Radiopharmaceuticals continue to transform both diagnostic imaging and targeted cancer therapy, with an increasing potential to expand into non-cancer therapies as treatment or biomarker. The supply chains supporting these technologies remain fragile. In 2025, the combined effects of rapid market expansion, recurring isotope shortages, aging reactor infrastructure, and uneven global production capacity are creating operational and clinical uncertainty. High-profile disruptions—particularly shortages of molybdenum-99 (Mo-99) and technetium-99m (Tc-99m)—have led to canceled procedures and strained hospital workflows. At the same time, demand for therapeutic isotopes such as actinium-225 (Ac-225), lead-212 (Pb-212), and lutetium-177 (Lu-177) is accelerating faster than new production capacity can be built. Although these remain in the clinical trial realm at present there is every indication of movement to early approvals.

Industry participants are responding with strategic investments, vertical integration, and new production technologies, while regulators move toward enhanced supply-chain mapping and risk mitigation frameworks. Hospitals, imaging centers, and drug developers will need initiative-taking strategies, including diversified sourcing, contingency planning, and strengthened CDMO partnerships to navigate volatility. Ultimately, ensuring reliable access to critical isotopes will require coordinated action across industry, academia, government, and healthcare systems. Academic institutions also play a critical role in sustaining isotope availability. Facilities such as the Missouri University Research Reactor (MURR), McMaster University, and TRIUMF exemplify the essential academic contribution to the radiopharmaceutical supply chain, supporting both clinical use and early-stage research through reactor- and accelerator-based production.

Why This Matters Now

Modern medicine depends heavily on a handful of radioisotopes. Tc-99m alone supports approximately 80% of all nuclear medicine procedures, making it indispensable for diagnosing cardiovascular disease, bone pathology, and cancer. Therapeutic isotopes—particularly Ac-225, Pb-212, and Lu-177—are driving a rapidly expanding market of targeted radionuclide therapies, with projections showing strong commercial growth and significant investment interest. In diagnostics, fluorine-18 (¹⁸F)—most notably used in FDG—remains pivotal for PET imaging across all clinical indications. Despite its significant role, the current cyclotron network faces structural limitations, creating growing constraints on reliable FDG supply.

Recent supply disturbances have underscored the system’s fragility. When the High Flux Reactor (HFR) in Petten went offline, widespread shortages in Mo-99 and Tc-99m quickly followed, forcing some facilities to delay or cancel patient procedures. These challenges persist: several Tc-99m radiopharmaceutical formulations remain listed as being in shortage in 2024–2025.

Given the continued growth of diagnostic and therapeutic radiopharmaceuticals—and the complex, time-sensitive logistics required for safe production and delivery, understanding the drivers of supply instability is more urgent than ever.

The Current Supply Picture: Diagnostics and Therapeutics 

Diagnostics: Mo-99 → Tc-99m 

Mo-99 production is concentrated among a small number of aging research reactors. Outages or maintenance events at any of these sites, including the Petten/HFR and South Africa’s SAFARI-1 reactor, cascade through the system. When reactors halt production, generator manufacturers face shortages, and downstream radiopharmacies must ration supply.

In 2024–2025, outages triggered regional disparities in Tc-99m availability, with hospitals in Europe and North America reporting reduced generator shipments and altered scheduling. Because the isotope decays rapidly—Mo-99 has a 66-hour half-life—buffer inventories are minimal, and disruptions propagate quickly through the clinical ecosystem. There have been continued fragilities in the Mo-99 supply chain since the first crisis in 2008 when the Chalk River reactor suddenly went out of commission for a prolonged period. Many reactors are aging and commissioning of promised new reactors have been repeatedly delayed, including the Jules Horowitz Reactor, now projected to come online around 2032, reflecting significant delays relative to earlier timelines.

Additionally, FDG production is approaching a practical ceiling in many regions due to saturation of the existing cyclotron network. Low reimbursement rates and limited economic incentives have slowed investment in new cyclotron infrastructure, even as PET demand continues to grow. This imbalance introduces a distinct but increasingly critical supply risk that differs from reactor-dependent isotopes and warrants focused planning by health systems and policymakers.

Therapeutics: Alpha and Beta Emitters

The surge in radiopharmaceutical development pipelines has put unprecedented pressure on isotope production, especially for:

• Actinium-225 (Ac-225): Considered a cornerstone for next-generation targeted alpha therapies, but global supply remains extremely limited.
• Lead-212 (Pb-212): Interest is expanding, yet scalable production methods are still maturing.
• Lutetium-177 (Lu-177): Demand for approved therapies and pipeline agents continues to grow, straining enrichment, irradiation, and processing capacity.

Major pharmaceutical companies have responded by buying stakes in isotope producers to secure supply for their therapeutic pipelines. These investments reflect both the clinical potential and the structural supply risk inherent in therapeutic isotopes.

A Market Under Strain

The radiopharmaceuticals market is expanding quickly, driven by clinical success, regulatory momentum, and investor confidence. Yet this demand growth is outpacing production capacity across key isotopes—leading to bottlenecks, competition for reactors and processing facilities, and downstream pressure on CDMOs and radiopharmacies and delays in clinical trial recruitments.

Key Vulnerabilities in the Radiopharmaceutical Supply Chain

1. Single-Point Production Risks

Isotope production relies heavily on a handful of reactors, many of which are decades old. An additional consideration is that some reactor-based production capacity is located in regions with more restricted geopolitical access, including parts of Russia and Central Asia, introducing potential long-term uncertainty related to trade, sanctions, and international transport.

New reactor projects often require a minimum of 8–12 years from design to commissioning, leaving limited flexibility in the near term.

2. A Complex, Multi-Step Chain

Producing most medical isotopes involves sequential steps—procurement of enriched targets and target material, irradiation, chemical processing, radiolabeling, quality control, and temperature-controlled transport. Each link introduces delays and risks.

3. Regulatory and Cross-Border Logistics

Radiopharmaceuticals must move quickly and compliantly across borders, often under tight decay timelines. Export controls, customs delays, and variable national regulations can slow delivery. The European Medicines Agency (EMA) has highlighted the need for improved coordination and real-time transport planning across jurisdictions.

4. Raw-Material and Capacity Mismatches

Novel therapeutic isotopes depend on specialized production methods (cycling, reactor, or accelerator-based). Production capacity for enriched targets and therapeutic isotopes remains well below demand, leading to delays in R&D and commercialization. Peer-reviewed analyses continue to highlight these mismatches as a barrier to pipeline progress.

5. Competition for Limited Resources

Because isotope producers and CDMOs often operate near full capacity, organizations with larger or long-standing supply contracts may receive priority. Smaller or emerging companies can face challenges securing irradiation slots, enriched materials, or manufacturing time—creating real obstacles for early-stage clinical programs. These competitive dynamics are increasingly evident in both market analyses and stakeholder discussions.

How Industry Is Responding

1. New Production Capacity

Companies and research institutions are investing in cyclotron-based and non-reactor production methods to reduce dependence on aging research reactors. Several commercial projects aim to create more resilient Mo-99 production pathways, including neutron-free technologies and regional facilities to localize supply.

3. Growth of CDMOs and Regional Radiopharmacies

Contract development and manufacturing organizations (CDMOs) are expanding capabilities in sterile manufacturing, handling short-lived isotopes, and scaling batch production. Regional radiopharmacies are investing in localized dose production to reduce transportation time and protect against national or international disruptions.

4. Regulatory and Policy Responses

The EMA and other regulatory bodies are increasingly focused on supply-chain mapping, risk assessment, and harmonized transport frameworks. These initiatives seek to provide earlier warnings of supply disruptions and improve resilience across borders.

What Hospitals, Imaging Centers, and Sponsors Should Do Now

1. Conduct Supply-Risk Mapping

Organizations should map all radiopharmaceuticals they depend on, identifying single-source isotopes and estimating buffer inventory capacity. EMA guidance emphasizes the importance of this structured risk assessment approach.

2. Strengthen Clinical Contingency Planning

Hospitals should define alternative imaging pathways, develop clear patient communication strategies, and establish policies for rescheduling in the event of shortages. Recent reporting on Mo-99 shortages highlights how disrupted schedules can cascade through care teams and patient populations.

3. Enhance Procurement Strategy

Diversifying suppliers—adding regional radiopharmacies, national distributors, or alternative generator providers—can help mitigate disruption. Contract language should address delivery windows and rapid-communication protocols.

4. Build Strategic Partnerships

Sponsors and imaging centers can collaborate with CDMOs and manufacturers to secure production slots, explore local dose-production models, and share logistics resources. These partnerships help reduce decay-related loss and cold-chain risks, particularly for short-lived isotopes.

Policy and Investment Implications

Governments and regulators have a critical role in stabilizing supply. Policy priorities should include:

• Incentives for domestic production to reduce dependence on aging international reactors.
• Streamlined customs processes for medical isotopes with short half-lives.
• Funding mechanisms to support commercially challenging, small-volume isotopes.
• Improved coordination and data sharing on supply risks, consistent with EMA recommendations.
• Shortening approval procedure for new production sites.

Investment in infrastructure, enrichment capabilities, and workforce development will also be necessary to meet long-term demand.

Outlook for 2026 and Beyond

Three plausible scenarios emerge:

• Diversification and Stability: New reactors, accelerator-based production, and pharma investments reduce disruptive outages.
• Demand Outpaces Capacity: Radiotheranostic pipelines grow faster than manufacturing infrastructure, leading to ongoing shortages.
• Geopolitical and Trade Risks: Export restrictions, supply conflicts, or logistical bottlenecks introduce new regional challenges.

Most experts expect a hybrid landscape—incremental improvements in Mo-99 availability paired with ongoing pressure on Ac-225, Pb-212, and other high-demand therapeutic isotopes. Market growth projections remain strong, and strategic investment continues to accelerate.

Conclusion

The radiopharmaceutical supply chain is under unprecedented strain—yet actionable steps can meaningfully reduce risk. By diversifying suppliers, strengthening partnerships, and implementing structured contingency planning, healthcare organizations and drug developers can enhance reliability and protect patients from disruptions.

Bracken supports stakeholders across medical imaging, nuclear medicine, and radiopharmaceutical development with clinical development, regulatory readiness, vendor evaluation, and strategic partnership planning. To discuss how we can help your organization prepare for the next era of radiopharmaceutical innovation, please contact us.