Indian Pharma Eyes $145 Billion US Oncology Market Amid Surge In FDA Approvals

New Delhi: Indian pharmaceutical companies are ramping up efforts to expand their footprint in the lucrative US oncology generics market, which is currently valued at $145 billion and growing at a robust pace of 11 per cent annually, according to a new report.

In recent months, several Indian drug makers have secured approvals from the US Food and Drug Administration (FDA) for generic versions of cancer drugs which marked a steady increase in the entry of complex generics and biosimilars into the American market.

With oncology emerging as one of the fastest-growing therapy segments globally, Indian firms are positioning themselves to tap into this high-value space by leveraging their strength in affordable manufacturing, technical expertise, and increasing regulatory approvals, the report said.

Industry experts say this marks a shift from traditional generics to more complex formulations -- reflecting the evolving capabilities of Indian pharma companies.

This growing global push coincides with robust foreign investment trends in the domestic sector.

According to the Department of Pharmaceuticals, India’s pharmaceutical and medical devices sector received a foreign direct investment (FDI) inflow of Rs 11,888 crore between April and December 2024.

Additionally, 13 FDI proposals worth Rs 7,246.40 crore for brownfield projects were approved during FY25, taking the total FDI to Rs 19,134.4 crore.

Much of this momentum is driven by the central government's production linked incentive (PLI) Scheme, which aims to boost domestic manufacturing, reduce import dependency, and enhance exports.

The scheme, launched in 2021 with a financial outlay of Rs 15,000 crore for pharmaceuticals, focuses on high-value products such as complex generics, biopharmaceuticals, and anti-cancer drugs.

One of the notable outcomes of the scheme is the exceeding of the initial investment target. While the original commitment stood at Rs 3,938.57 crore, actual investments touched Rs 4,253.92 crore by the end of 2024.

Projects like the Penicillin G unit in Andhra Pradesh and the Clavulanic Acid facility in Himachal Pradesh are among key beneficiaries, expected to significantly cut import costs.

Disclaimer: This is a syndicated feed. The article is not edited by the FPJ editorial team.