Theranostics Market Poised for Lucrative Growth, Projected to Reach USD 4.2 Billion by 2031 |Key Players: GE Healthcare, Cardinal Health, and Advanced Accelerator Applications

The theranostics market is emerging as one of the most promising segments in precision medicine, combining targeted diagnostics with personalized therapeutic interventions. By integrating diagnostic imaging and therapy, theranostics enables clinicians to identify disease at the molecular level and deliver tailored treatments that improve patient outcomes. This dual-function approach has become increasingly important in oncology, neurology, and cardiovascular disease management.

According to DataM Intelligence, the Global Theranostics Market reached USD 1.8 billion in 2022 and is expected to witness lucrative growth by reaching up to USD 4.2 billion by 2031, growing at a CAGR of 11.3% from 2024 to 2031. Growth is being driven by rising cancer prevalence, rapid advances in companion diagnostics, and increasing adoption of personalized medicine. North America leads the global market, while Asia-Pacific is witnessing the fastest adoption due to expanding healthcare infrastructure and clinical research.

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Key Highlights from the Report
➤ Global theranostics market projected to more than double by 2031 at a CAGR of 11.3%.
➤ Oncology remains the leading application, supported by targeted radiopharmaceuticals.
➤ Growing use of molecular imaging technologies fueling market expansion.
➤ North America dominates the market, while Asia-Pacific shows fastest growth.
➤ Strong investments in R&D and clinical trials for new theranostic agents.
➤ Strategic collaborations between pharma and diagnostic companies accelerating innovation.

Market Segmentation

By Application
The market is segmented into oncology, neurological disorders, cardiovascular diseases, and other applications. Oncology dominates the theranostics market, driven by the widespread use of targeted radioligand therapies (e.g., Lu-177 PSMA for prostate cancer) and companion diagnostics for personalized cancer treatment. Neurological disorders, such as neuroendocrine tumors and Alzheimer's disease, are emerging segments with innovative tracers for diagnosis and therapy. Cardiovascular applications include imaging and treatment of conditions like atherosclerosis. Other applications encompass endocrine, inflammatory, and rare diseases.

By Radioisotopes
Key radioisotopes include Technetium-99m, Gallium-68, Lutetium-177, Iodine-131, Zirconium-89, Yttrium-90, and others. Lutetium-177 is a cornerstone in theranostics, especially for peptide receptor radionuclide therapy (PRRT) in neuroendocrine and prostate cancers. Gallium-68 is widely used for PET imaging with ligands like DOTATATE and PSMA. Technetium-99m remains vital for SPECT imaging in cardiology and oncology. Iodine-131 is used for thyroid cancer therapy, while Yttrium-90 and Zirconium-89 serve in radioembolization and immuno-PET, respectively.

By End-User
Hospitals are the primary end-users, offering integrated diagnostic and therapeutic services for conditions like cancer and thyroid disorders. Cancer research institutes drive innovation through clinical trials and novel radioligand development. Diagnostic centers provide specialized imaging and monitoring services. Other end-users include academic institutions and nuclear pharmacies. The growth of theranostics relies on multidisciplinary collaboration between radiologists, oncologists, and nuclear medicine specialists, often within hospital-based centers of excellence.

Regional Insights

North America dominates the global theranostics market, supported by advanced healthcare systems, strong R&D investments, and early adoption of precision medicine in oncology. The U.S. leads with a large number of clinical trials, FDA support for companion diagnostics, and active collaborations between pharma and biotech companies. Canada is also contributing with expanding research programs and healthcare modernization.
Europe holds the second-largest share, with Germany, France, and the UK driving adoption through strong R&D infrastructure, favorable reimbursement policies, and rising clinical trial activity. EMA's regulatory support and growing collaborations between diagnostic developers and pharmaceutical firms are strengthening the regional market.

Asia-Pacific is projected to grow the fastest, fueled by rising cancer incidence, increasing healthcare spending, and government-backed precision medicine initiatives. China is leading with heavy investments in molecular diagnostics, Japan is advancing theranostics in oncology and rare diseases, and India is expanding adoption through growing cancer care needs and diagnostic capacity.
Latin America and the Middle East & Africa (MEA) are emerging markets. Brazil is seeing growth in oncology-focused diagnostics and treatment, while Saudi Arabia and the UAE are investing in advanced healthcare infrastructure and precision medicine initiatives, creating long-term opportunities for theranostics adoption.

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Market Dynamics

Market Drivers
The global theranostics market is primarily driven by the rising prevalence of cancer and chronic diseases, which continue to increase demand for early detection and targeted treatment solutions. The growing adoption of personalized and precision medicine is also playing a critical role, as healthcare systems shift toward patient-specific therapies that improve outcomes and reduce side effects. Rapid advancements in molecular diagnostics, nuclear imaging, and biomarker discovery are strengthening the ability to pair diagnostics with tailored therapies. Furthermore, strategic collaborations between pharmaceutical companies, diagnostic developers, and research institutions are accelerating innovation, enabling the development of new companion diagnostics and targeted therapies for oncology, cardiology, and neurology.

Market Restraints
Despite the strong growth outlook, the market faces several restraints. The high cost of theranostic procedures, including imaging and targeted radiotherapy, limits accessibility in cost-sensitive healthcare systems. In addition, the limited availability of radiopharmaceuticals in certain regions, due to supply chain and production challenges, continues to hinder widespread adoption. Regulatory hurdles also pose a challenge, as the approval process for combined diagnostic-therapeutic products is more complex than for standalone drugs or diagnostics, slowing down commercialization timelines. Shortages of skilled professionals trained in nuclear medicine and molecular imaging further add to the challenges in implementation.

Market Opportunities
Significant opportunities lie in the expansion of radiotheranostics in oncology, particularly for prostate cancer, neuroendocrine tumors, and other hard-to-treat cancers where targeted radioligand therapy is showing promising results. The integration of AI-driven molecular imaging platforms and advanced analytics is expected to enhance diagnostic accuracy, streamline clinical workflows, and support personalized treatment planning. Emerging markets in Asia-Pacific, Latin America, and the Middle East also present untapped potential as healthcare systems modernize, cancer incidence rises, and governments increase investments in precision medicine infrastructure. Growing interest from biotech startups and pharmaceutical companies in theranostics R&D is likely to further expand commercial opportunities over the coming years.

Reasons to Buy the Report
✔ Comprehensive forecasts of the global theranostics market up to 2031.
✔ Insights into oncology, cardiology, and neurology applications driving growth.
✔ Regional analysis highlighting opportunities in emerging economies.
✔ Competitive landscape profiling key players and their market strategies.
✔ Strategic guidance for companies investing in precision medicine solutions.

Frequently Asked Questions (FAQs)
◆ How big is the global theranostics market in 2022?
◆ What is the projected CAGR of the global theranostics market from 2024-2031?
◆ Which application dominates the theranostics market?
◆ Who are the key players operating in the theranostics market?
◆ Which region is expected to grow the fastest during the forecast period?

Company Insights
Key players operating in the global theranostics market include:

✔ Advanced Accelerator Applications
✔ CapVest Limited (Curium Pharma)
✔ Cardinal Health, LLC
✔ Clarity Pharmaceuticals
✔ GE Healthcare
✔ ITM Isotopen Technologien München AG
✔ Jubilant Pharmova Limited
✔ Lantheus Holdings, Inc.
✔ NuView Life Sciences
✔ Theragnostics Ltd.

Recent Developments:

✦ In 2023, Novartis AG expanded its radiotheranostics portfolio with regulatory approvals for targeted cancer therapies.

✦ In 2024, Siemens Healthineers launched an advanced molecular imaging platform to strengthen theranostic capabilities in oncology.

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Conclusion
The global theranostics market is on a path of significant growth, fueled by its ability to combine diagnosis and treatment into a unified, patient-centered approach. With a projected CAGR of 11.3% through 2031, theranostics is reshaping oncology and expanding into new therapeutic areas. Companies investing in innovation, partnerships, and emerging markets will be best positioned to capitalize on the growing demand for precision healthcare solutions.

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