Sterilization Services Market

Sterilization Services Market Outlook (2024 to 2034)

The global sterilization services market is poised to reach US$ 3.93 billion in 2024 and further increase to US$ 7.93 billion by the end of 2034. The market has been projected to expand at a CAGR of 7.3% from 2024 to 2034.

Eradication of all microorganisms, both vegetative and spore forms, from a surface or an object is known as sterilization in microbiology. Approximately 106 log colony-forming units are eliminated during sterilization, which is accomplished using a variety of physical and chemical techniques.

• According to a World Health Organization (WHO) report on Infection Prevention and Control in 2022, approximately 15 patients in low- and middle-income countries and seven patients in high-income countries will get at least one healthcare-associated infection (HAI) during their hospital stay out of every 100 patients in acute care hospitals.

These infections, known as nosocomial infections, are not noticed at the time of admission but instead develop during a patient's stay in hospitals and associated facilities. These infections include bloodstream infections linked to central lines, surgical site infections, urinary tract infections linked to catheters, pneumonia acquired in hospitals, pneumonia associated with ventilators, and Clostridium difficile infections.

The bacteria C. difficile, MRSA, Klebsiella, E. coli, Enterococcus, and Pseudomonas species are most frequently linked to healthcare-associated infections (HAIs). One of the main causes of HAIs is using contaminated medical equipment for therapeutic and diagnostic purposes.

Key Market Growth Drivers

• Main reason driving market growth include stringent government and regulatory body mandates in the healthcare sector to maintain compliance with good manufacturing practices (GMP), an increase in surgical procedures, and the growing trend of pharmaceutical companies, hospitals, and medical device manufacturers outsourcing sterilization services.
• Healthcare sector’s demand for single-use, disposable medical equipment has increased over time. In their design and manufacturing processes, many companies that produce medical devices and equipment make use of sterilizing technologies such as ethylene oxide, steam, gamma, and x-rays.
• Sterilization techniques used in the manufacture of medical devices are increasing along with the use of single-use devices. These procedures entail revalidating the packaging through additional sterilization services as well as validation and quality checks.
• Several regulatory bodies in the healthcare sector are concerned that expediting the licensing of new devices and drugs may result in lower healthcare costs.
• Prompt approvals are also projected to drive up demand for new sterility assessment techniques, encouraging progressive market companies to increase their investments in state-of-the-art technologies.

Report Attribute	Detail
Sterilization Services Market Size (2024E)	US$ 3.93 Billion
Forecasted Market Value (2034F)	US$ 7.93 Billion
Global Market Growth Rate (2024 to 2034)	7.3% CAGR
East Asia Market Share (2024E)	13.1%
North America Market Share (2024E)	45.9%
Contract Sterilization Services Segment Value (2024E)	US$ 2.79 Billion
Key Companies Profiled	STERIS Plc; Sotera Health Company; Stryker Corporation; Advanced Sterilization Products (ASP, US); E-BEAM Services, Inc.; MMM Group; Belimed AG; Medistri SA; Noxilizer, Inc.; Cretex Companies, Inc.; Life Science Outsourcing, Inc.; Johnson & Johnson.

Which Key Sterilization Services Market Trends Should Manufacturers Leverage for High Growth?

“Stringent Safety and Quality Standards Necessitating Sterilization of Medical Equipment”

Demand for disposable, single-use medical equipment has increased over time in the healthcare sector. In their design and manufacturing processes, many companies that produce medical devices and equipment use sterilizing technologies such as ethylene oxide, steam, gamma, and X-rays.

Sterilization services are being used more frequently throughout production lines by end users like hospitals and medical device manufacturers because of regulations set forth by governments and regulatory agencies in the healthcare industry to ensure compliance with good manufacturing practices (GMP). The expansion of pharmaceutical and medical device firms in developing countries, the adoption of e-beam sterilization, the readoption of ethylene oxide sterilization, the expansion of the healthcare sector, and the outsourcing of operations to developing countries are all projected to provide market participants with high-growth opportunities.

What is Hindering Sterilization Services Market Growth?

“Inadequate Sterilization Resulting in Spread of Multi-Drug Resistant Bacteria”

Reusable medical devices include surgical forceps, endoscopes, and stethoscopes. However, there are issues with reprocessed devices' performance and safety. Reprocessing medical devices has undergone a paradigm shift, with a greater focus on the quality management systems approach that calls for manufacturers to provide validated sterilization instructions and continuous sterilization monitoring technologies by reprocessing staff to ensure adequate sterilization.

There are certain concerns surrounding the cleaning, disinfection, and sterilization of advanced medical devices. If these devices are not properly sterilized, patients may be at risk of contracting HAIs. Several outbreaks of multi-drug resistance (MDR) pathogens have occurred as a result of improper sterilization of vital medical equipment for various endoscopy procedures, including bronchoscopy, cystoscopy, and duodenoscopy. These outbreaks have had serious consequences for patients.

Country-wise Insights

There are substantial growth opportunities in developing countries such as China, Brazil, and India. India and China are home to a sizable patient pool because of their large population. Production of medical devices in the Asia Pacific region is rising. Players' present development patterns point to even more potential in the years to come. This is explained by the advancements in technology, the increasing prevalence of illnesses in this region, and the rise in surgical procedures.

What is the Demand Outlook for Sterilization Services in the United States?

“Increasing Surgical Procedures Leading to Implementation of Infection Prevention Guidelines”

Attribute	United States
Market Value (2024E)	US$ 1.6 Billion
Growth Rate (2024 to 2034)	7.3% CAGR
Projected Value (2034F)	US$ 3.25 Billion

The United States is estimated to account for 88.9% of the sterilization services market share in North America in 2024. The market in the country is growing at a significant pace due to ongoing technological advancements in the manufacturing of healthcare services. The growing number of surgical procedures is leading to the implementation of infection prevention guidelines within the healthcare system.

The market in the United States is being driven by strategies to reduce the risk of infection between patients and healthcare personnel, as a result of a large population suffering from infectious and chronic disease conditions. Furthermore, the existence of significant players like Steris Plc. has strengthened the dominance of the United States in the global market.

• The United States Food and Drug Administration (FDA) granted an emergency-use authorization for respirator decontamination, according to STERIS’s announcement from April 2020. The authorization enables health practitioners to sanitize N95 respirators on-site by installing customized STERIS V-PRO Low-Temperature Sterilization Systems.

How is the Market for Sterilization Services Faring in Japan?

“Market Benefitting from Increasing Public Awareness of Healthcare-Acquired Infections”

Attribute	Japan
Market Value (2024E)	US$ 232 Million
Growth Rate (2024 to 2034)	7.9% CAGR
Projected Value (2034F)	US$ 495 Million

Japan is set to hold 45% market share in the East Asian region in 2024. The rising rates of infectious diseases and increasing public awareness of hospital-acquired infections are responsible for the market's overall growth in Japan. The demand for healthcare supplies is growing as the number of elderly people is rising in the country.

As the elderly population is more susceptible to infections and illnesses, this factor is expected to positively influence the Japanese market. Japan is benefiting from the presence of major international businesses and a few prominent domestic companies.

Category-wise Insights

High material compatibility and cost-effectiveness of ethylene oxide sterilization techniques are driving their widespread adoption compared to radiation sterilization techniques. Strict regulatory requirements mandating the implementation of sterilization procedures and the introduction of advanced biological indicators are contributing to the expansion of the sterilization services market size.

What are the Advantages of Opting for Contract Sterilization Services?

“Adoption of Contract Sterilization Facilitating Cost Savings for Healthcare Facilities”

Attribute	Contract Sterilization Services
Segment Value (2024E)	US$ 2.79 Billion
Growth Rate (2024 to 2034)	7.7% CAGR
Projected Value (2034F)	US$ 5.84 Billion

The contract sterilization services segment is set to account for 71.1% share of the global market in 2024. Contract sterilization is the term used to describe a business's provision of a contractual service meant to sterilize a product that is subject to FDA regulation. The contract sterilization facilities run constantly, almost entirely, and at maximum capacity. Many companies offer contract steam sterilization services on-site for items such as medical equipment, diagnostics, medication delivery systems, and individual parts.

Contract sterilization management is influenced by regulatory requirements for sterile equipment certification and the medical device's adaptability to the sterilization process. Contract sterilization provides customers with services that lower their production costs, thus boosting its widespread adoption.

Which Sterilization Service Technique Has Taken Center Stage in the Global Market?

“High Level of Regulation and Safety Associated with Ethylene Oxide Sterilization”

Attribute	Ethylene Oxide Sterilization
Segment Value (2024E)	US$ 1.6 Billion
Growth Rate (2024 to 2034)	6.9% CAGR
Projected Value (2034F)	US$ 3.13 Billion

Ethylene oxide sterilization is poised to account for 40.8% market share in 2024. Manufacturers commonly use the basic ethylene oxide sterilization process to ensure the safety of medical devices. Sterilization of essential (and sometimes semi-essential) items that are heat- or moisture-sensitive and cannot be cleaned by steam sterilization is done in healthcare facilities using ethylene oxide (EO) sterilization.

Using ethylene oxide gas to sterilize medical equipment is one of the most widely used techniques. This procedure is critical for preventing infections and guaranteeing that patients receive safe surgeries and medical treatments. It is also highly regulated and safe. One benefit of ethylene oxide (EO) sterilization is that materials are sterilized without the need for excessive heat, moisture, or radiation.

Competitive Landscape

Key players in the sterilization services market are focusing on providing effective sterilization techniques in compliance with regulatory clearance procedures. In addition, market players are forming business alliances with academic institutions to provide low-cost, high-quality services under contracts.

• In October 2022, 3M Health Care's Medical Solutions Division announced that more than 2,000 peer-reviewed medical journal studies had featured their 3MTM V.A.C. Therapy, which is a negative pressure wound therapy (NPWT) technique.

Fact.MR provides detailed information about the price points of leading providers of the sterilization services positioned across the world, sales growth, production capacity, and speculative technological expansion, in this new market report.

Segmentation of Sterilization Services Market Research

• By Service Type :

  • Contract Sterilization Services
  • Validation Sterilization Services

• By Technique :

  • Steam Sterilization
  • Gamma Irradiation
  • Electron Beam Irradiation
  • X-ray Irradiation
  • Ethylene Oxide Sterilization
  • Ion Beam Treatment
  • Plasma Sterilization

• By End User :

  • Hospitals
  • Ambulatory Surgical Centers
  • Medical Device Companies
  • Pharmaceutical Companies
  • Diagnostic Laboratories
  • Others

• By Region :

  • North America
  • Western Europe
  • Eastern Europe
  • Latin America
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa