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市场调查报告书
商品编码
1771699

美国手术罩衣AAMI 3 级市场规模、份额、趋势分析（按可用性、罩衣类型、手术、最终用途、地区、细分市场预测），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个工作天内

价格

市场规模与趋势：

美国手术罩衣级别 AAMI 3 市场规模预计在 2024 年为 1.9 亿美元，预计到 2033 年将达到 4.9 亿美元，2025 年至 2033 年的复合年增长率为 11.31%。该市场的主要驱动力是人们越来越意识到感染预防、安全和感染控制法规越来越严格、微创手术的兴起以及罩衣材料的技术进步。

例如，根据美国膝关节疼痛中心 2025 年 2 月发表的报导，每年约有 70 万例膝关节关节镜手术，每年花费超过 30 亿美元。此外，根据佛罗里达大学健康中心的数据，在美国，每年约有五百分之一的人患有肾结石疾病。在一生中，大约八分之一的男性（最常见于 40 至 60 岁之间）和大约十六分之一的女性（最常见于 20 至 50 岁之间）会患上这种疾病。此外，根据布莱根妇女医院的数据，每年有超过 10 万名女性接受某种形式的切除术。因此，肾结石疾病、乳癌病例的增加以及相应的切除术的增加正在推动市场成长。

AAMI 3级手术服提供中等程度的屏障保护，因此适用于医院和手术中心常见的中等体液暴露手术。手术量（尤其是门诊病人手术）的不断增加，导致对可靠防护衣的需求日益增长。腹腔镜等微创手术的日益普及，进一步推动了市场的成长。例如，根据北堪萨斯城医院和Meritas Health的报导，美国每年约有1500万例腹腔镜手术，使其成为最常见的手术之一，并为许多疾病带来了益处。

此外，美国人口老化加剧，导致需要外科手术介入的慢性病发生率上升。医院和外科中心越来越需要经济高效、性能卓越的罩衣，这刺激了对可重复使用和环保产品的需求。市场整合以及製造商和经销商之间的策略伙伴关係有助于简化供应链并提高供应量。最后，联邦和州政府为医院紧急准备和感染控制计画提供的资金支持了对高品质手术服的持续投资，例如符合AAMI 3级标准的手术服。在美国，战略防范与应变管理局（ASPR）于2002年成立的医院紧急准备计画（HPP）旨在完善医疗保健服务体系，以满足当地需求，确保公平获得医疗服务，并在灾难和紧急情况下挽救生命。根据《公共卫生服务法》（PHS）第319C-2条，战略防范与应变管理局（ASPR）根据法律规定的公式将医院紧急准备计画（HPP）合作协议资金分配给收件人。此外，CDC 的公共卫生紧急准备 (PHEP) 合作协议为所有 50 个州、4 个城市、8 个美国领土和自由联繫州提供资金。

强调医护人员和病人安全的法规导致了更严格的合规性要求，并推动了认证罩衣的采用。例如，据 Cardinal Health 称，防护衣（包括手术服）受所有製造商必须遵守的标准和测试通讯协定的监管。这些标准由医疗设备促进协会 (AAMI) 制定。具体来说，ANSI/AAMI PB70:2012 为医疗环境中使用的防护服（包括手术服）定义了一个分类系统（1-4 级）。此分类是基于透过标准化测试方法评估的液体阻隔性能。美国食品药物管理局(FDA) 已采用 ANSI/AAMI PB70:2012 作为所有手术服製造商必须遵守的强制性标准。

SMS（纺粘-熔喷-纺粘）和多层层压板等织物材料的技术进步提供了更高的保护性和舒适度，使其在市场上更具竞争力。

此外，癌症盛行率的上升也有望在预测期内刺激需求。例如，根据美国癌症协会 (美国 Cancer Society) 的报告，预计到 2025 年，美国女性将新增约 316,950 例侵袭性乳癌病例，男性将新增约 2,800 例侵袭性乳癌病例。此外，预计女性将新增 59,080 例乳管原位癌 (DCIS)。预计约有 42,680 例乳癌相关死亡病例，其中女性 42,170 例，男性 510 例。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国手术罩衣AAMI 3 级市场变数、趋势与范围

  • 市场展望
    • 母市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
    • 市场机会分析
    • 市场问题分析
  • 美国手术罩衣AAMI 3级市场分析工具
    • 产业分析-波特五力分析
    • PESTEL分析

第四章美国手术罩衣AAMI 3级市场：可用性评估与趋势分析

  • 细分仪表板
  • 美国手术罩衣AAMI 3级市场波动分析
  • 美国手术罩衣AAMI 3 级市场规模和趋势分析（按可用性），2021 年至 2033 年
  • 罩衣
  • 可重复使用的罩衣

第五章 手术罩衣AAMI 3 级市场：罩衣类型的估计与趋势分析

  • 细分仪表板
  • 美国手术罩衣AAMI 3级市场波动分析
  • 美国手术罩衣市场规模及趋势分析（AAMI 3 级，依罩衣类型，2021-2033 年）
  • 织物加固
  • 非织物加固

第六章 手术罩衣AAMI 3 级市场：手术估计与趋势分析

  • 细分仪表板
  • 美国手术罩衣AAMI 3级市场波动分析
  • 美国手术罩衣AAMI 3 级市场规模与趋势分析（依手术程序，2021-2033 年）
  • 一般外科
  • 整形外科
  • 内视镜手术
  • 妇科手术
  • 切除术
  • 其他的

7. 手术罩衣AAMI 3 级市场：最终用途估计与趋势分析

  • 细分仪表板
  • 美国手术罩衣AAMI 3级市场波动分析
  • 美国手术罩衣AAMI 3 级市场规模和趋势分析（按最终用途），2021 年至 2033 年
  • 手术室
  • 加护病房（ICU）
  • 急诊室
  • 其他的

第八章 竞争态势

  • 市场参与企业分类
  • 主要企业简介
    • 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年公司市场占有率分析
  • 其他主要市场参与者名单
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)