美国乳突病毒检测市场规模、份额和趋势分析报告：按应用、产品、技术、最终用途和细分市场预测，2025 年至 2033 年

市场规模与趋势：

美国乳突病毒检测市场规模预计在 2024 年达到 6.3837 亿美元，预计在 2025 年至 2033 年期间的复合年增长率约为 13.56%。

市场成长的驱动力来自于不断发展的临床指南、技术创新以及对预防性医疗保健日益增长的重视。美国预防服务工作小组 (USPSTF) 和美国癌症协会 (ACS) 建议 30 至 65 岁的女性进行 HPV 初级或联合检测，这进一步推动了 HPV 的广泛应用。美国食品药物管理局 (FDA)核准了雅培的 Alinity m HR HPV 检测试剂盒（2023 年 11 月上市）和罗氏的 cobas 人类乳突病毒 (HPV) 检测试剂盒等检测产品，扩大了高灵敏度和基因型特异性检测方案的可用性。由凯撒医疗集团 (Kaiser Permanente) 等组织主导的自我采样试验正在兴起，改善了服务匮乏人群的筛检可及性。美国疾病管制与预防中心 (CDC) 和美国性健康协会 (ASA) 加强了宣传宣传活动，这与降低子宫颈癌发病率的国家目标一致，进一步推动了需求。

在临床指南更新、突破性监管核准以及转向以患者为中心的筛检模式的推动下，美国HPV检测行业正在经历快速转型。 2020年7月，美国癌症协会(ACS)更新了其建议，建议25至65岁的人群每五年进行一次HPV初次检测，理由是与子宫颈抹片相比，HPV检测准确性更高、筛检间隔更长，并减少了不必要的干预。此举反映出越来越多的证据表明，HPV检测能够更可靠地检测出高级别癌前病变，同时避免了与巴氏抹片相关的过度诊断。

2024 年 12 月，美国预防服务工作小组 (USPSTF) 发布了拟议指南，建议 30 至 65 岁的女性每五年进行一次 HPV 检测。 USPSTF 首次将医疗机构中自行采集的 HPV检体纳入其指南，承认研究表明自行采集的筛检与临床医生采集的检体具有相当的准确性，并且在历史上筛检不足的人群中的接受率明显更高。

2024年5月，FDA核准HPV自采集技术用于临床子宫颈癌筛检。 ACS执行长表示：「自采集可以扩大筛检管道，减少障碍，让更多人有机会发现、治疗并最终战胜癌症。」 同日，罗氏公司cobas HPV自采集解决方案获得FDA核准，使患者能够私下采集和检测阴道样本。罗氏诊断公司执行长强调：“透过减少障碍并提供HPV筛检管道，我们的HPV自采集解决方案将有助于我们实现到2030年消除子宫颈癌的目标。”

在美国，每年有13,000例子宫颈癌新病例和4,000例死亡病例，其中超过一半发生在未接受筛检的族群。公私合作，例如美国癌症研究所的子宫颈癌「最后一哩路」倡议，与世界卫生组织的2030年消除子宫颈癌策略一致，正在扩大筛检覆盖率，更新筛检途径，并确保公平的可及性。随着自我采集和指南主导的HPV检测的加速普及，美国HPV检测市场预计将因对高灵敏度分子检测的需求不断增长、市场参与度不断扩大以及报销范围不断扩大而出现强劲增长。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国乳突病毒 (HPV) 检测市场变数、趋势和范围

• 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
  • 市场限制因素分析
• 美国乳突病毒（HPV）检测市场分析工具
  • 产业分析-波特五力分析
  • PESTLE分析

第四章美国乳头瘤病毒（HPV）检测市场：应用评估与趋势分析

• 应用程式细分仪表板
• 美国乳突病毒（HPV）检测市场：应用变化分析
• 美国乳突病毒 (HPV) 检测市场规模及应用趋势分析（2021-2033 年）
• 子宫颈癌筛检
• 阴道癌筛检

第五章美国乳头瘤病毒（HPV）检测市场：产品评估与趋势分析

• 产品细分仪表板
• 美国乳突病毒（HPV）检测市场：产品差异分析
• 美国乳突病毒 (HPV) 检测市场规模及趋势分析（按产品），2021-2033 年
• 装置
• 耗材
• 服务

第六章美国乳头瘤病毒（HPV）检测市场：技术评估与趋势分析

• 技术细分仪表板
• 美国乳突病毒（HPV）检测市场：技术变革分析
• 美国乳突病毒 (HPV) 检测市场规模及趋势分析（按技术），2021-2033 年
• PCR
• 免疫诊断
• 其他的

第七章美国乳头瘤病毒（HPV）检测市场：最终用途估计和趋势分析

• 最终用途细分仪表板
• 美国乳突病毒（HPV）检测市场：最终用途变异分析
• 美国乳突病毒 (HPV) 检测市场规模及趋势分析（按最终用途），2021-2033 年
• 医院和诊所
• 研究所
• 其他的

第八章 竞争态势

• 主要市场参与企业的近期趋势和影响分析
• 公司/竞争对手分类
• 供应商格局
  • Key Company Heat Map Analysis, 2024
• 公司简介
  • Abbott
  • Biomedical Diagnostics
  • bioMerieux
  • Bio-Rad Laboratories, Inc.
  • Fujirebio
  • Oncolab
  • Hologic, Inc.
  • Qiagen
  • F. Hoffmann-La Roche Ltd
  • Siemens Healthineers AG

Market Size & Trends:

The U.S. human papillomavirus testing market size was estimated at USD 638.37 million in 2024 and is projected to grow at a CAGR of around 13.56% from 2025 to 2033. The market growth is propelled by evolving clinical guidelines, technological innovation, and growing emphasis on preventive healthcare. The U.S. Preventive Services Task Force (USPSTF) and American Cancer Society (ACS) recommend primary HPV testing or co-testing for women aged 30-65, boosting adoption. FDA approvals, such as Abbott's Alinity m HR HPV assay (November 2023) and Roche's cobas Human Papillomavirus (HPV) Test, have expanded high-sensitivity, genotype-specific options. Increasing self-sampling pilots, led by organizations like Kaiser Permanente, are improving screening access for underserved populations. Rising awareness campaigns from the CDC and American Sexual Health Association further drive demand, aligning with national goals to reduce cervical cancer incidence.

The U.S. HPV testing industry is undergoing rapid transformation, fueled by updated clinical guidelines, landmark regulatory approvals, and a shift toward patient-centered screening models. In July 2020, the American Cancer Society (ACS) updated its recommendations, making primary HPV testing every five years the preferred method for individuals aged 25-65, citing superior accuracy, longer screening intervals, and reduced unnecessary interventions compared with Pap smears. This move reflects growing evidence that HPV testing more reliably detects high-grade precancerous lesions while avoiding the overdiagnosis associated with cytology.

In December 2024, the U.S. Preventive Services Task Force (USPSTF) released draft guidelines recommending HPV testing every five years for women aged 30-65, with Pap testing or HPV/Pap co-testing as acceptable alternatives. Critically, the USPSTF included self-collected HPV samples taken in healthcare settings for the first time, acknowledging studies showing comparable accuracy to clinician-collected specimens and significantly higher uptake among historically underscreened groups.

A major regulatory milestone followed in May 2024, when the FDA approved HPV self-collection for cervical cancer screening in clinical environments. ACS CEO stated, "Self-collection can expand access to screening and reduce barriers, giving more people the opportunity to detect, treat, and ultimately survive cancer." On the same day, Roche secured FDA approval for its cobas HPV self-collection solution, enabling patients to privately collect vaginal samples for laboratory testing. Roche Diagnostics CEO emphasized, "Our HPV self-collection solution helps support the goal of eliminating cervical cancer by 2030 by reducing barriers and providing access to HPV screening."

With 13,000 new cervical cancer diagnoses and 4,000 related deaths annually in the U.S.-over half in underscreened populations-these combined initiatives are poised to close critical screening gaps. Public-private collaborations, such as the National Cancer Institute's Cervical Cancer "Last Mile" Initiative, are aligning with WHO's 2030 elimination strategy to expand reach, modernize screening pathways, and ensure equity in access. As adoption of self-collection and guideline-driven HPV testing accelerates, the U.S. HPV testing market is expected to see robust growth, driven by increased demand for high-sensitivity molecular assays, broader participation, and expanded reimbursement coverage.

U.S. Human Papillomavirus Testing Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. HPV testing market report on the basis of application, product, technology, and end use:

• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Cervical Cancer Screening
• Vaginal Cancer Screening
• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Instruments
• Consumables
• Services
• Technology Outlook (Revenue, USD Million, 2021 - 2033)
• PCR
• Immunodiagnostics
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics
• Laboratories
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Application
  • 1.2.2. Product
  • 1.2.3. Technology
  • 1.2.4. End Use
  • 1.2.5. Regional Scope
  • 1.2.6. Estimates and Forecasts Timeline
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
  • 1.4.5. Details of Primary Research
• 1.5. Information or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
  • 2.2.1. Application Outlook
  • 2.2.2. Product Outlook
  • 2.2.3. Technology Outlook
  • 2.2.4. End Use Outlook
  • 2.2.5. Regional Outlook
• 2.3. Competitive Scenario

Chapter 3. U.S. Human Papillomavirus (HPV) Testing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. U.S. Human Papillomavirus (HPV) Testing Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrant
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
    • 3.3.2.1. Political Landscape
    • 3.3.2.2. Technological Landscape
    • 3.3.2.3. Economic Landscape

Chapter 4. U.S. Human Papillomavirus (HPV) Testing Market: Application Estimates & Trend Analysis

• 4.1. Application Segment Dashboard
• 4.2. U.S. Human Papillomavirus (HPV) Testing Market: Application Movement Analysis
• 4.3. U.S. Human Papillomavirus (HPV) Testing Market Size & Trend Analysis, By Application, 2021 to 2033 (USD Million)
• 4.4. Cervical Cancer Screening
  • 4.4.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 4.5. Vaginal Cancer Screening
  • 4.5.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)

Chapter 5. U.S. Human Papillomavirus (HPV) Testing Market: Product Estimates & Trend Analysis

• 5.1. Product Segment Dashboard
• 5.2. U.S. Human Papillomavirus (HPV) Testing Market: Product Movement Analysis
• 5.3. U.S. Human Papillomavirus (HPV) Testing Market Size & Trend Analysis, By Product, 2021 to 2033 (USD Million)
• 5.4. Instruments
  • 5.4.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 5.5. Consumables
  • 5.5.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 5.6. Services
  • 5.6.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)

Chapter 6. U.S. Human Papillomavirus (HPV) Testing Market: Technology Estimates & Trend Analysis

• 6.1. Technology Segment Dashboard
• 6.2. U.S. Human Papillomavirus (HPV) Testing Market: Technology Movement Analysis
• 6.3. U.S. Human Papillomavirus (HPV) Testing Market Size & Trend Analysis, By Technology, 2021 to 2033 (USD Million)
• 6.4. PCR
  • 6.4.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 6.5. Immunodiagnostics
  • 6.5.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 6.6. Others
  • 6.6.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)

Chapter 7. U.S. Human Papillomavirus (HPV) Testing Market: End Use Estimates & Trend Analysis

• 7.1. End Use Segment Dashboard
• 7.2. U.S. Human Papillomavirus (HPV) Testing Market: End Use Movement Analysis
• 7.3. U.S. Human Papillomavirus (HPV) Testing Market Size & Trend Analysis, By End Use, 2021 to 2033 (USD Million)
• 7.4. Hospitals & Clinics
  • 7.4.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 7.5. Laboratories
  • 7.5.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)
• 7.6. Others
  • 7.6.1. Market Estimates and Forecasts 2021 to 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Recent Developments & Impact Analysis, By Key Market Participants
• 8.2. Company/ Competition Categorization
• 8.3. Vendor Landscape
  • 8.3.1. Key Company Heat Map Analysis, 2024
• 8.4. Company Profiles
  • 8.4.1. Abbott
    • 8.4.1.1. Company Overview
    • 8.4.1.2. Financial Performance
    • 8.4.1.3. Product Benchmarking
    • 8.4.1.4. Strategic Initiatives
  • 8.4.2. Biomedical Diagnostics
    • 8.4.2.1. Company Overview
    • 8.4.2.2. Financial Performance
    • 8.4.2.3. Product Benchmarking
    • 8.4.2.4. Strategic Initiatives
  • 8.4.3. bioMerieux
    • 8.4.3.1. Company Overview
    • 8.4.3.2. Financial Performance
    • 8.4.3.3. Product Benchmarking
    • 8.4.3.4. Strategic Initiatives
  • 8.4.4. Bio-Rad Laboratories, Inc.
    • 8.4.4.1. Company Overview
    • 8.4.4.2. Financial Performance
    • 8.4.4.3. Product Benchmarking
    • 8.4.4.4. Strategic Initiatives
  • 8.4.5. Fujirebio
    • 8.4.5.1. Company Overview
    • 8.4.5.2. Financial Performance
    • 8.4.5.3. Product Benchmarking
    • 8.4.5.4. Strategic Initiatives
  • 8.4.6. Oncolab
    • 8.4.6.1. Company Overview
    • 8.4.6.2. Financial Performance
    • 8.4.6.3. Product Benchmarking
    • 8.4.6.4. Strategic Initiatives
  • 8.4.7. Hologic, Inc.
    • 8.4.7.1. Company Overview
    • 8.4.7.2. Financial Performance
    • 8.4.7.3. Product Benchmarking
    • 8.4.7.4. Strategic Initiatives
  • 8.4.8. Qiagen
    • 8.4.8.1. Company Overview
    • 8.4.8.2. Financial Performance
    • 8.4.8.3. Product Benchmarking
    • 8.4.8.4. Strategic Initiatives
  • 8.4.9. F. Hoffmann-La Roche Ltd
    • 8.4.9.1. Company Overview
    • 8.4.9.2. Financial Performance
    • 8.4.9.3. Product Benchmarking
    • 8.4.9.4. Strategic Initiatives
  • 8.4.10. Siemens Healthineers AG
    • 8.4.10.1. Company Overview
    • 8.4.10.2. Financial Performance
    • 8.4.10.3. Product Benchmarking
    • 8.4.10.4. Strategic Initiatives

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 U.S. Human Papillomavirus (HPV) Testing Market, by Application, 2021 - 2033 (USD Million)
• Table 4 U.S. Human Papillomavirus (HPV) Testing Market, by Product, 2021 - 2033 (USD Million)
• Table 5 U.S. Human Papillomavirus (HPV) Testing Market, by Technology, 2021 - 2033 (USD Million)
• Table 6 U.S. Human Papillomavirus (HPV) Testing Market, by End Use, 2021 - 2033 (USD Million)

List of Figures

• Fig. 1 Market Research Process
• Fig. 2 Data Triangulation Techniques
• Fig. 3 Primary Research Pattern
• Fig. 4 Primary Interviews
• 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. Human Papillomavirus (HPV) Testing Market: Market Outlook
• Fig. 10 Human Papillomavirus (HPV) 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. Human Papillomavirus (HPV) Testing Market Driver Impact
• Fig. 16 U.S. Human Papillomavirus (HPV) Testing Market Restraint Impact
• Fig. 17 U.S. Human Papillomavirus (HPV) Testing Market Strategic Initiatives Analysis
• Fig. 18 U.S. Human Papillomavirus (HPV) Testing Market: Application Movement Analysis
• Fig. 19 U.S. Human Papillomavirus (HPV) Testing Market: Application Outlook and Key Takeaways
• Fig. 20 Cervical Cancer Screening Market Estimates and Forecast, 2021 - 2033
• Fig. 21 Vaginal Cancer Screening Market Estimates and Forecast, 2021 - 2033
• Fig. 22 U.S. Human Papillomavirus (HPV) Testing Market: Product Movement Analysis
• Fig. 23 U.S. Human Papillomavirus (HPV) Testing Market: Product Outlook and Key Takeaways
• Fig. 24 Instruments Market Estimates and Forecast, 2021 - 2033
• Fig. 25 Consumables Market Estimates and Forecast, 2021 - 2033
• Fig. 26 Services Market Estimates and Forecast, 2021 - 2033
• Fig. 27 U.S. Human Papillomavirus (HPV) Testing Market: Technology Movement Analysis
• Fig. 28 U.S. Human Papillomavirus (HPV) Testing Market: Technology Outlook and Key Takeaways
• Fig. 29 PCR Market, 2021 - 2033 (USD Million)
• Fig. 30 Immunodiagnostics Market, 2021 - 2033 (USD Million)
• Fig. 31 Others Market, 2021 - 2033 (USD Million)
• Fig. 32 U.S. Human Papillomavirus (HPV) Testing Market: End Use Movement Analysis
• Fig. 33 U.S. Human Papillomavirus (HPV) Testing Market: End Use Outlook and Key Takeaways
• Fig. 34 Hospitals & Clinics Market, 2021 - 2033 (USD Million)
• Fig. 35 Laboratories Market, 2021 - 2033 (USD Million)
• Fig. 36 Others Market, 2021 - 2033 (USD Million)
• Fig. 40 U.S. Market Estimates and Forecasts, 2021 - 2033