美國乳突病毒檢測市場規模、佔有率和趨勢分析報告：按應用、產品、技術、最終用途和細分市場預測，2025 年至 2033 年

市場規模與趨勢：

美國乳突病毒檢測市場規模預計在 2024 年達到 6.3837 億美元，預計在 2025 年至 2033 年期間的複合年成長率約為 13.56%。

市場成長的驅動力來自於不斷發展的臨床指南、技術創新以及對預防性醫療保健日益成長的重視。美國預防服務工作小組 (USPSTF) 和美國癌症協會 (ACS) 建議 30 至 65 歲的女性進行 HPV 初級或聯合檢測，這進一步推動了 HPV 的廣泛應用。美國食品藥物管理局 (FDA)核准了雅培的 Alinity m HR HPV 檢測試劑盒（2023 年 11 月上市）和羅氏的 cobas 人類乳突病毒 (HPV) 檢測試劑盒等檢測產品，擴大了高靈敏度和基因型特異性檢測方案的可用性。由凱撒醫療集團 (Kaiser Permanente) 等組織主導的自我採樣試驗正在興起，改善了服務匱乏人群的篩檢可及性。美國疾病管制與預防中心 (CDC) 和美國性健康協會 (ASA) 加強了宣傳宣傳活動，這與降低子宮頸癌發病率的國家目標一致，進一步推動了需求。

在臨床指南更新、突破性監管核准以及轉向以患者為中心的篩檢模式的推動下，美國HPV檢測行業正在經歷快速轉型。 2020年7月，美國癌症協會(ACS)更新了其建議，建議25至65歲的人群每五年進行一次HPV初次檢測，理由是與子宮頸抹片相比，HPV檢測準確性更高、篩檢間隔更長，並減少了不必要的干涉。此舉反映出越來越多的證據表明，HPV檢測能夠更可靠地檢測出高級別癌前病變，同時避免了與巴氏抹片相關的過度診斷。

2024 年 12 月，美國預防服務工作小組 (USPSTF) 發布了擬議指南，建議 30 至 65 歲的女性每五年進行一次 HPV 檢測。 USPSTF 首次將醫療機構中自行採集的 HPV檢體納入其指南，承認研究表明自行採集的篩檢與臨床醫生採集的檢體具有相當的準確性，並且在歷史上篩檢不足的人群中的接受率明顯更高。

2024年5月，FDA核准HPV自採集技術用於臨床子宮頸癌篩檢。 ACS執行長表示：「自採集可以擴大篩檢管道，減少障礙，讓更多人有機會發現、治療並最終戰勝癌症。」 同日，羅氏公司cobas HPV自採集解決方案獲得FDA核准，使患者能夠私下採集和檢測陰道樣本。羅氏診斷公司執行長強調：“透過減少障礙並提供HPV篩檢管道，我們的HPV自採集解決方案將有助於我們實現到2030年消除子宮頸癌的目標。”

在美國，每年有13,000例子宮頸癌新病例和4,000例死亡病例，其中超過一半發生在未接受篩檢的族群。公私合作，例如美國癌症研究所的子宮頸癌「最後一哩路」舉措，與世界衛生組織的2030年消除子宮頸癌策略一致，正在擴大篩檢覆蓋率，更新篩檢途徑，並確保公平的可及性。隨著自我採集和指南主導的HPV檢測的加速普及，美國HPV檢測市場預計將因對高靈敏度分子檢測的需求不斷成長、市場參與度不斷擴大以及報銷範圍不斷擴大而出現強勁成長。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國乳突病毒 (HPV) 檢測市場變數、趨勢和範圍

• 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
  • 市場限制因素分析
• 美國乳突病毒（HPV）檢測市場分析工具
  • 產業分析-波特五力分析
  • PESTLE分析

第4章美國乳頭瘤病毒（HPV）檢測市場：應用評估與趨勢分析

• 應用程式細分儀表板
• 美國乳突病毒（HPV）檢測市場：應用變化分析
• 美國乳突病毒 (HPV) 檢測市場規模及應用趨勢分析（2021-2033 年）
• 子宮頸癌篩檢
• 陰道癌篩檢

第5章美國乳頭瘤病毒（HPV）檢測市場：產品評估與趨勢分析

• 產品細分儀表板
• 美國乳突病毒（HPV）檢測市場：產品差異分析
• 美國乳突病毒 (HPV) 檢測市場規模及趨勢分析（按產品），2021-2033 年
• 裝置
• 耗材
• 服務

第6章美國乳頭瘤病毒（HPV）檢測市場：技術評估與趨勢分析

• 技術細分儀表板
• 美國乳突病毒（HPV）檢測市場：技術變革分析
• 美國乳突病毒 (HPV) 檢測市場規模及趨勢分析（按技術），2021-2033 年
• PCR
• 免疫診斷
• 其他

第7章美國乳頭瘤病毒（HPV）檢測市場：最終用途估計和趨勢分析

• 最終用途細分儀表板
• 美國乳突病毒（HPV）檢測市場：最終用途變異分析
• 美國乳突病毒 (HPV) 檢測市場規模及趨勢分析（按最終用途），2021-2033 年
• 醫院和診所
• 研究所
• 其他

第8章 競爭態勢

• 主要市場參與企業的近期趨勢和影響分析
• 公司/競爭對手分類
• 供應商格局
  • Key Company Heat Map Analysis, 2024
• 公司簡介
  • 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