Lost in Translation? India’s Biologics R&D Shortfall

Biologics account for roughly 45% of the pharmaceutical market today and are projected to grow at 10% annually, reaching 55% by 2030. Within this segment, biosimilars alone are expected to swell to a $100 billion market by 2030, buoyed by more than 130 patent expiries valued at $180 billion over the next seven years.

Despite these favorable tailwinds, Indian firms command less than 5 percent of the global biosimilars market, underscoring a stark under‑utilization of R&D capabilities and strategic opportunity. At the heart of this shortfall lies a regulatory framework that struggles to keep pace with the demands of biologics development. India’s contract research, development, and manufacturing organizations (CRDMOs) have flagged slower approval processes—particularly for critical raw materials—as a key impediment to competitiveness. 

Compounding regulatory friction is a persistent funding gap. While U.S. biotech companies attracted $57 billion in financing in 2023 alone, Indian biotech firms have mustered only $5 billion over the past decade, a shortfall that stifles early‑stage discovery and scale‑up of novel biologics. Domestic manufacturers have petitioned for tax reliefs—such as income‑tax exemptions on new molecular entities—to incentivize high‑risk R&D, but as of mid‑2024, novel biologics remain ineligible for many government incentive schemes.

This misalignment between policy intent and practical support leaves innovators without the fiscal cover needed to pursue ambitious pipelines.

For course correction, the regulatory harmonization is imperative and non‑fiscal incentives must be recalibrated to reward R&D in novel biologics—expanding PLI (production‑linked incentive) coverage, offering R&D tax credits, and creating milestone‑based grants for first‑in‑class therapies will mobilize both established firms and agile start‑ups. Also, the strategic infrastructure investments—scaling existing bulk drug parks into comprehensive biopharma clusters, replicating models like Singapore’s Biopolis, and tripling the footprint of Genome Valley—will provide the shared resources and ecosystems that underpin breakthrough innovation.

Finally, nurturing talent through specialized postgraduate programs, industry‑sponsored fellowships, and reverse brain‑drain initiatives will build the critical mass of scientists and engineers needed to propel India’s biologics ambitions.