Infectious Disease Immunoassay Testing Market (2026 - 2033)

Infectious Disease Immunoassay Testing Market Summary

The global infectious disease immunoassay testing market size was valued at USD 8.9 billion in 2025 and is projected to grow from USD 9.1 billion in 2026 to USD 12.0 billion by 2033, at a CAGR of 4.0% from 2026 to 2033. The market in North America dominated with a revenue share of 47.7% in 2025.

Market Dynamics

Market Concentration & Characteristics

The infectious disease immunoassay testing industry demonstrates a high degree of innovation driven by advancements in automated chemiluminescent immunoassays (CLIA), multiplex immunoassays, and high-sensitivity antigen-detection technologies. Companies are increasingly focusing on improving assay sensitivity and specificity, as well as on automating workflows for infectious disease diagnostics. For instance, in 2025, Fujirebio highlighted advancements in its iTACT immunoassay technology integrated with the Lumipulse CLEIA platform to improve detection sensitivity for hepatitis B and hepatitis C viral antigens by reducing interference from antigen complexes and other interfering substances. Such innovations are supporting the development of more accurate, automated, and high-throughput infectious disease immunoassay testing solutions globally.

The infectious disease immunoassay testing industry is witnessing a moderate to high level of merger and acquisition activity as companies focus on strengthening immunoassay technology capabilities, expanding infectious disease testing portfolios, and improving decentralized diagnostic solutions. For instance, Fujirebio acquired Innogenetics to strengthen its specialty molecular and immunoassay testing capabilities, including infectious disease diagnostics and automated immunoassay technologies. Such acquisitions are supporting the development of advanced infectious disease immunoassay platforms with improved sensitivity, automation, and broader testing menus across hospitals and diagnostic laboratories globally.

Regulatory frameworks play a significant role in shaping the global market by ensuring the safety, accuracy, and clinical reliability of immunoassay-based diagnostic tests. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional health authorities impose stringent requirements for assay validation, clinical performance evaluation, manufacturing quality standards, and post-market surveillance. Updated regulatory frameworks, including the European Union In Vitro Diagnostic Regulation (IVDR), are increasing compliance requirements for manufacturers of ELISA, CLIA, rapid antigen tests, and multiplex immunoassays. These regulations are encouraging companies to invest in high-quality infectious disease testing technologies with improved sensitivity, specificity, and workflow automation across hospitals, diagnostic laboratories, blood banks, and public health agencies.

The infectious disease immunoassay testing industry is experiencing continuous expansion as diagnostic companies strengthen operational capabilities and increase investments in infectious disease testing infrastructure. The rising prevalence of infectious diseases, growing healthcare expenditure, and increasing demand for rapid, accessible diagnostic solutions are driving market participants to expand manufacturing capabilities, distribution networks, and strategic partnerships. Companies are increasingly focusing on developing cost-effective ELISA, CLIA, rapid antigen tests, and multiplex immunoassays to improve infectious disease detection and screening accessibility across healthcare settings. The growing adoption of immunoassay-based infectious disease testing solutions across hospitals, diagnostic laboratories, physician offices, and public health agencies continues to support global market expansion.

Disease Type Insights

The viral infections segment led the market with the largest revenue share of 63.0% in 2025, driven by the increasing global burden of HIV, hepatitis, influenza, RSV, COVID-19, and dengue infections, which require large-scale screening and surveillance. According to the World Health Organization (WHO), approximately 40.8 million people were living with HIV globally in 2024, supporting strong demand for ELISA, CLIA, rapid antigen tests, and combined antigen/antibody immunoassays. In addition, increasing influenza, RSV, and COVID-19 activity during the 2025 respiratory virus season accelerated adoption of multiplex immunoassays and rapid antigen testing solutions across hospitals, diagnostic laboratories, and public health agencies. The growing focus on early viral infection detection and outbreak surveillance continues to support the segment's global dominance.

The fungal infections segment is projected to grow at the fastest CAGR of 4.61% over the forecast period, fueled by the rising prevalence of invasive fungal infections among immunocompromised patient populations, including individuals with HIV/AIDS, cancer, organ transplants, and chronic respiratory diseases. According to a CDC report published in March 2026, more than 6,304 new clinical cases of Candida auris were reported in the United States in 2024, with cases continuing to increase significantly across healthcare facilities. The rising incidence of Candida auris, aspergillosis, and candidiasis is increasing demand for ELISA, CLIA, and antigen-based fungal immunoassay testing solutions across hospitals and diagnostic laboratories, further supporting segment growth globally.

Technology Insights

The ELISA segment led the market with the largest revenue share of 34.0% in 2025, driven by its high sensitivity, cost-effectiveness, ease of operation, and widespread use in routine infectious disease screening programs. Extensive use of ELISA-based assays for the detection of hepatitis, dengue, syphilis, parasitic infections, and healthcare-associated infections across diagnostic laboratories, blood banks, and public health agencies is contributing to the growth of the ELISA infectious disease testing market. According to a report published by the World Health Organization in July 2025, approximately 254 million people worldwide were living with hepatitis B infection, underscoring sustained demand for ELISA-based infectious disease screening and serological testing solutions. In addition, the technology offers high-throughput processing and compatibility with large-scale screening workflows, making it highly suitable for blood donor screening and infectious disease surveillance programs, thereby supporting continued serology testing dominance.

The multiplex immunoassay segment is projected to grow at the fastest CAGR of 10.19% over the forecast period, driven by increasing demand for simultaneous detection of multiple infectious pathogens from a single patient sample, improved diagnostic efficiency, and reduced turnaround time in infectious disease testing workflows. Multiplex immunoassays are increasingly utilized for respiratory infection panels, sexually transmitted infection screening, and blood-borne disease surveillance across hospitals, diagnostic laboratories, and public health agencies. The segment's growth is further supported by the increasing adoption of integrated multiplex rapid testing solutions that simultaneously detect HIV, hepatitis B, and syphilis infections for maternal healthcare and bloodscreening applications. Rising emphasis on outbreak management, infection surveillance, and high-throughput laboratory testing continues to support rapid segment growth globally.

Test Type Insights

The antibody testing segment led the market with the largest revenue share of 41.2% in 2025, driven by its widespread use in infectious disease screening, serological surveillance, blood donor testing, and long-term infection monitoring. Antibody-based immunoassays are widely used to detect HIV, hepatitis, dengue, syphilis, and other viral and bacterial infections in hospitals, diagnostic laboratories, blood banks, and public health agencies. The segment continues to benefit from increasing adoption of automated ELISA and CLIA platforms capable of processing high testing volumes with improved sensitivity and workflow efficiency. In addition, the growing emphasis on preventive healthcare, routine infectious disease screening, and seroprevalence studies continues to support strong global demand for antibody testing solutions.

The combined AG/AB tests segment is projected to grow at the fastest CAGR of 11.19% over the forecast period, driven by increasing demand for early-stage infectious disease detection, improved diagnostic accuracy, and shorter diagnostic windows compared to standalone antigen or antibody tests. Combined antigen/antibody immunoassays are increasingly utilized for HIV, hepatitis, and sexually transmitted infection screening across hospitals, blood banks, diagnostic laboratories, and public health agencies. For instance, a November 2024 study published in the Journal of Medical Virology reported that fourth-generation HIV rapid tests demonstrated enhanced sensitivity and reduced diagnostic window periods by simultaneously detecting HIV p24 antigen and HIV antibodies, supporting the growing adoption of combined Ag/Ab immunoassays in infectious disease screening programs globally.

End Use Insights

The hospitals segment led the market with the largest revenue share of 37.7% in 2025, driven by the high volume of infectious disease testing performed across inpatient, emergency, and critical care settings. Hospitals extensively utilize ELISA, CLIA, rapid antigen tests, fluorescent immunoassays, and multiplex immunoassays for diagnosis and monitoring of respiratory infections, HIV, hepatitis, sexually transmitted infections, and healthcare-associated infections. The segment's growth is further supported by the increasing adoption of high-sensitivity automated CLIA systems in hospital laboratories. For instance, a December 2024 study published in IJID Regions reported thatthe Mindray CL-900i HBsAg chemiluminescence immunoassay demonstrated 97% sensitivity and 100% specificity for hepatitis B surface antigen screening, supporting the growing use of automated CLIA-based infectious disease testing workflows across hospital settings. The increasing emphasis on rapid clinical decision-making, infection surveillance, and outbreak management continues to support the segment's global dominance.

The public health agencies segment is projected to grow at the fastest CAGR of 7.62% over the forecast period, driven by increasing government-led infectious disease surveillance programs, outbreak monitoring initiatives, and expansion of population-scale screening activities for HIV, hepatitis, tuberculosis, sexually transmitted infections, and respiratory diseases. Public health agencies are increasingly adopting ELISA, CLIA, rapid antigen tests, and multiplex immunoassays to support early disease detection and infection control programs. Growth of the segment is further supported by increasing implementation of integrated multiplex rapid immunoassay testing solutions capable of simultaneously detecting HIV, hepatitis B, and syphilis infections in maternal health and community screening programs. Rising focus on pandemic preparedness, blood safety monitoring, and infectious disease surveillance continues to accelerate adoption of immunoassay infectious diagnostics solutions across public health settings globally.

Regional Insights

North America dominated the global infectious disease immunoassay testing market with the largest revenue share of 47.7% in 2025, driven by advanced healthcare infrastructure, high infectious disease testing volumes, the strong presence of leading diagnostic companies, and widespread adoption of automated immunoassay technologies. The region demonstrates high utilization of ELISA, CLIA, rapid antigen tests, fluorescent immunoassays, and multiplex immunoassays across hospitals, diagnostic laboratories, blood banks, and public health agencies. The growing prevalence of respiratory viral infections, sexually transmitted infections, healthcare-associated infections, and chronic viral diseases such as HIV and hepatitis continues to support demand for immunoassay infectious diagnostics solutions. In addition, increasing government funding for infectious disease surveillance, blood safety screening, and outbreak preparedness programs further contributes to regional market dominance.

U.S. Infectious Disease Immunoassay Testing Market Trends

The infectious disease immunoassay testing market in the U.S. accounted for the largest market revenue share in North America in 2025, owing to high adoption of advanced immunodiagnostic technologies, large-scale infectious disease screening programs, and strong healthcare spending. The country continues to witness significant demand for ELISA, CLIA, rapid antigen tests, and multiplex immunoassays for the diagnosis of respiratory infections, HIV, hepatitis, sexually transmitted infections, and healthcare-associated infections. Increasing hospital admissions associated with influenza, RSV, COVID-19, and fungal infections are accelerating the utilization of rapid immunoassay testing solutions across hospitals and emergency care settings. In addition, strong regulatory support for blood donor screening and infectious disease surveillance programs, combined with the growing adoption of automated, high-throughput immunoassay analyzers across clinical laboratories, continues to support immunoassay infectious diagnostics market growth in the country.

Europe Infectious Disease Immunoassay Testing Market Trends

The infectious disease immunoassay testing market in Europe is supported by strong public healthcare systems, rising infectious disease surveillance, and the growing adoption of automated laboratory diagnostics. The region demonstrates extensive utilization of ELISA, CLIA, and multiplex immunoassay technologies for screening and monitoring of HIV, hepatitis, respiratory infections, and sexually transmitted infections. The continued focus on infection prevention, antimicrobial resistance management, and blood safety programs supports the growth of immunoassay-based infectious disease testing across hospitals, public health laboratories, and diagnostic centers. In addition, the implementation of stringent regulatory frameworks, such as the European Union In Vitro Diagnostic Regulation (IVDR), is encouraging the development and commercialization of highly sensitive, clinically validated infectious disease immunoassay solutions across the region.

The UK infectious disease immunoassay testing market is driven by growing demand for rapid infectious disease diagnostics, strong public health surveillance initiatives, and increasing utilization of automated immunoassay testing systems across National Health Service (NHS) laboratories and hospitals. The rising prevalence of respiratory, sexually transmitted, and healthcare-associated infections is driving higher testing volumes for ELISA, CLIA, rapid antigen tests, and multiplex immunoassays. The continued focus on early disease detection, outbreak preparedness, and blood donor screening supports the adoption of immunoassay-based infectious disease diagnostics. In addition, expansion of laboratory modernization initiatives and growing integration of high-throughput automated testing platforms across clinical laboratories are further supporting market growth in the UK.

The infectious disease immunoassay testing market in Germany is supported by advanced laboratory infrastructure, strong healthcare expenditure, and increasing adoption of automated immunodiagnostic technologies. Hospitals, diagnostic laboratories, and public health institutions extensively utilize ELISA, CLIA, and multiplex immunoassays for diagnosis and surveillance of respiratory infections, hepatitis, HIV, and healthcare-associated infections. The rising focus on infection control and antimicrobial resistance monitoring is driving increased demand for rapid, high-sensitivity infectious disease testing solutions. In addition, Germany’s strong presence in the in vitro diagnostics industry and growing investments in laboratory automation and infectious disease surveillance programs continue to support market expansion. The increasing use of high-throughput immunoassay analyzers in centralized laboratories further strengthens demand for infectious disease immunoassay testing solutions in the country.

Asia-Pacific Infectious Disease Immunoassay Testing Market Trends

The infectious disease immunoassay testing market in the Asia Pacific is projected to witness the fastest CAGR during the forecast period, driven by rising infectious disease burden, improved healthcare infrastructure, and increased government initiatives for disease surveillance and screening programs. The growing prevalence of dengue, hepatitis, tuberculosis, respiratory viral infections, and sexually transmitted infections is significantly increasing demand for ELISA, CLIA, rapid antigen tests, and multiplex immunoassays across hospitals and diagnostic laboratories. Expanding healthcare access, rising healthcare expenditure, and increasing awareness regarding early infectious disease diagnosis are further supporting market growth. In addition, the growing adoption of decentralized diagnostic solutions and the expansion of laboratory networks across developing healthcare systems continue to accelerate the utilization of infectious disease immunoassay testing technologies throughout the region.

The Japan infectious disease immunoassay testing market is driven by strong adoption of advanced diagnostic technologies, increasing elderly population, and growing focus on infectious disease surveillance and healthcare preparedness. The country demonstrates significant utilization of automated CLIA systems, ELISA platforms, and multiplex immunoassays for the diagnosis of respiratory infections, hepatitis, and healthcare-associated infections across hospitals and clinical laboratories. The increasing emphasis on high-sensitivity diagnostic testing and workflow automation is supporting the adoption of advanced immunoassay analyzers in centralized laboratory settings. In addition, continuous technological innovation by domestic diagnostic manufacturers and growing investments in laboratory automation are expanding infectious disease immunoassay testing capabilities nationwide.

The infectious disease immunoassay testing market in China is experiencing substantial growth driven by rising infectious disease prevalence, expanding healthcare infrastructure, and increased investments in diagnostic technology development. The growing demand for rapid, large-scale screening for infectious diseases is accelerating the adoption of ELISA, CLIA, rapid antigen tests, and multiplex immunoassays across hospitals, public health laboratories, and diagnostic centers. Increasing government initiatives for infectious disease surveillance, blood safety monitoring, and outbreak preparedness are further supporting market expansion. In addition, the rapid growth of domestic diagnostic manufacturing capabilities and the increasing integration of automated immunoassay analyzers across healthcare facilities continue to strengthen the country's infectious disease testing capacity.

Latin America Infectious Disease Immunoassay Testing Market Trends

The infectious disease immunoassay testing market in Latin America is witnessing steady growth due to the increasing prevalence of dengue, hepatitis, HIV, and other infectious diseases requiring routine screening and surveillance. The growing demand for rapid infectious disease diagnostics and the need to improve access to healthcare services are driving the adoption of ELISA, CLIA, rapid antigen tests, and multiplex immunoassays across hospitals and diagnostic laboratories. Governments and public health agencies are increasingly focusing on expanding infectious disease screening programs and outbreak management initiatives to improve early diagnosis and infection control. In addition, rising investments in laboratory infrastructure and increasing awareness regarding preventive healthcare and blood safety screening are contributing to market growth across the region.

Middle East & Africa Infectious Disease Immunoassay Testing Market Trends

The infectious disease immunoassay testing market in the Middle East & Africa is growing due to the rising burden of infectious diseases, improved healthcare infrastructure, and increased government focus on infectious disease surveillance and screening initiatives. The growing prevalence of hepatitis, HIV, tuberculosis, respiratory infections, and healthcare-associated infections is increasing demand for ELISA, CLIA, rapid antigen tests, and multiplex immunoassays across hospitals and public health laboratories. Expansion of healthcare access, increasing investments in laboratory modernization, and rising implementation of blood donor screening programs are further supporting market growth. In addition, the growing adoption of cost-effective, rapid infectious disease testing solutions in developing healthcare systems continues to support immunoassay infectious diagnostics market expansion across the region.

Key Infectious Disease Immunoassay Testing Company Insights

The infectious disease immunoassay testing industry is moderately consolidated, with leading companies focusing on expanding ELISA, CLIA, rapid antigen tests, fluorescent immunoassays, and multiplex immunoassay portfolios. Market participants are increasingly investing in automated chemiluminescence immunoassay (CLIA) systems, multiplex respiratory infection testing solutions, and rapid antigen technologies to improve diagnostic efficiency and strengthen infectious disease testing capabilities.

The growing focus on workflow automation, high-throughput testing, and decentralized diagnostic solutions is further supporting the adoption of immunoassay-based infectious disease testing across hospitals, diagnostic laboratories, physician offices, blood banks, and public health agencies globally.

Key Infectious Disease Immunoassay Testing Companies

The following key companies have been profiled for this study on the infectious disease immunoassay testing market.

• Abbott

• Siemens Healthineers

• Danaher Corporation (Beckman Colter)

• bioMerieux SA

• Quidel Corporation

• Sysmex Corporation

• Ortho Clinical Diagnostics

• Bio-Rad Laboratories, Inc.

• F. Hoffmann-La Roche AG

• Becton, Dickinson, and Company

• Thermo Fisher Scientific, Inc.

Competitive Benchmarking

Recent Developments

• In July 2025, the World Health Organization (WHO) prequalified the first rapid diagnostic test panel capable of simultaneously detecting HIV, hepatitis B, and syphilis infections. The immunoassay-based rapid testing solution is expected to support expansion of maternal health screening, blood safety programs, and integrated infectious disease surveillance initiatives globally, thereby increasing adoption of rapid antigen and antibody testing technologies.

• In 2025, Fujirebio highlighted advancements in its Lumipulse chemiluminescence enzyme immunoassay (CLEIA) platform integrated with iTACT technology for infectious disease testing applications. The technology was designed to improve detection sensitivity for hepatitis B and hepatitis C viral antigens by reducing interference from antigen complexes and other substances. The development is supporting growing adoption of high-sensitivity automated CLIA/CLEIA infectious disease immunoassay systems across hospitals, diagnostic laboratories, and blood screening facilities globally.

Infectious Disease Immunoassay Testing Market Report Scope

Global Infectious Disease Immunoassay Testing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global infectious disease immunoassay testing market report based on disease type, technology, test type, technology, and region:

• Disease Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Viral infections

  • Bacterial infections

  • Fungal infections

  • Parasitic infections

• Technology Outlook (Revenue, USD Million, 2021 - 2033)

  • ELISA

  • CLIA

  • Rapid antigen tests

  • Fluorescent immunoassay

  • Multiplex immunoassay

• Test Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Antigen testing

  • Antibody testing

  • Combined Ag/Ab tests

  • Toxin assays

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals

  • Diagnostic labs

  • Physician offices

  • Blood banks

  • Public health agencies

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

Delivered Customizations

This report has been delivered with the following In-depth customizations