United States Infectious Disease Diagnostics Market Assessment, By Product, By Sample Type, By Setting, By Type of Testing, By Indication, By End-user, By Region, Opportunities and Forecast, 2018-2032F

United States infectious disease diagnostics market is projected to witness a CAGR of 5.65% during the forecast period 2025-2032, growing from USD 10.14 billion in 2024 to USD 15.48 billion in 2032. The infectious disease diagnostics market is expected to thrive under the influence of factors like the growing prevalence of infectious diseases, the availability of a diverse range of diagnostic tests, and the increasing preference for point-of-care diagnostic testing techniques. The development of innovative disease diagnosis and monitoring technologies by key industry players greatly contributes to the market's expansion. Increasing investments in improving disease model analysis and the strategic activities of key players are also contributing to market growth.

Infectious disease diagnostics involve the identification of the causative agent of an infectious disease, such as bacteria, viruses, fungi, or parasites, in a patient with a compatible clinical illness. The process is essential for determining the most effective treatment. Diagnostic methods include laboratory tests, such as blood, urine, and tissue samples, as well as imaging scans to reveal evidence of the microbe causing the disease. The detection of the pathogen can be done through cultivation, isolation in cell culture, and identification biochemically, antigenically, or genetically. Additionally, specific immune responses and molecular technologies are used for accurate diagnosis, especially in low-resource settings.

However, the growth of the infectious disease diagnostics market may be hindered by a lack of awareness of novel diagnostic solutions, the absence of compiled regulatory guidelines, and lower positivity rates due to inferior laboratory conditions. Market players are actively involved in strategic product launches and business tactics to expand the market.

In January 2025, Inflammatix, Inc. received U.S. Food and Drug Administration (FDA) approval for marketing the TriVerity Test System (TriVerity). As a cutting-edge molecular test for suspected acute infection or sepsis, TriVerity provides accurate measurements of a patient's immune response. It successfully differentiates between bacterial and viral infections and assesses overall illness severity, giving clinicians an extensive and fast patient status summary. Such increased FDA approval is expected to considerably enhance the growth of the infectious disease diagnostics market in the U.S. by bringing innovative diagnostic capabilities and instilling confidence in accurate patient evaluations.

Growing Prevalence of Infectious Diseases

Infectious diseases have been on the rise in the 21st century, with outbreaks such as COVID-19, SARS, and swine flu having a devastating impact on lives and livelihoods globally. Factors contributing to the emergence and spread of infectious diseases include ecological, environmental, or demographic factors that place people in increased contact with a previously unfamiliar microbe, as well as increasing prevalence of these factors. The growing prevalence of infectious diseases is directly proportional to the demand for infectious disease diagnostic solutions, further expanding the market. Infectious diseases are one of the leading causes of death, and a suitable treatment plan can be effectively utilized through efficient diagnostics. According to the World Health Organization (WHO), in 2023, Tuberculosis (TB) was the top infectious disease. The Centers for Disease Control and Prevention (CDC) noted an increase in the number of TB cases in the USA from 8,332 in 2022 to 9,633 in 2023, representing a 15.6% increase. The increase in TB cases is fueling the growth of the US infectious disease diagnostics market by emphasizing the need for better diagnostic equipment.

Rising Prevalence of Infectious Diseases

Several factors have led to an upsurge of infectious diseases in the United States, including increased international traveling, urbanization, antibiotic resistance, and climatic changes that affect the disease vectors. Other factors include the aged population and increased vulnerability to disease. According to the U.S. Centers for Disease Control and Prevention, new HIV infections occurred in the United States in the year 2022. The country aims to reduce this figure from 32,800 in 2022 to 9,300 in 2025 and even lower to 3,000 in 2030. As these infections increase, the need for infectious disease diagnostics (POCD) also rises, mainly because of the urgent demand for quick access to testing and rapid therapy. POCD facilitates early detection and treatment, which is fundamental to controlling epidemics and better patient care. Therefore, such increasing demand propels the point-of-care diagnostic market in the United States.

