1. Executive Summary

• 1.1 Market Overview and Definition

• 1.2 Key Market Highlights and Findings

• 1.3 Market Size and Growth Projections (Base Year: 2025 | Current Year: 2026 | Forecast: 2026–2033)

• 1.4 Market Segmentation Snapshot

• 1.5 Regional Market Snapshot

• 1.6 Competitive Landscape Overview

• 1.7 Key Growth Drivers and Strategic Insights

2. Research Methodology

• 2.1 Research Framework and Approach

• 2.2 Data Collection Methods

  • 2.2.1 Primary Research (Oncologists, Nuclear Medicine Physicians, Radiologists, Molecular Imaging Scientists, Radiopharmacists, Biotech/Pharma R&D Directors, Clinical Trial Investigators, C-Suite Consultation)

  • 2.2.2 Secondary Research (Oncology and Nuclear Medicine Journals, FDA/EMA/IAEA Regulatory Databases, IQVIA Oncology Market Data, Company SEC Filings, Clinical Trial Registries, Patent Databases, WHO Cancer Reports)

• 2.3 Market Size Estimation Methodology

  • 2.3.1 Top-Down Approach

  • 2.3.2 Bottom-Up Approach

• 2.4 Data Triangulation and Validation Process

• 2.5 Forecasting Models and Techniques

• 2.6 Research Assumptions and Limitations

• 2.7 Base Year (2025), Current Year (2026), and Forecast Period (2026–2033)

3. Market Introduction

• 3.1 Market Definition and Scope

• 3.2 Overview of Theranostics: Scientific Definition, the Convergence of Diagnostics and Therapeutics, and the Paradigm Shift in Precision Medicine

• 3.3 Classification of Theranostics: Radiopharmaceutical Theranostics, Molecular Targeted Theranostics, Nanoparticle-Based Theranostics, Companion Diagnostics-Linked Theranostics, and Immunotheranostics

• 3.4 Theranostic Principle: Radiodiagnostic–Radiotherapeutic Pairs (Lu-177/Ga-68 PSMA, I-131/I-123, Y-90/Tc-99m, Cu-64/Cu-67) and Companion Diagnostics-Therapeutic Pairing

• 3.5 Evolution of Theranostics: From Radioiodine Thyroid Treatment and Tc-99m Nuclear Medicine to PSMA-Targeted Radioligand Therapy (Pluvicto), SSTR-Targeted PRRT (Lutathera), and Next-Generation Theranostic Platforms

• 3.6 Strategic Role of Theranostics in Oncology (Prostate, Thyroid, NETs, Breast, Lung), Neurology, Cardiovascular Diseases, and Immunological Disorders

• 3.7 Integration with Precision Medicine, Pharmacogenomics, and Biomarker-Driven Treatment Strategies

• 3.8 Market Taxonomy and Segmentation Framework

• 3.9 Currency and Units Considered

• 3.10 Stakeholder Ecosystem

4. Theranostics Market Characteristics

• 4.1 Product Type Overview (Instruments, Reagents, Radiopharmaceuticals, Software and Services)

• 4.2 Imaging Technique Overview (PET, SPECT, MRI, Ultrasound-Guided Theranostics)

• 4.3 Radioisotope Overview (Technetium-99m, Gallium-68, Lutetium-177, Iodine-131, Zirconium-89, Yttrium-90, Others)

• 4.4 Technology Overview (Polymerase Chain Reaction/PCR, Immunohistochemistry/IHC, In Situ Hybridization/ISH, Next-Generation Sequencing/NGS, Others)

• 4.5 Application Overview (Oncology, Cardiovascular Diseases, Neurological Disorders, Immunological Disorders, Others)

• 4.6 End-User Overview (Hospitals and Clinics, Cancer Care Centers, Diagnostic Laboratories, Research and Academic Institutes, Others)

• 4.7 Regulatory Classification: FDA 505(b)(2) and New Drug Application (NDA) for Radiopharmaceuticals, EMA Advanced Therapy Medicinal Products (ATMPs), IAEA Nuclear Medicine Safety Framework

• 4.8 Comparison: Radiotheranostics vs. Molecular-Targeted Theranostics vs. Nanoparticle-Based Theranostics vs. Companion Diagnostics-Linked Theranostics vs. Immunotheranostics

5. Assumptions and Acronyms Used

• 5.1 List of Key Assumptions

• 5.2 Currency and Pricing Considerations

• 5.3 Acronyms and Abbreviations

6. Market Dynamics

• 6.1 Introduction

• 6.2 Market Drivers

  • 6.2.1 Rising Global Prevalence of Cancer (Prostate, Thyroid, Neuroendocrine Tumors, Breast, Lung) Driving Demand for Targeted Theranostic Diagnostic and Therapeutic Solutions

  • 6.2.2 Escalating Demand for Personalized Medicine: Theranostics as the Cornerstone of Precision Oncology and Patient-Specific Treatment Planning

  • 6.2.3 Landmark FDA Approvals Accelerating Theranostics Adoption: Pluvicto (Lu-177-PSMA-617) for mCRPC, Lutathera (Lu-177-DOTATATE) for SSTR-Positive NETs, and Expanding Radiopharmaceutical Pipeline

  • 6.2.4 Technological Advancements in Molecular Imaging: Next-Generation PET/CT, PET/MRI, SPECT/CT Hybrid Systems, and Novel Radiotracer Development

  • 6.2.5 Growing Integration of Nanomedicine: HDL Nanoparticles, Liposomal Theranostic Carriers, and Superparamagnetic Iron Oxide Nanoparticle (SPION) Theranostic Platforms

  • 6.2.6 Expanding Biomarker Discovery and Companion Diagnostics Development Enabling Theranostic Pairing in Oncology and Beyond

