The radiopharmaceuticals market is entering an era of high-capacity infrastructure investment. NorthStar Medical Radioisotopes inaugurated a 52,000 sq. ft. advanced facility in Wisconsin for Ac-225 and Lu-177 production, while ITM is expanding its German facility tenfold for Lutetium-177. Specialized CDMOs, including SOFIE and Nucleus RadioPharma, are scaling clean-room manufacturing capabilities to meet clinical and investigational demands, reflecting sustained global consensus on long-term growth. In Canada, BWXT Medical is pioneering FDA approval for a Technetium-99m generator utilizing commercially produced molybdenum, securing a reliable domestic supply for 40 million annual diagnostic procedures.
Chicago, Jan. 13, 2026 (GLOBE NEWSWIRE) — The global radiopharmaceuticals market was valued at 6.8 billion in 2024 and is expected to reach US$ 13.4 billion by 2033, growing at a CAGR of 7.8% from 2025 to 2033.
Increasing market traction for radiopharmaceuticals is driven by powerful clinical results and expanding commercial adoption worldwide. The incredible sales performance of approved drugs, such as Pluvicto’s US$ 1.04 billion in revenue in the first nine months of 2024 and Pylarify’s projected sales of more than US$ 1 billion for the year, demonstrates a robust clinical adoption. This is built on a foundational diagnostic demand, evidenced by the 40 million procedures annually using Technetium-99m. The market’s value is further confirmed by massive acquisitions, including Bristol-Myers Squibb’s US$ 4.1 billion purchase of RayzeBio and AstraZeneca’s US$ 2 billion acquisition of Fusion Pharmaceuticals.
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Investor confidence is surging, funneling significant capital into emerging innovators. ITM Radiopharma’s US$ 205 million funding round and AdvanCell’s US$ 112 million Series C financing highlight a vibrant venture capital terrain. This investment is aimed at capturing a share of a rapidly expanding treatment paradigm. The sheer scale of potential is reflected in high-value collaborations, like Eli Lilly’s potential US$ 1.1 billion deal with Aktis Oncology, which was initiated with a US$ 60 million upfront payment.
Radiopharmaceutical Manufacturing Enters Era of High-Capacity Infrastructure
The radiopharmaceuticals market is undergoing a foundational expansion of its manufacturing infrastructure to fulfil explosive demand. On October 3, 2024, NorthStar Medical Radioisotopes inaugurated a 52,000 square-foot advanced manufacturing center in Beloit, Wisconsin. This purpose-built facility is created for the commercial-scale production of critical therapeutic isotopes, including Ac-225 and Lu-177. Similarly, ITM is vastly increasing its global footprint, adding a 7,000 square meter facility in Germany that will boost its Lutetium-177 production capacity tenfold. The direct investment in these large-scale facilities signals a clear industry consensus on sustained, long-term demand for targeted radionuclide therapies.
This build-out extends to specialized contract manufacturing organizations (CDMOs) in the radiopharmaceuticals market that deliver crucial development and production services. For example, SOFIE has commissioned a 20,000 square-foot theranostics manufacturing center in Totowa, New Jersey. The facility contains five Grade C (ISO 7) clean-rooms for aseptic manufacturing, with plans to double that footprint. Further illustrating the capital influx, Nucleus RadioPharma, a new CDMO, secured US$ 56 million in Series A funding to establish its own network of manufacturing facilities. In Canada, BWXT Medical is advancing its FDA submission for a new Technetium-99m generator, which will be supplied by molybdenum produced in a commercial power reactor for the first time, ensuring a stable North American supply for the 40 million diagnostic procedures performed annually.
Late-Stage Trials Drive Surging Need for Investigational Radiopharmaceuticals
Demand in the radiopharmaceuticals market is being intensely shaped by a rapidly rising and diversifying clinical trial terrain. The sheer number of patients being enrolled in late-stage studies emphasises the urgency for new treatment alternatives. Actinium Pharmaceuticals’ pivotal Phase 3 SIERRA trial for Iomab-B, for example, enrolled 153 patients with acute myeloid leukemia. Following its acquisition by AstraZeneca, Fusion Pharmaceuticals is advancing its pipeline; its AlphaBreak trial is enrolling about 60 patients in its Phase 2 portion and plans to enroll 550 patients in the subsequent Phase 3 registration study for FPI-2265 in prostate cancer, set to begin in 2025.
The scope of these trials in the radiopharmaceuticals market is broadening to new targets and indications, requiring a strong supply of investigational agents. Orano Med completed enrollment of 41 patients in its Phase II trial of AlphaMedix for neuroendocrine tumors. Perspective Therapeutics is also showing significant progress, with 42 patients having received at least one treatment in its Phase 1/2a trial of VMT-α-NET as of April 30, 2025. This includes an expansion cohort where 33 new patients were enrolled after initial positive safety signals. The progression of these numerous, large-scale, and diverse clinical programs is a primary engine pushing demand for both established and novel isotopes and precursor molecules within the global radiopharmaceuticals market.
Cardiovascular and Oncology Diagnostics Drive Sustained Tc-99m Adoption
Technetium-99m (Tc-99m) continues its undisputed reign in the radiopharmaceuticals market, holding a dominant revenue share of 42%. Its prevalence is underscored by its use in more than 110,000 medical imaging processes daily across the globe, with more than 40,000 of those occurring in the United States alone. The isotope’s utility is further solidified by a 2025 U.S. CMS proposal for a US$ 10 per dose add-on payment, enhancing its economic viability for healthcare providers. Demand is consistently propelled by the high prevalence of chronic conditions; cardiovascular diseases, which caused 19.8 million deaths in 2022, and a global cancer caseload of 19.3 million, both depend heavily on Tc-99m for diagnosis and monitoring.
The sustained leadership of Tc-99m is backed by its broad clinical applications and favorable technical characteristics. North America remains its largest market, benefiting from widespread availability and advanced healthcare systems. The constant modernization of SPECT imaging systems into more advanced hybrid technologies ensures that demand for Tc-99m remains stable and strong. The diagnostic segment of the radiopharmaceuticals market is therefore heavily influenced by the reliability and accessibility of this key isotope, which is crucial for a multitude of diagnostic pathways that inform patient treatment plans worldwide.
Government Funding and Incentives Fuel Radiopharmaceutical Expansion Across North America
North America commands the Radiopharmaceuticals market, holding more than 45% of the global share, boosted by substantial government funding, private investment, and a rapidly growing infrastructure. The U.S. government is actively securing the domestic supply chain, with the National Nuclear Security Administration selecting SHINE Technologies for US$ 32 million in funding to complete its Mo-99 production facility in Wisconsin. Further incentivizing domestic production, CMS will implement a US$ 10 add-on payment starting January 1, 2026, for radiopharmaceuticals utilizing U.S.-sourced Mo-99. The Department of Energy’s Isotope Program has a budget of US$ 43,629,000 for research in FY2025 alone, concentrating on alpha and beta-emitters for cancer therapy.
Infrastructure growth is strong across the radiopharmaceuticals market, with Ionetix adding more than 5,000 square feet to its Michigan facility to house a second cyclotron for Ac-225 production. In Canada, Kinectrics is building a new 26,000-square-foot facility in Toronto to scale up isotope production, scheduled for completion in 2025. The Canadian government has invested more than US$ 2 billion across 36 projects since 2020 to bolster its life sciences sector. Clinical trial activity is also intense, with a multi-center Phase 1b/2 trial for a novel breast cancer therapy running across about 20 sites in the U.S. Furthermore, a Phase 1 study for a new prostate cancer imaging agent aims to enroll its first patients by mid-June 2025 across 10 U.S. sites.
Radiopharmaceuticals Market Major Players:
- Bayer AG
- Boehringer Ingelheim International GmbH
- Bracco
- Cardinal Health Inc.
- Curium Pharma
- Eckert & Ziegler
- F. Hoffmann-La Roche Ltd
- GE HealthCare
- GSK plc
- Iso-Tex Diagnostics, Inc
- Jubilant Radiopharma
- Lantheus
- Lilly
- Mallinckrodt
- McKesson Corporation
- Novartis AG
- PharmaLogic
- Siemens Healthineers AG
- Telix Pharmaceuticals Limited
- Other Prominent Players
Key Market Segmentation:
By Type
- Diagnostic
- Therapeutic
By Radioisotope
- Iodine I
- Gallium 68
- Technetium 99m
- Fluorine 18
- Others
By Application
- Cancer
- Cardiology
- Others
By End User
- Hospitals and clinics
- Medical Imaging centers
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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