Radioligand therapy (RLT) targets cells expressing a specific biomarker, delivering a therapeutic cytotoxic radionuclide for localized radiation. There are currently several RLT products on market for oncology indications, including prostate cancer, neuroendocrine tumors, thyroid cancer, and certain brain tumors. In our first Insight in the Radioligand Therapy: A Future within Reach series, we highlighted the shortcomings of the healthcare system that have stunted the delivery of these therapies at scale. This Insight will dive deeper into the operational, infrastructural, and workforce complexities that have constrained RLT uptake to date.  

The Current State of Radioligand Therapy in the United States 

While the RLT landscape is dominated by just a handful of products, their clinical application is accelerating, and this momentum is expected to continue. The global RLT market is projected to increase by nearly 70% in the 2020s, growing from $7.78 billion in 2021 to $13.06 billion by 2030. As indications continue to expand for RLT, clinical openness is helping drive the growth in uptake. 

Despite strong clinical efficacy and growing physician interest, RLTs are underutilized in the US. This reflects the operational complexity of delivering these therapies, including infrastructure limitations, workforce constraints, logistical challenges, and evolving clinical pathways. 

What are the Operational Complexities in Accessing RLTs? 

1. Manufacturing Challenges and Supply Chain Complexity 

RLT delivery relies heavily on precise coordination across production, regulated transport, patient-specific dose preparation, and waste management, all within timelines tightly constrained due to radioactive decay. RLT manufacturing is also limited, relying on a small number of reactors, most of which are located in high-income countries.   

As a result, supply remains limited. For example, the annual global production of lutetium-177 (Lu-177), the radionuclide used in treatment for prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer, is estimated to support less than 200,000 patients annually. However, it is estimated that 158,000 patients with PSMA could be eligible for just one Lu-177 product.

In the US, public reports of RLT manufacturing indicate that capacity remains limited as well. However, to ensure that the supply of RLT products can meet patient demand, manufacturers are investing in expanded manufacturing facilities in CA, FL, IN, NJ, and TX. This investment establishes substantial geographic coverage across the US, reducing the reliance on global supply chains and geographic transportation constraints. Some manufacturers are also leveraging strategic partnerships to enter the RLT space, bringing together complementary capabilities to lower barriers that may be prohibitive for a single company to overcome independently.  

2. Theranostic Infrastructure 

Patient access to RLTs hinges not only on manufacturer production, but provider-level operational capacity, as delivery requires specialized treatment images and integrated imaging infrastructure. 

Foundational research supported by Avalere Health highlighted that RLT delivery is concentrated within specialized centers in the US, predominately large academic medical centers, creating referral and geographic access challenges. Community-based practices often lack the scale to justify the substantial upfront investment and regulatory burden, despite growing evidence of clinical benefit. Although capacity is expanding beyond specialized academic settings, many patients still must travel or be referred across healthcare systems because of the limited institutions with the necessary infrastructure.  These challenges are especially significant for patients in rural areas, who already face substantial structural challenges to accessing care. 

3. Workforce and Training Constraints 

RLT delivery depends on a highly coordinated, multidisciplinary workforce of physicians, medical physicists, nuclear medicine technologists, specialized pharmacy and nursing staff, and personnel trained in the safe handling of radioactive materials. Nuclear pharmacists, for example, play a critical role in radiopharmaceutical preparation and dispensing and receive rigorous training that includes substantial practice hours and passage of a nuclear pharmacy examination. Given the level of specialization required, workforce availability is a key constraint on the expansion of RLTs, as the current workforce may need to be expanded to meet projected demand. 

This potential gap is driven in part by limitations in workforce education and training infrastructure. Many existing nuclear medicine training programs have yet to universally incorporate structured curricula for RLT or relevant specialization. As therapeutic pipelines expand and demand grows, capacity across these specialized roles will become an increasingly important determinant of system readiness. 

Next Steps 

For the next generation of RLTs, strengthening radionuclide manufacturing and supply chains, expanding treatment infrastructure, and establishing clear operational pathways will be essential to improving patient access. Preparing these elements before launch is critical to driving product uptake and sustained utilization, and ensuring that RLTs reach EVERY PATIENT POSSIBLE.  

Avalere Health partners with drug developers and manufacturers to navigate the evolving RLT landscape and build market access and commercialization strategies that support: 

• New product planning, including coverage, coding and provider reimbursement 
• Supply chain and trade logistics 
• Patient support services 
• Access and value marketing 

Our subject matter experts understand the unique clinical, operational, and economic considerations shaping the RLT market. We integrate insights across patient dynamics, prescriber treatment patterns, and payer requirements to assess impact, guide commercialization and improve patient access to RLTs. 

To learn more, connect with us. 

This article is part of the Radioligand Therapy: A Future within Reach series exploring the evolving RLT landscape and strategies to advance access and readiness. It is important to note that this series focuses on RLT, not radioligand imaging or diagnostics. While RLI involves its own distinct and nuanced considerations, it adds to the overall operational landscape and is equally important alongside RLT when it comes to capacity constraints and operations. Keep an eye out for our next Insight on RLT coverage.