Immunoassay Global Market Report 2026

Immunoassay is a bioanalytical test that utilizes the binding of antibodies to antigens to detect and quantify specific chemicals, playing a crucial role in the diagnosis of diseases. Information derived from immunoassay test results can be used to establish appropriate courses of therapy. This method relies on a competitive binding reaction between a limited number of receptors on a highly specific anti-analyte antibody, labeled versions of an analyte, and a significant portion of an unlabeled sample analyte.

The main types of immunoassay products include reagents and kits, analyzers or instruments, and software and services. Reagents are substances or products that accelerate a reaction and are commonly used in various tests. Immunoassay specimens include blood, saliva, urine, and others, and the technique is applied in therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases, and more. The end users of immunoassay products are diverse and include research and academic laboratories, home care settings, pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), blood banks, hospitals and clinics, and clinical laboratories.

Tariffs are impacting the immunoassay market by increasing costs of imported reagents, antibodies, analyzers, electronic components, and laboratory consumables used across diagnostic and research applications. North America and Europe are most affected due to reliance on globally sourced assay materials and instrumentation, while Asia-Pacific faces cost pressures on export-oriented manufacturing of kits and analyzers. These tariffs are increasing testing costs and slowing procurement cycles for laboratories. However, they are also encouraging regional reagent manufacturing, local instrument assembly, and stronger domestic supply chains for immunoassay solutions.

The immunoassay market research report is one of a series of new reports from The Business Research Company that provides immunoassay market statistics, including immunoassay industry global market size, regional shares, competitors with a immunoassay market share, detailed immunoassay market segments, market trends and opportunities, and any further data you may need to thrive in the immunoassay industry. This immunoassay 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 immunoassay market size has grown strongly in recent years. It will grow from $37.32 billion in 2025 to $40.07 billion in 2026 at a compound annual growth rate (CAGR) of 7.4%. The growth in the historic period can be attributed to rising prevalence of infectious and chronic diseases, increased clinical laboratory testing volumes, widespread adoption of elisa-based diagnostics, expansion of pharmaceutical research activities, growing demand for early disease detection.

The immunoassay market size is expected to see strong growth in the next few years. It will grow to $52.83 billion in 2030 at a compound annual growth rate (CAGR) of 7.2%. The growth in the forecast period can be attributed to increasing demand for rapid diagnostics, rising investments in personalized medicine, expansion of decentralized testing models, growing adoption of digital laboratory workflows, increasing focus on companion diagnostics. Major trends in the forecast period include increasing adoption of high-sensitivity immunoassay kits, rising use of automated immunoassay analyzers, growing demand for point-of-care immunoassay testing, expansion of multiplex immunoassay platforms, enhanced integration of data management software.

The rising incidence of infectious and chronic diseases is anticipated to support the expansion of the immunoassay market in the coming years. Infectious and chronic diseases encompass conditions caused by pathogenic organisms as well as long-term health disorders that require continuous monitoring, diagnosis, and treatment. The growing burden of these diseases is largely attributed to increased exposure to environmental pollutants, which compromise immune function and heighten vulnerability to illness. As a result, demand for immunoassays is increasing, as the accelerating prevalence of infectious and chronic conditions is encouraging healthcare providers and diagnostic companies to adopt advanced testing solutions that facilitate early diagnosis, effective disease surveillance, and precise clinical decision-making. For example, in June 2025, data from the UK Health Security Agency, a United Kingdom-based government public health body, indicated that reported Campylobacter cases in England rose from 60,055 in 2023 to 70,352 in 2024, representing an increase of 10,297 cases, or 17.1%, with the reporting rate climbing from 104.1 to 121.9 per 100,000 population. Consequently, the growing prevalence of infectious and chronic diseases is driving demand for immunoassay-based diagnostic solutions.

Major companies operating in the immunoassay market are focusing on the launch of advanced immunoassay analyzers to strengthen their competitive positioning. Immunoassay analyzers are laboratory systems that automate the identification and measurement of biological substances, such as proteins and hormones, through immunological reactions. For example, in May 2023, Beckman Coulter Diagnostics, a United States-based company specializing in simplifying, automating, and innovating complex biomedical testing, introduced the DxI 9000 Access Immunoassay Analyzer. The DxI 9000 Access Immunoassay Analyzer is designed to meet clinical laboratory requirements for high speed, reliability, reproducibility, quality, and expanded test menus. The system demonstrates the ability to develop highly sensitive and clinically meaningful assays, supporting the effectiveness of new pharmaceutical therapies and contributing to improved patient outcomes. It incorporates innovations such as advanced analyte processing and detection technologies, precision sensors, intelligent algorithms, and remote real-time system monitoring, and is distinguished as the only immunoassay analyzer system that requires no daily maintenance.

In January 2023, Heska Corporation, a US-based biotechnology firm, acquired MBio Diagnostics, Inc. for an undisclosed sum. This acquisition is intended to strengthen Heska Corporation's research, development, and manufacturing capabilities, primarily by incorporating LightDeck's innovative point-of-care technology. This integration will facilitate the launch of advanced diagnostic platforms, including a product for canine cancer screening. MBio Diagnostics, Inc. is a US-based company that specializes in immunoassays.

Major companies operating in the immunoassay market are Siemens Healthineers GmbH, bioMerieux, Abbott, Beckman Coulter Inc., Quidel Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories Inc., Becton Dickinson and Company, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Merck KGaA, Agilent Technologies Inc., PerkinElmer Inc, WAK-Chemie Medical GmbH, J Mitra & Co Pvt Ltd, Kamiya Biomedical Company, Tosoh Corporation, Gyros Protein Technologies AB, BioCheck Inc., Bio-Techn, DiaSorin S.p.A, Meso Scale Diagnostics LLC, QIAGE, Randox Laboratories Ltd., Shenzhen Mindray Bio-Medical Electronics Co Ltd, Danaher Corporation, Hologic Inc., Tecan Trading AG, Eurofins Scientific, Abcam plc, Enzo Biochem Inc., Luminex Corporation, Quanterix Corporation, Roche Diagnostics, ZEUS Scientific Inc.

North America was the largest region in the immunoassay market in 2025. Asia-Pacific is expected to be the fastest-growing region in the immunoassay market report during the forecast period. The regions covered in the immunoassay market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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

The immunoassay market includes revenues earned by entities by supplying immunoassay kits, analyzers, and reagents. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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.

Immunoassay 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 immunoassay 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 immunoassay ? 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 immunoassay 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 Kits; Analyzers Or Instruments; Software And Services
• 2) By Specimen: Blood; Saliva; Urine; Other Specimens
• 3) By Application: Therapeutic Drug Monitoring; Oncology; Cardiology; Endocrinology; Infectious Disease Testing; Autoimmune Diseases; Other Applications
• 4) By End User: Research And Academic Laboratories; Pharmaceutical And Biotechnology Companies And CROs; Hospitals And Clinics; Clinical Laboratories
• Subsegments:
• 1) By Reagents And Kits: ELISA Kits; Rapid Test Kits; Control Reagents; Assay Development Reagents
• 2) By Analyzers Or Instruments: Automated Analyzers; Point-Of-Care Testing Devices; Microplate Readers; Luminometers
• 3) By Software And Services: Data Management Software; Analytical Software; Support And Maintenance Services; Consulting Services
• Companies Mentioned: Siemens Healthineers GmbH; bioMerieux; Abbott; Beckman Coulter Inc.; Quidel Corporation; Ortho Clinical Diagnostics; Sysmex Corporation; Bio-Rad Laboratories Inc.; Becton Dickinson and Company; F. Hoffmann-La Roche Ltd; Thermo Fisher Scientific Inc.; Merck KGaA; Agilent Technologies Inc.; PerkinElmer Inc; WAK-Chemie Medical GmbH; J Mitra & Co Pvt Ltd; Kamiya Biomedical Company; Tosoh Corporation; Gyros Protein Technologies AB; BioCheck Inc.; Bio-Techn; DiaSorin S.p.A; Meso Scale Diagnostics LLC; QIAGE; Randox Laboratories Ltd.; Shenzhen Mindray Bio-Medical Electronics Co Ltd; Danaher Corporation; Hologic Inc.; Tecan Trading AG; Eurofins Scientific; Abcam plc; Enzo Biochem Inc.; Luminex Corporation; Quanterix Corporation; Roche Diagnostics; ZEUS Scientific Inc.
• 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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