India currently contributes three-to-five per cent share of the global biotechnology sector

The outsourcing market size for CDMOs in India is roughly at Rs 20,000 crores and it is expected to grow to about Rs 40,000 crores in the next four-to-five years, informs Hitesh Windlass, Managing Director, Windlas Biotech, to Akanki Sharma in an exclusive interaction

What is the current market scenario of biotechnology sector in India?

As per the India Brand Equity Foundation (IBEF), the biotechnology sector in India amounts to $63 billion (Rs 4,60,000 crores), and is expected to reach $150 billion (Rs 10,95,000 crores) by 2025, with a CAGR of 16.4 per cent. As one of the top 12 biotechnology locations, India currently contributes three-tofive per cent share of the global biotechnology sector, which is expected to grow up to 19 per cent by 2025.

Some of the drivers of this growth would be rapidly improving clinical capabilities, pegging India as a desirable destination for clinical trials, contract research and manufacturing drugs. Increased government expenditure is estimated to further boost the biotechnology industry’s growth. The demand for healthcare services in India will continue to rise as the country’s economy grows and people become more health-conscious. The outsourcing market size for CDMOs in India is roughly at Rs 20,000 crores and it is expected to grow to about Rs 40,000 crores in the next four-to-five years. The PLI schemes offered by the government is also expected to benefit domestic manufacturers as well as the country.

Biotechnology sector is recognised as the key driver for contributing to India’s $5 trillion economy target by 2024. In what ways do you think this goal can be achieved? What role can Windlas Biotech play in this?
It is true that biotechnology sector holds the potential for providing innovative, low-cost and improved solutions for the existing gaps and challenges in sectors like health, environment, energy and industrial processes. The COVID-19 pandemic has accelerated the acceptance of many breakthrough technologies in research as well as in manufacturing. For instance, during the global pandemic, India cemented its position as an important hub for COVID-19 vaccine R&D. At one point, there were at least half-a-dozen Indian vaccine makers in different stages of vaccine development.

Globally, the biggest push has come in the field of Nucleic acid therapeutics. Many messenger RNA, anti-sense oligonucleotides have been approved and others are in advanced stages of development. While a lot of this action is within the innovator biopharma ecosystem in the west, Indian generic companies are ushering in advances in bioinformatics, protein synthesis, isolation, characterisation and large-scale manufacturing that will ultimately be required to make these breakthrough medicines viable on commercial scale. Windlas Biotech, as a CDMO, is investing in creating fill-finish capacity for injectable products which will help marketing companies launch their brands of different products.

Additionally, the Biotechnology Industry Research Assistance Council (BIRAC), a public sector enterprise set up by the Department of Biotechnology (DBT), Government of India, plays a pivotal role in the development of a bio-economy in India. Through its funds, BIRAC supports all stages of product development right from proof-of-concept demonstration to product commercialisation. Entrepreneurs, start-ups, companies and academic institutions can benefit from the schemes to work on research ideas that have translational potential.

Give us a brief about the CDMO sector in India current opportunities and challenges, and how COVID-19 pandemic has impacted this sector in India when compared globally.

The pandemic has opened doors of opportunities for accelerated vaccine development, drug repurposing to manage COVID-19 symptoms, novel and rapid diagnostics. We’ve seen an array of scientific advances in the last one year.

However, a majority of Indian biotech and pharmaceutical businesses are still focussing on the generic drug market and are not necessarily involved in New Chemical Entity (NCE) research. However, the ecosystem’s capabilities are ripe for value creation in the contract research, development and manufacturing services market. Due to the pandemic, reduced time span from concept to prototype to trial, the whole NCE world (innovator pharma/biotech companies) is recognising the value of collaborating with agile and scientifically-competent enterprises in India to hasten drug development.

For Indian CDMOs like us, this means that we can put our existing resources and facilities to work on a higher-value-added project and make a difference. When looking at the overall savings in terms of developmental timeline contraction and the ripple effect on total capital at risk on a specific NCE proposal, these partnerships are extremely synergistic. Even in the generic market, CDMOs have proven their worth to clients by quickly ramping up manufacturing volumes and averting stock-outs for essential products that witnessed a sudden spike in demand owing to the pandemic.

How has Windlas Biotech leveraged the opportunities in the CDMO sector? Tell us about your achievements so far.
Though a recently listed company, we’ve always had a strong track record on research, development, manufacturing and distribution of pharmaceutical products in India and several other emerging markets. Windlas Biotech works with large multinationals and Indian pharma companies to rapidly bring new products to market.

We primarily focus on three areas: improving existing molecules to lessen patient pill burden and hence enhance medication compliance; using innovative drug delivery technologies to boost medicine bioavailability or to deliver the drug directly to the location, hence improving the therapy’s safety profile; and reducing therapy cost for more improved accessibility and affordability.

We knew early on in the outbreak that scientists would require rapid prototyping and clinical trial skills to bring new concepts to market. We collaborated with Oncotelic, a biotechnology business based in the US, to develop and market an integrated drug and device therapy against respiratory illnesses and COVID-19. The therapy is known as ‘PulmoHeal,’ prepared from a plant extract of the indigenous herb Artemisia.

How, according to you, can governments support CDMOs better?
Under the Aatmanirbhar Bharat programme, the Indian government has taken a number of steps to make the country’s healthcare sector self-sufficient. For instance, the government stated last year that it will offer production linked incentives (PLIs) ranging from five per cent to 20 per cent to encourage the domestic manufacturing of essential Active Pharmaceutical Ingredients (APIs).

The government has been setting up mechanisms to take in account feedback and concerns of the industry. Two regulations have been changed where (a) the marketing firm has been given the same level of responsibility for product quality as the manufacturing firm and (b) through the revision of Schedule M, the new GMP guideline applicable under the Drugs and Cosmetics Act was brought in line with the global best practices. Both these regulations are expected to have significant impact on the quality of drugs and minimise the presence of sub-standard drugs in the market.

I believe that enforcement of these laws is crucial, and companies need to be proactive in upgrading their human systems, practices and infrastructure to fully reap the global opportunities now opening for us. Moreover, the government must encourage more international players to invest in R&D-driven pharma companies and CDMOs.

Going forward, what should be the focus to make the Indian biotechnology/CDMO sector Aatmanirbhar?
India is the leading exporter of OTCs and generics to the United States, with a market share of over 40 per cent. With over 3,000 pharmaceutical businesses and over 10,500 production facilities, the country is the world’s third-largest seller of pharmaceuticals. However, when it comes to generating a novel medicine molecule, the country trails far behind. As a result, it’s even more critical to bring all of the parties together-Indian pharma companies, CROs, and CDMOs – and to foster collaboration between industry and academic institutions. All of these players will be able to continue to develop, expand and strengthen their own experiences and push for an Atmanirbhar India.

What are the trends and patterns which will continue in the post-COVID world in the CDMO sector?
One of the major trends to follow would be investment in new facilities and new technologies – prompted by increasing quality standards as well as demand. So, as said before, the market has the potential to grow and the major stimulus for that would be innovation and greater access to larger section of the population. Newer technologies with new delivery systems like mRNA, and high potency products are areas of demand, such trends are expected to carry on. Lastly, the fact that collaborations among large pharma companies and CDMOs worked well during pandemic, is a testament that such partnerships could be explored for increasing access in other high-priority areas in a post-COVID-19 world as well.

biotechnology sectorCDMOsHitesh WindlassWindlas Biotech
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