Immunodiagnostics Global Market Report 2026

Immunodiagnostics is a diagnostic approach that relies primarily on the antigen-antibody response for detecting serum insulin. These tests are employed to identify antibodies and parasite antigens.

The principal products in the field of immunodiagnostics include reagents and consumables, instruments and software, and services. Reagents are substances used to initiate chemical reactions with other substances to detect the presence of specific substances, while consumables refer to traceable items utilized in the execution of analysis techniques. The technologies involved encompass enzyme-linked immunosorbent assay, chemiluminescence immunoassay, fluorescent immunoassay, radioimmunoassay, rapid tests, and others. These technologies find applications in various medical fields such as infectious diseases, oncology, endocrinology, bone and mineral diseases, autoimmunity disorders, cardiac biomarkers, drug monitoring, and more. The end-users of immunodiagnostics include hospitals, clinics, diagnostic laboratories, academic and research institutes, among others.

Tariffs are influencing the immunodiagnostics market by increasing costs of imported reagents, antibodies, assay kits, diagnostic instruments, and electronic components used in immunoassay analyzers. Diagnostic laboratories and hospitals in North America and Europe are most affected due to dependence on imported consumables and instruments, while Asia-Pacific faces pricing pressure on manufacturing and exports. These tariffs are raising test costs and impacting procurement budgets. However, they are also driving localization of reagent production, regional manufacturing of diagnostic instruments, and innovation in cost-efficient immunodiagnostic solutions.

The immunodiagnostics market research report is one of a series of new reports from The Business Research Company that provides immunodiagnostics market statistics, including immunodiagnostics industry global market size, regional shares, competitors with a immunodiagnostics market share, detailed immunodiagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the immunodiagnostics industry. This immunodiagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The immunodiagnostics market size has grown strongly in recent years. It will grow from $24.32 billion in 2025 to $26.16 billion in 2026 at a compound annual growth rate (CAGR) of 7.5%. The growth in the historic period can be attributed to increasing prevalence of infectious and chronic diseases, expansion of clinical laboratory networks, growing demand for early disease detection, rising use of antibody-based diagnostics, availability of standardized immunoassay technologies.

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.

The increasing prevalence of chronic and infectious diseases is expected to drive the growth of the immunodiagnostics market in the coming years. Rising prevalence refers to the growing number of individuals living with long-term or recurring conditions such as cancer, autoimmune disorders, cardiovascular diseases, and chronic viral infections that require repeated diagnostic testing based on antigen-antibody interactions for disease detection and monitoring. This trend continues to intensify as populations age and life expectancy increases, leading to a higher incidence of multiple comorbidities and a greater lifetime risk of developing such conditions. The immunodiagnostics market plays a critical role in addressing this expanding disease burden by enabling early identification of disease-specific biomarkers, supporting treatment selection, and monitoring therapeutic response across hospitals, diagnostic laboratories, and point-of-care settings. For instance, in June 2025, according to the World Health Organization (WHO), a Switzerland-based organization, 1.8 million avoidable deaths occur each year in the European region due to chronic noncommunicable diseases.

Major companies operating in the immunodiagnostics market are increasingly emphasizing the development of innovative solutions such as automated chemiluminescence immunoassays (CLIAs) to improve diagnostic accuracy, shorten testing time, and enhance laboratory efficiency. In parallel, companies are also advancing targeted assays such as the S. pneumoniae antigen immunodiagnostic assay to support the diagnosis of pneumococcal pneumonia. The S. pneumoniae antigen immunodiagnostic assay is designed to detect Streptococcus pneumoniae antigens in bodily fluids, enabling timely identification of pneumococcal infections. Automated chemiluminescence immunoassays use light-emitting chemical reactions combined with automation to rapidly and precisely 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(R) TSH-R Ab assay for the assessment of autoimmune thyroid disorders. The assay offers improved antibody specificity through a double-bridge architecture, integrates seamlessly with existing LIAISON(R) analyzers to optimize workflows, and features CE-marked compatibility for use across regulated markets.

In May 2023, Freenome, a biotechnology company based in the U.S., acquired Oncimmune for an undisclosed amount. This acquisition is intended to enhance Freenome's capabilities in early cancer detection by incorporating Oncimmune's innovative technology and expertise in immune profiling. The move aims to strengthen Freenome's position in the oncology diagnostics market and expand its portfolio of liquid biopsy solutions. Oncimmune, located in the UK, specializes in developing technologies for immune profiling and biomarker discovery to aid in cancer diagnosis and monitoring.

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., bioMerieux 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)

North America was the largest region in the immunodiagnostics market in 2025. The regions covered in the immunodiagnostics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the immunodiagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain

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.

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.

Immunodiagnostics Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses immunodiagnostics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

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Where is the largest and fastest growing market for immunodiagnostics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The immunodiagnostics market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

• The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
• The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
• The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
• The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
• The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
• The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
• The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
• The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
• Market segmentations break down the market into sub markets.
• The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
• Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
• The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
• The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.

Scope

• Markets Covered: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
• Companies Mentioned: Abbott Laboratories; F. Hoffmann-La Roche Ltd.; Siemens Healthineers AG; Danaher Corporation; Thermo Fisher Scientific Inc.; Bio-Rad Laboratories Inc.; DiaSorin S.p.A.; bioMerieux 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)
• Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain
• Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
• Time Series: Five years historic and ten years forecast.
• Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,
• Data Segmentations: country and regional historic and forecast data, market share of competitors, market segments.
• Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
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