In contrast to the robust domestic outlook, the U.S. market outlook is more cautious for the Indian pharmaceutical sector and after a strong FY25, where revenues grew 9.9% over the previous year, growth is expected to slow down due to price erosion and declining sales of lenalidomide, a key revenue contributor in previous years, according to ratings agency ICRA. Lenalidomide is used to treat anaemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS).
It added that regulatory scrutiny by the U.S. Food and Drug Administration (USFDA) remains an ongoing risk factor, with warning letters and import alerts delaying product launches and triggering the imposition of failure-to-supply penalties. These issues also impose significant costs for remediation, including consultant fees and increased management bandwidth, which tend to weigh on margins.
