North America Radiopharmaceutical Market

The North America Radiopharmaceutical Market is valued at US$  2,810.3 Million in 2019 and is estimated to grow at a CAGR of 5.92% over the forecast period to reach US$  XX Million by 2027.

North America is estimated to account for the largest share of the market, owing to the advancements in technology, including hybrid imaging, the introduction of new radiopharmaceuticals for diagnosis, and the development of molecular imaging.

In 2016, the AMIPA (American Medical Isotope Production Act) and the DOE/NNSA (Department of Energy) established a Uranium Lease and Take-Back (ULTB) program in the United States. Under this program, the DOE/NNSA makes LEU (Low Enriched Uranium) available through lease contracts for the irradiation and production of Mo99 for medical uses. The AMIPA not only promotes the domestic production of Mo-99, but also aims to replace the role of HEU (High Enriched Uranium) in the production of medical radioactive isotopes.

Moreover, Canada is one of the largest producers of Technetium-99m. With the use of Tc-99m in radiopharmaceuticals, the market is expected to grow at a tremendous rate in Canada. It is also combined with a variety of biologically active molecules to perform non-invasive, real-time imaging of the human body.

In 2016, the AMIPA (American Medical Isotope Production Act) and the DOE/NNSA (Department of Energy) established a Uranium Lease and Take-Back (ULTB) program in the United States. 

The premise of the American Medical Isotopes Production Act is: “To promote the production of molybdenum-99 in the United States for medical isotope production, and to condition and phase out the export of highly enriched uranium for the production of medical isotopes.”

Under the Act, the Secretaries for Energy and Health and Human Services have to make an assessment on whether there are adequate supplies of Mo-99 coming into the U.S. from sources other than highly enriched uranium (HEU) sources.

There is a date of January 2, 2020 for the secretaries making a recommendation on this. No more licenses are meant to be issued for the export of highly enriched uranium to produce Mo-99 unless there is an inability of the U.S. market to be supplied by low enriched uranium (LEU) sources.

New producers are using non-HEU methods, and the majority of current suppliers have already converted to non-HEU production of Mo-99.

In Canada the government has an Isotope Technology Acceleration Program (ITAP) to promote R&D on non-reactor based isotope production, particularly through the Medical Isotope Program (MIP). Canada Light Source (CLS) in Saskatoon is using a linear accelerator to bombard Mo-100 targets with x-rays, and has produced some Mo-99 for MIP.

On January 7th 2020, RadioMedix Inc. and its commercial partner Curium announced that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection.

NorthStar Medical Radioisotope’s (NorthStar) RadioGenix® System is a disruptive, innovative separation platform for processing non-uranium/non-highly enriched uranium-based Mo-99. NorthStar is the first US-based company to achieve production in more than 30 years, vertically integrated and ensures reliable Mo-99/Tc-99m US supply with predictable pricing for essential diagnostic imaging procedures while eliminating harmful radioactive waste, addresses moly availability, nuclear proliferation, and environmental concerns.

NorthStar is growing steadily, establishing a strong foothold with US radiopharmaceutical  market while scaling up capacity. It has a contract for 8 electron accelerators; the first pair will be ready next year for installation in the Beloit, Wisconsin isotope processing and manufacturing facility. The company is also adding processing capacity in Columbia, Missouri, to increase Mo-99 production. NorthStar anticipates having up to 60 installed systems by the end of 2020, and around 300 by the end of 2023, ensuring consistent US moly supply.

NorthStar plans to produce Mo-99 from Mo-100 in an accelerator, and in December 2016 received $11 million from NNSA for this. The award advances a $50 million cooperative agreement between the two organizations in which NorthStar raises $25 million, matched by NNSA upon full funding of the agreement.

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