Radiopharmaceutical Manufacturing Capacity Could Become A Bottleneck For Clinical Trials
By Elizabeth Urbanek, Executive Editor
Radiopharmaceutical demand is growing, but the specialized facilities needed to manufacture these drugs may not be able to keep pace. For clinical trial teams, that could mean fewer options for securing production time as studies advance and require more frequent doses.
A report published October 23 by GlobalData estimates that the global radiopharmaceutical market will grow from approximately $11 billion in 2026 to more than $20 billion by 2030. The report identifies manufacturing capacity as a constraint on clinical development, commercial supply and patient access. Read the GlobalData report.
Radiopharmaceuticals require specialized manufacturing facilities, and many use isotopes that decay quickly. That leaves little time to manufacture, test and distribute a dose before it is needed. A delay at any point can disrupt the schedule.
Novartis’ experience with Pluvicto illustrates the consequences. Manufacturing disruptions led to temporary treatment delays while the company worked to restore supply, according to GlobalData.
The problem extends beyond individual production delays. In an October 26 report, Pharma Manufacturing described how difficult it can be to find facilities that meet the technical and regulatory requirements for later-stage production. Thijs Spoor, CEO of Perspective Therapeutics, estimated that only a portion of U.S. manufacturing suites equipped with lead-shielded cells are suitable for Phase 3 or commercial production. His figures are internal estimates, not an industry-wide census.
For sponsors, finding a facility that can handle a radiopharmaceutical is only part of the problem. The facility must also have the right capabilities and available production time when the trial needs its next batch.
What This Means For Clinical Supply
Radiopharmaceutical supply planning has to account for the time between manufacturing and patient dosing. With short-lived isotopes, teams have limited room to absorb delays or move production dates without affecting delivery.
That makes manufacturing capacity an early planning decision, particularly for studies expected to enroll more patients as they progress.
Clinical supply teams need to work through several questions with manufacturing and clinical operations:
- How often will the trial need product? Patient enrollment and dosing schedules determine how frequently batches must be produced. A facility that can support occasional early-phase production may not have enough availability for a larger study requiring doses several days a week.
- Will the isotope be available when production is scheduled? Securing a manufacturing slot does not guarantee that the required isotope will be available in the right quantity at the right time.
- Can the facility support the next phase? Sponsors need to assess technical capabilities, regulatory requirements and available capacity before a program reaches a point where changing manufacturing arrangements could disrupt the timeline.
- Can the shipment reach the site in time? Production, testing, release, transportation and patient appointments must fit within the isotope’s usable life. A workable manufacturing schedule can still fail if the distribution plan leaves too little time for delivery.
These questions become harder when multiple programs need the same specialized infrastructure. A sponsor may have a promising candidate and a viable trial design but still struggle to secure production slots when needed.
Companies are investing in new facilities and isotope production to address the shortage. GlobalData points to expansion efforts by Novartis and Bristol Myers Squibb, along with investments in actinium-225 production by Niowave and TerraPower Isotopes. Those efforts may expand future supply, but they do not guarantee that a particular sponsor will have access to the right capacity for an upcoming study.
For clinical supply teams, the immediate task is to understand where manufacturing availability could constrain the trial schedule and raise that risk while there is still time to make other arrangements.
The Supply Question
How early must sponsors secure manufacturing capacity and isotope access to support a radiopharmaceutical trial as it advances into later phases?
Related Clinical Supply Leader Editorials
- When Drug Supply Has A Half-Life: Radiopharmaceutical Logistics
- Can Your Operating Model Grow? Preparing Clinical Supply For What Comes Next
- Building Better Resilience Into Your Clinical Supply Strategy
About The Author:
Elizabeth Urbanek is the Executive Editor of Clinical Supply Leader, where she works with clinical trial supply and logistics professionals to bring real-world perspectives and operational challenges to the field.
Before joining life sciences media, Elizabeth spent more than 15 years in broadcast, digital and live-event storytelling, helping highly technical teams communicate complex ideas with clarity and impact. She brings that same approach to clinical supply, creating editorial space for experts to share what is happening across clinical trial operations.
Elizabeth is passionate about connecting people and ideas, identifying emerging themes and showcasing work that can move the clinical supply field forward.