  • 6.2.7 Increasing R&D Investment and Pharmaceutical Company Acquisitions in Radiopharmaceuticals: Novartis–AAA, Bristol Myers Squibb–RayzeBio, Eli Lilly–Point Biopharma

• 6.3 Market Restraints

  • 6.3.1 High Cost of Theranostic Procedures: Specialized Radiopharmaceuticals, Hybrid Imaging Systems, and Individualized Treatment Protocols Substantially Increasing Healthcare Costs

  • 6.3.2 Radioisotope Supply Chain Vulnerability: Dependence on Nuclear Reactors and Cyclotrons for Tc-99m, Lu-177, Ga-68, and Emerging Theranostic Radionuclides

  • 6.3.3 Stringent Regulatory Requirements for Radiopharmaceutical Manufacturing: GMP Compliance, Radiopharmacy Infrastructure, and Radiation Safety Regulations

  • 6.3.4 Limited Access to Theranostic Facilities in Emerging Markets: Shortage of Nuclear Medicine Specialists, Radiation Oncology Infrastructure, and Radiopharmacy Networks

• 6.4 Market Opportunities

  • 6.4.1 Expanding Radioligand Therapy (RLT) Pipeline: Prostate Cancer (PSMA), Breast Cancer (HER2), Lung Cancer (SSTR), and Glioblastoma (FAP) Theranostic Programs

  • 6.4.2 Artificial Intelligence and Machine Learning Integration in Theranostic Dosimetry, Treatment Planning, and Molecular Image Analysis

  • 6.4.3 Asia-Pacific Market Expansion: Rising Cancer Burden, Nuclear Medicine Infrastructure Investment, and Government Precision Medicine Programs in China, India, South Korea, and Japan

  • 6.4.4 Next-Generation Radioisotopes: Actinium-225 (Ac-225), Bismuth-213, Terbium Isotope Pairs, and Alpha-Emitting Theranostic Pairs Entering Clinical Development

  • 6.4.5 Theranostics Beyond Oncology: Neurological Disorders (Alzheimer's, Parkinson's), Cardiovascular Diseases (Myocarditis, Atherosclerosis), and Immunological Disorders

• 6.5 Market Challenges

  • 6.5.1 Dosimetry Standardization and Radiation Protection: Clinical and Regulatory Challenges in Patient-Specific Dosimetry for Radioligand Therapies

  • 6.5.2 Infrastructure Gap: Cyclotron and Generator Availability, Radiopharmacy Setup, Hot Lab Requirements, and Trained Nuclear Medicine Staff Shortages

  • 6.5.3 Reimbursement Uncertainty for Novel Theranostic Agents in Multiple Markets (CMS Coverage, NICE Appraisal, HTA Processes)

  • 6.5.4 Complex Clinical Trial Design for Theranostics: Companion Diagnostic Co-Development Requirements, Response Assessment Complexity, and Regulatory Uncertainty for Combined Diagnostic-Therapeutic Products

• 6.6 Market Trends

  • 6.6.1 Technetium-99m (Tc-99m) Dominating Radioisotope Segment (~47.6% Share in 2024)​

  • 6.6.2 Gallium-68 and Lutetium-177 Fastest-Growing Radioisotopes Driven by PSMA and SSTR Theranostic Program Expansion

  • 6.6.3 Oncology Remaining Dominant Application (~Largest Market Share in 2025; >60% of Total Market)

  • 6.6.4 PET Imaging Fastest-Growing Imaging Technique; SPECT Maintaining Largest Installed Base

  • 6.6.5 North America Dominating Regional Market (~39.8% Share in 2024); Asia-Pacific Fastest-Growing Region (~17.8% Share in 2024)

  • 6.6.6 Hospitals and Cancer Care Centers Dominating End-User Segment

7. Value Chain and Ecosystem Analysis

• 7.1 Overview of Theranostics Market Value Chain

• 7.2 Upstream: Radioisotope Production (Nuclear Reactors, Cyclotrons, Radionuclide Generators), Ligand and Chelator Synthesis, and Radiopharmaceutical Precursor Manufacturing

• 7.3 Radiopharmaceutical Manufacturing: GMP Radiopharmacy, Quality Control, Aseptic Filling, and Radiation Safety Compliance

• 7.4 Companion Diagnostic and Biomarker Assay Developers (IHC, ISH, NGS, PCR) for Theranostic Patient Selection

• 7.5 Hybrid Imaging System Manufacturers (PET/CT, PET/MRI, SPECT/CT Equipment) and AI-Powered Imaging Software Providers

• 7.6 Specialty Distribution, Cold Chain Radiopharmaceutical Logistics, and Radiopharmacy Network Operators

• 7.7 End Users: Hospitals and Cancer Centers, Nuclear Medicine Departments, Diagnostic Laboratories, Academic Research Institutes

• 7.8 Regulatory and Payer Ecosystem (FDA, EMA, IAEA, CMS, NICE, National Health Ministries)

• 7.9 Value Addition at Each Stage

8. Porter's Five Forces Analysis

• 8.1 Threat of New Entrants

• 8.2 Bargaining Power of Suppliers (Radioisotope Producers, Cyclotron Operators, GMP Radiopharmacy Contract Manufacturers, Ligand/Chelator Suppliers)

• 8.3 Bargaining Power of Buyers (Hospital Networks, Cancer Center Consortia, Government Health Ministries, Payer Organizations)

• 8.4 Threat of Substitutes (Conventional Targeted Therapies, Immuno-Oncology Agents, CAR-T Cell Therapies, Antibody-Drug Conjugates Replacing Specific Theranostic Indications)

• 8.5 Intensity of Competitive Rivalry

9. PESTEL Analysis

• 9.1 Political Factors (Government Precision Medicine Programs, NCI/NIH Theranostics Research Funding, IAEA Technical Cooperation for Nuclear Medicine in Developing Countries)

