Contract Sterilization Market Size, Share, and Industry Analysis, By Type (Ethylene Oxide Sterilization, Gamma Irradiation Sterilization, Electron Beam Irradiation Sterilization, and Others), By Modality (On-site and Off-site), By End-user (Medical Device Companies, Pharmaceutical and Biotechnology Companies, Hospital & Clinics, and Others), and Regional Forecast, 2025-2032

The global contract sterilization market is witnessing significant growth due to the increasing demand for single-use medical devices, rising focus on infection control, and emphasis on outsourcing trends. Contract sterilization is a service offered to the manufacturers of medical devices, pharmaceuticals, and other healthcare-related products. These services ensure product safety and compliance with stringent regulatory standards, as sterilization eliminates microbial contamination. The contract sterilization service provider typically serves industries such as healthcare, biotechnology, cosmetics companies, and others.

Additionally, the presence of a large number of service providers for sterilization services, with strategic activities that help to decontaminate or sterilize desired items, equipment, supplies, and products on-site or in-house, is potentially propelling the growth of the market.

• For instance, in November 2024, IBA (Ion Beam Applications S.A.) was chosen by SteriLab to provide a state-of-the-art Be Soft electron beam (E-beam) sterilization solution for its new facility at Haina Port in the Dominican Republic. This facility aimed to cater to various sectors, including medical devices, food products, and semiconductors, enabling manufacturers to lower logistics costs and enhance sterilization efficiency.

Contract Sterilization Market Driver

Rising Hospital-Acquired Infections to Drive Market Growth

The increasing prevalence of hospital-acquired infections (HAIs) due to the inadequate sterilization of medical instruments and equipment is a significant factor driving the growth of the contract sterilization market. As healthcare facilities endeavor to enhance patient safety and reduce infection rates, they are increasingly outsourcing sterilization processes to specialized contract sterilization providers.

Moreover, stringent regulatory standards, demand for high-quality healthcare increases, and rising awareness about infection control hospitals to minimize the risk of infections allow healthcare facilities to focus on optimizing sterilization of complex medical devices with the help of adequate services.

• For instance, according to the World Health Organization, around 1 in 10 patients is affected by HAIs, which is higher in low-/middle-income countries and high-risk patients. Such numbers of cases boost the demand for contract sterilization and drive market growth.

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According to the Centers for Disease Control and Prevention, Healthcare-Associated Infections (HAIs) report, it was demonstrated that after maintaining proper sterilization guidelines, it was observed that the methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSI), C. difficile infection (CDI), CAUTI, and ventilator-associated events (VAE), decreased by 16.0%, 13.0%, 13.0%, 11.0%, and 5.0% respectively between 2022 and 2023.

Contract Sterilization Market Restraint

High Initial Investment to Hamper the Contract Sterilization Market Growth

Installing sterilization facilities requires high initial capital investment. Additionally, maintaining sterilization quality is one of the challenging factors for companies to sustain in the market.

Contract Sterilization Market Opportunity

Demand for Advanced Sterilization Methods to Foster Future Market Growth

In recent years, the challenges faced by traditional sterilization methods- steam and ethylene oxide sterilization- include long-cycle times, toxic residues, and inefficiency for heat-sensitive materials, imposing the demand for launching advanced techniques for sterilization. The new aged sterilization methods offer tailored, eco-friendly, and efficient solutions, meeting the demand for clients' different needs and maintaining proper regulatory standards.

• For instance, in August 2024, PENTAX Medical announced the Food and Drug Administration clearance for the DEC Duodenoscope (ED34-i10T2s), which was compatible with the STERRAD 100NX Sterilizer, the flagship product of Advanced Sterilization Products (ASP). This collaboration between PENTAX Medical and ASP led to a significant advancement in the reprocessing of duodenoscopes, addressing the critical issue of cross-contamination, which was sterilized with hydrogen peroxide gas plasma sterilization. This technology has transformed infection prevention across multiple medical fields. Such innovative technologies are expected to propel the market growth during the forecast period.

Segmentation

Key Insights

The report covers the following key insights:

• Overview: Contract Sterilization Services
• Overview: Diseases Caused Due to Microbial Contamination
• Key Industry Developments (Mergers, Acquisitions, Partnerships, and Launches)
• Impact of COVID-19 on the Market

Analysis by Type

Based on type, the market is divided into ethylene oxide sterilization, gamma irradiation sterilization, electron beam irradiation sterilization, and others.

The ethylene oxide sterilization segment held a substantial share of the market. The versatility and effectiveness of the ethylene oxide sterilization method are augmenting the segment growth. This method is used for heat-sensitive and moisture-sensitive materials such as plastic, polymers, and electronic components in medical devices. Thus, this method is ideal for sterilizing single-use medical devices. Additionally, rising strategic activities among the key players of the market to advance their services with ethylene oxide sterilization methods is set to propel the segment growth.

• For instance, in March 2023, Picarro, Inc. partnered with LESNI A/S to provide cutting-edge Ethylene Oxide (EtO or EO) monitoring solutions for medical device and contract sterilization facilities globally. The collaboration aimed to merge LESNI's emissions control and abatement with Picarro's state-of-the-art Continuous Emission Monitoring Systems (CEMS). The combined offerings provide substantial advantages to the medical device and contract sterilization sectors, including enhanced safety, reduced regulatory risks, minimized source and fugitive emissions, and improved operational efficiency.

Analysis by Modality

Based on modality, the market is divided into on-site and off-site.

The off-site segment held a significant share of the global contract sterilization market. In off-site sterilization, manufacturers send their products to specialized facilities equipped with advanced sterilization technologies, eliminating the need to build in-house systems. Therefore, this modality is beneficial for companies with diverse product offerings that require different sterilization methods. Hence, such benefits shift the company's focus toward off-site services and boost the segment growth.

Additionally, the establishment of new facilities by key companies to offer various sterilization facilities to the customers to boost the segment growth.

• For instance, in September 2023, SteriTek launched a new 105,000 sq. ft. E-beam/X-ray sterilization facility in Lewisville, U.S., to offer advanced electron beam sterilization methods to their consumers.

Analysis by End-user

Based on end-user, the market is subdivided into medical device companies, pharmaceutical and biotechnology companies, hospital & clinics, and others.

The medical device companies segment held a prominent share of the market. The growth of the segment is augmented by the rising production of advanced medical devices for various healthcare applications. Additionally, stringent regulatory policies to avoid severe health issues due to contamination are making it mandatory for companies to sterilize their products to maintain standards.

Such regulations mandate the companies to sterilize devices with authorized providers and offer better patient comfort.

• For instance, in September 2024, the U.S. Food and Drug Administration (FDA) held a program for the Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions. The program offers education on sterilization of medical devices to prevent serious infections due to inadequate sterilization.

Regional Analysis

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Based on region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for a significant share of the global contract sterilization market in 2023. The growth of the market in the region is augmented by the presence of stringent regulatory guidelines for maintaining proper sterilization for FDA-regulated products. Additionally, the presence of service providers with advanced sterilization technologies is expanding the growth of the region in the market.

• For instance, in November 2024, AptarGroup received a contract from the U.S. Federal Government to advance the development of its ActivShield technology. The technology is a portable, novel sterilization modality that offers solutions to protect sensitive drug products, medical devices, drug delivery systems, and probiotics. Such scenarios propel the growth of the market in the region.

Europe holds a considerable share of the contract sterilization market. Presence of prominent key players and stringent regulatory guidelines for maintaining the safety of medical devices, pharma, and cosmetics products for human safety.

Additionally, strategic activities amongst the key players of the market should be undertaken to expand its services in the region and boost the growth of the area.

• For instance, in June 2024, STERIMED acquired Riverside Medical Packaging, a supplier of sterilization packaging systems and services in the U.K. The acquisition helps to expand and strengthen service offerings to medical device manufacturers with high-end sterilization and packaging. Such strategic activities boost the region's growth.

Moreover, the Asia Pacific market is expected to grow during the forecast period due to the rising demand for adequate quality products and government regulations for marinating the products and sterilization for adequate human use.

Key Players Covered

The global contract sterilization market is fragmented, with a large number of group and standalone providers.

The report includes the profiles of the following key players:

• STERIS (Ireland)
• PolarSeal (U.K.)
• The Ecosense Company (U.S.)
• Prince Sterilization Services, LLC (U.S.)
• E-BEAM Services, Inc (U.S.)
• Sterigenics U.S., LLC (U.S.)
• BGS (Germany)
• Belimed INC. (U.S.)

Key Industry Developments

• In October 2024, STERIS constructed a new electron beam processing facility in Edmonton, Alberta, Canada. The new location offers a global technology-neutral service that includes radiation and gas processing options.

• In June 2023, STERIS announced the signing of an agreement with BD. The aim is to acquire surgical instrumentation, laparoscopic instrumentation, and sterilization container assets from BD.