Off-Site Sterilization Services Market Size, Share & Industry Analysis, By Service Type (Contract Sterilization Services, Validation Services, and Maintenance), By Method (Steam Sterilization, Hydrogen Peroxide Sterilization, Ethylene Oxide Sterilization, and Others), By End-user (Hospitals & Clinics, Pharmaceutical & Medical Device Manufacturers, and Others), and Regional Forecast, 2025-2032

The global off-site sterilization services market size was valued at USD 2.22 billion in 2024. The market is projected to grow from USD 2.29 billion in 2025 to USD 3.01 billion by 2032, exhibiting a CAGR of 4.0% during the forecast period. North America dominated the off-site sterilization services market with a market share of 39.63% in 2024. 

Off-site sterilization in healthcare refers to sterilizing medical & pharmaceutical instruments and devices at a location separate from the main healthcare facility, often at a specialized sterilization center or a third-party facility. This practice involves transporting medical equipment away from the hospital or any other healthcare facility to a designated off-site location for cleaning and sterilization before returning it for use.

The growing cases of hospital-acquired infections (HAIs) along with a rising number of surgeries are surging the demand for sterilization of the patient rooms, operating area, and medical devices. As a result, the medical technology companies and hospitals demand cost-effective solutions to manage their sterilization process through third parties. This influences key players to expand their service offerings, which is expected to fuel the global market growth in the coming years.

The major companies in the market include Steris, Sterigenics U.S., LLC (Sotera Health), and Medistri SA. These companies are focused on expanding their regional presence to increase their service reach.

MARKET DYNAMICS

Market Drivers

Increasing Number of Hospital Admissions to Drive Market Growth

In the past few years, the increasing burden of chronic conditions, such as gynecological conditions, cardiovascular conditions, and others, has resulted in significant growth in patient admissions. This has surged the demand for disinfection of hospital beds and instruments to prevent the spread of hospital-acquired infections (HAIs). Such a scenario is anticipated to encourage prominent companies to expand their service offerings for these facilities.

• For instance, according to data published by the American Hospital Association (AHA), it was reported that about 34.4 million hospital admissions were witnessed in 2023 in the U.S.

Moreover, the rising geriatric population globally is also increasing the risk of cardiovascular conditions in both developing and developed countries. This has resulted in an increased number of surgical procedures, driving the need to sterilize medical devices. Such a scenario is expected to drive the market growth during the forecast period.

Market Restraints

Cost Concerns for Off-Site Sterilization Services to Hamper Market Growth

Although the off-site sterilization services can potentially reduce some costs associated with staffing and space, the overall cost can be higher due to transportation expenses, potential damage costs, and the need for robust communication and quality control systems, which may deter healthcare facilities from opting for such a service.

• For instance, in 2023, an article by the NCBI stated that communication becomes a major challenge of off-site transportation.

Furthermore, healthcare facilities in countries with lower healthcare expenditures may be unable to transport sensitive surgical instruments off-site for sterilization, leading to limited usage of off-site sterilization services. Such a scenario is anticipated to hinder market growth in the coming years.

Market Opportunities

Strategic Collaborations Between Service Providers and Healthcare Facilities to Offer Lucrative Opportunities

In recent years, well-established healthcare infrastructure in developed countries has contributed to increased demand for technology-advanced off-site sterilization services, which is influencing major players toward merger and acquisition agreements, expanding their service reach globally.

• For instance, in January 2021, Vested Medical, Inc., Elmhurst, Illinois, and OrthoIllinois Surgery Center, LLC, signed a collaboration agreement for an innovative off-site sterilization processing program at the outpatient ambulatory surgery centers (ASCs) in Rockford, Illinois.

Moreover, the growing number of healthcare facilities, such as hospitals, clinics, and others, is expected to increase the demand for steam sterilization, ethylene oxide sterilization, and other off-site services, offering further opportunities for key players.

Market Challenges

Stringent Regulation and Compliance May Limit Market Expansion

In many countries, off-site sterilization requires strict adherence to federal regulations for transporting potentially infectious materials, adding complexity to the process. Personnel handling and transporting these materials must be trained and certified in the relevant regulations.

Additionally, the increasing cost associated with the sterilization equipment is resulting in growing costs for sterilization services, thereby limiting the ability of off-site service providers to expand. Such a scenario is expected to challenge off-site sterilization services market growth in the coming years.

Off-Site Sterilization Services Market Trends

Advances in Sterilization Methods to act as a Market Trend

Presently, there is an implementation of advanced sterilization technologies among off-site service providers to deal with the limitations of traditional techniques and offer high safety and sustainability.

Electron beam sterilization technology offers safer, faster, and more efficient results over conventional methods. This utilizes high-energy electrons for sterilizing medical devices, further eliminating the need for chemical agents. These benefits of electron beam sterilization are driving service providers' focus toward installing advanced systems globally.

• For instance, in December 2024, BGS announced the installation of a high-power e-beam accelerator at its first sterilization facility in the U.S.

Furthermore, integrating automated technologies in medical device sterilization enhances efficiency with features such as self-adjusting parameters, automated loading and unloading, and barcode tracking for compliance.

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SEGMENTATION ANALYSIS

By Service Type

Contract Sterilization Services are Expected to Hold Largest Market Share Due to Outsourcing of Sterilization Processes

Based on service type, the market is segmented into contract sterilization services, validation services, and maintenance.

The contract sterilization services segment dominated the market in 2024 and is also expected to lead the market share in the forecast period. The dominance is due to medical device manufacturers' demand for outsourcing sterilization processes. This is stimulating the prominent players to expand their contract sterilization services globally.

• For instance, in November 2021, STERIS became the first contract sterilizer acknowledged into the FDA’s Ethylene Oxide Sterilization Master File Pilot Program. This enabled the company to streamline regulatory processes for medical device manufacturers.

The validation services segment held a lower market share in 2024. Standard guidelines for healthcare sectors in high-income countries propel the demand for validation services due to their necessity to ensure the sterility of medical devices and improve patient safety. This is projected to augment the segment's growth in the coming years.

By Method

Cost-effectiveness of Steam Sterilization Services Result in its Leadership Position

Based on method, the market is segmented into steam sterilization, hydrogen peroxide sterilization, ethylene oxide sterilization, and others.

The steam sterilization dominated the market in 2024. There has been a surge in the adoption rate of steam sterilization services by several healthcare industries due to cost-effectiveness and reliability for eliminating microorganisms, including viruses, bacteria, and spores. This helps ensure product quality and improve patient safety.

The hydrogen peroxide segment is projected to expand at a substantial CAGR during the forecast period. Prominent players are introducing novel products due to the high demand for scalable solutions among healthcare facilities to sterilize and decontaminate their instruments and spaces. This is expected to drive the segment’s growth in the coming years.

• For instance, in October 2021, STERIS introduced a novel integrated VHP (Vaporized Hydrogen Peroxide) facility decontamination system. This enhanced rapid and effective sterilization for large spaces.

By End-user

Hospitals & Clinics are Leading End-users Due to Increased Cases of HAIs

Based on end-user, the market is segmented into hospitals & clinics, pharmaceutical & medical device manufacturers, and others.

The hospitals & clinics segment dominated the market in 2024. The growth is attributed to the high burden of HAIs, boosting the demand for sterilization services in these settings. Additionally, the higher utilization of surgical instruments is also propelling the demand for instrument reprocessing.

The pharmaceutical & medical device manufacturers segment held the second-largest market share in 2024. The growing requirement for sterilizing medical devices is influencing prominent companies to expand their facilities for service offerings.

• For instance, in September 2021, Sterigenics U.S., LLC, in collaboration with Nelson Labs, opened a microbiological testing laboratory in Wiesbaden, Germany, to cater to increasing demand from European medical device and pharmaceutical companies.

OFF-SITE STERILIZATION SERVICES MARKET REGIONAL OUTLOOK

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America

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North America dominated the market in 2024 and its off-site sterilization market size stood at USD 0.88 billion. The dominance is attributed to the high penetration of off-site sterilization services in the region due to substantial investments in sterilization processes.

In the U.S., the substantial growth in surgical procedures has driven the need to prevent hospital-acquired infections (HAIs), driving the demand for off-site sterilization. This is propelling the prominent players to increase the range of their services in the country.

• For instance, in September 2024, BGS planned to expand in the U.S. market with fully automated E-Beam irradiation technology at its Pittsburgh location. The operations at this site are anticipated to start in mid-2025.

Europe

Europe held the second-largest share in 2024. The growth is attributed to focus on regional healthcare settings toward hygienic practices, which is increasing the preference for outsourcing their disinfection and sterilization processes. In consideration of this, prominent players are focusing on expanding the region to increase their service reach.

• For instance, in October 2023, Medistri SA announced its plan to expand its sterilization capacity by adding a sixth chamber to enhance pharmaceutical and medical device sterilization services.

Asia Pacific

Asia Pacific is expected to showcase the highest CAGR during the forecast period. There has been an expansion in the pharmaceutical sector, including the production of sterile medicines, vaccines, and biologics in the region. This industry requires reliable sterilization services to ensure product safety and compliance with international standards. Such a scenario is expected to drive the demand for off-site sterilization services, contributing to the region’s growth in the coming years.

• For instance, according to the data published by the Department of Pharmaceuticals in September 2024, India had nearly 1400 WHO-GMP approved Pharma Plants and 253 European Directorate of Quality Medicines (EDQM) approved plants with availability of modern technologies.

Latin America and the Middle East & Africa

Latin America and the Middle East & Africa held the lower market share in 2024. The focus on increasing investments in untapped markets in the region's healthcare sector is projected to contribute to the market growth. Furthermore, guidelines and standard regulations set by the health authorities for sterilization facilities are anticipated to improve the service quality, attracting more customers.

• For instance, in May 2025, ETO sterilization facilities require a proper license and authorization from ANVISA before beginning operations in Brazil.

COMPETITIVE LANDSCAPE

Key Market Players

Strong Focus on Facility Expansions Led to Dominance of STERIS in 2024

STERIS held the largest global off-site sterilization services market share in 2024. The company has a broad range of off-site service offerings in the global market. Moreover, it is focused on building new facilities and expanding the existing ones.

Other players, such as Sterigenics U.S., LLC (Sotera Health) and others, are increasing their focus on partnerships, acquisitions, and mergers to expand the service reach in the market. They are focused on adding advanced products to their facilities to improve the service quality and gain a significant market share.

List Of Key Off-Site Sterilization Services Companies Profiled

• STERIS (U.S.)
• Sterigenics U.S., LLC (Sotera Health) (U.S.)
• Medistri SA (Switzerland)
• E-BEAM Services, Inc. (U.S.)
• BGS (Germany)
• VPT Rad, Inc. (U.S.)
• Scapa (U.S.)
• Microtrol Sterilisation Services Pvt Ltd. (India)

KEY INDUSTRY DEVELOPMENTS

• May 2025 – STERIS constructed a new ethylene oxide (EO) processing facility in Malaysia to provide sterilization services to medical device manufacturing companies.
• May 2025 – Sterigenics U.S., LLC announced its expansion plans with a new state-of-the-art X-ray sterilization facility at the Haw River, North Carolina campus, to meet rising demand for advanced sterilization services in the Southeast U.S.
• January 2023 – Ionisos acquired a facility from Studer Cables AG to enhance its electron beam capacity for offering off-site sterilization services in Switzerland.
• May 2022 – Sterigenics U.S., LLC introduced Noxilizer’s Nitrogen Dioxide (NO₂) sterilization technology at its Petit-Rechain, Belgium facility. This enabled ultra-low temperature sterilization for sensitive drug-device combination products.
• August 2020 – Sterigenics U.S., LLC, part of Sotera Health, acquired Iotron Industries, expanding its electron beam sterilization capacity and expertise across North America.

REPORT COVERAGE

The report provides a detailed market analysis and focuses on key aspects, such as competitive landscape, leading companies, service type, method, and end-user. Moreover, it includes market dynamics and trends and highlights key industry developments. It also covers factors contributing to market growth in recent years.

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Report Scope & Segmentation