“India stands to emerge as the biotech leader for the world”

About Author: Sanjay Vyas, EVP & MD, Parexel India and Global SBU Head- Safety services & Logistics, Parexel International. Sanjay Vyas has over 25 years of experience in Global & Regional P&L management, Logistics & Supply chain management, Sales & Marketing, M&A’s & Business Strategy, Product Development, Operations & People management. Currently Sanjay is the India Country Head for Parexel and manages a team with over 6,000 employees. He also leads the operational management for the organization’s global distribution centers and depots.

The last decade has been a testament to the global positioning that India holds among the countries of the world. With the current title of being the ‘Pharmacy of the World’, India has also gained the title of the ‘Largest Vaccine Manufacturer of the World’. Aligned with these existing global titles, India also has the unique position of being the leading manufacturer of 127 biosimilars that are approved in India.

The National Bioeconomy Vision

India is working towards becoming a key player in the global Bioeconomy space. According to the latest report from the Ministry of Science and Technology, India is working to meet the target of $150 billion by 2025 and $300 billion by 2030. This is underscored by the more than 5,300 biotech start-ups in the country (2021).

The Bioeconomy of the country is divided into BioPharma, Diagnostics, BioAgi, BioIndustial and Bio-IT/Research Services. Of these, BioPharma currently contributes $39.4 billion followed by Diagnostics contributing to $14.56 billion and Bio-IT/Research services contributing to $5.42 billion.

The government remains bullish in its resolve to support and strengthen the Bioeconomy of the country. They have been able to demonstrate this through multiple incubators, suitable funding and partnerships with national and international companies and bodies. The Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology (DBT) have established a network of 74 specialized bio-incubation centres in 21 states including 7 bio-incubators in the northeast region – an emerging cluster.

The Association of Biotechnology Led Enterprises (ABLE) in India estimates the size of the broader economic impact for biologics to grow at a compounded annual growth rate (CAGR) of 22 percent to become $12 billion by 2025. Clinical research services in early discovery and clinical development for biologics and biosimilars in India are estimated to be $200 million and growing at a CAGR of 40 percent.

Leading the Bioeconomy wave with Biologics and Biosimilars

With the global and national focus shifting towards preventive health, there is more demand for the development of monoclonal antibodies, vaccines, and biosimilars. This trend has resulted in renewed focus on research and development (R&D) by pharmaceuticals with strong R&D capabilities and focus. The Indian biologics market is expected to account for around $12 billion by 2025 supported by its dominance in simple biologics like insulin, erythropoietin, monoclonal antibodies, etc.

India, with the current know-how of setting up globally reputable development and manufacturing units with the United States Food and Drug Administration (FDA), and European Medicines Evaluation Agency (EMEA) amongst others will be able to continue to produce globally accepted biosimilars that cater to a range of diseases. Supporting this growth story are the conducive regulatory framework in India and the scientifically inclined R&D workforce, which powers the Indian biosimilar market towards the $40 billion mark by 2030.

Today, India has around 127 approved biosimilars, propelled by local biotechs, making it the country with the largest number of approved biosimilars after Germany and USA as per the Informa Pharma Intelligence report 2021.

Keeping in mind the renewed focus to lead the Bioeconomy space in the world, there are areas like Bio-IT/Research services that deserve further focus.

Powering Research and Development Services Sector

With India becoming the centre of global conversations on their generous contribution to the war against COVID, has found its affirmation in the power in R&D in addition to the globally recognised manufacturing position.

2021 saw funding of $1 billion towards R&D followed by the availability of more than 1,700 clinical research sites and more than 4,000 investigators that are trained and ready to carry out research activities to bring out novel products into India. The regulatory bodies have also revised their guidelines in 2019 and again in 2021 to accommodate fast-track clinical trials for new drugs, depending upon the global approvals and existing data that is available. With regard to strengthening the business environment in the biotech sector, there were four large international deals and 21 domestic deals in 2021. One of the regulatory modifications that came into effect during this period was that Novel Drug manufacturers could freely price their innovative product for five years from the date of market authorisation.

Clinical Research 2023 and Beyond

With only 5 percent of globally active/planned trials taking place in India, there is a huge opportunity to shape India into a leading country for clinical trials. The way forward is to ensure that the clinical research industry identifies and minimises all the limitations that are currently faced by the industry. Some of these challenges could be grouped into medical and/or scientific challenges, logistical challenges, and cultural and behavioural challenges when the patient is participating in the trial.

To understand these challenges and the best way to circumvent them, the ‘Patient Advisory Council India’, has been able to provide insights into the ‘patient first’ approach during the planning of a clinical trial. These are closed-door discussions with patients who provide insights into the best way to design the study based on their disease/condition, experience and expectations. Such discussions will provide clear patient expectations from the study and will support in decreasing the patient dropout rate during the trial.

Another important aspect to keep in mind is the diversity and inclusion of the clinical trial participants during the progress of the study. In other words, there should be a suitable representation of gender, demographics and ethnicity of patients during the conduct of the study as there are chances that the drugs may behave differently in patients with different groups of people.

The pandemic also brought about the importance of logistics and supply chain limitations that could limit the study or participation. This is where a majority of the clinical trials that were conducted around the world shifted to a decentralised clinical trial model. With the support of digitisation and careful use of technology and point-of-care devices, the logistic issues have been effectively tackled. Today, the decentralised clinical trial approach is becoming a standard practice across the world and is facilitated by online doctor visits, direct-to-patient shipments of the trial drugs, wearable devices and implants that provide continuous patient monitoring in real-world settings, at-home sample collection and nurse visits and real-time recording of patent readings on electronic medical records.

Patient awareness building through regular disease awareness and study protocol training have also gone online during this period and will mostly continue in the same format. Healthcare professional training and study protocol discussion have also followed similar online formats and are now considered a standard approach.

Conclusion

As we progress into 2023, India stands to emerge as the biotech leader for the world through the constant government, industry and people support to lead this sector and provide quality research-based solutions to global healthcare problems.

**This article was first published in the January 2023 edition of the BioVoice eMagazine. The views expressed by the author are his own.