美国HSV 检测市场规模、份额和趋势分析（按类型、检测类型、样本类型、最终用途、地区和细分市场），预测（2025-2033 年）

美国HSV检测市场摘要

预计 2024 年美国HSV 检测市场规模将达到 2.05 亿美元，2025 年至 2033 年的复合年增长率为 5.24%。

该市场涵盖一系列旨在准确及时检测1型和2型单纯疱疹病毒的诊断解决方案。检测方法涵盖从传统的血清学检测到先进的分子平台，可为医院、诊断实验室和门诊病人提供可靠的临床决策。这些检测广泛应用于性行为感染传染病管理和产前筛检，并且随着对快速便捷检测的需求不断增长，它们也越来越多地应用于分散式和照护现场机构。

分子诊断技术的持续进步，持续提升了美国HSV检测的敏感度和周转时间。能够同时检测HSV和其他性传染感染的多重PCR平台正成为门诊和急诊的首选。此外，简化从检体到结果的工作流程的新型检测套组已获得监管部门的批准，这将促进其在基层医疗和急诊环境中的广泛应用。

在一项重要的法规更新中，FDA 于 2025 年 6 月正式将用于中枢神经系统 (CNS) 感染的 HSV 核酸检测方法归类为 II 类（特殊控制）。此项变更适用于用于检测和鑑别脑脊髓液检体中 HSV-1 和 HSV-2 的定性体外诊断产品，与先前的 III 类分类相比，此分类提供了更清晰、更简化的上市途径。透过在确保安全性和有效性的同时减轻监管负担，此次重新分类预计将加速直接作用于中枢神经系统 (CNS) 的 HSV 检测的普及，使医院和神经病学中心受益。

政府主导的性传染感染监测和预防工作也推动了市场成长。青少年和生殖健康公共卫生宣传活动正在推动患者对便利可靠的单纯疱疹病毒（HSV）筛检的需求。此外，联邦卫生机构（例如美国疾病管制与预防中心和美国国立卫生研究院）与私人诊断公司之间的合作正在帮助缩小都市区和服务欠缺社区的检测差距。

目录

第 1 章美国HSV 检测市场：调查方法与范围

第 2 章美国HSV 检测市场：执行摘要

• 市场概述
• 类型和检验类型简介
• 样品类型和最终用途简介
• 竞争格局简介

第 3 章 HSV 检视市场变数、趋势与范围

• 市场区隔和范围
• 市场体系展望
  • 母市场展望
  • 相关/辅助市场展望
• 市场动态
• 市场驱动因素分析
  • HSV感染疾病的传播
  • 分子和就地检验技术的进步
  • 公共卫生倡议和定期性行为感染传染病检测项目
• 市场限制因素分析
  • 血清学检测的诊断准确性有限
  • 与 HSV 感染相关的耻辱感和漏报
• 波特五力分析
• PESTLE分析
• 管道分析

第四章美国HSV检测市场：类型估计与趋势分析

• 美国HSV 检测市场：类型变异分析
• HSV-1/HSV-2复合物
• HSV-1
• HSV-2

第五章美国HSV 检测市场：检测类型评估与趋势分析

• 美国HSV 检测市场：检测类型变化分析
• 血清学检测
• 直接检测试验
  • PCR
  • 病毒培养
• 就地检验

第六章美国HSV检测市场：样本类型估计与趋势分析

• 美国HSV 检测市场：样本类型变异分析
• 血
• 棉花棒
• 脑脊髓液

第七章美国HSV 检测市场：最终用途估计与趋势分析

• 美国HSV 检测市场：最终用途变异分析
• 医院
• 诊断实验室
• 诊所及性健康中心
• 居家护理/自我检测

第八章 竞争态势

• 公司分类
• 战略地图
  • 新产品发布
  • 伙伴关係
  • 获得
  • 合作
  • 资金筹措
• 2024年主要企业市占率分析
• 公司热图分析
• 公司简介
  • F. Hoffmann-La Roche Ltd
  • Abbott
  • Thermo Fisher Scientific Inc.
  • BD
  • Bio-Rad Laboratories, Inc
  • BIOMERIEUX
  • DiaSorin SpA
  • Hologic, Inc.
  • Cepheid
  • QuidelOrtho Corporation

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
• 1.2. 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

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