Novartis expands radioligand therapy manufacturing, offers scalable blueprint

Radioligand therapies (RLTs) are moving through a new phase of momentum, driven by clinical progress, increased regulatory support, and a wave of strategic investment from major biopharma players. While interest in the modality is accelerating, its growth has historically been constrained by the difficulty of manufacturing and delivering these therapies at scale.

RLTs rely on short-lived radioactive isotopes, requiring the production, release, and administration of the therapies within a tightly coordinated, time-sensitive window. Because of this, the modality inherently places unique pressure on manufacturing execution, logistics, and geographic proximity to patients.

Still, large-scale commitments from companies like Novartis — which in April 2025 announced a planned $23 billion investment in U.S.-based infrastructure over five years, including RLT manufacturing facilities — reinforce the modality’s potential for significant expansion.

Building a network around time, not just capacity

The global market for RLTs is anticipated to grow substantially in the coming years, projected to increase from $2.6 billion in 2025 to $4.8 billion by 2030. Much of that momentum is being driven by two leading therapies from Novartis — Lutathera and Pluvicto — which achieved blockbuster status in 2024, with $724 million and $1.39 billion in sales, respectively.

To support that demand, Novartis has rapidly expanded its domestic RLT manufacturing footprint. Central to that strategy is building a distributed network designed around speed and proximity.

The company recently announced plans to develop a 46,000-square-foot RLT manufacturing facility in Denton, Texas — its fifth such site in the U.S. — which is intended to complete a coast-to-coast network capable of supporting time-sensitive delivery of the therapies. The announcement follows earlier plans unveiled in January to develop an additional RLT facility in Winter Park, Florida.

Together, these new sites will complement Novartis’ existing network in Millburn, New Jersey, Indianapolis, Indiana, and Carlsbad, California — all of which are expanding their RLT manufacturing capabilities.

The Texas and Florida facilities are designed to fill a critical geographic gap, according to James Fredette, head of U.S. drug product operations for RLTs at Novartis, who also serves as site head for the company’s flagship Indianapolis RLT facility.

“If you look at our existing blueprint … the parts of the map that we’re missing are the South and Southeast, and that’s what the Denton facility really rounds out,” Fredette says.

Because some doses must reach patients within three to five days of manufacturing, geographic positioning is essential, making proximity to patients a core manufacturing parameter.

Delivering on time: RLT strategy meets execution

Through its distributed network, Novartis aims to place roughly 90% of patients within a 10-hour drive of a manufacturing site, according to Fredette, reducing reliance on air transport and improving delivery reliability.

“We don’t want to be dependent on commercial airline traffic because the reliability isn’t quite the same as being able to drive to your local hospital,” he says. “That’s what drives a lot of the strategic decision to have this network.”

The company reports delivering approximately 99% of doses on schedule, a metric that reflects manufacturing performance and end-to-end coordination from production through to point of care.

That network strategy is also being shaped by rising demand for therapies targeting markers expressed in cancers, most notably focused on prostate cancer, neuroendocrine tumors, thyroid cancer, and non-Hodgkin lymphoma. Efforts to expand the scope of indications for treatment and move RLTs into earlier lines of treatment are expected to significantly expand the eligible patient population. Fredette noted Novartis’ Phase 3 PSMAfore trial, which is evaluating Pluvicto in patients with metastatic castration-resistant prostate cancer prior to chemotherapy.

As the treatment paradigm for RLTs shifts, demand is expected to increase while placing additional pressure on manufacturing capacity and reinforcing the need for a highly coordinated, geographically distributed network.

Building a specialized workforce for RLT scale-up

As Novartis expands its RLT manufacturing network, developing a workforce capable of supporting this highly specialized modality is a parallel priority.

RLT production brings together roles that are less commonly found within traditional pharmaceutical manufacturing, including radiation safety officers, radiochemists, and radiopharmacists, alongside more familiar functions such as manufacturing technicians, quality professionals, and validation engineers.

Workforce considerations shaped site selection for Novartis’ distributed network. When announcing development of its RLT manufacturing facility in Florida, the company highlighted the state’s growing investment in life sciences education and its ability to support a skilled manufacturing workforce.

At the same time, Novartis is building internal capabilities to bridge talent gaps. According to Fredette, the company has developed dedicated training programs to adapt experience from adjacent fields — such as aseptic manufacturing, CAR-T, and gene therapy — into the specific requirements of radioligand production.

“We’ve had to really develop our own training programs … to take the existing knowledge out there and then add the special, unique elements that are in the radiotherapy space,” he says.

By combining knowledge developed at its manufacturing sites with local expertise, Novartis is working to “seed” new facilities with the capabilities needed to support RLT production.

Fredette says the company is also partnering with universities to build a longer-term talent pipeline, helping ensure a steady flow of candidates as demand for RLT manufacturing continues to grow.

“We also have a broad RLT footprint internationally that we also leverage to ensure we build and retain the best talent,” a Novartis spokesperson added.

Emphasizing its commitment globally to RLT manufacturing, the company announced in March plans to invest more than 3.3 billion yuan (nearly $480 million) to expand its research, production, and operations footprint in China, with a focus on RLTs.

Designing for long-term scale, not short-term demand

While recent investment in U.S. manufacturing has been shaped in part by broader reshoring trends, including policy signals and tariff threats, Novartis’ RLT strategy has been several years in the making.

“This isn’t a ‘flavor of the month,’” Fredette says, noting that projects like the company’s radioligand therapy manufacturing facility in Carlsbad, California, which opened last November, were initiated well before current reshoring discussions. “This is truly part of the core RLT strategy for Novartis to be closer to our patients.”

That long-term view is also reflected in how the company is designing its manufacturing footprint. Rather than building single-product facilities, Novartis is developing flexible infrastructure intended to support a growing pipeline of therapies.

“We don’t expect to have to keep making a new facility for every single new product,” Fredette says. “It’s going to be using the existing infrastructure that we’re building today for the long term.”

Facilities like the new Texas site are being built not just for current therapies like Pluvicto, but with the expectation that they will support multiple products over the next five to 10 years.

Taken together, Novartis’ investments point to a broader shift in how RLTs are being industrialized, moving from early commercial success toward a more durable, scalable model. As demand continues to grow, the ability to align manufacturing, logistics, and workforce development around the constraints of the modality may ultimately determine how far and how fast it can expand.