Immunoassay Global Market Report 2025

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.

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 $35.81 billion in 2024 to $37.63 billion in 2025 at a compound annual growth rate (CAGR) of 5.1%. The growth in the historic period can be attributed to disease prevalence, aging population, infectious disease outbreaks, point-of-care testing, increased research funding.

The immunoassay market size is expected to see strong growth in the next few years. It will grow to $50.12 billion in 2029 at a compound annual growth rate (CAGR) of 7.4%. The growth in the forecast period can be attributed to personalized medicine, expansion in emerging markets, pandemic preparedness, cancer diagnostics, shift to home-based testing. Major trends in the forecast period include regulatory harmonization efforts, multipurpose immunoassays, customized assay services, integration with wearable devices, and miniaturization of assays.

The growing prevalence of infectious and chronic diseases is expected to drive the growth of the immunoassay market in the near future. Chronic illnesses are generally defined as conditions that last for a year or longer, require ongoing medical attention, restrict daily activities, or both. Infectious diseases are illnesses caused by organisms such as bacteria, viruses, fungi, or parasites. Numerous organisms coexist within and on the human body, and several infectious diseases can be transmitted from one person to another. Immunoassays are utilized to detect various infectious and chronic diseases. For example, a report from the National Institutes of Health (NIH), a US-based biomedical research agency, stated that in 2023, the number of individuals aged 50 and older in the United States with at least one chronic illness is projected to increase by 99.5%, from 71.522 million in 2020 to 142.66 million by 2050. Moreover, the number of people with multimorbidity is expected to rise by 91.16%, from 7.8304 million in 2020 to 14.968 million by 2050. Therefore, the increasing incidence of infectious and chronic diseases is driving market growth.

Government-led research and development initiatives in healthcare are anticipated to support the growth of the immunoassay market in the future. These initiatives refer to specific actions, programs, policies, or projects undertaken by government authorities at various levels-local, regional, national, or international-to tackle specific issues, achieve certain objectives, or foster positive changes in society. Such initiatives have aimed at improving access to diagnostic testing, enhancing healthcare quality, and addressing public health challenges, thereby driving demand for immunoassays. For instance, in 2022, the Department of Health and Social Care, a UK government authority, announced £260 million (US$270.65 million) in funding to enhance healthcare research and manufacturing. This commitment, made by BEIS and DHSC, was aimed at supporting NHS-led health research into diagnostics and treatment through new privacy-preserving platforms and clinical research services, along with £60 million (US$63.60 million) to aid in expanding life sciences manufacturing in the UK. Consequently, the growth of government initiatives in healthcare is driving the immunoassay market.

A key trend gaining momentum is product innovation, with major companies striving to strengthen their market position through cutting-edge offerings. For instance, Getein Biotech Inc., a China-based biotechnological company, introduced the MAGICL 6000 at MEDICA 2022. This portable chemiluminescence immunoassay analyzer is designed for labs with mid- to high-workflow requirements, providing a one-step chemiluminescence solution. The instrument stands out for its efficiency, compact size, complete automation, and rapid assessment frequency, offering a technologically advanced option for diagnostic laboratories.

Major players in the immunoassay market are introducing innovative immunoassay analyzers to gain a competitive advantage. These analyzers automate the detection and quantification of biological molecules, such as proteins or hormones, through immunological reactions. Beckman Coulter Diagnostics launched the DxI 9000 Access Immunoassay Analyzer in May 2023, addressing the needs of clinical laboratories for speed, reliability, reproducibility, and expanded menu options. The analyzer incorporates advanced features such as new analyte processing and detection technology, precision sensors, smart algorithms, and remote real-time system monitoring. Its distinctive feature includes no daily maintenance, enhancing its efficiency in diagnostic workflows.

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 include 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 2024. 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, 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, 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 Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on 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.

Reasons to Purchase

• Gain a truly global perspective with the most comprehensive report available on this market covering 15 geographies.
• Assess the impact of key macro factors such as conflict, pandemic and recovery, inflation and interest rate environment and the 2nd Trump presidency.
• Create regional and country strategies on the basis of local data and analysis.
• Identify growth segments for investment.
• Outperform competitors using forecast data and the drivers and trends shaping the market.
• Understand customers based on the latest market shares.
• Benchmark performance against key competitors.
• Suitable for supporting your internal and external presentations with reliable high quality data and analysis
• Report will be updated with the latest data and delivered to you within 2-3 working days of order along with an Excel data sheet for easy data extraction and analysis.
• All data from the report will also be delivered in an excel dashboard format.

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? 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, competitive landscape, market shares, 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.
• 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 forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.

• 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. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
• 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 trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.

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; Home Care Settings; Pharmaceutical And Biotechnology Companies And CROs; Blood Banks; 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
• Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain
• Regions: Asia-Pacific; 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.
• Delivery format: PDF, Word and Excel Data Dashboard.