PUBLISHER: Grand View Research | PRODUCT CODE: 1813861
PUBLISHER: Grand View Research | PRODUCT CODE: 1813861
U.S. HSV Testing Market Size, Share & Trends Analysis By Type (HSV-1/HSV-2 Combines, HSV-1, HSV-2), By Test Type, By Sample Type (Blood, Swabs, Cerebrospinal Fluid), By End Use, By Region, And Segment Forecasts, 2025 - 2033
U.S. HSV Testing Market Summary
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.
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. For this study, Grand View Research 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
Table of Contents
Chapter 1. U.S. HSV Testing Market: Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.1.1. Segment Definitions
- 1.1.1.1. Type Segment
- 1.1.1.2. Test Type Segment
- 1.1.1.3. Sample Type segment
- 1.1.1.4. End Use Segment
- 1.1.1. Segment Definitions
- 1.2. Estimates and Forecast Timeline
- 1.3. Objectives
- 1.3.1. Objective - 1
- 1.3.2. Objective - 2
- 1.3.3. Objective - 3
- 1.4. Research Methodology
- 1.5. Information Procurement
- 1.5.1. Purchased Database
- 1.5.2. GVR's Internal Database
- 1.5.3. Secondary Sources
- 1.5.4. Primary Research
- 1.6. Information or Data Analysis
- 1.6.1. Data Analysis Models
- 1.7. Market Formulation & Validation
- 1.8. Model Details
- 1.8.1. Commodity Flow Analysis
- 1.9. List of Secondary Sources
- 1.10. List of Abbreviations
Chapter 2. U.S. HSV Testing Market: Executive Summary
- 2.1. Market Snapshot
- 2.2. Type and Test Type Snapshot
- 2.3. Sample Type and End Use Snapshot
- 2.4. Competitive Landscape Snapshot
Chapter 3. HSV Testing Market Variables, Trends, & Scope
- 3.1. Market Segmentation and Scope
- 3.2. Market Lineage Outlook
- 3.2.1. Parent Market Outlook
- 3.2.2. Related/Ancillary Market Outlook
- 3.3. Market Dynamics
- 3.4. Market Drivers Analysis
- 3.4.1. Rising prevalence of HSV infections
- 3.4.2. Advancements in molecular and point-of-care testing technologies
- 3.4.3. Public health initiatives and routine STI screening programs
- 3.5. Market Restraint Analysis
- 3.5.1. Limited diagnostic accuracy of serological tests
- 3.5.2. Stigma and underreporting associated with HSV infections
- 3.6. Porter's Five Forces Analysis
- 3.7. PESTLE Analysis
- 3.8. Pipeline Analysis
Chapter 4. U.S. HSV Testing Market: Type Estimates & Trend Analysis
- 4.1. U.S. HSV Testing Market: Type Movement Analysis
- 4.2. HSV-1/HSV-2 Combines
- 4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.3. HSV-1
- 4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.4. HSV-2
- 4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. HSV Testing Market: Test Type Estimates & Trend Analysis
- 5.1. U.S. HSV Testing Market: Test Type Movement Analysis
- 5.2. Serological tests
- 5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.3. Direct detection tests
- 5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.3.2. PCR
- 5.3.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.3.3. Viral culture
- 5.3.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4. Point-of-care tests
- 5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. HSV Testing Market: Sample Type Estimates & Trend Analysis
- 6.1. U.S. HSV Testing Market: Sample Type Movement Analysis
- 6.2. Blood
- 6.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.3. Swabs
- 6.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4. Cerebrospinal fluid
- 6.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. U.S. HSV Testing Market: End Use Estimates & Trend Analysis
- 7.1. U.S. HSV Testing Market: End Use Movement Analysis
- 7.2. Hospitals
- 7.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.3. Diagnostic Laboratories
- 7.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4. Clinics and sexual health centers
- 7.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5. Home care / self-testing
- 7.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
- 8.1. Company Categorization
- 8.2. Strategy Mapping
- 8.2.1. NEW PRODUCT LAUNCH
- 8.2.2. PARTNERSHIPS
- 8.2.3. ACQUISITION
- 8.2.4. COLLABORATION
- 8.2.5. FUNDING
- 8.3. Key Company Market Share Analysis, 2024
- 8.4. Company Heat Map Analysis
- 8.5. Company Profiles
- 8.5.1. F. Hoffmann-La Roche Ltd
- 8.5.1.1. Company Overview
- 8.5.1.2. Financial Performance
- 8.5.1.3. Product Benchmarking
- 8.5.1.4. Strategic Initiatives
- 8.5.2. Abbott
- 8.5.2.1. Company Overview
- 8.5.2.2. Financial Performance
- 8.5.2.3. Product Benchmarking
- 8.5.2.4. Strategic Initiatives
- 8.5.3. Thermo Fisher Scientific Inc.
- 8.5.3.1. Company Overview
- 8.5.3.2. Financial Performance
- 8.5.3.3. Product Benchmarking
- 8.5.3.4. Strategic Initiatives
- 8.5.4. BD
- 8.5.4.1. Company Overview
- 8.5.4.2. Financial Performance
- 8.5.4.3. Product Benchmarking
- 8.5.4.4. Strategic Initiatives
- 8.5.5. Bio-Rad Laboratories, Inc
- 8.5.5.1. Company Overview
- 8.5.5.2. Financial Performance
- 8.5.5.3. Product Benchmarking
- 8.5.5.4. Strategic Initiatives
- 8.5.6. BIOMERIEUX
- 8.5.6.1. Company Overview
- 8.5.6.2. Financial Performance
- 8.5.6.3. Product Benchmarking
- 8.5.6.4. Strategic Initiatives
- 8.5.7. DiaSorin S.p.A.
- 8.5.7.1. Company Overview
- 8.5.7.2. Financial Performance
- 8.5.7.3. Product Benchmarking
- 8.5.7.4. Strategic Initiatives
- 8.5.8. Hologic, Inc.
- 8.5.8.1. Company Overview
- 8.5.8.2. Financial Performance
- 8.5.8.3. Product Benchmarking
- 8.5.8.4. Strategic Initiatives
- 8.5.9. Cepheid
- 8.5.9.1. Company Overview
- 8.5.9.2. Financial Performance
- 8.5.9.3. Product Benchmarking
- 8.5.9.4. Strategic Initiatives
- 8.5.10. QuidelOrtho Corporation
- 8.5.10.1. Company Overview
- 8.5.10.2. Financial Performance
- 8.5.10.3. Product Benchmarking
- 8.5.10.4. Strategic Initiatives
- 8.5.1. F. Hoffmann-La Roche Ltd
List of tables
- Table 1 List of abbreviations
- Table 2 U.S. HSV Testing market, by type, (USD Million) 2021 - 2033
- Table 3 U.S. HSV Testing market, by test type, (USD Million) 2021 - 2033
- Table 4 U.S. HSV Testing market, by sample type, (USD Million) 2021 - 2033
- Table 5 U.S. HSV Testing market, by end use, (USD Million) 2021 - 2033
List of Figures
- Fig. 1 Market research process
- Fig. 2 Data triangulation techniques
- Fig. 3 Primary research pattern
- Fig. 4 Primary interviews in the U.S.
- Fig. 5 Market research approaches
- Fig. 6 Value-chain-based sizing & forecasting
- Fig. 7 QFD modeling for market share assessment
- Fig. 8 Market formulation & validation
- Fig. 9 U.S. HSV testing market: market outlook
- Fig. 10 U.S. HSV testing competitive insights
- Fig. 11 Parent market outlook
- Fig. 12 Related/ancillary market outlook
- Fig. 13 Penetration and growth prospect mapping
- Fig. 14 Industry value chain analysis
- Fig. 15 U.S. HSV testing market driver impact
- Fig. 16 U.S. HSV testing market restraint impact
- Fig. 17 U.S. HSV testing market strategic initiatives analysis
- Fig. 18 U.S. HSV testing market Type outlook key takeaways
- Fig. 19 U.S. HSV testing market: Type movement analysis
- Fig. 20 HSV-1/HSV-2 Combines market estimates, 2021 - 2033 (USD Million)
- Fig. 21 HSV-1 market estimates, 2021 - 2033 (USD Million)
- Fig. 22 HSV-2 market estimates, 2021 - 2033 (USD Million)
- Fig. 23 U.S. HSV testing market test type outlook key takeaways
- Fig. 24 U.S. HSV testing market: test type movement analysis
- Fig. 25 Serological tests market estimates, 2021 - 2033 (USD Million)
- Fig. 26 Direct detection tests market estimates, 2021 - 2033 (USD Million)
- Fig. 27 PCR market estimates, 2021 - 2033 (USD Million)
- Fig. 28 Viral culture market estimates, 2021 - 2033 (USD Million)
- Fig. 29 Point-of-care tests market estimates, 2021 - 2033 (USD Million)
- Fig. 30 U.S. HSV testing market sample type outlook key takeaways
- Fig. 31 U.S. HSV testing market: sample type movement analysis
- Fig. 32 Blood market estimates, 2021 - 2033 (USD Million)
- Fig. 33 Swabs market estimates, 2021 - 2033 (USD Million)
- Fig. 34 Cerebrospinal fluid market estimates, 2021 - 2033 (USD Million)
- Fig. 35 U.S. HSV testing market end use outlook key takeaways
- Fig. 36 U.S. HSV testing market: end use movement analysis
- Fig. 37 Hospitals market estimates, 2021 - 2033 (USD Million)
- Fig. 38 Diagnostic laboratories market estimates, 2021 - 2033 (USD Million)
- Fig. 39 Clinics and sexual health centers market estimates, 2021 - 2033 (USD Million)
- Fig. 40 Home care / self-testing market estimates, 2021 - 2033 (USD Million)
- Fig. 41 U.S. HSV testing market share and leading players
- Fig. 42 U.S. market share and leading players
- Fig. 43 U.S. SWOT
- Fig. 44 U.S. market estimates and forecasts, 2021 - 2033
- Fig. 45 Market share of key market players- U.S. HSV Testing market
