US Sterilization Equipment Market
US Sterilization Equipment Market by Product [Instruments, Accessories (Pouches, Indicators)], Service (Off-site, On-site), Technology [Heat (Steam, Dry), Low-temperature (H2O2, EtO, CH2O), Radiation (E-beam, Gamma, X-Ray)] - Forecast to 2031
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The US sterilization equipment market is expected to reach USD 10.79 billion by 2031, from USD 8.09 billion in 2026, with a CAGR of 5.9%. The primary driver of the market is the increasing focus on infection control in healthcare facilities and healthcare-associated infections. Advancements in healthcare infrastructure, investments from hospitals, ASC facilities, and pharmaceutical and medical device manufacturing plants are also fueling market growth. Additionally, improvements in sterilization technology, including low-temperature sterilization for medical devices, and stricter regulations related to sterilization and infection control are supporting the expansion of the sterilization equipment market in the US.
KEY TAKEAWAYS
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By Product & ServiceThe sterilization consumables & accessories segment is expected to record the highest CAGR of 9.2%.
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By TechnologyThe low-temperature sterilization segment is expected to grow at a CAGR of 7.7%.
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By End UserMedical device companies are expected to grow at the fastest rate during the forecast period.
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Competitive LandscapeSTERIS Corporation (US), Sotera Health (US), Fortive (US), Solventum (US), and Getinge (Sweden) were identified as stars in the US sterilization equipment market, supported by their strong market presence and extensive product portfolios.
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Competitive LandscapeCardinal Health (US) and Stryker (US) have distinguished themselves among start-ups and SMEs by securing strong footholds in specialized niche areas.
The rising number of surgeries and increased activities in hospitals, ambulatory surgical centers, and medical device manufacturing are primary drivers of the US sterilization equipment market. Additionally, the evolving regulatory environment and sterilization standards significantly contribute to market growth, which is expected to expand as the demand for advanced sterilization equipment in the healthcare and life sciences sectors continues to rise. The emphasis on patient safety, infection control, and cost-effective sterilization practices further propels the growth of the sterilization market in the US.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The US sterilization equipment market is experiencing steady growth as the medical industry continues to emphasize infection control and safety. Current trends in the market include the increasing use of advanced sterilization technology in hospitals, clinics, medical device companies, pharmaceutical firms, food and beverage businesses, and other end users to ensure effective and compliant sterilization. Additionally, the adoption of automated and low-temperature sterilization methods, along with eco-friendly procedures, is significantly transforming sterilization practices in the medical sector. Improvements in compact, easy-to-use sterilization equipment are enabling more facilities, especially smaller healthcare centers and outpatient surgery centers, to achieve consistent sterilization results.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Level
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Prevalence of HAIs
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Surge in surgical procedures
Level
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Sterilization of advanced medical instruments
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Adverse effects of chemical disinfectants
Level
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Increased demand for healthcare services and expanded hospital infrastructure
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Extensive use of E-beam sterilization
Level
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End-user non-compliance with sterilization standards
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Rapid adoption of single-use medical devices
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Prevalence of HAIs
Hospital-acquired infections (HAIs) significantly contribute to illness and death, impacting the sterilization equipment market in the US. They include urinary tract infections from catheters, surgical site infections, bloodstream infections, and ventilator-associated pneumonia. The CDC estimates 1.7 million HAIs occur annually among hospitalized patients in the US. The rise of HAIs, increasing antimicrobial resistance, an aging population, and more chronic diseases drive the demand for advanced sterilization equipment and infection control measures both domestically and globally.
Restraint: Sterilization of advanced medical instruments
A key challenge in the US sterilization equipment market is ensuring compatibility between medical device materials and sterilization methods. Advanced devices often require specialized, low-temperature sterilization due to their inability to withstand traditional steam methods. The increasing use of complex tools like flexible endoscopes drives demand for advanced sterilization systems. Improper sterilization raises the risk of healthcare-associated infections, emphasizing the need for efficient systems that meet strict regulatory standards.
Opportunity: Increased demand for healthcare services and expanded hospital infrastructure
The US sterilization equipment market is expected to grow due to increased demand for healthcare services, expanded hospital infrastructure, and more outpatient surgical centers. Factors driving this growth include rising surgery rates, heightened awareness of infection prevention, and stringent regulatory standards. Additionally, ongoing advancements in healthcare technology and the presence of major medical device manufacturers will create further opportunities in the market.
Challenge: End-user non-compliance with sterilization standards
A major challenge in the US sterilization equipment market is end-user non-compliance with sterilization standards. Issues like improper loading, incorrect cycles, and inadequate monitoring lead to failures in sterilization, resulting in infections and audit challenges, even with advanced equipment.
US STERILIZATION EQUIPMENT MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Implementation of advanced steam, low-temperature, and vaporized hydrogen peroxide sterilization systems in hospitals, ambulatory surgical centers, and medical device reprocessing facilities in the US. | Facilitates the sterilization process, infection control, and streamlining of workflows, and improves compliance with sterilization standards in healthcare environments. |
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Provision of contract sterilization services for medical devices and pharmaceutical products utilizing gamma irradiation, ethylene oxide (EtO), and electron beam technology for the healthcare and medical device industries in the US. | Reliable large-scale sterilization solutions, safe and compliant products, and validated sterilization services for medical device manufacturers. |
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Implementation of sterilization monitoring systems, biological indicators, and process control solutions for hospitals and sterile processing departments in the US. | It improves validation of the sterilization process, quality assurance, reduces sterilization failures, and supports regulatory compliance. |
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Supply of sterilization assurance products such as chemical indicators, biological indicators, and sterilization packaging solutions for healthcare facilities in the US. | It supports reliable sterilization monitoring, improves process traceability, and enhances patient safety. |
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Supply of washer-disinfectors and steam sterilizers used in the reprocessing of hospital and surgical equipment in the US healthcare industry. | Facilitates the reprocessing of medical instruments, improves infection control measures, enhances operational efficiency, and standardizes the process of sterilization. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The US sterilization equipment market encompasses key industry players throughout the value chain, including equipment and accessory suppliers, contract sterilization service providers, and research and development partners. End users include hospitals & clinics, medical device companies, pharmaceutical companies, food & beverage companies, and other organizations that rely on sterilization equipment and services to effectively control infections and comply with industry standards and regulations. These users need sterilization equipment to reprocess medical devices efficiently and maintain sterility across all healthcare and life sciences applications.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
US Sterilization Equipment Market, By Product & Service
The main driver of the sterilization instruments segment is the rising focus on infection prevention and control in US healthcare facilities. Additionally, the surge in surgeries, expansion of healthcare infrastructure, and strict sterilization regulations have driven demand for advanced sterilization instruments in healthcare and medical device manufacturing settings.
US Sterilization Equipment Market, By Technology
The widespread adoption of heat-based sterilization methods is due to their proven effectiveness in destroying microorganisms, their capability to sterilize a variety of medical instruments and devices, and the existing standard operating procedures in medical facilities. These factors make heat/high-temperature sterilization the most commonly used method in medical facilities, surgical centers, and medical device reprocessing facilities across the US.
US Sterilization Equipment Market, By End User
In recent years, hospitals and clinics have held the largest market share. This is mainly due to the rise in incidences of healthcare-associated infections and the crucial role of sterilization in ensuring patient safety and infection control in healthcare environments. Additionally, improved awareness about infection prevention has contributed to the ongoing growth in the use of sterilization equipment across the US.
US STERILIZATION EQUIPMENT MARKET: COMPANY EVALUATION MATRIX
STERIS (Star) has a significant presence in the US sterilization equipment market due to its comprehensive portfolio of sterilization equipment, consumables, and infection prevention solutions, which has resulted in steady demand for sterilization equipment and consumables from healthcare and life sciences organizations. The company is also committed to providing reliable sterilization equipment, compliance, and user-centric designs, which have helped it maintain a significant presence in the sterilization equipment industry in the US.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 7.70 BN |
| Market Forecast in 2031 (Value) | USD 10.79 BN |
| Growth Rate | CAGR of 5.9% from 2026 to 2031 |
| Years Considered | 2024–2031 |
| Base Year | 2025 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD BN/MN) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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WHAT IS IN IT FOR YOU: US STERILIZATION EQUIPMENT MARKET REPORT CONTENT GUIDE
RECENT DEVELOPMENTS
- March 2024 : STERIS Corporation announced the launch of its new line of Sterilization Consumables under the Verafit Sterilization Bags and Covers brand, which will aid in the process of effective sterilization. These consumables come with a patent-pending design that includes a window that can be used to visually verify dryness after the process of sterilization, enabling biopharmaceutical manufacturers to meet the EU GMP Annex 1 Sterilization requirement.
- May 2022 : Sotera Health, through its subsidiary Sterigenics, increased its sterilization services capabilities with the commencement of operations of its expanded electron beam (E-beam) sterilization facility in Columbia City, Indiana. The addition of a new accelerator at the facility allows for increased sterilization of medical devices and pharmaceutical products, enhancing its capabilities for meeting growing demand for sterilization services and safety of healthcare products in the country.
Table of Contents
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Methodology
The objective of this study is to analyze key market dynamics, including drivers, opportunities, restraints, and challenges, as well as the strategies of major players. We aim to track developments across leading firms, including acquisitions, product launches, expansions, agreements, and partnerships. The competitive landscape of US sterilization equipment will be examined by evaluating market players based on various parameters within the broader categories of business and product strategy. To estimate the market size, both top-down and bottom-up approaches were employed. Additionally, the market breakdown and data triangulation methods were used to estimate segment and subsegment sizes.
Secondary Research
In the secondary research process, various secondary sources such as annual reports, press releases & investor presentations of companies, white papers, certified publications, articles by recognized authors, gold-standard & silver-standard websites, regulatory bodies, and databases (such as D&B Hoovers, Bloomberg Business, and Factiva) were referred to identify and collect information for this study.
Primary Research
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Primary sources were primarily industry experts from core and related industries, as well as preferred suppliers, manufacturers, distributors, service providers, technology developers, researchers, and organizations across all segments of this industry’s value chain. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts, C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information as well as assess prospects.
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COMPANY NAME |
DESIGNATION |
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STERIS (US) |
Sales Manager |
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Getinge AB (Sweden) |
Product Manager |
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the europe sterilization equipment. These methods were also widely used to estimate the sizes of various subsegments of the market. The research methodology used to estimate the market size includes the following:
- The key players in the industry have been identified through extensive secondary research
- The revenues generated by leading players operating in the US sterilization equipment market have been determined through primary and secondary research
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources
Data Triangulation
After arriving at the overall market size by applying the process mentioned above, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Sterilization is a process that removes microorganisms and other pathogens from an object or surface by treating it with chemicals or by subjecting it to high heat or radiation. Sterilization is an integral part of infection control procedures. Europe sterilization equipment is used to sterilize various products and supplies in end-user facilities, whereas consumables & accessories help monitor and simplify the sterilization process. Sterilization services help eliminate contamination arising from all forms of life and other biological agents (such as microbes, particulate matter, and pyrogen) by treating them with chemicals or subjecting them to high heat or radiation. Sterilization is commonly used in laboratories and food processing & healthcare industries to prevent the spread of infections and maintain safety regulations.
Key Stakeholders
- Manufacturers & Distributors of Europe Sterilization Equipment
- Hospitals & Clinics
- Medical Device Companies
- Pharmaceutical Companies
- Food & Beverage Companies
- Research & Academic Institutes
- Contract Research Organizations
- Market Research & Consulting Firms
- Government Association
- Venture Capitalists & Investors
Report Objectives
- To define, describe, segment, and forecast the global US sterilization equipment by product & service, technology, end user, and region
- To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
- To analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the overall US sterilization equipment market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the market segments with respect to five regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
- To track and analyze company developments such as product launches & approvals, partnerships, acquisitions, agreements, and other developments
- To benchmark players within the US sterilization equipment using the Company Evaluation Matrix framework, which analyzes market players on various parameters within the broad categories of business strategy, market share, and product offerings.
Available customizations:
MarketsandMarkets offers the following customizations for this market report.
Country Information
- Additional country-level analysis of the europe sterilization equipment
Company Profiles
- Additional five company profiles of players operating in the europe sterilization equipment.
Product Analysis
- Product matrix, which provides a detailed comparison of the product portfolio of each company in the US sterilization equipment industry
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