The US $ 64 billion global clinical research industry is witnessing a transition as life science companies are turning toward emerging markets in Asia, Latin America and Eastern Europe to pursue clinical research. Increasing costs, declining productivity and rising drug development timelines, combined with the strategic advantages offered by these emerging markets, is driving research-driven pharmaceutical and biotechnology companies to conduct clinical research beyond established markets.

Over the previous 15 months, the share of Rest of the World countries (countries other than the US, Canada and Western Europe) has increased by 4.3 per cent  in total global study sites, which in absolute numbers corresponds to ~6500 sites.

The  Rest of the World today accounts for nearly 25.9 per cent  of Phase I-IV sites with the number of studies in some emerging markets growing nearly two to three times faster than the global average.

The emerging markets now contribute to ~36 per cent  of global patient enrolment as compared to ~20 per cent  in 2001.

Fast growing CR destination
India is one of the fastest growing clinical research destinations with a growth rate that is two and a half times the overall market growth. India participates in seven per cent  of global Phase III and 3.2 per cent  of Phase II trials with industry-sponsored trials having grown at a spectacular 39 per cent CAGR between 2004-2008.

The number of industry-sponsored Phase II-III sites in India has grown by 116 per cent  over the last 15 months and India has moved from rank 18 to 12 across the 60 most active countries. India ranks second in Asia after Japan in its number of industry-sponsored Phase II-III clinical trial study sites and accounts for nearly 20 per cent  of all Asian study sites.

As the world’s third-largest producer of drugs by volume, with the third-largest drug research and development workforce, India is a major player in the pharmaceutical industry. The most active 25 pharmaceutical companies worldwide, based on the number of study sites registered, are also active sponsors of clinical studies in the country.

The number of investigators in India has also grown the fastest among Asian, Latin American and Eastern European countries with a 42 per cent  CAGR between 2002–2008. India has one of the fastest subject recruitment rates globally (nearly three to five times the global average), with screen failure and drop out rates lower by nearly 40–50 per cent, as compared to global averages. As a result, India contributes 15–30 per cent of global enrolment in multi-centric studies where it is a participant.

Data submissions from India in the recent past have been part of at least 13 successful NDA approvals.

India is ranked third across all countries after the USA and China in terms of its overall attractiveness as a clinical trial destination according to a recent AT Kearney global survey.

Glorious metamorphosis
Further, India’s clinical research landscape is undergoing a glorious metamorphosis, aided by many uniquely differentiating capabilities, a rapidly transforming healthcare market and an enabling environment that is rapidly adapting itself to global standards.

Scientific feasibility
India constitutes 16 per cent  of the global population with 20 per cent of the global disease burden. With ~32 million patients in urban areas and ~72 million patients in rural areas at any given point of time, India has a diverse mix of subjects, who are relatively treatment naïve as well as subjects with a high standard of care to meet diverse study protocols.

The country’s disease burden is also well aligned with the new drug development therapy focus of global pharma and biotech, with a shift toward non-communicable diseases. India has 65 million patients with CNS disorders, 31 million diabetics, 29 million cardiac patients, 41 million COPD and asthma patients, 0.8 million cancer patients, with most of these ailments expected to increase by over 50 per cent  in the number of cases by 2015.

All the five major racial types — Australoid, Mongoloid, Europoid, Caucasian and Negroid — find representation among the people of India, with Caucasian being the most prevalent.

Medical  infrastructure
The urban healthcare infrastructure, in terms of the number of beds/physicians/nurses per 1000, is comparable with the global average. India has >8,40,000 urban beds.

There are over 6,00,000 English-speaking physicians and nearly 1,00,000 specialists, with many of them having been trained in the best global institutes.

There are 41 hospitals accredited under International Society for Quality in Healthcare (ISQua) by National Accreditation Board for Hospital and Healthcare Providers (NABH) and Joint Commission International (JCI), while 84 hospitals are currently in the process of applying for NABH.

The Clinical Establishment (Registration and Regulation)Act, which is being promulgated by the government to regulate private hospitals and laboratories across the country, will play a significant role in devising and implementing uniform standards of facilities/services and further enhance the quality of care provided by the Indian healthcare delivery system.

Clinical research expertise
There are ~350 clinical trials that are ongoing in the country with 64 per cent of the studies being in the five key therapies for oncology, cardio-vascular, neuro-psychiatry, diabetes and infectious diseases.

India has more than 2299 industry-sponsored Phase II-III clinical trial study sites that are carrying out clinical trial activity across the top 15 cities in the country. All medical records at the sites are maintained in English.

There are ~1500 investigators with the investigator base growing at >40% per year, faster than in other emerging markets.

The government is laying significant emphasis on training and capacity building, with the Department of Biotechnology (DBT) setting up six Clinical Research Training Centres (CRTCs) to provide specialized training to clinical investigators (MBBS and MD).

Nine of the top 15 global pharmaceutical and biotech companies have set up captive clinical research centres in the country. Seven of the top 10 global CROs have an established India presence.
There are more than 20 CAP-certified central laboratories with a significant number of international laboratories providing a suite of esoteric testing services.

Policy, regulations and public investment
The policies and regulations governing clinical trial conduct in the country, e.g., Revised Schedule Y (of the Drugs and Cosmetics IInd Amendment Rules, 2005), Good Clinical Practice Guidelines issued by the Central Drugs Standard Control Organization, Directorate General of Health Services

and the Ethical Guidelines for Biomedical Research on Human Participants issued by Indian Council of Medical Research, 2006 are consistent with the principles enshrined in the Declaration of Helsinki, which ensures the credibility of clinical trial data emanating from India.

The government is planning and executing a number of initiatives to strengthen the institutional machinery, e.g. mandatory registration of clinical trials (w.e.f.15 June 2009), mandatory registration of stakeholders (viz. CROs, ethics committees, investigator sites and investigators), enhanced monitoring and oversight (random audits,inspector training workshops by US FDA, imposition of penal provisions such as 10-year imprisonment for misconduct and fraud in trials) and “e-governance” of the entire drug approval process. These are a testimony of the government’s commitment to create a regulatory environment in line with the highest global standards.

The government is also embarking on a major multi-billion dollar initiative with 50 per cent public funding through a public-private partnership model to harness India’s innovation capability. The vision is to catapult India into one of the top five pharma Innovation hubs by 2020 with one out of every 5 to 10 drugs discovered worldwide coming from India by 2020.

Commercial attractiveness of India as a “pharmaceutical market”
The Indian pharmaceutical market — the third-largest globally by volume is expected to treble in value to US $ 20 billion by 2015, to be counted in the top 10 markets of the world.

The advent of the product patent regime in 2005 has instilled confidence in the intellectual property regime with many patented drug launches over the last two to three years.

While, pharmaceutical MNCs already present in India are further consolidating their presence through acquisitions, many MNCs have staged a re-entry post 2005. It is estimated that the share of pharmaceutical MNCs in the domestic pharmaceutical market will rise to 35 per cent  by 2015 from the current 25 per cent.

Cost competitiveness
 Last but not the least, in addition to the above advantages, clinical trial conduct in India comes at 50–60 per cent of the cost as compared to developed markets.

 India’s value proposition extends beyond Phase I-IV trials with other allied services such as data management, medical writing, pharmacovigilance and biostatistics services gaining the attention of sponsors and CROs.

 Delivery of allied services requires an appropriate blend of system and domain skills, and India’s proven IT/ITES track record, domain expertise and cost advantage has made it a destination of choice for these services. The Indian industry for these allied services is growing at 21 per cent , which is almost thrice the global average.

India has consistently been ranked as the most preferred destination for the provision of outsourcing services in the IT/ITES segment. India accounts for 65 per cent  of the global offshore IT services with KPO exports growing at 51per cent  p.a.(2004-08).

There are more than 45 companies with six to seven years experience spanning CROs, IT/ITES companies, specialized providers and the captive centres of global sponsors that are offering the complete spectrum of allied services. At least eight  of the top 10 pharma companies are providing one or more of these services from India, either by setting up captive centres or through tie-ups with CROs and IT/ITES companies.

Paradoxically, despite its inherent advantages, India still contributes only 1.5 per cent of global patient enrolment and sites and two per cent  of clinical trial volume. The global community is yet to harvest the full potential of its patient pool, medical infrastructure, clinical trial expertise, IT capabilities and regulatory reform to the fullest extent. A large part of this is attributable to the perception and lack of awareness about the transformational changes currently taking place in the country’s clinical research environment.

India is one of the most attractive clinical trial destinations worldwide and at the same time the most preferred choice for IT outsourcing, a unique advantage that is not enjoyed by any other emerging economy other than China. It is thus best placed to assume a leadership position among emerging economies as the location for clinical research services, and among the top five markets for clinical trial conduct worldwide by 2015.

The Indian clinical research stakeholder community is committed to demonstrate the capability required to enhance its credibility further, and gain the confidence and trust of the global life sciences community to make this aspiration a reality.