米国の手術用ガウンレベルAAMI 3の市場規模、シェア、動向分析：ユーザビリティ別、ガウンタイプ別、手術別、最終用途別、地域別、セグメント予測、2025年～2033年

市場規模と動向：

米国の手術用ガウンレベルAAMI 3の市場規模は、2024年に1億9,000万米ドルと推計され、2033年には4億9,000万米ドルに達すると予測され、2025年から2033年までのCAGRは11.31%で成長すると予測されています。

この市場の主な原動力は、感染予防に対する意識の高まり、安全・感染管理規制の強化、低侵襲手術の増加、ガウン素材の技術進歩などです。

例えば、2025年2月に発表されたKnee Pain Centers of Americaの記事によると、年間約70万件の膝関節鏡手術が行われ、その結果、年間30億米ドルを超える費用が発生しています。また、フロリダ大学健康学部によると、腎臓結石症は米国で年間約500人に1人の割合で発症しています。生涯を通じて、男性の約8人に1人（最も一般的な年齢は40～60歳）、女性の約16人に1人（最も一般的な年齢は20～50歳）がこの症状を経験します。また、ブリガム・アンド・ウィメンズ病院によると、毎年10万人以上の女性が何らかの形で乳房切除術を受けています。したがって、腎臓結石症、乳がん症例の増加、それに対応する乳房切除術の増加が市場成長の原動力となっています。

AAMIレベル3の手術衣は適度なバリア保護を提供するため、病院や手術センターで一般的な中程度の体液曝露を伴う処置に適しています。手術件数の増加、特に外来患者による手術は、信頼性の高い防護服へのニーズの高まりに寄与しています。腹腔鏡手術などの低侵襲手術の採用が増加していることも、市場の成長をさらに後押ししています。例えば、North Kansas City Hospital &Meritas Healthの記事によると、米国では年間約1,500万件の腹腔鏡手術が実施されており、最も頻繁に実施される手術の1つとなっており、多くの病状に効果をもたらしています。

さらに、米国では人口の高齢化が進んでおり、外科的介入を必要とする慢性疾患の発生率が高くなっています。病院や手術センターは、費用対効果が高く、高性能のガウンをますます求めるようになり、再利用可能で環境に優しいオプションの需要に拍車をかけています。市場の統合とメーカーや流通業者間の戦略的パートナーシップは、サプライチェーンの合理化と可用性の向上に役立っています。最後に、病院への備えと感染制御プログラムに対する連邦政府および州政府の資金援助は、AAMIレベル3基準を満たすような高品質の手術衣への持続的な投資を支えています。米国では、2002年に設立された戦略的準備・対応局（Administration for Strategic Preparedness &Response, ASPR）の病院準備プログラム（HPP）が、災害や緊急時に地域のニーズに対応し、医療への公平なアクセスを確保し、人命を救うための医療提供体制を整えることを目的としています。公衆衛生局（PHS）法第319C-2条により、戦略的準備・対応局（ASPR）は、法律で定められた方式に基づき、病院準備プログラム（HPP）の協力協定資金を受領者に配分します。さらに、CDCの公衆衛生緊急事態準備（PHEP）協力協定は、50の州、4つの市、8つの米国準州と自由に関連する州に資金を提供しています。

ヘルスケア従事者と患者の安全を重視する規制により、コンプライアンス要件が厳しくなり、認証ガウンの採用が後押しされています。例えば、カーディナル・ヘルス社によると、手術衣を含む防護服は、すべての製造業者が満たさなければならない基準と試験プロトコルによって規制されています。これらの基準は、医療機器振興協会（AAMI）によって制定されています。具体的には、ANSI/AAMI PB70：2012は、手術衣を含むヘルスケア環境で使用される防護衣の分類システム（レベル1～4）を定義しています。この分類は、標準化された試験方法で評価された液体バリア性能に基づいています。米国食品医薬品局（FDA）はANSI/AAMI PB70：2012を、すべての手術衣メーカーが従わなければならない必須規格として採用しています。

SMS（スパンボンド-メルトブローン-スパンボンド）や多層ラミネートのような生地素材の技術的進歩は、保護力と快適性を高め、市場競争力を高めています。

さらに、がんの有病率の増加も予測期間中の需要を押し上げると予想されます。例えば、米国がん協会の報告書によると、米国では2025年に女性で約316,950例、男性で約2,800例の浸潤性乳がんが新たに診断されると予想されています。さらに、女性では推定59,080例のin situ乳管がん（DCIS）が診断されます。乳がんに関連した死亡者数は約42,680人と予測され、42,170人が女性、510人が男性です。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国の手術用ガウンレベルAAMI 3市場の変数、動向、範囲

• 市場系統の見通し
  • 親市場の見通し
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
  • 市場機会分析
  • 市場課題分析
• 米国の手術用ガウンAAMIレベル3市場分析ツール
  • 業界分析- ポーターのファイブフォース分析
  • PESTEL分析

第4章 米国の手術用ガウンレベルAAMI 3市場：ユーザビリティの推定・動向分析

• セグメントダッシュボード
• 米国の手術用ガウンレベルAAMI 3市場変動分析
• 米国の手術用ガウンレベルAAMI 3市場規模と動向分析（ユーザビリティ別、2021年～2033年）
• 使い捨てガウン
• 再利用可能なガウン

第5章 手術用ガウンレベルAAMI 3市場：ガウンタイプの推定・動向分析

• セグメントダッシュボード
• 米国の手術用ガウンレベルAAMI 3市場変動分析
• 米国の手術用ガウン市場規模と動向分析（AAMI 3レベル、ガウンタイプ別、2021年～2033年）
• 布地補強
• 非布地補強

第6章 手術用ガウンレベルAAMI 3市場：手術推定・動向分析

• セグメントダッシュボード
• 米国の手術用ガウンレベルAAMI 3市場変動分析
• 米国の手術用ガウンレベルAAMI 3市場規模と動向分析（手術法別、2021年～2033年）
• 一般外科
• 整形外科
• 内視鏡手術
• 婦人科手術
• 乳房切除術
• その他

第7章 手術用ガウンレベルAAMI 3市場：最終用途の推定・動向分析

• セグメントダッシュボード
• 米国の手術用ガウンレベルAAMI 3市場変動分析
• 米国の手術用ガウンレベルAAMI 3市場規模と動向分析（最終用途別、2021年～2033年）
• 手術室
• 集中治療室（ICU）
• 救急処置室
• その他

第8章 競合情勢

• 市場参入企業の分類
• 主要企業プロファイル
  • 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
• 企業市場シェア分析、2024年
• その他の主要市場プレーヤーのリスト

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)

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