1. Preface
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1.1 Report Description and Scope
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1.2 Research Objectives
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1.3 Key Questions Answered in This Report
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1.4 Intended Audience
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1.5 Currency and Pricing Conventions Used
2. Executive Summary
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2.1 Global Theranostics Market Snapshot
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2.2 Key Findings and Highlights
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2.3 Market Attractiveness Analysis by Segment
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2.4 Precision Medicine and Nuclear Medicine Macro Trends
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2.5 Analyst Recommendations
3. Market Introduction
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3.1 Definition and Scope of Theranostics
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3.1.1 Integration of Targeted Diagnostics and Therapeutics in Precision Medicine
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3.1.2 Theranostic Pairs: Gallium-68 (Diagnostic) + Lutetium-177 (Therapeutic)
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3.1.3 Distinction Between Radiopharmaceutical Theranostics, Companion Diagnostics, and Nanotheranostics
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3.2 Historical Evolution of Theranostics: From Radioiodine Thyroid Treatment to PSMA-Targeted Therapy
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3.3 Key Theranostic Paradigms
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3.3.1 PSMA-Based Theranostics for Prostate Cancer (68Ga-PSMA-11 + 177Lu-PSMA-617)
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3.3.2 SSTR-Based Theranostics for Neuroendocrine Tumors (68Ga-DOTATATE + 177Lu-DOTATATE / Lutathera)
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3.3.3 FAP-Based Radionuclides for Pan-Tumor Applications
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3.3.4 HER2-Targeted Theranostic Pairs for Breast and GI Cancers
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3.3.5 CXCR4 and Terbium Radioisotope Theranostics (Emerging)
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3.4 Theranostic Isotopes: Alpha vs. Beta vs. Auger Emitters
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3.4.1 Beta Emitters: Lu-177, Y-90, I-131 (Current Clinical Workhorses)
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3.4.2 Alpha Emitters: Ac-225, Pb-212, Ra-223, Bi-213 (Fastest Growing)
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3.4.3 Auger Electron Emitters: In-111, I-125 (Research Stage)
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3.5 Regulatory Framework
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3.5.1 U.S. FDA Approvals: Lutathera (2018), Pluvicto/177Lu-PSMA-617 (2022), Gozellix/Telix (2025)
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3.5.2 EMA Guidelines for Radiopharmaceutical Theranostic Products
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3.5.3 China NMPA Mid- and Long-Term Development Plan for Medical Isotopes (2021–2035)
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3.5.4 Japan PMDA Framework for Theranostic Agent Approvals
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3.6 Value Chain Analysis
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3.6.1 Radioisotope Production: Nuclear Reactors (Ac-225, Lu-177), Cyclotrons (Ga-68, Cu-64), Linear Accelerators (Tb-149)
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3.6.2 Radiolabeling and Conjugation Chemistry
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3.6.3 Quality Control, GMP Manufacturing, and Regulatory Filing
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3.6.4 Cold-Chain Logistics and Short-Half-Life Isotope Distribution
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3.6.5 Hospital Radiopharmacy, Nuclear Medicine Departments, and Patient Administration
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3.7 Industry Ecosystem Map (Isotope Producers, Pharma Companies, Imaging Equipment Makers, CDMOs, Hospital Networks)
4. Research Methodology
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4.1 Research Design and Framework
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4.2 Primary and Secondary Data Sources
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4.3 Data Triangulation and Validation Approach
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4.4 Market Size Estimation and Forecasting Methodology
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4.5 Assumptions and Limitations
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4.6 List of Abbreviations
5. Market Dynamics
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5.1 Market Drivers
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5.1.1 Surging Global Cancer Burden — Rising Incidence of Prostate, Neuroendocrine, Breast, and Lung Cancers Driving PSMA and SSTR Theranostic Demand
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5.1.2 Growing FDA, EMA, and NMPA Regulatory Momentum — Accelerated Approvals, Breakthrough Therapy Designations, and Fast-Track Pathways for Theranostic Agents
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5.1.3 Increasing Adoption of Precision Oncology and Personalized Medicine Driven by Companion Diagnostics Integration
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5.1.4 Technological Advancements in Molecular Imaging: Hybrid PET/CT, PET/MRI, and SPECT/CT Systems Enhancing Diagnostic Precision
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5.1.5 Rapid Clinical Expansion of Alpha-Emitter Programs (Ac-225, Pb-212) for Radioresistant Cancers
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5.1.6 Growing Pharmaceutical Investments and Strategic M&A in Radiopharmaceutical Theranostics (Novartis-Endocyte, EliLilly-POINT Biopharma, Bristol-Myers Squibb-RayzeBio Acquisitions)
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5.2 Market Restraints
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5.2.1 High Infrastructure and Capital Expenditure: Specialized Cyclotrons, Hot Cells, Nuclear Medicine Facilities, and Trained Personnel
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5.2.2 Short Radioisotope Half-Lives Creating Complex Cold-Chain Logistics and Supply Chain Vulnerabilities
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5.2.3 Limited Availability of Key Radioisotopes — Ac-225 and Lu-177 Global Production Shortfalls
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5.2.4 Reimbursement Challenges and High Per-Cycle Treatment Costs for Theranostic Radiopharmaceuticals
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5.3 Market Opportunities
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5.3.1 Expanding Theranostic Targets Beyond Oncology: Cardiovascular, Neurological (Alzheimer's, Parkinson's), Infectious Diseases, and Autoimmune Disorders
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5.3.2 Innovation in Nanoparticle-Based Theranostics: Liposomes, Polymeric Nanoparticles, Gold Nanoparticles for Multimodal Imaging and Targeted Drug Delivery
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5.3.3 AI and Radiomics Integration: AI-Powered Imaging Analysis, Tumor Heterogeneity Overcoming, and Predictive Dosimetry Tools (SNMMI Global Radiopharmaceutical Trial Finder, Aug 2025)
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5.3.4 Domestic Radioisotope Production Initiatives: U.S. DOE National Isotope Development Center (NIDC), China Mid-and Long-Term Plan (2021–2035), EU Horizon Programs
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5.3.5 Emerging Theranostic CDMO Sector: PharmaLogic-TAG1 Pb-212 Partnership (Jun 2025), AtomVie-Radiopharm Ventures Lu-177 Collaboration
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5.4 Market Challenges
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5.4.1 Tumor Heterogeneity and Variable Target Expression Reducing Universal Theranostic Efficacy
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5.4.2 Complexity of Radiation Safety Regulations and Personnel Training Requirements
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5.4.3 Intellectual Property and Patent Barriers in Proprietary Theranostic Pair Development
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5.5 Porter's Five Forces Analysis
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5.5.1 Threat of New Entrants
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5.5.2 Bargaining Power of Suppliers (Radioisotope Producers, Reactor Operators, Cyclotron Facilities)
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5.5.3 Bargaining Power of Buyers (Oncology Centers, Hospital Networks, Government Payers)
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5.5.4 Threat of Substitutes (Conventional Chemotherapy, Immunotherapy, Targeted Oral Oncologics, CAR-T)
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5.5.5 Competitive Rivalry Among Existing Theranostic Players
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5.6 PESTLE Analysis
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5.7 Pipeline Analysis: Theranostic Agents in Phase I, II, and III Clinical Trials (2026)
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5.8 Companion Diagnostics and Biomarker Landscape
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5.9 Reimbursement and Health Technology Assessment (HTA) Framework Analysis
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5.10 AI and Digital Health Impact on Theranostic Treatment Planning and Patient Selection
6. Global Theranostics Market Analysis, By Product Type
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6.1 Overview and Key Findings
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6.2 Drugs (Dominant Segment — Radiopharmaceuticals ~38% Market Share in 2024)
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6.2.1 Market Size and Forecast
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6.2.2 Radiopharmaceuticals
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6.2.2.1 Market Size and Forecast
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6.2.2.2 FDA/EMA-Approved Products: Lutathera (Lu-177 DOTATATE), Pluvicto (Lu-177 PSMA-617), Xofigo (Ra-223 Dichloride), Gozellix (Telix Pharmaceuticals, U.S. Launch Jun 2025)
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6.2.2.3 Investigational Alpha Emitters: 225Ac-PSMA-617, 212Pb-DOTAMTATE, 149Tb (Nuclidium, CHF 79M Raised Jun 2025)
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6.2.3 Chemotherapeutic Agents
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6.2.3.1 Market Size and Forecast
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6.2.3.2 Antibody-Drug Conjugates (ADCs) with Dual Diagnostic and Therapeutic Radiolabeling Potential
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6.2.4 Immunotherapeutics (Fastest Growing Drug Sub-Segment)
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6.2.4.1 Market Size and Forecast
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6.2.4.2 Quantum Dot-Enabled Immune Cell Labeling; Checkpoint Inhibitor Companion Diagnostics
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6.2.4.3 OncoACP3 — Philochem/RayzeBio Clinical-Stage PSMA-Targeting Theranostic Agent (Jun 2025)
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6.2.5 Targeted Small Molecules
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6.2.5.1 Market Size and Forecast
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6.2.6 Others (Peptide-Receptor Conjugates, Nanobody Radiopharmaceuticals)
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6.3 Imaging Agents
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6.3.1 Market Size and Forecast
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6.3.2 PET Imaging Agents (68Ga, 18F, 64Cu, 89Zr-Labeled Tracers)
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6.3.3 SPECT Imaging Agents (99mTc, 111In, 123I-Labeled Tracers)
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6.3.4 MRI Contrast Agents (Gadolinium-Based, Iron Oxide-Based Nanoparticles)
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6.3.5 Optical Imaging Agents (NIR Fluorescent Dyes, Quantum Dots)
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6.3.6 Ultrasound Contrast Agents
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6.3.7 Others
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6.4 Devices and Instruments
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6.4.1 Market Size and Forecast
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6.4.2 Imaging Systems: PET/CT, PET/MRI, SPECT/CT, Hybrid Digital PET Systems (GE HealthCare, Siemens Healthineers, Philips)
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6.4.3 Therapy Delivery Systems: Radiolabeling Hot Cells, Remote Handling Equipment, Infusion Systems
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6.4.4 Laboratory Analyzers and Kits: Companion Diagnostic Assays (Roche Diagnostics, Thermo Fisher Scientific, Illumina, QIAGEN)
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6.4.5 Others (Radiation Dosimetry Systems, Cyclotrons — IBA Radiopharma Solutions, ARTMS)
7. Global Theranostics Market Analysis, By Technology
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7.1 Overview and Key Findings
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7.2 Molecular Imaging (Dominant Technology Segment — ~32% Market Share in 2024)
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7.2.1 Market Size and Forecast
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7.2.2 Positron Emission Tomography (PET)
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7.2.2.1 Market Size and Forecast
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7.2.2.2 Whole-Body Imaging, Quantitative Data, Non-Invasive Disease Mapping
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7.2.2.3 Key Applications: Prostate Cancer Staging (PSMA-PET), NET Imaging (DOTATATE-PET), Brain Tumor Assessment
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7.2.3 Single Photon Emission Computed Tomography (SPECT)
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7.2.3.1 Market Size and Forecast
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7.2.4 Magnetic Resonance Imaging (MRI)
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7.2.4.1 Market Size and Forecast
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7.2.5 Computed Tomography (CT) — AI-Integrated CT Systems (GE Healthcare Aurora EV-ICD, Japan Apr 2025)
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7.2.6 Optical Imaging and Ultrasound
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7.3 Nanoparticle-Based Theranostics (Fastest Growing Technology Segment)
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7.3.1 Market Size and Forecast
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7.3.2 Liposomes — Chemotherapeutic and Radiopharmaceutical Payload Encapsulation
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7.3.3 Polymeric Nanoparticles — Controlled Drug Release and Tumor Penetration
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7.3.4 Gold Nanoparticles — Photothermal Therapy and CT/Optical Imaging Contrast
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7.3.5 Other Nanoparticle Platforms (Iron Oxide, Carbon Nanotubes, Silica Nanoparticles)
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7.3.6 Blood-Brain Barrier (BBB) Crossing for CNS Theranostic Applications
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7.4 Radiopharmaceuticals (as Standalone Technology)
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7.4.1 Market Size and Forecast
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7.4.2 Beta Emitters: Lu-177, Y-90, I-131
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7.4.3 Alpha Emitters: Ac-225, Pb-212, Ra-223
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7.4.4 Auger Electron Emitters: In-111, I-125
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7.5 Biomarker-Based Therapies
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7.5.1 Market Size and Forecast
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7.5.2 Protein Biomarkers (PSMA, SSTR2, HER2, FAP, CXCR4)
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7.5.3 Genetic Biomarkers (RAS Mutations, BRCA1/2, MSI Status — Illumina/Foundation Medicine Companion Dx)
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7.5.4 Metabolite Biomarkers (Tumor Glucose Uptake, Lipid Metabolism Markers)
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7.6 Others (Photodynamic Therapy, Photothermal Theranostics, Magnetothermal Therapy)
8. Global Theranostics Market Analysis, By Application
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8.1 Overview and Key Findings
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8.2 Oncology (Dominant and Fastest Growing Application — ~27% Market Share in 2024)
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8.2.1 Market Size and Forecast
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8.2.2 Prostate Cancer (Largest Sub-Segment — PSMA Theranostic Paradigm)
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8.2.2.1 Market Size and Forecast
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8.2.2.2 PSMA-PET Staging: 68Ga-PSMA-11 (Illuccix), 18F-DCFPyL (Pylarify, Lantheus)
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8.2.2.3 PSMA-Targeted Therapy: Pluvicto (177Lu-PSMA-617, Novartis/AAA — FDA Approved 2022)
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8.2.2.4 Investigational Alpha Emitters: 225Ac-PSMA-617 (BAMF Health, ITM)
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8.2.3 Neuroendocrine Tumors (NETs) (Fastest Growing Sub-Segment)
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8.2.3.1 Market Size and Forecast
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8.2.3.2 SSTR Theranostics: 68Ga-DOTATATE (Netspot) + Lutathera (177Lu-DOTATATE) — Gold Standard
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8.2.3.3 Pituitary and Pancreatic NET Management
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8.2.4 Breast Cancer (HER2-Targeted Theranostics, FAPI-Based Agents)
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8.2.4.1 Market Size and Forecast
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8.2.5 Lung Cancer
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8.2.5.1 Market Size and Forecast
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8.2.6 Thyroid Cancer (Radioiodine I-131: Foundational Theranostic Application)
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8.2.6.1 Market Size and Forecast
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8.2.7 Colorectal Cancer (RAS Panel Companion Diagnostics — Illumina/FDA Panitumumab)
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8.2.8 Others (Kidney, Liver, Brain Tumors, Hematological Malignancies)
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8.3 Cardiovascular Diseases
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8.3.1 Market Size and Forecast
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8.3.2 Myocardial Perfusion Imaging with SPECT/PET and Radiolabeled Peptide Therapies
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8.4 Neurological Disorders
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8.4.1 Market Size and Forecast
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8.4.2 Alzheimer's Disease: Amyloid and Tau PET Imaging (Florbetapir, Flortaucipir)
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8.4.3 Parkinson's Disease: DaT Scan SPECT and Investigational Alpha-Synuclein Theranostics
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8.5 Infectious Diseases
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8.5.1 Market Size and Forecast
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8.5.2 Radiolabeled Antimicrobials and Pathogen-Targeted Diagnostic-Therapeutic Combinations
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8.6 Autoimmune Disorders
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8.6.1 Market Size and Forecast
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8.6.2 Radiolabeled Antibodies for Inflammatory Lesion Detection and Targeted Immunotherapy
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8.7 Others (Rare Diseases, Bone Metastases, Pediatric Oncology)
9. Global Theranostics Market Analysis, By End User
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9.1 Overview and Key Findings
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9.2 Hospitals and Clinics (Dominant Segment — ~45% Market Share in 2024)
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9.2.1 Market Size and Forecast
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9.2.2 Multidisciplinary Tumor Board Integration and PERT-Equivalent Theranostic Programs
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9.2.3 Nuclear Medicine Departments: PET/CT and SPECT Imaging Infrastructure
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9.2.4 Siemens Healthineers–MGH Therapy Command Center Partnership (Jun 2025)
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9.3 Diagnostic Imaging Centers (Fastest Growing End User)
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9.3.1 Market Size and Forecast
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9.3.2 AI-Integrated PET/SPECT Imaging, Affordability, and Outpatient Convenience
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9.3.3 Rising Adoption of Independent Molecular Imaging Centers for Prostate and NET Cancer Staging
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9.4 Academic and Research Institutes
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9.4.1 Market Size and Forecast
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9.4.2 Clinical Trials for Novel Theranostic Pairs, Isotope Development, and Translational Research
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9.4.3 Champions Oncology Radiopharmaceutical Services Platform Launch (Jul 2025)
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9.5 Specialty Care Centers (Oncology Centers, Nuclear Medicine Centers, BAMF Health, Evergreen Theragnostics)
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9.5.1 Market Size and Forecast
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9.6 Others (CDMOs, Government Radiopharma Facilities, Military Medical Centers)
10. Global Theranostics Market Analysis, By Region
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10.1 Overview and Regional Key Findings
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10.2 North America (Dominant Region — ~40% Market Share in 2024)
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10.2.1 Market Size and Forecast
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10.2.2 United States
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10.2.2.1 Market Size and Forecast
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10.2.2.2 FDA Approval Leadership: Pluvicto, Lutathera, Gozellix (Jun 2025) — World's Largest Approved Theranostic Product Market
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10.2.2.3 Strong U.S. Nuclear Medicine Infrastructure and Rising Prostate and NET Cancer Incidence
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10.2.2.4 Strategic Partnerships: NorthStar Medical–YAP Therapeutics (Jan 2025), TAG1–PharmaLogic Pb-212 Partnership (Jun 2025)
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10.2.3 Canada
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10.2.3.1 Market Size and Forecast
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10.2.3.2 AtomVie Global Radiopharma CDMO and Radiopharm Ventures Lu-177 Collaboration (Oct 2024)
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10.3 Europe
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10.3.1 Market Size and Forecast
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10.3.2 Germany (European Leader — ~16% Regional Dominance; Lu-177 Production Scaling)
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10.3.2.1 Market Size and Forecast
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10.3.2.2 ITM Isotope Technologies Munich — Global Alpha/Beta Emitter Production Leader
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10.3.2.3 Nuclidium $99M Fundraise for Copper-Based Radiopharmaceuticals (Jun 2025)
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10.3.3 United Kingdom — Lemer Pax/Synapse Medical Radiation Protection Distribution Partnership (Apr 2025)
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10.3.4 France — Curium Pharma Headquarters and EU Production Capacity
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10.3.5 Italy — Bracco Imaging S.p.A. as Key European Imaging Agent Player
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10.3.6 Spain
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10.3.7 Sweden and Denmark (Nordic Clinical Trial Hub)
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10.3.8 Norway
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10.3.9 Rest of Europe
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10.4 Asia Pacific (Fastest Growing Region — ~19.1% CAGR)
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10.4.1 Market Size and Forecast
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10.4.2 China
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10.4.2.1 Market Size and Forecast
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10.4.2.2 NMPA Mid-and Long-Term Plan for Medical Isotopes (2021–2035): Domestic Isotope Production Investment
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10.4.2.3 Rising Cancer Burden Driving PSMA and NET Theranostic Adoption
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10.4.3 Japan (~18% CAGR — Precision Medtech Hub)
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10.4.3.1 Market Size and Forecast
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10.4.3.2 SSTR Agonist Pipeline; Nihon Medi-Physics as Domestic Radiopharma Leader
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10.4.3.3 Curium–PDRadiopharma Collaboration for 177Lu-PSMA-I&T in Japan (Oct 2024)
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10.4.4 India
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10.4.4.1 Market Size and Forecast
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10.4.4.2 Growing Nuclear Medicine Infrastructure; Aurobindo Pharma Radiopharma Expansion
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10.4.5 South Korea (PSMA Therapy Investment Boom)
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10.4.5.1 Market Size and Forecast
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10.4.6 Australia — Cyclotron Expansions Fueling APAC Theranostic Surge; Telix Pharmaceuticals HQ
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10.4.7 Thailand and ASEAN
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10.4.8 Rest of Asia Pacific
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10.5 Latin America
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10.5.1 Market Size and Forecast
