The U.S. HSV testing market size was estimated at USD 205.0 million in 2024 and is expected to grow at a CAGR of 5.24% from 2025 to 2033. The market includes a range of diagnostic solutions designed for the accurate and timely detection of herpes simplex virus types 1 and 2. Testing methods span from conventional serological assays to advanced molecular platforms, enabling reliable clinical decision-making across hospitals, diagnostic laboratories, and outpatient settings. These tests are widely used for managing sexually transmitted infections and prenatal screening, with increasing adoption in decentralized and point-of-care environments as the demand for rapid and accessible testing grows.
Ongoing advancements in molecular diagnostic technologies continue to improve the sensitivity and turnaround time of HSV testing in the U.S. Multiplex PCR platforms that detect HSV alongside other STIs are gaining preference in outpatient clinics and emergency departments. Moreover, newer test kits with streamlined sample-to-answer workflows have received regulatory clearance, facilitating broader use in primary and urgent care environments.
In a significant regulatory update, the FDA formally classified HSV nucleic acid-based assays for central nervous system (CNS) infections as Class II (special controls) in June 2025. This change applies to qualitative in vitro diagnostics for detecting and differentiating HSV-1 and HSV-2 in cerebrospinal fluid samples, and it provides a clearer, more streamlined path to market compared to the previous Class III status. By reducing regulatory burdens while ensuring safety and effectiveness, this reclassification is expected to accelerate the availability of CNS-directed HSV tests, benefiting hospitals and neurology centers.
Government-led STI surveillance and prevention efforts are also driving market growth. Public health campaigns focused on adolescent and reproductive health are increasing patient demand for accessible, reliable HSV screening. Furthermore, collaborations between federal health agencies (such as the CDC and NIH) and private diagnostic companies are helping to reduce testing disparities across urban and underserved communities.
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Ongoing advancements in molecular diagnostic technologies continue to improve the sensitivity and turnaround time of HSV testing in the U.S. Multiplex PCR platforms that detect HSV alongside other STIs are gaining preference in outpatient clinics and emergency departments. Moreover, newer test kits with streamlined sample-to-answer workflows have received regulatory clearance, facilitating broader use in primary and urgent care environments.
In a significant regulatory update, the FDA formally classified HSV nucleic acid-based assays for central nervous system (CNS) infections as Class II (special controls) in June 2025. This change applies to qualitative in vitro diagnostics for detecting and differentiating HSV-1 and HSV-2 in cerebrospinal fluid samples, and it provides a clearer, more streamlined path to market compared to the previous Class III status. By reducing regulatory burdens while ensuring safety and effectiveness, this reclassification is expected to accelerate the availability of CNS-directed HSV tests, benefiting hospitals and neurology centers.
Government-led STI surveillance and prevention efforts are also driving market growth. Public health campaigns focused on adolescent and reproductive health are increasing patient demand for accessible, reliable HSV screening. Furthermore, collaborations between federal health agencies (such as the CDC and NIH) and private diagnostic companies are helping to reduce testing disparities across urban and underserved communities.
U.S. HSV Testing Market Report Segmentation
This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. The analyst has segmented the U.S. HSV Testing market report based on type, test type, sample type, end use, and region:Type Outlook (Revenue, USD Million, 2021-2033)
- HSV-1/HSV-2 Combines
- HSV-1
- HSV-2
Test Type Outlook (Revenue, USD Million, 2021-2033)
- Serological tests
- Direct detection tests
- PCR
- Viral culture
- Point-of-care tests
Sample Type Outlook (Revenue, USD Million, 2021-2033)
- Blood
- Swabs
- Cerebrospinal fluid
End Use Outlook (Revenue, USD Million, 2021-2033)
- Hospitals
- Diagnostic laboratories
- Clinics and sexual health centers
- Home care / self-testing
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- Comprehensive Market Analysis: Gain detailed insights into the industry across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
- COVID-19's impact and how to sustain in these fast-evolving markets
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Table of Contents
Chapter 1. U.S. HSV Testing Market: Methodology and Scope
Chapter 2. U.S. HSV Testing Market: Executive Summary
Chapter 3. HSV Testing Market Variables, Trends, & Scope
Chapter 4. U.S. HSV Testing Market: Type Estimates & Trend Analysis
Chapter 5. U.S. HSV Testing Market: Test Type Estimates & Trend Analysis
Chapter 6. U.S. HSV Testing Market: Sample Type Estimates & Trend Analysis
Chapter 7. U.S. HSV Testing Market: End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of tables
List of Figures
Companies Mentioned
The major companies profiled in this U.S. HSV Testing market report include:- F. Hoffmann-La Roche Ltd.
- Abbott
- Thermo Fisher Scientific Inc.
- BD
- Bio-Rad Laboratories, Inc.
- bioMérieux SA
- DiaSorin S.p.A.
- Hologic, Inc.
- Cepheid
- QuidelOrtho Corporation
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | August 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 205 Million |
| Forecasted Market Value ( USD | $ 320.76 Million |
| Compound Annual Growth Rate | 5.2% |
| Regions Covered | United States |
| No. of Companies Mentioned | 11 |
