Rising Demand for PET Imaging Agents to Drive Global Fluorine-18 Market Beyond US$ 3.2 Billion by 2035 - TMR Report

Fluorine-18 Market Outlook 2035

The global fluorine-18 market was valued at US$ 1.9 Billion in 2024 and is projected to cross US$ 3.2 Billion by the end of 2035, expanding at a CAGR of 4.8% from 2025 to 2035. Market growth is primarily driven by the rising demand for positron emission tomography (PET) imaging in oncology, neurology, and cardiology diagnostics. Increasing adoption of radioisotopes in advanced medical imaging and the expansion of nuclear medicine facilities are major factors fueling the market's expansion worldwide.

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Market Overview

Fluorine-18 (18F) is a radioactive isotope widely used as a tracer in PET scans to detect and monitor cancer, neurological disorders, and cardiovascular diseases. Its short half-life and high positron emission yield make it ideal for real-time imaging and accurate diagnostics.

The increasing prevalence of chronic diseases, coupled with the growing preference for non-invasive diagnostic imaging, is driving substantial demand for fluorine-18-based radiopharmaceuticals.

Analysts' Viewpoint on the Global Fluorine-18 Market

The global fluorine-18 market is expanding steadily, driven by the development of new cyclotron facilities and advancements in radiochemistry that have enhanced production efficiency and availability. These improvements are making fluorine-18 more accessible for a wide range of medical and diagnostic applications, particularly in positron emission tomography (PET) imaging.
Market growth is further supported by broader reimbursement coverage for PET procedures using F-18 tracers, stricter GMP compliance, and streamlined lot-release processes, all of which accelerate clinical adoption.

Additionally, service providers are implementing remote monitoring and preventive maintenance systems to reduce downtime and ensure reliable delivery of tracers-critical for this isotope given its short half-life of approximately 110 minutes.

Analysis of Key Fluorine-18 Market Manufacturers

Key players in the fluorine-18 (F-18) market are focusing on expanding their cyclotron networks, enhancing radiopharmaceutical manufacturing capabilities, and developing novel PET tracers for diverse clinical applications. Companies are also investing in automated synthesis technologies, digital ordering systems, and regulatory compliance initiatives to streamline isotope supply and improve reliability across diagnostic and research applications. Strategic partnerships and collaborations are playing a central role in broadening geographic reach, improving isotope distribution efficiency, and accelerating clinical adoption of new F-18-based tracers for oncology, cardiology, and neurology imaging.

Prominent players operating in the global fluorine-18 market include
• Lantheus Holdings, Inc.
• Siemens Healthineers AG
• Curium Austria GmbH
• GE HealthCare
• Blue Earth Diagnostics
• China lsotope & Radiation Corporation
• Eli Lilly and Company
• Yantai Dongcheng Pharmaceutical Group Co., Ltd.
• Advanced Accelerator Applications SA
• Telix Pharmaceuticals Limited
• SOFIE Co.
• Cardinal Health
• Life Molecular Imaging
• IBA Radiopharma Solutions
• GNC India
• ECKERT & ZIEGLER

Each of these companies has been profiled in the fluorine-18 market research report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments.

Key Developments in the Fluorine-18 Market

• June 2025 - Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) had approved a label update for Amyvid (florbetapir F 18 injection) for intravenous use. The update enhances clinical clarity and extends the diagnostic utility of Amyvid in Alzheimer's disease imaging, reinforcing Eli Lilly's leadership in neuroimaging tracers.

• September 2024 - GE HealthCare received FDA approval for Flyrcado (flurpiridaz F 18) injection, a novel PET myocardial perfusion imaging (MPI) agent developed for the non-invasive detection of coronary artery disease (CAD). The approval marks a milestone in cardiac imaging, expanding the company's PET radiopharmaceutical portfolio and strengthening its presence in precision diagnostics.

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Key Player Strategies

⚙️ Expansion of Cyclotron Networks
Companies are investing in regional cyclotron facilities to ensure a steady and timely fluorine-18 supply due to its short half-life.
🔬 Radiopharmaceutical Innovation
Development of new fluorine-18-labeled compounds for more targeted diagnostics and therapy monitoring.
💊 Integration with Diagnostic Centers
Partnerships with hospitals and imaging centers to expand clinical access to PET imaging.
🌍 Regulatory Approvals & Standardization
Focus on compliance with FDA, EMA, and IAEA standards for radiopharmaceutical safety and production.
📈 Adoption of Automation & AI
Use of AI-assisted systems in radiochemistry and quality control for faster and more accurate tracer synthesis.

Challenges

• Short half-life (approx. 110 minutes) limits transportation and storage range
• High production costs due to cyclotron and synthesis equipment requirements
• Regulatory and safety complexities in handling radioisotopes
• Limited access to PET imaging in low-income regions

Opportunities

🧠 Rising Prevalence of Cancer & Neurological Disorders
Increased use of PET imaging for early diagnosis and therapy monitoring.
🏥 Expansion of Nuclear Medicine Facilities
Hospitals and diagnostic centers are investing in PET infrastructure to meet growing demand.
💡 Emerging Radiopharmaceutical Research
Development of novel 18F tracers for targeted molecular imaging and theranostic applications.
📦 Contract Manufacturing & Distribution Partnerships
Growth of radiopharmaceutical outsourcing models to ensure continuous tracer supply.
🌐 Emerging Markets Expansion
Rising healthcare investments in Asia Pacific and Latin America present untapped opportunities.

Market Segmentations

➤ By Product Type
• 18F-FDG
• 18F-FLT
• 18F-FMISO
• 18F-DOPA
• Other 18F Tracers

➤ By Application
• Oncology
• Neurology
• Cardiology
• Research & Development

➤ By End User
• Hospitals
• Diagnostic Imaging Centers
• Research Laboratories
• Radiopharmaceutical Manufacturers

➤ By Region
• North America - Largest market with advanced nuclear imaging infrastructure
• Europe - Strong presence of radiopharmaceutical research networks
• Asia Pacific - Fastest-growing market driven by healthcare modernization
• Latin America - Increasing investments in PET diagnostic centers
• Middle East & Africa - Gradual adoption with rising oncology diagnostic needs

Why Invest in the Fluorine-18 Market Report?

✅ Long-term market forecasts up to 2035 for strategic planning
✅ Comprehensive analysis of key fluorine-18 tracers and applications
✅ Profiles of leading producers and supply chain players
✅ Insights into emerging radiopharmaceutical technologies
✅ Evaluation of regional production and distribution trends

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Conclusion

The global fluorine-18 market is on a steady growth trajectory, supported by the increasing adoption of PET imaging for early disease detection and the rising demand for precision diagnostics. With continuous advancements in radiopharmaceutical production, expansion of cyclotron networks, and the integration of AI and automation in imaging workflows, the market is set to play a pivotal role in the evolution of nuclear medicine and personalized healthcare by 2035.

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