• 9.2 Economic Factors (Oncology Healthcare Cost Burden, Theranostics ROI vs. Standard of Care, Hospital Capex for Nuclear Medicine Infrastructure, Radiopharmaceutical Reimbursement Models)

• 9.3 Social Factors (Rising Cancer Awareness and Early Detection Demand, Patient Advocacy for Precision Medicine Access, Aging Population, Chronic Disease Epidemic)

• 9.4 Technological Factors (AI/ML in Molecular Imaging Analysis, Digital Dosimetry, Next-Generation Radioligands, Alpha-Emitter Theranostics, Nanoparticle Platforms, CRISPR-Based Theranostic Research)

• 9.5 Environmental Factors (Radioactive Waste Management, Radiation Safety Compliance, Sustainable Radiopharmacy Operations, ALARA Principle in Nuclear Medicine Facilities)

• 9.6 Legal and Regulatory Factors (FDA NDA/BLA for Radiopharmaceuticals, EMA ATMP Regulations, IAEA Safety Standards, NRC Radioactive Material Licensing, EU IVDR for Companion Diagnostics)

10. Market Attractiveness Analysis

• 10.1 By Product Type (Instruments, Reagents, Radiopharmaceuticals, Software and Services)

• 10.2 By Imaging Technique (PET, SPECT, MRI, Ultrasound-Guided Theranostics)

• 10.3 By Radioisotope (Technetium-99m, Gallium-68, Lutetium-177, Iodine-131, Zirconium-89, Yttrium-90, Others)

• 10.4 By Technology (PCR, IHC, ISH, NGS, Others)

• 10.5 By Application (Oncology, Cardiovascular Diseases, Neurological Disorders, Immunological Disorders, Others)

• 10.6 By End User (Hospitals and Clinics, Cancer Care Centers, Diagnostic Laboratories, Research and Academic Institutes, Others)

• 10.7 By Region

11. COVID-19 Impact Analysis

• 11.1 Pandemic-Driven Postponement of Cancer Screening, Theranostic Procedures, and Hospital Visits Negatively Impacting Near-Term Market Growth

• 11.2 Disruptions in Radioisotope Supply Chains, Clinical Trial Enrollment, and Regulatory Review Timelines During COVID-19

• 11.3 COVID-19 as a Catalyst for AI-Driven Remote Dosimetry Monitoring, Tele-Nuclear Medicine, and Digital Theranostic Workflows

• 11.4 Post-Pandemic Acceleration: Renewed Oncology Care Demand, Increased R&D Investment in Radiopharmaceuticals, and Accelerated Regulatory Approvals Driving Market Recovery

12. Theranostics Technology and Innovation Landscape

• 12.1 Radioligand Therapy (RLT): PSMA-Targeted Therapy (Pluvicto/Lu-177-PSMA-617 for mCRPC), SSTR-Targeted Therapy (Lutathera/Lu-177-DOTATATE for NETs), and Expanding RLT Pipeline

• 12.2 Radioisotope Pairs in Theranostics: Diagnostic (Ga-68, Tc-99m, Zr-89, Cu-64) and Therapeutic (Lu-177, Y-90, I-131, Ac-225, Cu-67) Radioisotope Pairing Strategies

• 12.3 Alpha-Emitting Radioisotopes: Actinium-225, Bismuth-213, and Thorium-227 Theranostic Platforms in Clinical Development

• 12.4 Nanoparticle-Based Theranostics: Multifunctional Nanocarriers (SPION, Gold Nanoparticles, Liposomes, Polymeric Nanoparticles) Combining PET/MRI Imaging with Drug Delivery and Photodynamic/Photothermal Therapy

• 12.5 Companion Diagnostics and Biomarker-Driven Theranostics: NGS, IHC, ISH, and Liquid Biopsy Integration for Patient Stratification and Theranostic Agent Selection

• 12.6 Artificial Intelligence and Machine Learning in Theranostics: AI-Powered PET/CT Image Segmentation, Dosimetry Modeling, Treatment Response Prediction, and Radiomics

• 12.7 Immunotheranostics: Antibody-Based and Cell-Based Theranostic Platforms Combining PD-1/PD-L1 Checkpoint Imaging with Immunotherapy

13. Global Theranostics Market Size and Forecast (2026–2033)

• 13.1 Historical Market Size and Trends

• 13.2 Base Year Market Size (2025) 

• 13.3 Current Year Market Size (2026)

• 13.4 Market Size Forecast (USD Billion, 2026–2033)

• 13.5 Year-on-Year Growth Analysis

• 13.6 CAGR Analysis (2026–2033) 

• 13.7 Absolute Dollar Opportunity Assessment

14. Market Segmentation Analysis

14.1 By Product Type

• 14.1.1 Radiopharmaceuticals (Dominant – Largest Market Share in 2025)

  • Diagnostic Radiopharmaceuticals (Ga-68 PSMA, Tc-99m MDP, F-18 FDG, Zr-89 Antibodies, I-123 MIBG)

  • Therapeutic Radiopharmaceuticals (Lu-177-PSMA-617/Pluvicto, Lu-177-DOTATATE/Lutathera, Y-90 Microspheres, I-131 Therapy, Ac-225 Pipeline)

  • Radiolabeled Peptides and Small Molecule Radioligands

  • Radiolabeled Antibodies and Antibody Fragments (Immunotheranostics)

• 14.1.2 Instruments

  • PET Scanners and PET/CT Hybrid Systems

  • SPECT Scanners and SPECT/CT Hybrid Systems

  • PET/MRI Hybrid Imaging Systems

  • Cyclotrons and Radionuclide Generators (Ga-68, Tc-99m) for On-Site Radiopharmaceutical Production

