Rise of the Indian biopharma industry

This article is authored by Manju Sharma, former secretary, department of biotechnology, ministry of science and technology, Government of India.

India is poised for a breakthrough in becoming the global leader in the biopharma sector. Over the past decade, the Indian biopharma industry has experienced a notable rise in its valuation, with the Covid-19 pandemic providing an all-important boost to the industry.

Pharmacy

At present, the country ranks among the top 12 global destinations for biotechnology and is the third-largest hub for biotechnology in the Asia Pacific region. As of 2023, the Indian biotechnology industry has exceeded an estimated value of $92 billion, signifying a commendable 15% growth compared to the previous year.

Today, India is one of the largest suppliers of low-cost drugs and vaccines in the world. The Indian biopharma industry is leading in biosimilars, with themost number of biosimilars approved in the domestic market. Growing rapidly at a CAGR of 24%, biosimilars are expected to be a $36 billion global opportunity by 2025. Currently, India manufacturers contribute $500 million to $600 million in the $12 billion global market. Similarly, the Indian vaccines industry has also left an indelible mark on the global healthcare map, with experts suggesting that the industry could soon expand from a $2 billion market to a $5 billion opportunity.

At the core of the India’s significant advancement, lies strategic government intervention, providing an enabling ecosystem to foster innovation and growth of the industry. The department of biotechnology-led National Biopharma Mission (2017) is empowering over 150 MSMEs and startups. The mission along with crucial policy initiatives like Make in India, Atmanirbhar Bharat and the formulation of National Biotechnology Strategy (2021- 25) aims to create an environment that encourages the growth of India's technological and product development prowess in biopharma, positioning it on a global competitive stage within the next decade. Furthermore, aiming to accelerate the transition from discovery research to early-stage development of biopharmaceuticals, the department of biotechnology, in collaboration with the World Bank and Biotechnology Industry Research Assistance Council (BIRAC) launched the Innovate in India (I3) initiative.

Since no success story is devoid of challenges, the Indian biopharma industry is also grappled with a few. It is worth noting that Indian companies manufacture approximately $550 million to $600 million worth of biosimilar drugs, with a significant portion being sold within the domestic market. India is currently addressing only around 1.5% of the worldwide demand for biosimilars through exports. It is not due to a lack of capacity for producing quality biosimilars, but because the products sold in India fail to meet global regulatory standards.

While there is a notable rise in India's biotechnology R&D expenditure, growing from $320 million in 2021 to $1 billion in 2022, there is still need for additional measures to enhance the governance of research-related institutions and strengthen the connections between R&D institutions, academia, and industry.

Despite several initiatives aiming to enhance and establish shared infrastructure for product development and focusing on knowledge generation and skills development for technology management, the Global Biopharma Resilience Index (2023) has underscored the skills and talent gaps in the industry. Struggling to nurture fresh talent and acquire mature ones, India scores 5.03 out of 10, lagging behind the global average of 5.60, and ranks 17th out of 22 countries surveyed, in the talent pillar.

Similarly, a seamless transfer of technology is essential in the biopharma industry since it enables companies to leverage existing knowledge, expand their product portfolios, and venture into new markets. Inadequate execution carries the risk of diminishing both the quality and efficiency of the processes involved, proving detrimental to growth prospects of the industry.

While significant cooperation was witnessed among all the stakeholders including researchers, industry players, and regulators throughout the pandemic, a few challenges concerning the absence of an environment fostering collaborative research and innovation, lesser engagement of private funding entities compared to western nations, a disconnect between academia and industry where university researchers lacked adequate understanding of industry requirements, and a lack of awareness within the regulatory community regarding modern biotechnology applications came to the fore.

Moving forward, universities in India could introduce special training programmes to ensure that students gain an understanding of the legal and regulatory structures that determine the approval and use of new biotechnology interventions. This will further encourage students to diversify their job prospects. Furthermore, it is essential to establish technology transfer offices along with business development focus groups within academic research institutions. This would guarantee the licensing and transformation of proprietary knowledge generated by the institutions into products that can effectively address practical challenges.

In India, multiple authorities operating under different ministries often work in silos, leading to a complex approval process. Thus, it is imperative for Indian researchers, industry stakeholders, and the government to evaluate the situation and establish an integrated single-point regulatory framework to simplify the process.

Through collaboration with research institutions, biopharmaceutical companies could both finance and oversee clinical trials, which play a pivotal role in assessing the effectiveness and safety of innovative treatments. Moreover, it is solely through cooperation that the sector can achieve progress in pushing the frontiers of medical understanding and broadening the treatment options, which are consistent with global regulatory standards. Similarly, co- funded models, where the government matches the investments of a private fund in a project could be examined to attract more investment to propel innovation in the sector.

It is essential for the industry to work in closer collaboration with government policymakers and regulatory bodies to ensure manufacturing processes are better aligned with regulatory frameworks. With the adoption of technologies and automation, bio-manufacturers in India must continue strengthening their global footprint by enhancing quality, reducing production failures, and expediting their time-to-market strategies. The adoption of newer technologies such as the internet of things (IoT) enabled ‘smart’ manufacturing platforms, Artificial Intelligence (AI), systems for process automation, modalities for remote operations and systems for agile manufacturing would aid Indian biomanufacturers to comply with the global regulatory benchmarks.

In addition, the biopharma industry must focus on upskilling its existing workforce to alleviate the shortage of talent supply. Close engagement and collaboration of companies and academia along with constant support of the government in the design and delivery of the training programs for the potential workforce would further help India realise its biopharma potential to reach $120-125 billion by 2030.

Ensuring ongoing training and instilling a culture of adherence to quality standards concerning science communication and grant writing, compliance in GLP, GMP and GCP norms, regulatory knowledge, intellectual property reading, legal expertise and management skills like project management and business development among staff are critical components of this endeavour.

This article is authored by Manju Sharma, former secretary, department of biotechnology, ministry of science and technology, Government of India.