Infectious Disease Diagnostics Market is estimated to be valued at USD 1,750.8 Mn in 2025 and is expected to reach USD 3,370.8 Mn in 2032, exhibiting a compound annual growth rate (CAGR) of 9.81% from 2025 to 2032.
Infectious Diseases are caused by pathogens such as bacteria, virus, fungi or parasites. Infectious disease spreads from one person to other either through direct contact or indirectly through insect bites or through other vectors like food, soil, water, and air. Diagnosis means the identification of disease causing agents, by studying the symptoms exhibited by the afflicted individual. This plays a vital role in making decisions regarding treatment of infectious and other diseases.
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The market for infectious disease diagnostics in 2025 is being revolutionized by advanced diagnoses that leverage speed, accuracy, and connectivity as a result of escalating demands for healthcare worldwide. The increased incidence of infectious diseases and their early diagnosis have influenced advancements in diagnostic technology beyond traditional approaches for quicker decision-making and patient care.
In the infectious disease diagnostics market, some of the latest technology areas include molecular diagnostics (PCR and multiplex testing), rapid antigen/antibody assays, point of care testing systems, and digital health diagnostic tools. These technology areas enable the precise detection of microbes even at low levels and facilitate testing in early stages of infections like tuberculosis, HIV, influenza, dengue fever, and new viral infections.
With the growing focus on decentralized care, there has been an accelerated demand for point-of-care and rapid diagnostic tests in hospitals, diagnostic labs, and resource-limited regions. These tests offer reduced turnaround times, minimal requirements of infrastructure for centralized labs, and access to diagnostic services for underserved regions. Moreover, digital health platforms and laboratory information systems have further assisted in surveillance for diseases.
For instance, in November 2025, Co-Diagnostics, Inc. announced that it has started clinical performance evaluations for its Co-Dx™ PCR Flu A/B, COVID-19, RSV Test Kit on the Co-Dx PCR Pro™ platform, in preparation for a 510(k) submission to the U.S. FDA for point-of-care use.
By technology, the segment of the polymerase chain reaction (PCR) had a share of 45.2% in the market in 2025 due to its sensitivity, specificity, and ability to detect pathogens at very low concentrations. The technology has emerged as the gold standard for infectious disease diagnosis, with increasing demand in respiratory infections and emergent pathogens where early and precise detection becomes vital for the management and control of outbreaks.
PCR-based diagnostics thus allow the rapid amplification of genetic material, which enables clinicians to detect viral and bacterial infections even in the early stages of infection. That makes PCR essential for such illnesses as influenza, tuberculosis, and other respiratory infections. Compared to traditional diagnostic methods, however, PCR offers advantages in terms of speed and reliability, thus supporting timely clinical decisions and reducing the spread of disease.
For instance, in August 2025, Seegene Inc. introduced advanced multiplex PCR solutions integrated with automated analysis platforms, enhancing high-throughput infectious disease testing and reinforcing PCR’s central role in modern diagnostics.
In terms of disease indication, the respiratory infections segment accounts for 35% of the market share in 2025. The high prevalence of respiratory diseases and outbreaks make this market share feasible in 2025. Influenza, tuberculosis, bronchitis, and other viral and bacterial infections of the respiratory tract generate massive and constant need for diagnostic tests, thereby creating consistent market demand.
Respiratory infections commonly involve co-existing symptoms, and therefore, precise laboratory diagnosis is important in their control and treatment. Modern diagnostic tools, especially PCR and rapid antigens, provide accurate detection of the causative organisms, which helps the physician distinguish between viral and bacterial infections.
For instance, in April 2025, HealthTrackRx, in collaboration with public health authorities, announced the development of rapid PCR-based respiratory panels to support early detection and monitoring of emerging influenza strains.
In terms of end user, the hospitals segment contributes 30% of the market share in 2025, owing to high patient inflow, availability of advanced diagnostic infrastructure, and centralized infectious disease testing capabilities. Hospitals serve as primary points of care for patients with acute and severe infections, necessitating rapid and accurate diagnostic support for effective treatment decisions.
Hospital labs generally possess highly advanced molecular diagnostics platforms, automated analyzers, and trained staff, which enable hospitals to conduct various infectious disease tests effectively. Hospitals handle large numbers of test samples, especially during the outbreak of infectious diseases, making them the largest consumers of infectious disease test products.
For instance, in September 2025, HealthTrackRx announced the opening of a new advanced molecular diagnostics facility designed to expand infectious disease testing capacity and deliver next‑morning test results that support clinicians (including hospitals and healthcare providers) in making faster treatment decisions.
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North America region is expected to witness the leading growth of the infectious disease diagnostics market with a market share of 38.2% in 2025 due to a higher proportion of healthcare expenditures, advanced infrastructure, and acceptance of molecular and rapid diagnostic technology. The U.S. has an established infrastructure of hospitals, diagnostics, and research facilities, making large-scale testing for infectious diseases and early detection and intervention possible. In addition, public health initiatives, government intervention, and planning for pandemics and infectious diseases have further promoted the use of PCR, immunoassays, and POCT technology.
For instance, in September 2025, HealthTrackRx opened a new state-of-the-art molecular diagnostics facility, expanding next-morning infectious disease testing capacity nationwide. The facility enhances diagnostic access for hospitals and healthcare providers, supporting rapid clinical decision-making and strengthening the region’s infectious disease preparedness.
The Asia Pacific market is expected to be the fastest-growing market in the infectious disease diagnostics market. The factors contributing to the demand for advanced diagnostic methods in the Asia Pacific market include the high rate of population increase, increasing infectious disease cases, and increased investment in the healthcare industry in countries such as India, China, and Southeast Asia. The healthcare institutions and diagnostic centers in these countries are increasingly developing molecular diagnostic capacities and automated PCR solutions.
For instance, in January 2025, the World Health Organization (WHO) South-East Asia Region launched a multi-country initiative to strengthen pandemic preparedness and expand molecular and PCR-based diagnostic capabilities in hospitals and public health laboratories across several member countries. This initiative supports early detection, outbreak response, and regional health security.
The U.S. infectious disease diagnostics market is witnessing rapid growth in 2025, driven by high healthcare expenditure, advances in hospital infrastructure, and deeper penetration of molecular and rapid diagnosis technologies. Increasing incidence of respiratory infections, seasonal influenza, and other infectious diseases has led to strategic investments by hospitals and diagnostic laboratories in high-throughput PCR, immunoassays, and point-of-care solutions. Regulatory support for modern diagnostics, public health campaigns on infectious disease testing, and funding for automation within diagnostic laboratories reinforce the infectious disease diagnostics market growth.
For instance, in April 2025, HealthTrackRx announced a rapid PCR test for Avian Influenza A (H5N1) developed in partnership with the U.S. Centers for Disease Control and Prevention (CDC) to support early detection and national outbreak preparedness. This test emphasizes rapid molecular diagnostics for emerging infectious disease threats.
The infectious disease diagnostics market is rapidly growing in China in 2025, buoyed by growing healthcare investments, urbanization, and rising demand for early detection of infectious diseases such as influenza, tuberculosis, and dengue. The expansion of molecular diagnostic capabilities at hospitals and diagnostic centers is leading to the deployment of automated PCR platforms and the adoption of point-of-care testing to enhance turnaround times and outbreak response.
For instance, in December 2025, Roche Diagnostics China released its first quantitative real‑time PCR system developed in China, called the LightCycler PRO System, manufactured at its facility in Suzhou.
| Report Coverage | Details | ||
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| Base Year: | 2024 | Market Size in 2025: | USD 1,750.8 Mn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 9.81% | 2032 Value Projection: | USD 3,370.8 Mn |
| Geographies covered: |
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| Companies covered: |
Becton Dickinson & Company , Cepheid, Inc, Abbott Laboratories, BioMerieux SA, Hologic, Inc, Danaher Corporation, Thermo Fisher Scientific, Inc, Roche Diagnostics, DiaSorin S.p.A, Quidel Corporation, Bio-Rad Laboratories. |
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Definition: Infectious diseases are disorders caused by organisms — such as bacteria, viruses, fungi or parasites. Infectious diseases are diagnosed by detection of a bacterium, virus, fungus, protozoan, or helminth in a patient with a compatible clinical illness. Many organisms live in and on our bodies. They're normally harmless or even helpful. But under certain conditions, some organisms may cause disease. Some infectious diseases can be passed from person to person.
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About Author
Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.
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