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Clinical Development Opportunity in India
Dr. Nidhi Saxena, President & CEO, Karmic Lifesciences There are several factors favouring India to emerge as the top-notch clinical research location and will be seen as a highly preferred destination for clinical trials. However, while the opportunity is definitely unique and colossal, so are the several roadblocks and bottlenecks. The article talks about both the opportunities and challenges for the growth of clinical research in India.

Globally, Clinical Research is a sizeable industry pegged at approximately USD 26 billion in 2011 and growing at a CAGR of 25 per cent plus. Global Clinical Research Revenues are expected to touch USD 32.73 billion in 2015 and to exceed USD 65 billion in 2021, with the Top 10 Contract Research Organisations (CROs) accounting for roughly 50 per cent of the market.

Given such a huge industry size, the obvious next question is which geographies will account for bulk of the Clinical Research revenues and the Emerging Markets including the Brazil, Russia, India and China (BRIC) countries and Eastern Europe clearly seem to show a promising trend towards providing significant CRO services. Revenues from clinical trials in India and China will show compound annual growth of more than 20 per cent, with China becoming the world's second largest market for pharmaceutical clinical trial services by 2021.

The momentum clearly is accelerating when it comes to conducting clinical trials outside the boundaries of the United States or Western Europe, the Middle East and Africa (EMEA). 59 per cent of respondents to the UBM TechWeb/ Wipro Clinical Trial Research indicated that they already have begun conducting clinical trials in emerging markets, and the remaining 41 per cent had plans to begin doing so in the next 12 to 24 months. Asia is a main target for 46 per cent of the UBM TechWeb survey respondents.

Further, 26 per cent of the respondents said that they are either acquiring local infrastructure, building it up using their own resources, or using a third-party Contract Research Organisation (CRO) to deliver services for site monitoring, data management and other clinical activities.

Looking closely at the opportunity that India presents, India contributed USD 1.4 billion, i.e., 6.38 per cent of the clinical research global market in 2011. While the India growth story has largely not been as rosy as expected. There are several fundamental factors favouring India to emerge as the top-notch clinical research location and it is only a matter of time wherein the industry will see an inflection point and India will suddenly be seen as a highly preferred destination for clinical trials. ClinicalTrials.gov, a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world, currently reports close to 1628 studies being listed in India in 2011.

Apart from traditional benefits of lower cost and faster patient recruitment, India also offers an opportunity for highly strategic and innovative development models that can create a paradigm shift in the way the world does drug development today.

First analyse the traditional clinical research models wherein majority of the research has been taking place in developed ICH countries including US, Germany, UK, Switzerland, Japan, Australia, etc. Here, the Regulatory Bodies have a complex and elaborate drug approval process, and the costs and timelines are stupendous. As an example, it costs between USD 70-100 million and between 8-10 years to take a molecule from concept to clinic using the standard US FDA Investigational New Drug (IND) pathway.

Many of these studies are multi-country and multi-centric in nature and are co-located in the emerging markets given the need for multiple ethnicities to participate as well as generating data from emerging markets that could have huge future revenue potential. Hence, currently multinational big pharmaceutical companies, who conduct over 90 per cent of the industry-sponsored studies, use Indian sites mostly as a part of their global studies, which means that India is peripheral, and not core to their development strategy. Among other issues, challenges pertaining to regulatory ambiguity and concerns on Good Clinical Practice (GCP) adherence, acceptance, integrity and poolability of Indian data have been key roadblocks to this trend. Further Indian pharmaceutical companies primarily conduct studies in India for local registration only and they too look out for and locate complex, early phase work in US or Europe.

A large chunk (about 64 per cent) of the industry-sponsored trials are conducted by the pharmaceutical companies directly, while the remaining are outsourced to various global and local CROs in approximately equal proportions. Given that there are at least 40-50 Indian CROs who offer clinical trial services, this amounts to an average of only about five to six studies per CRO over the last two years.

From an Indian CRO perspective, we as a group need to question if we are satisfied being at the periphery of the global drug development game or want to be active players and indeed game changers here. And if we do want to go mainstream and grab upwards of 20 per cent share from a current <10 per cent share of the global market, we need to explore creative, indigenous clinical development models. As an example, Indian CROs can leverage an alternate clinical development and regulatory pathway in terms of in-licensing global molecules post Phase I (and in some cases, right from the pre-clinical stage) and conducting the Phase II and Phase III programmes in India, gaining local marketing approval and then going back to the Investigational New Drug (IND) pathway and exploring opportunities for a US FDA approval leveraging a single/ smaller Phase IIIb study or try to get a waiver and approval based on data generated from India.

This model can accomplish the same concept to clinic cycle albeit with USD 10-15 million, i.e., 1/10th of the standard IND investment and a 4-5 year timeline. These ideas can be further extended to development in specific areas such as Diabetes, Oncology, Biosimilars, etc.

Not only that, India offers a huge opportunity for Chemistry, Biology and Pre-Clinical Services outsourcing as well as some excellent GMP certified manufacturing units and bio-Informatics companies. Over the last 15 years, Indian pharmaceutical companies together with Indian CROs specialising in Bioavailability and Bioequivalence (BA/BE) studies have grown steadily to make India a dominant player in the generic business, and India today accounts for the second largest number of Abbreviated New Drug Application (ANDA) filings in the world. In fact, CROs who conduct both healthy volunteer studies (for generic research) and clinical or patient studies (for ethical research) have a significantly larger portion of their business coming from offering services to the generic industry.

However, while the opportunity is definitely unique and colossal, so are the roadblocks. The two paramount challenges to expanding the Clinical Research market in India are very clearly regulatory bottlenecks, wherein the government needs to get its act together and create clear, succinct and time-bound guidelines for clinical trial and marketing approvals and authorisations.

Secondly, the quality of the overall data and clinical trial, including various aspects such as GCP compliance, Manpower Training and Development, Patient Retention and Awareness building, need to be stepped up. Finally the industry needs to find its own voice. While we have recently been seeing a lot of negative portrayal of the industry by mainstream media, these examples quoted are often mis-informed and are anomalies and exceptions rather than the norm. The industry has many positives as well which need to be strongly highlighted including providing access to hundreds and thousands of patients to leading-edge treatment free of cost, providing employment to over a 100,000 people, generation of foreign exchange income for the country, contribution to leading-edge research and cures for killer diseases such as Oncology, Diabetes, Cardiovascular, Tuberculosis, etc and last but not the least the potential of Indian Science to capture the world stage in a few decades.

So where there is challenge, there is opportunity and it is really upto the entrepreneurs and scientists to take the industry to the next level where it truly starts creating a global impact.