Radiopharmaceutical Theranostics Market Poised for Strong Growth as Precision Oncology Enters a New Era by 2031

United States of America – December 29, 2025 – According to The Insight Partners, the radiopharmaceutical theranostics market size is expected to grow from US$ 1,814.58 million in 2022 to US$ 3,441.97 million by 2028; it is estimated to record a CAGR of 11.3% from 2022 to 2028. The global radiopharmaceutical theranostics market is gaining significant momentum as hospitals, cancer centers, and nuclear medicine departments increasingly adopt targeted diagnostic–therapeutic pairs to manage complex oncology indications. Combining molecular imaging with targeted radionuclide therapy in a single continuum of care, radiopharmaceutical theranostics enables more accurate patient selection, real-time response assessment, and personalized treatment planning, positioning the market for sustained expansion through 2031.​

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Human‑Centric Market Context

At the heart of radiopharmaceutical theranostics is a simple but powerful aim: ensuring that the right patient receives the right treatment at the right time, with as little collateral damage as possible. Patients with metastatic castration‑resistant prostate cancer, neuroendocrine tumors, and other hard‑to‑treat malignancies are increasingly accessing radiotheranostic options that can improve quality of life by reducing systemic toxicity compared with conventional chemotherapy.​

Clinicians value these solutions because the same molecular target can be visualized using diagnostic tracers and treated using therapeutic radionuclides, reducing uncertainty and supporting multidisciplinary decision‑making. Families, caregivers, and patient advocacy groups are also becoming more aware of theranostic pathways, which is driving demand for earlier diagnosis, specialist referral, and equitable access to nuclear medicine infrastructure in both mature and emerging markets.​

Key Market Highlights to 2031

• Market size and growth trajectory remain positive through 2031, supported by rising cancer incidence, increasing adoption of precision medicine, and continuous innovation in theranostic radioisotopes and vectors.​
• Market share is currently concentrated among a mix of global pharmaceutical leaders and specialized radiopharmaceutical firms, with growing participation from regional players and CDMOs focused on isotope production and labeling services.​
• Key trends shaping the market include expanding indications beyond prostate and neuroendocrine tumors, automation and digitalization of radiopharmacy workflows, and greater integration of PET/CT and SPECT/CT imaging in routine oncology practice.​
• Market analysis points to robust pipeline activity, active mergers and acquisitions, and strategic licensing agreements, particularly around novel ligands, alpha‑emitting therapies, and next‑generation PSMA- and SSTR‑targeted agents.​
• Forecasts to 2031 indicate sustained double‑digit adoption in high‑growth regions alongside steady expansion in established markets, underpinned by infrastructure upgrades, improved reimbursement, and broader clinical guideline inclusion.​

Global and Regional Outlook

Globally, radiopharmaceutical theranostics is moving from niche, late‑line interventions toward earlier‑line and combination strategies as real‑world evidence and long‑term outcome data accumulate. Major international cancer centers are scaling capacity with new cyclotrons, hot labs, and dedicated theranostics units, enabling higher procedure volumes and more standardized care pathways.​

• North America:
• North America currently leads adoption, supported by advanced nuclear medicine infrastructure, favorable reimbursement in select indications, and strong clinical trial activity. The region also hosts a large share of radiopharmaceutical manufacturing, distribution, and logistics capabilities, which helps ensure time‑critical supply of short‑lived isotopes to hospital sites.​
• Europe:
• Europe continues to expand access through coordinated oncology networks, cross‑border clinical trials, and national investments in PET/CT capacity and isotope production. EMA approvals of radiotheranostic agents and guideline endorsements by leading oncology societies are accelerating adoption in both public and private settings.​
• Asia Pacific:
• Asia Pacific is emerging as a high‑growth region, as countries such as China, India, Japan, and South Korea invest in nuclear medicine facilities, domestic radioisotope production, and fast‑track regulatory pathways for innovative oncologic agents. Rising cancer prevalence, growing middle‑class demand for advanced therapies, and public–private partnerships are expected to further expand the regional theranostics footprint.​
• Rest of the World:
• Latin America, the Middle East, and parts of Africa are gradually increasing adoption through referral hubs, regional radiopharmacies, and collaborations with multinational vendors, though access remains variable and often concentrated in tier‑1 urban centers.​

Market Segmentation Overview

The radiopharmaceutical theranostics market spans a broad set of products and technologies designed to deliver targeted diagnosis and therapy:

• By Product Type:
• Alpha emitters and beta emitters used in targeted radionuclide therapy for oncology and select non‑oncology indications.​
• Positron emission tomography (PET) tracers that visualize molecular targets, guide patient selection, and monitor therapeutic response.​
• By Radioisotope:
• Widely utilized isotopes include Technetium‑99, Gallium‑68, Iodine‑131, Iodine‑123, Fluorine‑18, Yttrium‑90, Lutetium‑177, Copper‑67, and Copper‑64, each offering distinct physical half‑lives and emission profiles tailored to specific clinical applications.​
• By Source:
• Nuclear reactors and cyclotrons remain the primary production sources, with countries investing strategically to reduce import dependence and stabilize supply.​
• By Application:
• Targeted therapeutic radiopharmaceuticals and companion diagnostics form the core of radiotheranostic practice, primarily across oncology but with growing exploration in cardiology, neurology, and inflammatory diseases.​

Leading Companies and Competitive Landscape

The competitive landscape is characterized by a blend of diversified healthcare conglomerates and focused theranostic innovators that are actively advancing clinical pipelines, partnerships, and manufacturing networks.​

Major market participants include:

• Bayer AG
• GE HealthCare Technologies Inc.
• Curium
• Lantheus Medical Imaging, Inc.
• Telix Pharmaceuticals Ltd.
• Cardinal Health, Inc.
• Advanced Accelerator Applications S.A.
• Jubilant Radiopharma
• Theragnostics

These companies are expanding portfolios through new indication approvals, radioligand therapy launches, in‑licensing of novel targets, and investments in GMP‑compliant radiopharmaceutical manufacturing and isotope logistics. Recent strategic moves include acquisitions to bolster diagnostic tracer lines, collaborations with academic centers for first‑in‑human studies, and long‑term supply agreements ensuring reliable access to key isotopes.​

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Recent Market News and Developments

Ongoing news flow underscores the dynamism of the radiopharmaceutical theranostics landscape:

• Regulatory agencies have continued to approve new radiotheranostic agents and expanded indications for existing products, particularly in prostate cancer and neuroendocrine tumors, strengthening clinical confidence and reimbursement prospects.​
• Large imaging and pharmaceutical companies are ramping up mergers, acquisitions, and joint ventures focused on radiotheranostics platforms, isotope production, and enabling technologies such as PET/CT and SPECT/CT systems.​
• Health systems and governments are investing in additional cyclotrons, radiopharmacies, and nuclear medicine training programs to address workforce and capacity constraints and to prepare for broader integration of theranostics into standard cancer care pathways.​

As radiopharmaceutical theranostics progresses toward 2031, stakeholders across industry, healthcare, and policy are expected to play a pivotal role in scaling access, optimizing care models, and unlocking the full potential of this rapidly evolving field for patients worldwide.

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