For the field of nuclear medicine, the horizon is filled with new diagnostic and therapeutic agents that will enable a personalized approach to treating cancer, neurological disease, and cardiovascular disease, among others.
Nuclear medicine is a unique imaging and therapeutic modality. Recent breakthroughs in nuclear brain imaging have allowed for better treatment of Alzheimer’s disease, and new therapeutic agents have enabled personalized treatment options for patients with prostate cancer. In the future, advances in nuclear medicine theranostics will expand treatment options for numerous forms of cancer and rare diseases.
In 2024, the U.S. radiopharmaceutical market was valued at approximately $2.43 billion, and it is projected to double by 2033, reaching $4.86 billion with a compound annual growth rate (CAGR) of 8%. This surge in demand is driven by the expanding use of nuclear medicine. In the United States, approximately 20 million diagnostic scans are performed annually, and approximately 2,830 hospitals provide these services to Medicare beneficiaries.
Roughly 80% of diagnostic nuclear medicine procedures require technetium-99m (Tc-99m), which is produced through the radioactive decay of molybdenum-99 (Mo-99). The Missouri University Research Reactor (MURR) is the only U.S. facility producing Mo-99, and that is solely for research, not commercial use. To meet the high demand for Mo-99, the United States is heavily reliant on foreign sources for key medical isotopes. Consequently, the U.S. imports all of its commercial Mo-99, primarily from South Africa, Belgium, the Netherlands, Austria, Poland, and the Czech Republic. The U.S. consumes more than half of the global Tc-99m supply, sourced exclusively from abroad, and trade stability with nations in Africa and Europe has been imperative for patients to receive lifesaving nuclear medicine imaging and therapies.
Mo-99 is just one of more than 30 medical isotopes that the U.S. imports from other nations. These isotopes are made into radiopharmaceuticals by American companies in Ohio, Wisconsin, Florida, and other states, then quickly distributed across the country to patients in need of molecular imaging and life-saving therapies. The radiopharmaceutical supply chain is especially fragile due to the short shelf life of isotopes and limited suppliers. Geopolitical instability, unplanned reactor outages, and adverse weather can further disrupt supply. Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by tariffs.
In the future, we hope to create domestic supplies of medical isotopes for radiopharmaceutical production; however, building commercial-scale facilities for Mo-99 and other medical isotopes in the U.S. will require approximately 10 to 15 years and significant investment. With assistance from the Department of Energy, companies are making strides in the domestic production of medical isotopes such as actinium-225, but our domestic capacity to produce more medical isotopes remains limited due to high costs for facility development and aging existing infrastructure.
Recently, SNMMI submitted comments to the Department of Commerce in response to a Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients. Given the delicate nature of the current radiopharmaceutical supply chain, SNMMI believes that imposing tariffs on medical isotopes would increase costs for patients and reduce access to nuclear medicine procedures.
SNMMI looks forward to working with the Administration on developing policies that would reduce regulatory burdens, streamline licensing, and create financial incentives to foster a durable and resilient environment for innovation and business to thrive in the United States.