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    Chemiluminescence Immunoassay Market

    ID: MRFR/HC/41705-HCR
    200 Pages
    Rahul Gotadki
    October 2025

    Chemiluminescence Immunoassay (CLIA) Market Research Report By Test Type (Infectious Disease Testing, Endocrine Testing, Oncology Testing, Cardiovascular Testing), By Product Type (Analyzers, Kits, Reagents), By Application (Laboratory Diagnostics, Point of Care Testing, Research), By End User (Hospitals, Diagnostic Laboratories, Research Institutions) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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    Chemiluminescence Immunoassay Market Infographic
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    Chemiluminescence Immunoassay Market Summary

    The Global Chemiluminescence Immunoassay (CLIA) Market is projected to grow from 6.25 USD Billion in 2024 to 10.7 USD Billion by 2035.

    Key Market Trends & Highlights

    Chemiluminescence Immunoassay (CLIA) Key Trends and Highlights

    • The market is expected to achieve a compound annual growth rate (CAGR) of 5.01% from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 10.7 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 6.25 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of chemiluminescence immunoassays due to their high sensitivity and specificity is a major market driver.

    Market Size & Forecast

    2024 Market Size 6.25 (USD Billion)
    2035 Market Size 10.7 (USD Billion)
    CAGR (2025-2035) 5.01%

    Major Players

    Ortho Clinical Diagnostics, Danaher Corporation, Abbott Laboratories, Abcam, Merck Group, Diagnostic Systems Laboratories, PerkinElmer, Siemens Healthineers, Thermo Fisher Scientific, Roche Diagnostics, BioRad Laboratories, Biosource Europe S.A., Beckman Coulter, Genetic Technologies, Hoffmann la Roche

    Chemiluminescence Immunoassay Market Trends

    Due to a number of key factors, the chemiluminescence immunoassay (CLIA) market is expanding significantly. The use of Chemiluminescence Immunoassay (CLIA) technology in healthcare settings is driven by the rising incidence of chronic kidney disease and the increased need for quick diagnostic testing. These assays' increased sensitivity and accuracy over conventional techniques also add to their appeal.

    The efficiency of Chemiluminescence Immunoassay (CLIA) tests is also being increased by technological developments and the incorporation of automation into laboratory procedures, which is propelling market growth. The Chemiluminescence Immunoassay (CLIA) industry is full of opportunities, especially for the creation of innovative assays for personalized medicine and newly developing diseases.

    As healthcare systems around the world prioritize preventive care, there is a growing need for point-of-care testing solutions that can provide quick results. Companies can explore partnerships with healthcare providers and research institutions to develop innovative testing solutions that cater to specific health concerns.

    Moreover, the growing trend of home healthcare and self-testing kits presents a unique opportunity for market players to expand their offerings and reach a wider audience. Recent trends in the Chemiluminescence Immunoassay (CLIA) market include the rise of multifunctional analyzers that can perform multiple tests simultaneously, improving convenience for laboratories.

    There is also a notable shift towards digital health solutions, where data management and analysis are integrated into testing systems. The focus on regulatory compliance and quality assurance is becoming more pronounced, ensuring that products meet stringent safety and effectiveness standards.

    As the market continues to evolve, stakeholders must remain adaptable and responsive to these shifts to fully leverage the potential of chemiluminescence immunoassays in the diagnostic landscape.

     

    The rising prevalence of chronic diseases and the increasing demand for rapid diagnostic tests are driving the expansion of the Chemiluminescence Immunoassay market, which appears poised for substantial growth in the coming years.

    U.S. Food and Drug Administration (FDA)

    Chemiluminescence Immunoassay Market Drivers

    Market Growth Projections

    The Global Chemiluminescence Immunoassay (CLIA) Market Industry is projected to experience substantial growth over the next decade. In 2024, the market is estimated at 6.25 USD Billion, with expectations to reach 10.7 USD Billion by 2035. This growth trajectory indicates a robust demand for CLIA technologies, driven by various factors including technological advancements, increasing healthcare investments, and a focus on personalized medicine. The anticipated CAGR of 5.01% from 2025 to 2035 further underscores the market's potential, suggesting a favorable environment for stakeholders within the industry.

    Rising Demand for Diagnostic Testing

    The Global Chemiluminescence Immunoassay (CLIA) Market Industry experiences a notable surge in demand for diagnostic testing, driven by the increasing prevalence of chronic diseases and infectious conditions. As healthcare systems globally prioritize early detection and preventive care, the adoption of CLIA technologies becomes more pronounced. In 2024, the market is projected to reach 6.25 USD Billion, reflecting a growing reliance on these assays for accurate and rapid results. This trend is expected to continue, with the market anticipated to expand significantly by 2035, potentially reaching 10.7 USD Billion, indicating a robust growth trajectory.

    Growing Focus on Personalized Medicine

    The shift towards personalized medicine significantly influences the Global Chemiluminescence Immunoassay (CLIA) Market Industry. As healthcare moves away from a one-size-fits-all approach, the need for tailored diagnostic solutions becomes increasingly apparent. CLIA technologies facilitate the identification of specific biomarkers, enabling healthcare professionals to make informed decisions regarding treatment plans. This trend aligns with the broader movement towards precision health, where diagnostics play a crucial role in patient management. The market's growth trajectory suggests a strong alignment with these evolving healthcare paradigms, potentially reaching 10.7 USD Billion by 2035.

    Technological Advancements in Assay Development

    Technological innovations play a pivotal role in shaping the Global Chemiluminescence Immunoassay (CLIA) Market Industry. The development of more sensitive and specific assays enhances the accuracy of diagnostic results, thereby improving patient outcomes. Advancements in automation and miniaturization of testing platforms facilitate higher throughput and efficiency in laboratories. These innovations not only streamline workflows but also reduce operational costs, making CLIA technologies more accessible. As a result, the market is likely to witness a compound annual growth rate (CAGR) of 5.01% from 2025 to 2035, underscoring the impact of technology on market expansion.

    Increasing Investment in Healthcare Infrastructure

    The Global Chemiluminescence Immunoassay (CLIA) Market Industry benefits from rising investments in healthcare infrastructure across various regions. Governments and private entities are channeling funds into enhancing laboratory capabilities and expanding diagnostic services. This investment is particularly evident in emerging economies, where the demand for advanced diagnostic solutions is growing. Improved infrastructure not only supports the implementation of CLIA technologies but also fosters collaboration between research institutions and healthcare providers. As a result, the market is poised for growth, with projections indicating a potential market size of 10.7 USD Billion by 2035.

    Regulatory Support for Advanced Diagnostic Solutions

    Regulatory bodies worldwide are increasingly supportive of advanced diagnostic solutions, which positively impacts the Global Chemiluminescence Immunoassay (CLIA) Market Industry. Streamlined approval processes and guidelines for the use of CLIA technologies encourage manufacturers to innovate and bring new products to market. This regulatory environment fosters competition and drives advancements in assay development, ultimately benefiting healthcare providers and patients alike. As the market evolves, the supportive regulatory landscape is expected to contribute to a CAGR of 5.01% from 2025 to 2035, reflecting the dynamic nature of the industry.

    Market Segment Insights

    Chemiluminescence Immunoassay (CLIA) Market Test Type Insights

    The Chemiluminescence Immunoassay (CLIA) Market, a crucial segment of the broader diagnostics industry, experienced significant growth and transformation through its Test Type segment.

    Within this framework, various testing categories were essential for understanding disease diagnostics and monitoring health conditions, highlighting the Chemiluminescence Immunoassay (CLIA) Market revenue's vital components.

    The Infectious Disease Testing segment was a major contributor, valued at 2.0 USD Billion in 2024, escalating to 3.5 USD Billion by 2035. This dominance stemmed from the increasing prevalence of infectious diseases globally, which necessitates timely and accurate diagnostic solutions to curb outbreaks and manage treatment effectively.

    Chemiluminescence Immunoassay (CLIA) Market Product Type Insights

    The segmentation of this market into Product Types reveals notable categories such as Analyzers, Kits, and Reagents, each playing a crucial role in the landscape. Analyzers are pivotal due to their ability to provide swift and accurate results, making them a core asset in laboratories and healthcare facilities.

    Kits are significantly popular as they facilitate ease of use and maximized efficiency, catering to a vast number of tests. Reagents, on the other hand, dominate the market as a fundamental component in conducting immunoassays, further driving the need for consistent supplies and innovations in high-quality chemical agents.

    As the Chemiluminescence Immunoassay (CLIA) Market continues to grow, these Product Type segments will exhibit distinct characteristics and trends, supported by substantial market growth and advancements in technology.

    Chemiluminescence Immunoassay (CLIA) Market Application Insights

    The Chemiluminescence Immunoassay (CLIA) Market is expected to experience substantial growth driven by various applications in the coming years.

    Within this landscape, Laboratory Diagnostics plays a crucial role, primarily due to its widespread use in clinical testing for various health conditions, making it a key area of focus. Point-of-care testing is also significant in the market, as it facilitates rapid diagnostics at the patient's location, enhancing efficiency and timely decision-making in medical scenarios.

    Additionally, Research applications are vital, contributing to advancements in biochemical research and the development of new assays, thus fostering innovation and improvement in testing accuracy.

    Chemiluminescence Immunoassay (CLIA) Market End User Insights

    The market is categorized by End Users, primarily comprising hospitals, diagnostic laboratories, and research institutions. Hospitals are essential players, as they conduct a high volume of tests, driving the demand for efficient and accurate immunoassay solutions. Diagnostic laboratories represent another significant segment, focusing on specialized testing and enhanced turnaround times for patient results.

    Research institutions are vital for the advancement of testing technologies and methodologies, contributing to innovation in the Chemiluminescence Immunoassay (CLIA) market. The increasing prevalence of chronic diseases and a rising geriatric population are key growth drivers, while the necessity for improved diagnostic accuracy and efficiency in healthcare systems further fuels market expansion.

    Nonetheless, challenges such as costly testing equipment and the need for skilled professionals may impede broader adoption in certain regions. Overall, the segmentation of the Chemiluminescence Immunoassay (CLIA) Market identifies specific needs that propel the overall industry forward, promoting significant advancements in diagnostic capabilities across diverse healthcare environments.

    Get more detailed insights about Chemiluminescence Immunoassay Market

    Regional Insights

    The Chemiluminescence Immunoassay (CLIA) Market revealed a well-distributed regional landscape, with varying levels of market valuation across different areas. North America emerged as a significant player, valued at 2.5 USD Billion in 2024 and projected to rise to 4.3 USD Billion by 2035, illustrating its majority holding in the market.

    Europe followed with notable strength, valued at 1.8 USD Billion in 2024, and expected to grow to 3.1 USD Billion by 2035, indicating the region’s strong healthcare infrastructure and investment in diagnostic technologies.

    The APAC region was valued at 1.5 USD Billion in 2024, and its growth to 2.7 USD Billion by 2035 showcases increasing healthcare accessibility and advancements in clinical laboratories, making it a region of significant potential.

    South America and the MEA regions, though smaller with valuations of 0.25 USD Billion and 0.2 USD Billion respectively in 2024, exhibited growth potential, doubling to 0.5 USD Billion and 0.4 USD Billion by 2035, highlighting emerging market opportunities.

    Overall, the insights into the Chemiluminescence Immunoassay (CLIA) Market segmentation reflected a diverse and dynamic landscape driven by advancements in technology and healthcare demands across different regions.

    Chemiluminescence Immunoassay (CLIA) Market Regional

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    The Chemiluminescence Immunoassay (CLIA) Market is characterized by rapid advancements and intense competition among key players vying for dominance. The market's competitiveness stems from factors such as innovation in assay technology, the increasing prevalence of chronic diseases, and a growing demand for faster and more accurate diagnostic solutions.

    Companies operating in this space invest heavily in research and development to enhance the efficiency of Chemiluminescence Immunoassay (CLIA) platforms. Moreover, strategic partnerships, mergers, and acquisitions are common practices as organizations aim to expand their market reach and improve their product portfolios.

    The competitive landscape is further shaped by regulatory considerations and the need to comply with stringent quality standards. Overall, the market presents a dynamic environment driven by technological advancements and the continuous pursuit of improved healthcare outcomes.

    Ortho Clinical Diagnostics holds a notable position within the Chemiluminescence Immunoassay (CLIA) Market, showcasing robust strengths that contribute to its competitive advantage. The company's commitment to innovation is reflected in its extensive product line aimed at a variety of diagnostic applications, which promotes a broad customer base.

    With a focus on high-quality standards and reliability, Ortho Clinical Diagnostics is recognized for its comprehensive menu of tests that cater to clinical laboratories and health institutions seeking efficient and accurate diagnostic solutions.

    Additionally, the company's strong emphasis on customer support and service ensures that its clients receive the necessary assistance in utilizing their products effectively. This blend of innovative technology, reliability, and dedicated customer service positions Ortho Clinical Diagnostics favorably within the competitive landscape of the Chemiluminescence Immunoassay (CLIA) market.

    Danaher Corporation also plays a significant role in the Chemiluminescence Immunoassay (CLIA) Market, leveraging its extensive experience in the diagnostics sector. The company is known for its cutting-edge Bioprocess Technology and innovative approach to assay development, which enhances the accuracy and performance of its Chemiluminescence Immunoassay (CLIA) platforms.

    With a strong portfolio that includes a diverse range of diagnostic instruments and reagents, Danaher Corporation is well-equipped to cater to the growing requirements of clinical laboratories worldwide. The company's reach and solid distribution network further reinforce its presence in the market, enabling it to meet the demands of various healthcare providers efficiently.

    Danaher Corporation's ongoing commitment to research and development ensures that it remains at the forefront of innovation, continually introducing new products and solutions that address the evolving needs of the chemiluminescence immunoassay segment.

    Key Companies in the Chemiluminescence Immunoassay Market market include

    Industry Developments

    • Q2 2024: Siemens Healthineers Launches Atellica CI Analyzer for Chemiluminescence Immunoassays Siemens Healthineers announced the commercial launch of its Atellica CI Analyzer, a new chemiluminescence immunoassay system designed for mid-volume laboratories, expanding its Atellica portfolio and aiming to improve workflow efficiency and diagnostic accuracy.
    • Q2 2024: BioMérieux Receives CE Mark for VIDAS KUBE Chemiluminescence Immunoassay Platform BioMérieux announced that its VIDAS KUBE, a next-generation chemiluminescence immunoassay platform, received CE marking, allowing commercialization in the European Union and supporting the company's expansion in automated diagnostics.
    • Q3 2024: Abbott Launches New Chemiluminescent SARS-CoV-2 Antigen Test in Europe Abbott announced the launch of a new chemiluminescent immunoassay-based SARS-CoV-2 antigen test for use on its ARCHITECT and Alinity i platforms, expanding its COVID-19 diagnostics portfolio in the European market.
    • Q3 2024: Roche Receives FDA Clearance for Elecsys Anti-Müllerian Hormone Plus Immunoassay Roche announced that the U.S. FDA cleared its Elecsys Anti-Müllerian Hormone Plus chemiluminescence immunoassay, enabling broader use in fertility testing and reproductive health diagnostics in the United States.
    • Q4 2024: Mindray Opens New Chemiluminescence Immunoassay Manufacturing Facility in Singapore Mindray, a leading medical device manufacturer, inaugurated a new production facility in Singapore dedicated to chemiluminescence immunoassay analyzers, aiming to strengthen its supply chain and meet growing global demand.
    • Q1 2025: Thermo Fisher Scientific Acquires ImmunoTech Diagnostics to Expand Chemiluminescence Immunoassay Portfolio Thermo Fisher Scientific completed the acquisition of ImmunoTech Diagnostics, a company specializing in chemiluminescence immunoassay reagents and systems, to enhance its offerings in clinical diagnostics.
    • Q1 2025: Beckman Coulter Launches Access SARS-CoV-2 IgG II Chemiluminescent Immunoassay in Japan Beckman Coulter announced the launch of its Access SARS-CoV-2 IgG II chemiluminescent immunoassay in Japan, following regulatory approval, to support COVID-19 antibody testing in clinical laboratories.
    • Q2 2025: Siemens Healthineers and Sysmex Announce Strategic Partnership for Chemiluminescence Immunoassay Development Siemens Healthineers and Sysmex Corporation entered a strategic partnership to co-develop next-generation chemiluminescence immunoassay platforms, aiming to accelerate innovation and expand their global diagnostics footprint.
    • Q2 2025: FDA Approves DiaSorin LIAISON XL Meningitis/Encephalitis Chemiluminescence Immunoassay Panel The U.S. FDA approved DiaSorin's LIAISON XL Meningitis/Encephalitis Panel, a multiplex chemiluminescence immunoassay, for use in clinical laboratories to aid in the rapid diagnosis of central nervous system infections.
    • Q2 2025: QuidelOrtho Secures $100 Million Contract for Chemiluminescence Immunoassay Systems with Major U.S. Hospital Network QuidelOrtho announced it has secured a $100 million multi-year contract to supply chemiluminescence immunoassay analyzers and reagents to a leading U.S. hospital network, strengthening its position in the clinical diagnostics market.

