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市場調查報告書
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1771699

美國手術罩衣AAMI 3 級市場規模、佔有率、趨勢分析（按可用性、罩衣類型、手術、最終用途、地區、細分市場預測），2025 年至 2033 年

U.S. Surgical Gowns Level AAMI 3 Market Size, Share & Trends Analysis By Usability (Disposable Gowns, Reusable Gowns), By Gown Type (Fabric Reinforced, Non-fabric Reinforced), By Surgery, By End Use, By Region, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10個工作天內

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市場規模與趨勢：

美國手術罩衣級別 AAMI 3 市場規模預計在 2024 年為 1.9 億美元，預計到 2033 年將達到 4.9 億美元，2025 年至 2033 年的複合年成長率為 11.31%。該市場的主要驅動力是人們越來越意識到感染預防、安全和感染控制法規越來越嚴格、微創手術的興起以及罩衣材料的技術進步。

例如，根據美國膝關節疼痛中心 2025 年 2 月發表的報導，每年約有 70 萬例膝關節關節鏡手術，每年花費超過 30 億美元。此外，根據佛羅裡達大學健康中心的數據，在美國，每年約有五百分之一的人患有腎結石疾病。在一生中，大約八分之一的男性（最常見於 40 至 60 歲之間）和大約十六分之一的女性（最常見於 20 至 50 歲之間）會患上這種疾病。此外，根據布萊根婦女醫院的數據，每年有超過 10 萬名女性接受某種形式的切除術。因此，腎結石疾病、乳癌病例的增加以及相應的切除術的增加正在推動市場成長。

AAMI 3級手術服提供中等程度的屏障保護，因此適用於醫院和手術中心常見的中等體液暴露手術。手術量（尤其是門診病人手術）的不斷增加，導致對可靠防護衣的需求日益成長。腹腔鏡等微創手術的日益普及，進一步推動了市場的成長。例如，根據北堪薩斯城醫院和Meritas Health的報導，美國每年約有1500萬例腹腔鏡手術，使其成為最常見的手術之一，並為許多疾病帶來了益處。

此外，美國人口老化加劇，導致需要外科手術介入的慢性病發生率上升。醫院和外科中心越來越需要經濟高效、性能卓越的罩衣，這刺激了對可重複使用和環保產品的需求。市場整合以及製造商和經銷商之間的策略夥伴關係有助於簡化供應鏈並提高供應量。最後，聯邦和州政府為醫院緊急準備和感染控制計畫提供的資金支持了對高品質手術服的持續投資，例如符合AAMI 3級標準的手術服。在美國，戰略防範與應變管理局（ASPR）於2002年成立的醫院緊急準備計畫（HPP）旨在完善醫療保健服務體系，以滿足當地需求，確保公平獲得醫療服務，並在災難和緊急情況下挽救生命。根據《公共衛生服務法》（PHS）第319C-2條，戰略防範與應變管理局（ASPR）根據法律規定的公式將醫院緊急準備計畫（HPP）合作協議資金分配給收件人。此外，CDC 的公共衛生緊急準備 (PHEP) 合作協議為所有 50 個州、4 個城市、8 個美國領土和自由聯繫州提供資金。

強調醫護人員和病人安全的法規導致了更嚴格的合規性要求，並推動了認證罩衣的採用。例如，據 Cardinal Health 稱，防護衣（包括手術服）受所有製造商必須遵守的標準和測試通訊協定的監管。這些標準由醫療設備促進協會 (AAMI) 制定。具體來說，ANSI/AAMI PB70:2012 為醫療環境中使用的防護服（包括手術服）定義了一個分類系統（1-4 級）。此分類是基於透過標準化測試方法評估的液體阻隔性能。美國食品藥物管理局(FDA) 已採用 ANSI/AAMI PB70:2012 作為所有手術服製造商必須遵守的強制性標準。

SMS（紡粘-熔噴-紡粘）和多層層壓板等織物材料的技術進步提供了更高的保護性和舒適度，使其在市場上更具競爭力。

此外，癌症盛行率的上升也有望在預測期內刺激需求。例如，根據美國癌症協會 (美國 Cancer Society) 的報告，預計到 2025 年，美國女性將新增約 316,950 例侵襲性乳癌病例，男性將新增約 2,800 例侵襲性乳癌病例。此外，預計女性將新增 59,080 例乳管原位癌 (DCIS)。預計約有 42,680 例乳癌相關死亡病例，其中女性 42,170 例，男性 510 例。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國手術罩衣AAMI 3 級市場變數、趨勢與範圍

  • 市場展望
    • 母市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
    • 市場機會分析
    • 市場問題分析
  • 美國手術罩衣AAMI 3級市場分析工具
    • 產業分析-波特五力分析
    • PESTEL分析

第4章美國手術罩衣AAMI 3級市場：可用性評估與趨勢分析

  • 細分儀表板
  • 美國手術罩衣AAMI 3級市場波動分析
  • 美國手術罩衣AAMI 3 級市場規模和趨勢分析（按可用性），2021 年至 2033 年
  • 罩衣
  • 可重複使用的罩衣

第5章 手術罩衣AAMI 3 級市場：罩衣類型的估計與趨勢分析

  • 細分儀表板
  • 美國手術罩衣AAMI 3級市場波動分析
  • 美國手術罩衣市場規模及趨勢分析（AAMI 3 級，依罩衣類型，2021-2033 年）
  • 織物加固
  • 非織物加固

第6章 手術罩衣AAMI 3 級市場：手術估計與趨勢分析

  • 細分儀表板
  • 美國手術罩衣AAMI 3級市場波動分析
  • 美國手術罩衣AAMI 3 級市場規模與趨勢分析（依手術程序，2021-2033 年）
  • 一般外科
  • 整形外科
  • 內視鏡手術
  • 婦科手術
  • 切除術
  • 其他

7. 手術罩衣AAMI 3 級市場：最終用途估計與趨勢分析

  • 細分儀表板
  • 美國手術罩衣AAMI 3級市場波動分析
  • 美國手術罩衣AAMI 3 級市場規模和趨勢分析（按最終用途），2021 年至 2033 年
  • 手術室
  • 加護病房（ICU）
  • 急診室
  • 其他

第8章 競爭態勢

  • 市場參與企業分類
  • 主要企業簡介
    • Cardinal Health.
    • Owens &Minor
    • Medline Industries, LP
    • Henry Schein, Inc.
    • Boston Scientific Corporation
    • Standard Textile Co., Inc.
    • Encompass Group, LLC
    • Dynarex Corporation
    • LDI Solutions, LLC
    • Taromed
  • 2024年公司市場佔有率分析
  • 其他主要市場參與者名單
Product Code: GVR-4-68040-628-9

Market Size & Trends:

The U.S. surgical gowns level AAMI 3 market size was estimated at USD 0.19 billion in 2024 and is projected to reach USD 0.49 billion by 2033, growing at a CAGR of 11.31% from 2025 to 2033. The market is primarily driven by growing awareness of infection prevention, enhanced safety and infection control regulations, increasing minimally invasive surgical procedures, and technological advancements in gown materials.

The U.S. surgical gowns Level AAMI 3 market is driven primarily by the increasing demand for infection prevention in healthcare settings, the rising number of arthroscopic orthopedic, endoscopic urological, and mastectomy procedures in the U.S. For instance, according to the Knee Pain Centers of America article published in February 2025, about 700,000 knee arthroscopies are performed yearly, resulting in costs exceeding USD 3.0 billion annually. Further, according to the University of Florida Health, kidney stone disease impacts roughly 1 in every 500 people in the U.S. annually. Throughout their lifetime, about 1 in 8 men-most commonly between ages 40 and 60, and one in sixteen women-most commonly between ages 20 and 50-will experience this condition. In addition, according to Brigham and Women's Hospital, each year, more than 100,000 women undergo some form of mastectomy. Therefore, the increase in kidney stone diseases, breast cancer cases, and the corresponding rise in mastectomy procedures are driving market growth.

AAMI Level 3 surgical gowns offer moderate barrier protection, making them suitable for procedures with moderate fluid exposure, which is common in hospitals and surgical centers. The rising number of surgeries, particularly outpatient procedures, contributes to the growing need for reliable protective apparel. The increasing adoption of minimally invasive procedures, such as laparoscopic surgeries, further propels market growth. For instance, according to an article by North Kansas City Hospital & Meritas Health, approximately 15 million laparoscopic procedures are performed annually in the U.S., making it one of the most frequently conducted surgeries and offering benefits for numerous medical conditions.

Additionally, the growing aging U.S. population contributes to a higher incidence of chronic diseases requiring surgical intervention. Hospitals and surgical centers increasingly seek cost-effective, high-performance gowns, spurring demand for reusable and eco-friendly options. Market consolidation and strategic partnerships among manufacturers and distributors help streamline supply chains and improve availability. Lastly, federal and state funding for hospital preparedness and infection control programs supports sustained investment in high-quality surgical gowns like those meeting AAMI Level 3 standards. In the U.S., founded in 2002, the Administration for Strategic Preparedness & Response, ASPR's Hospital Preparedness Program (HPP), aims to ready the healthcare delivery system to address community needs, ensure equitable access to care, and save lives during disasters and emergencies. By Section 319C-2 of the Public Health Service (PHS) Act, the Administration for Strategic Preparedness and Response (ASPR) allocates Hospital Preparedness Program (HPP) cooperative agreement funding to recipients based on a legislatively mandated formula. Furthermore, the CDC's Public Health Emergency Preparedness (PHEP) Cooperative Agreement funds 50 states, four cities, and 8 U.S. territories and freely associated states.

Regulatory emphasis on healthcare worker and patient safety has led to stricter compliance requirements, boosting the adoption of certified gowns. For instance, according to Cardinal Health, protective apparel, including surgical gowns, is regulated by standards and testing protocols that all manufacturers must meet. These standards are established by the Association for the Advancement of Medical Instrumentation (AAMI). Specifically, ANSI/AAMI PB70:2012 defines a classification system (Levels 1 through 4) for protective apparel used in healthcare settings, including surgical gowns. This classification is based on liquid barrier performance assessed through standardized testing methods. The U.S. Food and Drug Administration (FDA) has adopted ANSI/AAMI PB70:2012 as the mandatory standard that all surgical gown manufacturers must follow.

Technological advancements in fabric materials such as SMS (Spunbond-Meltblown-Spunbond) and multilayer laminates enhance protection and comfort, increasing market competitiveness.

In addition, the growing prevalence of cancer is also expected to boost demand during the forecast period. For instance, according to the American Cancer Society report, in the U.S. in 2025, approximately 316,950 new cases of invasive breast cancer are expected to be diagnosed in women, along with about 2,800 cases in men. Additionally, an estimated 59,080 cases of ductal carcinoma in situ (DCIS) will be diagnosed in women. The year is projected to see around 42,680 breast cancer-related deaths, with 42,170 occurring in women and 510 in men.

U.S. Surgical Gowns Level AAMI 3 Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis on the latest industry trends in each of the sub-segments from 2021 to 2033. For the purpose of this study, Grand View Research has segmented the U.S. surgical gowns level AAMI 3 market report on the basis of usability gown type, surgery, and end use:

  • Usability Outlook (Revenue, USD Million, 2021 - 2033)
  • Disposable Gowns
  • Reusable Gowns
  • Gown Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Fabric Reinforced
  • Non-fabric Reinforced
  • Surgery Outlook (Revenue, USD Million, 2021 - 2033)
  • General Surgery
  • Orthopedic Surgery
  • Endoscopic Surgery
  • Gynecological Surgery
  • Mastectomy
  • Others
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Operating Room
  • Intensive Care Unit (ICU)
  • Emergency Room
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
  • 1.2. Research Methodology
  • 1.3. Information Procurement
  • 1.4. Information or Data Analysis
  • 1.5. Market Formulation & Validation
  • 1.6. Model Details
  • 1.7. List of Data Sources

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Surgical Gowns Level AAMI 3 Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market driver analysis
    • 3.2.2. Market restraint analysis
    • 3.2.3. Market opportunity analysis
    • 3.2.4. Market challenge analysis
  • 3.3. U.S. Surgical Gowns Level AAMI 3 Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Bargaining power of suppliers
      • 3.3.1.2. Bargaining power of buyers
      • 3.3.1.3. Threat of substitutes
      • 3.3.1.4. Threat of new entrants
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTEL Analysis
      • 3.3.2.1. Political & Legal Landscape
      • 3.3.2.2. Economic and Social Landscape
      • 3.3.2.3. Technological landscape

Chapter 4. U.S. Surgical Gowns Level AAMI 3 Market: Usability Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Surgical Gowns Level AAMI 3 Market Movement Analysis
  • 4.3. U.S. Surgical Gowns Level AAMI 3 Market Size & Trend Analysis, by Usability, 2021 to 2033 (USD Million)
  • 4.4. Disposable Gowns
    • 4.4.1. Disposable Gowns market estimates and forecast 2021 to 2033 (USD Million)
  • 4.5. Reusable Gowns
    • 4.5.1. Reusable Gowns market estimates and forecast 2021 to 2033 (USD Million)

Chapter 5. Surgical Gowns Level AAMI 3 Market: Gown Type Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Surgical Gowns Level AAMI 3 Market Movement Analysis
  • 5.3. U.S. Surgical Gowns Level AAMI 3 Market Size & Trend Analysis, by Gown Type, 2021 to 2033 (USD Million)
  • 5.4. Fabric Reinforced
    • 5.4.1. Fabric reinforced market estimates and forecast 2021 to 2033 (USD Million)
  • 5.5. Non-fabric Reinforced
    • 5.5.1. Non-fabric reinforced market estimates and forecast 2021 to 2033 (USD Million)

Chapter 6. Surgical Gowns Level AAMI 3 Market: Surgery Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Surgical Gowns Level AAMI 3 Market Movement Analysis
  • 6.3. U.S. Surgical Gowns Level AAMI 3 Market Size & Trend Analysis, by Surgical Procedure, 2021 to 2033 (USD Million)
  • 6.4. General Surgery
    • 6.4.1. General surgery market estimates and forecast 2021 to 2033 (USD Million)
  • 6.5. Orthopedic Surgery
    • 6.5.1. Orthopedic surgery market estimates and forecast 2021 to 2033 (USD Million)
  • 6.6. Endoscopic Surgery
    • 6.6.1. Endoscopic surgery market estimates and forecast 2021 to 2033 (USD Million)
  • 6.7. Gynecological Surgery
    • 6.7.1. Gynecological surgery market estimates and forecast 2021 to 2033 (USD Million)
  • 6.8. Mastectomy
    • 6.8.1. Mastectomy market estimates and forecast 2021 to 2033 (USD Million)
  • 6.9. Others
    • 6.9.1. Other market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 7. Surgical Gowns Level AAMI 3 Market: End Use Estimates & Trend Analysis

  • 7.1. Segment Dashboard
  • 7.2. U.S. Surgical Gowns Level AAMI 3 Market Movement Analysis
  • 7.3. U.S. Surgical Gowns Level AAMI 3 Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
  • 7.4. Operating Room
    • 7.4.1. Operating room market estimates and forecast 2021 to 2033 (USD Million)
  • 7.5. Intensive Care Unit (ICU)
    • 7.5.1. Intensive Care Unit (ICU) market estimates and forecast 2021 to 2033 (USD Million)
  • 7.6. Emergency Room
    • 7.6.1. Emergency Room market estimates and forecast 2021 to 2033 (USD Million)
  • 7.7. Others
    • 7.7.1. Other market estimates and forecast 2021 to 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Market Participant Categorization
  • 8.2. Key Company Profiles
    • 8.2.1. Cardinal Health.
      • 8.2.1.1. Company overview
      • 8.2.1.2. Financial performance
      • 8.2.1.3. Product benchmarking
      • 8.2.1.4. Strategic initiatives
    • 8.2.2. Owens & Minor
      • 8.2.2.1. Company overview
      • 8.2.2.2. Financial performance
      • 8.2.2.3. Product benchmarking
      • 8.2.2.4. Strategic initiatives
    • 8.2.3. Medline Industries, LP
      • 8.2.3.1. Company overview
      • 8.2.3.2. Financial performance
      • 8.2.3.3. Product benchmarking
      • 8.2.3.4. Strategic initiatives
    • 8.2.4. Henry Schein, Inc.
      • 8.2.4.1. Company overview
      • 8.2.4.2. Financial performance
      • 8.2.4.3. Product benchmarking
      • 8.2.4.4. Strategic initiatives
    • 8.2.5. Boston Scientific Corporation
      • 8.2.5.1. Company overview
      • 8.2.5.2. Financial performance
      • 8.2.5.3. Product benchmarking
      • 8.2.5.4. Strategic initiatives
    • 8.2.6. Standard Textile Co., Inc.
      • 8.2.6.1. Company overview
      • 8.2.6.2. Financial performance
      • 8.2.6.3. Product benchmarking
      • 8.2.6.4. Strategic initiatives
    • 8.2.7. Encompass Group, LLC
      • 8.2.7.1. Company overview
      • 8.2.7.2. Financial performance
      • 8.2.7.3. Product benchmarking
      • 8.2.7.4. Strategic initiatives
    • 8.2.8. Dynarex Corporation
      • 8.2.8.1. Company overview
      • 8.2.8.2. Financial performance
      • 8.2.8.3. Product benchmarking
      • 8.2.8.4. Strategic initiatives
    • 8.2.9. LDI Solutions, LLC
      • 8.2.9.1. Company overview
      • 8.2.9.2. Financial performance
      • 8.2.9.3. Product benchmarking
      • 8.2.9.4. Strategic initiatives
      • 8.2.9.5. Strategic initiatives
    • 8.2.10. Taromed
      • 8.2.10.1. Company overview
      • 8.2.10.2. Financial performance
      • 8.2.10.3. Product benchmarking
      • 8.2.10.4. Strategic initiatives
  • 8.3. Company Market Share Analysis, 2024
  • 8.4. List of Other Key Market Players

List of Tables

  • Table 1 List of secondary sources
  • Table 2 List of abbreviations
  • Table 3 U.S. surgical gowns level AAMI 3 market, by usability, 2021 - 2033 (USD Million)
  • Table 4 U.S. surgical gowns level AAMI 3 market, by gown type, 2021 - 2033 (USD Million)
  • Table 5 U.S. surgical gowns level AAMI 3 market, by surgery, 2021 - 2033 (USD Million)
  • Table 6 U.S. surgical gowns level AAMI 3 market, by end use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Information Procurement
  • Fig. 2 Primary Research Pattern
  • Fig. 3 Market Research Approaches
  • Fig. 4 Value Chain-Based Sizing & Forecasting
  • Fig. 5 Market Formulation & Validation
  • Fig. 6 U.S. Surgical Gowns Level AAMI 3 Market, Market Segmentation
  • Fig. 7 Market Driver Analysis (Current & Future Impact)
  • Fig. 8 Market Restraint Analysis (Current & Future Impact)
  • Fig. 9 Market Opportunity Analysis (Current & Future Impact)
  • Fig. 10 Market Challenge Analysis (Current & Future Impact)
  • Fig. 11 SWOT Analysis, By Factor (Political & Legal, Economic, and Technological)
  • Fig. 12 Porter's Five Forces Analysis
  • Fig. 13 Regional Marketplace: Key Takeaways
  • Fig. 14 U.S. Surgical Gowns Level AAMI 3 Market, for Usability, 2021 - 2033 (USD Million)
  • Fig. 15 U.S. Surgical Gowns Level AAMI 3 Market, for Disposable Gowns, 2021 - 2033 (USD Million)
  • Fig. 16 U.S. Surgical Gowns Level AAMI 3 Market, for Reusable Gowns, 2021 - 2033 (USD Million)
  • Fig. 17 U.S. Surgical Gowns Level AAMI 3 Market, for Gown Type, 2021 - 2033 (USD Million)
  • Fig. 19 U.S. Surgical Gowns Level AAMI 3 Market, for Fabric Reinforced, 2021 - 2033 (USD Million)
  • Fig. 20 U.S. Surgical Gowns Level AAMI 3 Market, for Non-fabric Reinforced, 2021 - 2033 (USD Million)
  • Fig. 21 U.S. Surgical Gowns Level AAMI 3 Market, for Surgery, 2021 - 2033 (USD Million)
  • Fig. 22 U.S. Surgical Gowns Level AAMI 3 Market, for General Surgery, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. Surgical Gowns Level AAMI 3 Market, for Orthopedic Surgery, 2021 - 2033 (USD Million)
  • Fig. 24 U.S. Surgical Gowns Level AAMI 3 Market, for Endoscopic Surgery, 2021 - 2033 (USD Million)
  • Fig. 25 U.S. Surgical Gowns Level AAMI 3 Market, for Gynecological Surgery, 2021 - 2033 (USD Million)
  • Fig. 26 U.S. Surgical Gowns Level AAMI 3 Market, for Mastectomy, 2021 - 2033 (USD Million)
  • Fig. 27 U.S. Surgical Gowns Level AAMI 3 Market, for Others, 2021 - 2033 (USD Million)
  • Fig. 28 U.S. Surgical Gowns Level AAMI 3 Market, for End Use, 2021 - 2033 (USD Million)
  • Fig. 29 U.S. Surgical Gowns Level AAMI 3 Market, for Operating Room, 2021 - 2033 (USD Million)
  • Fig. 30 U.S. Surgical Gowns Level AAMI 3 Market, for Intensive Care Unit (ICU), 2021 - 2033 (USD Million)
  • Fig. 31 U.S. Surgical Gowns Level AAMI 3 Market, for Emergency Room, 2021 - 2033 (USD Million)
  • Fig. 32 U.S. Surgical Gowns Level AAMI 3 Market, for Others, 2021 - 2033 (USD Million)