Sterilization Equipment Market Set to Reach USD 27.1 Bn by 2031 Amid Rising HAIs and Stringent Global Sterility Regulations | TMR

The global sterilization equipment market, valued at US$ 13.8 Bn in 2022, is projected to grow at a CAGR of 7.9% from 2023 to 2031, reaching a value of US$ 27.1 Bn by the end of 2031. This growth trajectory reflects expanding surgical volumes worldwide, an increasing focus on infection control in healthcare settings, and the introduction of stricter guidelines regulating sterilization standards across major regions.

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The market outlook remains robust as hospitals, diagnostic centers, and medical device manufacturers increase capital expenditure on sterilization systems designed to enhance compliance, worker safety, and operational efficiency. In addition, demand is rising for high-temperature sterilizers, autoclaves, hydrogen peroxide systems, and filtration technologies used across diverse healthcare and laboratory applications.

Market Overview

Sterilization remains a foundational component of infection prevention and control within healthcare institutions, laboratories, and medical device manufacturing environments. As healthcare-associated infections (HAIs) continue to rise globally, healthcare systems are under pressure to implement more efficient and standardized sterilization processes. The market demonstrates a pronounced shift toward devices equipped with advanced monitoring and control systems, ensuring precise regulation of temperature, pressure, humidity, and exposure time-critical factors that impact sterilization efficacy.

Market participants are increasing their focus on automating sterilization workflows to reduce repetitive manual tasks that may expose workers to ergonomic risks. Vendors are also enhancing ergonomic designs to ensure safer operations and minimize occupational injuries linked to repetitive motion and lifting.

Sterilization methods in practice today include steam sterilization (autoclaving), dry heat sterilization, Ethylene Oxide (ETO), hydrogen peroxide gas plasma systems, ionizing radiation (gamma and electron beam), and filtration sterilization. Steam sterilization is widely adopted due to its cost-effectiveness and non-toxic nature, while dry heat approaches are preferred for products sensitive to moisture. ETO continues to be a key option for sterilizing heat- and moisture-sensitive medical products.

As surgical volumes increase-spanning orthopedic, cosmetic, cardiovascular, and minimally invasive procedures-the global demand for sterilization products grows in parallel, particularly in hospitals and diagnostic centers. Healthcare expansion through acquisitions, joint ventures, infrastructure upgrades, and the shift toward one-stop medical service models further drives the need for reliable sterilization systems.

Key Market Growth Drivers

1. Rising Prevalence of Healthcare-associated Infections (HAIs)

Healthcare-associated infections remain a critical global health concern. The European Union and European Economic Area record over 3.5 million HAI cases annually, resulting in more than 90,000 deaths and approximately 2.5 million disability-adjusted life years (DALYs). This substantial disease burden has compelled medical professionals and policymakers to adopt stricter decontamination and sterilization procedures. Consequently, hospitals, laboratories, and clinics are increasingly investing in advanced sterilization equipment to ensure compliance, reduce cross-contamination, and protect patient outcomes.

2. Increased Surgical Volumes Across Healthcare Systems

Surgical instruments-including scalpels, extraction forceps, surgical burs, and periodontal scalers-require sterilization after each use. Globally, the rise in orthopedic procedures, cosmetic surgeries, and minimally invasive treatments is fueling demand for autoclaves, steam-based sterilizers, and low-temperature sterilization solutions. The transition toward reusable instruments in certain clinical applications further increases sterilization requirements.

3. Implementation of Stringent Regulatory Standards

Regulatory bodies worldwide are tightening standards around sterilization. Examples include:

European Medical Devices Regulation (MDR) 2017/745, which mandates sterility-related general safety and performance requirements for medical devices.

U.S. FDA's recognition of new consensus standards (2023) supporting low-temperature vaporized hydrogen peroxide sterilization and streamlining regulatory approval pathways.

These evolving regulations encourage facilities to upgrade outdated sterilization systems and adopt technologies enabling precise regulation, automated controls, and validated sterility assurance levels.

4. Growth in Healthcare Infrastructure and Diagnostic Centers

Hospitals and diagnostic centers dominated the market in 2022. Expansion of healthcare facilities-driven by demographic shifts, rising disease burden, and an aging population-is increasing the need for sterilizers capable of handling high instrument loads, varied device geometries, and accelerated turnaround requirements.

5. Advancements in Sterilization Technology

The industry is witnessing rapid innovation, particularly in:

Automated high-level disinfection systems

Compact sterilizers optimized for faster operations

Advanced monitoring systems for precision sterilization cycles

Ergonomic designs enhancing worker safety

Market growth is further supported by ongoing vendor efforts to improve sterility assurance while reducing cycle times, operational complexity, and device handling risks.

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Market Challenges & Opportunities

Challenges

Shift Toward Disposable Medical Devices

Growing usage of single-use devices reduces the need for repeated sterilization cycles, potentially restraining long-term demand for sterilization units in certain applications.

Regulatory and Environmental Concerns Around ETO

Ethylene oxide remains a key sterilization method for heat-sensitive devices, but concerns related to environmental emissions and worker exposure have prompted regulatory revisions. For example, efforts by the U.S. Environmental Protection Agency to reduce ETO emissions could impact device manufacturers that rely heavily on this method.

Excise Duties on Medical Device Manufacturers

Taxes imposed on medical devices may increase production costs and impact market pricing strategies, particularly for low-margin sterilization manufacturers.

Opportunities

Automation and Robotics in Sterilization

The trend toward automated sterilization workflows-exemplified by partnerships such as the 2024 collaboration between Multiply Labs and Fedegari Group-will improve throughput, reduce errors, and accelerate cycle workflows.

Emergence of Compact, High-Efficiency Sterilizers

Smaller environments such as ambulatory surgical centers (ASCs), outpatient clinics, and private practices are increasingly adopting compact sterilization units that combine high-level disinfection with ease of use.

Adoption of Hydrogen Peroxide and Low-Temperature Sterilizers

As healthcare systems transition away from older methods with environmental concerns, low-temperature gas plasma systems offer significant growth potential due to their safety, speed, and compatibility with heat-sensitive devices.

Rising Demand in Emerging Economies

Asia Pacific, Latin America, and the Middle East & Africa present significant growth opportunities due to increasing healthcare investments, expanding surgical capacity, and modernization of hospital infrastructure.

Analysis of Key Players - Key Player Strategies

The market is dominated by global sterilization companies with diversified portfolios and strong R&D capabilities. Key players include:

3M

Advanced Sterilization Products Services, Inc.

Belimed AG

Cantel Medical Corp.

Getinge

Sakura Si Co., Ltd.

STERIS Corporation

Stryker

Sterigenics U.S., LLC

Matachana Group

Key Strategies Exhibited by Market Leaders:

1. Development of Automated High-Level Disinfection Systems
Companies are prioritizing the design of automated sterilization units that reduce manual handling, ensure consistency, and improve productivity. This strategy not only improves sterilization efficacy but also frees healthcare personnel to focus on patient care.

2. Compact and Ergonomic Product Designs

Manufacturers are producing sterilization equipment with compact footprints to serve smaller clinics and laboratories. Ergonomic designs also minimize worker injuries associated with lifting, loading, and repetitive motions.

3. Technology Integration for Monitoring & Control

Advanced monitoring systems regulating temperature, pressure, and exposure times are becoming central to product development roadmaps. These features enhance sterility assurance and regulatory compliance.

4. Strategic Partnerships and Collaboration

Industry leaders are forging alliances to enhance sterilization workflows. A notable example includes:

Multiply Labs & Fedegari Group (January 2024) - A partnership focused on automating sterilization for cell therapy robotic systems.

Such collaborations demonstrate the shift toward robotic-enabled healthcare manufacturing solutions.

5. Focus on High-Temperature and Autoclave Product Lines

With heat sterilization holding the largest method share, companies are expanding portfolios in autoclaves and hot-air ovens, particularly in hospital and laboratory settings.

6. Expansion into High-Growth Regions

Market leaders are increasing their footprint in North America, Asia Pacific, and Europe through strategic distribution networks and localized after-sales support frameworks.

Recent Developments

A major development shaping industry direction includes:

January 2024 - Multiply Labs & Fedegari Group Partnership
This collaboration aims to automate the sterilization of cell therapy robotic systems, marking a significant advancement in the convergence of robotics and sterilization technology. The partnership reflects the broader industry trend of integrating automation to improve efficiency, sterility assurance, and scalability of advanced therapies.

Regulatory Recognition and Updates (2023)

The U.S. FDA's recognition of new sterilization-related standards supports:

Innovation in low-temperature sterilization

Adoption of vaporized hydrogen peroxide methods

Streamlining of premarket submission processes

These regulatory changes are expected to accelerate product approvals and encourage broader adoption of new sterilization technologies.

Investment Landscape and ROI Outlook

The sterilization equipment market presents a favorable investment landscape for stakeholders across the healthcare ecosystem.

High ROI Drivers:

Essential Nature of Sterilization

Sterilization is mandatory across hospitals, laboratories, and device
manufacturers. Consequently, investments in sterilization equipment generate recurring value by ensuring operational continuity and regulatory compliance.

Growing Global Burden of HAIs

Increased healthcare awareness, rising surgical volumes, and infection control imperatives provide long-term stability and predictable growth for investors.

Continuous Technological Upgradation

Investments in next-generation sterilizers incorporating automation, robotics, and analytics are creating new revenue opportunities for manufacturers.

Government Support & Regulatory Modernization

Modernization in regulatory frameworks that encourage safer, cleaner sterilization technologies supports investment security and mitigates market risks.

Outlook

As hospitals expand and adopt modern sterilization workflows, demand will continue rising across heat sterilization systems, low-temperature technology, ionic radiation sterilization, and filtration systems. The growing use of autoclaves and integration of digital monitoring tools enhances the market's ROI profile. The strong CAGR of 7.9% further underscores the resilience and long-term potential of this market.

Market Segmentations (with Region)

By Method

1. Heat Sterilization / High-Temperature Sterilization

Autoclaves

Hot Air Ovens

Heat sterilization accounted for the largest share in 2022 due to its effectiveness, affordability, and compatibility with thermally stable products.

2. Low-Temperature Sterilization

Ethylene Oxide (ETO) Sterilization

Hydrogen Peroxide Gas Plasma

Others

Low-temperature techniques are critical for moisture- and heat-sensitive devices.

3. Ionizing Radiation Sterilization

Gamma Sterilization

Electron Beam Sterilization

Others

4. Filtration Sterilization

By End-user

Hospitals and Diagnostic Centers (largest segment in 2022)

Pharmaceutical Companies

Educational Institutes

Medical Device Companies

Hospital expansion and rising surgical rates drive the dominant share of this category.

Regional Analysis

North America (Leading Region, 2022)

High prevalence of infectious diseases

Advancements in sterilization technology

Regulatory emphasis on reducing ETO emissions

Europe
Increased HAI burden (3.5 million cases annually)

Strong regulatory framework under MDR 2017/745

Asia Pacific
Growing healthcare investments

Expansion of hospitals and diagnostic laboratories

Latin America
Growing adoption of sterilization standards

Middle East & Africa
Healthcare infrastructure expansion across key nations

Why Buy This Report?

Comprehensive Market Coverage: Detailed analysis of methods, end-users, and regional trends.

Accurate Market Forecasting: Reliable projections through 2031 based solely on industry-supplied data.

Competitive Intelligence: In-depth review of key players, strategies, and market positioning.

Regulatory Insights: Analysis of how evolving global regulations shape technology adoption.

Investment Guidance: ROI and opportunity assessment for manufacturers, investors, and distributors.

Strategic Planning Support: Helps decision-makers evaluate upcoming opportunities, challenges, and technological trends.

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FAQs (Five Main Questions)

1. What is the market size of the global sterilization equipment market?

The market was valued at US$ 13.8 Bn in 2022 and is projected to grow to US$ 27.1 Bn by 2031, at a CAGR of 7.9%.

2. Which sterilization method held the largest share in 2022?

Heat sterilization / high-temperature sterilization, particularly autoclaves, accounted for the largest share.

3. Which end-user segment dominates the market?

Hospitals and diagnostic centers held the largest share due to rising surgeries and healthcare facility expansions.

4. Which region leads the global market?

North America dominated in 2022, supported by high disease prevalence and advancements in sterilization technology.

5. What are the major factors driving market growth?

Rising HAIs, increased surgical volumes, strict regulatory standards, technological advancements, and greater healthcare investments.

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