Infectious Disease Testing Market By Product Type (Instruments, Kits & reagents, and Software), By Application (Immunodiagnostics, PCR, and DNA Sequencing & NGS), By End-user (Hospitals/Clinical Laboratories, Physician Offices, Reference Laboratories, and Academic/Research Institutes), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The Global Infectious Disease Testing Market size is expected to be worth around US$ 31.2 Billion by 2034, from US$ 24.4 Billion in 2024, growing at a CAGR of 2.5% during the forecast period from 2025 to 2034.

Increasing global awareness of infectious diseases and the need for rapid, accurate diagnostics have significantly propelled the infectious disease testing market. Advancements in diagnostic technologies, such as point-of-care (POC) testing and rapid diagnostic tests, have enhanced the speed and accuracy of disease detection, facilitating timely interventions. The rising prevalence of infectious diseases, including respiratory infections, sexually transmitted infections (STIs), and vector-borne diseases, has intensified the demand for effective diagnostic solutions.

Additionally, the growing geriatric population, which is more susceptible to infections, further contributes to the market’s expansion. The COVID-19 pandemic underscored the critical need for efficient diagnostic tools, leading to increased investments in research and development. This surge in funding has accelerated the development of innovative diagnostic platforms, such as molecular diagnostics and next-generation sequencing technologies.

The shift towards decentralized testing, with a focus on POC diagnostics, has improved accessibility and reduced turnaround times, benefiting both patients and healthcare providers. Furthermore, the integration of artificial intelligence and machine learning in diagnostic processes has enhanced the accuracy and efficiency of disease detection. The market is also witnessing a trend towards personalized medicine, where diagnostic tests are tailored to individual genetic profiles, enabling more effective treatment strategies.

In April 2022, Variohm EuroSensor introduced a next-generation NTC thermistor designed to detect subtle temperature variations within the human body and surrounding medical environments. This innovation enhances the precision of patient monitoring and supports improved diagnostics in healthcare applications. These developments collectively drive the growth of the infectious disease testing market, offering new opportunities for stakeholders and improving patient outcomes.

Key Takeaways

• In 2023, the market for infectious disease testing generated a revenue of US$ 24.4 billion, with a CAGR of 2.5%, and is expected to reach US$ 31.2 billion by the year 2033.
• The product type segment is divided into instruments, kits & reagents, and software, with kits & reagents taking the lead in 2023 with a market share of 53.2%.
• Considering application, the market is divided into immunodiagnostics, PCR, and DNA sequencing & NGS. Among these, PCR held a significant share of 52.5%.
• Furthermore, concerning the end-user segment, the market is segregated into hospitals/clinical laboratories, physician offices, reference laboratories, and academic/research institutes. The hospitals/clinical laboratories sector stands out as the dominant player, holding the largest revenue share of 49.7% in the infectious disease testing market.
• North America led the market by securing a market share of 38.5% in 2023.

Product Type Analysis

The kits & reagents segment led in 2023, claiming a market share of 53.2% as diagnostic testing becomes increasingly crucial for managing and controlling infectious diseases. The demand for diagnostic kits and reagents is anticipated to rise due to the increasing prevalence of infectious diseases worldwide, coupled with the need for rapid and accurate testing.

The growing adoption of point-of-care testing and home diagnostics is likely to drive the use of kits and reagents, as these products enable easy and convenient testing. Additionally, advancements in reagent technologies and the increasing availability of specialized kits for detecting a wide range of pathogens are projected to further boost the segment. The growing awareness of the importance of early detection and the desire for more accessible testing options are expected to contribute to the segment’s continued growth.

Application Analysis

The PCR held a significant share of 52.5% due to its widespread adoption in the detection and diagnosis of infectious diseases. PCR (Polymerase Chain Reaction) testing has become the gold standard for identifying pathogens with high sensitivity and specificity. As the demand for accurate, rapid diagnostic tests for diseases like COVID-19, HIV, and tuberculosis increases, the PCR segment is likely to expand.

The ability of PCR to detect low levels of pathogen DNA or RNA makes it essential for early diagnosis, driving its adoption in clinical laboratories and healthcare settings. Furthermore, ongoing advancements in PCR technology, such as real-time PCR and multiplex PCR, are anticipated to further enhance its applications in infectious disease testing, leading to broader usage in both developed and emerging markets.

End-user Analysis

The hospitals/clinical laboratories segment had a tremendous growth rate, with a revenue share of 49.7% as healthcare systems continue to prioritize the timely diagnosis of infectious diseases. Hospitals and clinical laboratories are likely to remain key end-users of infectious disease testing solutions, driven by their central role in patient care. The rising burden of infectious diseases, such as COVID-19, influenza, and antimicrobial-resistant infections, is expected to increase the demand for diagnostic testing in these settings.

Additionally, hospitals and clinical laboratories are projected to benefit from advancements in testing technologies, such as PCR and rapid antigen tests, which provide quick and accurate results. The growing focus on infection control and the need for precise diagnostics in hospital settings are anticipated to contribute to the expansion of this segment. As healthcare facilities continue to invest in diagnostic infrastructure, this segment is likely to see continued growth.

Key Market Segments

By Product Type

• Instruments
• Kits & reagents
• Software

By Application

• Immunodiagnostics
• PCR
• DNA Sequencing & NGS

By End-user

• Hospitals/Clinical Laboratories
• Physician Offices
• Reference Laboratories
• Academic/Research Institutes

Drivers

Rising Incidence of Infectious Diseases is Driving the Market

The increasing prevalence of infectious diseases significantly propels the infectious disease testing market. For instance, syphilis cases in the United States have surged by 80% over the past five years, with more than 200,000 diagnoses reported in 2022. This alarming rise underscores the urgent need for enhanced diagnostic capabilities to facilitate early detection and treatment. In response, the National Institutes of Health (NIH) allocated $2.4 million in 2024 to advance syphilis testing methodologies.

Such investments aim to develop more accurate and rapid diagnostic tools, addressing the growing demand for effective infectious disease management. The escalation of sexually transmitted infections exemplifies a broader trend of increasing infectious diseases, necessitating robust testing solutions. Consequently, healthcare systems are prioritizing the expansion and improvement of diagnostic infrastructures to combat these public health challenges effectively.

Restraints

Data Privacy and Security Concerns are Restraining the Market

Despite advancements in diagnostic technologies, data privacy and security concerns pose significant challenges to the infectious disease testing market. The handling and sharing of sensitive patient information during testing processes raise the risk of data breaches and unauthorized access. In 2022, the U.S. Department of Health and Human Services (HHS) reported over 700 healthcare data breaches, affecting more than 52 million individuals. These incidents highlight vulnerabilities in health information systems and contribute to hesitancy among patients and providers to fully engage in testing initiatives.

Ensuring compliance with regulations such as the Health Insurance Portability and Accountability Act (HIPAA) adds complexity and cost to implementing diagnostic solutions. Organizations must invest in advanced security measures and continuous monitoring to protect patient data, which can be resource-intensive. Balancing the need for comprehensive testing with stringent privacy protections remains a critical hurdle in advancing infectious disease diagnostics.

Opportunities

Integration of Artificial Intelligence (AI) is Creating Growth Opportunities

The integration of Artificial Intelligence (AI) into infectious disease diagnostics presents a significant opportunity for the market. AI can analyze vast amounts of health data to identify patterns, predict outbreaks, and support clinical decisions. In 2023, the National Institutes of Health (NIH) launched the Bridge2AI program, allocating $130 million to accelerate the use of AI in biomedical and behavioral research.

This initiative aims to create interoperable datasets that AI technologies can leverage to improve health outcomes. By standardizing data and enhancing its accessibility, AI integration facilitates more efficient and accurate information exchange among healthcare systems. This advancement not only improves patient care but also streamlines administrative processes. As AI technologies continue to evolve, their incorporation into diagnostic solutions is poised to transform healthcare delivery.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors significantly influence the infectious disease testing market. Economic growth enables increased investment in healthcare infrastructure, facilitating the development and distribution of advanced diagnostic tools. Conversely, economic downturns can lead to budget constraints, hindering access to essential testing services. Geopolitical tensions may disrupt global supply chains, affecting the availability of critical diagnostic equipment and reagents. For instance, trade disputes can result in tariffs or export restrictions, leading to increased costs and delays.

However, these challenges can also drive innovation, as companies seek to develop cost-effective and locally sourced solutions. Government policies promoting healthcare investment and international collaboration can further stimulate market growth. Overall, while macroeconomic and geopolitical factors present both challenges and opportunities, proactive strategies can help navigate this complex landscape.

Trends

Shift Towards At-Home Testing Solutions is Driving the Market

A notable trend in the infectious disease testing market is the transition towards at-home diagnostic solutions. The demand for accessible and private testing options has increased, particularly for sexually transmitted infections (STIs). In 2024, at-home STI tests for chlamydia and gonorrhea became available in Australia, marking the country’s first such diagnostic option.

These tests aim to provide quick and confidential diagnoses amid rising infection rates, with chlamydia and gonorrhea cases surging by 26% and 157%, respectively, over the past decade. The convenience of self-testing encourages more individuals to seek timely diagnosis and treatment, potentially reducing the spread of infections. This trend reflects a broader movement towards patient-centered healthcare, where individuals take proactive roles in managing their health. As technology advances, the availability and accuracy of at-home testing kits are expected to improve, further driving market growth.

Regional Analysis

North America is leading the Infectious Disease Testing Market

North America dominated the market with the highest revenue share of 38.5% owing to several key factors. The increasing prevalence of infectious diseases, such as respiratory infections and sexually transmitted diseases, raised the demand for diagnostic testing across healthcare settings. For example, the Centers for Disease Control and Prevention (CDC) reported a 16% increase in tuberculosis cases in the U.S. in 2023 compared to the previous year. Advancements in diagnostic technologies, including point-of-care testing and molecular diagnostics, significantly improved the speed and accuracy of disease detection, contributing to the market’s growth.

The widespread adoption of these technologies in healthcare facilities increased the accessibility of testing, especially in outpatient and emergency care settings. Additionally, increased healthcare spending and government initiatives aimed at improving disease surveillance and control further fueled market expansion. The growing reliance on faster and more accurate diagnostic tools, particularly for emerging infectious diseases, also played a critical role in strengthening the market’s growth trajectory.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to an increasing population and rising healthcare needs. The demand for diagnostic solutions is projected to grow due to the rising prevalence of infectious diseases such as malaria, influenza, and HIV in the region. The expansion of healthcare infrastructure, particularly in developing countries like India and China, will support the adoption of advanced diagnostic technologies. Governments across Asia Pacific are focusing on improving public health systems and expanding disease surveillance programs, which will likely increase the demand for effective diagnostic testing.

For example, India’s increased budget allocation for its fisheries sector to enhance aquaculture production is indicative of the region’s broader efforts to improve healthcare and disease management. The region’s growing healthcare expenditures and focus on disease prevention are expected to drive a sustained demand for advanced infectious disease testing solutions, with innovations in diagnostics expected to further support the market’s expansion over the coming years.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

Key players in the infectious disease testing market focus on developing rapid, accurate, and user-friendly diagnostic solutions to meet the growing demand for early disease detection. Companies invest in advanced technologies like PCR, next-generation sequencing, and antigen tests to enhance testing accuracy and speed. Strategic partnerships with hospitals, research institutions, and governments help expand testing capabilities and access in both clinical and point-of-care settings. Many players also prioritize the development of multiplex tests to identify multiple pathogens simultaneously, improving efficiency.

Geographic expansion into regions with increasing healthcare infrastructure supports market growth. Thermo Fisher Scientific is a leading company in this market, offering innovative diagnostic solutions such as the Applied Biosystems PCR systems for detecting infectious agents. The company focuses on continuous innovation and expanding its portfolio to address a broad range of infectious diseases. Thermo Fisher’s commitment to precision diagnostics and global accessibility positions it as a key player in the industry.

Top Key Players in the Infectious Disease Testing Market

• SEKISUI Diagnostics
• Tangen Biosciences
• Thermo Fisher Scientific
• Abbott Laboratories
• Roche Diagnostics
• Siemens Healthineers
• Bio-Rad Laboratories
• Beckman Coulter

Recent Developments

• In March 2024, SEKISUI Diagnostics secured Emergency Use Authorization (EUA) for its OSOM Flu SARS-CoV-2 Combo Test, allowing its deployment in both clinical and at-home testing environments. This approval expands access to rapid diagnostics for flu and COVID-19 detection.
• In October 2023, Tangen Biosciences and SD Biosensor gained EUA clearance from the U.S. FDA for their rapid point-of-care SARS-CoV-2 tests. These authorizations enable broader use of their diagnostic tools in healthcare settings, enhancing early detection and response efforts.

Report Scope