The global Sterilisation services market is expected to develop at a 6.5% CAGR from 2024 to 2031, reaching USD 4.8 billion by 2031.
North America dominates the market, with YY% of the global share. Key metrics include rising demand for sterilisation in healthcare facilities, a thriving medical device industry, and tight infection control legislation.
The Sterilisation services market is steadily growing, owing to reasons such as the rising prevalence of hospital-acquired infections (HAIs), increased surgical operations, and the expanding pharmaceutical and biotechnology sectors. The market is characterised by ongoing technological improvements in sterilisation technologies, as well as increased outsourcing of sterilisation services by healthcare facilities and medical device makers.
Market Trend: Adoption of Advanced Sterilization Technologies
Growing shift towards more efficient, eco-friendly, and versatile sterilization methods. The sterilisation services industry is seeing a considerable increase in the adoption of advanced sterilisation technology. Traditional technologies such as ethylene oxide (EtO) sterilisation are giving way to more sophisticated, environmentally friendly, and effective procedures such as hydrogen peroxide gas plasma and nitrogen dioxide sterilisation. These modern technologies have benefits such as shorter cycle times, lower temperature needs, and decreased environmental effects. For example, the use of low-temperature hydrogen peroxide gas plasma sterilisation is growing, particularly for heat-sensitive medical devices.
Companies such as STERIS and Sterigenics are investing in advanced technologies to address the changing needs of the healthcare industry. This tendency is especially noteworthy given the increased regulatory scrutiny of traditional sterilisation technologies and growing environmental concerns. The use of these advanced technologies is projected to propel market growth and innovation in the future years.
Market driver: Increasing surgical procedures and medical device production
Growing number of surgical interventions and expanding medical device industry driving demand for sterilization services. The growing number of surgical procedures worldwide, combined with a developing medical device sector, is a major driver of the sterilisation services market. The World Health Organisation estimates that more than 230 million surgical procedures are conducted globally each year. To avoid surgical site infections, strict sterilisation techniques are required due to the high volume of surgeries.
Furthermore, the worldwide medical device industry is expanding rapidly, with an increasing number of complicated and delicate pieces of equipment that necessitate specialised sterilisation. The COVID-19 pandemic has advanced this tendency, raising infection control awareness and increasing medical supply production. Contract sterilisation service providers are in high demand as medical device makers and healthcare facilities look to outsource their sterilisation needs to ensure regulatory compliance and focus on their core competencies. This driver is especially strong in emerging markets, where healthcare infrastructure is quickly expanding.
Market Restraint: Environmental and Safety Concerns
Regulatory challenges and environmental issues associated with certain sterilization methods are impacting market growth. Despite rising demand for sterilisation services, the market faces hurdles due to environmental and safety concerns about particular sterilisation procedures. While frequently utilised, ethylene oxide (EtO) sterilisation has come under fire for its potential environmental and health consequences.
Regulatory agencies such as the United States Environmental Protection Agency (EPA) have enforced stronger controls on EtO emissions, forcing the closure of certain sterilisation operations and raising running costs for others. This has caused market uncertainty and prompted corporations to invest in alternate sterilisation technologies. Concerns concerning worker safety when exposed to sterilisation chemicals, as well as the possibility of residuals on medical devices, represent additional obstacles. These factors can raise prices for sterilisation service providers and limit market expansion in some places. Overcoming these obstacles by developing safer, more environmentally friendly sterilisation technologies and procedures is critical for long-term industry success.
Ethylene Oxide Sterilization
Ethylene Oxide (EtO) sterilization dominates the market due to its versatility in sterilising a wide range of medical devices and its effectiveness against various microorganisms.
The Ethylene Oxide Sterilisation category has the biggest market share in the Sterilisation Services business. This dominance stems principally from EtO's ability to sterilise a wide range of medical instruments, particularly those sensitive to heat and moisture. EtO sterilisation is very successful for complex devices with lumens or elaborate designs, which are difficult to sterilise using other procedures.
Recent advances in EtO sterilisation have centred on increasing safety and minimising environmental effects. To address environmental concerns, some companies have created new EtO sterilisation systems that incorporate advanced emission control technologies. In addition, there is continuing research into optimising EtO sterilisation methods in order to minimise cycle durations and increase efficiency.
The ethylene oxide Sterilisation segment represents around YY% of the global Sterilisation services market. Medical equipment manufacturers are the most frequent customers of EtO sterilisation services, followed by hospitals and pharmaceutical industries. The market for EtO sterilisation services is expected to rise at a 5.8% CAGR between 2024 and 2031, driven by increased manufacture of complicated medical devices and the expansion of healthcare institutions in emerging regions.
Dominating Region: North America
North America dominates the worldwide Sterilisation services market thanks to its advanced healthcare infrastructure, strong regulatory standards, and a big medical device manufacturing industry.
Several factors contribute to North America's dominance in the Sterilisation services market, including its well-established healthcare system, high healthcare expenditure, and stringent regulatory environment governing medical device sterilisation and infection control. The United States, in particular, is a significant contributor to the region's market share for reasons such as the presence of top sterilisation service providers, a thriving medical device industry, and growing awareness of healthcare-related infections.
The region's leadership in technological innovation, as well as its early adoption of advanced sterilisation methods, have helped it dominate the market. Furthermore, the growing tendency of outsourcing sterilisation services by healthcare facilities and medical device makers has accelerated market expansion in North America.
Recent news illustrates the ongoing innovation in the North American sterilisation services business. For example, some corporations have invested in expanding sterilisation facilities and using innovative technologies to accommodate rising demand while also addressing environmental problems connected with traditional sterilisation procedures.
Key statistics show that North America accounts for roughly 35% of the worldwide Sterilisation services industry. Canada is the region's second-largest market, after the US. North America's market is expected to increase at a CAGR of 6.2% between 2024 and 2031, maintaining its worldwide leadership position.
The Sterilisation services market is characterised by the presence of a number of large, well-established competitors as well as regional service providers. Key participants include STERIS plc, Sterigenics International LLC (Sotera Health), Stryker Corporation, and Getinge AB. These businesses compete based on their technological capabilities, service quality, regulatory compliance, and geographic reach.
Emerging developments in the competitive landscape include a focus on developing more environmentally friendly sterilisation methods and broadening service offerings to include validation and consultancy. There is also an increased interest in using Industry 4.0 technologies such as IoT and AI to improve sterilisation process monitoring and control.
Financially, organisations with diversified sterilisation method portfolios and good ties with medical equipment makers have experienced consistent growth. Many companies are increasing their presence in emerging regions and investing in new facilities to fulfil rising demand.
The competitive landscape's future outlook remains dynamic, with the possibility of market consolidation as larger corporations purchase smaller, specialised sterilisation service providers to expand their technology capabilities and geographic reach. Partnerships between sterilisation service providers and medical device makers are increasingly growing, with the goal of developing customised sterilisation solutions for complex devices.
The Sterilisation services market is at a crossroads, attempting to balance rising sterilisation demand with increased environmental and safety concerns. As an analyst, I expect the market will shift significantly towards more sustainable and efficient sterilisation technologies in the next few years.
A unique trend to keep an eye on is the development of "green sterilisation" technologies that provide great efficacy while minimising environmental damage. This could involve innovative techniques such as supercritical CO2 sterilisation or the use of peracetic acid vapour. Furthermore, using blockchain technology for improved traceability and quality assurance in the sterilisation process has the potential to transform the sector by providing new levels of transparency and reliability in sterilisation services.
STERIS plc
Sterigenics International LLC (Sotera Health)
Stryker Corporation
Getinge AB
Advanced Sterilization Products (Fortive Corporation)
Cantel Medical Corp.
MATACHANA GROUP
Belimed AG (Metall Zug Group)
E-BEAM Services, Inc.
Sterile Technologies Inc. (STI)
September 2023: STERIS plc announced the addition of a new facility with sophisticated emission control technology to its ethylene oxide sterilisation capacity in Europe.
In July 2023, Sterigenics International LLC released a new X-ray sterilisation service, providing an alternative to standard gamma irradiation for medical equipment sterilisation.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope and Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking—Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies List by Country) (Premium)
5. COMPANY PROFILES
5.1. STERIS plc
5.2. Sterigenics International LLC (Sotera Health)
5.3. Stryker Corporation
5.4. Getinge AB
5.5. Advanced Sterilization Products (Fortive Corporation)
5.6. Cantel Medical Corp.
5.7. MATACHANA GROUP
5.8. Belimed AG (Metall Zug Group)
5.9. E-BEAM Services, Inc.
5.10. Sterile Technologies Inc. (STI)
5.11. Company name 11
5.12. Company name 12 (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Adoption of Advanced Sterilization Technologies
6.1.2. Green Sterilization Methods
6.1.3. Blockchain Integration for Traceability
6.2. Market Drivers
6.2.1. Increasing Surgical Procedures and Medical Device Production
6.2.2. Growing Awareness of Healthcare-Associated Infections
6.2.3. Stringent Regulatory Standards
6.3. Market Restraints
6.3.1. Environmental and Safety Concerns
6.3.2. High Initial Investment Costs
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY METHOD (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
7.1. Ethylene Oxide Sterilization
7.1.1. Traditional EtO Sterilization
7.1.2. Advanced EtO Systems with Emission Control
7.2. Gamma Sterilization
7.2.1. Cobalt-60 Irradiation
7.2.2. Other Gamma Sources
7.3. E-beam Sterilization
7.3.1. Low Energy E-Beam
7.3.2. High Energy E-Beam
7.4. Steam Sterilization
7.4.1. Gravity Displacement Autoclaves
7.4.2. Pre-vacuum autoclaves
7.5. Others
7.5.1. Hydrogen Peroxide Gas Plasma
7.5.2. Nitrogen Dioxide Sterilization
8. BY END-USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
8.1. Hospitals & Clinics
8.1.1. In-house Sterilization Departments
8.1.2. Outsourced Sterilization Services
8.2. Medical Device Companies
8.2.1. Large Medical Device Manufacturers
8.2.2. Small and Medium-sized Medical Device Companies
8.3. Pharmaceutical & Biotechnology Companies
8.3.1. Drug Manufacturing Facilities
8.3.2. Research Laboratories
8.4. Others
8.4.1. Food & Beverage Industry
8.4.2. Cosmetics Industry
9. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. North America
9.1.1. United States
9.1.2. Canada
9.1.3. Mexico
9.2. South America
9.2.1. Brazil
9.2.2. Argentina
9.2.3. Rest of South America
9.3. Europe
9.3.1. Germany
9.3.2. United Kingdom
9.3.3. France
9.3.4. Italy
9.3.5. Spain
9.3.6. Russia
9.3.7. Rest of Europe
9.4. Asia-Pacific
9.4.1. China
9.4.2. Japan
9.4.3. India
9.4.4. Australia
9.4.5. South Korea
9.4.6. Rest of Asia-Pacific
9.5. Middle-East
9.5.1. UAE
9.5.2. Saudi Arabia
9.5.3. Turkey
9.5.4. Rest of Middle East
9.6. Africa
9.6.1. South Africa
9.6.2. Egypt
9.6.3. Rest of Africa
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%, YOY GROWTH)--2020-2031.
By Method:
Ethylene Oxide Sterilization
Gamma Sterilization
E-beam Sterilization
Steam Sterilization
Others
By End-User:
Hospitals & Clinics
Medical Device Companies
Pharmaceutical & Biotechnology Companies
Others
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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