Radioconjugates, also known as radionuclude-drug conjugates (RDCs), combine a tumour-targeting ligand (an antibody, peptide or small molecule) with a radioisotope payload, connected by a chemical linker and/or chelator. Because they are targeted and deliver the payload directly to the disease site, they cause lower levels of damage to healthy tissues than systemically delivered radiation. The radionuclides do not need to be released or to enter the cells to stop cell growth and division, they act via bystander and distal effects[1, 2]
Radioconjugates include theranostics, which provide a complementary approach to diagnosis and therapy. These use a targeting ligand and linker with a diagnostic radionuclide to image the lesion, and then the same targeting ligand with a therapeutic radionuclide as a treatment. The diagnostic form allows the healthcare professionals to see what is happening at the disease site and then select the best treatment option and dose. As an example, 68-Ga DOTATATE and 177-Lu DOTATATE (the first peptide-radionuclide conjugate to be approved) are used for the diagnosis and treatment of well-differentiated neuroendocrine tumours (NETs). [3]
This piece is a follow up to the Pharma Sources May 2025 piece Radioconjugates: Targeting for Precision, with a focus on the global market landscape, and on the approval process in the US. Approval processes under other national regulatory authorities are likely to be similar, but it is important to seek local advice.
The radioconjugates market: Oncology and beyond
According to Verified Market Reports, the market for radioconjugates was worth an estimated $3.2 billion in 2024, growing to $7.5 billion by 2033 at a CAGR (compound annual growth rate) of 10.5% from 2026 to 2033. North America is the biggest market for radioconjugates, followed by Europe and Asia Pacific, and Asia-Pacific is the fastest growing region. The report suggests a market split between antibody-radionuclide conjugates (ARCs; 45%), peptide-radionuclide conjugates (PRCs; 35%) and small molecule-radionuclide conjugates (SMRCs; 35%). The peptide-based radioconjugate market share is growing the most quickly, as these show improved targeting capabilities and clinical results. Around four in 10 applications in 2023 were for neuroendocrine tumours, followed by prostate cancer and renal cell carcinoma (both around three in 10). Verified Market Reports expects prostate cancer applications to grow the fastest, based on improvements in diagnostic and treatment technology. [4]
Drivers behind the market growth include: [4]
· the aging global population
· the rising prevalence of cancer
· a growing adoption of nuclear medicine
· better technology
· increased interest from biopharma companies
· wider geographic adoption alongside increasing disposable income
· an increasing focus on precision medicine and personalised treatment plans.
Radioconjugates may have potential as combination therapies in cancer. They may also have applications beyond cancer, such as in the diagnosis and treatment of cardiovascular, autoimmune, inflammatory and neurological diseases. The uses outside of cancer are still in early stages of research, and researchers will need access to a wider spectrum of biomarkers to develop this area further. Expanding the use of radioconjugates beyond cancer may also be limited by the complexity of disease, for example the variety of neuropathological changes in neurodegenerative conditions. [3, 4]
The approval process for radioconjugates
The approval process prior to launching radioconjugates in the US is similar to that for non-radioactive therapeutics, but there are additional requirements because the molecules are made up of a number of different parts, as well as carrying additional risks because they include a radioactive component. [5]
Radioconjugates can be a...
(All Rights Reserved)