Bildnachweis: ITM.
The landscape for radiopharmaceutical therapies in oncology is evolving rapidly, propelled by early commercial successes and an expanding clinical pipeline. Yet realising the full potential of targeted radiopharmaceutical therapy requires overcoming operational, supply chain, and regulatory hurdles. To de-risk investments and advance novel cancer treatments, the industry must align clinical innovation with reliable radioisotope supply and manufacturing, supported by specialised business models.
Radiopharmaceutical therapy (RPT) is undergoing a significant transition, maturing into a cornerstone of precision oncology. This shift is reflected in growing clinical adoption. An analysis of Medicare claims data over the past decade found that RPT utilisation has surged by 2,000% in the US alone. This momentum is further supported by growing commercial validation in the sector. Novartis reported nearly USD 2 billion in 2025 sales for its approved radioligand therapy Pluvicto®, highlighting the increasing adoption and market potential of RPTs. Industry analysts project the global RPT market to reach up to USD 20 billion by the early 2030s, supported by a pipeline of more than 580 active drug candidates. As the market expands, so do the operational, logistical, scientific, and regulatory complexities associated with developing and delivering these therapies. RPTs combine targeting molecules with radioisotopes to deliver localised ionizing radiation directly to tumour cells while limiting exposure to surrounding healthy tissue. Harnessing this mechanism at scale demands precise execution across the entire value chain. From more than two decades of experience in radioisotope production, supply, and development, one lesson has become clear at ITM: advancing RPTs at scale requires pairing scientific innovation with deep infrastructure expertise. These capabilities become particularly important as radiopharmaceutical programmes progress toward commercialisation and regulatory review.
Expanding horizons across indications and isotopes
While initial success in RPT focused on gastroenteropancreatic neuroendocrine tumours (GEP-NETs) and prostate cancer, today’s development is expanding into difficult-to-treat solid tumours, including gastrointestinal, colorectal, lung, ovarian, and central nervous system (CNS) cancers, as well as renal cell carcinoma and refractory and metastatic diseases where current therapeutic options remain limited. To unlock these indications, developers are investigating novel targets, including carbonic anhydrase IX (CAIX), fibroblast activation protein (FAP), gastrin-releasing peptide receptor (GRPR), and human epidermal growth factor receptor 2 (HER2). In parallel, the field is undergoing rapid innovation in radioisotope selection. While beta-emitter lutetium-177 (Lu-177) remains foundational, emerging beta-emitters such as terbium-161 (Tb-161) offer unique physical properties that are being explored for their therapeutic potential in micrometa- static disease. Simultaneously, targeted alpha therapy using alpha emitter actinium-225 (Ac-225) is attracting considerable interest due to its high-energy radiation and ultra-short tissue penetration range, which may enable highly localised delivery of radiation to tumour cells. Each isotope brings distinct physical and biological characteristics, including radiation type, energy, and half-life, that influence its potential clinical application, therapeutic window, and manufacturing requirements. The future of precision oncology will therefore likely be a multi-isotope landscape, in which therapeutic radionuclides are selected according to the characteristics of the molecular target, tumour biology, and clinical requirements.
Manufacturing, logistics, and supply chain integrity
Unlike conventional small molecules or biologics, radiopharmaceuticals generally cannot be manufactured in bulk and distributed through standard pharmaceutical logistics networks. Radioactive decay makes these products highly time-sensitive, requiring production, quality control, radio-labelling, and patient administration to occur within a tight time window of days and hours. The physical half-life of an isotope has implications not only for its therapeutic use but also for manufacturing and delivery. Production schedules and transportation must be precisely coordinated to ensure the required level of radioactivity is available at the time of treatment. Delays at any point in this process can affect the amount of usable activity reaching the treatment centre or even making a patient’s customised dose ineffective. Consequently, supply chain reliability and manufacturing capacity are important considerations for the scalability of the radiopharmaceutical industry.
Navigating the global regulatory and competition landscape
Alongside supply chain constraints, RPT developers must navigate an evolving global regulatory environment. In August 2025, the US FDA issued draft guidance on dosage optimisation, requiring sponsors to account for complex dosimetry, cumulative exposure, and long-term safety. The heightened complexity of the RPT space is further underscored by the FDA’s issuance of four Complete Response Letters (CRLs) for RPTs in the past two years. All cited chemistry, manufacturing, and controls (CMC) concerns, reaffirming that manufacturing excellence is linked to regulatory success. Meanwhile, Europe has historically served as a global powerhouse for nuclear medicine and biotechnology, home to leading radiopharmaceutical companies and pioneering research institutions. Maintaining this competitive advantage requires aligning physical supply chain capabilities with an equally responsive regulatory landscape. Key strategic frameworks, such as the EU’s Beating Cancer Plan, the OECD’s High-Level Group on the Security of Supply of Medical Radioisotope (HLG-MR), and political initiatives such as Germany’s Nationale Pharma- strategie (‘National Pharmaceutical Strategy’), provide important support for the sector. However, translating these initiatives into innovation and commercial progress requires continued regulatory harmonisation to streamline clinical pathways and reduce development timelines, creating a more attractive environment for investment and supporting faster advancement of next-gen- eration therapies.
Lumara Bio: A dedicated therapeutics division within ITM
To navigate these complexities, ITM has established Lumara Bio as a dedicated oncology therapeutics division. Lumara Bio brings together dedicated clinical, research, regulatory, and commercial talent to deepen expertise in oncology development. This struc- ture combines therapeutic agility and specialised talent acquisition with the supply security and isotope expertise derived from ITM’s 20-year legacy in global radioisotope production, logistics, and nuclear medicine development. Lumara Bio is advancing a broad pipeline of clinical and discovery-stage programmes across ten indications leveraging seven molecular targets. Clinical studies will continue to evaluate the therapeutic potential of n.c.a. 177Lu-edotreotide in GEP-NETs. Building on the published re- sults of the pivotal phase III COMPETE trial, evaluation for its investigational Lu-177-based lead candidate, ITM-11, continues through the ongoing phase III COMPOSE trial in grade II and grade III GEP-NETs, and the investigator-sponsored phase III LEVEL trial in lung and thymus NETs. Additionally, the phase I KinLet trial is evaluating ITM- 11 in paediatric patients with SSTR-positive tumours. Lumara Bio remains dedicated to advancing this innovative late-stage RPT toward potential commercialisation in ongoing discussions with regulators. The pipeline further includes ITM-31, in phase I evaluation for glioblastoma, and the theranostic pair ITM-91/ITM- 94, in a phase I trial for clear cell renal cell carcinoma (ccRCC) and CAIX-positive tumours. Sup- ported by ITM’s isotope capabilities and scientific collaborations, Lumara Bio is also exploring early-stage applications for therapies based on Ac-225 and Tb-161, broadening the range of potential clinical applications.
Conclusion
The radiopharmaceutical industry has entered a phase in which long-term success requires pairing scientific innovation with operational execution, manufacturing excellence, and reliable isotope access. Companies that can combine these capabilities with meaningful clinical innovation will be best positioned to lead the next generation of precision oncology and better outcomes for people living with cancer. By combining Lumara Bio’s focused therapeutic development and ITM’s isotope platform and supply capabilities, our team is advancing a diversified pipeline while strengthening the infrastructure that underpins the broader radiopharmaceutical ecosystem.
About the author:
Dr Andrew Cavey is a physician and an experienced healthcare executive, with expertise and a successful track record in radiopharmaceutical drug development and commercialisation across leading global biopharmaceutical organisations including Novartis and Bristol Myers Squibb. As CEO of ITM, he leads the company as it continues to grow and strengthen its leadership in radiopharmaceutical therapy innovation.