    Future Outlook

    Chemiluminescence Immunoassay Market Future Outlook

    The Chemiluminescence Immunoassay (CLIA) Market is projected to grow at a 5.01% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for diagnostics, and rising healthcare expenditures.

    New opportunities lie in:

    • Developing point-of-care CLIA devices for rapid diagnostics. Expanding CLIA applications in personalized medicine and oncology. Leveraging AI for data analysis in CLIA testing processes.

    By 2035, the CLIA market is expected to achieve substantial growth, reflecting its critical role in global healthcare.

    Market Segmentation

    Chemiluminescence Immunoassay (CLIA) Market End User Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Research Institutions

    Chemiluminescence Immunoassay (CLIA) Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Chemiluminescence Immunoassay (CLIA) Market Test Type Outlook

    • Infectious Disease Testing
    • Endocrine Testing
    • Oncology Testing
    • Cardiovascular Testing

    Chemiluminescence Immunoassay (CLIA) Market Application Outlook

    • Laboratory Diagnostics
    • Point of Care Testing
    • Research

    Chemiluminescence Immunoassay (CLIA) Market Product Type Outlook

    • Analyzers
    • Kits
    • Reagents

    Report Scope

    Report Attribute/MetricDetails
    Market Size 20235.96(USD Billion)
    Market Size 20246.25(USD Billion)
    Market Size 203510.7(USD Billion)
    Compound Annual Growth Rate (CAGR)5.0% (2025 - 2035)
    Report CoverageRevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2023
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledOrtho Clinical Diagnostics, Danaher Corporation, Abbott Laboratories, Abcam, Merck Group, Diagnostic Systems Laboratories, PerkinElmer, Siemens Healthineers, Thermo Fisher Scientific, Roche Diagnostics, BioRad Laboratories, Biosource Europe S.A., Beckman Coulter, Genetic Technologies, HoffmannLa Roche
    Segments CoveredTest Type, Product Type, Application, End User, Regional
    Key Market OpportunitiesRising demand for early disease diagnosis, Technological advancements in assay development, Expanding applications in personalized medicine, Increasing healthcare expenditure globally, and Growth in research and development activities.
    Key Market DynamicsTechnological advancements, Rising prevalence of diseases, Increasing demand for rapid diagnostics, Government initiatives for healthcare improvement, Growth in research and development activities
    Countries CoveredNorth America, Europe, APAC, South America, MEA

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    FAQs

    What is the expected market size of the Global Chemiluminescence Immunoassay CLIA Market in 2024?

    The Global Chemiluminescence Immunoassay CLIA Market is expected to be valued at 6.25 billion USD in 2024.

    What is the projected market size of the Global Chemiluminescence Immunoassay CLIA Market by 2035?

    The market is projected to reach a value of 10.7 billion USD by 2035.

    What is the expected CAGR for the Global Chemiluminescence Immunoassay CLIA Market from 2025 to 2035?

    The expected CAGR for the market from 2025 to 2035 is 5.0%.

    Which region holds the largest market share in the Global Chemiluminescence Immunoassay CLIA Market in 2024?

    North America holds the largest market share, valued at 2.5 billion USD in 2024.

    What will be the market value of the Global Chemiluminescence Immunoassay CLIA Market in Europe by 2035?

    The market value in Europe is expected to reach 3.1 billion USD by 2035.

    What is the expected market size for Infectious Disease Testing in the Global Chemiluminescence Immunoassay CLIA Market in 2024?

    Infectious Disease Testing is expected to be valued at 2.0 billion USD in 2024.

    Which companies are considered key players in the Global Chemiluminescence Immunoassay CLIA Market?

    Key players include Ortho Clinical Diagnostics, Danaher Corporation, Abbott Laboratories, and Roche Diagnostics, among others.

    What is the market value for Oncology Testing in the Global Chemiluminescence Immunoassay CLIA Market in 2035?

    Oncology Testing is projected to reach a market value of 3.0 billion USD by 2035.

    What is the expected market growth for the APAC region in the Global Chemiluminescence Immunoassay CLIA Market from 2024 to 2035?

    The APAC region is expected to grow from 1.5 billion USD in 2024 to 2.7 billion USD in 2035.

    What are the key applications driving growth in the Global Chemiluminescence Immunoassay CLIA Market?

    Key applications include Infectious Disease Testing, Endocrine Testing, Oncology Testing, and Cardiovascular Testing.

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