United States Syphilis Testing Market is expected to reach US$ 2.21 billion by 2032 | Top 3 key players - Thermo Fisher Scientific Inc., Becton, Dickinson and Company (BD), Abbott Laboratories.

Market Size and Growth:

The Global Syphilis Testing Market size reached US$ 1.37 billion in 2024 and is expected to reach US$ 2.21 billion by 2032, growing at a CAGR of 7.1% during the forecast period 2025-2032. The Market is growing due to the rising prevalence of sexually transmitted infections and increased adoption of advanced, rapid diagnostic testing methods.

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The Syphilis Testing Market encompasses the development, production, and commercialization of diagnostic tests used to detect Treponema pallidum, the bacterium causing syphilis. It includes rapid diagnostic tests, ELISA, and PCR-based methods, serving hospitals, laboratories, and clinics. Market growth is driven by rising STI prevalence, increasing awareness, technological advancements, and the need for early and accurate disease detection worldwide.

Industry Recent Developments:

United States:

✅ October 2025: The market experienced a boost in growth driven by FDA approvals for new syphilis diagnostic tests, along with increasing cases of syphilis and government initiatives to expand testing coverage. The focus has also been on integrating rapid, point-of-care testing solutions in various healthcare settings to improve early detection and treatment.​

✅ September 2025: The adoption of at-home syphilis testing kits gained momentum, driven by technological innovations and regulatory support to facilitate self-testing. Efforts by public health agencies to increase awareness and testing among high-risk populations contributed to this surge.​

✅ November 2025: The U.S. market observed an expansion of multiplex STI panels that include syphilis testing, enabling comprehensive screenings. The ongoing epidemiological rebound with a sharp rise in cases prompted increased investment in next-generation diagnostic technologies.​

Japan:

✅ September 2025: Japan's syphilis rapid test kit market continued to grow, led by major companies focusing on innovation and strategic growth. The market segments, including hospital, clinical, and point-of-care settings, saw increased deployment of rapid test kits, supported by technological advancements such as AI integration in testing procedures.​

✅ October 2025: Japan witnessed a rise in the adoption of AI-enabled diagnostic tools and self-testing kits, driven by regulatory updates that facilitate home-based and decentralized testing. These advancements are helping to boost market penetration, especially in remote and underserved areas.​

✅ November 2025: The government launched public awareness campaigns promoting early detection and screening initiatives, further accelerating the adoption of rapid syphilis testing solutions in healthcare and community settings.

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Major 5 Key Players:

1. Thermo Fisher Scientific Inc.
Thermo Fisher Scientific is a leading global provider of laboratory instruments, reagents, and diagnostic solutions. The company offers a range of syphilis testing products, including immunoassays and molecular diagnostics, catering to both laboratory and point-of-care settings. Their products are known for high accuracy and reliability, making them a preferred choice for healthcare providers worldwide.

2. Becton, Dickinson and Company (BD)
BD is a prominent player in the medical technology sector, offering a variety of diagnostic solutions. In the syphilis testing market, BD provides rapid test kits that enable quick and accurate detection of syphilis antibodies. These tests are widely used in clinical settings for their ease of use and rapid results.

3. Abbott Laboratories
Abbott Laboratories is a global healthcare company known for its diagnostic products. The company offers syphilis testing solutions that are integrated with their broader infectious disease testing platforms. Abbott's tests are designed to deliver accurate results efficiently, supporting healthcare providers in managing syphilis and other sexually transmitted infections.

4. Trinity Biotech
Trinity Biotech specializes in the development and manufacture of diagnostic products, including those for syphilis testing. The company offers a range of syphilis test kits, such as the TPHA and RPR tests, which are widely used in laboratories and clinics for the detection of syphilis infections.

5. Bio-Rad Laboratories
Bio-Rad Laboratories is a global leader in life science research and clinical diagnostics. The company provides a variety of diagnostic products, including syphilis testing reagents and kits. Bio-Rad's products are known for their quality and are used in various diagnostic applications, including syphilis detection.

FDA Approvals and Innovations:

Breakthrough Device Designation
In July 2025, Chembio Diagnostics received FDA Breakthrough Device Designation for its DPP® Syphilis Screen & Confirm Assay. This designation aims to expedite the development and review of diagnostic devices that offer significant advantages over existing alternatives.

First At-Home Syphilis Test Approved
In August 2024, the U.S. Food and Drug Administration (FDA) granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This over-the-counter, at-home test detects Treponema pallidum antibodies using a single drop of blood and provides results in about 15 minutes. While it offers a preliminary result, users are advised to seek follow-up testing for confirmation.

Mergers, Acquisitions, and Strategic Collaborations:

The syphilis testing market is witnessing moderate levels of mergers and acquisitions (M&A), with larger companies acquiring smaller, innovative firms to enhance their product portfolios and technological capabilities. Additionally, strategic partnerships and collaborations are common as stakeholders seek to expand into new markets and strengthen their competitive positions.

Regulatory Developments:

1. State-Level Policy Changes
In 2025, several U.S. states, including New York, introduced legislation to expand access to syphilis testing. For example, New York's S 2704 bill would require health insurance coverage for certain approved at-home STI test kits, providing individuals with convenient and private testing options.

2. Global Regulatory Initiatives
The World Health Organization (WHO) has included syphilis diagnostics in its prequalification (PQ) assessment process for 2025. This initiative aims to ensure the quality and accessibility of syphilis testing, particularly in low- and middle-income countries.

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Segments Covered in the Syphilis Testing Market:

1. By Test Type
Syphilis testing methods are classified into different types based on technology and methodology:

Non-Treponemal Tests

Detect antibodies not specifically directed against Treponema pallidum (the bacteria causing syphilis).

Examples: VDRL (Venereal Disease Research Laboratory), RPR (Rapid Plasma Reagin).

Widely used for initial screening because they are cost-effective and easy to perform.

Treponemal Tests

Detect antibodies directly against Treponema pallidum.

Examples: FTA-ABS (Fluorescent Treponemal Antibody Absorption), TPHA (Treponema Pallidum Hemagglutination Assay), EIA (Enzyme Immunoassay).

Used to confirm syphilis infections after a positive non-treponemal test.

Point-of-Care (POC) Tests

Rapid tests that provide results within minutes.

Ideal for remote or resource-limited settings.

Growing in demand due to convenience and ability to improve early detection rates.

2. By End-User
The market is segmented based on where the tests are primarily used:

Hospitals and Clinics

The largest end-user segment due to routine screening and patient care.

Diagnostic Laboratories

Conduct large-scale and confirmatory testing.

Equipped with advanced automated systems for treponemal and non-treponemal tests.

Point-of-Care Settings / Community Health Centers

Focused on rapid detection and outreach testing programs, especially in rural or underserved areas.

Research Institutes & Blood Banks

Use syphilis tests for screening blood donations and conducting epidemiological studies.

3. By Geography
The market is often analyzed regionally:

North America - High adoption of advanced diagnostics and POC tests.

Europe - Strong presence of research labs and government health initiatives.

Asia-Pacific - Fast-growing demand due to rising awareness, government programs, and improving healthcare infrastructure.

Latin America & Middle East & Africa - Emerging markets with increasing screening initiatives and mobile testing programs.

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People Also Ask:

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