Global Infectious Disease Diagnostics Market Size, Share and Trends Analysis Report – Industry Overview and Forecast to 2033

Infectious Disease Diagnostics Market Size

• The global infectious disease diagnostics market size was valued at USD 26.63 billion in 2025 and is expected to reach USD 41.80 billion by 2033, at a CAGR of 5.8% during the forecast period
• The market growth is largely fueled by the rising global burden of infectious diseases (such as HIV, tuberculosis, hepatitis, and emerging viral outbreaks), coupled with advancements in molecular diagnostics, rapid testing technologies, and point‑of‑care solutions that enable quicker and more accurate disease detection in both clinical and decentralized settings
• Furthermore, increasing healthcare investments, public health initiatives, and growing demand for early and precise diagnostics to improve patient outcomes and strengthen epidemic preparedness are driving the uptake of infectious disease diagnostics solutions worldwide, significantly boosting the industry’s growth

Infectious Disease Diagnostics Market Analysis

• Infectious disease diagnostics, encompassing molecular, serological, and point-of-care tests, are becoming essential tools in modern healthcare systems for timely detection, monitoring, and management of infectious diseases across clinical, hospital, and decentralized settings due to their accuracy, speed, and integration with digital health platforms
• The growing demand for infectious disease diagnostics is primarily driven by the rising prevalence of infectious diseases, increasing government and private healthcare initiatives for early detection, and the need for rapid, reliable, and cost-effective testing solutions, particularly in outbreak scenarios
• North America dominated the infectious disease diagnostics market with the largest revenue share of 38.5% in 2025, supported by advanced healthcare infrastructure, high adoption of innovative diagnostic technologies, and a strong presence of leading industry players. The U.S. has seen substantial growth in testing adoption across hospitals and diagnostic laboratories, fueled by innovations in PCR and immunodiagnostic technologies as well as rapid point-of-care solutions
• Asia-Pacific is expected to be the fastest growing region in the infectious disease diagnostics market during the forecast period due to increasing healthcare expenditure, growing awareness of infectious diseases, and expanding healthcare infrastructure in emerging economies
• Reagents segment dominated the infectious disease diagnostics market with a market share of 44.2% in 2025, driven by their critical role in laboratory and point-of-care testing, wide applicability across bacterial, viral, and fungal infections, and growing utilization in both conventional and molecular diagnostic techniques

Report Scope and Infectious Disease Diagnostics Market Segmentation     

Infectious Disease Diagnostics Market Trends

Expansion of Rapid and Point-of-Care Testing

• A significant and accelerating trend in the global infectious disease diagnostics market is the growing adoption of rapid and point-of-care (POC) testing platforms, which provide timely results outside traditional laboratory settings, enabling faster clinical decision-making
  • For instance, Abbott’s ID NOW COVID-19 test delivers results in under 15 minutes, allowing clinics and small healthcare facilities to quickly identify infections and reduce patient wait times
• Integration of POC testing with digital health platforms and mobile reporting apps enables seamless result sharing with healthcare providers and public health authorities, improving response times for disease management
• These portable and easy-to-use testing solutions facilitate decentralized diagnostics, reaching remote or resource-limited areas, and supporting mass screening initiatives during outbreaks
• This trend towards faster, more accessible, and connected diagnostic solutions is reshaping healthcare delivery models, as companies such as Cepheid develop cartridge-based molecular assays compatible with small automated analyzers for rapid, on-site testing
• The demand for rapid and POC infectious disease diagnostics is growing rapidly across both hospitals and ambulatory clinics, as healthcare systems increasingly prioritize timely detection and outbreak containment
• Integration of AI and data analytics in diagnostic devices is enhancing predictive capabilities, helping detect outbreaks earlier and providing actionable insights for healthcare decision-making

Infectious Disease Diagnostics Market Dynamics

Driver

Rising Prevalence of Infectious Diseases and Healthcare Awareness

• The increasing incidence of bacterial, viral, and fungal infections worldwide, coupled with greater awareness of early diagnosis benefits, is a significant driver for the heightened demand for infectious disease diagnostics
  • For instance, in March 2025, Roche launched the cobas Liat SARS-CoV-2 & Influenza A/B test, enabling simultaneous detection of multiple respiratory pathogens in a single assay, supporting faster clinical interventions
• As governments and healthcare providers prioritize infection control and epidemic preparedness, diagnostic solutions offering high accuracy and rapid turnaround are increasingly adopted in hospitals and laboratories
• Furthermore, growing investment in healthcare infrastructure and expansion of diagnostic networks in emerging economies is supporting the widespread adoption of advanced testing platforms
• Increasing patient awareness of early detection benefits and demand for convenient, reliable testing solutions are key factors propelling the adoption of infectious disease diagnostics in both clinical and point-of-care settings
• The rise of telemedicine and home healthcare services is driving demand for portable diagnostic kits, allowing patients to test at home and share results digitally with physicians
• Collaboration between diagnostic companies and governments for epidemic preparedness programs is boosting large-scale deployment of infectious disease testing solutions in high-risk regions

Restraint/Challenge

High Cost and Regulatory Compliance Hurdles

• The high cost of advanced molecular diagnostic assays and POC platforms, along with complex regulatory requirements, poses a significant challenge to broader market penetration, particularly in developing regions
  • For instance, the price of multiplex PCR panels for respiratory infections remains prohibitive for small clinics or low-income regions, limiting access to these advanced testing solutions
• Strict regulatory approvals and certification requirements for diagnostic devices, such as FDA or CE marking, can delay market entry and increase development costs for manufacturers
• In addition, limited trained personnel to operate sophisticated molecular platforms in certain regions may hinder adoption, especially in decentralized or remote healthcare settings
• Overcoming these challenges through cost-effective assay development, simplified testing workflows, and streamlined regulatory pathways will be vital for sustained market growth
• Supply chain disruptions and shortages of critical reagents or instruments during global outbreaks can constrain the availability of diagnostic tests, limiting market growth
• Concerns regarding data privacy and secure handling of patient test results in digital diagnostic platforms may slow adoption, particularly in regions with strict data protection regulations

Infectious Disease Diagnostics Market Scope

The market is segmented on the basis of product, test, technology, techniques, condition, and end user

• By Product

On the basis of product, the infectious disease diagnostics market is segmented into reagents, assays, and instruments. The reagents and assays segment dominated the market with the largest revenue share of 44.2% in 2025, driven by their critical role in ensuring accurate laboratory and point-of-care testing. Reagents and assays are essential for performing molecular, immunodiagnostic, and microbiology tests, ensuring reliable results across bacterial, viral, and fungal infections. Their versatility and high reproducibility make them indispensable for both routine diagnostics and outbreak management. In addition, continuous innovations, such as multiplex assays and rapid test kits, enhance workflow efficiency and reduce turnaround time. The segment also benefits from growing adoption in emerging markets with expanding healthcare infrastructure.

The instruments segment is expected to witness the fastest growth rate during 2026–2033, fueled by rising automation in laboratories and the deployment of portable and integrated diagnostic analyzers. Instruments such as PCR machines, automated immunoassay analyzers, and NGS platforms enable high-throughput testing, faster results, and improved accuracy. Hospitals and research institutes are increasingly investing in advanced instruments to support molecular diagnostics and rapid outbreak response. The introduction of AI-enabled and connected devices further streamlines laboratory workflows and reduces manual errors. Rising demand for multiplexing and real-time data integration is also supporting growth.

• By Test

On the basis of test, the market is segmented into laboratory-based testing and point-of-care (POC) testing. The laboratory testing segment dominated the market in 2025 due to its ability to deliver highly accurate, reliable results across a wide spectrum of infectious diseases. Centralized laboratories possess advanced instrumentation, skilled personnel, and standardized protocols that ensure high-quality testing. Laboratory testing also enables large-scale disease surveillance and multi-pathogen panels, which are crucial for hospitals and public health agencies. The segment benefits from continuous technological upgrades, including automation and integrated data management systems. Its strong presence in hospitals, research centers, and government programs ensures stable market dominance.

The point-of-care testing segment is expected to witness the fastest growth rate during 2026–2033, driven by the need for rapid diagnostics in outpatient clinics, remote areas, and home healthcare settings. POC tests, including antigen, antibody, and molecular assays, provide immediate results, enabling faster clinical decision-making. The portability, ease of use, and minimal training requirements make these tests ideal for decentralized healthcare delivery. Increasing adoption of mobile-connected and smartphone-integrated POC devices further accelerates growth. This segment is also supported by government initiatives to expand access to rapid diagnostics in underserved regions.

• By Technology

On the basis of technology, the market is segmented into immunodiagnostics, microbiology, PCR, NGS, and INAAT. The PCR segment dominated the market in 2025, owing to its high sensitivity, specificity, and ability to detect pathogens at early infection stages. PCR-based diagnostics are widely adopted for viral, bacterial, and fungal infections, particularly during epidemics and pandemics. Continuous innovations, including multiplex PCR panels and fully automated PCR platforms, strengthen its market dominance. The segment also benefits from integration with laboratory information systems, improving workflow efficiency and reporting accuracy. Hospitals and research centers rely heavily on PCR for clinical and epidemiological applications.

The immunodiagnostics segment is expected to witness the fastest growth rate during 2026–2033, driven by rising demand for rapid, cost-effective, and point-of-care-compatible tests. Immunodiagnostic assays, such as ELISA and lateral flow tests, detect antigens or antibodies quickly and are widely used for screening and routine diagnostics. The segment benefits from continuous improvements in sensitivity, portability, and ease of use. Increasing adoption in home healthcare, ambulatory clinics, and remote testing scenarios supports growth. Multiplex immunoassays and integration with automated analyzers further enhance operational efficiency.

• By Techniques

On the basis of techniques, the market is segmented into conventional techniques, biochemical techniques, and molecular techniques. The molecular techniques segment dominated the market with the highest revenue share in 2025 due to its ability to provide rapid, sensitive, and highly accurate pathogen detection. Molecular diagnostics are critical for early detection, outbreak monitoring, and pandemic preparedness. They are widely used in hospital laboratories, research institutes, and centralized diagnostic centers. Automation and integration with AI analytics further enhance their efficiency and throughput. The adoption of molecular techniques continues to grow, particularly in emerging markets with expanding healthcare infrastructure.

The biochemical techniques segment is expected to witness the fastest growth rate during 2026–2033, fueled by rising use in clinical laboratories for enzyme-based and antigen-antibody detection methods. Biochemical techniques are cost-effective, easy to perform, and increasingly integrated with automated analyzers. They support high-throughput workflows and are suitable for routine diagnostics in resource-limited settings. Adoption is growing in ambulatory clinics, home healthcare, and smaller laboratories. Advancements in assay sensitivity and miniaturized platforms are driving market expansion.

• By Condition

On the basis of condition, the market is segmented into bacterial infection, viral infection, CNS infections, cardiovascular infection, fungal infection, GI infections, sexually transmitted disease, and others. The viral infection segment dominated the market in 2025 due to high prevalence of influenza, HIV, hepatitis, and emerging viral outbreaks worldwide. Viral diagnostics rely on both molecular and immunodiagnostic techniques for early detection, monitoring, and outbreak containment. Hospitals and diagnostic laboratories widely use viral testing for routine surveillance and patient management. Government screening programs and pandemic preparedness initiatives further support segment dominance. Continuous technological advancements enhance throughput, accuracy, and portability of viral diagnostics.

The bacterial infection segment is expected to witness the fastest growth rate during 2026–2033, fueled by rising incidence of antibiotic-resistant infections and growing demand for rapid pathogen identification. Adoption of automated PCR panels, culture-independent diagnostics, and multiplex testing is supporting segment growth. Point-of-care bacterial tests are increasingly deployed in remote clinics and home healthcare. Integration with digital health systems enables faster reporting and treatment decisions. Continuous product innovation in reagents, assays, and instruments further drives adoption.

• By End User

On the basis of end user, the market is segmented into diagnostic laboratories, academic and medical institutes, contract research organizations, hospitals and surgical centers, ambulatory clinics, and home healthcare. The hospitals and surgical centers segment dominated the market in 2025 due to large patient volumes, high adoption of advanced diagnostic platforms, and critical need for rapid and accurate results. Hospitals invest in molecular, immunodiagnostic, and POC systems to enhance patient care and operational efficiency. They rely on centralized laboratories for multi-pathogen testing and high-throughput workflows. Strong integration with hospital IT systems and electronic health records reinforces dominance. Continuous technology upgrades and government support for hospital diagnostics further strengthen the segment.

The home healthcare segment is expected to witness the fastest growth rate during 2026–2033, driven by the increasing availability of at-home diagnostic kits, growing patient awareness, and integration of remote monitoring technologies. Home testing solutions for viral and bacterial infections allow patients to monitor health conveniently while reducing the burden on hospitals. Digital reporting of results ensures timely communication with healthcare providers. The segment is further supported by telemedicine adoption and government initiatives promoting decentralized diagnostics. Rising consumer demand for convenience and rapid results continues to fuel segment growth.

Infectious Disease Diagnostics Market Regional Analysis

• North America dominated the infectious disease diagnostics market with the largest revenue share of 38.5% in 2025, supported by advanced healthcare infrastructure, high adoption of innovative diagnostic technologies, and a strong presence of leading industry players
• Healthcare providers and laboratories in the region prioritize accuracy, speed, and reliability, adopting molecular, immunodiagnostic, and point-of-care testing platforms to manage bacterial, viral, and fungal infections effectively
• This widespread adoption is further supported by substantial government funding for public health initiatives, a strong presence of leading diagnostic companies, and the growing emphasis on epidemic preparedness and rapid outbreak response

U.S. Infectious Disease Diagnostics Market Insight

The U.S. infectious disease diagnostics market captured the largest revenue share of 42% in 2025 within North America, driven by advanced healthcare infrastructure, high adoption of molecular and point-of-care testing platforms, and a strong emphasis on early disease detection. Healthcare providers prioritize rapid, accurate, and reliable diagnostics for bacterial, viral, and fungal infections, boosting demand across hospitals, diagnostic laboratories, and research centers. The growing integration of AI-assisted diagnostics and digital health platforms is enhancing workflow efficiency and enabling remote reporting. Moreover, government initiatives for epidemic preparedness and public health screening programs further support market growth. The widespread adoption of telemedicine and at-home testing solutions is also contributing to the expansion of infectious disease diagnostics across the U.S.

Europe Infectious Disease Diagnostics Market Insight

The Europe infectious disease diagnostics market is projected to expand at a substantial CAGR throughout the forecast period, primarily driven by increasing healthcare investment, stringent regulations, and rising awareness of early disease detection. The demand for rapid, accurate, and connected diagnostic solutions is growing across residential, clinical, and commercial laboratories. Urbanization and expansion of healthcare infrastructure are fostering the adoption of advanced testing platforms, including PCR and immunodiagnostic assays. European healthcare providers are increasingly leveraging point-of-care diagnostics to improve patient outcomes and reduce hospital burden. Continuous technological advancements and government-supported public health initiatives are further encouraging market growth.

U.K. Infectious Disease Diagnostics Market Insight

The U.K. infectious disease diagnostics market is anticipated to grow at a noteworthy CAGR during the forecast period, driven by heightened awareness of infection prevention, rising demand for early diagnosis, and increased adoption of connected diagnostic platforms. Hospitals and diagnostic laboratories are actively implementing molecular and immunodiagnostic technologies for routine testing and outbreak management. In addition, concerns regarding antimicrobial resistance and epidemic preparedness are encouraging investment in advanced diagnostic solutions. The country’s robust healthcare system, coupled with strong government support and digital health initiatives, is expected to continue stimulating market growth. The convenience and speed of point-of-care testing also support increased adoption in ambulatory and home healthcare settings.

Germany Infectious Disease Diagnostics Market Insight

The Germany infectious disease diagnostics market is expected to expand at a considerable CAGR during the forecast period, fueled by strong healthcare infrastructure, rising awareness of early detection, and the adoption of technologically advanced diagnostic platforms. Hospitals, research institutes, and diagnostic laboratories are increasingly deploying PCR, molecular, and immunodiagnostic systems for comprehensive pathogen detection. Germany’s focus on innovation, precision medicine, and sustainability promotes the adoption of eco-conscious and automated diagnostic solutions. Integration of laboratory information systems and digital health technologies enhances workflow efficiency and reporting accuracy. Government initiatives and proactive epidemic surveillance programs further support market growth.

Asia-Pacific Infectious Disease Diagnostics Market Insight

The Asia-Pacific infectious disease diagnostics market is poised to grow at the fastest CAGR of 25% during the forecast period of 2026 to 2033, driven by increasing healthcare expenditure, rising awareness of infectious diseases, and rapid technological adoption in countries such as China, Japan, and India. Expansion of healthcare infrastructure, government-supported screening programs, and growing demand for rapid point-of-care testing are key growth factors. The region’s focus on improving access to diagnostics in urban and rural areas is driving adoption of portable, cost-effective, and digital solutions. Increasing prevalence of infectious diseases and large patient populations are further fueling market growth. In addition, local manufacturing of diagnostic reagents and instruments is improving affordability and accessibility.

Japan Infectious Disease Diagnostics Market Insight

The Japan infectious disease diagnostics market is gaining momentum due to advanced healthcare infrastructure, technological sophistication, and a growing focus on early detection of infections. Adoption of molecular, immunodiagnostic, and rapid point-of-care platforms is rising in hospitals, laboratories, and home healthcare settings. Integration with digital health platforms and connected diagnostic devices improves patient monitoring and data management. Japan’s aging population increases demand for easy-to-use, reliable testing solutions in both residential and clinical settings. Continuous investment in research and development, along with government initiatives for epidemic preparedness, is further driving market growth.

India Infectious Disease Diagnostics Market Insight

The India infectious disease diagnostics market accounted for the largest market revenue share in Asia-Pacific in 2025, attributed to rapid urbanization, expanding healthcare infrastructure, and growing patient awareness. Rising prevalence of bacterial, viral, and fungal infections is increasing demand for laboratory and point-of-care testing solutions. Government-supported public health programs, expansion of diagnostic networks, and promotion of telemedicine are driving adoption. Affordable diagnostic kits, local manufacturing of reagents and instruments, and growing penetration of molecular and immunodiagnostic technologies are further propelling the market. In addition, rising disposable incomes and a technologically aware population support adoption across residential, commercial, and home healthcare settings.

Infectious Disease Diagnostics Market Share

The Infectious Disease Diagnostics industry is primarily led by well-established companies, including:

• Abbott (U.S.)
• QIAGEN (Netherlands)
• Thermo Fisher Scientific Inc. (U.S.)
• Quest Diagnostics Incorporated (U.S.)
• EKF Diagnostics Holdings plc (U.K.)
• BIOMÉRIEUX (France)
• F. Hoffmann La Roche Ltd. (Switzerland)
• Bio Rad Laboratories, Inc. (U.S.)
• Siemens Healthineers AG (Germany)
• Hologic, Inc. (U.S.)
• Danaher (U.S.)
• BD (U.S.)
• DiaSorin S.p.A (Italy)
• Grifols, S.A. (Spain)
• Sysmex Corporation (Japan)
• QuidelOrtho (U.S.)
• Meridian Bioscience (U.S.)
• Seegene, Inc. (South Korea)
• OraSure Technologies, Inc. (U.S.)
• Trinity Biotech Plc (Ireland)

What are the Recent Developments in Global Infectious Disease Diagnostics Market?

• In September 2025, QIAGEN’s QIAstat‑Dx Rise system, designed for rapid syndromic testing, received FDA clearance in the United States. The platform can process up to 160 samples per day with minimal hands‑on time, expanding access to fast and automated infectious disease diagnostics in hospitals and reference labs
• In July 2025, Seegene Inc. unveiled STAgora™, a real‑time infectious disease analytics platform integrating PCR‑derived diagnostic data with advanced statistical modeling and AI to visualize outbreaks and support proactive public health responses globally. The platform aims to combine real‑time pathogen trends with predictive insights for better decision‑making
• In March 2025, QIAGEN received U.S. FDA clearance for its QIAstat‑Dx Gastrointestinal Panel 2 Mini B, a rapid syndromic panel focused on major bacterial pathogens causing GI infections. This expansion strengthened QIAGEN’s portfolio for outpatient and laboratory settings with faster diagnosis
• In January 2024, QIAGEN announced the launch of QIAstat‑Dx Gastrointestinal Panel 2 and Meningitis/Encephalitis Panel in India, using multiplex PCR to rapidly and accurately detect a broad range of pathogens from a single sample. These panels improve speed and accuracy for diagnosing infectious diseases such as CNS and GI infections
• In October 2021, Roche introduced its first infectious disease tests on the Cobas 5800 molecular laboratory platform, including assays for HIV‑1/HIV‑2, HBV, and HCV, enhancing compact high‑performance molecular testing for infectious diseases across clinical labs

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