RADIOACTIVE TRACER MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

Market Challenges And Opportunities

Global Radioactive Tracer Market- Drivers

• Increasing prevalence of chronic diseases such as cancer, cardiovascular diseases, and neurological disorders is expected to boost demand for radioactive tracers. The growing burden of chronic illnesses globally has led to increase in diagnostic procedures involving nuclear medicine imaging techniques such as PET and SPECT. These utilize radioactive tracers to visualize, characterize and measure processes in the body. According to the WHO, by 2030, chronic disease prevalence is expected to rise by 57%. The high sensitivity of techniques like PET scans boosts its adoption for disease staging, monitoring treatment effectiveness and disease recurrence.
• Technological advancements in clinical imaging are anticipated to increase adoption of radioactive tracers. Ongoing developments to improve image quality, resolution and 3D reconstruction have enhanced the capability of diagnostic equipment using radioactive tracers. Vendors are focused on integrating imaging modalities and introducing multi-modal systems. For instance, the introduction of integrated PET-MRI systems enables superior imaging with the combination of anatomical and functional data. Furthermore, the development of novel diagnostic agents is expanding the applications of radioactive tracers.
• Growing geriatric population susceptible to chronic conditions is expected to drive the radioactive tracer market growth. According to UN population estimates, the global population aged 65 years or over is projected to grow from 727 million in 2020 to 1.5 billion in 2050. Aging is a significant risk factor for oncological, cardiac, neurological and other conditions. This is anticipated to boost usage of nuclear imaging tests and procedures using radioactive tracers for diagnosis and treatment monitoring.

• Investments to enhance production capacities and supply of radioisotopes are projected to favor radioactive tracer market expansion. Initiatives by governments and private players to increase isotope production and processing facilities to meet growing radiopharmaceutical demand offers opportunities for the market growth. For instance, in 2021, the U.S. Department of Energy (DOE) announced plans to invest US$ 45 million in building a technetium-99m production facility in North America by end of 2025. Such investments secure supplies improving tracer availability.

Global Radioactive Tracer Market- Opportunities

• Emerging applications in oncology such as theranostics provide significant growth opportunities. Targeted alpha therapy using alpha-emitting radioactive isotopes conjugated to tumor-specific molecules is an emerging therapeutic approach. Alpha emitters such as Actinium-225 have gained interest for the treatment of metastatic cancers. Advanced clinical trials assessing the efficacy of alpha-labeled radiopharmaceuticals will drive its adoption. Moreover, the use of matched diagnostic and therapeutic pairs allows personalized therapy.
• The growing focus on radioactive tracers for neurological applications presents future prospects. Beta-amyloid binding radiotracers have shown promise in detecting beta-amyloid plaque deposits in Alzheimer's disease. In 2020, U.S. FDA approved AVID Radiopharmaceutical's 18F flutemetamol injection to estimate beta-amyloid neuritic plaque density. Tau imaging tracers that bind to tau protein aggregates have potential for diagnosis of tauopathies. Investments in R&D will expand radiotracer applications in neurology.
• Increasing demand for radioisotopes from emerging countries offers lucrative opportunities. Growing investments in healthcare infrastructure, rising income levels and increasing prevalence of lifestyle diseases in developing nations is escalating usage of nuclear medicine diagnostics. Isotope suppliers are through new production facilities and distribution partnerships. Localizing production and enhancing supply chains will support tracer adoption.

• Advancements in radioactive tracer using alternative isotope production methods could enable market expansion. Accelerator technology shows promise as an alternative for producing radioisotopes as it offers advantages like reduced nuclear waste. Approaches using cyclotrons and linear accelerators are being explored for wider commercial applications. Further technological improvements and decline in accelerator prices will support decentralized tracer production.

Global Radioactive Tracer Market- Restraints

• Short half-life of radiopharmaceuticals: The short half-lives of commonly used radioisotopes used in radioactive tracers poses logistical challenges impacting clinical adoption. For instance, fluorine-18 used in FDG has a half-life of approximately 110 min, limiting its availability. Short half-lives necessitate specialized infrastructure for production and fast delivery to clinical sites. Centralized manufacturing leads to higher costs and reliability concerns. Decentralized supply chain models are still emerging.
• High costs associated with radioactive tracers: High costs related to radioactive tracers and. Radioisotope production in nuclear reactors and accelerators requires heavy capital investments. Compliance with strict regulatory standards for radiopharmaceutical manufacturing and handling also adds costs. Prices for single patient doses for many tracers range from US$ 1000-3000. Reimbursement restrictions can affect affordability.
• Stringent regulatory policies: Stringent regulatory policies for approval and manufacturing of radioactive tracers hampers rapid clinical translation of novel radiopharmaceuticals. Complex approval procedures due to safety and efficacy concerns deter investment. Adherence to cGMP, radiation safety guidelines and specialized facilities add time and expenses to development. Harmonization of global regulations will be needed to accelerate access.
• Limited reimbursements policies: Limited reimbursement for diagnostic radiotracers and emerging alpha/beta-emitting radiotherapies constrains the market penetration. Lack of reimbursement codes and coverage policies for novel PET tracers affects clinical adoption. Outpatient payment rules for therapeutic radiopharmaceuticals also limit revenue potential. Dialogue between stakeholders to align value demonstration with payer evidence needs is required to improve access.