Radiopharmaceutical Supply Chain Under Pressure: Can Infrastructure Keep Up with Demand?

Radiopharmaceuticals are experiencing a renaissance. From precision oncology with lutetium-177-based therapies to increasing demand for diagnostic procedures performed daily in the U.S., nuclear medicine has never been more clinically vital. However, beneath this wave of innovation lies a supply chain struggling to keep pace — one where aging infrastructure, production bottlenecks, and constraints based on the physics of radioactive decay create persistent vulnerabilities for both PET and SPECT.

Fragile Foundations: The Tc-99m Challenge

The most widely used diagnostic isotope in nuclear medicine, Tc-99m, depends almost entirely on a handful of aging research reactors scattered across the globe. Although the United States began limited domestic commercial Mo-99 production in 2018, it still relies on a small number of aging foreign reactors for the bulk of its supply. The consequences of that dependency became painfully clear in late 2024, when a pipe deformation forced the High Flux Reactor in Petten, Netherlands offline — just as reactors in Poland and Belgium entered scheduled maintenance. According to the Society of Nuclear Medicine and Molecular Imaging, the overlapping shutdowns triggered supply shortages of 50% or more across regions, with some areas experiencing complete (100%) shortfalls. Some departments were forced to halt affected procedures entirely. Because Tc-99m has a half-life of just six hours, there is no option to stockpile. When supply breaks, patient care breaks with it.

Therapeutic Isotopes: Demand Outpacing Capacity

On the therapeutic side, demand for isotopes like lutetium-177 and actinium-225 is surging as radioligand therapies gain traction in oncology. But production has struggled to keep up. After Pluvicto’s 2022 launch for metastatic prostate cancer, demand quickly outpaced output from Novartis’s single manufacturing site in Ivrea, Italy, and the FDA placed the drug on its shortage list in early 2023, disrupting patient access until additional capacity came online later that year. The challenge is fundamental: producing lutetium-177 requires isotopically enriched targets, high-flux neutron sources, and weeks-long irradiation cycles, and the specialized workforce needed to manage these supply chains remains thin.

The Last-Mile Problem

Even when isotopes are produced, getting them to patients is a significant logistical hurdle to overcome. Short half-lives mean radiopharmaceuticals cannot sit in warehouses — they must move through tightly choreographed delivery networks measured in hours, not days. International supply routes add further risk, as geopolitical disruptions, tariffs, and trade barriers can immediately constrain an already inelastic supply. On the receiving end, hospitals must maintain specialized equipment, safety protocols, and trained staff to handle these products — a readiness gap that not all facilities have closed.

A Response Taking Shape

The industry and government are responding with unprecedented investment. SHINE Technologies is building the Chrysalis facility in Wisconsin, a fusion-driven production site expected to produce roughly 20 million Mo-99 patient doses annually and backed by a conditional commitment from the U.S. Department of Energy for a loan of up to $263 million. CMS has introduced a $10 add-on payment incentivizing the use of domestically sourced Mo-99. On the therapeutic side, Novartis has scaled to four global manufacturing sites with capacity exceeding 250,000 radioligand therapy doses per year, while SHINE’s Cassiopeia facility has become North America’s largest producer of no-carrier-added Lu-177. Across the industry, the push toward modular manufacturing, regional supply chain diversification, and redundant isotope sourcing signals a maturing infrastructure — but one still racing to catch up with clinical demand.