By Daniel Blumin, Associate Partner

Nuclear medicine has spent two decades as a specialized corner of the treatment landscape; clinically meaningful, limited in scale, and operationally unlike almost anything else a manufacturer brings to market. That characterization is becoming harder to defend. More than 20 PET radiotracers now carry FDA approval alongside 25 or more SPECT analogs, with the global radiopharmaceuticals market projected to grow at roughly 7.3% annually through 2033.1 Since 2021 the space has averaged more than three acquisitions per year, with eight in 2025 alone, spanning therapeutics, diagnostics, isotope production, radiopharmacy networks, and CDMO capacity. Manufacturers have not only been buying assets; they have been buying the ability to produce and distribute them.

The question is not whether this category expands, but what happens when a class built around low volume and limited competition absorbs a wave of new entrants. Density is rising for both diagnostics & therapeutics. RLT pipelines are expanding into earlier lines of therapy, with development tilting noticeably toward alpha emitters such as Ac-225, Ra-223, and Pb-212. The provider question shifts from whether a tracer exists for an indication, to which agent a site can obtain reliably, on schedule, with reimbursement that holds. Competition is now fully moving from label & availability, to delivery capability & provider choice.

Source: The Dedham Group landscape analysis.

Novel Market Access Risk: RBM & Payer Attention

With this increase in class saturation, payers & affiliated radiology benefit managers (RBMs) are starting to take notice of this shift. Major RBM groups like EviCore, Carelon and Evolent are growing their partnerships with over ~68 payer plans representing ~34% Total Medical Lives*. Of these payers, ~88% involve or fully carve out the development of their UM policies to RBMs, to navigate the rapidly moving complexities of the growing PET and SPECT market. Denials across novel tracers are starting to grow (primarily in cardiac & oncology diagnostics), with ~68% of surveyed providers citing RBM involvement in radiotherapeutic access as negatively affecting care delivery (e.g. delays, appeals, & peer-to-peer assessment).

Policy development from RBMs is becoming increasingly more stringent, nuanced, and divergent based on analysis of published guidelines and economics. EviCore, Carelon, and Evolent each maintain independently developed imaging criteria that diverge in consequential ways; some permit PET as a first-line option while others reserve it for cases where an alternative modality is unsuitable. Novel patient management criteria are being introduced by certain RBM-affiliated payers where PET scans are accessible only if certain patient criteria are met. RBMs are also starting to take notice of economic levers within the radiotherapeutic space, citing potential for preferences when tracer costs reach a ~15-20% difference, reacting to the CMS CY2025 unbundling policy2, and monitoring TPT status & expiration. This increased emphasis on brand economics & patient journey continues to apply pressure to manufacturers entering the market.

Supply Chain & Distribution Access Gaps

Another core access element impacting manufacturers focuses on delivery. Radiopharmaceutical supply chains differ from traditional oncology distribution structurally, as isotope half-life dictates the entire distribution framework. F-18 agents (with a ~110-minute half-life)3 support centralized production and regional distribution, while shorter-lived isotopes compress the window between production and administration to the point that scheduling, transport, and imaging capacity must be coordinated as a single system. A delayed shipment is not a backorder; it is a missed dose and a cancelled appointment.

Site-level requirements compound this, as handling nuclear material requires hot lab capability or conversion, specialized administration suites, dedicated disposal pathways, licensed transport vessels, and staff certification against NRC and state requirements most practices have never carried. Isotope sourcing adds a further dependency, as the pipeline’s tilt toward Ac-225 concentrates demand on material whose production and waste handling sit under strict federal management.

These constraints bind hardest in the community channel, where practices often lack the capital, infrastructure, and staffing for a compliant program, and are reasonably reluctant to assume regulatory risk without financial support. Private equity, vertical integration, and MSOs are beginning to change that arithmetic, while manufacturers pursue radiopharmacy and CDMO partnerships aimed at bringing hot lab capability closer to the point of care by ~2030.

Why This Matters Now

For manufacturers bringing novel tracers or RLTs to market, the launch roadmap has to be built backward from administration. Distribution design, CDMO and vendor selection, isotope sourcing, and site enablement are not downstream execution details; they determine whether a product can be prescribed, received, and given to a patient at all. Those networks will only grow more competitive as entrants pursue the same limited capacity.

For established on-market assets, the more immediate exposure is access. The combination of rising competitive density, newly visible per-dose cost, and growing RBM infrastructure already positioned to manage imaging suggests that a category accustomed to open access should expect a more managed environment. Manufacturers whose access strategy was built for an unmanaged market may find it aging quickly, and the most durable defenses take time to build.

More broadly, there will simply be more attention on nuclear medicine through 2030. Incumbents that have operated with limited competition will face entrants with fresh capital and integrated supply. New entrants will find that scientific differentiation is necessary but not sufficient for success and downstream patient administration. For both radiodiagnostics and radiotherapeutics, the strategic work is the same; a market access approach that anticipates management rather than reacting to it, and a launch plan that treats the delivery system as a core design input rather than a logistics problem to solve later on in the patient journey.

Find out how The Dedham Group’s expertise can inform your radiopharmaceutical launch, supply chain, and market access strategy. Contact us. 

 

 

Sources

* Total percentage lives figure factors in state-level carveouts for large national plans

1 Congruence Market Insights. Radiopharmaceuticals Market Size, Trends, Share, Growth, and Opportunity Forecast, 2026–2033. August 2026. https://www.congruencemarketinsights.com/report/radiopharmaceuticals-market

2 Centers for Medicare & Medicaid Services. CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1809-FC). Fact sheet, November 1, 2024. https://www.cms.gov/newsroom/fact-sheets/cy-2025-medicare-hospital-outpatient-prospective-payment-system-ambulatory-surgical-center-payment

3 U.S. Food and Drug Administration. Fludeoxyglucose F 18 Injection, prescribing information (NDA 21-870), section 11.2 Physical Characteristics. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021870lbl.pdf