U.S. Sterilization Services Market Size, Share & Trends Analysis Report By Service Type (Contract Services, Validation Services), By Delivery Mode (Offsite, Onsite), By Region, And Segment Forecasts, 2024 - 2030

U.S. Sterilization Services Market Trends

The U.S. sterilization services market size was valued at USD 1.32 billion in 2023 and is projected to grow at a CAGR of 10.9% from 2024 to 2030. The rising demand for surgery, hospital-acquired infections, and medical device growth are driving market growth in the country, prompting healthcare facilities to adopt rigorous sterilization protocols to ensure patient safety and compliance with regulatory standards.

As the number of surgeries continues to rise, healthcare facilities are under pressure to adopt stringent sterilization protocols to ensure patient safety and reduce the risk of infection. According to the NCBI data, approximately 310 million major surgeries are performed globally annually, with 40-50 million of these surgeries occurring in the U.S. This surge in demand is particularly evident in the wake of rising obesity rates, spinal cord injuries, and sports-related injuries, which have led to an increase in the number of surgical operations being performed.

The prevalence of HAIs is prompting healthcare facilities to adopt more rigorous sterilization practices, thereby boosting the demand for sterilization services. Furthermore, the expansion of the medical device industry is also contributing to the growth of the market, as companies require effective sterilization methods to guarantee product safety and compliance with regulatory standards.

In addition to these factors, outsourcing trends and technological advancements are also driving the growth of the U.S. sterilization services market. Many healthcare facilities are opting to outsource sterilization services to specialized providers, allowing them to reduce costs and improve efficiency. Meanwhile, innovations in sterilization methods, such as ethylene oxide (EtO) and gamma radiation, are enhancing the effectiveness and efficiency of sterilization processes, attracting more users to the market. Lastly, regulatory compliance is also a key driver, as stringent government regulations regarding sterilization standards necessitate the use of professional sterilization services, thereby supporting market expansion.

Service Type Insights

Contract services dominated the market and accounted for a share of 70.3% in 2023. Hospitals and manufacturers are leveraging contract sterilization services to optimize efficiency and ensure compliance with stringent standards. By outsourcing, they can alleviate equipment and staff maintenance burdens, while also gaining access to advanced technologies without significant capital expenditures. This approach enables healthcare providers to effectively meet their operational needs while reducing costs.

Validation services is expected to grow significantly with a CAGR of 9.6% over the forecast period.The healthcare industry is driven by stringent regulations and a heightened emphasis on preventing hospital-acquired infections, necessitating the validation of sterilization processes to ensure the sterility of medical devices. As medical technology advances, the development of complex devices demands specialized sterilization techniques and validation procedures to guarantee their safety and efficacy.

Delivery Mode Insights

Offsite sterilization services accounted for the largest market revenue share of 67.7% in 2023, driven by cost analysis and the convenience of outsourcing. Providers employ skilled staff and adhere to high standards, ensuring compliance with state regulations. By minimizing costs and time, these services have created demand, making them an attractive option for hospitals seeking efficient and effective sterilization solutions.

Onsite sterilization services are projected to grow significantly at a CAGR of 8.9% over the forecast period. On-site sterilization enables facilities to rapidly process equipment, minimizing downtime and ensuring instruments are readily available for procedures. This is particularly crucial for emergency surgeries or situations where equipment is not readily accessible from the central sterile processing department. For hospitals with limited storage capacity, on-site sterilization is a practical solution, eliminating the need to store large quantities of sterilized equipment.

Key U.S. Sterilization Services Company Insights

Some key companies in the U.S. sterilization services market include STERIS plc; Sterigenics U.S., LLC; E-BEAM Services, Inc; and others. Companies are prioritizing expanding their customer roster to obtain a competitive advantage in the market. Hence, major stakeholders are implementing various strategic moves such as merging with other companies, acquiring businesses, and forming partnerships with leading firms.

• STERIS plc is a provider of infection prevention and procedural products and services, offering a comprehensive range of solutions, including capital equipment, services, and support. Its portfolio includes capital equipment, microbial reduction services, equipment installation and maintenance, laboratory testing, and off-site reprocessing solutions.

• Sterigenics U.S., LLC offers solutions such as medical and pharmaceutical sterilization, laboratory testing, food safety, gamma irradiation, contract sterilization, and consulting services. The company’s global clients span the pharmaceutical, food, and commercial product industries, as well as packaging and medical devices.

Recent Developments

• In August 2024, Advanced Sterilization Products (ASP), a Fortive division, received FDA clearance for the ULTRA GI Cycle, a hydrogen peroxide gas plasma sterilization method for duodenoscopes, aiming to enhance patient safety in healthcare settings.

• In July 2024, Midwest Sterilization Corporation partnered with Saint Francis Mobile Wellness, bringing a state-of-the-art 3D mammography unit to southeast Missouri for 45-50 weeks annually, providing residents with convenient access to preventive breast cancer screenings and essential health services.

• In October 2023, E-BEAM Services, Inc. completed a significant facility expansion in Lebanon, Ohio, adding 52,000 square feet of cutting-edge technology to support the company's continued growth and increased demand for sterilization and crosslinking services.

U.S. Sterilization Services Market Report Scope

U.S. Sterilization Services Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. sterilization services market report based on services type and delivery mode. 

• Service Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Contract Sterilization Services

  • Validation Sterilization Services

• Delivery Mode Outlook (Revenue, USD Million, 2018 - 2030)

  • Offsite

  • Onsite