Automated Immunoassay Analyzers Market Size, Share, and Trends 2025 to 2034

Automated Immunoassay Analyzers Market Size and Forecast 2025 to 2034

The global automated immunoassay analyzers market size was estimated at USD 22.23 billion in 2024 and is predicted to increase from USD 25.42 billion in 2025 to approximately USD 82.85 billion by 2034, expanding at a CAGR of 14.06% from 2025 to 2034.

Automated Immunoassay Analyzers Market Key Takeaways

• North America led the market with the largest market share of 35% in 2024.
• Asia Pacific is observed to expand at a rapid pace during the forecast period.
• By product, the chemiluminescence segment contributed the highest market share of 33% in 2024.
• By product, the immunofluorescence segment is expected to witness a significant share during the forecast period.
• By application, the infectious diseases segment held a major market share of 30% in 2024.
• By application, the chronic diseases segment is expected to grow significantly during the forecast period.
• By end user, the hospitals segment has held the largest market share of 35% in 2024.

U.S. Automated Immunoassay Analyzers Market Size and Forecast 2025 to 2034

The U.S. automated immunoassay analyzers market size reached USD 5.45 billion in 2024 and is expected to be worth around USD 20.74 billion by 2034 at a CAGR of 14.30% from 2025 to 2034.

North America held the dominant share of the automated immunoassay analyzers market in 2024. The region is observed to witness prolific growth during the forecast period. The growth of the region is driven by the presence of prominent market players, a well-established healthcare infrastructure, a rising genetic population, and an increasing number of hospitals and diagnostic centers. Moreover, the increasing deployment of innovative technologies and the increasing prevalence of chronic diseases are likely to contribute to the growth of the region’s growth.

• According to the Centers for Disease Control and Prevention, 6 in 10 adults in the US have a chronic disease and 4 in 10 adults in the US have two or more chronic diseases, driving regional market growth.

Among all countries, the United States is the major contributor to the automated immunoassay analyzers market. Factors such as a rise in healthcare expenditure, rising incidence of infectious diseases, increasing research and development expenditures, rapid advancement in technology, increasing demand for clinical diagnostic of immunoassay analyzers for various applications, and an increasing trend towards lab automation. Automation reduces the time needed for sample processing and enables faster turnaround times and accurate diagnoses of patients. Automated immunoassay analyzers reduce human error and enhance accuracy in managing the incubation periods, volumes, and other variables. It can also perform numerous tests simultaneously on a single sample.

Asia Pacific is observed to expand at a rapid pace during the forecast period owing to the increasing investment in the healthcare infrastructure, rise in government initiatives for providing better healthcare facilities, technology improvement in the field of lab equipment, increasing prevalence of chronic, rising demand for diagnostic solutions, increase in R&D activities, and increasing aging population. In addition, prominent market players are engaged in strategic approaches such as new product launches, partnerships or collaborations, acquisitions, and mergers.

Market Overview

Immunoassay is a method that is used to accurately identify the presence of a substance in the human body such as antibody, antigen, pathogen, hormone, enzyme, and others. An automated Immunoassay analyzer is an analytical instrument used in the field of healthcare. Automated immunoassay analyzers provide quantitative measurements of analytes, offering healthcare professionals a clear understanding of the concentration of specific substances in the sample. This information is vital for disease diagnosis and monitoring. An immunoassay assists in detecting the presence or absence of a specific substance within the body. In recent years, the automated immunoassay analyzers market has observed the application of immunoassays has evolved tremendously. It is a cutting-edge technology and a type of point-of-care testing.

The instrument uses antigens to detect the existence of target biological substances in the blood and other bodily fluids. Clinical laboratories and hospitals run automated biochemical tests by using automatic immunoassay analyzers. Many types of tests are performed by automatic immunoassay analyzers such as therapeutic drug monitoring, testing for cancer markers, cardiac analysis, diagnosing infectious diseases, allergy testing, and others.

Automated Immunoassay Analyzers Market Growth Factors

• The increasing prevalence of various chronic diseases leads to an increasing adoption of advanced diagnostic solutions and is estimated to accelerate the market’s revenue during the forecast period.
• The rise in applications of automated immunoassay analyzers is expected to lead to an increase in demand and result in rapid adoption of these devices, driving the revenue growth for the global automated immunoassay analyzers market during the forecast period.
• The massive shift towards automated labs is anticipated to boost the expansion of the market in the coming years.
• The rising aging population coupled with rising healthcare expenditures are factors that would contribute to the automated immunoassay analyzers market growth during the forecast period.
• The rising efforts taken to increase the accuracy of diagnostic results coupled with advancements in technology are factors projected to offer significant opportunities for the market’s expansion.
• The rise in new product launches is expected to expand the geographic reach and strengthen the market position globally.

Market Scope

Market Dynamics

Driver

Increasing prevalence of chronic diseases

The rising prevalence of infectious and chronic diseases such as HIV, cardiovascular disease, cancer, diabetes, autoimmune disorders, and others is one of the major driving factors contributing to the growth of the automated immunoassay analyzers market. Immunoassays play a vital role in disease diagnosis and assist in early treatment to avoid complications. The automated immunoassay analyzer is used for the detection and quantification of various analytes in biological samples, such as urine and blood, through immunoassay techniques.

The increasing use of technologically advanced immunoassay analyzers helps to determine infectious diseases. The accurate diagnosis of microorganism-based illnesses will aid in treatment planning effectively. Therefore, the increasing incidence of chronic diseases around the globe has resulted in a rise in diagnostic tests propelling the growth of the market.

• According to the data provided by the WHO, in 2022, there were estimated 20 million new cancer cases and 9.7 million deaths. About 1 in 5 people develop cancer in their lifetime, approximately 1 in 9 men and 1 in 12 women die from the disease.
• According to the report of the Institute for Health Metrics and Evaluation in June 2023, more than half a billion people are living with diabetes globally, affecting men, women, and children of all ages in every country, and it is estimated diabetes cases to rise from 529 million to 1.3 billion in the next 30 years.
• The latest estimates indicate that the current global prevalence rate is 6.1 percent, which makes diabetes one of the leading causes of death and disability. At the regional level, the highest rate is 9.3 percent in North Africa and the Middle East, and that number is anticipated to increase to 16.8 percent by 2050. The rate in Latin America and the Caribbean is anticipated to increase to 11.3 percent.

Restraint

Lack of skilled professional

The lack of skilled professionals in the healthcare sector is anticipated to hamper the automated immunoassay analyzers market's expansion. The operation of automated immunoassay analyzers requires a set of skills. In addition, the lack of sophisticated healthcare infrastructure and less awareness regarding advanced diagnostic equipment in underdeveloped countries or economically backward regions restricts the expansion of the market.

Opportunity

Technological advancements

Multiple technological advancements in the automated immunoassay analyzers market have led to efficient and easy application, this factor is observed to create a set of lucrative opportunities in the industry. Simultaneous detection of immunoassays with advanced solutions and integration of AI into the systems are observed to be the most promising advancements in the field. Laser-based detection systems offer improved sensitivity, specificity, and dynamic range compared to traditional detection methods. By employing lasers to excite fluorescent labels or chemiluminescent substrates, these analyzers achieve enhanced signal detection and quantification of biomolecules, enabling accurate measurement of low-abundance analytes in complex biological samples.

Product Insights

The chemiluminescence segment accounted for the dominating share of the automated immunoassay analyzers market in 2024 owing to its high accuracy and high sensitivity of the diagnosis using low analytes concentration. Chemiluminescence immunoassay is a widely used laboratory technique for detecting specific analytes. It assists in the detection and analysis of various antibodies, antigens, enzymes, fatty acids, hormones, proteins, and others. It is also used in the fields of clinical diagnosis, life science, environmental monitoring, drug analysis, and others.

• The Shine i8000/9000 is the most recent chemiluminescence immunoassay system from Fapon, a Chinese business. The Shine i8000/9000 Chemiluminescence Immunoassay Analyzer will address the continuously growing needs of laboratories while enhancing exceptional testing performance. The tools are made to provide medium-to large-sized laboratories with effective and clever solutions. The high-speed, completely automated analyzer can process 900 tests per hour, which is an extremely high throughput.

The Immunofluorescence segment is expected to witness a significant share during the forecast period. This automated immunofluorescence analyzer is widely used by healthcare professionals in the diagnosis of health conditions such as pregnancy, infection, diabetes, cardiovascular disease, renal injury, and cancer. This instrument provides reliable and quantitative results for a variety of analytes in human urine and blood.

• In July 2023, Anbio Biotechnology Ltd. announced the launch of the Anbio AF-100S, an automated, compact, and affordable fluorescent immunoassay (FIA) solution that it hopes will transform the field of clinical diagnostics and empower healthcare providers. The AF-100S FIA is a handheld point-of-care immunodiagnostic solution that provides rapid, accurate, and reliable results for a wide range of analytes.

Applications Insights

The infectious diseases segment held the largest share of the automated immunoassay analyzers market in 2024, the segment is expected to sustain the position throughout the forecast period. The increasing number of infectious diseases around the world such as coronavirus (COVID-19), hepatitis, influenza, HIV, measles, and others increases the adoption of automated immunoassay analyzers in the healthcare sector.

The chronic diseases segment is expected to grow significantly during the forecast period. The growth of the segment is driven by the rising cases of chronic diseases globally including heart disease, stroke, cancer, type 2 diabetes, arthritis, and others. The increasing prevalence of chronic diseases leads to a surge in demand for advanced diagnostic solutions for accurate disease diagnosis and monitoring. These automated immunoassay analyzers offer high throughput, accuracy, and efficiency, making them vital tools in clinical diagnostics. Thereby fueling the segment’s growth.

End-user Insights

The hospitals segment held the largest share of the automated immunoassay analyzers market in 2024. The growth of the segment is driven by the rising use of automated immunoassay analyzers by doctors and healthcare professionals in hospitals for detecting and monitoring diseases in patients. In addition, the presence of well-established healthcare infrastructure, availability of skilled professionals, and access to advanced equipment for rapid and accurate diagnostic testing.

The diagnostic test laboratories segment is expected to grow fastest during the forecast period owing to the increasing deployment of automated immunoassay analyzers for in vitro detection of human serum, plasma, whole blood, and urine samples.

Automated Immunoassay Analyzers Market Companies

• Abbott Laboratories
• Arlington Scientific, Inc.
• Becton Dickinson and CompanyB
• Bio-Rad Laboratories, Inc.
• Biobase Biodusty(Shandong), 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
• Medline Industries, LP
• Meril Life Sciences Pvt. Ltd.
• PerkinElmer, Inc.
• Qiagen N.V.
• Randox Laboratories
• Siemens Healthineers
• Sysmex Corporation
• Arlington Scientific
• Becton Dickinson and Company
• Carolina Liquid Chemistries Corporation
• Roche Diagnostics
• BioMerieux
• Aesku Diagnostics

Automated Immunoassay Analyzers Market Recent Developments

• The UNIQO 160 automated indirect immunofluorescence test (IIFT) system was introduced by EUROIMMUN in June 2023 for the purpose of diagnosing autoimmune diseases. The new test increases the effectiveness of every step of the IIFT procedure, including image analysis and capture, slide washing and mounting, sample preparation, incubation, and mounting. The company has secured the certificate of compliance with the European In Vitro Diagnostic Medical Device Regulation and is now offering the new all-in-one solution in countries that accept the CE mark.
• Leading global player in in vitro diagnostics, bioMérieux, made a strategic investment in Proxim Diagnostics in March 2023. The money will be utilized to finish the development and launch Proxim's Profile System, a fully automated, mobile immunodiagnostic tool that uses disposable cartridges to perform a range of multiplexed tests.
• Epitope Diagnostics, Inc. announced in February 2023 the release of panel kits containing both common and specialized chemiluminescence immunoassay tests across many clinical domains, in addition to their fully automated chemiluminescence immunoassay analyzers (ECL25 and ECL100).

Segments Covered in the Report

By Product

• Immunofluorescence
• Chemiluminescence
• Enzyme Linked Fluorescent System
• Radioimmunoassay

By Application

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

By End User

• Academic Research Institutes
• Biotech And Pharma Companies
• Hospitals
• Diagnostic Test Laboratories
• Others

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa