PET 방사성 트레이서 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the pET radiotracer market size is expected to grow from USD 2.57 billion in 2025 to USD 2.76 billion in 2026 and is forecast to reach USD 4.35 billion by 2031 at 9.55% CAGR over 2026-2031.

This report is Segmented by Radiotracer Type (18F-FDG, PSMA-Targeted Agents [F-18, Ga-68], Amyloid Agents, 18F-NaF [bone], and Others), Isotope (Fluorine-18, Gallium-68, Carbon-11, Zirconium-89, Copper-64, and Others), Application (Oncology, Neurology, Cardiology and Others), End User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Global PET Radiotracer Market Trends and Insights

Oncology Burden and PET Procedure Growth

Rising cancer incidence, including a projected 334,000 new U.S. prostate cancer cases and more than 36,000 deaths in 2026, intensifies reliance on PET for staging, response assessment, and recurrence detection where other modalities have limitations. The ongoing integration of theranostic care models links diagnostic PSMA-PET and somatostatin receptor PET with radioligand therapies, which increases imaging frequency per patient as treatment pathways require confirmation scans. Evidence from the PSMAfore study supporting earlier PSMA-based therapy adoption and better radiographic progression-free survival has encouraged use of PET earlier in the disease trajectory.

In Asia-Pacific, the rapid buildout of cyclotrons and PET facilities, complemented by reactor-based lutetium-177 capacity in China, enhances availability for theranostic protocols. East Asian clinical experience showing 62.5% PSA response rates to PSMA radioligand therapy supports expanding adoption across diverse patient profiles.

US CMS Separate Payment Boosts Tracer Access

The U.S. policy to separate payment for diagnostic radiopharmaceuticals above the high-cost threshold, effective January 2025, restructured hospital outpatient economics and preserved product viability after pass-through, which reduces the historical volume cliff that discouraged innovation. The indexed threshold increased to USD 655 for 2026, reinforcing inflation protection and signaling stability in reimbursement design for premium PET tracers.

While CMS pays based on mean unit cost from hospital claims rather than average sales price, the decoupled payment approach curbs margin compression and sustains product availability in both hospitals and outpatient centers. Transitions from pass-through to regular payment can create rate volatility for lower-utilization products, yet the framework still improves access relative to prior bundled-payment dynamics. Over the medium term, private insurers and international payers are likely to study U.S. policy for reference, which may influence broader reimbursement benchmarks for the PET radiotracer market.

High PET/CT Capex and Siting Constraints

PET/CT acquisition and installation budgets remain significant, which limits adoption in settings where throughput cannot meet return thresholds within standard equipment lifecycles. Facilities face additional costs for hot cells, cleanrooms, and compliance with GMP-grade manufacturing and handling standards, and these costs are coupled with licensing complexity across national regulatory bodies. Approval timelines, zoning restrictions, and community opposition can add to delays and create uneven geographic distribution of PET capacity. Analysis published in 2025 indicated that extending hours on short-axial-field-of-view scanners is less efficient than upgrading technology, but many providers still rely on extended hours due to capital constraints. Limited domestic production and uneven reimbursement environments in some countries exacerbate disparities in access, concentrating PET services in a few metropolitan corridors.

Other drivers and restraints analyzed in the detailed report include:

1. PSMA-PET Adoption and Product Proliferation
2. Alzheimer's Care Pathways Expand Amyloid/tau PET
3. Short Half-lives and Isotope/Parent Shortages

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Fluorine-18 FDG accounted for 45.22% share of the PET radiotracer market size in 2025, reflecting entrenched use across oncology, neurology, and cardiology and a large installed base of cyclotrons and PET/CT systems. FDG's broad clinical applicability keeps baseline volumes steady, although growth rates are moderating as disease-specific agents expand in scenarios where glucose metabolism is less informative. PSMA-targeted agents are the fastest-growing radiotracer class at a 13.27% CAGR through 2031, as they serve both diagnostic and therapy-selection roles in prostate cancer pathways.

Piflufolastat's trajectory, including an FDA-cleared manufacturing-optimized formulation in March 2026 that increases batch sizes by about 50%, supports broader geographic coverage from central production hubs. Generator-based gallium-68 kits enable same-day preparation with improved shelf life, which helps smaller hospitals without cyclotrons offer PSMA-PET imaging. East Asian evidence of strong PSA response to PSMA radioligand therapy, despite different genomic profiles compared with Western populations, supports a broadening addressable base for PSMA-driven diagnostic volumes.

Clinical workflow changes underscore why PSMA agents amplify demand rather than substitute for other tests in the PET radiotracer market. Each candidate for PSMA-directed therapy requires PET confirmation of target expression, which adds scans even when the diagnostic pathway is already in place. Competitive dynamics across four FDA-cleared PSMA agents collectively expand capacity and reach through differentiated formats and logistics, resulting in wider access and more flexible scheduling for providers. In parallel, somatostatin receptor tracers, amyloid agents, and bone tracers extend addressable uses in neuroendocrine tumors, Alzheimer's disease, and metastatic surveillance. Pipeline activity in fibroblast activation protein and other targets may add future options across solid tumors, though near-term growth remains most intense in prostate cancer and neuroendocrine indications. Together, these trends reinforce diversified growth drivers across modalities for the PET radiotracer market.

Fluorine-18 held 67.51% share in 2025 on the strength of FDG ubiquity and scale advantages in centralized cyclotron networks that serve regional imaging centers within the 110-minute half-life window. Hub-and-spoke production architectures enable redundancy and help providers manage scheduling risks for high-throughput sites in major metropolitan areas. Gallium-68 is the fastest-growing isotope class at a 13.4% CAGR through 2031, driven by generator-based access for PSMA and somatostatin receptor imaging where sites prefer flexible, on-demand preparation. Generator costs and supply constraints have been hurdles in some markets, though technological improvements and domestic generator initiatives are beginning to address longevity and efficiency.

Cyclotron-based gallium-68 production offers higher yields and regional distribution potential that can complement or replace generators in select geographies, subject to regulatory and process requirements. Fluorine-18's scale economics are reinforced by continuous investment in PET manufacturing infrastructure across growth corridors. Examples include multi-site PET network expansions and capacity additions that aim to reduce delivery lead times and increase supply resilience for high-demand tracers.

Ongoing isotope innovation, such as zirconium-89 for immuno-PET and copper-64 for theranostic pairs, diversifies the clinical toolkit and aligns with the shift toward precision oncology where imaging and therapy decisions are closely coupled. Localization of isotope production in Asia-Pacific further reduces import dependence and supports scalable commercial supply in large countries with rising PET volumes. These changes strengthen the PET radiotracer market by balancing centralized efficiency with decentralized access.

Geography Analysis

North America led with 42.32% in 2025, supported by multiple FDA approvals, clear reimbursement frameworks, and recent capacity investments across CDMOs and radiopharmacies that together add meaningful throughput and resilience. The region has also seen substantial M&A in radiopharmaceuticals, which strengthens integrated supply chains and scales commercial infrastructure to handle growing volumes of PSMA and amyloid imaging. Ongoing policy refinements in Medicare outpatient payment systems sustain economic incentives for high-value tracers, and that environment continues to influence private payer decisions and facility planning. The concentration of clinical trial activity and a large installed base of PET/CT scanners also support continued leadership of the PET radiotracer market in North America.

Asia-Pacific is the fastest-growing region with a 13.95% CAGR through 2031, driven by the localization of isotope production, the expansion of PET manufacturing networks, and high-density healthcare infrastructure in countries like Japan and South Korea. Japan's mature ecosystem for nuclear medicine, combined with recent licensing and manufacturing agreements, positions rapid adoption for PSMA and neurology-focused tracers as regulatory pathways mature. In South Korea, domestic production initiatives for multiple isotopes, including advances in gallium-68 generator technology, aim to reduce import reliance and broaden access for mid-tier hospitals. China's reactor-based lutetium-177 batch production provides strategic support for regional theranostic adoption and reduces exposure to overseas supply constraints. Together, these developments reinforce a multi-country expansion where the PET radiotracer market size for Asia-Pacific is set to accelerate over the forecast horizon.

Europe continues to address structural vulnerabilities linked to aging reactors, transport logistics, and enriched material dependencies, while also investing to expand domestic production and harmonize regulatory frameworks for radiopharmaceuticals. EU-level recommendations seek to diversify raw material supply, improve certification processes, and continue strategic initiatives to build a more resilient supply chain. New capacity additions from industry players, including expanded PET networks in Western Europe, aim to enhance reliability of tracer supply for oncology, neurology, and cardiology programs.

In South America, regional collaboration programs that emphasize capacity building, quality systems, and training are designed to improve availability and foster adoption of theranostics, while targeted national approvals streamline market entry for select radiopharmaceuticals. These regional moves, along with agency guidance and industry investment, help sustain momentum for the PET radiotracer market.

1. Advanced Accelerator Applications SA
2. Alliance Medical Limited
3. Blue Earth Diagnostics
4. Cardinal Health
5. China lsotope & Radiation Corporation
6. Curium Pharma
7. Cyclotek
8. Eckert & Ziegler
9. GE Healthcare
10. IBA Radiopharma
11. Isologic Innovative Radiopharmaceuticals
12. Jubilant Pharma Limited
13. Lantheus
14. Nihon Medi-Physics Co.,Ltd.
15. NTP Radioisotopes
16. Siemens Healthineers
17. SOFIE
18. Telix Pharmaceuticals Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Oncology Burden and PET Procedure Growth
  • 4.2.2 US CMS Separate Payment Boosts Tracer Access
  • 4.2.3 PSMA-PET Adoption and Product Proliferation
  • 4.2.4 Alzheimers Care Pathways Expand Amyloid/tau PET
  • 4.2.5 Consolidation and CDMO Capacity Expand Supply
  • 4.2.6 Ga-68 Generator Access Enables Decentralized PET
• 4.3 Market Restraints
  • 4.3.1 High PET/CT Capex and Siting Constraints
  • 4.3.2 Short Half-lives and Isotope/Parent Shortages
  • 4.3.3 Staffing and GMP Compliance Bottlenecks
  • 4.3.4 Tariff/trade Uncertainties Raise Generator Input Costs
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porters Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Radiotracer Type
  • 5.1.1 18F-FDG
  • 5.1.2 PSMA-targeted Agents (F-18, Ga-68)
  • 5.1.3 Somatostatin Receptor Agents (Ga-68 DOTATATE/DOTATOC/DOTANOC)
  • 5.1.4 Amyloid Agents (F-18 florbetapir, flutemetamol, florbetaben)
  • 5.1.5 18F-NaF
  • 5.1.6 Others (Neurology Amino-Acid Tracers, Inflammation & Infection Tracers)
• 5.2 By Isotope
  • 5.2.1 Fluorine-18
  • 5.2.2 Gallium-68
  • 5.2.3 Carbon-11
  • 5.2.4 Zirconium-89
  • 5.2.5 Copper-64
  • 5.2.6 Others (Oxygen-15, Nitrogen-13, Rubidium-82, etc)
• 5.3 By Application
  • 5.3.1 Oncology
  • 5.3.2 Neurology
  • 5.3.3 Cardiology
  • 5.3.4 Others (Inflammation & Infection, Drug Development & Theranostic Selection)
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Diagnostic Imaging Centers
  • 5.4.3 Others (Academic & Research Institutes, Nuclear Medicine Clinics)
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Strategic Moves
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 Advanced Accelerator Applications SA
  • 6.3.2 Alliance Medical Limited
  • 6.3.3 Blue Earth Diagnostics
  • 6.3.4 Cardinal Health
  • 6.3.5 China lsotope & Radiation Corporation
  • 6.3.6 Curium
  • 6.3.7 Cyclotek
  • 6.3.8 Eckert & Ziegler
  • 6.3.9 GE HealthCare
  • 6.3.10 IBA Radiopharma
  • 6.3.11 Isologic Innovative Radiopharmaceuticals
  • 6.3.12 Jubilant Pharma Limited
  • 6.3.13 Lantheus
  • 6.3.14 Nihon Medi-Physics Co.,Ltd.
  • 6.3.15 NTP Radioisotopes SOC Ltd
  • 6.3.16 Siemens Healthineers AG
  • 6.3.17 SOFIE
  • 6.3.18 Telix Pharmaceuticals Limited

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment