In an interaction with Industry Outlook, Abby Abraham, Global Head, Data Science & Country Head – India, shares his views on the current market for Contract Research Organizations evolving in India and how does George Clinical with its deep global expertise in various therapeutic areas leverage for the conduct of clinical trials in India.
How do you see the current market evolving for contract research organizations in India? What are the major factors driving this market growth?
According to an industry report, the India CRO market was estimated in 2020 to be $ 970 Mn and have a CAGR of 12% over the next 5 years. It is expected to expand in the foreseeable future for the following reasons:
India, as a clinical trial destination, has undergone a course correction during the early part of the last decade. Regulatory processes have evolved and been streamlined over the last three years. It is reflected in the New Drugs Clinical Trial Rules (2019) which provides clarity on a few areas that are imperative for conducting global clinical trials. We have witnessed global biopharma showing renewed interest in including India as one of the key countries to conduct clinical studies.
India is a promising market for global medical device innovators. New regulatory requirements for registration of medical devices and submitting post-marketing safety data in India is a welcome move that streamlines this segment and ensures that only safe products with assured quality are used with the Indian population. This is already influencing global medical device-focused organizations to conduct clinical trials supporting the registration of their product in India.
Indian biopharma has increased focus on biosimilar clinical development, especially in inflammatory and immuno-oncology indications. This is going to continue and perhaps expand as some of these biologics are now being re-purposed to combat cytokine storms in moderate to severe COVID cases.
What are the major expectations of clients from the players in this space? How do you meet their expectations?
Our clients conduct global clinical trials and hence they expect that India, as one of the many key countries around the globe, would be productive in helping increase the speed of clinical development of new molecules. This would mean effectively contributing to total subject
enrollment and ensuring the quality of clinical trials meet the standards of both Indian and Western regulatory authorities such as FDA and EMA.
How is George Clinical positioned in this segment?
George Clinical has established deep global expertise in various therapeutic areas such as kidney and metabolic; oncology; cardiovascular; and chronic diseases which the company leverages for the conduct of clinical trials in India.
While the top Indian biopharma who are in the early stages of clinical development require support, the current regulatory framework in India is not conducive to conduct Phase 1 studies, especially first in human studies. George Clinical is uniquely positioned here since the company has significant capabilities and expertise in Australia. Australia offers top-quality clinical research operational practices and data that are accepted by regulatory authorities around the world.
Furthermore, we are already conducting clinical trials specialized in COVID-19 and therefore are well-positioned to be an integral part of clinical development programs for global or local biopharma.
In the space of biosimilars, the market access strategy of domestic pharma follows an Asia-first approach before moving to Europe and the USA. This is an area that requires a combination of global expertise and regional execution and George Clinical is uniquely positioned to deliver exactly that.
It is reflected in the New Drugs Clinical Trial Rules (2019) which provides clarity on a few areas that are imperative for conducting global clinical trials. We have witnessed global biopharma showing renewed interest in including India as one of the key countries to conduct clinical studies
We also conduct complex medical device clinical trials that put us as one of the front runners in this growing space.
What makes George Clinical different?
We are a scientific leadership “first” CRO. To set the context, George Clinical is one of the important divisions of the parent organization - The George Institute of Global Health (TGI). TGI
is a not-for-profit global research-focused organization collaborating with renowned academic researchers around the world. The organization is a leader in conducting high-impact research that helps shape global health policy. This collaborative model benefits and extends to George Clinical which helps us to tap into high-quality and relationship-driven scientific researchers globally and locally.
We have built full-service capabilities in India and we deliver global reach with specialization in
managing trials across the Asia-Pacific region.
What are the various features and benefits of your services that can be leveraged by your clients? Also, elucidate on your therapeutic expertise.
We offer end-to-end service from helping design a clinical trial to the submission of the clinical study report to regulatory authorities. If there are specific needs such as clinical monitoring, data management, or medical monitoring, we are flexible to support those client needs.
How has the company been successful in becoming one of the leading global clinical research organizations?
a. We label it: ‘Science, Service and Solutions’
b. Our success thus far has been due to a few key factors:
i. A cohesive and committed global team with a can-do attitude to achieve client deliverables
ii. Scientific-driven operational expertise
iii. Collaboration with scientific leaders
across the globe
iv. Flexibility to work according to different client needs.
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