Radioligand therapies (RLTs) are poised to transform the oncology treatment paradigm and transition to more mainstream treatment in oncology. Recent commercial success with RLTs like Lutathera and Pluvicto in hard-to-treat cancers (GEP-NETs and late-stage prostate cancer, respectively) emphasizes the clinical benefit supported by their unique mechanism of action. With a robust pipeline showing increasing diversification in isotopes, ligand targets, and tumor types, RLTs have the potential to deliver clinical value to a broader group of patients in oncology in an even more precise manner. For many stakeholders, however, this novel modality is relatively unknown, and manufacturers must overcome unique barriers to unlock broad patient access and maximize the commercial potential.
RLTs are designed to bind specifically to their target cell and induce cell death by emitting alpha or beta radiation depending on the isotope used.
The evolving pipeline shifts from bone-targeting moieties to leveraging different targeting ligands for specific tumors. Currently, various isotopes and tumor types are under investigation.
Enablers and barriers for radioligand therapies
To optimize the opportunity for next wave RLTs it will be key to carefully navigate the market access, commercial, and policy landscape.
Enablers
Market access
» Strong access outcomes due to breakthrough clinical value and survival outcomes, enabled by targeted delivery of radiation that destroys cancer cells
» Potential to expand into broader indications, in combinations, and into earlier line settings for high unmet need populations
» Dual role in diagnostics and therapy leveraging different isotopes on the same target e.g., PSMA
Commercial
» Strong market growth (estimated CAGR ~5-10%) for emerging innovations like novel ligands and alpha-emitting therapies signaled by recent commercial success (e.g., Pluvicto in 3L mCRPC)
» Barriers to competitive entry due to complex manufacturing and infrastructure requirement may reduce competition across the product lifecycle, including post-LoE
Policy
» Growing interest in enhancing healthcare system readiness to harness the potential of radiopharmaceuticals and support equitable access
» Increasing investment and funding to support system readiness, including the expansion of diagnostic services and training for nuclear medicine
Barriers
Market access
» Limited payer recognition of innovation of RLTs
» Evidence challenges in demonstrating robust QoL and long-term efficacy/safety
» Fractured funding and access pathways for diagnostics (e.g., PSMA-PET) across markets and regions
Commercial
» Variable healthcare system readiness and complex patient journeys
» Manufacturing and supply chain challenges and risk of in-house production
» Low physician and patient awareness and hesitancy around radioactive medicine
Policy
» Remaining regulatory complexity (e.g., dual governance by medicines and nuclear agencies)
» Long lead times and slow implementation of policy changes, with need to engage many different stakeholders across disciplines
The recent success of next-generation radiopharmaceuticals highlights the opportunity for this innovative treatment class across indications. Given the evolving market access, commercial, and policy landscape, early cross-functional planning, proactive market shaping to support RLT readiness, and tailored value communication will be critical to optimize development and launch success.
Sources: CRA Analysis, Clinicaltrials.gov | Acronyms: CNS – central nervous system; GEP-NETs – Gastroenteropancreatic neuroendocrine tumors; LoE – Loss of exclusivity; mCRPC – metastatic castrate resistant prostate cancer; NENs – Neuroendocrine neoplasms; PC – Prostate cancer; PET – Positron emission tomography; PSMA – Prostate-specific membrane antigen
