Syphilis Immunoassay Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Product (Analyzer, Kit & Reagent), By Technology (CLIA, ELISA), By End User (Blood Bank, Diagnostic Lab, Hospital, Others), By Region, and By Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 350.42 Million
CAGR (2026-2031)	5.79%
Fastest Growing Segment	Hospital
Largest Market	North America
Market Size (2031)	USD 491.20 Million

Market Overview

The Global Syphilis Immunoassay Diagnostic Market will grow from USD 350.42 Million in 2025 to USD 491.20 Million by 2031 at a 5.79% CAGR. The Global Syphilis Immunoassay Diagnostic Market comprises diagnostic tests designed to detect antibodies associated with the bacterium Treponema pallidum using nontreponemal screening and treponemal confirmatory methods. The primary drivers supporting market growth include the escalating global prevalence of sexually transmitted infections and the implementation of rigorous government mandates for prenatal screening to prevent vertical transmission. According to the American Sexual Health Association, in 2024, nearly 4,000 cases of congenital syphilis were reported, which represents a 1.6 percent increase from the previous year.

A significant challenge impeding market expansion is the persistent social stigma surrounding sexually transmitted diseases, which frequently deters individuals from seeking timely diagnosis. This reluctance leads to substantial underdiagnosis and reduced testing volumes, thereby limiting the addressable market size despite the rising disease burden. Consequently, while infection rates drive the theoretical demand, overcoming these social barriers remains a critical obstacle for the industry to maximize the adoption of diagnostic solutions.

Key Market Drivers

The escalating global prevalence of syphilis and congenital infections acts as the primary catalyst for the expansion of the immunoassay diagnostic sector, necessitating the widespread deployment of high-throughput screening and confirmatory tests. This resurgence is not limited to developing regions but is also evident in developed markets, driving the demand for automated treponemal and nontreponemal diagnostic solutions to manage the increasing disease burden. For instance, according to the World Health Organization, May 2024, in the 'Implementing the global health sector strategies on HIV, viral hepatitis and sexually transmitted infections, 2024 report', new syphilis cases among adults aged 15–49 years increased by over 1 million in 2022, reaching a total of 8 million globally. This rising incidence underscores the urgent clinical need for robust testing protocols to facilitate early detection and treatment. Reinforcing this trend in developed economies, the UK Health Security Agency, June 2024, reported that syphilis diagnoses in England rose by 9.4% to reach 9,513 cases in 2023, the highest annual number since 1948, further validating the critical necessity for advanced diagnostic infrastructure.

Concurrently, the implementation of mandatory government screening programs and favorable funding for STI prevention initiatives are significantly propelling market growth. Governments are increasingly allocating dedicated budgets to modernize sexual health services and support national strategic plans aimed at eliminating vertical transmission. A notable example of such financial commitment occurred when the U.S. Department of Health and Human Services, June 2024, in the 'Funding Available to Address the HIV, HCV, and Syphilis Epidemics in Indian Country' announcement, publicized an expected total program funding of $14 million to support communities in increasing diagnoses and treatment. These investments directly subsidize the procurement of point-of-care and laboratory-based immunoassays, reducing economic barriers to access and ensuring compliance with expanded prenatal and routine screening mandates. Such fiscal policies create a stable revenue stream for diagnostic manufacturers and encourage the adoption of rapid testing methodologies in both public health laboratories and community settings.

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Key Market Challenges

The persistent social stigma associated with sexually transmitted infections acts as a substantial barrier to the growth of the global syphilis immunoassay diagnostic market. This deep-rooted psychological and cultural deterrent frequently causes individuals to avoid seeking medical advice or undergoing necessary screenings due to fear of judgment, embarrassment, or social isolation. Consequently, this avoidance behavior leads to a significant reduction in the volume of diagnostic tests performed in both clinical and point-of-care settings. By discouraging voluntary testing, stigma creates a divergence between the actual prevalence of the disease and the commercial utilization of diagnostic products, directly limiting the addressable revenue base for manufacturers.

The impact of this testing gap is highlighted by the disparity between rising infection rates and diagnostic adoption. According to the World Health Organization, in 2024, it was reported that annual new cases of syphilis among adults aged 15 to 49 years reached approximately 8 million globally. Despite this high disease burden, the reluctance of at-risk populations to participate in screening programs prevents the market from fully capitalizing on the theoretical demand. As long as cultural taboos discourage individuals from accessing healthcare services, the industry will face restricted market penetration and suppressed growth rates.

Key Market Trends

The proliferation of multiplex HIV-syphilis point-of-care assays is fundamentally reshaping the market by streamlining diagnostic workflows and enhancing screening efficiency. This trend is driven by the urgent clinical necessity to address high co-infection rates through a single fingerstick device, which significantly reduces logistical costs and patient wait times compared to performing separate tests. Manufacturers are prioritizing the development of these dual-target immunoassays to support international elimination targets for vertical transmission, ensuring high sensitivity for both pathogens in resource-limited settings. Validating the performance of these next-generation tools, according to Unity Health Toronto, January 2025, in the 'St. Michael's research leads to Health Canada approval of dual HIV-Syphilis rapid test' press release, a landmark clinical study found the newly approved Multiplo TP/HIV test to be 100 percent accurate in identifying HIV infection and more than 98 percent accurate in detecting syphilis.

Simultaneously, the emergence of direct-to-consumer and at-home sample collection kits is democratizing access to diagnostics by overcoming the privacy concerns and scheduling barriers that traditionally hinder testing. This trend is characterized by the widespread commercialization of self-collection solutions that allow individuals to screen for antibodies without visiting a clinic, thereby circumventing the deep-rooted social stigma associated with sexually transmitted infections. Public health programs and private retailers are increasingly adopting these decentralized models to expand reach among asymptomatic populations who might otherwise forego screening. Illustrating the scale of this consumer shift, according to The Journal, January 2025, in the 'Over 126,000 STI home test kits and 1.2 million condoms distributed through the HSE last year' article, the Health Service Executive reported that 126,090 home testing kits were ordered and dispatched in 2024, representing a continued year-on-year increase in public adoption.

Segmental Insights

The hospital segment currently represents the fastest-growing category within the Global Syphilis Immunoassay Diagnostic Market due to the increasing volume of patient admissions for sexually transmitted infections. This expansion is primarily driven by the widespread implementation of centralized testing protocols, which favor large healthcare facilities capable of processing high daily sample volumes. Furthermore, updated screening guidelines from the Centers for Disease Control and Prevention encourage routine institutional testing to ensure early detection. Consequently, hospitals are rapidly upgrading their diagnostic infrastructure to accommodate this rising demand, resulting in accelerated segmental growth.

Regional Insights

North America holds the leading position in the global syphilis immunoassay diagnostic market due to rising infection rates and robust public health policies. The region benefits from extensive screening guidelines established by the Centers for Disease Control and Prevention, which drive consistent testing volumes across medical facilities. Furthermore, the market is supported by the U.S. Food and Drug Administration, which facilitates the commercial availability of reliable diagnostic tests through rigorous approval processes. These regulatory and clinical frameworks, combined with favorable reimbursement coverage, ensure the sustained adoption of syphilis diagnostics throughout the region.

Recent Developments

• In March 2025, bioLytical Laboratories Inc. announced the launch of its INSTI Multiplex HIV-1/2 Syphilis Antibody Test in the Australian market following its inclusion in the Australian Register of Therapeutic Goods. The rapid flow-through immunoassay is designed to detect antibodies for both HIV and syphilis from a single fingerstick blood sample, providing results in one minute. This launch expands the availability of the company's testing solutions to healthcare professionals in Australia, supporting public health strategies to combat the rising prevalence of sexually transmitted infections through efficient, simultaneous screening.
• In October 2024, Chembio Diagnostics, Inc., a subsidiary of Biosynex, was awarded a $1.5 million grant from the Bill & Melinda Gates Foundation to develop a rapid point-of-care diagnostic test for congenital syphilis. The company intends to utilize its Dual Path Platform technology to create an assay capable of simultaneously detecting specific antibodies in newborns, addressing the diagnostic challenges posed by maternal antibody transfer. This initiative aims to produce a high-quality, affordable testing solution for low- and middle-income settings, facilitating early diagnosis and treatment to prevent severe health complications in infants.
• In September 2024, Beckman Coulter Diagnostics obtained 510(k) clearance from the U.S. FDA for new diagnostic tests designed to aid in the diagnosis of syphilis. This regulatory milestone was part of a broader set of approvals the company secured during the month, which also included assays for other infectious conditions. The clearance enables the company to expand its portfolio of immunoassay solutions available to clinical laboratories, supporting efforts to address the resurgence of syphilis through accurate and timely detection. The approval reflects the ongoing industry response to the growing demand for effective sexually transmitted infection testing.
• In August 2024, NOWDiagnostics, Inc. received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its First To Know Syphilis Test. This product is the first over-the-counter diagnostic device capable of detecting Treponema pallidum antibodies in human blood to be authorized for home use in the United States. The test utilizes a single drop of blood and delivers results in approximately 15 minutes, aimed at increasing access to initial screening amid rising infection rates. This authorization allows individuals to privately screen for the infection, though a positive result requires confirmatory testing by a healthcare professional.

Key Market Players

• Bio-Rad Laboratories Inc
• Danaher Corp
• Becton Dickinson SA
• F Hoffmann-La Roche AG
• Siemens Healthineers AG
• DiaSorin SpA
• Abbott Laboratories Inc
• Ortho-Clinical Diagnostics Inc
• Fujirebio Diagnostics Inc
• BioMerieux SA

By Product	By Technology	By End User	By Region
Analyzer Kit & Reagent	CLIA ELISA	Blood Bank Diagnostic Lab Hospital Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Syphilis Immunoassay Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Syphilis Immunoassay Diagnostic Market, By Product:

• Analyzer
• Kit & Reagent

• Syphilis Immunoassay Diagnostic Market, By Technology:

• CLIA
• ELISA

• Syphilis Immunoassay Diagnostic Market, By End User:

• Blood Bank
• Diagnostic Lab
• Hospital
• Others

• Syphilis Immunoassay Diagnostic Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE