Radiopharmaceuticals represent an expanding market that is drawing in new pharmaceutical players, especially in the fields of oncology and neurology. However, challenges related to supply, the requirement for specialized expertise in nuclear medicine, and the need for specific equipment (such as radioisotopes generators or PET scanner), traditionally controlled by a limited number of players, continue to prevent their widespread use. What are radiopharmaceuticals, and why are they not accessible everywhere and to everyone? In this article, Alcimed explores the radiopharmaceutical market, its evolutions, and the challenges to overcome over the next few years to extend their adoption.
A radiopharmaceutical is a drug composed of three building blocks: a radioactive isotope (radioisotope), a targeting molecule, and a linker that binds them. The radioisotope, an unstable chemical element, emits traceable radiation (most often alpha, beta or gamma) that can alter substances it contacts. The chosen radioisotope determines the type of radiation emitted which dictates the drug’s application. The role of the targeting molecule is to bring the radioisotope to a targeted tissue or organ by binding to a biological compound (e.g., FDG, PSMA ligand).
Radiopharmaceuticals have diagnostic, therapeutic and theragnostic applications, which are currently mainly driven by oncology and neurology such as for Alzheimer’s disease or epilepsy.
An analysis of radiopharmaceutical deals from 2018 to 2023 demonstrates that diagnostics are primarily used in neurology/psychiatry (54%) and oncology (31%), utilizing radioisotope imaging markers (e.g., 68Ga) for nuclear techniques such as scintigraphy, SPECT, and PET scans. Therapeutics, mainly applied in oncology, use radioisotopes like 177Lu releasing high-energy radiations that destroy unwanted cells. In oncology (more rarely in gastrointestinal and endocrine/metabolic disorders), diagnostic and therapeutic radiopharmaceuticals can be combined in a “see and treat” approach called “theragnostic” using isotope pairs (e.g., 68Ga/177Lu ), or the same molecule radiolabeled differently or administrated in other dosages. This approach first employs a diagnostic component to visualize and assess the disease, helping to determine if a patient is likely to benefit from a particular treatment. Based on these findings, a therapeutic radiopharmaceutical tailored to the diagnostic results is administered. Theragnostic can be valuable for predicting potential treatment response and assessing possible toxicity.
In practice, radiopharmaceuticals require the involvement of multiple workforces and specialized capabilities throughout their supply chain: radioisotope production by nuclear engineers using reactors or cyclotrons for example; radiolabeling by radiopharmacists to create the radiopharmaceuticals; delivery to hospitals; and the administration and supervision of clinical protocols by nuclear medicine physicians, radiation oncologists, nurses, and technologists.
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The radiopharmaceuticals space has been very dynamic over the past 5 years (from 2018 to 2023), with multiple approvals and consolidation movements from biopharma and nuclear medicine companies. About 86 strategic radiopharmaceuticals deals have been made and multiple drugs approvals have been released in both diagnostics (e.g., Illuccix® and Pylarify®/Pylclari® in 2021, Posluma® in 2023) and therapeutics (e.g., Lutathera® in 2018).
Historically, active consolidators in this market have included global biopharma companies (such as Bayer and Novartis) and dedicated nuclear medicine firms (e.g., Fusion Pharmaceuticals and Curium Pharma). Today, new major pharma companies are entering the radiopharmaceuticals space through M&As, such as BMS who acquired RayzeBio in December 2023 for $4.1 billion or AstraZeneca with the acquisition of Fusion Pharmaceuticals in March 2024 for $2.4 billion. Among the big pharma companies, Bayer, BMS, Lilly and AstraZeneca have therapeutic products in their portfolios, while Novartis offers diagnostic (Locametz® in 2022), therapeutic (Pluvicto® in 2022), and theragnostic solutions.
The radiopharmaceuticals market growth is being driven by the rising incidence of neurological disorders and cancers, along with advancements and developments in imaging technologies. For instance, the International Agency for Research on Cancer estimates that cancer cases will reach 35.3 million by 2050, a 76% rise from 2022 figures. Meanwhile, the number of PET scanners is increasing, indicating progress in this technology. A Eurostat study highlights that France saw a jump from 5 to 183 PET scanners between 2002 and 2020, with most European countries experiencing a greater availability of PET scanners.
As it grows, the radiopharmaceuticals sector faces increasingly important challenges related to its logistics, but also to clinical practices and the overall perception of nuclear medicine.
Radiopharmaceuticals production often requires access to generators as source of radioisotopes. This equipment is expensive, requires special accreditations and is not available in all healthcare establishments. Securing access to a sufficient supply with high-quality drugs is thus an issue. After manufacturing, the shelf-life of radiopharmaceuticals can last from a few minutes to about ten days, creating pressure around delivery speed, the need to design a shipping method and a scalable, on-demand manufacturing process. Downstream, waste management may follow very strict and specific procedures because of the risks associated with the presence of radioisotopes.
Institutions are addressing these issues, for example by creating action plans such as SAMIRA. SAMIRA is the EU’s first comprehensive action plan which aims to secure radioisotope supply and improve radiation safety. It is supported by several EU programs such as the EU4Health which supports the quality and safety of radiation technology in diagnostics and cancer treatment. Parallelly, the European Council recently approved conclusions to ensure the supply of medical radioisotopes (June 2024). The Council conclusions urge the Commission to take action, notably on monitoring and forecasting the demand and supply of all relevant medical radioisotopes.
The preparation and the administration of radiopharmaceuticals require specific expertise in nuclear medicine with proper certification. This leads to a systemic shortage and an inequitable distribution of the nuclear medicine workforce worldwide between high-income, middle-income and low-income countries (according to World Bank classification). On average, there are 100 times more nuclear medicine physicians in high-income countries than in middle-income countries.
Education and training can help addressing the shortage of specialists. In this regard, the global initiative committee of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) has initiated a project to evaluate the global educational and training resources for theragnostic from 2018 to 2022. In addition, organizations like the European Nuclear Education Network (ENEN) are actively working to sustain and enhance nuclear expertise in Europe through education and training.
For radiopharmaceuticals to be used, patients and key providers in the patient pathways must be convinced of their value and effectiveness. The problem is that nuclear medicine physicians are poorly represented in multidisciplinary teams, they have limited involvement in non-diagnostic decision-making and little collaboration with other specialists (e.g., oncologist, radiologist, radiotherapist). For example, this is particularly unfortunate in the context of prostate cancer, where nuclear medicine physicians can offer significant benefits through their expertise in interpreting PET scan images and understanding theragnostic opportunities. Raising specialists’ awareness through education and encouraging research through European programs such as the PRISMAP project could be ways of generating interest in these technologies and involving more experts.
Radiopharmaceuticals hold great promise in a world where the prevalence of cancer and neurological diseases is on the rise and for which they have diagnostic and therapeutic potential. To drive research and innovation forward and improve radiopharmaceutical’s accessibility, action plans, projects and organizations emerged working for a better demand forecast, supply management and expertise expansion. Alcimed can support you in this dynamic, fast-moving environment! Don’t hesitate to contact our team!
About the author:
Mariam, Consultant in Alcimed’s Healthcare team in France.
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