Europe has spent much of the past several years confronting one of nuclear medicine’s most visible vulnerabilities: whether enough medical radioisotopes will be available to support growing clinical demand. That work accelerated this month when the European Commission formally advanced the European Radioisotope Valley Initiative, a framework intended to strengthen domestic production, modernize aging infrastructure and reduce strategic dependencies on suppliers outside the European Union. Four days from now, European nuclear medicine organizations will turn their attention to a different problem; having an isotope or approved radiopharmaceutical available does not necessarily mean a patient can access it.
On September 29, the European Association of Nuclear Medicine and Nuclear Medicine Europe will hold their first joint European Nuclear Medicine Day in Brussels, bringing clinicians, industry representatives, regulators, policymakers and patients together around what the organizations describe as persistent differences in access across Europe. The meeting is expected to conclude with the first joint recommendations toward a European Access Roadmap for Nuclear Medicine, with priorities including workforce development, regulatory alignment and strategic investment. The agenda also includes dedicated discussions on reimbursement, infrastructure, isotope security and the capacity needed to support continued growth in theranostics and advanced imaging.
The timing is important. Nuclear medicine is already a substantial component of European healthcare, with more than 10 million diagnostic and therapeutic procedures performed annually, but the clinical system being asked to deliver those procedures is entering a considerably more demanding phase. Radioligand therapy is expanding, new PET tracers are moving toward clinical use, personalized dosimetry is receiving greater attention and drug developers are building pipelines that could substantially increase the number of patients eligible for radionuclide treatment over the next decade.
The distinction between supply and access is becoming increasingly important. Europe is one of the world’s largest medical-isotope producers and exports roughly half of the radioisotopes it produces, according to the European Commission. At the same time, the Commission has acknowledged vulnerabilities created by aging facilities, foreign dependencies and competition for investment, which is why isotope security has become a strategic policy issue through ERVI.
But isotope availability is only one link in a much longer chain. A radiopharmaceutical therapy also requires an appropriately equipped treatment center, trained nuclear medicine physicians, technologists, medical physicists, radiopharmacists and nurses, along with imaging capacity, radiation-safety procedures, reimbursement and referral pathways capable of moving an eligible patient into treatment. Diagnostic radiopharmaceuticals face their own barriers, particularly when access to PET/CT or SPECT/CT systems, specialized tracers or reimbursement differs materially between healthcare systems.
Those limitations become more consequential as the addressable patient population grows. A modeling study published this year by researchers including the European Commission’s Joint Research Centre estimated that the theoretical population eligible for radioligand therapies across the EU-27 could rise from approximately 11,000 to 13,000 patients in 2025 to roughly 130,000 to 180,000 by 2035 as existing treatments move into new settings and additional therapies reach the market. The researchers estimated that between 17,000 and 35,000 patients could actually receive RLT in France, Germany, Italy and Spain in 2030 under one utilization scenario, increasing to approximately 37,000 by 2035, and warned that demand could overwhelm available treatment capacity even in countries with comparatively developed nuclear medicine infrastructure.
That is a different capacity challenge from producing more lutetium-177, actinium-225 or another therapeutic isotope. Those materials can exist, the drug can be manufactured and regulatory approval can be secured while patients still encounter delays because there are not enough treatment rooms, physicians, scanners or appropriately structured clinical programs to administer it.
The September 29 agenda reflects how broadly European organizations are now defining the problem. One session focuses on regulatory and reimbursement barriers and includes representation from the European Medicines Agency, national regulators and industry. Another is dedicated to infrastructure and security of supply, followed by a workforce discussion examining whether Europe has enough trained professionals to support both existing nuclear medicine services and new requirements emerging from theranostics and advanced imaging.
That wider definition matters because Europe does not have a single healthcare system. Radiopharmaceuticals may receive centralized regulatory authorization, but reimbursement, hospital investment, staffing, referral patterns and treatment capacity remain heavily influenced by national and regional systems. A therapy available in one European country therefore may not reach patients on the same timetable or under the same conditions in another, even when the underlying medicine has cleared the same regulatory process.
The European Association of Nuclear Medicine has increasingly argued that these differences threaten to create uneven adoption of new nuclear medicine technologies. Its 2026 policy work identifies disparities in training structures, workforce capacity, referral pathways and access to advanced technology across the EU, while calling for greater coordination in education, regulation, isotope supply and investment. The organization has also launched a separate European Nuclear Medicine Forum focused on personalized theranostics through 2035, with working groups dedicated to workforce and education, infrastructure, policy, reimbursement, research and collaboration.
Taken together, those initiatives suggest that Europe is moving from a series of individual nuclear medicine policy problems toward something closer to systems planning. Isotope security is part of that system, but so are the scanners, treatment rooms, people, funding mechanisms and regulatory processes that determine whether a radiopharmaceutical ultimately reaches a patient.
The pressure is likely to become most visible in therapy. Diagnostic nuclear medicine departments have long operated within constrained staffing and equipment environments, but therapeutic radiopharmaceuticals add additional operational requirements and often keep patients inside nuclear medicine departments for longer periods. Treatment planning, administration, radiation protection, post-therapy imaging and dosimetry can all require personnel and infrastructure that were not designed around high-volume therapeutic programs.
The commercial pipeline could magnify those pressures quickly. Europe is no longer preparing for a market consisting of a small number of radionuclide treatments used in relatively narrow populations. Companies are developing radiopharmaceutical therapies against multiple biological targets and tumor types, while established products are being evaluated earlier in treatment pathways where the potential patient populations can be much larger.
The JRC-linked modeling study provides one indication of the scale that could follow. Its estimate of as many as 130,000 to 180,000 theoretically RLT-eligible patients across the EU-27 by 2035 is not a forecast that all of those patients will receive treatment, and the authors explicitly distinguish theoretical eligibility from actual utilization. The number is nevertheless useful because it illustrates the size of the population European healthcare systems may eventually have to evaluate, image, refer and potentially treat if the radiopharmaceutical pipeline continues to expand.
That creates a planning horizon very different from simply deciding whether an individual hospital should add another therapy suite. Workforce training takes years. Nuclear medicine departments require capital investment. Radiopharmacies and imaging systems have finite capacity, and reimbursement systems can move considerably more slowly than drug development. Waiting until demand arrives before addressing those constraints could leave approved therapies competing for clinical infrastructure that was never designed for their volume.
Europe has already begun addressing pieces of the problem separately. ERVI is focused on strengthening the medical-radioisotope supply chain. The European Nuclear Medicine Forum is developing a longer-term vision for personalized theranostics. EU research programs are supporting nuclear medicine technologies and workforce development, while EANM has increased its policy engagement around reimbursement, regulation and access.
European Nuclear Medicine Day appears intended to pull more of those strands together around the patient. The organizations behind the meeting are expected to present their first joint recommendations on September 29, meaning the details of any future European access roadmap are still being developed rather than finalized. The direction, however, is increasingly clear: producing more isotopes and approving more radiopharmaceuticals will not be enough if the clinical system responsible for delivering them does not expand at the same pace.
For an industry investing billions of dollars in isotopes, manufacturing plants, radiopharmaceutical pipelines and new imaging technologies, that distinction deserves more attention. Europe already performs more than 10 million nuclear medicine procedures a year and possesses some of the world’s most sophisticated isotope-production and clinical infrastructure. The challenge now is making sure the next generation of nuclear medicine does not expand faster than the healthcare system built to deliver it.
