The global theranostics market reached USD 1.8 billion in 2022 and is projected to grow to USD 4.2 billion by 2031, exhibiting a CAGR of 11.3% during the forecast period 2024–2031, driven by rising demand for personalized and precise medical treatments. Theranostics combines diagnostics and targeted therapy to tailor care based on individual disease profiles, leveraging molecular and genetic insights. This integrated approach enables physicians to make informed treatment decisions, enhancing therapeutic outcomes and transforming disease management, particularly in oncology.

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Market Drivers

1. Surge in Cancer Cases Globally

The rising prevalence of cancer—with over 19 million new cases reported globally in 2023—has intensified the demand for effective, targeted treatment. Theranostics offers a dual advantage: early detection and real-time therapeutic intervention.

2. Radiotheranostics Development

Advancements in alpha-emitting and beta-emitting radiopharmaceuticals are redefining targeted radionuclide therapy, especially in hard-to-treat tumors like neuroendocrine tumors, prostate cancer, and thyroid cancer.

3. Personalized and Precision Medicine Growth

The increasing focus on tailored treatment plans based on genomic and proteomic data is pushing the adoption of companion diagnostics that predict patient responses to targeted drugs, especially in oncology.

4. Regulatory Support and Fast-Track Approvals

The U.S. FDA, EMA, and Japan’s PMDA are streamlining regulatory approvals for theranostic pairings. This is particularly evident in the approval of Lutathera (Lutetium-177) and companion imaging agents.

5. Integration of Artificial Intelligence

AI algorithms in molecular imaging are improving tumor detection, treatment planning, and response monitoring, making theranostics more accessible and efficient.

Regional Insights

United States

The U.S. remains the largest market due to:

• High incidence of cancer and neurological disorders.
• Expanding adoption of nuclear medicine and molecular imaging.
• Favorable reimbursement for PET-based imaging.
• Active research from institutions like Mayo Clinic, MD Anderson, and NIH in radiotheranostics.

Companies like Lantheus Holdings, Telix Pharmaceuticals, and Novartis are leading the commercial roll-out of radiopharmaceuticals targeting PSMA-positive prostate cancer and NETs (neuroendocrine tumors).

Japan

Japan is driving:

• Clinical use of theranostic agents for prostate cancer under the national health insurance system.
• Development of compact cyclotrons and PET isotopes for in-hospital use.
• Integration of theranostics with robotic surgery and AI-assisted diagnostic imaging.

Leading Japanese universities and research centers, including Osaka University and RIKEN, are at the forefront of combining AI with PET imaging to improve patient outcomes.

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Key Applications

1. Oncology – Prostate, Breast, Thyroid, Neuroendocrine tumors.
2. Cardiology – Atherosclerosis imaging and targeted vascular interventions.
3. Neurology – Alzheimer’s, Parkinson’s, and epilepsy diagnosis and potential targeted therapies.
4. Infectious Diseases – Exploring theranostic techniques for real-time pathogen tracking.

Theranostic Components

• Radiopharmaceuticals – Lutetium-177, Gallium-68, Iodine-131.
• Companion Diagnostics – PSMA PET/CT, FDG-PET.
• Therapeutic Agents – Targeted antibodies, peptides, small molecules.
• Imaging Modalities – PET, SPECT, MRI, CT integrated with molecular tracers.

Latest Industry Trends

1. Theranostics for Prostate Cancer Dominate Pipeline
   Lutetium-based compounds such as Pluvicto (Lu-177-PSMA-617) approved in the U.S. show superior efficacy in advanced prostate cancer patients.
2. AI Imaging Startups Secure VC Funding
   U.S. and Japanese startups integrating AI with PET/SPECT imaging for oncology diagnostics are gaining traction from venture capitalists.
3. PET Tracer Innovation for Neurological Conditions
   Ga-68-labeled tracers are under development for detecting tau proteins and amyloid-beta, enhancing Alzheimer’s diagnosis accuracy.
4. Theranostic Radioligand Therapies Enter Cardiovascular Trials
   Early-stage trials evaluate radiopharmaceuticals for imaging and treating vascular inflammation and plaque instability.
5. Global Partnerships for Theranostic Infrastructure
   Strategic alliances between pharma companies and hospitals are being forged to expand radiopharmacy manufacturing and nuclear medicine departments.

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Growth Opportunities

• Theranostic Applications in Rare Cancers
  Opportunity to develop niche therapies for orphan indications where personalized therapy offers higher success rates.
• AI-Powered Image-Guided Therapy Platforms
  Software companies can create platforms to automate interpretation, optimize dosing, and enhance safety of radiotherapies.
• Expansion into Cardio-Oncology and Neuro-Oncology
  Dual pathology cases can benefit from integrated diagnostics and treatments, especially with aging populations.
• Decentralized Radiopharmaceutical Manufacturing
  Establishing mini-cyclotrons and isotope generators in regional hospitals for faster access to radiotracers.
• Integration with Genomics for Multi-Omics Personalized Care
  Combining theranostics with genomics and metabolomics for highly individualized patient profiling and treatment selection.

Leading Market Players

• Novartis AG
• Lantheus Holdings, Inc.
• GE HealthCare Technologies
• Siemens Healthineers
• Curium Pharma
• Telix Pharmaceuticals
• Advanced Accelerator Applications
• Fusion Pharmaceuticals

These companies are investing in:

• Acquisitions to expand diagnostic-imaging + drug delivery portfolios.
• Developing alpha particle-emitting therapies.
• Strategic collaborations with academic institutions and imaging software firms.

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Conclusion

The theranostics market is positioned at the intersection of diagnostics, therapy, and personalized medicine—offering unmatched potential in addressing some of the world’s most complex diseases. With increasing investments in oncology, nuclear medicine, and AI-assisted diagnostics, the market is entering a transformative era.

Countries like the U.S. and Japan are not only fostering clinical adoption but also pioneering technological advancements that will shape the next wave of personalized healthcare. As targeted diagnostics and therapy become inseparable, theranostics will be the future blueprint of patient-centered care.

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