Key Findings
- The increasing integration of diagnostics and therapeutics into a single platform is revolutionizing personalized medicine in North America, driving demand for theranostics-based approaches.
- Radiopharmaceuticals are dominating the theranostics space in North America, especially for oncology applications involving prostate cancer and neuroendocrine tumors.
- Rising investments from pharmaceutical giants and nuclear medicine facilities in North America are strengthening the infrastructure and pipeline of targeted radionuclide therapies.
- Companion diagnostics linked to precision oncology treatments are enabling enhanced treatment stratification, especially in breast, lung, and thyroid cancers.
- Collaborations between diagnostics companies and drug developers in North America are leading to co-development of dual-purpose theranostic agents.
- The regulatory ecosystem in North America is increasingly adapting to hybrid products, improving the market access and reimbursement of theranostic solutions.
- Theranostics is gaining traction beyond oncology, with active research underway in cardiovascular, infectious, and neurological disorders.
North America Theranostics Market Size And Forecast
The North America Theranostics Market was valued at USD 7.6 billion in 2025 and is expected to reach USD 21.4 billion by 2031, growing at a CAGR of 18.6% during the forecast period.
The strong growth trajectory is supported by increasing demand for precision medicine, rapid adoption of radioligand therapies in oncology, and a growing pipeline of companion diagnostics. Regulatory and reimbursement frameworks in North America are also evolving to support the commercialization of integrated diagnostic-therapeutic offerings.
Introduction
The North America Theranostics Market refers to the emerging medical paradigm that integrates therapeutics with diagnostics, allowing for targeted treatment delivery and real-time monitoring of therapeutic efficacy. Theranostics involves agents that can both detect and treat disease, typically through radiopharmaceuticals, nanocarriers, or biomarker-based molecular diagnostics.
In North America, theranostics is primarily being adopted in oncology, with increasing application in nuclear medicine for prostate cancer (e.g., PSMA-targeted therapies) and neuroendocrine tumors (e.g., Lutathera). The approach enables high treatment precision and significantly reduces systemic toxicity, aligning with the goals of personalized medicine. Increasing clinical trials and partnerships between diagnostic and pharmaceutical companies in North America are fostering a robust theranostic ecosystem.
Future Outlook
The future of the North America theranostics market lies in the expansion of its applications across a broader range of diseases, including cardiovascular inflammation, Alzheimer's, and infectious diseases. Advanced molecular imaging, AI-driven diagnostic analytics, and next-generation sequencing (NGS)-based biomarker discovery are expected to further strengthen theranostic potential.
With growing investments in nuclear medicine facilities and targeted radioligand production in North America, the market is poised to see rapid growth in novel radiopharmaceutical pipelines. Furthermore, regulatory convergence between diagnostics and therapeutic oversight will be crucial to accelerating theranostic drug-device approvals in the years ahead.
North America Theranostics Market Trends
- Rise of radiopharmaceutical theranostics
In North America, radiolabeled agents that combine diagnostic imaging with radionuclide therapy—such as Lutetium-177-based compounds—are becoming widely accepted in clinical oncology, particularly for PSMA and SSTR-targeting. - Advancement in companion diagnostics
Companion diagnostics (CDx) are essential in identifying patient subpopulations likely to benefit from specific therapies. The expansion of CDx in North America is boosting the market for co-developed theranostic drugs and improving treatment outcomes. - Nanoparticle-based theranostics
Research centers in North America are increasingly developing nanocarriers capable of simultaneously delivering imaging agents and therapeutic payloads. These platforms enable site-specific release and multiplexed diagnostics, enhancing both efficacy and safety. - Growing use of AI in theranostic imaging
AI and machine learning are being used in North America to improve image acquisition, interpretation, and therapy response prediction in nuclear imaging, helping refine patient stratification and dosing protocols. - Expanding beyond oncology
Although oncology remains the key application, theranostics is seeing emerging use cases in cardiovascular diseases (e.g., plaque targeting), neurodegenerative conditions (e.g., beta-amyloid targeting), and antimicrobial therapies in North America.
