Infectious Disease Diagnostics Market Overview

The Global Infectious Disease Diagnostics Market is witnessing robust growth, driven by the increasing prevalence of infectious diseases, rising global health awareness, and advancements in molecular diagnostic technologies. Valued at USD 23.3 billion in 2025, the market is projected to reach USD 37.4 billion by 2033, growing at a CAGR of 6.4% during the forecast period.

Infectious disease diagnostics encompasses the testing and identification of pathogenic organisms such as bacteria, viruses, fungi, and parasites in human samples. These diagnostics are crucial for early detection, prevention, and management of diseases including HIV, hepatitis, influenza, tuberculosis, and COVID-19. Growing global concerns about emerging infectious threats, coupled with a strong focus on preparedness and surveillance, have significantly expanded the role of diagnostic testing in healthcare systems.

Infectious Disease Diagnostics Market Drivers and Opportunities

​Widening Burden of Infectious Diseases and Expanded Screening Programs Are Driving Market Growth

The persistent global burden of infectious diseases such as HIV, hepatitis, and seasonal influenza continues to drive investments in diagnostics. National screening programs, vaccination campaigns, and surveillance efforts have increased testing volumes across public health systems and private providers. Early detection and rapid diagnosis are critical for controlling outbreaks and enabling timely treatment; this has resulted in higher demand for validated assays and robust reagent kits. Additionally, efforts to expand access to diagnostics in low- and middle-income countries through donor-funded programs and public-private partnerships are increasing utilization of standardized tests and point-of-care solutions. The resultant scale-up of testing infrastructure is stimulating demand for instruments, consumables, and integrated diagnostic workflows. As healthcare systems prioritize preparedness and routine screening, the infectious disease diagnostics market is expected to benefit from consistent demand and policy-backed spending.

​Rapid Adoption of Molecular and Point-of-Care Technologies Is Accelerating Market Expansion

Technological advances, particularly in molecular diagnostics (PCR) and point-of-care immunodiagnostics, are reshaping the infectious disease testing landscape. PCR-based assays offer high sensitivity and specificity for pathogen detection and are now widely used in centralized labs and near-patient settings. Concurrently, improved immunodiagnostic rapid tests and multiplex panels are enabling decentralized screening with immediate clinical utility. The convergence of automation, microfluidics, and digital diagnostics (including connected platforms and cloud-based reporting) is improving throughput, reducing manual error, and enabling rapid epidemiological surveillance. Additionally, adoption of next-generation sequencing (NGS) for pathogen characterization and antimicrobial resistance surveillance is creating new high-value use cases. These technological trends are prompting laboratories and healthcare systems to upgrade equipment portfolios and adopt integrated software solutions, driving overall market growth.

​Integration of Diagnostics with Digital Health and Surveillance Systems Presents Major Upside

The integration of infectious disease diagnostics with digital health platforms, electronic health records (EHRs), and national surveillance systems offers a significant growth opportunity. Real-time data flows from diagnostic instruments and connected point-of-care devices enable faster public health responses, automated case reporting, and better resource allocation during outbreaks. Diagnostic companies that provide end-to-end solutions, assay kits, instruments, and interoperable software are well-positioned to capture incremental value by offering subscription or data analytics services. In addition, expanding telehealth and remote testing models creates demand for validated home-collection kits and companion diagnostics linked to laboratory workflows. Investments in digital integration, regulatory-compliant data pipelines, and analytics-driven decision support will create differentiated offerings and open commercial models beyond traditional product sales.

Infectious Disease Diagnostics Market Scope

Infectious Disease Diagnostics Market Report Segmentation Analysis

The global Infectious Disease Diagnostics Market is segmented by Product, by Disease Type, by Technology, and by Region.

Assays & Reagents segment accounted for the largest market share in the global Infectious Disease Diagnostics market

By Product, the market is segmented into Assays & Reagents, Instruments, Software, and Others. The Assays & Reagents segment accounted for the largest share of the market in 2025 (approximately 44.8%), driven by high demand for consumables required across centralized laboratories and decentralized testing sites. Assays and reagent kits covering immunoassays, PCR reagents, rapid antigen/antibody tests, and multiplex panels are recurring revenue sources for diagnostic companies due to repeat testing and programmatic screening needs. The segment benefits from continuous assay development responding to emerging pathogens and strain variations, as well as from the expanding use of multiplex panels for differential diagnosis. Given their clinically critical role and recurring purchasing cycles, assays & reagents are expected to remain the most significant revenue contributor.

The Human Immunodeficiency Virus (HIV) segment holds a major share in the Infectious Disease Diagnostics market

By Disease Type, the market is divided into Human Immunodeficiency Virus (HIV), Hepatitis, Influenza, and Others. The HIV segment holds the largest share in 2025 due to the persistent global burden of HIV/AIDS and widespread implementation of screening programs. Continuous WHO and CDC efforts to promote early diagnosis, antiretroviral therapy (ART) monitoring, and viral load testing have strengthened this segment’s growth. Technological progress in molecular and immunoassay-based detection has improved test reliability and accessibility, particularly in low-resource regions. Furthermore, self-testing kits and rapid diagnostic devices have expanded patient reach, driving higher testing rates. As healthcare systems strive toward achieving UNAIDS 95-95-95 targets, the demand for accurate, fast, and user-friendly diagnostic solutions for HIV remains exceptionally strong.

The Immunodiagnostics technology segment leads the global Infectious Disease Diagnostics market

By Technology, the market is segmented into Immunodiagnostics, Clinical Microbiology, Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS), and Others.
The Immunodiagnostics segment dominates the market and is widely used for detecting infectious agents through antigen-antibody interactions. Its reliability, cost-effectiveness, and high throughput make it the preferred choice in clinical laboratories and point-of-care settings. Techniques such as enzyme immunoassays (EIA), chemiluminescence assays (CLIA), and lateral flow assays are key components in detecting diseases like HIV, hepatitis, and influenza. Advances in automation and integration with digital analyzers have further improved assay accuracy and turnaround times. The versatility of immunodiagnostic platforms across multiple sample types, combined with the rapid response to emerging pathogens, ensures their continued leadership in the infectious disease diagnostics market.

The following segments are part of an in-depth analysis of the global Infectious Disease Diagnostics market:

Infectious Disease Diagnostics Market Share Analysis by Region

The Asia Pacific region is projected to hold the largest share of the global Infectious Disease Diagnostics market over the forecast period

The Asia Pacific (APAC) region held the largest share of 39.4% in 2025 and is expected to maintain its dominance during the forecast period. The region’s growth is fueled by high infection prevalence, growing healthcare expenditure, and rapid adoption of advanced diagnostic technologies. Governments in China, India, and Japan are actively expanding infectious disease control programs, vaccination initiatives, and diagnostic infrastructure to strengthen pandemic preparedness and surveillance. The region’s large population base and increased accessibility to affordable testing kits further drive market demand. Local manufacturing initiatives and collaborations with global diagnostic companies have also accelerated innovation and availability.

Meanwhile, North America is expected to record the fastest growth rate, supported by continuous R&D investments, well-established healthcare infrastructure, and the presence of leading diagnostic firms. Strong regulatory frameworks, government funding, and the early adoption of molecular and digital diagnostic platforms position North America as a key growth engine in the coming years.

Infectious Disease Diagnostics Market Competition Landscape Analysis

The global infectious disease diagnostics market is highly competitive, characterized by innovation-driven strategies, product diversification, and extensive R&D investments. Key players focus on developing rapid, high-accuracy diagnostic solutions while expanding their global distribution networks. ​

Global Infectious Disease Diagnostics Market Recent Developments News:

• In March 2025, DiaSorin received U.S. FDA 510(k) clearance for the LIAISON PLEX platform and its inaugural test, the LIAISON PLEX® Respiratory Flex Assay. The multiplex platform is designed to streamline and enhance respiratory infection testing, supporting efficient and accurate diagnostic workflows.

• In April 2025, BD (Becton, Dickinson and Company) secured U.S. FDA 510(k) clearance for its Respiratory Viral Panel (RVP) on the BD MAX™ System. The panel enables the simultaneous detection and differentiation of Influenza A, Influenza B, SARS-CoV-2, and Respiratory Syncytial Virus (RSV), providing rapid, high-throughput results to aid in the management of respiratory infections.

The Global Infectious Disease Diagnostics Market Is Dominated by a Few Large Companies, such as

●        Roche Diagnostics

●        Abbott Laboratories

●        Thermo Fisher Scientific

●        bioMérieux

●        BD

●        Danaher

●        Siemens Healthineers

●        Qiagen

●        Hologic

●        Cepheid

●        Sysmex Corporation

●        Bio-Rad Laboratories

●        DiaSorin

●        Luminex Corporation

●        QuidelOrtho

●        GenMark Diagnostics

●        Mesa Biotech

●        Seegene

●        Ellume

●        Guangzhou Wondfo Biotech

●        Others