감염 예방 기기 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the infection prevention devices market size is expected to grow from USD 22.95 billion in 2025 to USD 24.38 billion in 2026 and is forecast to reach USD 33.02 billion by 2031 at 6.25% CAGR over 2026-2031.

Global Infection Prevention Devices Market Trends and Insights

Rising Healthcare-Associated Infection Prevention Spending

Underfunded national infection prevention and control systems are converting policy commitments into procurement for validated infrastructure. The World Health Organization reported that 71% of countries had an active infection prevention and control program, but only 6% met all minimum requirements in 2023-2024. Its 2024-2030 action plan seeks to raise the share of countries meeting those requirements above 90% by 2030. Patients in low- and middle-income countries faced up to 20 times the healthcare-associated infection risk seen in high-income countries. This gap directs funding toward categories that offer documented audit results, including sterilization monitoring, biological indicators, and assurance consumables. The infection prevention devices market can therefore benefit as national programs in Southeast Asia and Sub-Saharan Africa move from policy adoption toward facility-level implementation. These procurement cycles can widen the addressable base for the infection prevention devices market.

Increasing Surgical and Interventional Procedure Volumes

Higher procedure volumes raise sterilization throughput needs within facilities and increase demand for reprocessing equipment, consumables, and monitoring devices. Outpatient care has moved more surgical activity into smaller settings that require dependable sterile processing capacity. Many ambulatory surgery centers have fewer than 3 operating rooms and do not maintain dedicated sterile processing staff. This setting favors compact and automated infection prevention devices that require limited operator training. A concentrated range of procedures can also make procedure-specific sterilization specifications more important in purchasing decisions. The infection prevention devices market has an opportunity where providers need standardized equipment and service support across distributed sites. This setting places ease of operation at the center of the purchasing of infection prevention devices.

Ethylene Oxide Emission Controls and Sterilization Capacity Risk

Ethylene oxide is an essential sterilization method for medical devices, but it is also classified as a carcinogen. The EPA finalized amendments in April 2024 that required more than 90% reductions in ethylene oxide emissions at commercial sterilization facilities. The agency stated that the action addressed facilities that sterilize roughly 50% of U.S. medical devices, or 20 billion devices annually. In March 2026, the EPA proposed reconsidering the 2024 commercial sterilizer rule on medical supply-chain grounds. This uncertainty complicates investment planning for sterilization operators and alternative technology developers. It can promote low-temperature alternatives while limiting new capacity for a method that has no complete substitute for many complex multi-lumen devices.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Low-Temperature Sterilization for Heat-Sensitive Devices
2. Digitization of Sterilization Assurance and Instrument Tracking
3. High Capital and Lifecycle Costs of Advanced Systems

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Endoscope Reprocessing Devices are projected to grow at a 9.15% CAGR through 2031, ahead of the 6.25% overall forecast. Sterilization Equipment held 38.31% of revenue share in 2025 and remains the largest revenue category. Its broad role spans hospital central sterile supply departments, pharmaceutical manufacturing facilities, and ambulatory care settings. Disinfection Devices support environmental hygiene in intensive care units, isolation rooms, and procedure suites. Sterilization Monitoring and Assurance Devices are becoming more important as providers formalize every-load monitoring under accreditation and audit requirements.

Protective Infection-Prevention Devices provide staff protection, while Medical Waste and Containment Devices support biohazard management. Standards including ISO 374 and EN 374 establish requirements for protective barrier performance. Endoscopy units are processing the same scope fleets more often as procedure backlogs continue, which makes throughput a central purchasing requirement. Getinge's Aquadis Endo 110 delivers 36% higher throughput than its predecessor and a 20-minute standard cycle. The system also provides RFID-enabled traceability through its FleetView and T-DOC Endo connections. Advanced Sterilization Products acquired UVSmart, bringing endoscope high-level disinfection closer to environmental photonic disinfection within a single portfolio.

Heat and High-Temperature Sterilization accounted for 45.24% of revenue share in 2025. It remains established in central sterile supply departments because stainless-steel surgical instruments continue to make up much of the surgical kit inventory. Low-Temperature Sterilization is forecast to record an 8.22% CAGR through 2031 as thermolabile instruments become more common in robotic surgery, minimally invasive procedures, and flexible endoscopy. Radiation Sterilization, including gamma and electron beam methods, remains important for contract sterilization of single-use devices. Chemical Sterilization and Disinfection includes peracetic acid and liquid chemistries used in endoscope reprocessing and environmental cleaning.

X-ray radiation processing is gaining attention as a more precise alternative to ethylene oxide for some applications. STERIS Applied Sterilization Technologies completed an expansion of its X-ray radiation processing facility in Hochstadt, Germany, in July 2026, increasing regional processing capacity for medical device manufacturers. UV-C and photonic disinfection are smaller technologies that are moving from supplementary use toward more central roles in selected clinical settings. A phase II trial conducted from November 2024 to April 2025 in 12 long-term care facilities in Denmark reported 10.4 hospital-treated infections per 10,000 resident-days in far-UVC common rooms, compared with 86.2 under standard care. The adjusted incidence rate ratio was 0.12, with a 95% confidence interval of 0.04-0.34. Developing compliance frameworks and the need for clinical validation make early regulatory clarity important for suppliers in this part of the infection prevention devices market, where equipment performance must be matched with practical adoption requirements.

Complete Report Scope:

• By Device Type
  • Sterilization Equipment
  • Disinfection Devices
  • Endoscope Reprocessing Devices
  • Sterilization Monitoring and Assurance Devices
  • Protective Infection-Prevention Devices
  • Medical Waste and Containment Devices
• By Technology
  • Heat and High-Temperature Sterilization
  • Low-Temperature Sterilization
  • Radiation Sterilization
  • Chemical Sterilization and Disinfection
  • UV-C and Photonic Disinfection
  • Other Technologies
• By Use Case
  • Healthcare-Associated Infection Prevention
  • Surgical Site Infection Prevention
  • Respiratory Infection Control
  • Endoscope-Associated Infection Prevention
  • Environmental and Surface Hygiene
  • Other Use Cases
• By End User
  • Hospitals and Clinics
  • Ambulatory Surgery Centers
  • Diagnostic Centers and Clinical Laboratories
  • Long-Term Care Facilities
  • Pharmaceutical and Medical Device Manufacturers
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 36.61% of the revenue share in 2025. Device reprocessing validation standards, healthcare-associated infection reporting requirements, and Joint Commission accreditation obligations support the United States. These requirements make procurement difficult to defer when facilities need documented compliance. Canada aligns closely with comparable sterilization expectations through provincial health authorities. Mexico is reinforcing infection prevention requirements as hospital capacity expands under national healthcare access programs.

Asia-Pacific is projected to grow at a 7.45% CAGR through 2031. China's hospital construction and renovation commitments, and India's Ayushman Bharat digital health infrastructure program, are extending secondary and tertiary care access. A 10-year study published in 2026 at a major healthcare institution in Southwestern China found declining healthcare-associated infection rates while antimicrobial use stabilized. The finding supports the value of sustained institution-wide infection prevention investment. It also supports the continued adoption of validated systems in the infection prevention devices market. Japan's hospital accreditation framework supports replacement cycles for sterilization and reprocessing equipment. South Korea and Australia also contribute through mature private hospital sectors with stringent infection control requirements.

MEA and South America remain smaller contributors but can grow faster as hospital construction and quality improvement programs continue. GCC countries are investing in hospital infrastructure under Vision 2030 and related diversification programs. Their higher-income base can support advanced low-temperature sterilization systems that remain less accessible in other MEA countries. South Africa and the wider Sub-Saharan Africa region represent a longer-term opportunity as World Health Organization program rollout and development funding support structured procurement. Brazil is modernizing public hospital infection control infrastructure, while Argentina's private hospital sector is upgrading sterilization capacity. The infection prevention devices market size in these regions remains smaller, but their growth can become more relevant to the infection prevention devices market later in the forecast period.

1. Advanced Sterilization Products
2. ANSELL LTD.
3. Belimed
4. Cardinal Health
5. Ecolab
6. Getinge
7. Kimberly-Clark Worldwide
8. MATACHANA GROUP
9. Medline Industries
10. Midmark
11. MMM Group
12. Olympus
13. Hartmann Group
14. PDI Healthcare
15. Solventum Corporation
16. Sotera Health Company
17. SteelcoBelimed
18. STERIS
19. Tuttnauer

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Healthcare-Associated Infection Prevention Spending
  • 4.2.2 Increasing Surgical and Interventional Procedure Volumes
  • 4.2.3 Expansion of Low-Temperature Sterilization for Heat-Sensitive Devices
  • 4.2.4 Stricter Sterilization Validation and Traceability Requirements
  • 4.2.5 Outpatient and Ambulatory Care Migration
  • 4.2.6 Digitization of Sterilization Assurance and Instrument Tracking
• 4.3 Market Restraints
  • 4.3.1 High Capital and Lifecycle Costs of Advanced Systems
  • 4.3.2 Complexity of Reprocessing and Protocol Compliance
  • 4.3.3 Ethylene Oxide Emission Controls and Sterilization Capacity Risk
  • 4.3.4 Single-Use Device Waste and Sustainability Trade-Offs
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Device Type
  • 5.1.1 Sterilization Equipment
  • 5.1.2 Disinfection Devices
  • 5.1.3 Endoscope Reprocessing Devices
  • 5.1.4 Sterilization Monitoring and Assurance Devices
  • 5.1.5 Protective Infection-Prevention Devices
  • 5.1.6 Medical Waste and Containment Devices
• 5.2 By Technology
  • 5.2.1 Heat and High-Temperature Sterilization
  • 5.2.2 Low-Temperature Sterilization
  • 5.2.3 Radiation Sterilization
  • 5.2.4 Chemical Sterilization and Disinfection
  • 5.2.5 UV-C and Photonic Disinfection
  • 5.2.6 Other Technologies
• 5.3 By Use Case
  • 5.3.1 Healthcare-Associated Infection Prevention
  • 5.3.2 Surgical Site Infection Prevention
  • 5.3.3 Respiratory Infection Control
  • 5.3.4 Endoscope-Associated Infection Prevention
  • 5.3.5 Environmental and Surface Hygiene
  • 5.3.6 Other Use Cases
• 5.4 By End User
  • 5.4.1 Hospitals and Clinics
  • 5.4.2 Ambulatory Surgery Centers
  • 5.4.3 Diagnostic Centers and Clinical Laboratories
  • 5.4.4 Long-Term Care Facilities
  • 5.4.5 Pharmaceutical and Medical Device Manufacturers
  • 5.4.6 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Advanced Sterilization Products
  • 6.3.2 ANSELL LTD.
  • 6.3.3 Belimed AG
  • 6.3.4 Cardinal Health, Inc.
  • 6.3.5 Ecolab Inc.
  • 6.3.6 Getinge AB
  • 6.3.7 Kimberly-Clark Corporation
  • 6.3.8 MATACHANA GROUP
  • 6.3.9 Medline Industries, LP
  • 6.3.10 Midmark Corporation
  • 6.3.11 MMM Group
  • 6.3.12 Olympus Corporation
  • 6.3.13 PAUL HARTMANN AG
  • 6.3.14 PDI Healthcare
  • 6.3.15 Solventum Corporation
  • 6.3.16 Sotera Health Company
  • 6.3.17 SteelcoBelimed
  • 6.3.18 STERIS plc
  • 6.3.19 Tuttnauer

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment