To kick off 2025, we’re looking back at the radiopharma advancements and challenges that shaped 2024 and laid the groundwork for even greater progress in the year ahead.
Here’s a recap of the key milestones and obstacles of 2024, along with our predictions for the trends and innovations that will define 2025.
Key radiopharmaceutical achievements of 2024
1. Expansion of PSMA therapies for prostate cancer
One of the most notable achievements in 2024 was the continued progress of Prostate-Specific Membrane Antigen (PSMA)-targeted therapies. Clinical trials have shown positive outcomes in moving PSMA therapy from late-stage prostate cancer to earlier lines of treatment, including pre-chemotherapy settings.
This expansion could significantly increase the number of eligible patients—potentially doubling or even quadrupling depending on the hospital and its treatment capacity. Additionally, there’s growing excitement about the potential for PSMA therapies to extend to even earlier treatment stages, such as hormone-sensitive prostate cancers.
2. Broadening applications across cancer types
In 2024, the industry made significant strides in extending radiopharmaceuticals to treat a variety of cancers beyond prostate.
Trials are now targeting:
- Breast cancer
- Pancreatic cancer
- Hepatocellular carcinoma
- Melanoma
- Small cell lung cancer
3. Improved reimbursement policies for imaging
One of the most impactful policy changes this year was CMS’s proposed unbundling of reimbursement for diagnostic radiopharmaceuticals. Hospitals have often faced financial challenges when the cost of imaging agents exceeded bundled reimbursement rates.
While the CY25 ruling is still being finalized, it represents a significant breakthrough for both hospitals and patients. Improved reimbursement encourages long-term investment in imaging agents, which is critical for theragnostic approaches where diagnostic scans guide therapy decisions. This change will particularly benefit smaller community hospitals and improve access for Medicare patients.
4. Investments in next-generation targeting molecules
Pharmaceutical investments surged in 2024, focusing on developing novel targeting molecules that overcome previous limitations.
Companies are exploring technologies such as:
- DARPins (designed ankyrin repeat proteins)
- Aptamers
- Small, high-affinity peptides
- Cyclic DNA and RNA molecules
Unlike traditional peptides, these new molecules exhibit higher binding affinity, rapid tumor targeting, and faster clearance from the body, addressing challenges such as renal toxicity. These innovations provide exciting opportunities to refine drug delivery, increase therapeutic effectiveness, and reduce side effects—particularly for cancers where existing approaches have fallen short.
5. Progress with alpha emitters and radionuclide diversity
Alpha emitters—known for their ability to deliver high-energy radiation over shorter distances directly to cancer cells (compared to beta-emitting radionuclides)—are advancing toward regulatory approval. While supply chain issues remain a barrier, these therapies have shown promise in early trials.
Additionally, trials are exploring a broader range of radionuclides, such as Copper-67. Early data from Clarity Pharmaceuticals’ trials revealed surprising efficacy, with tumors continuing to shrink well beyond the expected timeframe.
Challenges and barriers to radiopharmaceutical adoption
While 2024 brought tremendous progress, challenges remain in bringing radiopharmaceutical therapies into mainstream clinical practice:
Access and infrastructure
The majority of therapies are still delivered at a handful of academic or specialized centers. Expanding access to community hospitals—where 80% of U.S. cancer patients receive care—requires significant investments in education and infrastructure. Concurrently, logistical challenges such as handling radioactive materials, implementing safety protocols, and acquiring specialized equipment demand targeted solutions to build capacity at smaller facilities.
Regulatory hurdles
The Nuclear Regulatory Commission (NRC)’s release criteria continue to pose challenges for smaller hospitals. They require clear guidelines and tools to ensure safe administration, and many smaller institutions express uncertainty about meeting these requirements without significant investment in training and equipment.
Supply chain limitations
For therapies to become truly mainstream, turnaround times for radiopharmaceutical production and delivery must be drastically improved. Patients cannot afford to wait weeks for treatment. Addressing these delays will require a concerted effort to build out isotope production facilities and optimize transport logistics.
Dosing optimization
Many therapies, like Pluvicto, have yet to reach optimized dosing levels. While trials explore higher doses, extended treatment cycles, and combination therapies to maximize efficacy, the balancing act of increasing dosage while minimizing side effects remains a focal area for research.
Cost barriers
Despite progress in reimbursement, the high costs associated with developing, manufacturing, and administering radiopharmaceuticals remain prohibitive for many healthcare systems. Innovative financial models or government incentives may be necessary to expand accessibility.
Emerging radiopharmaceutical trends for 2025
As we look to the year ahead, several trends are poised to drive further innovation in radiopharmaceuticals:
Dose optimization trials
Clinical trials are pushing the boundaries of dosing by increasing administered doses and extending treatment cycles. Additionally, innovative dosing regimens, such as splitting doses or pairing therapies with agents that enhance uptake, are under active investigation to overcome resistance and maximize patient outcomes.
Combination therapies
Integrating radiopharmaceuticals with immunotherapy, chemotherapy, and hormonal therapy offers opportunities to enhance treatment outcomes. For instance, pairing radiopharmaceuticals with immunotherapies can trigger an immune response against residual cancer cells, while hormonal therapies may improve target expression in specific cancers.
Innovative targeting molecules
Beyond peptides, we expect advancements in aptamers, DARPins, and cyclic molecules to continue for improved tumor targeting, reduced toxicity, and enhanced imaging capabilities.
Supply chain innovations
Advances in isotope production, such as centralized manufacturing hubs and novel transport methods, are expected to address delays. Companies are also exploring shelf-stable radiopharmaceutical formulations to overcome logistical barriers and enhance treatment accessibility.
What’s to come in 2025
Want to hear Dr. Geoff Johnson’s expert insights about all the information above? He recently joined us during our virtual event, “Greatest Hits in Radioligand Therapy: A Year in Review + Prognostications for 2025,” to discuss 2024 and what’s to come in 2025.