Radiopharma's 4 Critical Questions: A Pre-TRP Briefing
Radiopharma has proven the science and attracted the capital. What it has not settled is how to execute. This briefing frames the four strategic questions - targeting, dosimetry, supply chain, and European access - that now decide which programmes reach patients and which stall after approval.
What this report answers
- Should a developer pursue novel biology or industrialise a validated target?
- Is personalised dosimetry a regulatory requirement, a clinical differentiator, or an operational tax?
- Build vertically integrated isotope and manufacturing capability, or buy from a constrained ecosystem?
- Why does European marketing authorisation so often fail to convert into actual patient access?
- Which capabilities separate the programmes that industrialise from those that stall?
504 days
the average time to reimbursement for innovative treatments across the EU, which is why the briefing treats approval and access as two separate problems.
$14bn
the market size the sector is projected to exceed by the early 2030s - the number underwriting the capital inflow the briefing then stress-tests against operational reality.
What the analysis establishes
The target dilemma
The briefing sets out the trade-off between novel, potentially transformative biology and validated pathways already addressed by other modalities. It works through the specific engineering constraint that governs whether a broad target can be made safe enough to pursue, and treats target selection as a capital allocation decision rather than a scientific one.
The dosimetry debate
It examines the tension between precision and pragmatism in dose planning: what regulators are moving toward, what a personalised approach demands of clinical workflow, and why the constraint is a shortage of specific expertise rather than a shortage of technology. The consequences fall on trial design and site readiness.
Build or buy across the supply chain
The isotope chapter treats supply fragility as a determinant of corporate strategy, not a procurement problem. It works through the distinct constraints attaching to the workhorse beta emitter, the leading alpha emitter, and the short half-life isotopes that force a decentralised model, and frames the resulting build-versus-buy decision at the scale of hundreds of millions.
Approval against access in Europe
A single European authorisation splinters into dozens of sovereign pricing and reimbursement processes. The briefing maps how the major markets diverge in what they assess and when, and pairs that with the site-readiness constraint that limits how quickly an approved therapy can actually be delivered.
A five-year execution roadmap
The closing chapter gives separate recommendations for drug developers and for the service providers around them, organised around what the briefing argues is now the real differentiator: mastery of complexity across the whole chain rather than discovery of new targets.
How it was built
A strategic framing document rather than a data compendium. Each of the four questions is set out as a genuine industry tension with the argument on both sides, the underlying structural driver, and the implications for capital allocation and hiring. Written ahead of the 7th TRP Summit Europe, it previews the debates the sector was actively having rather than asserting settled answers.
Written for CEOs, board members and investors in radiopharmaceutical developers, and for the CDMOs and service providers around them.
Contents
- Foreword: The Gold Rush Paradox
- The Target Dilemma: innovation against industrialisation
- The Dosimetry Debate: precision against pragmatism
- The Supply Chain Crisis: vertical integration against the ecosystem
- The Commercial Hurdle: European approval against actual access
- Conclusion: a five-year roadmap for execution
Organisations covered
AstraZeneca, Bayer, BMS, Eli Lilly, Novartis, Fusion Pharmaceuticals, RayzeBio, POINT Biopharma, Clarity Pharmaceuticals, ARTBIO, ITM, Nucleus RadioPharma, AtomVie, Perspective Therapeutics, Telix, Debiopharm, Molecular Partners, Affibody, Bicycle Therapeutics, EMA, FDA, NICE, G-BA, HAS, NRC
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The State of Radiopharmaceuticals 2026
The flagship radiopharma report takes these four questions further, with the full sector structure, named operators, and the capacity picture behind them.
See the full report →