Indian contract research, development, and manufacturing organizations (CRDMOs) are positioning themselves as strategic alternatives to global biotech supply chains, with the US Senate’s passage of the Biosecure Act and escalating trade tensions with China.
The Biosecure Act, embedded in the U.S. National Defense Authorization Act (NDAA) for FY2026, aims to restrict federal contracts with Chinese biotech firms such as WuXi AppTec and BGI Genomics, citing national security concerns over genetic data. While the bill awaits reconciliation with the House version, its passage in the Senate has already sent ripples through the global pharmaceutical outsourcing ecosystem.
WuXi alone is bigger than all the Indian CDMOs revenue put together.
“This represents a continuation of the pathway envisaged in the original Biosecure Act,” said Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma.
“It supports a move toward a diversified and resilient biotech supply chain. We believe this development can create meaningful opportunities for Indian CDMOs and for companies like OneSource, which are equipped with the infrastructure, regulatory strength, and agility to support this transformation.”
India’s CRDMO sector, currently valued at $3–3.5 billion, accounts for just 2–3% of the $140–145 billion global market. But with a 15% CAGR from 2019 to 2024—double the global average—the industry is at an inflection point.
Analysts at Macquarie in their report earlier forecast the Indian CRDMO market could triple to $22 billion by 2030, should geopolitical tailwinds and regulatory shifts like the Biosecure Act accelerate outsourcing away from China.
"Over the past few quarters, we have already seen an increase in queries and RFPs from global customers,” Sharma added, noting growing interest in biologics, sterile injectables, and drug-device combinations.
Nandini Piramal, Chairperson of Piramal Pharma, echoed the sentiment. “The passage of the U.S. Biosecure Act in Senate represents an important development. If it becomes law, it would impact how the industry looks at supply chain choices. We expect to see greater client interest in understanding the potential implications and exploring diversified supply partnerships.”
Piramal Pharma, with CDMO sites across North America, Europe, and India, is among a handful of Indian players with a global footprint—an advantage as clients seek to de-risk their supply chains.
Structural challenges
Yet, India’s CRDMO sector faces structural challenges. According to a joint report by BCG and IPSO, the industry must scale its workforce 6–7x by 2035, address regulatory delays that extend approval cycles by up to 10 months compared to the West, and reduce its 60–70% dependence on China and the West for raw materials. Access to capital remains constrained, with Indian CRDMOs facing a cost of capital nearly 500 basis points higher than U.S. peers.
Despite these hurdles, the opportunity is significant. BCG estimates that $10–15 billion worth of CRDMO demand could shift to India over the next five years, driven by the “China+1” strategy and pricing pressures from U.S. legislation like the Inflation Reduction Act.
To capture this upside, Indian CRDMOs are investing in high-tech capabilities. Companies like Cohance Lifesciences are expanding into antibody-drug conjugates (ADCs) and oligonucleotides, while Divi’s Laboratories is scaling up its custom synthesis business, including GLP-1 and contrast media APIs. OneSource, meanwhile, is betting on multi-modality platforms to serve a broader range of biotech clients.
Still, the sector’s global ambitions hinge on policy support. IPSO, a newly formed industry body, is lobbying for CRDMO-specific incentives, streamlined regulations, and the creation of innovation parks to attract global suppliers and talent.
“The momentum is here. The time to seize it is now,” said Manni Kantipudi, CEO of Aragen Life Sciences and a founding member of IPSO.
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