Radiotheranostics Market By Radioisotope (Lutetium-177, Gallium-68, Iodine-131, Actinium-225, Others), By Application (Oncology, Cardiology, Neurology, Others.), By End-user (Hospitals, Diagnostic Imaging Centers, Cancer Research Institutes, Specialty Clinics, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

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Industry Outlook

The Radiotheranostics market accounted for USD 7.81 Billion in 2024 and USD 8.87 Billion in 2025 is expected to reach USD 31.8 Billion by 2035, growing at a CAGR of around 13.6% between 2025 and 2035. The radiotheranostics market is based on an innovative medical practice in which diagnosis and treatment are combined with radioactive materials. In this method, one uses the radio pharmaceuticals which may be useful in detecting (for diagnostic purposes) and treating (for therapeutic purposes) the illnesses, mainly prostate, thyroid, and neuroendocrine tumors. As far as diagnostics are concerned, these agents assist in locating the disease by use of imaging techniques such as PET and SPECT scans. During treatment, the identical or altered agents are used to transmit focused radiation to kill malignant cells with limited damage to the healthy cells.

Radiotheranostics has an individual-based medical implementation where clinicians can equip the patient with personalized treatment depending on how they react to the diagnostic scan. It is trending because the rate of cancer has been on the rise, there has been an improvement in nuclear medicine, and there is an increased trend towards targeted therapy. Market growth is also enhanced because of regulatory assistance and financing of new radiopharmaceuticals. Nonetheless, issues such as prohibitive cost of the procedures, specialized infrastructure required and associated regulatory difficulties continue to exist. This notwithstanding, radiotheranostics has great potential in the advancement of treatment precision, disease tracking, and better patient outcomes. 

Industry Experts Opinion

"Combining our Affilin® platform with SCK CEN’s isotope expertise, especially Terbium‑161, represents a breakthrough step in designing radiotheranostics with enhanced tumor specificity and therapeutic efficacy."

• Dr. Andreas Kroll, Chief Scientific Officer, Navigo Proteins GmbH

Report Scope:

Market Dynamics

The rising incidence of neuroendocrine and prostate cancers requires targeted treatment solutions.

Increasing incidence of neuroendocrine tumors (NETs) and prostate cancer, which are regarded as perfect targets of targeted radiopharmaceutical therapies, is one of the major radiotheranostics market drivers. The added advantage of radiotheranostics is that it provides both proper imaging and local treatment, hence its effectiveness, especially for diseases like cancers that are not easily diagnosable or easily treated due to their nature of spreading. Prostate cancer has been rated as the most common form of cancer in men in the United States, with a figure of 299,010 new cases likely to be witnessed during the year 2024 alone, according to the National Cancer Institute (NCI).

Likewise, the incidences of NETs are on the constant rise, which is emphasized by the Surveillance, Epidemiology, and End Results (SEER) Program, according to which the number of NET diagnoses has been on the rise within the past decades. These figures indicate an increasing clinical demand for accurate and minimally invasive modalities such as radiotheranostics. The key factors that will drive the market further are the increase in awareness among oncologists and positive clinical outcomes that should lead to the increasing demand for such targeted solutions in the foreseeable future.

The growing use of personalized medicine is driving demand for dual diagnostic-therapeutic tools.

The trend of moving towards personalized medicine is a key contributor to the radiotheranostics market since it perfectly feeds into the potential of the field to treat and diagnose diseases through the same molecular platform in a given patient. Radiotheranostics allows doctors to design treatments depending on a given tumor biology as well as uptake of radiotracers, promotes enhanced precision in therapy, and also minimizes its side effects.

This dual application is particularly valuable in cancers such as neuroendocrine tumors and prostate cancer, whose early and correct diagnosis and subsequent application of targeted radiotherapy can save a lot. The National Institutes of Health (NIH) defined that more than 38 % of clinical trials concerning precision oncology currently contain radiopharmaceutical elements, suggesting that there is an increasing use of such tools in patient-specific therapies. The institutional trends to support the idea of individualized care are increasingly driving the implementation of radiotheranostic solutions in clinical practice.

The high cost of radiopharmaceuticals and therapies is limiting accessibility in low-resource settings.

The limitation of communications and limited access to radiopharmaceuticals and related treatments due to high prices is one of the major market restraints in the radiotheranostics market. Complex processes, special facilities, and regulatory requirements are associated with the production of radiopharmaceuticals and increase the cost of operations. In addition, other isotopes such as Lutetium-177 and Actinium-225 are also transported and handled using specific requirements, thus incurring additional logistical costs.

It is highly accurate and, therefore, its treatment is usually expensive when compared with other kinds of traditional therapies. The reimbursement policies in most of the healthcare systems are also limited, which additional limits access to the patient. This has led to the fact that despite the better results provided by radiotheranostics, its accessibility is very restricted to the developed world, which has an intricate network of nuclear medicine, and hence, there exist disparities in global health care access.

Expansion into non-oncology applications, like cardiology and neurology.

The potential future as revealed in the radiotheranostics market is to extend its use beyond oncology into areas such as cardiology and neurology. Although cancer therapy remains the dominant area of concern in this regard, the radiotheranostic agents are also being investigated more routinely to treat diseases like Alzheimerech`s disease, Parkinson's disease, and cardiac sarcoidosis. Radiotracers may be useful in the cardiology setting, such as the ability to localize inflammatory or ischemic pathology in the heart, and in the neurology setting, the ability to image aberrant protein deposition in neurodegenerative conditions.

The applications create new opportunities for early intervention available to non-cancer health conditions and precision therapy. Media, academic institutions, and research institutions are also in the process of trials to confirm the validity of the uses. An example is that the National Institute on Aging (part of NIH) conducts research on radiolabeled tracers to detect beta-amyloid in Alzheimer, with increasing government interest, this is the expansion effort, which is a significant growth opportunity of the market, because this would increase the applicability of radiotheranostics in treatment of a broader set of disorders.

Integration with AI in imaging interpretation for more precise diagnostics.

The application of artificial intelligence (AI) in the interpretation of images is gradually generating a positive prospect for the radiotheranostics market by boosting the precision, speed, and repeatability of diagnostics. The specific problem where AI may be of benefit is in PET and SPECT scans due to the complexity of the data sets involved, but the ability to analyze complex data sets to determine subtle patterns, thereby enhancing detection of lesions and prediction of outcomes in treatment, where the traditional methods fail.

Such accuracy is essential in radiotheranostics, in which the effectiveness of follow-up treatment directly depends on diagnostic accuracy. Automated quantification, image fusion, and individualized dose planning are also facilitated by AI, and the whole process becomes more efficient. As reported by the Radiological Society of North America (RSNA), more than 60 percent of imaging departments in mature healthcare environments have started to embrace AI tools, which points to increased adoption in the clinical workflow. This combination of AI with radiotheranostics can transform the care standards and enlarge the market niche by making the involved processes more reliable and scalable in various settings of medical care.

Segment Analysis

Based on the Radioisotopes Type, the Radiotheranostics Market has been classified into Lutetium-177, Gallium-68, Iodine-131, Actinium-225, and Others. Lutetium-177 (Lu-177) is the most powerful radioisotope segment in the radiotheranostics market. The properties of Lu-177 that make it commonly used consist of ideal physical and chemical characteristics to be used in radiation therapy, including an appropriate half-life and probable beta emissions of low energy that make it possible to accurately target cancerous cells and harm the surrounding healthy ones to a minimal point. It can be used particularly in the treatment of neuroendocrine tumors and metastatic prostate cancer, which are major targets where radiotheranostics have registered decent clinical results.

The versatility of the isotope lies in the fact that the isotope can be conjugated to targeting molecules such as peptides or antibodies. It also enjoys regulatory approvals and favorable clinical trial results, and thus, it is being adopted continuously. Moreover, therapy involving Lu-177, including Lutathera 177 and Pluvicto, has established standards in the sector that increase commercial and healthcare uptake. As the prevalence of appropriate cancer types and physician awareness has been improved, Lu-177 remains the leader of this segment in terms of both use and revenue shares.

Based on the Application, the Radiotheranostics Market has been classified into Oncology, Cardiology, Neurology, and Others. The largest application segment within the radiotheranostics market is oncology. Such domination is attributable to the rising world cancer burden, as well as the rising need for highly tailored, targeted treatments. Radiotheranostics can distinguish itself as a novel practice in oncology as it allows the precision in diagnostic imaging to be combined with similarly precise radiation therapy, thereby enhancing the effect of treatment and reducing the number of its side effects.

