Radioconjugate Therapy: The Approval Process And the Market Landscap

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 approved via the new drug application (NDA) or biologics license application (BLA) pathways. This involves presenting nonclinical and clinical data to the FDA (Food and Drug Administration), along with assessments of chemistry, manufacturing and controls (CMC). The CMC data is particularly important for therapeutics that incorporate radionuclides. [5, 6]

The FDA has expedited programs for therapeutics that meet unmet medical needs in serious conditions. Some radioconjugates may fit into these programs, which provide access to more support from the FDA, and/or quicker approval. [5, 6]

· Fast Track Designation – potential to address an unmet medical need

· Breakthrough Therapy Designation – substantial improvement over available therapies

· Accelerated Approval Pathway – meaningful advantage over available therapies 

· Priority Review Designation – significant improvement in safety or effectiveness

Some radioconjugates may fall into the FDA’s definition of combination products because they include both a radionuclide and a biologic. This may mean that the approval process involves both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). [5]

Additional data required for radioconjugates includes: [5]

· Preclinical data

   · Nonclinical studies need to show biodistribution, dosimetry and safety, including quantification of the radiation dose delivered to health tissues compared with tumour sites

· Chemistry, manufacturing and controls

   · Manufacturing protocols and processes must be precise and validated because radionuclides have short half-lives and particular handling requirements

   · The connections between the components must be stable

   · Production batches must be consistent, and processes must be reproducible

· Clinical trial data

   · Clinical trial data needs to show that the targeting is effective and safe, through assessments of pharmacokinetics, pharmacodynamics, adverse event type and severity, and clinical efficacy (disease response, survival, quality of life and other endpoints)

   · Radiation safety and dosimetry assessment should be part of the clinical trials process, and the reports should include radiation exposure to patients and healthcare professionals to demonstrate that the benefits outweigh the risks

Into the future for radioconjugates

Research goals for radioconjugates include finding more and better targets for radioconjugates, improving their efficacy and increasing their potential applications. The goals also need to include reductions of the associated side effects such as fatigue, myelosuppression and nausea to improve the quality of life for people undergoing treatment. Other areas for improvement include streamlining manufacturing, distribution and storage to cut costs and reduce delays. 

The next generation radioconjugates will support the ongoing market growth and help to get more effective and safe treatment options into the hands of healthcare professionals and patients, in order to improve survival rates and day to day life for people with cancer and other serious diseases. 

References 

1.Jia, G., Y. Jiang, and X. Li, Targeted drug conjugates in cancer therapy: Challenges and opportunities.Pharmaceutical Science Advances, 2024. 2: p. 100048.

2.Li, J.H., L. Liu, and X.H. Zhao, Precision targeting in oncology: The future of conjugated drugs. Biomed Pharmacother, 2024. 177: p. 117106.

3.Zhang, S., et al., Radiopharmaceuticals and their applications in medicine. Signal Transduction and Targeted Therapy, 2025. 10: p. 1.

4.Global Radionuclide Drug Conjugates (RDC) Market Size By Type of Radionuclide (Alpha Emitters, Beta Emitters), By Application (Cancer Treatment, Cardiovascular Diseases), By Conjugate Type (Antibody-Drug Conjugates (ADCs), Peptide Conjugates), By Route of Administration (Intravenous, Oral), By End User (Hospitals, Research Laboratories), By Geographic Scope And Forecast. Verified Market Reports. February 2025. Available from: https://www.verifiedmarketreports.com/product/radionuclide-drug-conjugates-rdc-market/.

5.How many FDA approved Radionuclide Drug Conjugates (RDC) are there? PatSnap. Last accessed: 17 March 2025. Available from: https://synapse.patsnap.com/article/how-many-fda-approved-radionuclide-drug-conjugates-rdc-are-there.

6.FDA’s Expedited Programs Explained. ProPharma. Last accessed: 29 March 2022. Available from: https://www.propharmagroup.com/thought-leadership/fda-expedited-approvals.

About the Author

Based in the north of England, Suzanne Elvidge is a freelance medical writer with a 30-year experience in journalism, feature writing, publishing, communications and PR. She has written features and news for a range of publications, including BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView and other Nature publications, to name just a few. She has also written in-depth reports and ebooks on a range of industry and disease topics for FirstWord, PharmaSources, and FierceMarkets. Suzanne became a freelancer in 2006, and she writes about pharmaceuticals, consumer healthcare and medicine, and the healthcare, pharmaceutical and biotechnology industries, for industry, science, healthcare professional and patient audiences.