Radioligand therapies have gone mainstream. Eli Lilly’s $1.4 billion acquisition of Point Biopharma and Novartis’s $23 billion U.S. infrastructure investment signal that Big Pharma sees this as the next major oncology opportunity.
But our work with industry leaders and analysis of the radionuclide ecosystem reveal a troubling pattern: most organizations still lack a complete understanding of what it takes to bring these therapies to market successfully.
Success requires orchestrating an end-to-end experience that connects manufacturing, logistics, clinical sites, payers, and patients seamlessly. The companies that treat this orchestration as a strategic competency, rather than just operational logistics, will be best positioned to scale.
In a field where radioactive drugs decay by the hour and treatment coordination spans multiple specialists, operational and service excellence isn’t just important, it’s existential.
Three strategic approaches are emerging among the companies best positioned for scale.
Strategy 1: Pick your operational battle carefully
The landscape: Lutetium-177 dominates with 80 clinical trials across 30+ sponsors and 20+ disease types since 2013, largely because companies like ITM built reliable supply networks that enabled Novartis’s Pluvicto success. But in the alpha emitter race, Actinium-225 leads early-stage development (20+ Phase 1 trials) while Lead-212 (Pb-212) gains momentum (4 trials) with a critical advantage: 99% dose delivery within 72 hours.
Why this matters: Pb-212’s tight timeline creates operational demands that can only be addressed by design. Companies choosing this path must nail production scheduling, patient preparation, and clinical administration with military precision. One missed connection kills the dose.
How leaders are responding: ARTBIO’s Series B funding specifically targets integrated supply chain infrastructure because the company recognizes that Pb-212’s complex operational demands can turn into competitive advantage. Meanwhile, Novartis, Telix, Lantheus and ITM are building multi-isotope platforms that can adapt to different scenarios, a hedge against technical risk but requiring broader operational capabilities.
What investors should ask: Can management articulate their operational strategy as clearly as their clinical strategy? Companies that treat isotope choice as purely scientific are missing half the equation.
Strategy 2: Build platforms, not just pipelines
The data shows clear market concentration:
PSMA: 100+ trials, 38 companies
SSTR: 38 trials across 14 diseases
FAP: 16 trials, 6 disease types, 10 companies
GRPR: 12 trials, 6 diseases, 4 companies
CAIX: 10 trials, 5 diseases, 4 companies
The strategic reality: Companies targeting PSMA and SSTR aren’t just chasing biological targets, they’re leveraging existing clinical infrastructure and physician familiarity to reduce operational friction. When doctors already understand the treatment pathway, companies can focus resources on delivery optimization rather than education.
Platform leaders to watch: Novartis has built the largest platform (35 trials across 16 disease types), while ITM, Clarity, Telix, and Lantheus are expanding beyond traditional indications into breast, pancreatic, and brain cancers. This is more than portfolio diversification; it’s infrastructure optimization that creates economies of scale in manufacturing and patient access.
The execution challenge: Newer targets like CAIX often necessitates the creation of new development and delivery pathways. Companies must simultaneously educate physicians, design patient identification protocols, and manage unfamiliar safety profiles. Telix and ITM (via Debiopharm) are advancing multi-center clinical programs that test both therapeutic efficacy and operational scalability.
What executives should prioritize: Effective platform approaches require shared infrastructure, alongside shared chemistry. Can your operational systems and processes support multiple indications without rebuilding from scratch?
Strategy 3: Own the last mile or risk everything
The fundamental decision: As pipelines mature, delivery complexity becomes the primary constraint on growth. Companies have to choose between building integrated capabilities in-house and coordinating through partners. Both models can work, but only when designed around patient and provider needs from day one.
Vertical integration advantages: Companies like Novartis, Telix, and ARTBIO control touchpoints from isotope sourcing to patient treatment. The trend is accelerating, ITM and Orano Med have both pivoted from pure isotope supply to developing their own therapies, recognizing that value chain control creates competitive advantage.
Partnership model success factors: Clear information flows and decision points that work regardless of which partner handles each step. The difference between success and failure often comes down to seemingly operational details: physician referral ease, treatment scheduling efficiency, patient information consistency, and real-time supply visibility.
The core challenge: “If you have phenomenal products, but you don’t have a way to make them and ship them, you have nothing,” said ARTBIO CEO Emanuele Ostuni. “The whole is greater than the sum of the individual parts.”
What this means for different stakeholders:
- Investors – Due diligence should focus more on operational readiness assessments
- Big Pharma – Acquisition targets should be evaluated on delivery capabilities, not just pipeline assets
- Emerging biotech – The core elements of your clinical infrastructure (order management, study management, quality control) should be designed as scalable foundations for commercial services, not as temporary systems.
When clinical success meets commercial reality
Radiopharmaceuticals succeed when companies design systems that connect isotope supply, clinical delivery, and patient experience into a seamless whole. Patients and physicians already navigate complex treatment processes involving scheduling, insurance approval, preparation, and follow-up coordination. When these processes break down, adoption suffers regardless of supply stability.
The opportunity: Companies that design every touchpoint in the treatment journey, ensuring patients receive consistent information, physicians can easily access resources, and care teams have clear protocols for complex logistics — will capture disproportionate market share.
What companies should be asking themselves now:
- Can we articulate our customer service strategy as clearly as our clinical strategy?
- Could our systems and processes be adapted to multiple indications/isotopes without rebuilding?
- Are we designing the customer and patient experience, or just managing supply chains?
What investors should look for:
- Management teams with operational background, with an understanding of the importance of the customer experience
- Clear infrastructure investment plans, not just R&D budgets
- Customer experience metrics, not just manufacturing capacity
Companies treating delivery infrastructure as their primary competitive advantage are best positioned for success. In a field where product differentiation may be limited, operational and service excellence will determine market winners.
Editor’s note: Neither the authors nor their company have any relationship with the companies/products mentioned.
Photo: flickr user stefan rschwendner
Estelle Ricoux is the co-founder and Service and Design Director of Firm. She has 15 years experience partnering with clients and leading teams to improve customer and employee experiences. Estelle combines a holistic service design practice with product methodologies to bring focus on business goals and key metrics. She leads Firm’s design teams, assessing current experiences and operations, crafting visions for future experiences and products, and guiding in the design and delivery, helping companies adopt new approaches and ways of working in the process.
Kostja Paschalidis is the Co-Founder, Systems & Logistics of Firm, a consultancy specializing in designing the services and building the capabilities that enable pharmaceutical companies to deliver advanced therapies at scale. He specializes in operational strategy, process optimization, and logistics innovation within the biotech and healthcare industries. Kostja merges technical insight with strategic planning, re-engineering systems to align with evolving medical advancements to help organizations refine their approaches to developing and delivering transformative treatments.
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