By Manoj Panicker
India is at a strategic crossroads in biopharmaceuticals. The global biosimilar market is projected to exceed $60 billion by 2030, nearly half of India’s targeted $130 billion pharma exports. To capitalize this, India must augment traditional cost advantages with world-class process capabilities, skilled talent, shared infrastructure, high-yield technologies, and a resilient supply chain.
India has built a meaningful presence in biosimilars over the past decade, backed by strong scientific talent, improving manufacturing capability, and competitive costs. Yet global market entry remains uneven. The challenge is no longer just about developing biosimilars at lower cost. It is about ensuring that Indian products are designed, documented, manufactured, and monitored in line with the expectations of the world’s most demanding regulators. This requires a shift in mindset where regulatory readiness is embedded early in development rather than treated as a final stage requirement. The urgency is evident. As per the Global Biopharma Index 2025, 59 percent of firms report delays in time to market for new therapies, while 51 percent of executives highlight policy and regulatory inconsistency across markets. For India, this means that global alignment must begin at the level of capability creation itself.
Building Capability at Scale through Talent and Infrastructure
That capability creation begins with talent, because regulatory credibility is ultimately delivered by people. India produces thousands of biotechnology graduates each year, yet only a small fraction are trained on advanced bioprocess equipment, quality systems, and regulatory expectations relevant to global biosimilars. This gap slows development, increases compliance risk, and affects product quality. Strengthening training ecosystems that mirror real-world manufacturing environments and embedding regulatory science into learning pathways can ensure that talent is not just abundant but industry-ready.
Talent, however, must be supported by the right environments to translate knowledge into scalable outcomes. This is where the absence of shared, pilot scale, regulatory-grade infrastructure becomes a critical constraint. Without access to such facilities, even well-trained teams struggle to move efficiently from laboratory research to clinical readiness. Establishing open access biologics infrastructure at a national level can bridge this gap, linking scientific capability with industrial-scale execution. Global examples such as Sweden’s Testa Center demonstrate how shared facilities accelerate development, reduce cost barriers, and preserve intellectual property through public-private partnership models. In the Indian context, similar infrastructure could compress development timelines and enable both startups and established firms to iterate faster.
Indigenous High Productivity Cell Line Platforms
As development scales within such environments, productivity and technological independence become central considerations. Many Indian manufacturers continue to operate with cell line yields of around 2 to 5 g/L, while next-generation global platforms routinely achieve 5 to 10 g/L or higher. This gap is not merely about efficiency. It directly influences cost competitiveness, scalability, and the ability to demonstrate manufacturing consistency to regulators. Developing indigenous high-productivity cell line platforms, therefore, becomes a natural next step in strengthening the ecosystem. Such platforms can allow companies to reduce development timelines, increase output per batch, and eliminate licensing dependencies, while ensuring that manufacturing performance aligns with global benchmarks.
From Cost Advantage to Regulatory Credibility
As productivity improves, the reliability of inputs that sustain manufacturing becomes equally important. Indian biomanufacturers currently depend on imports for nearly 70 to 80 percent of critical bioprocess inputs such as single-use systems, media, and resins. This dependency introduces variability in cost, timelines, and supply continuity, all of which can affect manufacturing consistency. Building a resilient domestic supply chain is therefore not only an economic priority but a regulatory one, because consistent access to high-quality inputs underpins reproducible manufacturing outcomes.
What emerges is a shift from isolated interventions to a connected system. Talent enables infrastructure, infrastructure accelerates development, technology enhances productivity, and supply chains ensure continuity. Together, these elements determine whether Indian biosimilars can meet global regulatory expectations. Increasingly, regulatory confidence is built not just on the final dossier, but on the robustness of the entire system behind it. This includes consistency in manufacturing, traceability across the supply chain, validated quality systems, and readiness for post-market surveillance.
The broader implications extend well beyond regulatory approval. A system that is globally aligned attracts investment, generates skilled employment, and strengthens India’s position in the global pharmaceutical value chain. It also expands access to affordable biologic therapies, improving health outcomes in both domestic and international markets. Enabling regulatory market entry for Indian made biosimilars therefore requires a deliberate transition from cost advantage to system-level credibility. India has already proven its ability to supply affordable medicines to the world. The next chapter is to become a trusted global hub for biosimilars – built on quality, speed, and regulatory confidence. When regulatory thinking is embedded early and capabilities across talent, technology, infrastructure, and supply resilience some together as a connected system, India can build on its position as the pharmacy of the world and expand its leadership in the future of biologics.
The author is General Manager at Cytiva South Asia.
Disclaimer: The views expressed are the author’s own and do not reflect the official policy or position of Financial Express.
