Prostate applications generated the largest share of theranostics revenue in 2025. Commercial research firms report widely different estimates of the market share, making their figures difficult to reconcile. The more reliable conclusion is therefore directional rather than numerical: prostate applications lead the market by a wide margin. The more consequential point for anyone planning capital or capacity is that the concentration has started to loosen.
From a Single Indication Toward a Precision Oncology Platform
Somatostatin receptor targeting is the second established axis, and it is broadening. The FDA has approved lutetium-177 dotatate for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors in patients twelve years and older, supported by the NETTER-P and NETTER-1 studies, marking the first time a radiopharmaceutical has carried an adolescent indication in this disease. Preplanned and post-hoc analyses from the phase 3 NETTER-2 trial, published in eClinicalMedicine, demonstrated consistent first-line benefits across tumor grades and sites of origin, supporting earlier use of peptide receptor radionuclide therapy in neuroendocrine tumor management, much as PSMAfore supported earlier use of radioligand therapy in prostate cancer.
Gallium-68 dotatate imaging is identifying candidates who would previously have gone undetected, which widens the eligible population rather than simply reallocating it. A parallel development shows how far platform logic can be pushed inside one molecule, since Clarity Pharmaceuticals has advanced copper-64 and copper-67 forms of the same bisPSMA agent into late-stage prostate cancer trials, using a single sarcophagine-chelated molecule for both imaging and therapy. Early 2026 reports indicated that copper-64 imaging more than doubled lesion and patient detection compared with gallium-68 PSMA-11 in a head-to-head study. The market is moving beyond a single-indication model toward a platform approach in which diagnostics and therapeutics share a molecular target, with imaging serving as a commercial decision point rather than simply a clinical step.
Patient Selection Has Become the Commercial Control Point
That gate is where the commercial risk now sits. A theranostic program generates revenue only if the imaging agent, scanner, reader, and the referral pathway are all in place before the therapeutic dose is ordered. The Society of Nuclear Medicine and Molecular Imaging has been building this infrastructure precisely, designating radiopharmaceutical therapy Centers of Excellence since February 2022 across three tiers corresponding to the acuity of therapy offered, and launching a coordinated Theranostics Program in 2025 to address access, reimbursement, workforce capacity, and regulatory alignment.
The SNMMI highlights a critical bottleneck in the growth of theranostic therapies: a shortage of qualified professionals and restricted patient access. The Clinical Trials Network oversees a critical but often overlooked program to validate PET scanners and helps address these challenges. By ensuring isotope-specific accuracy, this program standardizes patient selection data, which is essential for cross-site collaboration and reliable research outcomes. For developers, the practical implication is that site readiness needs to be built into the launch plan, not addressed after launch. For investors and market access teams, the scarce asset may prove to be trained delivery capacity rather than molecules.
Radiopharmaceuticals USA 2027 sets out how theranostic pairing is being built into commercial strategy, from PSMA and somatostatin receptor patient selection through dosimetry, scanner validation, and the referral pathways that determine whether an approved therapy reaches the patients it targets.
