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Indian pharma enters $145 billion US oncology market against FDA

Indian pharma enters $145 billion US oncology market against FDA

Indian pharma majors are redoubling efforts to become significant players in the $145 billion US oncology generic market, expanding at a staggering 11% annually. Recent approvals by the FDA of generic cancer drugs have provided elbow room for Indian drugmakers to play the high-margin game as a testament to their strengthening in complex generics and biosimilars.


Among the most rapidly growing segments of therapy globally, oncology is being approached by Indian pharma players using their low-cost manufacturing capabilities and technical skills to enter this segment. Stepping up acceptance of Indian generics by the US regulatory system adds more power to their numbers, a sign of the switch from the old generics to the new ones.

Indian pharma enters $145 billion US oncology market

Global push is the advantage of strong foreign investment inflows into India’s pharma sector. The sector has received foreign direct investment (FDI) of Rs 11,888 crore in the period from April to December 2024. In addition to that, 13 proposals amounting to Rs 7,246.40 crore FDI for brownfield projects were approved in FY25, which took the overall FDI to Rs 19,134.4 crore.


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Government support under the PLI scheme

The central government’s PLI scheme has been one of the key drivers for this thrust. The scheme was introduced in 2021 with an outlay of Rs 15,000 crore and has been stressing high-value pharma like complex generics, biopharma, and oncology products. The plan has not only exceeded its target investment of Rs 4,000 crore as a first phase by collecting Rs 4,253.92 crore in 2024 but has achieved that by reducing dependence on imports and increasing exports.

Big Projects and Outlook

Facilities such as the Andhra Pradesh-based Penicillin G facility and the Himachal Pradesh-based Clavulanic Acid facility will reduce import costs by a significant amount and promote domestic strengths. Indian pharma players, driven by strong manufacturing, innovation, and government-supported fundamentals, will pick up a sizable chunk of the US oncology market.

This strategic growth not only establishes India’s place in the world of pharma but also demonstrates its ability to emerge as a market leader of high-value therapeutic classes.

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