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Sterilization Services Market Analysis & Forecast: 2025-2032

Sterilization Services Market, By Method (Ethylene Oxide (ETO) Sterilization, Gamma Sterilization, Steam Sterilization, Electron Beam, Radiation Sterilization, and Other Methods), By Business Type (Contract Sterilization Services and Sterilization Validation Services), By End User (Medical Device Companies, Hospitals and Clinics, Pharmaceutical and Biotechnology Industry, and Other End Users), and By Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

  • Published In : 11 Aug, 2025
  • Code : CMI5657
  • Pages :157
  • Formats :
      Excel and PDF
  • Industry : Medical Devices
  • Historical Range: 2020 - 2024
  • Forecast Period: 2025 - 2032

Sterilization Services Market Size and Forecast – 2025 to 2032

Sterilization Services Market is estimated to be valued at USD 4,625.0 Mn in 2025 and is expected to reach USD 7,093.2 Mn in 2032, exhibiting a compound annual growth rate (CAGR) of 6.3% from 2025 to 2032.

Key Takeaways

  • By Method, Ethylene Oxide (ETO) Sterilizationacquired the prominent share of 48.1% in 2025 as escalating demand for sterile medical devices.
  • By Business Type, Contract Sterilization Services dominates the overall market share in 2025 owing to the surge in outsourcing from medical & pharma industries.
  • By End-User, Medical Device Companies hold the largest market share in 2025 owing to the regulatory compliance & quality assurance.
  • By Region, North America dominates the overall market with an estimated share of 39.2% in 2025 owing to the advanced healthcare infrastructure & high surgical volume.

Market Overview

The sterilization services market demand continues to grow steadily as healthcare, pharmaceutical, and medical device companies prioritize infection control. Rising surgical volumes, strict regulatory standards, and the need to sterilize complex, single-use devices are driving demand for both on-site and outsourced sterilization solutions. Companies are adopting advanced low-temperature and eco-friendly technologies to improve efficiency and meet environmental standards. A strong emphasis on quality assurance and safety is also accelerating the use of sterilization services across hospitals, laboratories, and industrial facilities globally.

Current Events and their Impact on the Sterilization Services Market

Current Events

Description and its impact

US Regulatory Environment Transformation

  • Description: Trump Administration EtO Emissions Rule Rollback
  • Impact: Creates two-year compliance delay providing competitive advantage to existing EtO facilities while potentially deterring investment in alternative technologies.
  • Description: EPA Interim Decision Implementation
  • Impact: Introduces stricter worker exposure limits (0.1 ppm by 2035) and continuous monitoring requirements increasing operational costs for commercial sterilization facilities

European Union Regulatory Harmonization Initiative

  • Description: Withdrawal of EtO Biocidal Product Approval
  • Impact: Eliminates surface disinfectant applications by February 2025, concentrating EtO use exclusively in medical device sterilization and potentially reducing overall market demand.
  • Description: MDCG Medical Device Regulation Clarification
  • Impact: Provides regulatory certainty for EtO use in medical device sterilization under MDR/IVDR framework, stabilizing European market operations.

Supply Chain Disruption and Facility Consolidation

  • Description: Strategic Commercial Facility Closures
  • Impact: Multiple high-profile shutdowns including Sterigenics Willowbrook and BD facilities reduce market capacity while increasing pricing leverage for remaining operators.
  • Description: FDA Critical Shortage Warnings
  • Impact: Official warnings about medical device supply chain vulnerabilities create urgency for diversified sterilization capacity and alternative method adoption.

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End-user Feedback and Unmet Needs in the Sterilization Services Market

  • Demand for Faster Turnaround Times: End-users often express the need for quicker sterilization cycles to minimize equipment downtime and support faster clinical workflows. Delays can impact surgical schedules and patient care, making rapid yet reliable sterilization services a critical requirement for hospitals and medical device manufacturers.
  • Need for Enhanced Transparency and Traceability: Users seek improved digital tracking and documentation of sterilization processes to ensure regulatory compliance and audit readiness. Enhanced transparency helps build trust and reduces risks associated with sterilization failures or recalls, especially in highly regulated markets.
  • Preference for Eco-Friendly Sterilization Methods: Healthcare providers increasingly prioritize environmentally sustainable sterilization techniques that reduce harmful emissions and chemical residues. There is a growing demand for greener alternatives that align with global environmental regulations without compromising sterilization efficacy.

Role of Artificial Intelligence (AI) in Sterilization Services

AI plays a vital role in sterilization services by enhancing efficiency, safety, and workforce management. It optimizes workflow by identifying bottlenecks and streamlining processes, enabling higher throughput without additional staff. AI also supports predictive maintenance, reducing equipment downtime and preventing failures. Through real-time monitoring, AI ensures sterilization quality and compliance with safety standards by detecting anomalies early.

CensisAI2 is an advanced interactive platform that utilizes AI and Actionable Intelligence to assist organizations in boosting sterile processing efficiency, handling more case volumes without adding extra full-time employees, and minimizing overtime and staff burnout.

Segmental Insights

Sterilization Services Market By Method

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Sterilization Services Market Insights, By Method - Ethylene Oxide (ETO) Sterilization  contribute the highest share of the market owing to its healthcare infrastructure expansion

Ethylene Oxide Sterilization dominates the market with a share of 48.1%. The ethylene oxide sterilization services market share is expanding as healthcare, pharmaceutical, and manufacturing industries increase their efforts to sterilize heat- and moisture-sensitive, single-use medical devices. Healthcare providers and medical device companies depend on EO’s high effectiveness to maintain infection control and protect patient health. Sterilization service providers implement advanced technologies like closed-loop gas capture, catalytic abatement, and AI-based monitoring to comply with strict environmental and regulatory standards. Growing demand from pharmaceutical, food, and high-tech sectors further boosts the need for EO-based sterilization solutions. For instance, in June 2025, Sonata Scientific, an advanced industrial air purification solution, launched the Helios MP500—a cutting-edge, high-performance system designed to eliminate fugitive ethylene oxide (EtO) emissions from medical device sterilization facilities.

Sterilization Services Market Insights, By Business Type - Contract Sterilization Services contribute the highest share of the market owing to its technological innovation & eco-friendly solutions

Medical device and pharmaceutical companies are driving growth in the contract sterilization services market by outsourcing sterilization to specialized third-party providers. These providers ensure compliance with global regulations, uphold strict quality standards, and improve operational efficiency. They offer scalable solutions that accommodate both small and large production volumes while utilizing advanced methods like ethylene oxide and gamma irradiation. As healthcare production rises and infection control becomes more critical, manufacturers increasingly rely on these services to reduce costs and avoid significant capital investment.

Sterilization Services Market Insights, By End-User - Medical Device Companies contribute the highest share of the market owing to its increased surgical volumes & product throughput

Medical device companies drive demand in the sterilization services market by actively outsourcing to specialized contract sterilization providers. They rely on these partners to meet regulatory standards, enhance quality control, and streamline operations. Providers deliver scalable solutions for both low and high production volumes, using advanced techniques like ethylene oxide and gamma irradiation. By outsourcing, companies avoid costly investments in infrastructure and focus on core areas like design and innovation. Increasing infection-control demands and device complexity further push companies toward external sterilization solutions. For instance, in August 2025, BGS US opened a 100,000 ft² Electron Beam (E-Beam) sterilization facility in Imperial, PA, near Pittsburgh International Airport. Strategically located to serve the Northeast, Midwest, and South, the facility offers comprehensive E-Beam sterilization services for medical devices, pharmaceutical packaging, and biotech products.

Regional Insights

Sterilization Services Market Regional Insights

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North America Sterilization Services Market Trends

North America acquires the dominant share of 39.20%. Advanced healthcare systems, strong pharmaceutical and medical device manufacturing, and strict infection-control regulations drive growth in North America’s sterilization services market. Hospitals and clinics actively engage contract sterilization providers to maintain safety, meet regulatory standards, and reduce capital expenses. These providers invest in advanced technologies such as ethylene oxide, gamma irradiation, and low-temperature plasma. They also implement eco-friendly practices and digital monitoring tools to deliver efficient, high-quality, and scalable sterilization solutions across healthcare and life sciences sectors.

In May 2025, Sterigenics, part of Sotera Health and a provider of outsourced terminal sterilization services, revealed plans to expand its Haw River campus in North Carolina by adding a new X-Ray facility next to its current gamma facility.

Asia Pacific Sterilization Services Market Trends

India, China, Indonesia, and other Asia Pacific countries are rapidly increasing healthcare investments, driving higher demand for sterilization services. Hospitals and clinics actively seek external sterilization partners to ensure infection control and patient safety. As medical device production expands, companies turn to contract sterilization providers to meet regulatory standards and accelerate product delivery. Growing cases of hospital-acquired infections across the region have led regulators to enforce stricter sterilization protocols, prompting healthcare facilities to adopt more reliable and compliant sterilization solutions. For instance, Hamamatsu University Hospital, Hamamatsu Nissan Motor Co., Ltd., and ASP Japan, G.K. jointly conducted a demonstration in which they powered STERRAD™ sterilization equipment using electricity supplied by electric vehicles (EVs) at Hamamatsu University Hospital.

United States Sterilization Services Market Trends

Hospitals and medical device manufacturers are increasingly outsourcing sterilization to specialized providers to cut costs, boost efficiency, and concentrate on their core operations. They adopt stringent FDA regulations to maintain consistent sterilization quality. The use of low-temperature methods, including hydrogen peroxide gas plasma and ozone, is growing, as these safer, more efficient technologies better sterilize heat-sensitive medical devices compared to traditional ethylene oxide and steam methods.

For instance, in July 2025, SurGenTec®, a leading innovator in minimally invasive orthopedic and spine surgery, has launched its new TiLINK®-INSITE™ Sacroiliac Joint Fusion System. Now offered in a sterile, surgery-ready kit, the system has already been successfully used in initial procedures at multiple U.S. sites and has received strong endorsements from physicians.

India Sterilization Services Market Trends

Government and private investments are rapidly developing India’s healthcare infrastructure, boosting demand for sterilization services. New hospitals, clinics, and surgical centers actively seek reliable sterilization solutions to uphold hygiene and protect patient safety. Rising surgical procedures, driven by an aging population and increased chronic diseases, further increase sterilization services market demand. For instance, in October 2024, Japanese logistics firm Konoike Transport unveiled a service in India to clean and sterilize used medical equipment from hospitals, applying its domestic expertise to enter the expanding international medical market.

Market Report Scope

Sterilization Services Market Report Coverage

Report Coverage Details
Base Year: 2024 Market Size in 2025: USD 4,625.0 Mn
Historical Data for: 2020 To 2024 Forecast Period: 2025 To 2032
Forecast Period 2025 to 2032 CAGR: 6.3% 2032 Value Projection: USD 7,093.2 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Method: Ethylene Oxide (ETO) Sterilization, Gamma Sterilization, Steam Sterilization, Electron Beam, Radiation Sterilization, and Other Methods
  • By Business Type: Contract Sterilization Services and Sterilization Validation Services
  • By End User: Medical Device Companies, Hospitals and Clinics, Pharmaceutical and Biotechnology Industry, and Other End Users
Companies covered:

Steris Corporation, Noxilizer Inc., Medistri SA, Judd Medical Limited, E-BEAM Services Inc., Cantel Medical Corporation, Stryker Corporation (TSO3 Inc.), BGS Beta-Gamma-Service GmbH & Co. KG, and B Braun Melsungen AG (B Braun Medical Ltd.), among others.

Growth Drivers:
  • Rise in burden of hospital acquired infections
  • Rise in demand for sterilization agents/equipment
Restraints & Challenges:
  • Harmful effects of chemical agents 
  • Lack of availability of correct manuals

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Sterilization Services Market Trend

  • Advancement in Low-Temperature Sterilization Technologies

The market sees growing adoption of low-temperature sterilization methods like hydrogen peroxide gas plasma, ozone, and vaporized hydrogen peroxide. These technologies provide safer alternatives for heat- and moisture-sensitive medical devices that traditional steam sterilization can damage. They also reduce cycle times and environmental impact, aligning with stricter global regulations. Hospitals and device manufacturers increasingly prefer these eco-friendly, efficient methods to maintain sterility without compromising device integrity or patient safety.

Sterilization Services Market Opportunity

  • Integration of Digital and Automation Technologies

The rise of digital health and Industry 4.0 trends opens opportunities to integrate advanced automation, IoT, and real-time monitoring into sterilization services. Providers can improve operational efficiency, quality control, and regulatory compliance through automated data tracking and predictive maintenance. This technological integration supports faster turnaround times and enhanced traceability, which are increasingly demanded by hospitals and medical device manufacturers aiming to streamline sterilization workflows.

Sterilization Services Market News

  • In June 2025, cultivate(MD), a leading medical device venture capital firm, announced that its portfolio company, Sterile Processing Express (SPDx), has been acquired by Instrumentum, LLC, a rapidly growing provider of surgical instrument sterilization services.
  • In August 2025, Bardez unveiled an eight-day free vaccination and sterilization drive for stray and pet dogs. Officials noted that despite ongoing sterilization efforts, the dog population has not decreased. They urged the public to support the mission by helping identify dogs and eliminate the threat of rabies.
  • In March 2024, STERIS launched its Verafit Sterilization Bags and Covers, featuring a patent-pending viewing window that allows users to visually inspect and confirm the dryness of sterilized parts. This innovative design supports biopharmaceutical manufacturers in meeting the latest EU GMP Annex 1 requirements for verifying dryness during sterilization cycle acceptance.

