiatives being taken to regulate the industry and bring in
more checks and balances. As an early player in the industry in India,
Quintiles has played a significant role in the evolution of the Indian industry
towards a more robust regulatory pathway and will continue to play a role in
working with regulatory authorities and industry bodies. We are therefore
appreciative of steps being taken by the regulatory bodies to collaborate with
and invite industry feedback on planned changes. The government’s priority to
develop India as an innovation hub and encourage the growth of the domestic
industry is again good for the clinical research industry.
Another challenge that we have
faced and will continue to face in 2012 is the talent shortfall in the
industry. Government and educational institutions need to spend more on
developing career-ready educational programmes and creating greater awareness
about the exciting opportunities in clinical research. This is a clear
opportunity waiting to be tapped, where organised professional courses covering
the end-to-end spectrum of the healthcare industry needs can be addressed. We
need a “NIIT” of professional education for the healthcare services industry.
The IT industry grew leaps and bounds in India, not just on the availability of
raw engineering talent with the requisite analytical skills, but also because
of the NIITs, Aptechs, and other private professional educational institutes
that churned out high-quality professionals in large numbers.
Investigation sites and
resources are areas that also need to evolve. The industry needs to work more
closely with healthcare practitioners and administrators to bring about greater
operational efficiencies at sites. For the future growth of the industry in
India, the importance of an adherence to quality at sites cannot be undermined.
Principal investigators (PIs) need to invest time in ensuring that clinical
research activities are being done in accordance with standards. The strength
of processes at the sites, the adoption of technology/process automation,
real-time information updates and the knowledge/competency levels of site staff
have to go through a marked improvement in a measurable manner. The only way
this is possible is if there is a business model that emerges and invests in
this much needed area of improvement.
India’s ability to become an
innovation centre is dependent on a mature research eco-system and we must make
a collective effort to address the shortfalls.
There must be efforts to bring
better and safer healthcare to India, increase the competency levels of the
Indian healthcare workforce, make India an innovation hub and grow the services
revenue from India. To achieve these goals, I believe we should have a holistic
five to ten year plan (created by all stakeholders including the government,
industry bodies, academia, media and organisations) that focuses on a strong
regulatory framework (covering both policy and governance), professional
healthcare education, the promotion of a culture of innovation, effective
public awareness and a positive media environment. With India’s success and
focus on growth in services industries based on knowledge-based businesses, the
abundant talent and government support, the prospects for the clinical research
industry is promising and we are confident that the industry will continue to
sustain its growth trajectory. Contributing towards better health for all, while
safeguarding patients, is our focus and commitment.
In 2010, Quintiles published a
white paper, ‘The New Health’ where we said that biopharma companies must
deliver improved patient outcomes at a lower cost to consumers and to
themselves, and be able to demonstrate that value to stakeholders across the
healthcare spectrum. They can only achieve this goal by looking beyond their
own teams, to create a new model for drug development that incorporates the
tools, information and expertise of the constellation of stakeholders.
Strategic alliances enable multiple organisations to bring their varied
expertise to the table to create a robust network for drug development that
will meet more effectively the needs of stakeholders on a global scale. These
efforts will not just increase speed to market but will also ensure that
quality, cost and value for all stakeholders remain top priorities. The New
Health continues to be as relevant today as it was a year ago. I believe we
will see greater efforts in India in 2012 to build and strengthen alliances
across the industry ecosystem. The need is greater now, than ever before.
The clinical research industry
in India is at a refuelling pit stop. And on that note, we look forward to 2012
with optimism and excitement. May the new year bode well for all of you.
Hemant Rehani, Vice President
and Head — Clinical Development Services, India and Sri Lanka, Quintiles,
speaks about the potential and future prospects of India's clinical research
industry
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