The global syphilis testing market size recorded US$ 2.29 billion in 2024, set to grow to US$ 2.45 billion in 2025 and projected to hit nearly US$ 4.57 billion by 2034, with a CAGR of 6.85% throughout the forecast timeline.
Funding and Investments - Increased investments support R&D for advanced diagnostics and expand testing infrastructure.
Government and Public Health Initiatives – Screening programs, especially during pregnancy, promote routine testing and support public health goals.
Clinical Trials: Clinical trials in syphilis testing evaluate rapid and point-of-care tests for accuracy and reliability, aiming to improve screening, accelerate diagnosis, and enhance treatment and partner notification across clinical settings.
Regulatory Approvals: Regulatory approval for syphilis tests is overseen by the U.S. Food and Drug Administration (FDA) in the United States and involves ensuring the test's safety and effectiveness through mechanisms like the De Novo pathway for novel devices.
Patient Support and Services: Patient support for syphilis testing involves pre- and post-test counseling, confidential testing at government centers like NACO, and access to at-home test kits. It also includes partner notification and contact tracing services, with some platforms providing free and anonymous options, helping ensure timely treatment and reducing the spread of infection.
In 2024, NOWDiagnostics, Inc. (NOWDx) launched its First To Know® Syphilis Test nationwide, making it the first FDA-authorized over-the-counter syphilis self-test in the U.S. Available on Amazon and in thousands of pharmacies and retail stores, the test provides accurate in-home results in just 15 minutes using a single drop of blood. Priced under $30, it aims to expand access, reduce stigma, and encourage timely testing. CEO Rob Weigle stated that the test is designed to “break down barriers to healthcare access” and support public health efforts to curb syphilis spread.
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