Supply Chain Under Radioactive Pressure: More Capacity, New Bottlenecks for Radiopharmaceuticals in 2026
Bracken
The radiopharmaceutical supply problem is changing.
For years, much of the industry's supply-chain conversation centered on a straightforward question: Can enough isotope be produced to meet demand? That question is still important to pose, but it no longer captures the full challenge.
Across the industry, manufacturers, isotope producers, pharmaceutical companies, and governments are investing in new capacity. New production routes are being developed, manufacturing footprints are expanding, and additional suppliers are entering markets that have historically depended on a relatively small number of sources.
At the same time, demand is scaling. Commercial radiopharmaceutical therapies are reaching larger patient populations, clinical pipelines continue to expand, and more programs are progressing toward later-stage development and commercialization.
The result is a larger and more distributed supply chain—but not necessarily a simpler one.
Increasing isotope production can relieve one constraint while exposing another downstream. Precursor materials, processing, finished-dose manufacturing, quality control, transportation, treatment-site capacity, and workforce availability can each become the next limiting factor.
Now, supply-chain resilience means managing the entire pathway from isotope source to patient, not simply producing more isotopes.
Demand is Scaling Alongside Supply
Radiopharmaceutical therapies are no longer being planned only around relatively contained clinical-trial volumes. Commercial demand is increasingly part of the equation.
One clear example came in March 2025, when the FDA expanded the indication for Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) to include certain patients with PSMA-positive metastatic castration-resistant prostate cancer before taxane chemotherapy. That moved the therapy earlier in the treatment pathway and broadened the population that may be eligible to receive it.
Changes like this have implications well beyond the drug itself. More eligible patients mean greater requirements for isotope supply, drug-product manufacturing, geographic manufacturing coverage, transportation, qualified treatment centers, and trained personnel.
That makes commercial forecasting increasingly important. A supply model capable of supporting an early clinical study may look very different from one needed to reliably manufacture and deliver thousands of patient-specific doses across multiple regions.
The question is therefore shifting from whether the industry can produce enough isotope to whether the rest of the ecosystem can scale alongside that production.
The 2026 Supply Picture: Progress is Uneven Across Isotopes
There is no single radiopharmaceutical supply chain. Different isotopes have different production routes, precursor requirements, half-lives, manufacturing needs, and vulnerabilities. The progress being made across several important isotopes illustrates just how varied those challenges can be.
Mo-99 / Tc-99m: Reducing Dependence Does Not Eliminate Downstream Risk
Molybdenum-99, the parent isotope of technetium-99m, remains essential to nuclear medicine and has historically depended on a relatively small global production network.
Efforts to strengthen U.S. domestic production continue. In April 2026, the U.S. Department of Energy issued a conditional commitment for a loan of up to $263 million to support completion of SHINE Technologies' Chrysalis facility in Wisconsin. The project is intended to establish a domestic commercial supply of Mo-99 without relying on proliferation-sensitive highly enriched uranium.
Yet the experience of Tc-99m-based products also demonstrates why reactor or isotope capacity is only part of the equation.
In early 2026, U.S. sites experienced shortages of Tc-99m pyrophosphate (PYP) and Tc-99m hydroxymethylene diphosphonate (HMDP/HDP), products used in cardiac amyloidosis imaging. Manufacturer updates cited constraints including active-ingredient availability, limited released lots, and the need to rebuild safety stock.
In other words, the radioactive isotope can be available while another component required to turn it into a usable product becomes the bottleneck.
Lu-177: A More Diverse Supply Base Is Taking Shape
Lutetium-177 supply is becoming more geographically and commercially diversified.
In March 2026, the University of Missouri Research Reactor announced worldwide availability of its GMP no-carrier-added Lu-177, expanding access beyond its established U.S. customer base.[4] In Europe, NRG PALLAS and Global Morpho Pharma announced a partnership intended to establish an independent supply chain for no-carrier-added Lu-177 chloride in the Netherlands.
There is also an important precursor issue behind Lu-177 production. European authorities have identified dependence on foreign supplies of enriched ytterbium-176—a key starting material for some Lu-177 production routes—as a strategic vulnerability. That is driving additional efforts to diversify not just isotope production, but the materials required to produce the isotope in the first place.
Finished-dose manufacturing is expanding as well. Novartis opened its third U.S. radioligand therapy manufacturing site in Carlsbad, California, in 2025 and has since moved forward with additional facilities in Florida and Texas, while expanding existing capabilities in Indianapolis and New Jersey.
Together, those investments represent real progress. They also illustrate how resilience increasingly depends on several layers of capacity at once: target material, isotope production, processing, drug-product manufacturing, and geographic proximity to patients.
Ac-225: Significant Investment, but Supply Remains a Development Constraint
Actinium-225 remains one of the industry's most closely watched supply challenges. Its capacity is growing. Cardinal Health began routine Ac-225 production in late 2024 and announced another major expansion in April 2026, noting that it had quadrupled weekly output since starting routine production.
Much larger projects are also underway. In May 2026, TerraPower Isotopes broke ground on a 250,000-square-foot cGMP Ac-225 manufacturing facility in Philadelphia. The company says the new facility, together with expansion of its existing Washington operation, is expected to increase its production capacity twentyfold. Commercial cGMP production at the Philadelphia site is planned to begin in 2029.
Large amounts of future capacity are being developed, but future capacity cannot support today's development programs. Sponsors still have to plan around the supply that is qualified and available now.
Upstream materials add another consideration. In May 2026, the Department of Energy described efforts to recover and recycle radium-226 from legacy inventories because Ra-226 can serve as feedstock for the production of Ac-225 and other medically important alpha emitters.[10]
That is an important lesson for the broader industry: expanding production can simply move the supply question one step upstream if precursor and target-material availability are not considered at the same time.
Pb-212: Generator Models Could Change the Geography of Supply
Lead-212 presents a different challenge because of its relatively short half-life.
One response is to change the supply model itself. Partnerships involving Pb-212 increasingly pair centralized production of longer-lived precursors with generator technology that enables Pb-212 to be produced closer to where it will be used.
Generator-based approaches will not remove every manufacturing or logistical constraint, but they illustrate an important direction for the industry: for some isotopes, resilience may depend less on shipping finished isotope farther and more on moving part of the production process closer to the end user.
The Bottleneck Is Moving Down the Chain
All of these developments point to the same underlying issue.
Isotope production is only one step in a tightly connected process: Raw and precursor material → isotope production → separation and purification → drug-product manufacturing → quality control and batch release → transportation → site receipt → patient administration. An interruption anywhere in that sequence can prevent an otherwise available isotope from becoming an administered dose.
Even organizations responsible for isotope production emphasize this distinction. This is why total announced production capacity should not be treated as a proxy for total available patient doses.
A reactor outage matters. So does a shortage of enriched precursor material. So does a purification constraint, an unavailable manufacturing slot, a batch that cannot be released, or a shipment that misses its delivery window. Resilience has to be evaluated end to end.
Aging Infrastructure Still Creates Transition Risk
At the same time that new production models are emerging, much of the traditional medical-isotope ecosystem still depends on aging reactor infrastructure.
The challenge is not simply building replacements. New nuclear infrastructure takes years to design, permit, construct, validate, and bring into commercial operation. New capacity will strengthen the system over time, but the transition itself is a supply-chain risk that requires active management.
Logistics and Treatment Capacity Are Part of the Supply Chain
Radiopharmaceutical logistics are unusually unforgiving. Unlike conventional pharmaceutical inventory, radioactive material is losing usable activity from the moment it is produced. Because of this, a delayed shipment can be more than an inconvenience. It can shorten a product's usable window or make a dose unusable altogether.
The problem is significant enough that the International Atomic Energy Agency established a Denial of Shipment Working Group focused specifically on delays and refusals involving compliant radioactive-material shipments. Its 2026 findings noted that persistent shipment delays and denials continue to disrupt supply chains and can jeopardize healthcare when time-sensitive radioactive medical materials do not arrive as planned.
But successful delivery still does not guarantee patient access. Radiopharmaceutical therapy depends on qualified facilities and multidisciplinary teams that may include nuclear medicine physicians, radiopharmacists, radiochemists, medical physicists, technologists, nurses, radiation safety personnel, and other specialists. Centers also need appropriately licensed space, treatment rooms, equipment, procedures, and operational capacity.
More Capacity Requires Better Forecasting
There are signs that some isotope supply conditions are improving.
A June 2026 Government Accountability Office review found that, in Department of Energy Isotope Program data, the number of isotopes experiencing market disruptions declined from 40 in 2023 to 25 in 2025.
But the same report identified an important weakness: DOE's isotope program did not systematically assess market demand and align production decisions to those needs. GAO warned that without more proactive forecasting and mitigation, responses to emerging shortages could come too late.
The lesson extends beyond government isotope production. As radiopharmaceutical programs move from research into clinical development and from clinical development into commercial use, forecasts have to become more sophisticated. Sponsors need visibility into more than the quantity of isotope they expect to need. They need to understand the dependencies behind it, as well. Where does the precursor material originate? How many production routes are qualified? What competing programs could draw from the same capacity? Where will drug product be manufactured? How long does release take? How will doses move to treatment centers? What happens when a shipment is delayed? Can sites absorb a sudden increase in patient volume?
Those questions are easier—and generally less expensive—to address before a program is approaching launch.
What Sponsors and Manufacturers Should Do Now
For sponsors, manufacturers, and other organizations developing radiopharmaceutical programs, supply-chain planning should begin early and extend beyond procurement.
Several practical priorities stand out:
- Map the full supply chain. Include precursor materials, targets, isotope production, processing, manufacturing, QC and release, transportation, treatment sites, and waste-handling requirements.
- Identify secondary sources before they are needed. Alternative suppliers and manufacturing routes are most useful when they have already been evaluated, contracted, and qualified.
- Model scale early. Clinical-stage supply requirements can understate what will be needed if an indication expands or a product reaches commercialization.
- Evaluate geography alongside capacity. For short-lived isotopes in particular, where something is produced can matter almost as much as how much can be produced.
- Build transportation contingencies into the plan. Alternate carriers, routes, packaging strategies, and delivery scenarios should be considered before an interruption occurs.
- Assess treatment-site readiness. Manufacturing capacity is only useful if qualified centers have the people, licenses, space, equipment, and scheduling capacity to administer the therapy.
- Connect supply planning across functions. CMC, clinical operations, regulatory strategy, site feasibility, commercial planning, and supply-chain teams should be working from the same assumptions.
Most importantly, supply resilience should be treated as a development-strategy issue, not simply a procurement responsibility.
Outlook: More Capacity, New Bottlenecks
There is good reason for optimism about radiopharmaceutical supply.
Production is expanding. Manufacturing is becoming more geographically distributed.
Generator technologies offer new options for shorter-lived isotopes. New commercial suppliers are entering the market. Governments are investing in domestic capabilities and precursor security. The industry's dependence on individual facilities or production routes should gradually decrease.
But greater capacity will not eliminate complexity. The emerging radiopharmaceutical supply network is likely to be a hybrid of established research reactors, new reactor capacity, accelerator-based production, regional manufacturing, generator technologies, precursor recovery and recycling, and multiple commercial suppliers.
That model can be considerably more resilient than the one it is replacing—but only if the connections between those pieces are planned as carefully as the individual pieces themselves. The strongest radiopharmaceutical programs will be those that anticipate where the next constraint could emerge rather than waiting for the current one to be solved.
Build Supply Resilience Into Development Strategy
Radiopharmaceutical development requires coordination across science, manufacturing, clinical operations, logistics, regulation, and patient delivery. Bracken helps organizations identify those cross-functional risks early and build strategies that account for how decisions in one part of a program affect the rest.
Our radiopharmaceutical expertise spans development strategy, manufacturing and CMC, clinical operations, regulatory strategy, medical imaging, due diligence, and supply-chain evaluation. Contact Bracken to learn more about how we can support your program.