오프사이트 멸균 서비스 시장 규모, 점유율, 성장 및 세계 산업 분석 : 유형별, 용도별, 지역별 인사이트 및 예측(2024-2032년)

Growth Factors of off-site sterilization services Market

The global off-site sterilization services market was valued at USD 2.22 billion in 2024 and is projected to reach USD 2.29 billion in 2025, growing further to USD 3.01 billion by 2032. North America dominated the market in 2024 with a 39.63% share, driven by advanced healthcare infrastructure, a high number of hospital admissions, and the increasing prevalence of hospital-acquired infections (HAIs).

Off-site sterilization involves transporting medical and pharmaceutical instruments to specialized facilities for sterilization, ensuring equipment safety and compliance with hygiene standards before returning them to healthcare facilities. This model is increasingly preferred due to its efficiency, cost-effectiveness, and ability to handle the rising number of surgeries and patient admissions worldwide. Major companies operating in the market include STERIS, Sterigenics U.S., LLC (Sotera Health), and Medistri SA, which are expanding their service capabilities to meet growing demand.

Market Drivers

The market is primarily driven by the increasing number of hospital admissions and surgical procedures globally. Chronic conditions, such as cardiovascular diseases and gynecological disorders, have increased patient load, necessitating frequent sterilization of medical instruments. For example, the American Hospital Association (AHA) reported approximately 34.4 million hospital admissions in the U.S. in 2023. Additionally, the aging population is contributing to a higher incidence of surgeries, further driving demand for off-site sterilization services.

Rising cases of HAIs also promote the adoption of off-site services to maintain infection control standards. Outsourcing sterilization reduces the risk of contamination while ensuring compliance with stringent healthcare regulations. Advanced sterilization technologies, such as electron beam (E-beam) sterilization and vaporized hydrogen peroxide (VHP), offer faster, more efficient, and safer alternatives to conventional methods, enhancing adoption.

Market Restraints

Despite the benefits, cost concerns may limit market growth. Off-site sterilization incurs transportation expenses, potential equipment damage costs, and requires robust quality control and communication systems. Healthcare facilities in countries with limited healthcare budgets may find it challenging to adopt such services. Additionally, strict regulations for transporting potentially infectious materials add compliance complexities, increasing operational costs for service providers.

Market Opportunities

Strategic collaborations between service providers and healthcare facilities present significant opportunities. Partnerships, mergers, and acquisitions enable companies to expand regional coverage and offer advanced sterilization technologies, including steam sterilization, ethylene oxide (EO), and VHP sterilization. Expanding pharmaceutical manufacturing and the growing number of hospitals, clinics, and ambulatory surgery centers drive demand for high-quality off-site sterilization services.

Market Trends

A key trend is the integration of advanced sterilization technologies. Electron beam sterilization, which uses high-energy electrons to sterilize medical devices without chemicals, is gaining popularity due to efficiency, speed, and sustainability. Automation technologies, including self-adjusting parameters, automated loading/unloading, and barcode tracking, improve operational efficiency and regulatory compliance. For instance, in December 2024, BGS installed a high-power E-beam accelerator at its U.S. facility, highlighting industry adoption of advanced technologies.

Segmentation Analysis

By service type, contract sterilization services dominated in 2024, reflecting the preference of medical device manufacturers for outsourcing sterilization. Validation services, while smaller in 2024, are expected to grow due to regulatory compliance requirements.

By method, steam sterilization led the market in 2024, appreciated for cost-effectiveness and reliability. Hydrogen peroxide and ethylene oxide methods are expanding, offering scalable and specialized sterilization solutions for sensitive instruments.

By end-user, hospitals and clinics dominated in 2024 due to the high prevalence of HAIs and frequent surgical procedures. Pharmaceutical and medical device manufacturers form the second-largest segment, driving demand for contract sterilization and advanced technology integration.

Regional Outlook

North America led the market in 2024 with a market size of USD 0.88 billion, driven by high surgical volumes and investment in sterilization infrastructure. Europe ranked second, focusing on outsourcing sterilization in healthcare settings. Asia Pacific is expected to witness the highest growth during the forecast period, supported by expanding pharmaceutical production, modernized healthcare facilities, and increasing adoption of sterilization technologies. Latin America and the Middle East & Africa are emerging markets, where regulatory frameworks and healthcare infrastructure are improving.

Competitive Landscape and Key Developments

Key players, including STERIS, Sterigenics U.S., LLC, and Medistri SA, focus on expanding facilities, partnerships, and technological capabilities. Notable recent developments include STERIS constructing a new EO processing facility in Malaysia in May 2025 and Sterigenics U.S., LLC opening a state-of-the-art X-ray sterilization facility in North Carolina in May 2025. These expansions aim to meet rising demand for advanced sterilization services globally.

Conclusion

The off-site sterilization services market, valued at USD 2.22 billion in 2024, USD 2.29 billion in 2025, and projected to reach USD 3.01 billion by 2032, is poised for steady growth. Increasing hospital admissions, rising HAIs, advanced sterilization technologies, and strategic collaborations are driving market expansion, while cost and regulatory challenges remain key considerations. North America leads in market share, with Asia Pacific emerging as the fastest-growing region.

Segmentation By Service Type

• Contract Sterilization Services
• Validation Services
• Maintenance

By Method

• Steam Sterilization
• Hydrogen Peroxide Sterilization
• Ethylene Oxide Sterilization
• Others

By End-user

• Hospitals & Clinics
• Pharmaceutical & Medical Device Manufacturers
• Others

By Region

• North America (By Service Type, Method, End-user, and Country)
  • U.S.
  • Canada
• Europe (By Service Type, Method, By End-user, and Country/Sub-Region)
  • U.K.
  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific (By Service Type, Method, End-user, and Country/Sub-Region)
  • Japan
  • Australia
  • China
  • India
  • South East Asia
  • Rest of APAC
• Latin America (By Service Type, Method, End-user, and Country/Sub-Region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (By Service Type, Method, End-user, and Country/Sub-Region)
  • GCC
  • South Africa
• Rest of the Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Incidence of Hospital-Acquired Infections (HAI), Key Countries/Regions, 2023/2024
• 4.2. Key Industry Developments - (Mergers, Acquisition & Partnerships, etc.)
• 4.3. Overview: Guidelines for Sterilization Processes

5. Global Off-Site Sterilization Services Market Analysis, Insights and Forecast, 2019-2032

• 5.1. Market Analysis, Insights and Forecast - By Service Type
  • 5.1.1. Contract Off-Site Sterilization Services
  • 5.1.2. Validation Services
  • 5.1.3. Maintenance
• 5.2. Market Analysis, Insights and Forecast - By Method
  • 5.2.1. Steam Sterilization
  • 5.2.2. Hydrogen Peroxide Sterilization
  • 5.2.3. Ethylene Oxide Sterilization
  • 5.2.4. Others
• 5.3. Market Analysis, Insights and Forecast - By End-user
  • 5.3.1. Hospitals & Clinics
  • 5.3.2. Pharmaceutical & Medical Device Manufacturers
  • 5.3.3. Others
• 5.4. Market Analysis, Insights and Forecast - By Region
  • 5.4.1. North America
  • 5.4.2. Europe
  • 5.4.3. Asia Pacific
  • 5.4.4. Latin America
  • 5.4.5. Middle East & Africa

6. North America Off-Site Sterilization Services Market Analysis, Insights and Forecast, 2019-2032

• 6.1. Market Analysis, Insights and Forecast - By Service Type
  • 6.1.1. Contract Off-Site Sterilization Services
  • 6.1.2. Validation Services
  • 6.1.3. Maintenance
• 6.2. Market Analysis, Insights and Forecast - By Method
  • 6.2.1. Steam Sterilization
  • 6.2.2. Hydrogen Peroxide Sterilization
  • 6.2.3. Ethylene Oxide Sterilization
  • 6.2.4. Others
• 6.3. Market Analysis, Insights and Forecast - By End-user
  • 6.3.1. Hospitals & Clinics
  • 6.3.2. Pharmaceutical & Medical Device Manufacturers
  • 6.3.3. Others
• 6.4. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 6.4.1. U.S.
  • 6.4.2. Canada

7. Europe Off-Site Sterilization Services Market Analysis, Insights and Forecast, 2019-2032

• 7.1. Market Analysis, Insights and Forecast - By Service Type
  • 7.1.1. Contract Off-Site Sterilization Services
  • 7.1.2. Validation Services
  • 7.1.3. Maintenance
• 7.2. Market Analysis, Insights and Forecast - By Method
  • 7.2.1. Steam Sterilization
  • 7.2.2. Hydrogen Peroxide Sterilization
  • 7.2.3. Ethylene Oxide Sterilization
  • 7.2.4. Others
• 7.3. Market Analysis, Insights and Forecast - By End-user
  • 7.3.1. Hospitals & Clinics
  • 7.3.2. Pharmaceutical & Medical Device Manufacturers
  • 7.3.3. Others
• 7.4. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 7.4.1. U.K.
  • 7.4.2. Germany
  • 7.4.3. France
  • 7.4.4. Spain
  • 7.4.5. Italy
  • 7.4.6. Scandinavia
  • 7.4.7. Rest of Europe

8. Asia Pacific Off-Site Sterilization Services Market Analysis, Insights and Forecast, 2019-2032

• 8.1. Market Analysis, Insights and Forecast - By Service Type
  • 8.1.1. Contract Off-Site Sterilization Services
  • 8.1.2. Validation Services
  • 8.1.3. Maintenance
• 8.2. Market Analysis, Insights and Forecast - By Method
  • 8.2.1. Steam Sterilization
  • 8.2.2. Hydrogen Peroxide Sterilization
  • 8.2.3. Ethylene Oxide Sterilization
  • 8.2.4. Others
• 8.3. Market Analysis, Insights and Forecast - By End-user
  • 8.3.1. Hospitals & Clinics
  • 8.3.2. Pharmaceutical & Medical Device Manufacturers
  • 8.3.3. Others
• 8.4. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 8.4.1. Japan
  • 8.4.2. China
  • 8.4.3. India
  • 8.4.4. Australia
  • 8.4.5. Southeast Asia
  • 8.4.6. Rest of Asia Pacific

9. Latin America Off-Site Sterilization Services Market Analysis, Insights and Forecast, 2019-2032

• 9.1. Market Analysis, Insights and Forecast - By Service Type
  • 9.1.1. Contract Off-Site Sterilization Services
  • 9.1.2. Validation Services
  • 9.1.3. Maintenance
• 9.2. Market Analysis, Insights and Forecast - By Method
  • 9.2.1. Steam Sterilization
  • 9.2.2. Hydrogen Peroxide Sterilization
  • 9.2.3. Ethylene Oxide Sterilization
  • 9.2.4. Others
• 9.3. Market Analysis, Insights and Forecast - By End-user
  • 9.3.1. Hospitals & Clinics
  • 9.3.2. Pharmaceutical & Medical Device Manufacturers
  • 9.3.3. Others
• 9.4. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 9.4.1. Brazil
  • 9.4.2. Mexico
  • 9.4.3. Rest of Latin America

10. Middle East & Africa Off-Site Sterilization Services Market Analysis, Insights and Forecast, 2019-2032

• 10.1. Market Analysis, Insights and Forecast - By Service Type
  • 10.1.1. Contract Off-Site Sterilization Services
  • 10.1.2. Validation Services
  • 10.1.3. Maintenance
• 10.2. Market Analysis, Insights and Forecast - By Method
  • 10.2.1. Steam Sterilization
  • 10.2.2. Hydrogen Peroxide Sterilization
  • 10.2.3. Ethylene Oxide Sterilization
  • 10.2.4. Others
• 10.3. Market Analysis, Insights and Forecast - By End-user
  • 10.3.1. Hospitals & Clinics
  • 10.3.2. Pharmaceutical & Medical Device Manufacturers
  • 10.3.3. Others
• 10.4. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 10.4.1. GCC
  • 10.4.2. South Africa
  • 10.4.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2024)
• 11.2. Company Profiles
  • 11.2.1. STERIS
    • 11.2.1.1. Overview
    • 11.2.1.2. Products
    • 11.2.1.3. SWOT Analysis
    • 11.2.1.4. Recent Developments
    • 11.2.1.5. Strategies
    • 11.2.1.6. Financials (Based on Availability)
  • 11.2.2. Sterigenics U.S., LLC (Sotera Health)
  • 11.2.3. Overview
  • 11.2.4. Products
  • 11.2.5. SWOT Analysis
  • 11.2.6. Recent Developments
  • 11.2.7. Strategies
  • 11.2.8. Financials (Based on Availability)
  • 11.2.9. Medistri SA (Switzerland)
  • 11.2.10. Overview
  • 11.2.11. Products
  • 11.2.12. SWOT Analysis
  • 11.2.13. Recent Developments
  • 11.2.14. Strategies
  • 11.2.15. Financials (Based on Availability)
  • 11.2.16. E-BEAM Services, Inc.
  • 11.2.17. Overview
  • 11.2.18. Products
  • 11.2.19. SWOT Analysis
  • 11.2.20. Recent Developments
  • 11.2.21. Strategies
  • 11.2.22. Financials (Based on Availability)
  • 11.2.23. BGS
  • 11.2.24. Overview
  • 11.2.25. Products
  • 11.2.26. SWOT Analysis
  • 11.2.27. Recent Developments
  • 11.2.28. Strategies
  • 11.2.29. Financials (Based on Availability)
  • 11.2.30. VPT Rad, Inc.
  • 11.2.31. Overview
  • 11.2.32. Products
  • 11.2.33. SWOT Analysis
  • 11.2.34. Recent Developments
  • 11.2.35. Strategies
  • 11.2.36. Financials (Based on Availability)
  • 11.2.37. Scapa
  • 11.2.38. Overview
  • 11.2.39. Products
  • 11.2.40. SWOT Analysis
  • 11.2.41. Recent Developments
  • 11.2.42. Strategies
  • 11.2.43. Financials (Based on Availability)
  • 11.2.44. Microtrol Sterilisation Services Pvt Ltd.
  • 11.2.45. Overview
  • 11.2.46. Products
  • 11.2.47. SWOT Analysis
  • 11.2.48. Recent Developments
  • 11.2.49. Strategies
  • 11.2.50. Financials (Based on Availability)