Fluorine-18 Market Analysis and Opportunities by 2031

[Research Report] The fluorine-18 market forecast can help stakeholders in this marketplace outline their growth strategies. The market is projected to grow from US$ 1.85 billion in 2024 to US$ 2.54 billion by 2031; it is estimated to record a CAGR of 4.7% during 2025–2031.

Market Insights and Analyst View:

Fluorine-18 is a radioisotope used in medical diagnostic procedures, and it is one of the most commonly used medical radioisotopes globally. It has good positron-emitting properties and a half-life of 109.8 minutes. Factors such as the high prevalence of chronic diseases and the increasing use of nuclear imaging techniques propel the fluorine-18 market growth. However, the short shelf-life of fluorine-18 impedes the growth of the market. Further, the use of radioactive tracers in cancer diagnosis is expected to bring new fluorine-18 market trends in the coming years.

Growth Drivers:

Increasing Use of Nuclear Imaging Techniques Drives Market Growth

Advanced radiation technology has opened new horizons in diagnostic and nuclear medicine, radiotherapy, and interventional radiology. The application of ionizing radiation in diagnoses and treatments benefits millions of patients globally. Positron emission tomography (PET) is a commonly used nuclear medicine radiology modality in clinical settings, as it aids in the accurate detection, localization, and characterization of diseases. According to the World Health Organization (WHO), more than 3,600 million radiology-based diagnostic examinations, 37 million nuclear medicine procedures, and 7.5 million radiotherapy treatments are performed annually in the world. As per the European Commission, ~10 million nuclear medicine procedures are performed with radiopharmaceuticals and imaging instruments every year in Europe to diagnose diseases and deliver targeted treatments. These techniques are also adopted in oncology, immunology, infection studies, gastroenterology, cardiology, neurology, and psychiatry. The development and introduction of new radiopharmaceuticals for PET/CT, and the growing accuracy of different tumor staging methods contribute to the fluorine-18 market growth. For instance, newly introduced cardiac radiopharmaceuticals such as flurpiridaz F-18 help in more precise imaging of cardiovascular conditions.

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Fluorine-18 Market: Strategic Insights

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Report Segmentation and Scope:

The fluorine-18 market analysis has been carried out by considering the following segments: product type, application, and end user. By product type, the market is segmented into FDG, NaF, and others. The FDG segment held the largest fluorine-18 market share in 2022 and it is anticipated to register the highest CAGR during the forecast period.

The fluorine-18 market, by application, is divided into oncology, cardiology, neurology, and others. The oncology segment held the largest market share in 2022, and it is anticipated to register the highest CAGR during the forecast period.

The market, by end user, is categorized into hospitals, diagnostic centers, and others. The hospitals segment held the largest fluorine-18 market share in 2022. It is anticipated to register the highest CAGR during the forecast period.

Regional Analysis:

In terms of geography, the scope of the fluorine-18 market report includes North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2022, North America held the largest market share. Nuclear medicine in the US has grown significantly owing to advancements in technologies such as hybrid imaging, the introduction of novel radiopharmaceuticals for diagnosis and treatment, and the development of molecular imaging techniques based on the tracer principle. Access to advanced healthcare infrastructure, the rising incidence and prevalence of target conditions, and product innovations by key players further contribute to the expansion of the fluorine-18 market size in North America. According to the International Agency for Research on Cancer (IARC), the number of cancer cases in the US is expected to increase from 2.28 million cases in 2020 to 3.12 million cases in 2040. Additionally, the Centers for Medicare & Medicaid Services (CMS), the US has adopted standards associated with human laboratory research under the Clinical Laboratory Improvement Amendments (CLIA), which favors the market progress.

Industry Developments and Future Opportunities:

A few strategic developments by leading players operating in the fluorine-18 market are listed below:

• In October 2023, Blue Earth Diagnostics Ltd signed an exclusive strategic agreement with Sinotau Pharmaceutical Group for flotufolastat (18F) injection (formerly referred to as 18F-rhPSMA-7.3). Under the terms of the agreement, the companies became close strategic partners to join forces for technology and regulatory support for the distribution of flotufolastat (18F), a PET imaging agent, for Chinese men suffering from prostate cancer. This event marked an important phase in the Blue Earth Diagnostics’ strategy to make flotufolastat (18F) available to patients and clinicians globally.
• In July 2023, the European Commission granted marketing authorization for Pylclari, an innovative 18F-PSMA PET tracer from Curium, indicated for the detection of PSMA-positive (i.e., prostate-specific membrane antigen) lesions with PET in adults suffering from prostate cancer in the clinical settings.
• In May 2023, Blue Earth Diagnostics won the US Food and Drug Administration (FDA) approval for its optimized, high‐affinity radiohybrid (rh) PSMA‐targeted PET imaging agent—POSLUMA (flotufolastat F 18) injection (formerly referred to as 18F‐rhPSMA‐7.3). POSLUMA is indicated for the detection of PSMA-positive lesions via PET in prostate cancer patients, with suspected metastasis or suspected recurrence based on elevated serum prostate‐specific antigen (SA) level. Metastatic patients are considered as candidates for initial definitive therapy. POSLUMA was the first and only FDA‐approved, PSMA‐targeted imaging agent developed with proprietary rh technology. It was made commercially available in June 2023 through certain radiopharmacies in the national radiopharmacy network of Blue Earth Diagnostics, comprising its commercial manufacturers and distributors from the US.
• In May 2021, Lantheus Holdings, Inc. received FDA approval for PYLARIFY, a fluorine 18-labeled PSMA-targeted PET imaging agent employed to identify suspected metastasis or recurrence of prostate cancer. PYLARIFY was the first and only commercially available, FDA-approved PSMA PET imaging agent for prostate cancer.

Fluorine-18 Market Regional Insights

The regional trends and factors influencing the Fluorine-18 Market throughout the forecast period have been thoroughly explained by the analysts at The Insight Partners. This section also discusses Fluorine-18 Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Fluorine-18 Market Report Scope

Fluorine-18 Market Players Density: Understanding Its Impact on Business Dynamics

The Fluorine-18 Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Competitive Landscape and Key Companies:

Siemens Healthineers, Lantheus Medical Imaging Inc, Novartis AG, Cardinal Health, GE HealthCare, Jubilant Radiopharma, Eli Lilly and Company, Nukleon Nuclear Technology Research Ind Co Ltd, Curium Pharma, and Blue Earth Diagnostics Inc are among the prominent companies profiled in the fluorine-18 market report. These companies focus on developing new technologies, upgrading existing products, and expanding their geographic presence to meet the growing consumer demand worldwide.