The next frontier: Global leadership in biopharma

India has traced a journey of grit and glory to emerge as a major supplier of generic drugs and vaccines globally. Today, it is a key player in the global pharma landscape. However, as healthcare demands and the life sciences landscape evolves, it is now time to conquer new frontiers and expand its horizons far beyond generics.

With advancements in biotechnology, robust scientific capabilities, cost-effective

manufacturing processes, a large workforce and a shift towards more complex biologic drugs, India is at the cusp of a huge opportunity to emerge as a leader in biopharma.

Brimming with potential

As per an Invest India report of 2023, the Indian Bioeconomy, valued at $137 billion in 2023, is targeted to reach $150 billion by 2025 and $300 billion by 2030. IBER Report 2023 divulges, “The biopharma vaccines (non-COVID alone) market makes a significant daily contribution of approximately $38 million. On a monthly basis, this market adds around $1.16 billion.” It adds, “India notably leads global vaccine supply by volume, producing nearly two billion doses annually.”

The same report informs that “The biopharma therapeutics segment commands an annual value of $16.8 billion, On a daily basis, this sector generates approximately $46.03 million and contributes around $1.4 billion monthly.” The Invest India report reveals, “The rise in domestic demand is fuelled by initiatives such as Aatmanirbhar Bharat and Make In India, while overseas demand for Indian vaccines and biopharma is due to the globally competitive efficacy of Indian products. India has about three per cent share in the global biotechnology industry.”

Thus, industry experts and analysts alike are bullish on India’s biopharma sector. They point out the country’s competitive advantages, including cost-effective production, a skilled workforce, and a growing pipeline of new therapies.

However, despite the promise and potential, it won’t be all plain sailing for India Biopharma Inc. To achieve true global leadership, the sector will have to address several critical challenges and capitalise on its unique strengths. As Sibaji Biswas, ED and CFO, Syngene International cautions, “Several essential areas for improvement in the current ecosystem need addressing to unlock its full potential.”

So, what are the challenges and complexities faced by India Biopharma Inc?

Limited investments in R&D and innovation is a major one. Dr Arun Anand, COO and Board Director, Immuneel Therapeutics explains that risk aversion, longer timelines for ROI, lack of adequate early-stage funding, and absence of an ecosystem that does not reward innovation hamper investments in biopharma R&D in India.

Sasmitha Sahu, Managing Consultant, GlobalData states, “While India has demonstrated success in generic drug production, the same is not true for novel and biosimilar biopharma products.” He explains that there is limited interest in biopharma product research and development due to process-intensive and cost-intensive production associated with biopharma therapies, coupled with a complex regulatory environment and weaker IP framework that could translate to higher risks in this space.”

Dr Cyrus Karkaria, President – Biotech, Lupin concurs, “India has a good network of research labs and well-developed base industries, a large pool of qualified scientific talent, several research labs and R&D institutions. Despite these factors, there are hurdles facing biotech innovation in India. Indian academia, industry and research labs lack a strong patenting culture, and the academia-industry linkages are weak.” He adds, “Most academic and research institutions are not well equipped to undertake innovative and translational research. India needs support in setting up an ecosystem, in terms of scientific expertise and incubation centres with seed funding to help develop innovative ideas leading to sustainable growth.”

Manufacturing and supply chain gaps also pose significant hurdles. As India’s biopharma sector tries to keep pace with evolving market demands and patient needs, modernising existing biopharma manufacturing facilities and building future-ready facilities are crucial for India’s emergence as a biopharma global leader. This will be pivotal for ensuring quality compliance, managing cost pressures, and adapting to evolving regulatory standards too.

Dr Karkaria elucidates, “Manufacturing and end-to-end supply chain are pivotal components within the biopharma industry. Over the past few years, several emerging trends such as pricing and inflation, technology implementation, focus on sustainability practices, the transition toward personalised and next-generation therapeutics, and innovative healthcare delivery models, are compounding the complexities within manufacturing and supply chain operations. These trends serve as crucial catalysts, necessitating a shift in priorities and a much-needed transformation of the manufacturing sector.” He adds, “To sustain innovation and leapfrog to the next level, Indian players will have to focus more on preserving, optimising and investing capital, along with raising capital. Improving operating efficiency and building top-class infrastructure will be required to efficiently utilise capital amid funding constraints.”

Lack of clarity in the IPR framework causes complexities

A robust IP framework is essential for fostering innovation in the biopharma sector. India has made strides in improving its IP regime, but further reforms are needed to align with international standards. The IP protection framework in India is perceived as weak, with concerns over patent infringement and compulsory licensing. This hinders innovation and foreign investment. As Sahu highlights, “With India recognising patents on pharmaceutical products, there is an existing IP ecosystem in the country but a robust system with clear guidelines is still lacking to address potential patent conflicts.” Slow and bureaucratic regulatory approval processes also often lead to delays in drug approvals and market access. Inconsistent enforcement of standards, lengthy approval timelines, and a lack of harmonisation with international regulatory practices are affecting India’s growth trajectory in biopharma.

Plugging the skill gaps and retaining top talent is challenging. While India has a large workforce, there’s a need for more specialised skills in advanced biopharma technologies. Pointing this out, Sahu says, “Biopharma sector is still in nascent stages in India. As with any sector, creation of ample training, career and growth opportunities will be pivotal to develop and retain top talent in the biopharma sector as well.” 

She underscores, “Changing advancements in digital innovations and a greater focus on data analytics means the skills employers need are shifting, changing the makeup of workforces across the sector. This also means employers are constantly in a state of assessing needs and hiring to ensure they have the right people in place to meet demand — the people who will create, develop and bring their solutions to market. Finding and retaining talent, however, has gotten more challenging due to a range of factors: skills gaps, greater competition within and outside the industry, and rising inflation.

Strategising for progress 

So, what can be done to mitigate these risks and challenges? Let’s take a look at the strategies and measures recommended by experts to make India a prominent biopharma hub.

Collaborate to conquer: Experts emphasise collaborations are key to build and sustain a robust ecosystem for the biopharma sector. They recommend different kinds of partnerships such as fostering international tie-ups with leading biopharma companies and research institutions, encouraging PPPs to bridge the gap between academic research and commercialisation, developing consortia to tackle complex diseases and promote knowledge sharing etc. 

For instance, according to Biswas, “Collaboration stands as a prerequisite in building a sustainable and scalable ecosystem within India’s pharma sector, particularly through partnerships among raw materials manufacturers and the pharma product companies and the Contract Research Development Manufacturing Organizations (CRDMOs).” 

He points out that to overcome the historical trend of sourcing from China due to cost advantages, we need to share knowledge and work cohesively with the thousands of local manufacturers to build capability and scale in the ecosystem. This approach will help overcome existing challenges and build on the opportunities shaped by the current geopolitical landscape. 

Sahu recommends, “Indian companies can leverage the latest biopharma innovation happening in academia and invest in R&D for novel biologics. Building public-private partnerships can aid in capability building, while favourable policies and financial aid by the Government can foster industry growth.” She also suggests, “India can foster collaboration between the IT and the biopharma companies through government or private initiated collaborative channels – these can help facilitate discussions around latest technological advancements available that could help in overcoming challenges in biopharma drug development and advancement.”

Embrace technology to transform: Experts and observers also believe that technology will be the true game-changer. With the immense potential of emerging technologies such as AI/ML, automation and data analytics, India can boost its strengths, mitigate risks and overcome its shortcomings across functions and processes in biopharma, like accelerating drug discovery and development, optimising clinical trial design, enhancing manufacturing processes through predictive maintenance and enabling supply chain efficiencies. They strongly urge the industry to leverage the huge potential of technology to catapult their growth.

Biswas outlines, “Adopting advanced manufacturing technologies, including continuous processing, digitally programmed manufacturing systems (MES) and deep learning based continuous process improvements are factors that hold immense promise for transforming biopharma production. Unlike traditional batch processing, continuous processing involves maintaining steady-state operations over extended periods, potentially increasing productivity manifold and reducing costs significantly. This shift is facilitated by the need for smaller facilities, improved process control, enhanced product quality consistency, and more efficient facility utilisation. Regulatory bodies like the US FDA and EMA are supportive of this transition, encouraging manufacturers to embrace these innovations.”

He adds, “Robust automation and digitisation for effective controls, and continuous manufacturing are likely to lead to productivity enhancements that far outweigh the initial investment costs. Like any other segment, there is also an opportunity to build a layer of artificial intelligence that can continuously learn and improve the input parameters to enhance the dependability and throughput of the manufacturing process. Indian pharmaceutical companies stand to significantly enhance their global competitiveness by aggressively pursuing