Global Automated Immunoassay Analyzers Market Size, Share, and COVID-19 Impact Analysis, By Product (Immunofluorescence, Chemiluminescence, Enzyme Linked Fluorescent System, and Radioimmunoassay), By Application (Infectious Diseases, Endocrinology, Drug Monitoring, Chronic Diseases, and Allergy Testing), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035

Global Automated Immunoassay Analyzers Market Insights Forecasts To 2035

• The Global Automated Immunoassay Analyzers Market Size Was Estimated at USD 21.35 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 14.11% from 2025 to 2035
• The Worldwide Automated Immunoassay Analyzers Market Size is Expected to Reach USD 91.16 Billion by 2035
• Asia Pacific is expected to grow the fastest during the forecast period.

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According to a research report published by Spherical Insights and Consulting, The Global Automated Immunoassay Analyzers Market Size was worth around USD 21.35 Billion in 2024 and is projected to grow from USD 24.36 Billion in 2025 to around USD 91.16 billion by 2035 at a compound annual growth rate (CAGR) of 14.11% during the forecast period (2025–2035).  One of the key opportunities is the rising incidence of infectious and chronic diseases, which require prompt and precise diagnosis. Technological developments in immunoassays improve the accuracy and efficiency of testing. The development of healthcare infrastructure increases access to cutting-edge diagnostic equipment, especially in emerging nations.  

 

Global Automated Immunoassay Analyzers Market Forecast and Revenue Size

• 2024 Market Size: USD 21.35 Billion
• 2025 Market Size: USD 24.36 Billion
• 2035 Projected Market Size: USD 91.16 Billion
• CAGR (2025-2035): 14.11%
• North America: Largest market in 2024
• Asia Pacific: Fastest growing market

 

Market Overview

Automated immunoassay analysers are sophisticated diagnostic tools made to run immunoassay tests on fluid or blood samples with the least amount of human involvement. An immunoassay is a method used to accurately identify the presence of a substance, for example, an antibody, antigen, pathogen, hormone, enzyme, or another in the human body. Automated analyzers for immunoassays are used by health professionals as analytic tools. Automated immunoassay analyzers are helpful to medical professionals because they provide quantitative measures of analytes. By interpreting these measures, medical professionals gain a clear understanding of the concentration of specific substances in a sample. The ability to detect whether or not a given material is in the body relies on the immunoassay. The market for automatic immunoassay analysers has experienced major changes in regard to the application of immunoassays in recent years. The device uses antigens to detect the presence of target biological materials in blood and other body fluids. Hospitals and clinical labs use immunoassay analyzers to complete automated chemical testing. Automatic immunoassay analyzers can perform a broad range of tests, including allergy tests, cardiac analysis, cancer marker tests, therapeutic drug monitoring, and infectious disease testing. Anbio Biotechnology Ltd. launched the AF 100S, a compact and affordable fluorescent immunoassay solution aimed at transforming clinical diagnostics. This handheld point of care device provides rapid and reliable results for a wide range of analytes, enhancing accessibility in resource-limited settings in 2023.

Governments all around the world are actively supporting and encouraging the development and application of automated immunoassay analyzers in an effort to enhance public health outcomes and diagnostic capabilities. For instance, Brazil's Programa Mais Saúde was updated in January 2024 to include funding for 150 new regional labs that would be equipped with immunoassay lines that could perform 800 tests per hour using chemiluminescent technology.   

 

Key Market Insights

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

 

Automated Immunoassay Analyzers Market Trends

• Integration of Artificial Intelligence and Cloud Connectivity
• Rise of Point of Care Testing
• Advancements in Multiplexed and High-Sensitivity Testing
• Miniaturization and Cost Reduction
• Strategic Partnerships and Regional Expansion

 

Report Coverage

This research report categorizes the automated 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 automated 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 automated immunoassay analyzers market.

 

Driving factors: Advanced diagnostic tools drive the automated immunoassay analyzers market.

One major contributing factor to the automated immunoassay analyzers market includes the rising prevalence of chronic and infectious diseases, e.g., diabetes, autoimmune diseases, cancer, heart disease, and HIV. Immunoassays are crucial for identifying diseases and supporting early treatment measures to avoid sequelae. The automated immunoassay analyzer utilizes immunoassay techniques to identify and quantify a variety of analytes in biological specimens, such as blood and urine. A report by the Institute for Health Metrics and Evaluation in June 2023 reported that more than half a billion individuals of all ages currently have diabetes in every country worldwide. It is anticipated that the number of diabetes cases will increase to 1.3 billion from 529 million individuals over the next 30 years.

 

Restraining Factor: Inadequate diagnostic infrastructure restricts the market.

The market for automated immunoassay analyzers is restricted by several important factors, such as the shortage of trained staff. Certain capabilities are needed to run an automated immunoassay analyzer. Also, the absence of advanced healthcare infrastructure and an absence of knowledge about advanced diagnostic tools in developing or underdeveloped areas will further stifle the market's growth.

 

Market Segmentation 

The global automated immunoassay analyzers market is divided into product and application.

 

Global Automated Immunoassay Analyzers Market, By Product:

Why does the chemiluminescence segment hold the largest revenue share in the global automated immunoassay analyzers market, accounting for approximately 7.53% of the total market during the forecast period?

The chemiluminescence segment led the automated immunoassay analyzers market, generating the largest revenue share. The chemiluminescence is praised for its diagnostic method, which entails the use of low analyte concentrations with high sensitivity and specificity. Chemiluminescence immunoassay is the most widely used laboratory technique for identifying specific analytes. Using this method, many analytes can be determined and quantified, including antibodies, antigens, enzymes, fatty acids, hormones, proteins, and other assays. This is true for various areas such as clinical diagnosis, life sciences, pharmacological studies, environmental studies, and more.

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The immunofluorescence segment in the automated immunoassay analyzers market is expected to grow at the fastest CAGR over the forecast period. When diagnosing conditions such as cancer, diabetes, infections, cardiovascular disease, kidney disease, and pregnancy, healthcare professionals will often use this automated immunofluorescence analyzer. This instrument is capable of providing accurate and quantitative results for a variety of analytes in a human blood or urine sample.

 

Global Automated Immunoassay Analyzers Market, By Application:

Why do infectious diseases represent the largest application segment, capturing approximately 9.40% market share during the forecast period in the global automated immunoassay analyzers market?  

The infectious diseases segment held the largest market share in the automated immunoassay analyzers market. The rise in infectious diseases, such as measles, hepatitis, influenza, HIV, and coronavirus (COVID-19), has likewise increased the demand for automated immunoassay analyzers in the healthcare sector.    

The chronic diseases segment in the automated immunoassay analyzers market is expected to grow at the fastest CAGR over the forecast period. The increasing occurrence of chronic diseases such as cancer, heart disease, stroke, type 2 diabetes, arthritis, and others around the world is contributing to the growth of the segment. The rise in chronic diseases has increased the demand for advanced diagnostic devices for the accurate diagnosis and tracking of disease progression. High throughput, accuracy, and efficiency make these automated immunoassay analyzers key devices in clinical diagnostics.  

 

Regional Segment Analysis of the Global Automated 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 Automated Immunoassay Analyzers Market Trends

What factors contribute to the North America region holding the largest share, approximately 40%, of the global automated immunoassay analyzers market during the forecast period?

North America is dominant in the global automated immunoassay analyzers market, with an estimated 40% share during the forecast period. The automated immunoassay analyzers market in North America has expanded greatly because of the increasing genetic population, established healthcare facilities, a network of hospitals and diagnostic facilities, and the strong presence of prominent market players. Moreover, the increasing prevalence of chronic diseases and the increasing application of advanced technologies are expected to facilitate the area's growth. The American Medical Association reports that U.S. health spending climbed 4.1% to $4.4 trillion in 2022. This increased spending encourages hospitals, clinics, and diagnostic labs in the North America region to implement cutting edge medical equipment, such as automated analyzers.

 

Asia Pacific Automated Immunoassay Analyzers Market Trends

How is the Asia Pacific region expected to capture approximately 25% of the automated immunoassay analyzers market by 2025, with the fastest growth rate? 

Asia Pacific is expected to capture approximately 25% of the automated immunoassay analyzers market by 2025, with the fastest growth rate due to several key factors. The APAC region is a result of the increasing government initiatives to improve healthcare facilities, investments into healthcare infrastructure development, advancements in lab equipment technology, rising incidence rates of chronic diseases, increasing demand for diagnostic solutions, increased R&D activities, and an aging population. Key market players are also exploring various strategic initiatives, including mergers and acquisitions, alliances, and product launches.

 

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global automated 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 Automated Immunoassay Analyzers Market Include

• Abbott Laboratories
• Arlington Scientific, Inc.
• Becton Dickinson and Company
• Bio Rad Laboratories, Inc.
• Biobase Biodust, Co., Ltd.
• bioMerieux SA
• Carolina Liquid Chemistries Corp.
• Charles River Laboratories
• Chengdu Vacure Biotechnology Co., Ltd.
• Danaher Corporation
• F. Hoffmann La Roche AG
• Getein Biotech, Inc.
• Hipro Biotechnology Co., Ltd.
• Illumina, Inc.
• Laboratory Corporation of America Holdings
• Others

 

Key Target Audience

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

 

Recent development

• In June 2023, EUROIMMUN introduced the UNIQO 160 automated indirect immunofluorescence test technology to diagnose autoimmune disorders. Every stage of the IIFT process, image analysis and capture, slide cleaning and mounting, sample preparation, and incubation, is made more effective by the new test. The business is now providing the new all-in-one solution in nations that recognize the CE mark after obtaining a certificate of compliance with the European In Vitro Diagnostic Medical Device Regulation.

 

• In March 2023, Proxim Diagnostics received a strategic investment from bioMérieux, a major leader in the global in vitro diagnostics market. Proxim's Profile System, a mobile, fully automated immunodiagnostic device that employs disposable cartridges to conduct a variety of multiplexed assays, will be developed and launched with the help of the funding.

 

• In February 2023, Biogennix, Epitope Diagnostics, Inc., announced the introduction of panel kits that comprise both standard and custom chemiluminescence immunoassay tests across multiple clinical domains, in addition to their fully automated chemiluminescence immunoassay analyzers (ECL25 and ECL100).

 

• In November 2021, the new automated immunoassay analyzer with a blood collection tube was introduced by the Korean company Boditech Med. One of its special features is the ability to run ten tests in parallel for every parameter. In the upcoming years, this strategic move will increase the company's income and industry visibility.

 

Market Segment

This study forecasts revenue at the global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the automated immunoassay analyzers market based on the following segments:

 

 Global Automated Immunoassay Analyzers Market, By Product

• Immunofluorescence
• Chemiluminescence
• Enzyme Linked Fluorescent System
• Radioimmunoassay

 

Global Automated Immunoassay Analyzers Market, By Application

• Infectious Diseases
• Endocrinology
• Drug Monitoring
• Chronic Diseases
• Allergy Testing

 

Global Automated 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