Scaling for a New Era: The Rise of Radiopharma

Radiopharmaceuticals are entering a rapid scale-up phase, driven by strong clinical validation in oncology (e.g., Novartis’ Pluvicto and Lutathera) and growing confidence that hospital and commercial infrastructure can reliably produce and deliver these agents safely.1 5

Market forecasts now project radiopharma to grow from about $9–10 billion in 2023–2024 to roughly $26.5–42 billion by 2031–2032, implying mid‑teens to nearly 20% compound annual growth, far outpacing traditional oncology segments.1

Big Pharma has triggered a consolidation wave:
in under a year, Novartis, Eli Lilly, AstraZeneca, and Bristol Myers Squibb acquired four leading radiopharma players (Mariana Oncology, Point Biopharma, Fusion Pharmaceuticals, RayzeBio) in deals ranging from about $1 billion to $4.1 billion, alongside multibillion‑dollar licensing agreements.1

Clinical development is scaling quickly:
global therapeutic radiopharmaceutical trials have expanded from only a few in 2018 to more than 80 active studies by mid‑/late‑2025, mostly in early phases but with rising late‑stage activity in resistant and hard‑to‑treat tumors.2 3

CROs and specialized operational frameworks are becoming critical enablers for scale, as radiopharma trials involve complex global logistics, regulatory pathways, and handling of short‑half‑life isotopes that demand highly coordinated manufacturing and distribution.2 3

There is strong momentum behind *targeted alpha therapies (TATs):*
alpha‑emitting radionuclides such as actinium‑225 (Ac‑225) are seen as the “next revolution” after beta‑emitter Lutetium‑177 because they deliver higher energy over a shorter path length, potentially improving tumor kill while sparing healthy tissue.1 2

Scaling is constrained by isotope supply:
Lutetium‑177 is currently the dominant workhorse, while Ac‑225 supply is limited, prompting new production ventures such as Belgium‑based PanTera and U.S. partner TerraPower Isotopes to develop alternative production routes and expand global availability.1

Novartis and others are investing directly in isotope and manufacturing capacity, including new facilities (e.g., at Novartis’ Indianapolis campus) and deal-making focused on Ac‑225 programs and potential combination regimens (e.g., combining radioligands with protein degraders to move into earlier treatment lines).1

Venture and growth financing are surging:
in 2025, companies like Actithera (≈$75.5M Series A) and Nuclidium (≈$98M Series B) closed landmark rounds, reflecting that radiotheranostics is shifting from a niche bet to a core oncology modality with expectations for platform‑level capabilities.4

Investor and pharma expectations have risen:
new radiopharma companies are now expected to integrate isotope science, medicinal chemistry, targeting biology, and manufacturing/logistics from the outset, with larger, more ambitious Series A rounds and pressure to demonstrate differentiated pipelines and scalable infrastructure.1 4

Radiopharma is converging with *companion diagnostics and imaging:*
theranostic models that pair diagnostic tracers with therapeutic agents are gaining traction, and the companion diagnostics market is projected to nearly double from around $5 billion in 2024 to more than $8 billion by 2030, supporting more precise patient selection.4

Regulatory and policy environments are becoming more prominent news topics, including concerns over tariffs and trade policy on radiopharmaceuticals and precursors, which major medical societies warn could disrupt already fragile supply chains and patient access.6 7

Supply‑chain fragility is a key scaling constraint:
short isotope half‑lives, limited production sites, transportation regulations, and just‑in‑time delivery models are creating pressure on manufacturers to invest in redundant capacity, diversified sourcing, and regional production hubs.1 2 7

New data readouts (e.g., from trials like COMPETE and others) and upcoming oncology congress presentations are expected to act as inflection points, driving further partnering, acquisitions, and expansion into broader indications beyond current prostate and neuroendocrine tumor use cases.1 2 8

Across recent analyses by CROs, industry consultants, and market researchers, radiopharmaceuticals are increasingly framed as a transformative force in oncology drug development, likely to become a durable therapeutic pillar alongside small molecules, antibodies, cell therapies, and bispecifics.2 3 5