The field of targeted nuclear medicine is rapidly evolving as new players and innovative therapies enter the space. Two Lu-177 targeted radiotherapies are currently marketed from Novartis, for Prostate Cancer (Pluvicto), and Neuroendocrine Tumors, NETs, (Lutathera). These registered a combined revenue of USD 2.7B in 2025.
The Lu-177 market is undergoing rapid evolution and growth due to new entrants and expansion of indications. A generic for Lutathera has been tentatively approved by FDA, and final approval is likely by June ‘26 based on the timeline for legal requirements. An NDA from a European company for the NETs is awaiting approval, with assigned PDUFA date of August 28,2026. Last year, patient pool of Pluvicto was significantly expanded by excluding the requirement of chemotherapy prior to radiotherapy. Studies on the expansion to earlier stage of the disease, for hormone-sensitive prostate cancer patients, are in progress.
A detailed report on the current market scope, competitive landscape, market analysis, and TAM projection till 2035, useful for investors and business and enthusiasts, is available for purchase at this website at this link: Lu-177 Landscape.