It has great application in the treatment of prostate cancer, neuroendocrine and thyroid cancer, where the standard methods might prove inadequate. Adoption in oncology has been enhanced tremendously due to the approval and the launch of radiotheranostics such as Lutathera and Pluvicto. Moreover, the investment in the clinical trials involving oncology and increased access to nuclear medicine facilities only furthers the top position of oncology in this market.

Regional Analysis

North America also has a major share in the radiotheranostics market, due to large prevalence rates of cancer along with well-developed health care systems and early use of nuclear medicine technologies. The United States is the leader of the region and is backed by a large presence of key players, ongoing clinical trials, and a growing number of FDA approvals of radiotheranostic agents.

The growth of investment in oncology research, as well as the positive reimbursement policies and the increase in awareness among healthcare providers, drive the growth of the market. There are also alliances between universities and drug companies that encourage innovation and the invention of new treatments. Canada is also consistent with its contribution, having the advantage of the growing programs in nuclear medicine, and is sponsored by the government in terms of cancer care.

The Asia-Pacific market is developing fast and is being dominated by factors such as the number of people afflicted by cancer, the heightened level of healthcare spending, and the enhanced accessibility to modern diagnostic and therapeutic devices. Other countries such as China, Japan, South Korea, and India are engaging in huge investments in nuclear medicine infrastructure and the production of radiopharmaceuticals. Programs by the government on the modernization of healthcare systems and the promotion of early detection of cancer are also driving the demand.

The region is being led by Japan, which is strongly rooted in medical imaging and radiopharmaceuticals adoption. In the meantime, domestic ventures are also establishing partnerships with international partners to increase the scope and introduce innovative radiotheranostic options to patients. The area offers great opportunities that are found in the vast patient population and the growing clinical research environment.  

Competitive Landscape

The radiotheranostics market is a competitive market with the existence of developed pharmaceutical corporations as well as specialized radiopharmaceutical enterprises. Approved products and global presence of the leading companies, such as Novartis AG and its subsidiary organization Advanced Accelerator Applications, using the possibility of the development of therapies such as Lutathera and Pluvicto allows directing their positions in the market. The strong competition is also an issue because companies such as Telix Pharmaceuticals and Lantheus Holdings are primarily concentrated on acquiring regulatory permissions in various regions and extending their pipeline. In the meantime, other companies like Curium and Jubilant radiopharma are taking advantage of their capabilities in manufacturing and their distribution and retailing to enhance their standings.

There is also enhanced cooperation among pharma companies, diagnostic firms, and research institutes in order to hasten the development of products and expand their use other than in oncology. Production of radioisotopes, infrastructure investments, and strategic alliances in global supply chains are also leading trends. Also influencing the market is the innovation in the targeted molecular imaging and therapy, which has led to competitor differentiation. Moreover, the popular course of action to reach new technologies or geographical presence is M&A activities and licensing agreements. On the whole, the market is dynamic, and the primary competitive levers are innovation, regulatory success, and geographical expansion.

Radiotheranostics Market, Company Shares Analysis, 2024

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Recent Developments:

• In April 2025, Navigo Proteins and Belgium’s Nuclear Research Centre SCK CEN announced a strategic R&D collaboration to develop next-generation radiotheranostic treatments harnessing the Auger-electron emitting isotope Terbium‑161 (¹⁶¹Tb).

Report Coverage:

By Radioisotope

• Lutetium-177
• Gallium-68
• Iodine-131
• Actinium-225
• Others

By Application

• Oncology
• Cardiology
• Neurology
• Others

By End-user

• Hospitals
• Diagnostic Imaging Centres
• Cancer Research Institutes
• Specialty Clinics
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Novartis AG
• Telix Pharmaceuticals Limited
• Curium
• Cardinal Health, Inc.
• GE HealthCare
• Lantheus Holdings, Inc.
• ITM Isotope Technologies Munich SE
• Eckert & Ziegler Strahlen- und Medizintechnik AG
• Jubilant Radiopharma
• Bayer AG
• Theragnostics Ltd
• NorthStar Medical Radioisotopes, LLC
• Advanced Accelerator Applications S.A.
• Bracco Imaging S.p.A.
• Alpha Tau Medical Ltd.

Frequently Asked Questions (FAQs)