Analyst Opinion (Expert Opinion)

  • The Sterilization Services Market is undergoing a critical transformation driven by regulatory rigor and technological evolution. Ethylene oxide (EO) sterilization remains indispensable—despite its environmental concerns—because of its unparalleled efficacy on complex, heat-sensitive medical devices. Recent data from the U.S. Environmental Protection Agency highlights that over 70% of single-use medical devices rely on EO sterilization, underscoring its entrenched market position.
  • However, providers ignoring the push for eco-friendly alternatives risk obsolescence. For example, Sterigenics’ investment in closed-loop EO gas capture systems represents a strategic pivot to balance compliance and environmental stewardship, setting a new industry benchmark. Low-temperature technologies like hydrogen peroxide plasma are promising but still struggle to match EO’s versatility and throughput, limiting their role to niche applications.
  • The accelerated outsourcing trend is another disruptor reshaping the market dynamics. OEMs increasingly demand end-to-end sterilization solutions that integrate validation, compliance, and supply chain agility. Consider Medline’s expansion of contract sterilization services in North America, which leverages automation and digital traceability, delivering reliability that internal sterilization units often fail to match.
  • Moreover, the market must brace for escalating infection control standards post-pandemic, as healthcare-associated infections (HAIs) continue to pose significant challenges worldwide. Hospitals are under pressure to adopt advanced sterilization methods that not only guarantee sterility but also enhance workflow efficiency—something that only leading contract service providers can sustainably offer.

Market Segmentation

  • Global Sterilization Services Market, By Method
    • Ethylene Oxide (ETO) Sterilization
    • Gamma Sterilization
    • Steam Sterilization
    • Electron Beam
    • Radiation Sterilization
    • Other Methods
  • Global Sterilization Services Market, By Business Type
    • Contract Sterilization Services
    • Sterilization Validation Services
  • Global Sterilization Services Market, By End User
    • Medical Device Companies
    • Hospitals and Clinics
    • Pharmaceutical and Biotechnology Industry
    • Other End Users
  • Global Sterilization Services Market, By Geography
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Argentina
      • Mexico
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • Spain
      • France
      • Italy
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC Countries
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • North Africa
      • Central Africa
  • Key Players Insights
    • Steris Corporation
    • Noxilizer Inc.
    • Medistri SA
    • Judd Medical Limited
    • E-BEAM Services Inc.
    • Cantel Medical Corporation
    • Stryker Corporation (TSO3 Inc.)
    • BGS Beta-Gamma-Service GmbH & Co. KG
    • B Braun Melsungen AG (B Braun Medical Ltd.)

Sources

Primary Research Interviews

  • Sterilization plant managers
  • Hospital infection control officers
  • Regulatory affairs specialists from medical device companies
  • Quality assurance heads from pharmaceutical manufacturing units
  • Senior engineers from contract sterilization service providers
  • Procurement leads from multispecialty hospitals

Databases

  • U.S. Food & Drug Administration (FDA) MAUDE database
  • Centers for Medicare & Medicaid Services (CMS) Hospital Compare
  • World Health Organization (WHO) Global Health Observatory
  • ClinicalTrials.gov
  • United States Patent and Trademark Office (USPTO)

Magazines

  • Medical Device and Diagnostic Industry (MD+DI)
  • Healthcare Packaging
  • Pharmaceutical Technology
  • Infection Control Today
  • BioPharm International

Journals

  • Journal of Hospital Infection
  • American Journal of Infection Control
  • Journal of Applied Microbiology
  • Sterilization Technology Journal
  • International Journal of Pharmaceutics

Newspapers

  • The New York Times (Healthcare Section)
  • The Guardian (Global Health Section)
  • The Hindu Business Line (Healthcare Industry)
  • Economic Times (Pharma and Healthcare)
  • Wall Street Journal (Medical Device and Life Sciences coverage)

Associations

  • Association for the Advancement of Medical Instrumentation (AAMI)
  • International Association of Healthcare Central Service Materiel Management (IAHCSMM)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Association for Professionals in Infection Control and Epidemiology (APIC)
  • Medical Device Innovation Consortium (MDIC)

Public Domain Sources

  • U.S. Environmental Protection Agency (EPA)
  • National Health Service (NHS – UK)
  • India’s Ministry of Health and Family Welfare
  • European Medicines Agency (EMA)
  • National Institute for Occupational Safety and Health (NIOSH)

Proprietary Elements

  • CMI Data Analytics Tool, and Proprietary CMI Existing Repository of information for last 8 years

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About Author

Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.

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Frequently Asked Questions

The Sterilization Services Market is estimated to be valued at USD 4,625.0 Mn in 2025, and is expected to reach USD 7,093.2 Mn by 2032.

The CAGR of the Sterilization Services Market is projected to be 6.3% from 2025 to 2032.

Rise in burden of hospital acquired infections and rise in demand for sterilization agents/equipment is fueling the market.

The Ethylene Oxide (ETO) Sterilization segment is the leading method segment in the market.

Harmful effects of chemical agents and lack of availability of correct manuals are major factors restraining market.

Major players operating in the market are Steris Corporation, Noxilizer Inc., Medistri SA, Judd Medical Limited, E-BEAM Services Inc., Cantel Medical Corporation, Stryker Corporation (TSO3 Inc.), BGS Beta-Gamma-Service GmbH & Co. KG, and B Braun Melsungen AG (B Braun Medical Ltd.), among others.

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