U.S. Sterilization Services Market to Hit Around USD 5.22 Billion by 2033

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.

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U.S. Sterilization Services Market Key Takeaways:

• The contract sterilization services segment accounted for the largest revenue share of 70.29% in 2023
• Moreover, the contract sterilization services segment is anticipated to experience the fastest CAGR over the forecast period.
• The offsite segment dominated the market with a share of 68.0% in 2023
• The offsite model is expected to grow at the fastest CAGR over the forecast period.

The market growth is influenced by several key drivers, including the growing demand for infection control in healthcare settings, the rise in surgical procedures and medical device use, increasing regulatory requirements, and technological advancements in sterilization methods. For instance, in August 2024, PENTAX Medical announced that the DEC Duodenoscope (ED34-i10T2s) received FDA clearance for compatibility with the STERRAD 100NX Sterilizer.?

The surge in surgical procedures is a significant driver for the market growth. According to a recent study, over 900,000 cardiac surgeries are performed annually in the U.S., with forecasts indicating this number will rise to 1.3 million by 2029. The U.S. cardiac surgery market is expanding rapidly due to an increase in various underlying procedures. These procedures require the sterilization of medical equipment and devices, driving demand for effective sterilization services.

The growing geriatric population is another key driver of the sterilization services market. As the population ages, the demand for healthcare services, including surgical procedures, is expected to increase. This trend likely drives the need for effective sterilization of medical equipment and devices, contributing to the growth of the U.S. market.

With an increasing emphasis on preventing hospital-acquired infections (HAIs) and ensuring patient safety, healthcare facilities are investing more in rigorous sterilization practices. According to a 2023 report from the Centers for Disease Control and Prevention (CDC), about 1 in 31 hospital patients are affected by healthcare-associated infections (HAIs) daily, highlighting the urgent necessity for effective sterilization methods to reduce these risks. This growing concern has driven healthcare providers to seek comprehensive sterilization services to maintain high hygiene and safety standards.

U.S. Sterilization Services Market By Service Type Insights

The contract sterilization services segment accounted for the largest revenue share of 70.29% in 2023 due to several key drivers, including the increasing demand for outsourcing sterilization processes by healthcare and pharmaceutical companies, which allows them to focus on core competencies while ensuring compliance with stringent regulatory standards. In addition, advancements in sterilization technologies, such as ethylene oxide (EtO) and gamma radiation, enhance efficiency and effectiveness, further propelling market growth.

Moreover, the contract sterilization services segment is anticipated to experience the fastest CAGR over the forecast period. The rise in healthcare-associated infections (HAIs) heightened awareness of infection control measures, leading hospitals and clinics to seek reliable sterilization partners. Furthermore, the growing trend of outsourcing non-core functions allows businesses to reduce operational costs while maintaining high-quality standards. Innovations between major medical device manufacturers and contract sterilizers exemplify this trend, showcasing how companies leverage external expertise to meet regulatory demands and improve product safety.

U.S. Sterilization Services Market By Delivery Mode Insights

The offsite segment dominated the market with a share of 68.0% in 2023, driven by the increasing demand for outsourced sterilization services from healthcare facilities. This trend is largely attributed to the growing need for efficient and cost-effective solutions that allow hospitals and clinics to focus on core medical services while outsourcing sterilization processes. Factors such as stringent regulatory requirements, advancements in sterilization technologies, and the rising prevalence of healthcare-associated infections (HAIs) have further propelled the growth of this segment.

The offsite model is expected to grow at the fastest CAGR over the forecast period due to its associated benefits and cost-efficiency. Maintaining and operating an in-house sterilization facility can be capital-intensive and resource-heavy. Organizations can avoid these significant investments and operational costs by outsourcing to offsite sterilization services while ensuring high-quality sterilization outcomes. This trend is particularly beneficial for smaller facilities or those experiencing fluctuating demand, as it allows them to access state-of-the-art sterilization technologies without the financial burden of maintaining such systems internally. The increasing adoption of offsite services is also driven by the need for space optimization and a focus on core healthcare functions, further accelerating the segment's growth.

U.S. Sterilization Services Market Recent Developments

• In June 2023, STERIS plc disclosed that the company entered into a formal agreement to acquire the assets related to surgical instrumentation, laparoscopic instrumentation, and sterilization containers from Becton, Dickinson, and Company.
• In January 2024, the FDA issued final guidance for medical device manufacturers titled "Submission and Review of Sterility Information in 510(k) Premarket Notifications for Devices Labeled as Sterile."
• In August 2023, the FDA granted approval for the V-PRO maX 2 Low-Temperature Sterilization System, marking it as the first sterilization technology specifically designed for 3D-printed medical devices.

Some of the prominent players in the U.S. sterilization services market include:

• STERIS
• MEDIVATORS Inc.
• Pall Corporation
• Ecolab
• BD
• Thermo Fisher Scientific Inc.
• Merck & Co., Inc.
• 3M
• E-BEAM Services, Inc.
• Stryker

Reasons to Purchase this Report

• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
• Provision of market value (USD Billion) data for each segment and sub-segment
• Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
• Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled
• Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players
• The current as well as the future market outlook of the industry with respect to recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions
• Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis
• Provides insight into the market through Value Chain
• Market dynamics scenario, along with growth opportunities of the market in the years to com

Segments Covered in the Report

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

Service Type

• Contract Sterilization Services
• Validation Sterilization Services

Delivery Mode

• Offsite
• Onsite

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