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10.5.2 Brazil — ICPO Foundation and SBMN Strategic Partnership for Clinical Theranostics Centers (Jul 2025)
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10.5.3 Mexico
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10.5.4 Argentina
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10.5.5 Rest of Latin America
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10.6 Middle East and Africa
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10.6.1 Market Size and Forecast
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10.6.2 GCC Countries (UAE, Saudi Arabia, Kuwait)
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10.6.3 South Africa
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10.6.4 Egypt and Nigeria
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10.6.5 Rest of Middle East and Africa
11. Competitive Landscape
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11.1 Global Market Share Analysis by Key Players
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11.2 Competitive Benchmarking Matrix (Pipeline Depth, Theranostic Pair Coverage, Isotope Supply Control, Geographic Reach)
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11.3 Vendor Positioning Grid: Technology Innovators, Pipeline Leaders, Vertically Integrated Players, Niche Biotech
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11.4 Key Strategic Developments
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11.4.1 Major M&A Transactions (Novartis–Advanced Accelerator Applications; Eli Lilly–POINT Biopharma; Bristol-Myers Squibb–RayzeBio; AstraZeneca–Fusion Pharmaceuticals)
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11.4.2 New Product Launches and Regulatory Approvals (Telix Gozellix U.S. Launch Jun 2025; Medtronic Japan Aurora EV-ICD Mar 2025)
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11.4.3 Strategic Collaborations and CDMO Partnerships (Curium–PDRadiopharma Japan Agreement Oct 2024; NorthStar–YAP Therapeutics Jan 2025; Philochem–RayzeBio OncoACP3 Jun 2025)
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11.4.4 Clinical Trial Initiations and Phase Progressions (Starget DOTA-PTR-58 Phase 1b, Oct 2024; AVENTUS IDE Trial; CLEAN-PE)
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11.4.5 Geographic Expansions and Facility Investments
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11.5 Patent Landscape and IP Pipeline Analysis
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11.6 Market Concentration Analysis
12. Company Profiles
The final report includes a complete list of companies.
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12.1 Novartis AG (Advanced Accelerator Applications S.A.)
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12.1.1 Company Overview
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12.1.2 Financial Performance
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12.1.3 Product Portfolio
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12.1.4 Strategic Initiatives
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12.1.5 SWOT Analysis
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12.2 Bayer AG
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12.3 GE HealthCare Technologies, Inc.
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12.4 Siemens Healthineers AG
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12.5 Lantheus Holdings, Inc.
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12.6 Telix Pharmaceuticals Limited
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12.7 Curium Pharma
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12.8 ITM Isotope Technologies Munich SE (ITM)
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12.9 Cardinal Health, Inc.
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12.10 F. Hoffmann-La Roche Ltd. (Roche Diagnostics)
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12.11 Thermo Fisher Scientific Inc.
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12.12 Jubilant Radiopharma (Jubilant Pharmova Limited)
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12.13 Eckert & Ziegler SE
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12.14 Bracco Imaging S.p.A.
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12.15 NorthStar Medical Radioisotopes, LLC
13. Recent Developments and Industry News
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13.1 Key Product Launches and Regulatory Approvals (2024–2026)
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13.2 Major M&A Transactions, Funding Rounds, and Strategic Alliances
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13.3 R&D Breakthroughs: Alpha Emitters, Nanotheranostics, AI-Radiomics Integration
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13.4 Regulatory and Policy Updates: FDA, EMA, NMPA, PMDA
14. Appendix
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14.1 Detailed Research Methodology
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14.2 Theranostic Radioisotope Reference Table (Half-Life, Emission Type, Clinical Status)
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14.3 List of Tables and Figures
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14.4 List of Abbreviations
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14.5 Data Sources and References
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14.6 About the Publisher
15. Disclaimer