Syphilis Rapid Test Market Size, Share, and Forecast 2026 to 2034

What is Syphilis Rapid Test Market?

The syphilis rapid diagnostic test market comprises diagnostic products designed to detect syphilis infection within a short testing period and support testing outside or alongside conventional laboratory workflows. The market covers rapid tests used across antenatal care, public health programs, clinical settings, community testing, and outreach programs.

The market includes rapid tests based on whole blood, serum, plasma, and other applicable sample types. It covers standalone syphilis tests, including treponema pallidum antibody tests, as well as multiplex products that combine syphilis testing with HIV and other infectious disease diagnostics. Conventional laboratory-only tests, confirmatory laboratory procedures, and unrelated sexually transmitted infection diagnostics are excluded from the market scope. Market development is closely linked to the need for timely diagnosis and treatment. Rapid tests can provide results during the same healthcare visit, eliminating the need for a separate lab visit and allowing for timely treatment.

Market Dynamics

Driver Impact Analysis

Market Driver	Geographic Relevance	Impact Timeline
Rising Congenital Syphilis Cases	North America	Ongoing, immediate
WHO Triple Elimination Initiative	Global, led by Africa and Asia Pacific	Near-term, scaling through 2027
Dual Treponemal/Non-Treponemal Testing	United States	Pending FDA review, 2026–2027
Volume Guarantee Pricing	60+ low- and middle-income countries	Active, ongoing procurement impact

Source: Company filings, WHO, CDC, and Polaris Market Research Analysis

Driver: Rising Congenital Syphilis Cases

The rising number of congenital syphilis cases has led to increasing demand for rapid syphilis testing in antenatal and public health settings. Higher infection rates require faster screening to identify pregnant women who need treatment before transmitting to newborns. In 2024, the U.S. saw nearly 4,000 cases of congenital syphilis, making testing access and faster diagnosis even more important. Rapid point-of-care tests can reduce the time between screening and treatment, particularly in areas where laboratory testing is not readily available. This is prompting healthcare providers and public health programs to increase their use of rapid testing, which in turn is driving demand for syphilis rapid diagnostic products (Source: cdc.gov).

Driver: Increasing Adoption of Multiplex Testing

The WHO triple elimination initiative is driving demand for integrated HIV, hepatitis B, and syphilis screening in antenatal care. The integration of testing eliminates the need for separate testing pathways and enables multiple infections to be evaluated during a single patient visit. In July 2025, WHO prequalified the Determine Antenatal Care Panel, the first package of rapid diagnostic tests bundled together for HIV, hepatitis B and syphilis. The panel is designed to be used at the point-of-care, using capillary whole blood and is suitable for settings with limited access to laboratory testing. Widespread use of integrated antenatal screening can therefore pave the way for multiplex products and increase demand beyond stand-alone syphilis assays (Source: who.int).

Restraint: Limited Point-of-Care Product Availability

Access to rapid syphilis testing in decentralized healthcare settings may be limited by limited availability of authorized point-of-care products in the U.S. Before clinics, pharmacies and outreach programs can offer testing outside of traditional laboratories, products must meet applicable regulatory and CLIA requirements. Both Syphilis Health Check and Chembio’s DPP HIV-Syphilis have received FDA clearance and CLIA waiver status, the source said. The limited availability of these products decreases the options for procurement by providers interested in expanding decentralized testing services. New manufacturers need to meet regulatory requirements before entering these channels, which can add to development timelines and commercialization costs. Greater availability of authorized products could therefore expand access to rapid testing across decentralized settings.

Opportunity: Use of Dual Treponemal and Non-Treponemal Tests

Dual treponemal and non-treponemal rapid tests can expand the information available during a single syphilis testing workflow. Treponemal tests detect antibodies associated with exposure to Treponema pallidum, and nontreponemal testing provides additional information for clinical assessment. The Chembio DPP Syphilis TnT Assay is designed to detect treponemal and non-treponemal antibodies simultaneously and was submitted for review to the FDA in January 2026. This product approach can reduce the need for separate testing steps when both test types are required. Wider adoption could therefore create new applications across antenatal care, community testing, and other decentralized settings where rapid clinical assessment is needed (Source: chembio.com).

