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.

Number of Cases and Rates (per 100,000 persons) of Chlamydia, Gonorrhea, Syphilis, and Chancroid - Minnesota, (2020 - 2024)

Source: Minnesota Department of Health

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.

Market Concentration & Characteristics

The U.S. molecular diagnostics market for STD is experiencing significant innovation, particularly in point-of-care and at-home testing solutions. Companies are leveraging advanced PCR technologies, multiplex panels, and miniaturized platforms to deliver rapid, user-friendly diagnostics. A notable example is Visby Medical, which received FDA authorization in April 2024 for the first at-home, single-use PCR test that detects chlamydia, gonorrhea, and trichomoniasis from a vaginal swab. Such innovations are transforming STI detection from centralized labs to decentralized, consumer-facing environments, increasing early diagnosis and treatment.

The U.S. market has witnessed a moderate but strategic level of M&A activity, aimed at expanding diagnostic portfolios and technological capabilities. A key development includes R-Biopharm AG’s acquisition of AusDiagnostics (2024), a molecular diagnostics company with expertise in multiplex PCR testing. While AusDiagnostics is based in Australia, the acquisition signals a move by R-Biopharm to strengthen its STI and vaginitis testing capabilities, including planned market expansion in the U.S. This trend reflects companies’ strategies to enhance their molecular platforms and extend geographic footprints via acquisitions.

Regulatory frameworks in the U.S., particularly through the FDA and CLIA, play a crucial role in shaping product approvals and market readiness. The FDA’s increasing support for over-the-counter (OTC) molecular STI tests has paved the way for broader consumer access. For example, in June 2024, Cepheid received Health Canada licensing for its Xpert HIV-1 Viral Load XC test, which is already under review for broader North American rollout, including the U.S. This regulatory flexibility is driving innovation and pushing companies to develop tests that meet evolving approval pathways, especially for high-prevalence STDs like HIV and HPV.

Product diversification remains a central theme, with diagnostic companies expanding test menus and multiplex panels to cover a broader spectrum of STIs. Roche Diagnostics, for instance, recently launched a multiplex molecular STI test panel targeting chlamydia, gonorrhea, trichomonas, and Mycoplasma genitalium at the point of care. The increasing demand for syndromic testing has encouraged companies to deliver solutions that can rapidly diagnose co-infections in a single sample, improving clinical outcomes and reducing treatment delays.

Regional expansion of molecular diagnostics in the U.S. is robust, with strong growth in the West, Midwest, and Southeast. States such as California, Texas, and Florida are experiencing high volumes of STD cases, prompting increased adoption of molecular tests in both public health settings and commercial labs. Government-funded screening initiatives, particularly in urban and underserved areas, are fueling diagnostic uptake. Additionally, regional healthcare systems are increasingly integrating rapid molecular platforms into emergency departments and urgent care centers, enhancing reach beyond traditional laboratories.

Product Insights

The consumables segment, which covers reagents and kits, held the largest share of the U.S. molecular diagnostics for STD industry in 2024. This dominance is due to the recurrent demand for test kits in both high-throughput laboratory settings and point-of-care applications. Companies like BD, Abbott, and Roche continue to expand their consumables portfolio with multiplex panels for simultaneous detection of multiple STIs, including Chlamydia trachomatis and Neisseria gonorrhoeae. For example, Cepheid’s Xpert CT/NG test cartridges remain widely used across U.S. clinical labs and urgent care centers.

The instruments & services segment is expected to witness significant growth over the forecast period, due to increasing adoption of advanced, automated platforms like Roche’s cobas 5800, BioFire’s FilmArray, and Qiagen’s NeuMoDx systems. In 2025, Roche received FDA clearance for its cobas liat POC system for STI testing, boosting demand for instrumentation in decentralized settings. Additionally, service-based testing contracts from public health departments and retail clinics are fueling long-term instrument leasing and service agreements.

Application Insights

The HIV testing segment held the largest market share in 2024. In 2022, only about 36% of U.S. adults aged 18-64 reported ever having been tested for HIV. This reveals a significant testing gap, considering CDC guidelines recommend routine testing for all individuals aged 13-64 and annual tests for those at higher risk. An estimated 13% of the 2 million people living with HIV in the U.S. are unaware of their status. These undiagnosed individuals account for nearly 40% of new HIV transmissions. Furthermore, continuous federal funding, routine screening recommendations from the CDC, and increasing use of viral load monitoring in treatment programs. In June 2025, Cepheid received Health Canada approval for the Xpert HIV-1 Viral Load XC test, with a U.S. launch expected soon underscoring strong innovation in this space.

The HPV testing segment is expected to showcase notable growth during the forecast period, driven by expanding cervical cancer screening programs and inclusion of HPV genotyping in STI panels. At-home HPV test development has intensified, with firms like Thermo Fisher and Hologic advancing easy-to-use kits tailored for underserved U.S. populations. Public health emphasis on HPV vaccination and early detection is further boosting this segment. In November 2023, the FDA approved Abbott's molecular human papillomavirus (HPV) screening solution to run on the Alinity m platform. This assay detects 14 high-risk, cancer-causing types of HPV and is approved for primary cervical cancer screening, aligning with professional medical guidelines.

Technology Insights

The laboratory testing segment held the largest market share in 2024, due to its ability to deliver high-throughput, highly accurate results. Centralized laboratories often utilize automated systems and multiplex PCR platforms capable of testing for multiple STIs simultaneously, which enhances diagnostic efficiency and supports clinical decision-making. In 2024, this segment benefited from strong integration with electronic health records (EHRs), contributing to faster reporting and patient follow-ups. Leading reference labs such as LabCorp and Quest Diagnostics expanded their molecular STD test offerings, including the adoption of next-generation platforms for high-sensitivity HPV and HIV viral load testing. Increasing demand for confirmatory testing and surveillance by public health agencies has also driven this segment's growth. Additionally, collaborations between hospital networks and molecular diagnostics firms have further improved access and reduced turnaround times, particularly in underserved areas.

The point-of-care (PoC) testing segment is expected to experience the fastest growth during the forecast period, due to the urgent need for decentralized, rapid diagnostics in urgent care centers, community clinics, and mobile health units. FDA approvals in 2024 for several PoC molecular assays, including Cepheid’s Xpert HIV-1 Viral Load XC and binx health’s STI panel, have revolutionized STD screening at the point of care. These tests allow for accurate results within 30-60 minutes, reducing the likelihood of patient loss to follow-up and enabling immediate treatment initiation. Moreover, the CDC and HRSA have supported pilot programs deploying PoC diagnostics in high-burden zip codes, targeting populations disproportionately affected by chlamydia, gonorrhea, and syphilis.

Key U.S. Molecular Diagnostics For STD Company Insights

Leading players are focusing on expanding their service portfolios to increase revenue. Several companies have launched PCR tests for vaginitis in the U.S., including Cepheid with its Xpert Xpress MVP. Another company, BD, also launched a BD Max Vaginal Panel, a multiplex PCR test, for detecting these common causes of vaginitis. These PCR tests offer faster and more accurate results compared to traditional methods, aiding in better treatment decisions.

For instance, In Nov 2022, Cepheid Launches Multiplex Vaginal Panel (MVP) to Support More Accurate Women's Health Diagnosis in U.S. A molecular diagnostic test designed to simultaneously detect multiple causes of vaginitis, including bacterial vaginosis (BV), Candida species (yeast infections), and Trichomonas vaginalis. The MVP is designed for use on Cepheid’s GeneXpert system, providing accurate and rapid results in about an hour. BD's BD Max Vaginal Panel is a multiplex microbiome-based real-time PCR assay that detects the three main infectious causes of vaginitis. It is the first of its kind to be FDA-cleared for this purpose, according to BD.

Recent Developments

• ​In February 2025, Abbott received FDA 510(k) clearance for its Simpli COLLECT STI Test, a self-collection kit enabling lab-based molecular detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. The clearance supports growing demand for at-home sample collection paired with centralized molecular testing, reflecting broader trends toward improved accessibility and patient-centered STD diagnostics.

• In January 2024, QIAGEN received FDA clearance for its NeuMoDx CT/NG Assay 2.0, designed for the direct detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This assay is compatible with both NeuMoDx 96 and 288 Molecular Systems, offering rapid results and aiming to improve accessibility and timeliness in STI testing in the U.S.

• In November 2023, the FDA approved Abbott's molecular human papillomavirus (HPV) screening solution to run on the Alinity m platform. This assay detects 14 high-risk, cancer-causing types of HPV and is approved for primary cervical cancer screening, aligning with professional medical guidelines.

U.S. Molecular Diagnostics for STD Market Report Scope

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, Grand View Research 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