The U.S. sterilization services market size was exhibited at USD 1.85 billion in 2023 and is projected to hit around USD 5.22 billion by 2033, growing at a CAGR of 10.93% during the forecast period 2024 to 2033.
The U.S. sterilization services market is a vital pillar in the nation's healthcare and medical manufacturing ecosystem, playing a critical role in ensuring product safety, infection control, and regulatory compliance. Sterilization services are essential across a range of industries including hospitals, pharmaceuticals, biotechnology, and medical device manufacturing, where eliminating microbial contamination is non-negotiable.
Sterilization services in the U.S. have evolved beyond traditional in-house autoclaving practices to sophisticated outsourced solutions using technologies such as ethylene oxide (EtO), gamma radiation, steam, and hydrogen peroxide gas plasma. These services cater to the sterilization of surgical instruments, pharmaceuticals, laboratory equipment, packaging, and single-use medical products. The demand for sterilization services in the U.S. is propelled by stringent regulations from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Association for the Advancement of Medical Instrumentation (AAMI), which mandate rigorous validation and documentation protocols.
In recent years, several trends have reshaped the U.S. sterilization services landscape. The COVID-19 pandemic highlighted the indispensable need for reliable sterilization infrastructure, leading to expanded capacity, emergency validation protocols, and the adoption of mobile or modular sterilization units. The ongoing rise in hospital-acquired infections (HAIs), increasing outsourcing by medical device companies, and growth of surgical procedures all contribute to robust market demand. As innovation in medical devices accelerates, especially for implantable and minimally invasive tools, the need for compatible, material-safe sterilization technologies becomes increasingly complex—creating opportunities for specialized sterilization providers and validation services.
Increasing Outsourcing of Sterilization by OEMs (Original Equipment Manufacturers) to Third-Party Providers
Growing Preference for Contract Sterilization to Optimize Facility Space and Cost
Expansion of Low-Temperature and Material-Compatible Sterilization Methods
Heightened Regulatory Scrutiny Around Ethylene Oxide (EtO) Sterilization Emissions
Rising Adoption of Sterilization-as-a-Service (SaaS) Models with Real-Time Monitoring
Integration of Digital Validation Platforms for Compliance and Traceability
Surge in Demand for Onsite Mobile Sterilization Units in Emergency and Rural Settings
Growth in Biopharmaceutical Sterilization for Complex Biologics and Drug Delivery Devices
Increased Focus on Green Sterilization Alternatives Amid Sustainability Pressures
Emergence of AI and Automation in Workflow Management and Validation Documentation
| Report Coverage | Details |
| Market Size in 2024 | USD 2.05 Billion |
| Market Size by 2033 | USD 5.22 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 10.93% |
| Base Year | 2023 |
| Forecast Period | 2024-2033 |
| Segments Covered | Service Type, Delivery Mode |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Key Companies Profiled | STERIS, MEDIVATORS Inc., Pall Corporation, Ecolab, BD, Thermo Fisher Scientific Inc., Merck & Co., Inc., 3M, E-BEAM Services, Inc., Stryker |
A primary driver fueling the U.S. sterilization services market is the expansion of the domestic medical device manufacturing sector, which is one of the most technologically advanced and regulated industries in the country. The U.S. is home to over 6,000 medical device companies, many of which rely on sterilization to meet FDA requirements before devices can be sold or implanted.
Sterilization is a crucial step in the value chain for single-use instruments, implants, stents, catheters, and surgical kits. As the number of surgical interventions and hospital admissions increases, so does the demand for reliable, third-party sterilization solutions. The diversity of materials and designs in today’s medical devices necessitates tailored sterilization approaches, including EtO for heat-sensitive devices and gamma for dense packaging configurations. Contract sterilization services provide these manufacturers with scalability, validation expertise, and regulatory-compliant solutions without the need for capital-intensive sterilization infrastructure.
Furthermore, as more OEMs transition to just-in-time manufacturing, they increasingly rely on offsite, outsourced sterilization partners with quick turnaround capabilities, warehousing services, and integrated logistics. These trends are central to market growth and are reflected in the expansion plans of several major sterilization providers across the U.S.
One significant restraint to the U.S. sterilization services market is the environmental and regulatory pressure associated with the use of ethylene oxide (EtO)—one of the most commonly used sterilization methods due to its efficacy and compatibility with complex, heat-sensitive devices.
EtO is classified as a carcinogen and has been associated with potential air quality issues in communities located near sterilization plants. In recent years, facilities in Illinois, Georgia, and other states faced temporary shutdowns or were required to implement enhanced emissions control systems following EPA and public health reviews. These events led to delays in device availability and raised concerns about the reliance on a single sterilization modality.
In response, the FDA launched initiatives to support alternative sterilization technologies and encouraged the development of lower-emission processes. Nevertheless, retrofitting facilities, achieving compliance, and transitioning to alternative technologies require time and capital, which poses a barrier to smaller sterilization providers and limits short-term scalability.
A high-potential opportunity within the U.S. market lies in the growth of onsite and mobile sterilization units, particularly in ambulatory surgical centers (ASCs), emergency response units, and rural healthcare facilities. These solutions allow for decentralized sterilization at the point of care, reducing the need to transport instruments or products offsite—minimizing delays and contamination risks.
Mobile sterilization pods and trailers equipped with steam or hydrogen peroxide-based sterilizers are gaining traction in military, humanitarian, and disaster-response applications. Additionally, healthcare providers are showing interest in leasing modular, self-contained sterilization rooms that can be temporarily deployed during facility renovations or service overflow scenarios.
Startups and established vendors are innovating in this space by offering portable sterilization technologies with low energy and water consumption, built-in digital tracking, and compliance-ready documentation. These capabilities not only meet the operational needs of healthcare providers but also support contingency planning, infection control, and continuity of surgical services in crisis settings.
The contract sterilization services segment accounted for the largest revenue share of 70.29% in 2023 These services involve outsourcing sterilization to specialized third-party providers equipped with advanced facilities and multi-modality sterilization lines. OEMs, pharmaceutical companies, and hospitals prefer this model as it allows them to focus on core operations while ensuring regulatory compliance and cost savings through economies of scale.
Contract sterilization facilities offer a range of modalities under one roof—EtO, gamma, electron beam (e-beam), and steam—along with ancillary services like packaging, logistics, and environmental testing. Leading providers such as STERIS and Sotera Health have built expansive networks of such facilities, capable of servicing high volumes and complex product portfolios. Their experience with FDA and ISO standards also ensures that clients meet compliance requirements efficiently.
Validation sterilization services, while smaller in market share, are the fastest-growing segment. These services are essential in the product development and pre-commercialization phase. They include sterility assurance testing, bioburden studies, dose mapping, and protocol development. As regulatory bodies tighten sterilization documentation requirements and product complexity increases, the demand for validation expertise is growing rapidly. Emerging biotech and medtech firms particularly rely on validation partners to conduct feasibility assessments and ensure successful audits.
The offsite segment dominated the market with a share of 68.0% in 2023, These centralized facilities offer economies of scale and advanced safety protocols for handling hazardous gases and radioactive sources. Offsite delivery also facilitates centralized documentation, quality control, and logistics, making it the model of choice for large-scale production and nationwide distribution.
However, onsite sterilization services are gaining popularity, particularly among large hospital systems, ASCs, and specialty device producers that require faster turnaround or have high customization needs. Onsite models offer greater control over scheduling, inventory, and workflow, and can be especially useful in sterile processing departments (SPDs) of major hospitals. In many cases, sterilization equipment is leased and managed by service providers who maintain compliance and perform regular audits, enabling hospitals to benefit from advanced capabilities without full ownership responsibilities.
The U.S. remains the largest and most sophisticated sterilization services market globally, driven by its mature medical device sector, extensive hospital network, and strict regulatory landscape. The FDA’s oversight ensures that sterilization practices adhere to high standards, pushing service providers to continually invest in facility upgrades, training, and innovation.
High procedure volumes, aging demographics, and strong public-private investment in healthcare infrastructure further stimulate demand. Additionally, the U.S. is at the forefront of digital transformation in healthcare, fostering the growth of data-integrated sterilization platforms that support traceability, audit readiness, and real-time reporting.
In states such as California, Texas, Florida, and New York, where healthcare systems are highly consolidated and procedure-intensive, sterilization outsourcing is deeply embedded into operations. The Midwest, meanwhile, serves as a manufacturing hub with major sterilization and packaging facilities serving national and global supply chains.
Recent U.S. regulatory developments around EtO emissions, however, have prompted both challenges and innovation. The push toward lower-emission sterilization, including vaporized hydrogen peroxide (VHP) and nitrogen dioxide (NO2) systems, is expected to create new growth niches within the national market.
March 2025: STERIS Corporation announced a $60 million investment in expanding its EtO and gamma sterilization capacity in Ohio and Texas to meet growing OEM demands and implement advanced emissions control systems.
February 2025: Sotera Health launched a new Sterility Assurance Lab in Minnesota dedicated to providing advanced validation and material compatibility testing for complex medical devices.
January 2025: Cantel Medical (a Steris subsidiary) introduced a mobile hydrogen peroxide sterilization unit for hospital emergency preparedness programs and rural healthcare deployment.
December 2024: Nelson Labs completed the acquisition of a validation testing facility in California to expand its bioburden, endotoxin, and sterility assurance services to medtech clients.
November 2024: Advanced Sterilization Products (ASP) unveiled its new STERRAD VELOCITY® system, featuring reduced cycle times and AI-driven cycle monitoring for faster, automated low-temperature sterilization.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. sterilization services market
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