Reports - Immunoassay Market
Immunoassay Market Size, Share & Trends Analysis Report by Product Type (Reagents & Kits, Analyzers/Instruments, Software & Services) by Specimen (Blood, Serum/Plasma, Saliva, Urine, Tissue Samples, Others) by Technology (Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay (RIA), Chemiluminescent Immunoassay (CLIA), Fluorescent Immunoassay (FIA), Rapid Tests (Lateral Flow Assays, Immunochromatographic Assays), Western Blot, Nephelometric and Turbidimetric Immunoassays, Electrochemiluminescence Immunoassay (ECLIA), Other Emerging Technologies) by Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, Others) by End Use (Hospitals & Clinics, Diagnostic Laboratories, Research & Academic Institutes, Pharmaceutical & Biotechnology Companies, Blood Banks & Organ Transplant Centers, Home Care Settings, Veterinary Clinics & Diagnostic Labs) by Region (North America, Europe, Asia Pacific, Latin America, Middle East and Africa) - Global Industry Assessment (2018 - 2023) & Forecast (2024 - 2032)
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USD 35.57 Billion
USD 60.5 Billion
4.95%
North America
Asia Pacific
2024
2021 - 2023
2025 - 2035
By Product Type, By Specimen, By Technology, By Application, By End Use, By Region
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The global Immunoassay Market is valued at USD 35.57 Billion in 2024 and is projected to reach a value of USD 60.5 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 4.95% between 2025 and 2035.
Growth in Biopharmaceuticals and Biotechnology Industries
The growth of the biopharmaceutical and biotechnology industries is a key driver of the Immunoassay market. For drive the development of innovative biologics, biosimilars, and personalized medicine, there is a growing need for extremely sensitive and specific immunoassays for drug discovery, development, and quality control. In biopharmaceutical research Immunoassays tools are used because they can detect biomarkers, assure treatment efficacy, and track immune responses. Furthermore, in clinical diagnostics increased usage of immunoassay for cancer diagnosis, infectious disease testing, and autoimmune condition identification, is boosting Immunoassay market growth. The increased investment in biotechnology R&D, together with regulatory support for biopharmaceutical innovation, is likely to boost immunoassay usage globally.
Increasing Demand For Point-Of-Care Testing And Personalized Medicine
Increasing the demand for point-of-care testing and personalized medicine is a key driver of a Immunoassay market. The healthcare shifts towards decentralized and personalized approaches, there is increasing interest in portable immunoassay devices that can deliver rapid results outside of traditional laboratory settings. Furthermore, advancements in multiplexing technologies allow for simultaneous detection of multiple analytes in a single sample, expanding the applications of immunoassays in disease diagnosis, drug development, and research.
Increasing Incidence of Chronic Diseases
The increasing incidence of chronic diseases such as cancer, cardiovascular disorders, and autoimmune diseases, along with the rising burden of infectious diseases like HIV, tuberculosis, hepatitis, and emerging viral infections (e.g., COVID-19, Zika, and influenza), is a significant driver of Immunoassay market. The growing demand for highly sensitive, rapid, and cost-effective diagnostic solutions is driving healthcare providers and research institutions to adopt advanced immunoassay technologies such as chemiluminescence immunoassays (CLIAs), enzyme-linked immunosorbent assays (ELISAs), and lateral flow assays (LFAs). Additionally, government initiatives and investments in disease surveillance programs, vaccination campaigns, and routine screening further enhance the adoption of immunoassay-based diagnostics worldwide.
The Product Type segment is divided into Reagents & Kits, Analyzers/Instruments, Software and Services. The Reagents & Kits segment is categorized into ELISA Reagents & Kits, Rapid test reagents & kits, ELISPOT Reagents & kits, Western blot Reagents & kits, Other Reagents & kits. The Reagents & kits segment held the dominant share in 2024, accounting for significant Immunoassay industry share of 67.60%.
Reagents & Kits: Reagents and kits form a crucial part of the Immunoassay market, enabling accurate and efficient detection of biomarkers for disease diagnosis and research applications. These include a variety of specialized test kits and chemical reagents designed for different immunoassay techniques.
Analyzers/Instruments: Immunoassay analyzers and instruments are essential laboratory equipment designed to automate, standardize, and enhance the accuracy of immunoassay testing. These systems improve workflow efficiency and reduce human errors, making them highly valuable in hospitals, diagnostic labs, and research facilities.
Software and Services: Software solutions play a critical role in data management, assay automation, and result interpretation in immunoassay testing. These tools enhance efficiency, accuracy, and regulatory compliance by integrating laboratory instruments with data analysis platforms and cloud-based storage. Furthermore, the services segment includes a wide range of offerings such as installation, maintenance, training, assay development, and contract research services. Many laboratories and healthcare providers rely on outsourced immunoassay services for complex testing and biomarker discovery.