  • Radiation Dosimetry and Hot Laboratory Equipment

• 14.1.3 Reagents and Kits

  • Companion Diagnostic Kits (IHC, ISH, NGS, PCR-Based Biomarker Testing)

  • Radiolabeling Kits and Precursors

  • In Vitro Diagnostic Reagents for Theranostic Patient Selection

• 14.1.4 Software and Services (Fastest-Growing Product)

  • AI-Powered Molecular Image Analysis and Segmentation Software

  • Dosimetry Calculation and Treatment Planning Software (OLINDA, MIM Software, Hermes Dosimetry)

  • PACS Integration and Nuclear Medicine Workflow Management Software

  • Radiopharmacy Compliance, Quality Management, and Batch Record Software

  • Contract Radiopharmacy, CDMO, and Theranostics Consulting Services

14.2 By Imaging Technique

• 14.2.1 PET Imaging (Fastest-Growing Technique)

  • Ga-68 PET Tracers: PSMA-PET (Illuccix, Pylarify), DOTATATE-PET, FAPI-PET

  • F-18 PET Tracers: FDG-PET/CT, Fluciclovine, PSMA-1007, Fluorodopa

  • Zr-89 and Cu-64 Immuno-PET for Antibody Biodistribution and Dosimetry

  • Total-Body PET Systems (Explorer, uExplorer) for Low-Dose Precision Theranostics

• 14.2.2 SPECT Imaging (Dominant – Largest Installed Base)

  • Tc-99m SPECT/CT: Bone Scintigraphy, Myocardial Perfusion Imaging, Renal, Thyroid Scans

  • I-123 MIBG SPECT for Pheochromocytoma/Paraganglioma Theranostics

  • Quantitative SPECT/CT-Based Dosimetry for I-131 and Lu-177 Therapy

• 14.2.3 MRI-Guided Theranostics

  • Superparamagnetic Iron Oxide Nanoparticle (SPION) MRI Contrast and Hyperthermia Therapy

  • MRI-Guided Focused Ultrasound (MRgFUS) Integrated Theranostics

  • Gadolinium-Based Theranostic Complexes for MRI-Visible Drug Delivery

• 14.2.4 Ultrasound-Guided Theranostics​

  • Microbubble-Based Ultrasound Contrast and Sonoporation Drug Delivery Platforms

  • High-Intensity Focused Ultrasound (HIFU) with Theranostic Monitoring

14.3 By Radioisotope

• 14.3.1 Technetium-99m (Tc-99m) (Dominant – 47.6% Share in 2024)​

  • Tc-99m for Bone Metastasis Detection, Myocardial Perfusion, Thyroid Imaging, and Sentinel Node Mapping

  • SPECT/CT-Based Tc-99m Theranostic Pairing in Hematological Malignancies and Soft Tissue Tumors

• 14.3.2 Gallium-68 (Ga-68) (Fastest-Growing Diagnostic Radioisotope)

  • Ga-68 PSMA PET: Prostate Cancer Staging, Biochemical Recurrence Localization, and Pluvicto Patient Selection

  • Ga-68 DOTATATE/DOTATOC PET: Neuroendocrine Tumor (NET) Imaging and Lutathera Patient Selection

  • Ga-68 FAPI PET: Fibroblast Activation Protein-Targeted Imaging for Multiple Tumor Types

• 14.3.3 Lutetium-177 (Lu-177) (Fastest-Growing Therapeutic Radioisotope)

  • Lu-177-PSMA-617 (Pluvicto): FDA/EMA-Approved Radioligand Therapy for mCRPC

  • Lu-177-DOTATATE (Lutathera): FDA/EMA-Approved PRRT for SSTR-Positive Gastroenteropancreatic NETs

  • Lu-177-Based Pipeline Agents: HER2-Targeted, FAP-Targeted, Integrin-Targeted RLT Programs

• 14.3.4 Iodine-131 (I-131)

  • I-131 Radioiodine Therapy for Differentiated Thyroid Cancer (DTC): The Original Theranostic Pair

  • I-131-mIBG (Azedra) for Pheochromocytoma and Paraganglioma

  • I-131 Tositumomab (Historical) and Next-Generation I-131 Antibody Programs

• 14.3.5 Yttrium-90 (Y-90)

  • Y-90 Radioembolization (TheraSphere, SIR-Spheres) for Hepatocellular Carcinoma and Liver Metastases

  • Y-90 Ibritumomab Tiuxetan (Zevalin) for Non-Hodgkin's Lymphoma (NHL) Radioimmunotherapy

• 14.3.6 Zirconium-89 (Zr-89)

  • Zr-89 Immuno-PET for Antibody and ADC Biodistribution, Tumor Uptake Quantification, and Dosimetry

• 14.3.7 Others (Actinium-225/Ac-225 – Alpha Therapy Pipeline; Bismuth-213; Rhenium-188; Holmium-166; Copper-64/67; Terbium Isotope Quartet for Theranostic Pairing; Fluorine-18)

14.4 By Technology

• 14.4.1 Polymerase Chain Reaction (PCR) (Dominant Technology – Largest Market Share)

  • RT-PCR for Biomarker-Based Patient Selection (KRAS, EGFR, BRAF Mutation Testing)

  • Digital PCR for Liquid Biopsy-Based Theranostic Companion Diagnostics

  • Multiplex PCR Panels for Simultaneous Multi-Target Oncology Biomarker Analysis

• 14.4.2 Immunohistochemistry (IHC)

  • PSMA IHC for Prostate Cancer Theranostic Patient Selection

  • HER2 IHC for Breast Cancer and Gastric Cancer Theranostic Antibody Programs

  • PD-L1 IHC for Immunotheranostics and Checkpoint Inhibitor Companion Diagnostics

• 14.4.3 In Situ Hybridization (ISH)

  • FISH (Fluorescence In Situ Hybridization) for HER2 Amplification, ALK/ROS1 Rearrangements

  • CISH (Chromogenic ISH) for Cost-Effective HER2 and HPV Companion Diagnostics

• 14.4.4 Next-Generation Sequencing (NGS) (Fastest-Growing Technology)

  • Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) Testing for Theranostic Immunotherapy Selection

  • Comprehensive Genomic Profiling for Multi-Biomarker Theranostic Companion Diagnostic Development

  • Liquid Biopsy NGS for Circulating Tumor DNA (ctDNA) Theranostic Monitoring

• 14.4.5 Others (Proteomics, Metabolomics, Single-Cell Sequencing for Theranostic Biomarker Discovery)

14.5 By Application

• 14.5.1 Oncology (Dominant Application – >60% of Total Market Share in 2025)

  • Prostate Cancer (Ga-68 PSMA-PET + Lu-177-PSMA-617 Theranostic Pair: Fastest-Growing Sub-Segment)

  • Neuroendocrine Tumors (Ga-68 DOTATATE-PET + Lu-177-DOTATATE/Lutathera PRRT)

  • Thyroid Cancer (I-123/I-124/I-131 Radioiodine Theranostic Pair for DTC)

  • Breast Cancer (HER2-Targeted Radioimmunotherapy, ADC Theranostics, Zr-89/Lu-177 Antibody Pairs)

  • Hepatocellular Carcinoma (Y-90 Radioembolization Theranostics)

  • Hematological Malignancies: NHL, Multiple Myeloma Theranostic Programs

  • Other Oncology: Lung Cancer (SSTR, FAPI-Targeted), Colorectal Cancer, Glioblastoma (FAP-Targeted)

• 14.5.2 Neurological Disorders

  • Alzheimer's Disease: Amyloid and Tau PET Theranostics (F-18 Florbetapir, Flortaucipir)

  • Parkinson's Disease: Dopamine Transporter (DaT) Theranostic Imaging and Targeted Neurological Therapy​

  • Glioblastoma Multiforme: FAPI-PET and Targeted Radiolabeled Theranostic Programs

  • Other Neurological Disorders (Neuroendocrine and Neuroinflammatory Disease Theranostics)​

• 14.5.3 Cardiovascular Diseases

  • Myocardial Perfusion and Viability Theranostics (Tc-99m, F-18 FDG, Rb-82 PET)

  • Atherosclerosis Plaque Theranostics: Vulnerable Plaque Imaging and Targeted Anti-Inflammatory Nanoparticle Delivery

  • Cardiac Amyloidosis: Tc-99m Pyrophosphate SPECT Theranostics and ATTR-Targeted Therapy Monitoring​

• 14.5.4 Immunological Disorders

  • Rheumatoid Arthritis and Autoimmune Disease Theranostics: Targeted Anti-TNF and Anti-IL-6 Radiolabeled Antibody Programs

  • PD-1/PD-L1 Immunotheranostics: Immune Checkpoint Imaging and Immunotherapy Response Prediction

• 14.5.5 Others (Infection and Inflammation Theranostics, Bone and Joint Disorders, Renal Disease, Endocrine Disorders)​

14.6 By End User

• 14.6.1 Hospitals and Clinics (Dominant – Largest End-User Segment)

  • Comprehensive Cancer Centers with Nuclear Medicine Departments

  • Tertiary and Academic Teaching Hospitals with Radiopharmacy and PET/CT Infrastructure

  • Community Hospitals with SPECT/CT and Theranostics Programs

• 14.6.2 Cancer Care Centers (Fastest-Growing End User)

  • Specialized Oncology and Radioligand Therapy Centers

  • PSMA-Targeted RLT and PRRT Accredited Treatment Facilities

  • Multidisciplinary Tumor Boards Integrating Theranostic Decision-Making

• 14.6.3 Diagnostic Laboratories

  • Clinical Pathology Laboratories Performing IHC, ISH, PCR, and NGS Companion Diagnostics

  • Reference Laboratories for Molecular Biomarker Theranostic Patient Selection

• 14.6.4 Research and Academic Institutes

  • University Medical Centers and NCI-Designated Cancer Centers

  • Translational Research Programs in Theranostics, Nuclear Medicine, and Molecular Imaging

  • Preclinical Theranostics Research Using Small Animal PET, SPECT, and MRI

• 14.6.5 Others (Pharmaceutical and Biotech Companies for Clinical Trials, CDMO Radiopharmacy Sites, Contract Research Organizations)

14.7 By Region

• 14.7.1 North America (Dominant – 39.8% Share in 2024)

• 14.7.2 Europe

• 14.7.3 Asia Pacific (Fastest-Growing – 17.8% Share in 2024; Highest CAGR)

• 14.7.4 Latin America / South America

• 14.7.5 Middle East and Africa

15. Regional Market Analysis

15.1 North America

• 15.1.1 Market Overview and Key Trends (Dominant – 39.8% Share in 2024; FDA Approval Leader for Pluvicto, Lutathera, and Emerging RLT Pipeline)

• 15.1.2 Market Size and Forecast

• 15.1.3 Market Share by Segment

• 15.1.4 Country-Level Analysis

  • United States (Leading Market: NCI-Designated Centers, FDA Radiopharmaceutical Pipeline, Novartis–Eli Lilly–BMS Radiopharmaceutical Investments)

  • Canada (Canadian Nuclear Laboratories; TRIUMF Cyclotron-Produced Isotopes; National Health Programs)

  • Mexico

• 15.1.5 Market Attractiveness Analysis

15.2 Europe

• 15.2.1 Market Overview and Key Trends (EMA-Approved Lutathera and Pluvicto; Strong Nuclear Medicine Society Advocacy; EANM Guidelines)

