(MENAFN- GlobeNewsWire - Nasdaq) The United States Radioimmunoassay Market is projected to climb to US$ 310.82 billion by 2033 from US$ 213.71 billion in 2024, with a CAGR of 4.25% from 2025 to 2033. Growth is fueled by advancements in diagnostic technologies, chronic disease prevalence, and precise laboratory testing methods. RIAs, utilizing radiolabeled molecules, excel in sensitivity and specificity, becoming crucial in diagnosing hormonal and chronic disorders. Key states like California and Texas drive market growth, supported by robust healthcare infrastructure. Challenges include stringent regulatory frameworks and competition from non-radioactive alternatives. Recent innovations and increased automation strengthen industry capabilities and adoption.Dublin, Dec. 03, 2025 (GLOBE NEWSWIRE) -- The "United States Radioimmunoassay Market Report by Product, Application, End User, States and Company Analysis, 2025-2033" report has been added to ResearchAndMarkets's offering.
The United States Radioimmunoassay Market is expected to reach US$ 310.82 billion by 2033 from US$ 213.71 billion in 2024, with a CAGR of 4.25% from 2025 to 2033
The market is projected to expand steadily, driven by advancements in diagnostic technologies, growing prevalence of chronic diseases, and increasing adoption of precise and sensitive laboratory testing methods. California, Texas, New York, and Florida lead the U.S. market, supported by advanced healthcare infrastructure, research institutions, and biotechnology presence, driving demand for precise and reliable diagnostic testing technologies across clinical and research applications.
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RIA is now one of the primary methods of evaluation in a clinical laboratory for diagnostic purposes, such as determining the plasma concentrations of the majority of hormones, checking donated blood for the hepatitis B surface antigen (HBsAg), screening for certain drugs of abuse, and related tasks. Applications for RIAs include the treatment of peptic ulcer illness, the early detection of cancer, neurotransmitter research, the identification of infectious agent genera, the detection of allergens in dust and food, and many more.
The increased awareness of chronic diseases like cancer and thyroid disorders, which radioimmunoassay is frequently used to monitor, has helped the U.S. dominate the RIA market. Establishing these diagnostic techniques and continuing to develop in healthcare delivery is made relatively simple by a workforce that is technologically savvy and well-educated, as well as by the reliance on academic institutions for joint research. Because of innovation prompted by value provided and clinical-level requirements, the United States is still leading this business.
For instance, the U.S. Department of Energy's Isotope Program announced in February 2024 that the Oak Ridge National Laboratory (ORNL) was the first domestic supplier to start producing Iridium-192 (Ir-192), a significant and commonly used radioisotope in the industrial and medical fields. With the ultimate goal of reducing the U.S. dependency on foreign suppliers, regardless of the industry or sector, this will be the first Ir-192 produced domestically in almost 20 years. Diagnostic enterprises in the RIA sector can scale sensitive assay methods to assure consistent manufacturing of test kits and product R&D since they can reduce their dependency on foreign suppliers for isotopes.
Key Factors Driving the United States Radioimmunoassay Market Growth
Rising Prevalence of Chronic and Hormonal Disorders
The growing burden of chronic and hormonal disorders in the United States is a key driver of the radioimmunoassay market. Conditions such as thyroid dysfunction, diabetes, infertility, and endocrine abnormalities require accurate hormone level assessments, for which RIA offers high sensitivity and specificity. Healthcare providers rely on RIA for precise quantification of hormones and biomarkers that guide treatment planning.
The aging population and lifestyle-related diseases have amplified the need for early detection tools. As awareness of preventive healthcare increases, demand for reliable diagnostic testing continues to grow. RIA's ability to detect low analyte concentrations makes it indispensable in clinical endocrinology and metabolic research. With the expanding diagnostic network and focus on precision medicine, the use of radioimmunoassay for chronic disease management remains a major growth driver in the U.S. market.
Advancements in Laboratory Automation and Assay Design
Technological innovations in laboratory automation and assay development are significantly enhancing the performance of radioimmunoassay techniques. Automated platforms have reduced manual errors, improved throughput, and shortened turnaround times, making RIA more efficient for large-scale clinical testing. Modern assay kits now feature enhanced binding efficiency, reduced radioactive exposure, and greater reproducibility. Innovations in radiolabeling, data management, and safety protocols have increased laboratory adoption, particularly in research and hospital settings.
Furthermore, improved calibration standards and digital data integration support consistent test accuracy. These advancements allow laboratories to handle diverse analyte panels across clinical chemistry, endocrinology, and pharmaceutical research. As laboratories focus on automation and quality assurance, RIA continues to play an integral role in delivering accurate diagnostic insights, thereby contributing to the U.S. market's technological evolution.
Expanding Research Applications and Pharmaceutical Development
Radioimmunoassay plays a critical role in clinical and pharmaceutical research due to its precision in detecting trace molecules. In drug discovery and pharmacokinetic studies, RIA helps evaluate compound efficacy, metabolism, and safety profiles. Research institutions and biopharmaceutical companies rely on RIA for hormone assays, receptor binding studies, and biomarker validation. The increasing collaboration between academia and industry has accelerated the adoption of RIA across diverse applications.
Moreover, funding initiatives supporting biomedical research are boosting demand for validated analytical techniques. RIA's long-standing credibility and accuracy make it a preferred method for standardizing laboratory results and ensuring data reliability. As the U.S. research ecosystem continues to expand, the use of radioimmunoassay in clinical trials, diagnostic test development, and regulatory submissions is expected to rise, reinforcing its market importance.
Challenges in the United States Radioimmunoassay Market
Stringent Regulatory Framework and Safety Concerns
The handling, storage, and disposal of radioactive materials used in radioimmunoassay pose significant regulatory and safety challenges. Laboratories are required to comply with strict federal and state-level guidelines to ensure radiation safety and environmental protection. These compliance requirements often increase operational complexity and costs. Facilities must invest in trained personnel, secure infrastructure, and proper waste management systems, creating barriers for smaller laboratories.
Additionally, increasing regulatory scrutiny on radioactive substances limits flexibility in assay development and usage. Concerns over radiation exposure and safety protocols also discourage adoption in certain clinical settings. Although improved radiolabeling techniques and automation have mitigated some risks, compliance burdens remain a major restraint. Simplifying regulations and advancing non-hazardous assay alternatives could help address these concerns and support broader RIA adoption in the U.S. market.
Competition from Non-Radioactive Immunoassay Alternatives
The growing adoption of non-radioactive immunoassay methods such as ELISA and CLIA poses a significant challenge to the radioimmunoassay market. These alternatives offer comparable accuracy, reduced safety risks, and easier regulatory compliance, making them more appealing to modern laboratories. Additionally, ELISA and CLIA require simpler infrastructure and less hazardous waste management, lowering operational costs. As technological advancements enhance the sensitivity of non-radioactive assays, many laboratories are transitioning toward these options.
This shift is further supported by manufacturers focusing on automation-friendly and high-throughput formats. Despite RIA's superior precision in certain applications, the convenience, safety, and efficiency of newer immunoassay technologies continue to pressure its market share. Sustaining RIA's relevance will require continuous innovation, improved assay safety, and cost-effective solutions tailored to specialized diagnostic and research needs.
Recent Developments in U.S. Radioimmunoassay Market
The automated chemiluminescence immunoassay (ChLIA) test developed by Euroimmun for the direct quantitative determination of free testosterone levels in serum or plasma received 510(k) clearance from the U.S. Food and Drug Administration in January 2025. This is the first assay of its kind to receive FDA approval. It uses iSYS or i10 platforms to provide fast results in 48 minutes, greatly increasing the speed and accuracy of diagnosis for hormonal disorders like PCOS and hypogonadism.
Company Analysis: Overview, Key Persons, Recent Developments, SWOT Analysis, Revenue Analysis
Danaher (Beckman Coulter, Inc.) Berthold Technologies GmbH & Co. KG DIAsource ImmunoAssays SA BioCheck, Inc. (DRG International Inc.) IBL International Merck KGaA Abbexa Institute of Isotopes Co. Ltd. Marin Biologic Laboratories, Inc. Demeditec Diagnostics GmbH
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