Opportunity: Reduced Rapid Test Costs Due to Volume Guarantee Pricing

Volume guaranty agreements are opening possibilities to reduce rapid syphilis testing costs while giving manufacturers more demand certainty. In January 2026, WHO announced that the price of SD Biosensor’s STANDARD Q HIV/Syphilis Combo test had dropped to USD 0.84 per test after the earlier volume promise agreement, resulting in a 32% price reduction. The lower price allowed for wider procurement, in over 60 low- and middle-income countries. This model can provide a commercial framework for expanding affordable multiplex testing, particularly after WHO prequalified the first HIV, hepatitis B, and syphilis triple diagnostic test in 2025. Therefore, reduced costs of rapid tests are expected to create lucrative market opportunities in the coming years (Source: extranet.who.int).

Syphilis Rapid Test Market Segmentation Analysis

The report provides a comprehensive analysis of the syphilis rapid test market by test type, sample type, end user, and region to identify established market segments and high-growth opportunities.

Test Type Insights

The dual HIV/syphilis rapid test segment held an 35.64% share in 2025, making it the established test format. The product integrates syphilis and HIV diagnostics testing in one workflow. There is no need to go through multiple testing steps. This structure is relevant for antenatal care and public health programs where multiple infections need to be screened at the same health care visit. Availability of existing products also provides a known commercial base for procurement in decentralized settings. Continued use of the dual testing formats in maternal and public health programs can sustain demand. Availability of the product, regulatory approval, test performance and procurement pricing will determine future adoption in a range of health care systems.

The triple HIV/Hepatitis B/syphilis rapid test segment is expected to register an 12.16% CAGR during 2026–2034, making it the fastest-growing test format. The prequalification of the Determine Antenatal Care Panel by WHO in July 2025 established an explicit standard for integrated antenatal screening. The format offers the potential to cut down on separate screening needs with three disease targets in one testing workflow. Increased uptake of integrated maternal health programs can increase demand for triple testing. The market will evolve according to access to regulation, uptake of procurement, test performance and implementation throughout antenatal and public health programs.

The syphilis-only rapid test segment held a 55.82% market share in 2025, which indicates the need for syphilis screening only. These products continue to be relevant for health care programs that require separate testing for syphilis versus multiplex disease panels. Standalone tests may be implemented in clinical, public health, community, and outreach settings, depending on regulatory authorization and testing needs. It also provides an entry point into decentralized programs that require a simple testing workflow. Demand in the future will be driven by the volume of screening, availability of point-of-care testing, availability of products and the growth of community-based testing programs.

Sample Type Insights

The fingerstick whole blood segment held the largest share in 2025, contributing to 62.48% of the total sample type. Fingerstick collection demands minimal equipment and is suited for point-of-care workflows where testing is performed rapidly away from central laboratories. Its format makes it suitable for use in antenatal clinics, community programs, outreach activities and other decentralized settings. Simple sample collection reduces operational needs and enables testing programs in locations lacking laboratory facilities. Wider deployment of rapid diagnostics can therefore sustain demand for fingerstick-based products. Product design, operator usability, testing accuracy, and regulatory requirements will influence adoption across different healthcare settings.

The serum / plasma segment is projected to grow at a 7.23% CAGR during 2026–2034 and is the fastest-growing sample segment. Rapid testing of serum or plasma can be optimized for clinical sites that routinely collect venous samples as part of their diagnostic workflow. The demand for products compatible with these specimens may rise with the increasing use of rapid diagnostics in hospitals and clinics. The category may also grow as healthcare providers integrate rapid syphilis testing into wider diagnostic pathways. Adoption will be driven by sample preparation requirements, turnaround time, test performance and compatibility with existing clinical workflows.

The other sample types segment of accounted for 5.35% share in 2025. The segment consists of appropriate specimen formats besides the main whole blood, serum and plasma categories. The demand is driven by product design and testing environments where alternative specimens can improve accessibility or make collection easier. They can offer more flexibility for manufacturers who are targeting decentralized or specialty testing environments. The market development will be dependent on regulatory authorization, clinical validation, specimen stability and usability. Wider adoption will depend on demonstrating clear operational advantages over traditional sample types.

End User Insights

The antenatal care/public health programs segment held significant share with a 29.84%  in 2025. Timely syphilis screening is important to reduce the risk of congenital syphilis and drives ongoing demand across maternal health programs. The WHO prequalification of a triple HIV, hepatitis B, and syphilis test in 2025 further increases the relevance of integrated screening within antenatal care. Rapid tests can be used by public health programs to increase coverage of screening in areas with limited laboratory access. Future demand will be influenced by procurement volumes, program funding, regulatory status and test performance.

The community & outreach testing programs segment is projected to witness the highest CAGR of 11.36% during 2026-2034. Rapid testing could expand syphilis screening beyond conventional health care settings and diminish dependence on centralized laboratory services. This decentralized approach is exemplified by Philadelphia FIGHT’s 2025 expansion of community testing through a retail pharmacy partnership. Increased outreach may increase access among populations that may not routinely use clinical services. Growth will be fueled by public health funding, ease of testing, regulatory access, distribution infrastructure and partnerships between diagnostic providers and community organizations.

The hospitals & clinics segment contributed 34.62% in 2025, supported by routine diagnostic activity and need for faster testing workflows. Rapid tests can be used by hospitals and clinics for immediate clinical decision-making, or when laboratory turnaround times are delayed. Venous specimen collection facilities may also use serum and plasma formats. Increasing the use of point-of-care testing in clinical settings can boost product use in emergency, outpatient, antenatal and STI services. Adoption will depend on the accuracy of the tests, their integration in workflows, regulatory approval and the economics of procurement.

The laboratories segment held 13.12% share in 2025, owing to the demand for rapid diagnostic products in laboratory supported testing workflows. The rapid formats may be employed when shorter turnaround times are needed or when rapid testing complements broader diagnostic services. The segment also serves as a channel for products that demand trained personnel or controlled testing environments. Future demand will be driven by workflow economics, sample compatibility, test performance, and the role of rapid testing in overall laboratory strategies. Where healthcare providers look for faster preliminary results, adoption can increase.

Other end users segment captured 6.69% market share in 2025 through additional testing venues that were not a part of the healthcare and public health routes. The need was for decentralized testing from organizations looking to test certain populations. Rapid products can provide value where conventional laboratory access is limited or where same-visit results are useful. Market development will depend on regulatory permissions, procurement structures, distribution access, and testing-site requirements. Broader availability of simple rapid formats can expand use across additional decentralized settings.

Regional Analysis

North America Syphilis Rapid Test Market Trends

North America was the leader in the syphilis rapid test market in 2025 and accounted for 31.42% of market share, due to the high testing demand within the US healthcare system and to continue to tackle the problem of congenital syphilis. In August 2026, HHS announced that it will spend USD 4 million to expand rapid point-of-care syphilis testing and treatment, especially in nontraditional health care settings, to help prevent congenital syphilis. The region has established a rapid testing process in the antenatal, public health, clinical, and community settings, while federal and state-level testing programs have expanded the reach. The availability of point-of-care products and growing use of decentralized testing can further increase regional demand (Source: hhs.gov).

Asia Pacific Syphilis Rapid Test Market Trends

Asia Pacific is expected to register an 8.24% CAGR during 2026–2034, as expanding healthcare access and public health screening programs increase demand for rapid diagnostics. In March 2026, Doherty Institute researchers have developed a rapid STI test that can detect syphilis and other infections in under an hour, allowing for faster diagnosis and treatment. The region also has an established diagnostic manufacturing base which can improve product availability and support local and international supply. The regional market can be further expanded with the greater adoption of antenatal screening and multiplex rapid testing as healthcare providers look for simpler testing workflow (Source: doherty.edu.au).

Europe Syphilis Rapid Test Market Trends

Europe accounted for an 18.24% share of the syphilis rapid test market in 2025, owing to the presence of well-developed healthcare systems and diagnostic infrastructure and the prevalence of STI screening activities. There is a suitable environment provided by the region to encourage the adoption of validated rapid diagnostic products since clinicians can easily incorporate these tests within their practice and public health programs. An increased adoption of rapid screening could lead to more demand from the health care system as they strive for more efficient diagnosis and access to the tests. Europe's role as a coordination and validation hub propels the regional industry growth (Source: ecdc.europa.eu).

Latin America Syphilis Rapid Test Market Trends

Latin America had an 11.54% market share in 2025, as the demand grew in both clinical settings, antenatal clinics, and public health applications. Rapid tests can cut back on the reliance on centralized laboratory facilities and increase access to testing in regions that lack laboratory facilities. An increase in screening of pregnant women and other priority groups can increase the number of tests done. Decentralized testing also provides a route for reaching populations located outside major healthcare facilities. Market development will depend on public health programs, procurement funding, regulatory access, product availability, and distribution infrastructure. Greater use of simple rapid formats can increase testing coverage across underserved settings.

Middle East & Africa Syphilis Rapid Test Market Trends

Middle East & Africa is expected to register an 9.63% CAGR during 2026–2034, driven by the need to expand access to testing across antenatal and public health programs. In 2025, the WHO and the Medicines Patent Pool have entered into an agreement with the Nigerian company Codix Bio to locally develop and manufacture rapid diagnostic tests, including technology that can be adapted for the testing of syphilis. Increasing local manufacturing capacity can improve product availability and reduce supply barriers. Broader use of rapid tests can increase access in settings with limited laboratory infrastructure (Source: epinews.emphnet.net).

Regulatory Approval and Test Pipeline Analysis

The regulatory environment is an important consideration in the development and uptake of syphilis rapid tests. The regulatory approvals dictate where the products can be used and the prequalification programs define the requirements for products intended for broader use in public health. The WHO performance target provides an additional benchmark for evaluating test performance within global health programs. The current pipeline includes standalone syphilis tests, dual HIV/syphilis products, and newer multiplex formats covering multiple maternal health screening requirements.

In the U.S., the regulatory pathway is more limited for decentralized testing as products require applicable FDA authorization and CLIA waiver status to be used in eligible non-laboratory settings. The limited number of products meeting these requirements reduces the available product choice for healthcare providers and public health programs seeking point-of-care syphilis testing.

New Product Development Pipeline and Approval Analysis

Test / Candidate	Company	Regulatory Status	Stage
Determine Antenatal Care Panel	Abbott	WHO prequalified, July 10, 2025	Newly listed, rollout targeted
DPP Syphilis TnT Assay	Chembio	FDA submission filed Jan 2026; Breakthrough Device, July 2025	Under FDA review
SyphiDuo	Shuwen Biotech	Launched July 2026	Commercial
STANDARD Q HIV/Syphilis Combo	SD Biosensor	WHO prequalified	Established, volume-priced
DPP HIV-Syphilis System	Chembio	FDA cleared 2020; CLIA waived 2023	Marketed
Syphilis Health Check	Diagnostics Direct	FDA cleared; CLIA waived	Marketed
Dual HIV-Syphilis Rapid Test	Unnamed (Health Canada)	Health Canada authorized, Jan 2025	Marketed, Canada

Source: FDA, WHO, Health Canada, company filings, and Polaris Market Research Analysis

WHO performance requirements also influence the development and evaluation of new rapid syphilis tests. WHO sets minimum targets of more than 80% sensitivity for the treponemal component, more than 95% sensitivity for the non-treponemal component when included, and more than 90% specificity. Meeting these thresholds is important for products seeking WHO prequalification and access to procurement programs. Candidates under diagnostic accuracy evaluation, including dual treponemal and non-treponemal formats, therefore remain part of the pipeline until formal regulatory or prequalification decisions are completed.

Syphilis Rapid Test Market Competitive Landscape

The syphilis rapid test market includes established diagnostic manufacturers, point-of-care specialists, and public health organizations involved in product development and deployment. Competition depends on regulatory clearance, testing accuracy, ease of use, sample requirements, product availability, and suitability for decentralized testing.

The market is also developing toward multiplex formats. The 2025 WHO prequalification of the Determine Antenatal Care Panel increases the importance of manufacturers capable of combining several infectious disease tests within one rapid diagnostic workflow. Competitive outcomes depend on regulatory access, product accuracy, test simplicity, sample requirements, distribution reach, and the ability to serve decentralized testing programs.

Competitive Landscape Snapshot

Company	Headquarters	Market Position	Analysis
Abbott Diagnostics	United States	Market Leader	Determine Antenatal Care Panel, WHO prequalified July 2025
SD Biosensor, Inc.	South Korea	Market Leader	STANDARD Q HIV/Syphilis Combo, sub-$1 WHO pricing
Chembio Diagnostic Systems	United States (Biosynex subsidiary)	Established	DPP HIV-Syphilis, only dual FDA-cleared, CLIA-waived test
Trinity Biotech plc	Ireland	Established	Broad treponemal and non-treponemal portfolio
bioLytical Laboratories	Canada	Established	INSTI Multiplex, ~1-minute results
Diagnostics Direct, LLC	United States	Established	Syphilis Health Check, CLIA-waived
Guangzhou Wondfo Biotech	China	Established	One Step Syphilis WHO-documented test
CTK Biotech, Inc.	United States	Emerging Challenger	OnSite Syphilis Ab Combo, multi-specimen
Shuwen Biotech	China	Emerging Challenger	SyphiDuo, launched July 2026
NOWDiagnostics, Inc.	United States	Emerging Challenger	First to Know, Labcorp-distributed
MedMira Inc.	Canada	Niche Specialist	Reveal TP treponemal antibody test
Meril Diagnostics	India	Niche Specialist	MERISCREEN Syphiline
Premier Medical Corporation	India	Niche Specialist	First Response Anti-TP Card, WHO prequalified
OraSure Technologies	United States	Niche Specialist	Distributes Diagnostics Direct's product

Source: Company filings and Polaris Market Research Analysis

Syphilis Rapid Test Market Technology and Innovation Landscape

Multiplex rapid diagnostics represent a major area of current development. The 2025 WHO prequalification of the Determine Antenatal Care Panel demonstrates the movement toward combining HIV, hepatitis B, and syphilis screening within one testing workflow.

Point-of-Care syphilis testing is another field in which technological advancement is necessary since speedy results help to shorten the time period between diagnosis and treatment. This is particularly relevant in antenatal and community settings where patients may not return for a separate laboratory visit.

Technology and Innovation Landscape Snapshot

Technology	Leading Developer(s)	Capability	Status
Triple Multiplex (HIV/HBV/Syphilis)	Abbott	Determine Antenatal Care Panel	WHO prequalified, July 2025
Dual Treponemal/Non-Treponemal	Chembio	DPP Syphilis TnT Assay	FDA review pending, filed Jan 2026
Ultra-Rapid Multiplex	bioLytical	INSTI, ~1-minute results	Commercially deployed
Low-Cost Dual HIV/Syphilis	SD Biosensor	STANDARD Q Combo	WHO prequalified, volume-priced
Objective Digital Readout	Chembio	DPP Micro Reader	Commercially deployed
Rapid Multi-Infection POC	Doherty Institute	Sub-1-hour STI panel	In development, March 2026

Source: Company filings, WHO, and Polaris Market Research Analysis

Test design is moving toward simpler sample collection and decentralized use. The fingerstick whole blood method can make the requirement for devices lower, whereas the portable testing device can broaden the use of testing beyond healthcare settings. These developments create a connected diagnostic ecosystem involving rapid test manufacturers, healthcare providers, public health programs, regulatory bodies, pharmacies, and community organizations.

Use Case Analysis

• Antenatal Screening: Antenatal screening represents a major use case because untreated maternal syphilis can result in congenital syphilis. Rapid testing allows screening to take place during the pregnancy care visit and can reduce dependence on later laboratory results. The 2025 WHO prequalification of the triple HIV, hepatitis B, and syphilis panel further expands this use case. One test can address several maternal screening requirements during the same visit.
• Community Testing: Community-based testing provides another important use case for rapid syphilis diagnostics. In 2025, Philadelphia FIGHT increased testing in the community by utilizing retail pharmacies, thus illustrating how testing has moved beyond traditional health care sites. Community deployment could enhance access to populations that do not use routine clinical services. This increases the addressable testing population for rapid diagnostic manufacturers.
• Public Health Programs: Public health programs can use rapid testing to increase screening coverage and improve treatment linkage. The approach becomes more relevant when testing needs to reach large or geographically dispersed populations. Multiplex testing can further simplify public health workflows because one test can address several infectious diseases. This can reduce separate procurement and testing requirements.

Buyer Analysis and Barriers to Market Entry

Buyer Decision Framework

Buyer Type	Primary Decision Driver	Representative Example
US State/Local Health Departments	CLIA waiver status, CDC program eligibility	Mississippi's point-of-care expansion under CDC guidance
Global Public Health Programs (WHO/NGO-coordinated)	WHO prequalification, volume guarantee pricing	MedAccess/CHAI/SD Biosensor sub-$1 pricing agreement
Community Health Organizations	Same-day results, retail/outreach partnership fit	Philadelphia FIGHT's Walgreens-partnered testing events

Source: Company filings and Polaris Market Research Analysis

Purchasing decisions depend on more than test price. Purchasers will consider regulatory approval, accuracy, turnaround time, specimen requirements, ease of use, accessibility, and appropriateness for the testing setting.

Barriers to Market Entry

• Regulatory requirements: Appropriate regulatory approval is required for manufacturers prior to commercialization.
• Clinical performance: Tests have to exhibit satisfactory clinical performance.
• Product qualifications: Public health procurements may necessitate further testing of products.
• Distribution availability: The manufacturers will need adequate distribution channels to distribute their products to these dispersed testing sites.
• Training needs: Some point-of-care devices may need proper training and quality control mechanisms.
• Purchase requirements: There may be some purchase requirements from public health organizations.
• Multiplex development: Combining several disease targets increases product-development and validation requirements.

Syphilis Rapid Test Market Premium Insights and Forward Outlook

Multiplex Testing Is Creating a New Product Development Path

The 2025 WHO prequalification of the Determine Antenatal Care Panel demonstrates a shift toward broader infectious disease screening through a single rapid diagnostic format. The development can increase demand for products that combine several testing requirements. Commercial opportunity depends on regulatory expansion, procurement adoption, and the ability of manufacturers to maintain test performance across multiple targets.

Community Testing Is Expanding the Addressable Market

The 2025 expansion of community-based testing via a retail pharmacy model demonstrates the use of rapid syphilis testing outside of traditional healthcare settings. Broader deployment can extend outreach to populations who may not otherwise obtain clinical services. Regulatory access, testing-site requirements, product simplicity and public health funding will drive further expansion.

Same-Visit Diagnosis Can Improve Treatment Linkage

Rapid testing provides results during the healthcare encounter, which can reduce the time between screening and clinical action. This is relevant to congenital syphilis prevention as delayed diagnosis can reduce the opportunity for timely treatment. The market opportunity therefore extends beyond the test itself and includes healthcare programs seeking faster diagnosis-to-treatment workflows.

Cost and Pricing Benchmarking Analysis

Publicly comparable pricing data for current syphilis rapid tests is limited. Pricing varies by product configuration, geography, procurement model, testing volume, regulatory status, and whether the test is supplied as a standalone or multiplex product. As per the available evidence, there is a significant difference between U.S. clinical pricing and global public-health procurement. For instance, Chembio’s DPP HIV/Syphilis test is reported at approximately US$16 per test in clinic cost. However, WHO-coordinated procurement of SD Biosensor’s STANDARD Q HIV/Syphilis Combo reached US$0.84 per test following a volume-guarantee agreement and a 32% price reduction. Retail and bulk pricing for Syphilis Health Check is varying considerably by order configuration. Public pricing for triple HIV/HBV/syphilis panels remains insufficient for a reliable benchmark.

Syphilis Cost and Pricing Benchmarking

Product / Test	Market / Procurement Channel	Indicative Price	Pricing Context
Chembio DPP HIV/Syphilis	U.S. clinical	~US$16/test	Average clinic cost; reimbursement reported at ~US$26.95/test
SD Biosensor STANDARD Q HIV/Syphilis Combo	WHO-coordinated LMIC procurement	~US$0.84/test	32% reduction following volume-guarantee agreement
Syphilis Health Check	U.S. retail/bulk	US$20–US$10,780	Varies substantially by order volume and configuration

Source: Company filings and Polaris Market Research Analysis

Key Players

• Abbott Diagnostics Medical Co., Ltd.
• bioLytical Laboratories Inc.
• Chembio Diagnostic Systems, Inc.
• CTK Biotech, Inc.
• Diagnostics Direct, LLC
• Guangzhou Wondfo Biotech Co., Ltd.
• MedMira Inc.
• Meril Diagnostics Pvt. Ltd.
• NOWDiagnostics, Inc.
• OraSure Technologies, Inc.
• Premier Medical Corporation Private Limited
• SD Biosensor, Inc.
• Shuwen Biotech
• Trinity Biotech plc

Syphilis Rapid Test Market Vendor Positioning

Company	Vendor Positioning	Key Syphilis Rapid-Test Offering / Strength
Abbott Diagnostics Medical Co., Ltd.	Multiplex and antenatal-care testing leader	Determine Syphilis TP and the Determine Antenatal Care Panel, covering HIV, HBV, and syphilis testing. WHO prequalified the Antenatal Care Panel in July 2025 as the first bundled set of three RDTs for simultaneous detection of these infections.
SD Biosensor, Inc.	Affordable dual HIV/syphilis testing provider	STANDARD Q HIV/Syphilis Combo Test is WHO prequalified and provides combined screening for HIV and syphilis.
Chembio Diagnostic Systems, Inc.	U.S. point-of-care dual-testing specialist	DPP HIV-Syphilis System provides simultaneous HIV and syphilis testing. FDA records show the product received a CLIA waiver.
Diagnostics Direct, LLC	U.S. rapid treponemal testing specialist	Syphilis Health Check is positioned for rapid syphilis antibody screening and is designed for decentralized testing settings.
bioLytical Laboratories Inc.	Ultra-rapid multiplex HIV/syphilis testing provider	INSTI Multiplex HIV-1/2 Syphilis Antibody Test simultaneously detects HIV-1/2 and syphilis antibodies from fingerstick blood and provides results in approximately one minute.
CTK Biotech, Inc.	Broad rapid-test and multiplex diagnostics supplier	OnSite Syphilis Ab Combo Rapid Test supports serum, plasma, and whole-blood testing, while its HIV/Syphilis Ab Combo provides simultaneous screening for the two infections.
Guangzhou Wondfo Biotech Co., Ltd.	High-volume rapid diagnostic test manufacturer	Portfolio includes rapid infectious-disease diagnostics, with WHO documentation identifying its One Step Syphilis Whole Blood/Serum/Plasma Test.
MedMira Inc.	Rapid syphilis antibody testing specialist	Reveal TP is a rapid treponemal antibody test, while MedMira also develops multiplex and dual-marker syphilis testing technologies.
Meril Diagnostics Pvt. Ltd.	India-focused rapid diagnostics supplier	MERISCREEN Syphiline provides rapid syphilis antibody screening within Meril's broader infectious-disease diagnostics portfolio.
OraSure Technologies, Inc.	Commercial distribution and decentralized-testing participant	Participates in the syphilis rapid-test market through distribution of Diagnostics Direct's Syphilis Health Check rather than as its manufacturer.
Premier Medical Corporation Private Limited	WHO-prequalified standalone syphilis RDT supplier	First Response Syphilis Anti-TP Card Test is a lateral-flow RDT for plasma, serum, and whole blood and has been WHO prequalified.
Trinity Biotech plc	Broad syphilis diagnostic portfolio provider	Offers treponemal, non-treponemal, screening, and confirmatory syphilis diagnostics, including Syphilis Health Check in its product portfolio.

Source: Company filings and Polaris Market Research Analysis

Industry Developments

• July 2026: PATH and Unitaid announced partnership with GiveWell to expand integrated HIV–syphilis testing for newborns, mothers, and their families across five countries in Africa. (Source: unitaid.org)
• July 2026: Shuwen Biotech launches SyphiDuo, a dual rapid point-of-care test to improve syphilis detection in pregnancy and prevent congenital syphilis. (Source: einnews.com)
• July 2025: Labcorp and NOWDx partnered to expand access to rapid syphilis testing by providing First to Know test kits free of charge to community health organizations across the U.S. (Source: labcorp.com)
• October 2025: Philadelphia FIGHT expanded free community-based rapid syphilis testing in partnership with Walgreens Specialty Pharmacy. (Source: finance.yahoo.com)
• January 2025: Health Canada authorized a dual HIV–syphilis rapid test to respond to increasing infection cases across the country. (Source: reachnexus.ca)

Syphilis Rapid Test Market Segmentation

By Test Type Outlook (Revenue, USD Million, 2021–2034)

• Dual HIV/Syphilis Rapid Test
• Triple HIV/Hepatitis B/Syphilis Rapid Test
• Syphilis-Only Rapid Test

By Sample Type Outlook (Revenue, USD Million, 2021–2034)

• Fingerstick Whole Blood
• Serum / Plasma
• Other Sample Types

By End User Outlook (Revenue, USD Million, 2021–2034)

• Antenatal Care / Public Health Programs
• Hospitals & Clinics
• Community & Outreach Testing Programs
• Laboratories
• Other End Users

By Regional Outlook (Revenue, USD Million, 2021–2034)

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Taiwan
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • South Africa
  • Rest of Middle East & Africa

Syphilis Rapid Test Market Report Scope

Report Attributes	Details
Market Size in 2025	USD 177.07 Million
Market Size in 2026	USD 193.64 Million
Revenue Forecast by 2034	USD 399.89 Million
CAGR	8.39% from 2026–2034
Base Year	2025
Historical Data	2021–2024
Forecast Period	2026–2034
Quantitative Units	Revenue in USD Million and CAGR
Report Coverage	Revenue Forecast, Growth Factors, Competitive Landscape, Industry Trends, and Strategic Analysis
Segments Covered	By Test Type By Sample Type By End User
Regional Scope	North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Competitive Landscape	Syphilis Industry Trend Analysis (2025) Company Profiles/Industry participants profiling includes company overview, financial information, product/service benchmarking, and recent developments
Report Format	PDF + Excel
Customization	Available by Country, Region, and Segment

Source: Polaris Market Research Analysis

Why Choose Polaris Market Research

Polaris Market Research & Consulting, Inc. combines regulatory research, company disclosures, clinical evidence, public health information, industry developments, and market analysis to assess the syphilis rapid test industry.

The syphilis rapid diagnostic test market analysis focuses on point-of-care testing, antenatal screening, community testing, multiplex diagnostics, regulatory developments, and product availability. The analysis also examines factors affecting adoption across healthcare facilities and public health programs. Clients evaluating rapid diagnostic opportunities, regional demand, competitive positioning, product development, or public health applications can request a tailored scope review of the analysis.

Syphilis Rapid Test Market Research Methodology

The syphilis rapid test market report uses secondary research across regulatory publications, public health organizations, company announcements, clinical evidence, diagnostic industry publications, and regional healthcare sources to assess market trends and develop the syphilis rapid diagnostic test industry forecast.

Market sizing figures remain reserved for confirmed Polaris proprietary data. No third-party syndicated market-sizing figures are used as substitutes for internal estimates. The methodology distinguishes publicly disclosed diagnostic and commercial information from Polaris proprietary market estimates. The source base focuses on recent 2024–2025 developments to maintain relevance to the 2025 base year.

Research Methodology Phases

Source: Polaris Market Research Analysis.