Oncology Segment, by Application to Account Largest Share in Fluorine 18 Market during 2025-2031

According to our new research study on "Fluorine 18 Market Forecast to 2031 - Global Analysis - by Treatment Type, Disease Type, and End User," the market was valued at US$ 1,85 billion in 2024 to US$ 2.53 billion by 2031; the market is expected to register a CAGR of 4.7% during 2025-2031. The fluorine 18 market growth is attributed to the rising prevalence of cancers, increasing pet imaging, technological advancements in PET scanners and imaging systems, and regulatory approvals and development of novel fluorine-18 tracers.

The surge in regulatory endorsements for innovative Fluorine-18-labeled tracers has invigorated the market by broadening therapeutic windows and enhancing specificity across diverse pathologies, thereby accelerating clinical integration and production imperatives. The US Food and Drug Administration's (FDA) approval trajectory exemplifies this momentum: since 2012, three amyloid-targeting agents-florbetapir, florbetaben, and flutemetamol have gained clearance for Alzheimer's evaluation, enabling in vivo plaque quantification with 90-95% sensitivity owing to the 55 million global dementia cases projected for 2025. In September 2024, flurpiridaz F-18 (Flyrcado) received FDA nod as the first novel PET myocardial perfusion agent in decades, boasting a 110-minute half-life that permits centralized production and distribution, unlike short-lived rubidium-82; phase III trials demonstrated 87% accuracy in detecting coronary artery disease, rivaling SPECT while slashing scan times by 30%. In oncology, fluoroestradiol F-18 (Cerianna), approved in 2020, visualizes estrogen receptor-positive breast lesions with 78% detection rates in metastatic settings, guiding endocrine therapy selection and averting ineffective chemotherapy in 20-30% of cases. The pipeline burgeons further: over 40 novel Fluorine-18 compounds, including PSMA-targeted agents such as 18F-DCFPyL for prostate cancer, have entered clinical trials since 2020, with uptake sensitivities exceeding 92% for biochemical recurrence, per multicenter data. These approvals stem from robust evidence frameworks, such as the National Oncologic PET Registry's analysis of 40,863 scans showing management alterations in 38% of instances via expanded indications. Europe's European Medicines Agency mirrors this, approving flutemetamol in 2013 and fostering harmonized protocols that expedite multinational trials. In Asia, China's development of over 40 radiopharmaceuticals by 2021, including Fluorine-18 variants for Tc-99m alternatives, underscores regional acceleration, supported by investments exceeding US$ 500 million in nuclear infrastructure. Such endorsements mitigate prior barriers such as short shelf-life, as longer-lived Fluorine-18 enables off-site synthesis via automated modules, increasing yield by 20-50% and curbing costs. Theranostic synergies amplify impact; for instance, Fluorine-18 PSMA PET/CT preselects patients for Lutetium-177 therapy, yielding 38% progression-free survival gains in advanced prostate cancer. As over 120 approved radiopharmaceuticals incorporate Fluorine-18, and ongoing trials target hypoxia markers such as 18F-FMISO for glioblastoma, this driver not only diversifies applications but fortifies the ecosystem, promising growth in procedural volumes and redefining precision diagnostics.

Based on product type, the fluorine-18 market is segmented into FDG, NaF, and Others. In 2024, the FDG segment held a significant fluorine-18 market share. FDG (fluorodeoxyglucose) is the primary radiotracer for PET (positron emission tomography) imaging, due to its ability to visualize glucose metabolism in diseased tissues. Due to FDG's short half-life of about 110 minutes, it has to be produced on-site in the cyclotron, which allows a quick delivery to the imaging centers for the same-day use. About 3-5 million PET scans are performed globally per year, with more than 2 million conducted in the US only. Most of these scans are made with the use of FDG to ensure the diagnostic precision as well as the treatment of oncology, cardiology, and neurology fields. For instance, an FDG-PET is very helpful in the early identification of therapy responses; thus, it is a good tool for recurrence prediction, with a high sensitivity of up to 96% in the case of esophageal cancer after chemotherapy, which is the source of recurrence.

FDG is leading in cardiology as well, thus it is a good tool for the assessment of myocardial viability in ischemic heart disease, and in such a way, it shows up to 70% of viable tissue in those segments which are judged as non-viable on echocardiography, and thus revascularization decisions are made accordingly. In neurology, FDG is utilized for the separation of Alzheimer's disease from other dementias by measuring the area of hypometabolism in the temporoparietal regions, and thus the decline of cognitive functions is connected to the drop of the uptake here, which is more than 20%. These applications are the proof of FDG being multitalented and very much loved as a product for efficient production modules with a yield ranging from 10 to 20 curies per batch, and thus can supply high-volume centers performing thousands of scans annually without any time delay. Thus, it allows developments in the hybrid PET/CT systems for better spatial resolution and patient outcomes.

Based on application, the market is segmented into oncology, cardiology, neurology, others. The oncology segment held the largest fluorine 18 market share in 2024, and the same segment is estimated to register the higher CAGR during 2025-2031. The oncology segment driven by the widespread use of Fluorodeoxyglucose (FDG) in positron emission tomography (PET) imaging, which accounts for roughly 80-85% of all Fluorine-18-based scans globally. Oncology applications leverage FDG's ability to detect elevated glucose metabolism in malignant tissues, facilitating cancer diagnosis, staging, and treatment monitoring. As per Read My MRI, there were ~3-5 million PET scans are performed annually for oncology worldwide, with the US contributing ~2 million PET scans annually. In lung cancer, FDG-PET achieves diagnostic sensitivity of 85-95%, identifying metastases in 10-15% of cases missed by conventional imaging, thus altering treatment plans in about 20% of patients. For lymphoma, FDG-PET detects residual disease with 90-95% accuracy, guiding therapy adjustments, as seen in Hodgkin's lymphoma where early response assessment predicts 5-year survival rates of 85-90%. Beyond FDG, tracers like Fluorothymidine (FLT) are emerging for proliferation imaging, particularly in high-grade gliomas, showing 80-90% correlation with tumor aggressiveness. These scans influence surgical planning in 25-30% of brain tumor cases. Fluorine-18's 110-minute half-life supports high-throughput cyclotron production, yielding 10-20 curies per batch to meet demand in busy oncology centers performing thousands of scans yearly. The integration of PET/CT systems enhances diagnostic precision, with hybrid imaging improving lesion localization by 15-20% compared to PET alone. As precision oncology grows, Fluorine-18's role in tailoring therapies such as immunotherapy response monitoring in melanoma, where FDG uptake predicts response in 70-80% of cases continues to expand, solidifying its critical impact on cancer care.

Lantheus Medical Imaging Inc, Siemens Healthineers AG, GE HealthCare Technologies Inc, Curium Pharma, Blue Earth Diagnostics Limited, Eli Lilly and Co, IBA Radiopharma Solutions are among the leading companies operating in the global fluorine 18 market.

Companies operating in the fluorine 18 market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the fluorine 18 market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall fluorine 18 market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

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