The Infrastructure Nobody Funds: Why Clinical Trial Sites Are Missing From Radiopharma Investment
.png)
Radiopharmaceutical investment is accelerating. Capital is flowing into isotope production, manufacturing capacity, and acquisitions across the industry.
This momentum matters. Radiopharmaceuticals depend on reliable supply and specialized production. But one part of the system continues to lag behind.
Clinical trial infrastructure.
While manufacturing scales, the sites need to move these therapies forward. This imbalance is becoming a clear bottleneck in development.
Investment Is Concentrated Upstream
Manufacturing investment is easy to measure. Facilities can be built. Output can be tracked. Supply chains can be planned.
Recent activity reflects this focus. Novartis has expanded production capacity for Pluvicto, through large scale manufacturing facilities [1].
These investments are necessary. But manufacturing alone does not move a therapy toward approval.
Clinical trials do.
Without enough capable sites, increased production does not lead to faster development. It creates supply without the ability to test it in patients.
In practical terms, the industry is building a warehouse full of parts, without enough capacity to build the cars.
Clinical Infrastructure Is Not Keeping Pace
Radiopharmaceutical trials require more than standard oncology trial capabilities.
Sites must be able to handle and store radioactive materials. They must coordinate across nuclear medicine, imaging, and clinical research teams. They must perform specialized imaging for patient selection and response. They must manage radiation safety and regulatory requirements. They must support staff trained in radiopharmaceutical workflows.
These requirements limit how many sites can participate.
At the same time, the science is advancing quickly. Radiopharmaceuticals are being used in both imaging and therapy across multiple diseases, increasing the demand for clinical implementation [2].
The result is a gap between what can be developed and what can be successfully executed.
This Is a Global Challenge
This is not limited to one region.
Global health organizations highlight that access to radiopharmaceutical therapies remains uneven and is shaped by infrastructure, workforce capacity, and regulatory and supply factors [3].
IAEA-supported analyses also point to significant disparities in imaging resources and emphasize the need for coordinated investment and training to expand access to nuclear medicine and Theragnostic therapies [3].
Radiopharmaceutical development depends on an ecosystem. When one part of that ecosystem lags, progress slows.
Expanding Site Capacity Is Not Simple
Adding more trial sites is not straightforward.
Radioligand therapy programs require coordination across facilities, staff, workflows, and leadership. Building this capability takes time and planning [4].
Practical challenges include licensing, storage, waste handling, scheduling, and workflow design. These are essential for safe and consistent delivery, but they also slow expansion [5].
This is why site capacity does not scale as quickly as manufacturing.
The Economic Disconnect
This creates a mismatch in how capital is deployed.
Investment is flowing toward manufacturing and production, isotope supply, and pipeline expansion.
Less attention is given to site development, clinical workflow integration, workforce expansion, and activation readiness.
For sponsors and investors, this introduces risk.
A therapy only creates value if it can move through clinical trials. If limited site capacity slows activation or enrollment, timelines extend and costs increase.
The value of manufacturing depends on clinical execution.
Regulatory Expectations Are Increasing
Regulators are recognizing the complexity of radiopharmaceutical development.
The European Medicines Agency has highlighted the need for more defined approaches to evaluating these therapies, including considerations around dosing, safety, and clinical trial design [6].
This raises the bar for what sites must support.
As expectations increase, the gap between general clinical capability and true trial readiness becomes more significant.
Theragnostic Insight - Radiopharmaceutical development is scaling faster than the workforce required to execute it. Capacity is not just about sites. It is about people.
What This Means for Sponsors and Investors
For sponsors, site strategy should be part of early development planning.
That includes understanding real site capacity, activation timelines, workforce and workflow constraints, and radiation safety requirements.
For investors, clinical infrastructure should be evaluated alongside manufacturing and pipeline strength.
Key questions include:
- Does the program have access to enough trial ready sites
- How dependent is the timeline on a small number of centers
- What risks exist beyond manufacturing and supply
Ignoring these factors can lead to overly optimistic timelines.
What This Means for You
Radiopharmaceutical development is often framed as a manufacturing challenge.
It is also a clinical infrastructure challenge.
At Theragnostic Insights, we help development teams understand where execution risk actually lives. That includes aligning trial design with site capabilities and identifying infrastructure gaps early.
Because in radiopharmaceutical development, progress is defined by what can be tested and delivered in the clinic.
Stay tuned for more in this mini-series: Clinical Capacity Crisis: The Hidden Bottleneck in Radiopharma Development.
In the coming weeks, we’ll continue exploring the clinical capacity crisis holding back radiopharmaceutical innovation, from regional access gaps to operational gridlock and infrastructure blind spots. Don’t miss the next post as we map out the road to a truly trial-capable ecosystem.
- The Trial Site Gap: Why Radiopharmaceutical Innovation Is Hitting a Wall
- Geography Is Destiny: The Clinical Access Gaps in Radiopharmaceutical Research
- Operational Gridlock: Where Radiopharmaceutical Trials Break Down on Site
- Beyond the Badge: Rethinking What “Trial-Ready” Really Means in Radiopharma
- Infrastructure as Investment Strategy: Clinical Site Access and Radiopharma ROI
- Built for What’s Next: Redefining Clinical Site Design for Theragnostic Trials
- Speed as Strategy: How Site Scarcity Is Slowing Radiopharmaceutical Pipelines
- One Roof, Many Bottlenecks: Why Fragmented Site Models Undermine RLT Trials
- The Dosimetry Dilemma: Why Many Sites Aren’t Ready for Radioligand Trials
- Licensing & Radiation Safety: The Regulatory Maze Behind Radiopharmaceutical Trials
- The Hidden Role of Radiation Safety in Clinical Trial Activation
- The Radiopharma Workforce Gap: Who’s Actually Running These Trials?
- The Infrastructure Nobody Funds: Why Clinical Trial Sites Are Missing From Radiopharma Investment
References:
[1] Novartis, 2024. Novartis expands production of Pluvicto with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis. Novartis
[2] Zhang et al., 2025. Radiopharmaceuticals and their applications in medicine. Nature
[3] International Atomic Energy Agency, 2024. Nuclear medicine in therapy and diagnosis. IAEA
[4] Mittra et al., 2024. Establishing a robust radioligand therapy program: A practical approach for North American centers. National Library of Medicine
[5] Herrmann et al., 2023. Tackling the Last Mile: A Major Component to Successfully Establish Radioligand Therapy as Part of Standard of Care. Journal of Nuclear Medicine
[6] European Medicines Agency, 2024. Concept paper on the clinical evaluation of therapeutic radiopharmaceuticals in oncology. EMA
https://www.nature.com/articles/s41392-024-02041-6
https://humanhealth.iaea.org/resources/portfolio/nmdi-nm-in-therapy.html
https://pmc.ncbi.nlm.nih.gov/articles/PMC10905220/