Market Growth Drivers
- Rising cancer burden and precision oncology initiatives
The increasing incidence of cancer in North America is creating demand for highly targeted treatments with minimal side effects. Theranostics aligns well with this need by combining diagnosis and treatment into a personalized workflow. - Government support for nuclear medicine infrastructure
In North America, public sector investments in cyclotron facilities, isotope production, and academic radiopharmacy programs are laying the groundwork for a sustainable theranostic pipeline. - Advancements in imaging modalities
Innovations in PET/CT, SPECT/CT, and MRI imaging systems in North America are improving the sensitivity and specificity of theranostic procedures, enabling more accurate treatment monitoring and decision-making. - Strong pharma-diagnostics partnerships
Increasing collaborations in North America between pharmaceutical and diagnostics companies are driving the co-development of theranostic agents, streamlining regulatory approvals and clinical adoption. - Favorable reimbursement for targeted therapies
Reimbursement agencies in North America are beginning to recognize the clinical value and long-term cost-effectiveness of theranostics, particularly in cancers where standard treatments have limited efficacy.
Challenges in the Market
- Regulatory complexities of hybrid products
Theranostics involve combined diagnostic and therapeutic elements, making regulatory approval more complex in North America due to multiple oversight pathways and slower coordination across health authorities. - Short half-life of radiopharmaceuticals
The logistics of producing, transporting, and administering short-lived isotopes such as 68Ga and 18F present significant operational challenges in North America, particularly in remote or underserved regions. - Limited trained personnel and infrastructure
The execution of theranostic protocols requires specialized training in radiopharmacy, nuclear medicine, and hybrid imaging—areas where North America still faces workforce shortages and skill gaps. - High cost of development and equipment
Theranostic development in North America is capital-intensive, requiring advanced cyclotron installations, GMP radiopharmaceutical production units, and multimodal imaging devices—all of which increase market entry barriers. - Ethical and safety concerns in targeted radiotherapy
There are ongoing concerns in North America regarding radiation exposure, off-target effects, and long-term safety of radioligand therapies, which may affect patient acceptance and clinical utilization.
North America Theranostics Market Segmentation
By Product Type
- Radiopharmaceuticals
- Companion Diagnostics
- Imaging Agents
- Nanoparticles
- Others
By Technology
- Molecular Imaging (PET, SPECT)
- Radiotherapy
- Nanotechnology
- Gene Therapy
- Immunotherapy
By Application
- Oncology
- Cardiovascular Diseases
- Neurological Disorders
- Infectious Diseases
- Others
By End-Use
- Hospitals
- Cancer Research Institutes
- Diagnostic Centers
- Academic & Research Laboratories
- Nuclear Medicine Facilities
Leading Players
- GE HealthCare
- Siemens Healthineers
- Telix Pharmaceuticals
- Lantheus Holdings
- Jubilant Radiopharma
- Bayer AG
- Theragnostics Ltd.
- Advanced Accelerator Applications (Novartis)
- Curium Pharma
- SOFIE Biosciences
Recent Developments
- Telix Pharmaceuticals received regulatory approval in North America for its PSMA-targeting radiopharmaceutical agent for prostate cancer diagnosis and therapy, marking a significant milestone in the expansion of targeted oncology.
- GE HealthCare launched a new hybrid PET/CT imaging platform in North America designed specifically to support theranostic workflows and improve precision in radioligand therapy planning.
- Bayer AG expanded its theranostic pipeline in North America by initiating Phase III trials for its alpha-emitting radionuclide targeting prostate-specific membrane antigen (PSMA).
- Theragnostics Ltd. announced a strategic collaboration with local academic hospitals in North America to evaluate novel radiopharmaceuticals for neuroendocrine tumor applications.
- Siemens Healthineers introduced advanced SPECT/CT systems in North America with AI-augmented image analysis tools aimed at enhancing theranostic treatment response assessment.
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