U.S. Molecular Diagnostics For STD Market Size, Share & Trends Analysis Report By Product (Instruments & Services, Consumables), By Application (Chlamydia Testing, Syphilis Testing), By Technology, And Segment Forecasts, 2025 - 2033

Market Size & Trends

The U.S. molecular diagnostics for sexually transmitted diseases market size was estimated at USD 1.11 billion in 2024 and is projected to grow at a CAGR of 7.60% from 2025 to 2033. The growing burden of sexually transmitted diseases (STDs) across the U.S. is a primary growth driver. According to the Centers for Disease Control and Prevention (CDC), STDs such as chlamydia, gonorrhea, and syphilis have been increasing steadily over the past decade, with over 2.5 million cases reported in recent years. Molecular diagnostics, particularly those based on PCR and nucleic acid amplification technologies (NAATs), are emerging as the gold standard due to their high sensitivity and specificity, thus supporting early detection and timely intervention.

Furthermore, the increasing prevalence influences patient behavior and healthcare policies by encouraging routine screening and diagnostic testing. More individuals are seeking medical advice for symptoms related to STIs and vaginitis, prompting healthcare providers to favor molecular diagnostics for accurate confirmation. Surveillance data on infection rates inform national healthcare strategies, further expanding the utilization of PCR tests. The rising prevalence of these infections continually fuels growth in the STI & Vaginitis PCR Testing Market by broadening its user base and diagnostic reach.

The data indicates a general downward trend in the incidence rates of major sexually transmitted infections (STIs) such as chlamydia, gonorrhea, and syphilis from 2020 to 2024. Chlamydia, while still the most prevalent, shows a consistent decline in both cases and rates, dropping from 21,942 cases (384.3 rate) in 2020 to 19,703 cases (345 rate) in 2024. Gonorrhea follows a similar pattern, with a marked reduction from 10,217 cases in 2020 to 7,131 in 2024. Although the total syphilis burden initially rose, peaking in 2022, a decline is seen in 2023 and 2024, suggesting improved detection or intervention efforts. Notably, congenital syphilis continues to increase each year, highlighting a critical public health concern requiring targeted prenatal care strategies. The sustained absence of chancroid cases across all years suggests successful long-term control or eradication within the monitored population.

The increasing integration of molecular diagnostics into routine screening programs is also influencing the market landscape. Public health initiatives and recommendations from authorities such as the CDC and the U.S. Preventive Services Task Force advocate regular STI screening, especially for high-risk groups such as sexually active youth, pregnant women, and men who have sex with men (MSM). As a result, healthcare providers are adopting advanced molecular tests to ensure rapid detection, improve clinical decision-making, and reduce the risk of long-term complications like infertility, neonatal infections, and HIV co-infections. These testing programs are further supported by government funding and insurance reimbursements, which reduce the financial barrier to access for both providers and patients.

In May 2024, Sherlock Biosciences initiated the PROMISE Study, a multicenter clinical trial evaluating its over-the-counter (OTC) disposable molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae against the gold standard for diagnosing STIs, the polymerase chain reaction (PCR) test. This test utilizes self-collected penile meatal or vaginal swabs and provides results in under 30 minutes by analyzing DNA and RNA. The study aims to enroll approximately 2,500 participants across 20 diverse sites in the U.S., reflecting the varied demographics affected by STIs. By seeking FDA marketing authorization for OTC use and CLIA waiver categorization, Sherlock aims to make STI testing more accessible, especially for underserved populations.

U.S. Molecular Diagnostics for STD Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the U.S. molecular diagnostics for Sexually Transmitted Diseases (STDs) market report based on product, application, and technology:

Product Outlook (Revenue, USD Million, 2021 - 2033)

• Instruments & Services
• Consumables (Reagents and kits)
• Software

Application Outlook (Revenue, USD Million, 2021 - 2033)

• CT/NG testing
• Syphilis testing
• Gonorrhea testing
• HSV testing
• HPV testing
• HIV testing
• Trichomonas
• Ureaplasma + Mycoplasma
• Others

Technology Outlook (Revenue, USD Million, 2021 - 2033)

• Laboratory Testing
• Commercial/Private Labs
• Public Health Labs
• PoC testing

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