Sterilization Services Market

Sterilization Services Market Outlook (2023-2033)

The global revenue from the sterilization services market stands at US$ 3.4 Bn in 2022, with the global market expected to grow at a CAGR of 6.8% to reach a valuation of approximately US$ 7.1 Bn by the end of 2033.

As assessed by Persistence Market Research, contract sterilization service holds a market share of around 70.3% in 2022. Overall, sterilization services market sales account for approximately 15.2% revenue share in the global high-level disinfection services market, which was valued at around US$ 22.39 Bn in 2022.

Sales Analysis of Market from 2014 to 2022 Vs Market Outlook for 2023 to 2033

The global market recorded a historic CAGR of 6.7% in the last 8 years from 2014 to 2022.

To maintain or increase their market share, the majority of businesses are expanding the application of their existing services in underserved communities.

One of the important trends among major participants in the sterilisation services market is economic incentives in the extension of sterilisation services.

For example, Sterigenics' new facility in 2018 has developed to offer routine gamma irradiation services, which are crucial for verification, as well as lab testing services in surrounding Somercotes through its Nelson Labs business. The facility has assisted in expanding Sterigenics' overall capacity for gamma irradiation in Europe by supplementing its existing gamma facilities in Belgium and Italy.

Key sterilisation service firms have a history of investing in businesses inorganically to drive significant business growth in the sterilisation services market through various market consolidation strategies.

For instance, