United States HSV Testing Market By Sample Type (Blood, Swabs, Cerebrospinal Fluid, Others), By Test Type (Serological Tests, Direct Detection Tests, Point-of-Care Tests, Others), By Region and Competition, Forecast & Opportunities, 2020-2030F

Market Overview

United States HSV Testing Market was valued at USD 203.45 Million in 2024 and is expected to reach USD 259.83 Million by 2030 with a CAGR of 4.36%. HSV, which includes both HSV-1 and HSV-2, is one of the most prevalent viral infections in the country. While HSV-1 is traditionally associated with oral herpes and HSV-2 with genital herpes, changing patterns of transmission have blurred these distinctions, reinforcing the need for accurate and early detection.

One of the key drivers of the HSV testing market is the rising emphasis on early diagnosis and disease management. Although HSV is not curable, timely testing allows for more effective treatment, reduced transmission risk, and improved quality of life for patients. However, challenges remain. Social stigma associated with herpes can deter individuals from seeking testing or disclosing symptoms, limiting the market’s full potential. Furthermore, disparities in healthcare access across different regions and socioeconomic groups continue to impact testing rates, particularly in underserved communities.

Key Market Drivers

Growth in Healthcare Industry

The ongoing growth of the healthcare industry in the United States has emerged as a key driver of the herpes simplex virus (HSV) testing market. In 2023, U.S. healthcare expenditures grew by 7.5%, reaching a total of USD 4.9 trillion, or USD 14,570 per capita. Healthcare spending accounted for 17.6% of the nation’s Gross Domestic Product. As healthcare infrastructure expands and public health priorities shift toward early diagnosis and disease prevention, there is a rising demand for accurate and accessible diagnostic services, including those for sexually transmitted infections such as HSV-1 and HSV-2.

One of the most influential factors behind this trend is the increasing awareness around sexual health. For instance, the American Sexual Health Association has designated September 30 as National Get Tested Day, dedicated to raising awareness about the critical importance of testing for sexually transmitted infections. Healthcare providers, government programs, and advocacy groups are placing greater emphasis on routine screening and education, encouraging more individuals to seek testing even in the absence of symptoms. This cultural shift has helped to normalize STI testing, driving higher testing volumes across clinical laboratories, hospitals, and point-of-care settings.

Surge in Technological Advancements

The surge in technological advancements is a pivotal driver of growth in the United States HSV (Herpes Simplex Virus) testing market. Innovations in molecular diagnostics, such as polymerase chain reaction (PCR) and next-generation sequencing (NGS), have significantly improved the sensitivity, accuracy, and speed of HSV detection. The NGS Quality Initiative provides a foundational, next-generation sequencing (NGS)-focused quality management system (QMS) based on the Clinical & Laboratory Standards Institute’s (CLSI) framework of 12 Quality Systems Essentials (QSEs). This initiative facilitates the implementation of quality management practices in laboratories by leveraging these QSEs to develop robust QMS for NGS-based testing.

Integration of automation and digital health platforms has further streamlined laboratory workflows and data management, reducing turnaround times and operational costs. These technological improvements have expanded testing accessibility, encouraged early diagnosis, and supported personalized treatment approaches. As a result, market players investing in cutting-edge HSV testing technologies are driving market expansion across the United States.

Download Free Sample Report

Key Market Challenges

High Initial Investment

High initial investment is a significant challenge in the United States HSV testing market, particularly for diagnostic laboratories, healthcare providers, and companies developing advanced testing platforms. Setting up and maintaining the infrastructure required for accurate and reliable HSV testing involves substantial capital expenditure. This includes the cost of acquiring sophisticated diagnostic equipment, implementing automated systems, ensuring laboratory compliance with regulatory standards, and hiring trained personnel.

Modern testing technologies such as molecular diagnostics, including PCR-based platforms, offer high sensitivity and specificity, but they come with high setup costs. In addition to the equipment itself, laboratories must invest in consumables, software, and ongoing calibration and maintenance. These costs can be prohibitive for smaller labs, clinics, or startups, limiting their ability to enter or scale within the market.

Key Market Trends

Integration of Smart Technologies and IoT in Devices

In the United States, the seroprevalence rates for adult infections are approximately 80% for HSV-1 and 20% for HSV-2. The integration of smart technologies and the Internet of Things (IoT) into diagnostic devices is emerging as a transformative trend in the United States HSV testing market. As healthcare systems increasingly prioritize efficiency, connectivity, and real-time data access, the adoption of intelligent diagnostic solutions is reshaping how HSV testing is conducted, monitored, and managed across clinical and home-based settings.

Smart diagnostic devices equipped with IoT capabilities offer enhanced functionality compared to traditional testing methods. These devices can capture, store, and transmit test results securely to electronic health records (EHRs) or cloud-based platforms, enabling healthcare providers to access patient data in real time. This seamless data exchange improves clinical decision-making, reduces diagnostic delays, and supports more personalized treatment plans for HSV-positive individuals.

Segmental Insights

Sample Type Insights

Based on Sample Type, Blood have emerged as the fastest growing segment in the United States HSV Testing Market in 2024. This is due to its high accuracy, reliability, and ability to detect both active and latent infections. Unlike swab-based tests that primarily identify active lesions, blood-based serological tests can detect HSV antibodies, making them ideal for screening asymptomatic individuals or confirming past exposure. The growing demand for early and accurate diagnosis, particularly in prenatal screening, high-risk populations, and routine health checks has driven increased adoption of blood-based HSV testing.

Test Type Insights

Based on Test Type, Serological Tests have emerged as the fastest growing segment in the United States HSV Testing Market during the forecast period. This is due to their ability to detect past or latent infections with high accuracy and efficiency. Unlike molecular tests, which are primarily used during active outbreaks, serological tests identify HSV-specific antibodies in the blood, making them highly valuable for screening asymptomatic individuals or confirming previous exposure. This broader diagnostic application, combined with the rising awareness of sexually transmitted infections (STIs) and increased demand for comprehensive screening, has significantly boosted the adoption of serological testing.

Download Free Sample Report

Regional Insights

Based on Region, Midwest have emerged as the dominating region in the United States HSV Testing Market in 2024. This is due to a convergence of demographic, healthcare infrastructure, and policy-related factors. One of the key drivers is the region's relatively high burden of HSV infections, particularly in densely populated urban areas and underserved communities where testing and early diagnosis are critical to disease management.

Recent Development

• In March 2025, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Visby Medical for its Women’s Sexual Health Test. This innovative diagnostic solution is the first FDA-authorized, over-the-counter test for chlamydia, gonorrhea, and trichomoniasis that can be fully self-administered at home without a prescription. Designed for use by women with or without symptoms, the test delivers results in approximately 30 minutes. The single-use kit includes a self-collected vaginal swab and a powered testing device that securely transmits results to the Visby Medical App upon completion of the test.
• In September 2024, GSK plc announced the completion of the primary objective data analysis from the Phase II segment of the TH HSV REC-003 trial. This combined Phase I/II proof-of-concept study evaluated the potential clinical efficacy of GSK3943104, an early-stage therapeutic vaccine candidate for herpes simplex virus (HSV), to inform decisions on further clinical development. The results indicated that GSK3943104 did not achieve the study’s primary efficacy endpoint and, consequently, will not advance to Phase III trials. No safety concerns were identified. The TH HSV REC-003 study will continue with routine safety monitoring and the collection of follow-up data to provide additional insights into recurrent genital herpes.

Key Market Players

• F. Hoffmann-La Roche Ltd
• Abbott Laboratories
• Thermo Fisher Scientific Inc.
• Becton, Dickinson and Company
• Bio-Rad Laboratories, Inc
• BIOMÉRIEUX
• Hologic, Inc.

Report Scope

In this report, the United States HSV Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States HSV Testing Market, By Sample Type:

o   Blood

o   Swabs

o   Cerebrospinal Fluid

o   Others

• United States HSV Testing Market, By Test Type:

o   Serological Tests

o   Direct Detection Tests

o   Point-of-Care Tests

o   Others

• United States HSV Testing Market, By Region:

o   Northeast

o   Midwest

o   South

o   West

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the United States HSV Testing Market.

Available Customizations:

United States HSV Testing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

United States HSV Testing Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]