• 15.2.2 Market Size and Forecast

• 15.2.3 Market Share by Segment

• 15.2.4 Country-Level Analysis

  • Germany (Leading European Nuclear Medicine and Theranostics Market; Advanced Therapy Center Network)

  • United Kingdom (NHS England Lutathera/Pluvicto Access; NICE Appraisal Programs)

  • France (National Cancer Institute Programs; INCA Theranostics Research)

  • Italy

  • Spain

  • Netherlands (Erasmus MC; Advanced Radionuclide Therapy Programs)

  • Rest of Europe

• 15.2.5 Market Attractiveness Analysis

15.3 Asia Pacific

• 15.3.1 Market Overview and Key Trends (Fastest-Growing Region – 17.8% Share in 2024; Rising Cancer Burden; Nuclear Medicine Infrastructure Expansion)

• 15.3.2 Market Size and Forecast

• 15.3.3 Market Share by Segment

• 15.3.4 Country-Level Analysis

  • China (NMPA Radiopharmaceutical Approvals; Government Nuclear Medicine Investment; Rising PSMA-PET Adoption)

  • Japan (PMDA Radioligand Therapy Pathway; Aging Population; Advanced PET/CT Network)

  • India (Rising Cancer Incidence; Growing Nuclear Medicine Centers; BARC Theranostics Programs)

  • South Korea (K-MFDS Approvals; Samsung Medical Center RLT Programs; Strong IVD Industry)

  • Australia (Telix Pharmaceuticals Headquarters; TGA Illuccix/Ga-68 Approvals; Icon Cancer Centres RLT)

  • Rest of Asia Pacific

• 15.3.5 Market Attractiveness Analysis

15.4 Latin America / South America

• 15.4.1 Market Overview and Key Trends (IAEA Technical Cooperation Programs; Brazil ANVISA Radiopharmaceutical Regulations; Growing PET/CT Network)

• 15.4.2 Market Size and Forecast

• 15.4.3 Market Share by Segment

• 15.4.4 Country-Level Analysis

  • Brazil

  • Mexico

  • Argentina

  • Rest of South America

• 15.4.5 Market Attractiveness Analysis

15.5 Middle East and Africa

• 15.5.1 Market Overview and Key Trends (UAE King Hussein Cancer Center Regional Model; Saudi Vision 2030 Healthcare Investment; IAEA Collaborating Center Programs)

• 15.5.2 Market Size and Forecast

• 15.5.3 Market Share by Segment

• 15.5.4 Country-Level Analysis

  • UAE

  • Saudi Arabia (Vision 2030 Oncology Infrastructure Programs)

  • South Africa

  • Rest of Middle East and Africa

• 15.5.5 Market Attractiveness Analysis

16. Competitive Landscape

• 16.1 Market Concentration and Competitive Intensity

• 16.2 Market Share Analysis of Key Players (Novartis/AAA, GE HealthCare, Siemens Healthineers, F. Hoffmann-La Roche, Thermo Fisher Scientific, Eli Lilly/Point Biopharma, Telix Pharmaceuticals)

• 16.3 Market Ranking and Positioning Analysis

• 16.4 Competitive Strategies and Benchmarking

• 16.5 Recent Developments and Strategic Moves

  • 16.5.1 New Radiopharmaceutical Approvals and Product Launches (Pluvicto Global Rollout, Illuccix BASG Authorization in Austria – July 2025, Lutathera Label Expansion)

  • 16.5.2 Siemens Healthineers Molecular Imaging – MGH Research Collaboration for Theranostics Advancement (June 2025)​

  • 16.5.3 Western Australia's First Theranostics and Molecular Imaging Facility: Icon Cancer Centre and PMITC at Hollywood Medical Centre (July 2025)​

  • 16.5.4 Pharmaceutical Company Acquisitions in Radiopharmaceuticals: Eli Lilly–Point Biopharma, Bristol Myers Squibb–RayzeBio, Novartis–Mariana Oncology

  • 16.5.5 Alpha-Emitter Theranostics R&D Expansion: Ac-225, Bi-213, and Thorium-227 Pipeline Developments

• 16.6 Competitive Dashboard and Company Evaluation Matrix

17. Company Profiles

The final report includes a complete list of companies

17.1 Novartis AG (Advanced Accelerator Applications – AAA)

• Company Overview

• Financial Performance

• Product Portfolio

• Strategic Initiatives

• SWOT Analysis

17.2 GE HealthCare Technologies Inc.

17.3 Siemens Healthineers AG

17.4 F. Hoffmann-La Roche AG

17.5 Thermo Fisher Scientific Inc.

17.6 Eli Lilly and Company (Point Biopharma)

17.7 Bristol Myers Squibb Company (RayzeBio)

17.8 Telix Pharmaceuticals Limited

17.9 Becton, Dickinson and Company

17.10 Abbott Laboratories

17.11 Illumina, Inc.

17.12 QIAGEN N.V.

17.13 Myriad Genetics, Inc.

17.14 Jubilant Pharmova Limited (Jubilant Radiopharma)

17.15 Lantheus Holdings, Inc.

18. Technology and Innovation Trends

• 18.1 Alpha-Emitting Radioisotope Theranostics: Actinium-225, Bismuth-213, and Thorium-227 Next-Generation Radioligand Therapy Programs in Prostate Cancer and Solid Tumors

• 18.2 AI and Machine Learning in Theranostics: Automated PET/CT Lesion Detection, AI-Driven Dosimetry, Radiomics-Based Response Prediction, and Digital Twin Theranostic Modeling

• 18.3 Nanoparticle-Based Theranostic Platforms: Multifunctional Nanocarriers Combining Molecular Imaging (PET/MRI) with Targeted Drug Delivery, Photothermal Therapy, and Photodynamic Therapy

