Immunodiagnostics Market Report 2026

Immunodiagnostics Market Overview

• Immunodiagnostics market size has reached to $24.32 billion in 2025 • Expected to grow to $35.76 billion in 2030 at a compound annual growth rate (CAGR) of 8.1% • Growth Driver: The Rising Prevalence Of Chronic Diseases Fueling The Growth Of The Immunodiagnostics Market • Market Trend: Innovative Automated Tests Set To Transform Laboratory Diagnostics • North America was the largest region in 2025.

What Is Covered Under Immunodiagnostics Market?

Immunodiagnostics refers to a diagnostic methodology that relies primarily on an antigen-antibody response for the detection of serum insulin. Immunodiagnostic tests are used to detect antibodies and parasite antigens. The main products of immunodiagnostics are reagents and consumables, instruments and software and services. Reagents refer to substances that are used to perform chemical reactions with other substances to detect the presence of other substances and consumables refer to the trackable items used to carry out an analysis technique. The technologies involved are enzyme-linked immunosorbent assay, chemiluminescence immunoassay, fluorescent immunoassay, radioimmunoassay, rapid test, and others that are used for infectious diseases, oncology and endocrinology, bone and mineral diseases, autoimmunity disorders, cardiac biomarkers, drug monitoring, and other applications by hospitals, clinics, diagnostic laboratories, academic and research institutes, and others.

What Is The Immunodiagnostics Market Growth Forecast?

The immunodiagnostics market size is expected to see strong growth in the next few years. It will grow to $35.76 billion in 2030 at a compound annual growth rate (CAGR) of 8.1%. The growth in the forecast period can be attributed to increasing adoption of personalized diagnostics, rising investments in automated laboratories, expansion of point-of-care immunodiagnostics, growing integration of AI-based result interpretation, increasing focus on preventive healthcare testing. Major trends in the forecast period include increasing adoption of automated immunoassay analyzers, rising demand for high-sensitivity diagnostic tests, growing use of rapid immunodiagnostic kits, expansion of multiplex testing capabilities, enhanced integration of laboratory data management systems.

Global Immunodiagnostics Market Segmentation

1) By Product: Reagents And Consumables, Instruments 2) By Technology: Enzyme-Linked Immunosorbent Assay, Chemiluminescence Immunoassay, Fluorescent Immunoassay, Rapid Test, Other Technologies 3) By Application: Infectious Diseases, Oncology And Endocrinology, Bone And Mineral Diseases, Autoimmunity Disorders, Cardiac Biomarkers, Drug Monitoring, Other Applications 4) By End User: Hospitals, Clinics, Diagnostic Laboratories Subsegments: 1) By Reagents And Consumables: Antibodies, Assay Kits, Buffers And Substrates 2) By Instruments: Immunoassay Analyzers, ELISA Readers

What Is The Driver Of The Immunodiagnostics Market?

The increasing prevalence of chronic diseases is expected to propel the growth of the immunodiagnostics market going forward. Chronic diseases are long-lasting health conditions that usually progress slowly over time, such as diabetes, heart disease, and arthritis, and often require ongoing medical attention and lifestyle management to control symptoms and prevent complications. Chronic diseases are increasing largely due to unhealthy lifestyles, including poor diet, physical inactivity, and smoking, which raise the risk of conditions such as diabetes, heart disease, and obesity. Immunodiagnostics aid chronic disease diagnosis by enabling accurate detection of biomarkers and immune responses associated with long-term health conditions. They enhance early identification and monitoring of diseases such as diabetes, autoimmune disorders, and cardiovascular conditions, improving patient management and supporting timely treatment decisions. For instance, in June 2024, according to the National Health Service, a UK-based government department, 3,615,330 individuals registered with a general practitioner (GP) were diagnosed with non-diabetic hyperglycemia or pre-diabetes (a condition with elevated blood sugar levels, not high enough to be classified as diabetes) in 2023, marking an 18% increase from 3,065,825 cases in 2022. Therefore, the rising prevalence of chronic and infectious diseases is driving the growth of the immunodiagnostics industry.

Key Players In The Global Immunodiagnostics Market

Major companies operating in the immunodiagnostics market are Abbott Laboratories, F. Hoffmann-La Roche Ltd., Siemens Healthineers AG, Danaher Corporation, Thermo Fisher Scientific Inc., Bio-Rad Laboratories Inc., DiaSorin S.p.A., bioMérieux SA, Sysmex Corporation, Becton Dickinson and Company, Grifols S.A., Ortho Clinical Diagnostics, Beckman Coulter Inc., Fujirebio Holdings Inc., Quidel Corporation, Luminex Corporation, Bio-Techne Corporation, PerkinElmer Inc., Merck KGaA, Gold Standard Diagnostics Corp., OraSure Technologies Inc., Immunodiagnostic Systems Holdings Plc (IDS)

Global Immunodiagnostics Market Trends and Insights

Major companies operating in the immunodiagnostics market are increasingly focusing on developing innovative solutions, such as automated chemiluminescence immunoassays (CLIAs), to enhance diagnostic accuracy, reduce testing time, and improve laboratory efficiency. Automated chemiluminescence immunoassays (CLIAs) are laboratory tests that use light-emitting chemical reactions and automation to quickly and accurately detect specific proteins or antibodies in blood or other samples. For instance, in September 2025, DiaSorin S.p.A., an Italy-based diagnostics company, launched the LIAISON® TSH-R Ab assay for autoimmune thyroid disorder assessment. The test introduces features such as enhanced antibody specificity through double-bridge assay architecture, seamless integration into existing LIAISON analyzers to streamline laboratory workflows, and CE-marked compatibility supporting deployment across multiple regulated regions.

What Are Latest Mergers And Acquisitions In The Immunodiagnostics Market?

In May 2023, Freenome, a US-based biotechnology company, acquired Oncimmune for an undisclosed amount. With this acquisition, Freenome aims to enhance its capabilities in early cancer detection by integrating Oncimmune's innovative technology and expertise in immune profiling, thereby strengthening its position in the oncology diagnostics market and expanding its portfolio of liquid biopsy solutions. Oncimmune is a UK-based biotechnology company that specializes in the development of immune profiling and biomarker discovery technologies for cancer diagnosis and monitoring.

Regional Outlook

North America was the largest region in the immunodiagnostics market in 2025. The regions covered in this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain

What Defines the Immunodiagnostics Market?

The immunodiagnostics market consists of revenues earned by entities by providing agglutination, nephelometry, immunoprecipitation, and radial immunodiffusion test services. The market value includes the value of related goods sold by the service provider or included within the service offering. The immunodiagnostics market also includes sales of anti-streptolysin-O latex, infectious mononucleosis slide, rheumatoid factor, and syphilis serology reagent. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

How is Market Value Defined and Measured?

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.