The Technology segment is divided into Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay (RIA), Chemiluminescent Immunoassay (CLIA), Fluorescent Immunoassay (FIA), Rapid Tests (Lateral Flow Assays, Immunochromatographic Assays), Western Blot, Nephelometric and Turbidimetric Immunoassays, Electrochemiluminescence Immunoassay (ECLIA). The Enzyme-Linked Immunosorbent Assay (ELISA) segment is categorized into Direct ELISA, Indirect ELISA, Sandwich ELISA, Competitive ELISA. The Enzyme-Linked Immunosorbent Assay (ELISA) segment held the dominant share in 2024, accounting for significant Immunoassay industry share of 59.40%.
Enzyme-Linked Immunosorbent Assay (ELISA): ELISA is known for its high sensitivity and specificity, making it essential for clinical diagnostics, food safety, and biomedical research applications.
Radioimmunoassay (RIA): RIA is a highly sensitive technique that uses radioactive isotopes to quantify antigens or antibodies. It is extensively used in hormone assays, tumor marker detection, and pharmacokinetics research, but its use has declined due to radiation safety concerns.
Chemiluminescent Immunoassay (CLIA): CLIA employs light-emitting chemical reactions for signal detection, offering high sensitivity and automation. It is commonly used in infectious disease diagnostics, cancer screening, and endocrinology, providing faster and more accurate results than traditional ELISA.
Fluorescent Immunoassay (FIA): FIA uses fluorescent-labeled antibodies to detect target molecules, offering real-time and high-throughput testing. It is widely used in point-of-care (PoC) diagnostics, drug monitoring, and allergen detection, benefiting from improved sensitivity and multiplexing capabilities.
Rapid Tests (Lateral Flow Assays, Immunochromatographic Assays): Rapid immunoassays provide quick, point-of-care diagnostics through lateral flow and immunochromatographic techniques. They are extensively used for COVID-19, HIV, pregnancy, and drug abuse testing, offering convenient, low-cost, and immediate results.
Western Blot: Western blot is a protein detection technique combining gel electrophoresis and immunoassay. It is commonly used in HIV confirmatory testing, neurology research, and protein biomarker analysis, offering high specificity but requiring longer processing times.
Nephelometric and Turbidimetric Immunoassays: These assays measure antigen-antibody complexes based on light scattering properties. They are widely used in autoimmune disease diagnostics, kidney function testing, and protein quantification, offering rapid and automated analysis.
Electrochemiluminescence Immunoassay (ECLIA): ECLIA uses electrochemically activated luminescent reactions to detect biomarkers with ultra-high sensitivity. It is a preferred technology in cancer diagnostics, infectious disease testing, and cardiac biomarker analysis, benefiting from automation and multiplex testing capabilities.
The Specimen segment is divided into Blood, Serum/Plasma, Saliva, Urine, Tissue samples, and others. The blood segment held the dominant share in 2024, accounting for significant Immunoassay industry share.
The Application segment is divided into Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, Others. The Infectious disease testing segment held the dominant share in 2024, accounting for significant Immunoassay industry share of 36.98%.
In 2024, the North America captured 41.30% of the revenue share.
North America Immunoassay Market Trends
North America Immunoassay Market is driven by high healthcare expenditure, increasing prevalence of chronic diseases, and technological advancements. Moreover, the region has a well-established healthcare infrastructure and favorable reimbursement policies, which drive the market’s growth. For instance, in April 2024, Abbotts i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patients bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.
Asia Pacific Immunoassay Market Trends
Asia Pacific Immunoassay Market is driven by factors such as the rising prevalence of chronic diseases, increasing healthcare investments, and advancements in diagnostic technologies. The growth of the Asia Pacic Immunoassay market is also supported by improvements in healthcare access and the expansion of diagnostic services in urban and rural areas. Additionally, the region’s emphasis on enhancing healthcare quality and increasing the adoption of advanced diagnostic technologies contributes significantly to its projected market leadership.
Based on the provided market data, Vantage Market Research offers customizations in the reports to meet the specific needs of clients.
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The global Immunoassay market is highly competitive, characterized by the significant presence of many market players operating on a global and regional scale. Key players in this market focus on product innovations, strategic collaborations, mergers and acquisitions, and capacity expansions to sustain their market position. Major companies such as Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Thermo Fisher Scientific, bioMérieux, Beckman Coulter, and Ortho Clinical Diagnostics dominate the industry. These companies invest heavily in R&D to develop high-sensitivity, automated, and multiplex immunoassays for a wide range of applications, including infectious disease testing, oncology, and therapeutic drug monitoring.
The key players in the global Immunoassay market include - Danaher among others.
Bio-Rad launches external quality assurance services specialty immunoassay program
Roche announces collaboration with Lilly to enhance early diagnosis of Alzheimers disease
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North America
Europe
Asia Pacific
Latin America
The Middle-East and Africa
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