• 18.4 Immunotheranostics and Cell Therapy Theranostics: Radiolabeled CAR-T Cell Tracking, PD-L1 Immunotheranostic Imaging, and Cytokine-Targeted Diagnostic-Therapeutic Platforms

• 18.5 Total-Body PET and Digital PET Systems: Ultra-High-Sensitivity Imaging for Low-Dose Theranostic Dosimetry, Pharmacokinetic Modeling, and Whole-Body Radiotracer Distribution Analysis

19. Regulatory and Compliance Landscape

• 19.1 Overview of Global Regulatory Framework for Radiopharmaceuticals and Theranostic Products (FDA, EMA, IAEA, NRC, PMDA)

• 19.2 FDA NDA/BLA Pathway for Radiopharmaceuticals: Pluvicto (Lu-177-PSMA-617), Lutathera (Lu-177-DOTATATE), Illuccix (Ga-68 PSMA), and Emerging RLT Pipeline Submissions

• 19.3 EMA Centralized Approval for Advanced Therapy Medicinal Products (ATMPs) and Radiopharmaceuticals: EU Regulatory Framework for Theranostic Agents

• 19.4 IAEA Safety Standards and Technical Guidance for Nuclear Medicine Facilities: Radiation Protection, Dosimetry, and Theranostics Program Accreditation

• 19.5 Companion Diagnostic Co-Development Regulatory Requirements: FDA Draft Guidance on In Vitro Companion Diagnostics, EU IVDR for CDx Approval, and Simultaneous PMA/NDA Submissions

• 19.6 Reimbursement Frameworks: CMS Medicare Coverage for Pluvicto and Lutathera, NICE Technology Appraisals, and HTA Submissions for Novel Theranostic Agents in Europe

20. Patent and Intellectual Property Analysis

• 20.1 Key Patents in Radioligand Synthesis (PSMA-617, DOTATATE), Radiolabeling Methods, Nanoparticle Theranostic Platforms, and AI Dosimetry Algorithms

• 20.2 Patent Landscape by Radioisotope, Application Area, and Technology Platform

• 20.3 Regional Patent Filing Trends (U.S., EU, Asia Pacific)

• 20.4 Leading Companies in Patent Holdings (Novartis/AAA, Siemens Healthineers, GE HealthCare, Telix, Lantheus)

• 20.5 Emerging Patent Activity: Alpha-Emitter Theranostics, AI-Driven Dosimetry, Immunotheranostics, and Nanoparticle-Based Theranostic Carrier Patents

21. ESG and Sustainability Analysis

• 21.1 Environmental Sustainability: Radioactive Waste Management in Theranostic Facilities, ALARA Radiation Protection Principles, and Green Nuclear Medicine Infrastructure

• 21.2 Social Responsibility: Expanding Theranostic Access in Low- and Middle-Income Countries via IAEA Programs, Patient Assistance Programs for Pluvicto and Lutathera, and Health Equity in Precision Oncology

• 21.3 Governance and Ethical Standards: Clinical Trial Conduct for Theranostic Agents, Patient Informed Consent for Radiation Therapy, Transparent Companion Diagnostic Development, and Responsible Data Use in AI Dosimetry

• 21.4 Corporate ESG Initiatives by Novartis, GE HealthCare, Siemens Healthineers, Eli Lilly, and Other Key Players

22. Epidemiology and Clinical Demand Analysis

• 22.1 Global Cancer Incidence and Mortality: Prostate, Thyroid, Breast, Lung, Colorectal, and Neuroendocrine Tumor Burden Driving Theranostics Demand

• 22.2 Prostate Cancer Epidemiology: Global PSA Screening Trends, mCRPC Patient Population, and Pluvicto-Eligible Patient Identification

• 22.3 Neuroendocrine Tumor (NET) Epidemiology: GEP-NET Incidence, SSTR-Positivity Rates, and Lutathera-Eligible Patient Populations

• 22.4 Neurological and Cardiovascular Disease Burden as Emerging Theranostics Demand Drivers

• 22.5 Aging Global Population and Chronic Disease Prevalence as Long-Term Theranostics Market Demand Catalysts

23. Clinical Use Case Analysis

• 23.1 PSMA Theranostics in Prostate Cancer: Ga-68 PSMA-PET for Staging + Lu-177-PSMA-617 (Pluvicto) for mCRPC Treatment (VISION Trial Outcomes and Clinical Adoption)

• 23.2 SSTR Theranostics in NETs: Ga-68 DOTATATE-PET for Diagnosis + Lu-177-DOTATATE (Lutathera) for PRRT (NETTER-1 Trial and Real-World Use)

• 23.3 Radioiodine Theranostics in Thyroid Cancer: I-123/I-124 Diagnostic Scanning + I-131 Ablation Therapy for Differentiated Thyroid Cancer

• 23.4 Y-90 Radioembolization Theranostics in Liver Cancer: Tc-99m MAA Pre-Treatment Dosimetry SPECT + Y-90 TheraSphere/SIR-Spheres Therapy

• 23.5 Emerging Theranostic Use Cases: FAP-Targeted FAPI Theranostics, HER2-Targeted Immuno-PET + Radioimmunotherapy, and Glioblastoma Theranostics

24. Theranostics Market Trends and Strategies 

• 24.1 Current Market Trends (continued)

  • 24.1.2 Oncology Retaining Dominant Application Share (>60% of Market in 2025); Prostate Cancer and NETs as Fastest-Growing Oncology Sub-Segments

  • 24.1.3 PET Imaging Fastest-Growing Technique Driven by Ga-68 PSMA-PET and Total-Body PET Adoption

  • 24.1.4 Hospitals and Cancer Care Centers Dominating End-User Segment; Specialized RLT and PRRT Centers Fastest-Growing

  • 24.1.5 North America Dominating Regional Market (39.8% Share in 2024); Asia-Pacific Fastest-Growing Region (17.8% Share in 2024)

  • 24.1.6 Major Pharma Acquisitions Reshaping Competitive Landscape: Eli Lilly–Point Biopharma, BMS–RayzeBio, Novartis–Mariana Oncology

• 24.2 Market Entry and Radiopharmaceutical Pipeline Expansion Strategies

• 24.3 Radioligand Therapy Commercialization Strategies: Radiopharmacy Network Development, Healthcare Provider Accreditation, and Patient Access Program Design

• 24.4 Alpha-Emitter Theranostics Platform Differentiation: Ac-225, Bi-213, and Th-227 Clinical Positioning and Regulatory Strategy

• 24.5 Partnerships Between Pharma Companies, Nuclear Medicine Centers, Cyclotron Operators, and Contract Radiopharmacies

25. Strategic Recommendations

• 25.1 Recommendations for Large Pharmaceutical and Radiopharmaceutical Companies (Novartis/AAA, Eli Lilly/Point Biopharma, BMS/RayzeBio) Expanding Radioligand Therapy Portfolios

• 25.2 Recommendations for Medical Imaging Equipment Manufacturers (GE HealthCare, Siemens Healthineers) Integrating AI-Powered Theranostic Dosimetry and Workflow Solutions

• 25.3 Recommendations for Emerging Theranostics Biotech Companies (Telix Pharmaceuticals, Lantheus, Jubilant Radiopharma) on Pipeline Prioritization and Geographic Expansion

• 25.4 Recommendations for Hospital Systems and Cancer Care Centers Establishing Accredited Radioligand Therapy and PRRT Programs

• 25.5 Regional Expansion Strategies: Asia-Pacific Nuclear Medicine Infrastructure Investment, Latin America IAEA Collaboration, and MEA Precision Oncology Programs

• 25.6 Regulatory Compliance Roadmap: FDA NDA/BLA for Radiopharmaceuticals, EMA ATMP Authorization, Companion Diagnostic Co-Development, and CMS Reimbursement Strategy

26. Key Mergers and Acquisitions

• 26.1 Overview of M&A and Strategic Partnership Activity in the Theranostics Market

• 26.2 Major Transactions and Strategic Rationale

  • Eli Lilly Acquisition of Point Biopharma (2023): Lu-177-PNT2002 PSMA and RLT Pipeline Expansion

  • Bristol Myers Squibb Acquisition of RayzeBio (2024): Ac-225 Alpha-Emitter Theranostics Platform

  • Novartis Acquisition of Mariana Oncology (2024): Expanding PSMA and Solid Tumor Radioligand Pipeline

  • Novartis Acquisition of Advanced Accelerator Applications (AAA): Foundation for Pluvicto and Lutathera Commercial Platforms

  • AstraZeneca–Fusion Pharmaceuticals (2024): Targeted Alpha Therapy and Ac-225 Theranostic Expansion

• 26.3 Impact on Market Dynamics, Radiopharmacy Infrastructure, Pipeline Depth, and Competitive Positioning

27. High-Potential Segments and Growth Strategies

• 27.1 High-Growth Segments (Lutetium-177 and Actinium-225 Therapeutic Radioisotopes, PET Imaging Technique, AI-Powered Dosimetry Software, Oncology – Prostate Cancer and NETs, Cancer Care Centers, Asia-Pacific)

• 27.2 Emerging Geographies with Strongest Market Potential

• 27.3 Growth Strategies

  • 27.3.1 Market Trend-Based Strategies (Radioligand Therapy Network Expansion, Digital Dosimetry Adoption, Alpha-Emitter Pipeline Acceleration)

  • 27.3.2 Competitor Benchmarking and Differentiation Strategies (Novel Target Identification, First-in-Class Alpha Emitter Positioning, AI-Integrated Workflow Differentiation)

28. Future Market Outlook and Trends (2026–2033)

• 28.1 Radioligand Therapy Becoming a Standard-of-Care Pillar in Oncology by 2028–2030: PSMA, SSTR, HER2, FAP, and Alpha-Emitter Theranostic Pairs Across Multiple Solid Tumor Types

• 28.2 AI-Powered Dosimetry and Digital Twin Theranostic Modeling Enabling Fully Personalized, Patient-Specific Radioligand Therapy Protocols

• 28.3 Nanoparticle-Based and Immunotheranostic Platforms Bridging Molecular Oncology, Immunotherapy, and Nuclear Medicine into a Unified Precision Medicine Ecosystem

• 28.4 Asia-Pacific Emerging as a Global Theranostics Hub by 2030–2033: China NMPA Pipeline Approvals, India Nuclear Medicine Infrastructure Scale-Up, and South Korea Radioligand Therapy Commercialization

29. Conclusion

• 29.1 Summary of Key Findings

• 29.2 Market Outlook Summary (2026–2033)

• 29.3 Future Growth Drivers and Opportunities

• 29.4 Final Insights and Strategic Perspectives

30. Appendix

• 30.1 List of Abbreviations and Acronyms

• 30.2 Glossary of Technical Terms (RLT, PRRT, PSMA, SSTR, GEP-NET, mCRPC, FAP, FAPI, PET, SPECT, MRI, HIFU, SPION, CDx, NGS, IHC, ISH, TMB, MSI, ctDNA, ALARA, CRC, NRC, IAEA, NDA, BLA, ATMP, OLINDA, CMS, NICE, HTA, AAA, CDMO, GMP, PACS, CoA, DaT, ATTR, etc.)

• 30.3 Research Instruments and Questionnaires 

• 30.4 List of Figures and Tables

• 30.5 List of Primary and Secondary Data Sources

• 30.6 Additional Resources and References

31. Disclaimer