Growth Spurt
By Keith Loria
Radiology Today
Vol. 26 No. 6 P. 18

A Look at How the Radioisotope Market Is Changing

Health care has used radioisotopes for decades, but supply has not kept up with demand, leaving some patients without the benefits of these lifesaving, proven tools. To address this need, more companies are entering the radiopharmaceutical space, increasing the availability and variety of these vital compounds. According to Cathy Sue Cutler, PhD, president of SNMMI, the market is growing and is expected to double over the next 10 years.

“The number of clinical trials is at an all-time high, leading to a further increase in demand for radioisotopes,” says Cutler, the director of the Medical Isotope Research and Production program at Brookhaven National Laboratory, which is part of the department of energy isotope program. “Large pharmaceutical companies are spending billions on radiopharmaceutical development, and with the CMS unbundling, diagnostic radiopharmaceuticals companies are seeing that producing radioisotopes—particularly for theranostics—is economical.”

SNMMI is seeing a shift in which companies are starting to provide radioisotopes. “A challenge for the US is that although we use 50% of the world’s radioisotope supply, we are currently dependent on supply from outside of the country for 30 medical isotopes,” Cutler says.

Mohamed Fouda, US general manager of molecular imaging in the pharmaceutical diagnostics division of GE HealthCare, notes that just five years ago, PET imaging was largely centered around oncology, and only a few novel applications, such as prostate cancer and neuroendocrine tumors, with FDG dominating the space.

“Today, we’re witnessing a dynamic expansion,” he says. “New PET radioisotopes are addressing unmet needs in areas like breast cancer, with innovations such as Cerianna (fluoroestradiol F18) and even extending beyond oncology into neurology and cardiology. The emergence of PET imaging for Alzheimer’s disease and cardiac conditions is opening new frontiers and redefining the role of molecular imaging in patient care.”

For radiopharmaceuticals to achieve their full potential—meaning multiple commercially approved drugs, widely available throughout the United States and the world—increased radioisotope production capacity is needed.

In-Demand Isotopes
Mike Pintek, president of nuclear and precision health solutions at Cardinal Health, says significant market growth and rising demand are driven by demographic shifts such as an aging population and increased disease awareness, innovations in early theranostics, technological advancements in imaging for more accurate diagnoses, and a heightened focus on personalized, precision medicine.

“The oncology landscape and increasing demand is evolving new classes of drugs,” he says. “Radioligand therapies, in particular, will play a role as we see the promise of drug performance with these novel therapies.” For example, clinical trials are evaluating the efficacy and safety of actinium-225 (Ac-225) radioligand therapies.

“[Research and development] efforts are moving from antibody-drug conjugates to radioligand therapies with the promise of improved efficacy and toxicity profiles,” Pintek says. “There are also significant advancements and investments being made today in radioligand therapies in the areas of prostate cancer and neuroendocrine tumor cancer. These therapies are also being expanded into breast cancer, lung cancer, pancreatic cancer, and other disease areas of oncology.”

Molybdenum-99, which decays into technetium-99m, is still the most highly used diagnostic radioisotope, being used in over 80% of all scans, according to SNMMI. Gallium-68 (Ga-68) use is increasing, as well, and it is used in clinical trials for PET scans, particularly for diagnostics and follow-up management of cancer.

“We are seeing increases in the use of copper-64, due to its longer half-life and superior nuclear properties, and zirconium- 89 (Zr-89), due to its longer halflife for diagnosis for large proteins such as monoclonal antibodies,” Cutler says. “Iodine-131 (I-131) and lutetium-177 (Lu- 177) are still the most-used radioisotopes for therapeutics; the number of clinical trials using Lu-177 is the highest of all therapeutics. The expansion of use of Pluvicto has further increased the demand for Lu-177.

“The use and demand for alpha emitters is also expanding—particularly Ac-225, lead-212, and astatine-211 (At-211)—due to the high dose they deliver and short range, which limits toxicity to normal tissues. Alpha emitters have demonstrated efficacy in patients in the clinic when no other treatments worked.”

Volumetric Growth
Cardinal Health has seen and made significant investments around several additional isotopes, including Ga-68, fluorine- 18 (F-18), Zr-89, and Lu-177, which are being used for diagnostic imaging and targeted therapies.

GE is seeing significant demand growth for both Vizamyl (flutemetamol F18) and Flyrcado (flurpiridaz F18). “Vizamyl’s growth is fueled by the growing adoption of PET imaging in Alzheimer’s diagnostics, thanks to the increased adoption of novel Alzheimer’s therapies,” Fouda says. “The recently updated Vizamyl label now includes the use of the product with quantitative analysis of amyloid plaques and removes previous limitations on its use for diagnosis, prediction, and therapy monitoring. These changes reflect revised criteria from the Alzheimer’s Association and growing clinical evidence that amyloid PET imaging can support earlier, more confident diagnosis and personalized treatment planning.”

Flyrcado, he adds, recently approved by the FDA as the first F-18 labeled PET radioisotope for known or suspected coronary artery disease, is generating significant interest. “Its unique characteristics promise to expand access to cardiac PET and address a substantial unmet need in cardiovascular care,” Fouda says. “Both isotopes are helping to serve larger patient populations and are making precision diagnosis a reality for patients across both disease areas.”

PETNET Solutions Inc, a Siemens Healthineers Company, focuses on PET radiodiagnostics and is the largest producer of PET radiopharmaceuticals in the world, in addition to being the only company that has a large cyclotron network footprint in the United States and Europe. PETNET Solutions has a network of 60 radiopharmacies in the United States, Europe, and India that manufacture diagnostic radiopharmaceuticals for PET/CT scans.

“Ten years ago was not anything like what we are seeing today,” says Barry Scott, CEO of PETNET Solutions. “Everybody believes in PET, but the growth came later than expected, and it’s a great place to be and gratifying to see radioisotopes helping so many patients.

“In the last three to four years, we’ve seen significant dose-volume growth,” Scott says. “Specific to biomarkers that are often mentioned in the press, like PSMA [prostate-specific membrane antigen] imaging and amyloid imaging for Alzheimer’s disease, PET has really taken off quite a bit and received a lot of attention. But even FDG, the generic multiuse biomarker, has also grown by about 10% a year over the last few years because of the overall realization about what PET can do for these patients in need.”

Theranostic Applications
Theranostic applications are also fueling some of the growth and drawing attention to the space. Scott points to F-18–based biomarkers as being the most in-demand. These biomarkers have a half-life of approximately 110 minutes, which allows time for production, transportation, and imaging, while also minimizing patient exposure. Meanwhile, FDG is still the most commonly used by a wide margin.

“PSMA would be the next one in volume, and that has grown significantly over the last several years,” Scott says. “Other isotopes, like Ga-68, are starting to rise as well, but it has half the half-life of F-18.”

Nusano recently announced the first isotopes from its upcoming commercial line will be available in early 2026, marking a key milestone for its new 190,000-square-foot facility in West Valley City, Utah. This advanced manufacturing plant aims to transform the production of radioisotopes used in cancer therapy, clean energy, aerospace, and other fields.

Using its proprietary high-volume production platform, Nusano’s goal is to stabilize global isotope supplies. The platform can produce up to 12 isotopes simultaneously and a total of more than 40 different radioisotopes. Among other isotopes, the company plans to produce Ac-225, a highly valuable cancer-fighting isotope, and At-211, also used in targeted cancer therapies, in 2026. In addition, Nusano will support a suite of isotopes used in diagnostic applications such as indium-111 (In-111), Zr-89, and others.

“We’re proud to supply rare and hardto- produce medical radioisotopes in quantities needed for commercial-stage therapeutics and diagnostics so they can advance their product pipeline and create new, personalized cancer treatments,” says Chris Lowe, CEO of Nusano.

Cardinal Health offers the largest radiopharmaceutical network in the United States, including more than 130 nuclear pharmacies and three central pharmacies, reaching 95% of hospitals within three hours and all populated zip codes within 24 hours—more than 30 PET manufacturing sites and more than 12 million time-critical, patient-specific doses annually with a 99.8% delivery rate.

“We’re in the early stages of growth in nuclear medicine, and there is currently a significant focus in oncology and urology, in addition to other disease areas including cardiology and neurology,” Pintek says. “We are seeing success of novel radiopharmaceuticals that have come to market in the areas of prostate and neuroendocrine tumor cancers.”

The use of new radiopharmaceuticals for cardiology and diagnostics for Alzheimer’s disease are expanding. “Nuclear medicine is also becoming more widely accepted in medical oncology practice with radioligand therapies moving into the second line of therapy,” Pintek says. “We’re also seeing improved outcomes from the use of radioligand therapies with other classes of cancer treatment, for example, chemotherapy and immunotherapy.”

Challenges Ahead
Increased demand, supply chain disruptions, and production complexities remain challenges with radioisotope production. Radioisotopes are shortlived, lasting from mere minutes to days, and need to be produced on a regular basis to support patient access. This is quite different from other pharmaceutical supplies that can be produced, stored on a shelf, and used as needed. In addition, Cutler notes, the nuclear reactors or accelerators that produce radiopharmaceuticals are expensive to run, highly regulated, and require significant expertise to operate.

“As the demand increases, the need for new facilities and infrastructure to produce radioisotopes also increases,” she says. “Some of this can only be done at national laboratories that have the expertise and facilities to support it. Support for these facilities is increasing, but more is needed to meet the growing demand.”

Lowe says many of the existing manufacturing techniques and facilities relied upon by drugmakers around the world are aging, outdated, inefficient, and have limited production capabilities. This threatens the ability to meet current needs and stifles innovation.

“The traditional route to making radioisotopes, and in particular medical isotopes, is via irradiation of a target material with neutrons in a nuclear reactor or with an accelerated proton beam,” he says. “However, it is well proven that accelerating certain heavier ions, such as alpha and deuterium ions, results in a richer production of a wider range of radioisotopes. While ion sources exist for producing these heavy ions, they are limited to research purposes since these ion sources are only able to generate very low currents and are thus insufficient for mass production of isotopes.”

PET production is highly complex and requires a set of strict processes in the pharmacy to get a dose out the door. “The cyclotrons are usually very reliable, but because the demand is so high, if there are any issues along the way, it can be a problem,” Scott says. “The other thing is logistics. You’re in a race against the clock, so every dose made for a patient is meant to be injected at a certain time. If the dose needs to be administered at 3:00 in the afternoon, you could be making it at 4:00 in the morning.”

Tariff Concerns
Since the US imports many of its radioisotopes, tariffs are a significant concern to some people in the industry. “Tariffs lead to increased cost and reduced patient access, and they result in reimbursement that is below cost for Medicare beneficiaries,” Cutler says. “This in turn results in underserved populations not receiving access to nuclear medicine procedures that can provide optimal care, with better quality of life and lower expense.”

Furthermore, much of the infrastructure needed to expand into remote areas is imported. Tariffs lead to increases in costs that are hard to cover and can halt expansion.

“For this reason, SNMMI is asking legislators to defer tariffs on the radiopharmaceutical supply chain and support policies that support a reliable, resilient domestic supply of radioisotopes to ensure patient access,” Cutler says.

Despite these concerns, there is optimism in the nuclear medicine community that radiopharmaceutical use will continue to change and improve rapidly over the next five years. “We are excited about the continued growth in the industry and the potential benefit to patients,” Pintek says. “As the growing pipeline of diagnostics and radioligand therapies come to market, we’ll be able to target disease in a much more specific way, helping to affect disease and improve patient outcomes.”

—Keith Loria is a freelance writer based in Oakton, Virginia. He is a frequent contributor to Radiology Today.