Given the surging demand, companies and governments are working. For example, in April 2025, Cepheid Inc., a subsidiary of Danaher Corporation, received WHO prequalification for its Xpert HIV-1 Qual XC-an in vitro test that is available for the detection of HIV-1 in blood samples.

Availability of a Diverse Range of Diagnostic Tests

A diverse range of diagnostic tests are available for infectious diseases, including laboratory tests, rapid diagnostic tests, serological testing, and polymerase chain reaction (PCR) testing. These tests can detect antibodies, antigens, and specific microorganisms to aid in the diagnosis of infectious diseases. Laboratory tests use samples of blood, urine, sputum, or other fluids to identify microorganisms through staining, culturing, or molecular methods. Rapid diagnostic tests, available in various formats and platforms, provide rapid results to inform clinical decision-making and enable point-of-care management. Serological testing looks for antibodies to verify previous exposure, while PCR testing detects the genetic material of microorganisms. These diverse testing methods are crucial in the accurate and timely diagnosis of infectious diseases. The diverse range is anticipated to contribute to the expansion of the market. Market players offer a variety of rapid diagnostic kits for different diseases.

In December 2024, Delve Bio, Inc. launched Delve Detect, a ground-breaking metagenomic test for infectious disease. Developed from the University of California San Francisco's platform, Delve Detect performs genomic testing of cerebrospinal fluid (CSF) for more than 68,000 pathogens and reports within 48 hours. Through easy room-temperature CSF transfer kits, overnight shipping, and access to qualified analysis, the launch expands diagnostic capacity and propels expansion in the U.S. infectious disease diagnostics market by responding to the demand for fast, reliable testing.

Reagents, Kits and Consumables Segment Accounts for Significant Market Share

The consumables and kits segment is leading the United States infectious disease diagnostics market at present. The segment is experiencing high growth, mainly attributed to repeat purchases and an increased emphasis on improving patient compliance with easy-to-use testing options. The recurring revenue from repeated purchases maintains its top position. Further, advances in molecular diagnostics, infectious disease incidence, and competitive conditions with many suppliers significantly promote the continued growth and market leadership of reagents, kits, and consumables. For instance, in December 2024, Panadea Diagnostics GmbH launched innovative Fc-receptor-based ELISA kits for detecting IgG antibodies against Zika, Dengue, and West Nile viruses, in addition to an IgM detection kit for Dengue. These innovative kits reflect the supremacy of kits and consumables in the USA infectious disease diagnostics market, substantially contributing to the market's growth by providing accurate and efficient diagnostic products.

Future Market Scenario (2025-2032F)

The diagnostic industry is witnessing growing regulatory approvals for infectious disease diagnostic solutions, which are expected to be marketed soon, further boosting the market. For instance, the Biomedical Advanced Research and Development Authority (BARDA) has supported a diverse portfolio of medical solutions, and these products have received a total of 86 FDA approvals, licensures, or clearances. Similarly, the Infectious Diseases Society of America (IDSA) has highlighted the need for new incentives and regulatory changes to spur R&D into new antibiotics and flexible regulations to allow innovative test development to keep pace with emerging infectious diseases. The increasing number of regulatory-approved products for infectious disease diagnosis is anticipated to land the market in the future and bring healthy competition among key players. The FDA has approved several diagnostic devices and authorized the emergency use of uncleared devices for infectious diseases, including influenza and respiratory syncytial virus.

Key Players Landscape and Outlook

These companies have a strong market presence with a vast product portfolio to offer in the field of diagnostics and research. With the growing infectious disease scenario, these players have strengthened their offerings through collaborations, mergers and acquisitions, and other market tactics.

In January 2025, F. Hoffmann-La Roche AG received FDA approval for the highly sensitive VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail test, which is to help in the diagnosis of B-cell lymphoma. This test helps pathologists differentiate B-cell malignancies from normal reactive infections, thus helping patients gain quicker access to treatment. This further solidifies Roche's leadership in the U.S. infectious disease diagnostics market through greater precision in the detection of disease.