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    Chemiluminescence Immunoassay Analyzers Market

    ID: MRFR/HC/7311-CR
    78 Pages
    Rahul Gotadki
    February 2020

    Chemiluminescence Immunoassay (CLIA) Analyzers Market Research Report Information By Type (High Throughput, Medium Throughput, and Low Throughput), By Product (Reagents, Analyzer, and Consumables), By Application (Oncology & Endocrinology, Hepatitis and Retroviruses, Cardiac Markers, Infectious Disease, Bone and Mineral Disorders, Auto-Immune Diseases, Allergy, GI Stool Testing, Drug Discovery and Development), By End User (Hospitals & Clinics, Medical & Diagnostic Laboratories, and Pharmaceutical Companies) And By Region (North ...

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    Chemiluminescence Immunoassay Analyzers Market Summary

    As per Market Research Future Analysis, the Chemiluminescence Immunoassay (CLIA) Analyzers Market was valued at USD 13.60 billion in 2024 and is projected to reach USD 28.98 billion by 2035, growing at a CAGR of 7.12% from 2025 to 2035. The market is driven by the rising prevalence of chronic diseases and the increasing demand for point-of-care testing, which enhances the adoption of advanced CLIA analyzers that provide rapid and accurate results.

    Key Market Trends & Highlights

    Key trends driving the Chemiluminescence Immunoassay (CLIA) Analyzers market include advancements in technology and increasing healthcare investments.

    • High throughput CLIA analyzers are expected to dominate the market, with significant growth anticipated during the forecast period.
    • The reagent segment is projected to be the fastest-growing segment, driven by the essential role of reagents in analyzers.
    • North America accounted for USD 2.51 billion in 2022, being the largest market due to established healthcare infrastructure.
    • The Asia-Pacific region is expected to grow at the fastest CAGR, fueled by rising healthcare expenditure and awareness about early disease diagnosis.

    Market Size & Forecast

    2024 Market Size USD 13.60 Billion
    2035 Market Size USD 28.98 Billion
    CAGR (2025-2035) 7.12%

    Major Players

    Major players in the market include Abbott, Hoffmann-La Roche Ltd, Siemens Healthcare GmbH, Danaher, DiaSorin S.p.A., and Ortho Clinical Diagnostics.

    Chemiluminescence Immunoassay Analyzers Market Trends

    Rising prevalence of chronic diseases to boost market growth

    The increasing incidence of chronic diseases such as cancer, cardiovascular diseases, and infectious diseases is driving the demand for CLIA analyzers. These analyzers help in the accurate diagnosis and monitoring of these diseases, which is essential for effective treatment. The development of advanced CLIA analyzers that offer faster and more accurate results is driving their adoption. These analyzers also offer features such as automation, high throughput, and connectivity, which enhance their usability and efficiency.

    Increasing demand for point-of-care testing The growing demand for point-of-care testing is also driving the growth of the CLIA analyzers market. CLIA analyzers are widely used in point-of-care testing as they offer rapid and accurate results, which is crucial in emergency situations. Governments around the world are investing heavily in healthcare infrastructure and research and development activities, which is boosting the growth of the CLIA analyzers market. 

    Additionally, favorable reimbursement policies are also encouraging the adoption of CLIA analyzers. The aging population is more susceptible to chronic diseases, which is driving the demand for CLIA analyzers. These analyzers are essential in the early diagnosis and management of these diseases, which is crucial for improving patient outcomes.

    The increasing prevalence of chronic diseases and the growing demand for rapid diagnostic tests are driving advancements in chemiluminescence immunoassay technologies, which are poised to enhance diagnostic accuracy and efficiency in clinical laboratories.

    U.S. Food and Drug Administration (FDA)

    Chemiluminescence Immunoassay Analyzers Market Drivers

    Rising Demand for Diagnostic Testing

    The Global Chemiluminescence Immunoassay (CLIA) Analyzers Market Industry experiences a surge in demand for diagnostic testing, driven by the increasing prevalence of chronic diseases and the need for early detection. As healthcare systems globally prioritize preventive care, the adoption of CLIA analyzers is likely to rise. In 2024, the market is projected to reach 13.6 USD Billion, reflecting a growing reliance on accurate and efficient diagnostic tools. This trend is expected to continue, with the market anticipated to expand significantly, potentially reaching 29.2 USD Billion by 2035, indicating a robust growth trajectory.

    Market Segment Insights

    Chemiluminescence Immunoassay (CLIA) Analyzers Type Insights

    The Chemiluminescence Immunoassay (CLIA) Analyzers market segmentation, based on type, includes High Throughput, Medium Throughput, and Low Throughput. The high throughput segment dominated the market in 2022 and is projected to be the faster-growing segment during the forecast period, 2025-2035. High Throughput CLIA analyzers are capable of analyzing a large number of samples in a short period of time, making them an essential tool for clinical laboratories. 

    One company that has developed a high throughput CLIA analyzer is Abbott Laboratories. Abbott's Architect i2000SR is a fully automated analyzer that can process up to 200 tests per hour. It offers a wide range of assays for infectious diseases, cardiac markers, thyroid function, and more.

    Chemiluminescence Immunoassay (CLIA) Analyzers Product Insights

    The Chemiluminescence Immunoassay (CLIA) Analyzers market data has been bifurcated by product into Reagents, Analyzer, and Consumables. The reagent segment dominated the market in 2022 and is projected to be the faster-growing segment during the forecast period, 2025-2035. Reagents are an essential component of CLIA analyzers, as they enable the detection and quantification of analytes in biological samples. 

    One company that has developed a wide range of reagents for CLIA analyzers is Roche Diagnostics. Roche also offers innovative assays, such as its Elecsys SARS-CoV-2 antigen test, which enables rapid detection of COVID-19. With its extensive range of reagents, Roche is a leading player in the CLIA analyzer market. 

    Figure 2 Chemiluminescence Immunoassay (CLIA) Analyzers Market, by Product, 2022 & 2032 (USD Billion)

    Get more detailed insights about Chemiluminescence Immunoassay (CLIA) Analyzers Market Research Report - Forecast till 2032

    Regional Insights

    By Region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. North America Chemiluminescence Immunoassay (CLIA) Analyzers market accounted for USD 2.51 billion in 2022 and is expected to exhibit a significant CAGR growth during the study period. North America is the largest market for CLIA analyzers due to the presence of a well-established healthcare infrastructure, increasing geriatric population, and favorable reimbursement policies. The US and Canada are the major contributors to the growth of the market in this region. 

    Further, the US Chemiluminescence Immunoassay (CLIA) Analyzers market held the largest market share, and the Canada Chemiluminescence Immunoassay (CLIA) Analyzers market was the fastest growing market in the North American region.

    Further, the major countries studied in the market report are The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

    Figure 3 Chemiluminescence Immunoassay (CLIA) Analyzers Market Share by Region 2022 (%)

    Chemiluminescence Immunoassay (CLIA) Analyzers Market Share by Region 2022 (%)

    Source Secondary Research, Primary Research, MRFR Database and Analyst Review

    Europe Chemiluminescence Immunoassay (CLIA) Analyzers market accounts for the second-largest market share. Europe is the second-largest market for CLIA analyzers due to the increasing prevalence of chronic diseases, rising demand for point-of-care testing, and increasing healthcare spending. The UK, Germany, and France are the major contributors to the growth of the market in this region.

    The Asia-Pacific Chemiluminescence Immunoassay (CLIA) Analyzers market is expected to grow at the fastest CAGR from 2022 to 2030. Due to the increasing awareness about early disease diagnosis, rising healthcare expenditure, and increasing demand for advanced medical technologies. China, India, and Japan are the major contributors to the growth of the market in this region. Moreover, China Chemiluminescence Immunoassay (CLIA) Analyzers market held the largest market share, and the India Chemiluminescence Immunoassay (CLIA) Analyzers market was the fastest growing market in the Asia-Pacific region.

    Key Players and Competitive Insights

    Major market players are spending a lot of money on R&D to increase their product lines, which will help the Chemiluminescence Immunoassay (CLIA) Analyzers market grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the Chemiluminescence Immunoassay (CLIA) Analyzers industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

    One of the primary business strategies adopted by manufacturers in the Chemiluminescence Immunoassay (CLIA) Analyzers industry to benefit clients and expand the market sector is to manufacture locally to reduce operating costs. In recent years, Chemiluminescence Immunoassay (CLIA) Analyzers industry has provided innovative products with some of the most significant benefits. 

    The Chemiluminescence Immunoassay (CLIA) Analyzers market major player such as Abbott, Hoffmann-La Roche Ltd, Siemens Healthcare GmbH (Siemens AG), Danaher (Beckman Coulter Inc.), DiaSorin S.p.A., Ortho Clinical Diagnostics (Part of Carlyle Group), Shenzhen New Industries Biomedical Engineering Co.Ltd., Sysmex Corporation, Randox Laboratories Ltd., Tosoh Corporation, and others are working to expand the market demand by investing in research and development activities.

    Abbott Laboratories is a healthcare company that develops and manufactures a wide range of products, including diagnostic tests, medical devices, and nutritional products. The company is a leading player in the CLIA analyzer market, offering a range of high throughput analyzers and assays for infectious diseases, oncology, cardiac markers, and more. 

    In recent news related to CLIA analyzers, Abbott announced in November 2021 that its Architect i1000SR and i2000SR analyzers received CE Mark approval for a new quantitative test for the detection of antibodies to the SARS-CoV-2 virus, the causative agent of COVID-19. The test, called SARS-CoV-2 IgG Quant II, is designed to measure the level of antibodies present in a patient's blood, which can help in assessing their immune response to the virus. 

    The test is highly sensitive and specific, and has a broad dynamic range, allowing for accurate detection and quantification of antibodies in both vaccinated and unvaccinated individuals. The approval of this test is significant, as it can help in monitoring the immune response to COVID-19 vaccines and in identifying individuals who may require booster doses.

    Siemens Healthineers is a medical technology company that offers a range of products and services, including diagnostic imaging and laboratory diagnostics. The company is also a leading player in the CLIA analyzer market, offering a range of high-performance systems and assays. In recent news related to CLIA analyzers, Siemens Healthineers announced in December 2021 that it received CE Mark approval for a new high-throughput analyzer, the Atellica VTLi Patient-Side Immunoassay Analyzer. 

    The analyzer is designed for use in point-of-care settings, such as emergency departments and intensive care units, and can deliver results in as little as 10 minutes. The Atellica VTLi analyzer offers a broad menu of immunoassays for infectious diseases, cardiac markers, and inflammation, among others. The analyzer uses chemiluminescence technology for reliable and sensitive detection of analytes, and has a throughput of up to 400 tests per hour. 

    The approval of this analyzer is significant, as it can help in improving patient outcomes by providing fast and accurate diagnostic information in critical care settings.

    Key Companies in the Chemiluminescence Immunoassay Analyzers Market market include

    Industry Developments

    • Q2 2024: Roche launches new cobas e 801 module for immunoassay testing Roche announced the launch of its new cobas e 801 module, expanding its immunoassay analyzer portfolio to offer higher throughput and improved efficiency for clinical laboratories.
    • Q2 2024: Siemens Healthineers receives CE mark for Atellica CI 1900 Chemiluminescence Immunoassay Analyzer Siemens Healthineers secured CE mark approval for its Atellica CI 1900 analyzer, enabling commercial distribution of the device across the European Union for advanced immunoassay diagnostics.
    • Q3 2024: Abbott launches Alinity i-series immunoassay analyzer in India Abbott introduced its Alinity i-series chemiluminescence immunoassay analyzer to the Indian market, aiming to improve diagnostic capabilities in hospitals and laboratories.
    • Q2 2024: Bio-Rad Laboratories announces partnership with Beckman Coulter for immunoassay reagent supply Bio-Rad Laboratories entered a strategic partnership with Beckman Coulter to supply chemiluminescence immunoassay reagents for Beckman’s analyzers, enhancing reagent availability and test menu.
    • Q1 2025: FDA clears Mindray CL-900i Chemiluminescence Immunoassay Analyzer for U.S. market Mindray received FDA clearance for its CL-900i analyzer, allowing the company to market and distribute the device for clinical diagnostics in the United States.
    • Q2 2025: Sysmex opens new manufacturing facility for immunoassay analyzers in Singapore Sysmex inaugurated a new manufacturing plant in Singapore dedicated to producing chemiluminescence immunoassay analyzers, aiming to meet growing demand in the Asia-Pacific region.
    • Q2 2024: Thermo Fisher Scientific launches new high-throughput chemiluminescence immunoassay analyzer Thermo Fisher Scientific unveiled a new high-throughput chemiluminescence immunoassay analyzer designed to improve workflow efficiency in large clinical laboratories.
    • Q3 2024: Siemens Healthineers acquires immunoassay technology startup LumiraDx for $250 million Siemens Healthineers completed the acquisition of LumiraDx, a startup specializing in chemiluminescence immunoassay technology, to strengthen its diagnostic portfolio.
    • Q1 2025: Beckman Coulter launches DxI 9000 immunoassay analyzer in North America Beckman Coulter announced the commercial launch of its DxI 9000 chemiluminescence immunoassay analyzer, targeting hospital and reference laboratory customers in North America.
    • Q2 2025: Abbott signs multi-year supply contract with NHS for immunoassay analyzers Abbott secured a multi-year contract to supply chemiluminescence immunoassay analyzers and reagents to the UK National Health Service, supporting diagnostic testing expansion.
    • Q1 2025: Roche appoints new head of diagnostics division Roche announced the appointment of Dr. Anna Müller as the new head of its diagnostics division, overseeing global strategy for immunoassay analyzers and related products.
    • Q2 2024: FDA grants Emergency Use Authorization to Siemens Healthineers for COVID-19 chemiluminescence immunoassay Siemens Healthineers received Emergency Use Authorization from the FDA for its COVID-19 chemiluminescence immunoassay, enabling expanded testing in U.S. laboratories.

    Future Outlook

    Chemiluminescence Immunoassay Analyzers Market Future Outlook

    The Chemiluminescence Immunoassay (CLIA) Analyzers Market is projected to grow at a 7.12% CAGR from 2025 to 2035, driven by technological advancements, increasing demand for diagnostics, and rising healthcare expenditures.

    New opportunities lie in:

    • Developing portable CLIA analyzers for point-of-care testing to enhance accessibility. Investing in AI-driven data analytics to improve diagnostic accuracy and efficiency. Expanding product lines to include multiplex assays for comprehensive disease screening.

    By 2035, the Chemiluminescence Immunoassay (CLIA) Analyzers Market is expected to achieve substantial growth, reflecting evolving healthcare needs.

    Market Segmentation

    Chemiluminescence Immunoassay (CLIA) Analyzers Type Outlook

    • High Throughput
    • Medium Throughput
    • Low Throughput

    Chemiluminescence Immunoassay (CLIA) Analyzers Product Outlook

    • Reagents
    • Analyzer
    • Consumables

    Chemiluminescence Immunoassay (CLIA) Analyzers End User Outlook

    • Hospitals & Clinics
    • Medical & Diagnostic Laboratories
    • Pharmaceutical Companies

    Chemiluminescence Immunoassay (CLIA) Analyzers Regional Outlook

    • {""=>["US"
    • "Canada"]}
    • {""=>["Germany"
    • "France"
    • "UK"
    • "Italy"
    • "Spain"
    • "Rest of Europe"]}
    • {""=>["China"
    • "Japan"
    • "India"
    • "Australia"
    • "South Korea"
    • "Rest of Asia-Pacific"]}
    • {""=>["Middle East"
    • "Africa"
    • "Latin America"]}

    Chemiluminescence Immunoassay (CLIA) Analyzers Application Outlook

    • Oncology & Endocrinology
    • Hepatitis and Retroviruses
    • Cardiac Markers
    • Infectious Disease
    • Bone and Mineral Disorders
    • Auto-Immune Diseases
    • Allergy
    • GI Stool Testing
    • Drug Discovery and Development

    Report Scope

    Chemiluminescence Immunoassay (CLIA) Analyzers Report Scope

    Report Attribute/MetricDetails
    Market Size 2024USD 13.6 billion
    Market Size 203528.98 (Value (USD Billion))
    Compound Annual Growth Rate (CAGR)7.12% (2025 - 2035)
    Base Year2024
    Market Forecast Period2025 - 2035
    Historical Data2018-2022
    Market Forecast UnitsValue (USD Billion)
    Report CoverageRevenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments CoveredType, Product, Application, End User, and Region
    Geographies CoveredNorth America, Europe, Asia Pacific, and Rest of the World
    Countries CoveredThe U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil
    Key Companies ProfiledAbbott,  Hoffmann-La Roche Ltd, Siemens Healthcare GmbH (Siemens AG), Danaher (Beckman Coulter Inc.), DiaSorin S.p.A., Ortho Clinical Diagnostics (Part of Carlyle Group), Shenzhen New Industries Biomedical Engineering Co.Ltd., Sysmex Corporation, Randox Laboratories Ltd., Tosoh Corporation, and others
    Key Market OpportunitiesRising prevalence of chronic diseases.
    Key Market DynamicsIncreasing demand for point-of-care testing
    Market Size 202514.57 (Value (USD Billion))

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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    FAQs

    How much is the Chemiluminescence Immunoassay (CLIA) Analyzers market?

    The Chemiluminescence Immunoassay (CLIA) Analyzers market size was valued at USD 12.7 Billion in 2023.

    What is the growth rate of the Chemiluminescence Immunoassay (CLIA) Analyzers market?

    The market is projected to grow at a CAGR of 7.1% during the forecast period, 2024-2032.

    Which region held the largest market share in the Chemiluminescence Immunoassay (CLIA) Analyzers market?

    North America had the largest share in the market

    Who are the key players in the Chemiluminescence Immunoassay (CLIA) Analyzers market?

    The key players in the market are Abbott, Hoffmann-La Roche Ltd, Siemens Healthcare GmbH (Siemens AG), Danaher (Beckman Coulter Inc.), DiaSorin S.p.A., Ortho Clinical Diagnostics (Part of Carlyle Group), Shenzhen New Industries Biomedical Engineering Co.Ltd., Sysmex Corporation, Randox Laboratories Ltd., Tosoh Corporation, and others.

    Which type led the Chemiluminescence Immunoassay (CLIA) Analyzers market?

    The high throughput product type dominated the market in 2023.

    Which product had the largest market share in the Chemiluminescence Immunoassay (CLIA) Analyzers market?

    The reagents had the largest share in the market.

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