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市場調查報告書
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1813861

美國HSV 檢測市場規模、佔有率和趨勢分析（按類型、檢測類型、樣本類型、最終用途、地區和細分市場），預測（2025-2033 年）

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
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10個工作天內

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美國HSV檢測市場摘要

預計 2024 年美國HSV 檢測市場規模將達到 2.05 億美元，2025 年至 2033 年的複合年成長率為 5.24%。

該市場涵蓋一系列旨在準確及時檢測1型和2型單純皰疹病毒的診斷解決方案。檢測方法涵蓋從傳統的血清學檢測到先進的分子平台，可為醫院、診斷實驗室和門診病人提供可靠的臨床決策。這些檢測廣泛應用於性行為感染傳染病管理和產前篩檢，並且隨著對快速便捷檢測的需求不斷成長，它們也擴大應用於分散式和照護現場機構。

分子診斷技術的持續進步，持續提升了美國HSV檢測的敏感度和周轉時間。能夠同時檢測HSV和其他性傳染感染的多重PCR平台正成為門診和急診的首選。此外，簡化從檢體到結果的工作流程的新型檢測套組已獲得監管部門的批准，這將促進其在基層醫療和急診環境中的廣泛應用。

在一項重要的法規更新中，FDA 於 2025 年 6 月正式將用於中樞神經系統 (CNS) 感染的 HSV 核酸檢測方法歸類為 II 類（特殊控制）。此項變更適用於用於檢測和鑑別腦脊髓液檢體中 HSV-1 和 HSV-2 的定性體外診斷產品，與先前的 III 類分類相比，此分類提供了更清晰、更簡化的上市途徑。透過在確保安全性和有效性的同時減輕監管負擔，此次重新分類預計將加速直接作用於中樞神經系統 (CNS) 的 HSV 檢測的普及，使醫院和神經病學中心受益。

政府主導的性傳染感染監測和預防工作也推動了市場成長。青少年和生殖健康公共衛生宣傳活動正在推動患者對便利可靠的單純皰疹病毒（HSV）篩檢的需求。此外，聯邦衛生機構（例如美國疾病管制與預防中心和美國國立衛生研究院）與私人診斷公司之間的合作正在幫助縮小都市區和服務欠缺社區的檢測差距。

目錄

第 1 章美國HSV 檢測市場：調查方法與範圍

第 2 章美國HSV 檢測市場：執行摘要

  • 市場概述
  • 類型和檢驗類型簡介
  • 樣品類型和最終用途簡介
  • 競爭格局簡介

第 3 章 HSV 檢視市場變數、趨勢與範圍

  • 市場區隔和範圍
  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
  • 市場促進因素分析
    • HSV感染疾病的傳播
    • 分子和就地檢驗技術的進步
    • 公共衛生舉措和定期性行為感染傳染病檢測項目
  • 市場限制因素分析
    • 血清學檢測的診斷準確性有限
    • 與 HSV 感染相關的恥辱感和漏報
  • 波特五力分析
  • PESTLE分析
  • 管道分析

第4章美國HSV檢測市場：類型估計與趨勢分析

  • 美國HSV 檢測市場：類型變異分析
  • HSV-1/HSV-2複合物
  • HSV-1
  • HSV-2

第5章美國HSV 檢測市場：檢測類型評估與趨勢分析

  • 美國HSV 檢測市場：檢測類型變化分析
  • 血清學檢測
  • 直接檢測試驗
    • PCR
    • 病毒培養
  • 就地檢驗

第6章美國HSV檢測市場：樣本類型估計與趨勢分析

  • 美國HSV 檢測市場：樣本類型變異分析
  • 血
  • 棉花棒
  • 腦脊髓液

第7章美國HSV 檢測市場：最終用途估計與趨勢分析

  • 美國HSV 檢測市場：最終用途變異分析
  • 醫院
  • 診斷實驗室
  • 診所及性健康中心
  • 居家護理/自我檢測

第8章 競爭態勢

  • 公司分類
  • 戰略地圖
    • 新產品發布
    • 夥伴關係
    • 獲得
    • 合作
    • 資金籌措
  • 2024年主要企業市佔率分析
  • 公司熱圖分析
  • 公司簡介
    • F. Hoffmann-La Roche Ltd
    • Abbott
    • Thermo Fisher Scientific Inc.
    • BD
    • Bio-Rad Laboratories, Inc
    • BIOMERIEUX
    • DiaSorin SpA
    • Hologic, Inc.
    • Cepheid
    • QuidelOrtho Corporation
Product Code: GVR-4-68040-702-7

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