Global Immunoassay Analyzers Market Size, Share, and COVID-19 Impact Analysis, Russia-Ukraine War Impact, Tariff Analysis, By Product (Chemiluminescence Immunoassays (CLIA), Fluorescence Immunoassays (FIA), Radioimmunoassay, Enzyme-Linked Immunoassay, and Consumables and Accessories), By Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Infectious Disease Testing, and Others), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035

Global Immunoassay Analyzers Market Insights Forecasts To 2035

• The Global Immunoassay Analyzers Market Size Was Estimated at USD 7.05 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 3.91% from 2025 to 2035
• The Worldwide Immunoassay Analyzers Market Size is Expected to Reach USD 10.75 Billion by
• 2035
• Asia Pacific is expected to grow the fastest during the forecast period.

According to a research report published by Spherical Insights and Consulting, The Global Immunoassay Analyzers Market Size was worth around USD 7.05 Billion in 2024, and is Projected to Grow from USD 7.32 Billion in 2025 to around USD 10.75 Billion by 2035 with a compound annual growth rate (CAGR) of 3.91 % from 2025 to 2035. With the increased understanding of immunology, technological advancements and shifting healthcare demands, immunoassay analyzers are evolving. The growing prevalence of chronic and infectious diseases, technological advancement in diagnostic tools, along with the investments in biotechnology & pharmaceutical sectors, are key driving the immunoassay analyzers market.

Global Immunoassay Analyzers Market Forecast and Revenue Outlook

• 2024 Market Size: USD 7.05 Billion
• 2035 Projected Market Size: USD 10.75 Billion
• CAGR (2025-2035): 3.91%
• North America: Largest market in 2024
• Asia Pacific: Fastest growing market

Market Overview

The immunoassay analyzers market is the market emphasizing the manufacturing, sales, and use of automated instruments performing immunoassays. Immunoassay analyzers are used for identifying and detecting the concentration of specific substances in a sample, often used in clinical diagnostics, drug discovery, drug monitoring, and food testing. This bioassay usually uses an antibody as a reagent, which uses the specificity of the antigen-antibody reaction to aid in detecting and quantifying target molecules in a biological sample. The increasing prevalence of chronic diseases leads to the demand for innovative solutions, encouraging companies to develop more advanced and effective diagnostic technologies in immunoassay analyzers.

The global market share is anticipated to be supported by expanding R&D efforts and collaborations by major industry participants, including Abbott, Roche Diagnostics, Siemens Healthineers, and others, for developing advanced analyzers. There are opportunities in the developing market due to technological advancements and increasing efforts to enhance the accuracy of diagnostic results. For instance, Fujirebio and Agappe entered into an agreement on business collaboration for cartridge-based CLIA system reagents manufacturing projects.

Key Market Insights

• North America is expected to account for the largest share in the immunoassay analyzers market during the forecast period.
• In terms of product, the consumables and accessories segment is projected to lead the immunoassay analyzers market throughout the forecast period
• In terms of application, the infectious disease testing segment captured the largest portion of the market

Immunoassay Analyzers Market Trends

• Demand for high-throughput and high-sensitivity technologies such as chemiluminescence (CLEIA)
• Automation and integration of artificial intelligence for improving accuracy and reducing lab turnaround times
• Emergence of technologies, including miniaturization and lab-on-a-chip technologies for enhancing accessibility and adaptability in low-resource environments

Report Coverage

This research report categorizes the immunoassay analyzers market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyzes the key growth drivers, opportunities, and challenges influencing the immunoassay analyzers Market. Recent market developments and competitive strategies, such as expansion, type launch, development, partnership, merger, and acquisition, have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyzes their core competencies in each sub-segment of the immunoassay analyzers market.

Driving factors

The increasing prevalence of chronic and infectious diseases is responsible for driving the demand for immunoassay analyzers, as they are used in diagnosis by detecting the presence of specific molecules in the blood or other bodily fluids, which ultimately aids in identifying the cause of symptoms, determining the appropriate treatment approach, and monitoring treatment. Technological advancement, including the integration of AI and machine learning, automation, and nanotechnology, is promoting market growth. In addition, the increasing investments in pharma and biotech sectors are contributing to supporting the immunoassay analyzers market.

Restraining Factor

One of the main factors restraining the immunoassay analyzers market is the increased initial costs and expenses on equipment, reagents, and maintenance, which is hindering adoption in smaller labs and emerging economies due to budget constraints and uncertain reimbursement strategies. Further, the lack of a skilled workforce and limited awareness about advanced diagnostic equipment are restraining the market growth.

Market Segmentation 

The global Immunoassay Analyzers Market is divided into product and application.

Global Immunoassay Analyzers Market, By Product:

• The consumables and accessories segment dominated the market in 2024 and is projected to grow at a substantial CAGR during the forecast period.   

Based on product, the global immunoassay analyzers market is segmented into chemiluminescence immunoassays (CLIA), fluorescence immunoassays (FIA), radioimmunoassay, enzyme-linked immunoassay, and consumables and accessories. Among these, the consumables and accessories segment dominated the market in 2024 and is projected to grow at a substantial CAGR during the forecast period. The segment includes reagent kits, sample and reagent trays, calibration solutions, and other disposables that are used for instrument operation. The growing adoption of immunoassay analyzers for diagnostic purposes, along with the continuous innovation of consumables, is driving the market.

The enzyme-linked immunoassay (ELISA) segment is anticipated to grow at the fastest CAGR during the forecast period, due to its use for detecting antibodies, proteins, peptides, and hormones. ELISA technology is used for applications including new drug development, vaccine development, drug monitoring, and other clinical and non-clinical applications.

Global Immunoassay Analyzers Market, By Application:

• The infectious disease testing segment accounted for the largest revenue share in 2024 and is anticipated to grow at a significant CAGR during the forecast period.

Based on application, the global immunoassay analyzers market is segmented into therapeutic drug monitoring, oncology, cardiology, infectious disease testing, and others. Among these, the infectious disease testing segment accounted for the largest revenue share in 2024 and is anticipated to grow at a significant CAGR during the forecast period. Immunoassay analyzers are used for detecting specific antibody classes in serum, plasma, or CSF, or detecting antigens from stool samples. An increasing demand for the detection of infectious diseases is driving the need for efficient diagnostic solutions, thereby propelling the market demand.

The oncology segment is anticipated to grow at a significant CAGR during the forecast period, due to the precision therapy protocols that drive the need for on-treatment toxicity monitoring. Immunoassay analyzers aid in detecting cancer by measuring the concentration of tumor markers.

Regional Segment Analysis of the Global Immunoassay Analyzers Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America Immunoassay Analyzers Market Trends

North America is expected to hold the largest share of the global immunoassay analyzers market over the forecast period.

The North American region's supremacy includes the increasing burden of cancer and cardiovascular disease conditions, with the expanding application of immunoassays. Further, the integration of AI in diagnostic platforms and the automation of laboratory workflows aid in propelling the market growth. The presence of key market players in the region, along with the continuous technological advancements, is enhancing the regional market.

U.S. Immunoassay Analyzers Market Trends

This is attributed to the country’s advanced healthcare infrastructure, increasing healthcare expenditure, and adoption of novel diagnostic technologies. Additionally, upsurging awareness regarding the significance of early disease detection and diagnosis, with the prevalence of chronic diseases, is promoting the market demand.

Asia Pacific Immunoassay Analyzers Market Trends

Asia Pacific is expected to grow at the fastest CAGR in the immunoassay analyzers market during the forecast period. In the Asia Pacific market, the rapid rise in demand for diagnostics in emerging economies is contributing to driving the market demand. With the increasing prevalence of chronic diseases like cardiovascular disease, cancer, and diabetes, companies are developing and launching innovative products for improving early disease detection and treatment, which is promoting the immunoassay analyzers market

China Immunoassay Analyzers Market Trends

China’s increasing ageing population and surge in chronic disease cases are significantly contributing to the market of immunoassay analyzers. Further, increasing technological advancements in immunoassay methods, with the surging need for efficient diagnostic tools, are propelling the market growth.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global immunoassay analyzers market, along with a comparative evaluation primarily based on their type of offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborate analysis focusing on the current news and developments of the companies, which includes type development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

Worldwide Top Key Players In The Immunoassay Analyzers Market Include

• Siemens Healthineers AG
• BIOMÉRIEUX
• Abbott
• QuidelOrtho Corporation
• Sysmex Corporation
• BD
• Thermo Fisher Scientific Inc.
• F. Hoffmann-La Roche Ltd
• Beckman Coulter, Inc.
• DiaSorin S.p.A.
• Others  

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent development

• In January 2025, Anbio Biotechnology, a global leader in diagnostics innovation, announced the launch of its Dry Chemiluminescence Immunoassay (CLIA) Solution ADL-1000, a transformative technology designed to deliver rapid, reliable, and cost-effective diagnostic results.
• In July 2024, Beckman Coulter Diagnostics, a clinical diagnostics leader, introduced the new DxC500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer. Beckman Coulter continues to introduce new innovations to address the needs of the entire network with specific solutions for satellite or independent laboratories, as well as core laboratories.
• In April 2024, Mindray launched simple yet efficient solutions for Mid-volume Laboratories, comprising two stand-alone analyzers (CL-2600i & BS-1000M) and two integrated solutions (M680 & M980). These new products showcase Mindray's ongoing commitment to innovation in chemiluminescence immunoassay and clinical chemistry technologies.
• In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd have agreed with Contract Development and Manufacturing Organization (CDMO) partnership for a cartridge-based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121.

Market Segment

This study forecasts revenue at the global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the Immunoassay Analyzers Market based on the following segments:

 Global Immunoassay Analyzers Market, By Product

• Chemiluminescence Immunoassays (CLIA)
• Fluorescence Immunoassays (FIA)
• Radioimmunoassay
• Enzyme-Linked Immunoassay
• Consumables and Accessories

Global Immunoassay Analyzers Market, By Application

• Therapeutic Drug Monitoring
• Oncology
• Cardiology
• Infectious Disease Testing
• Others

Global Immunoassay Analyzers Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa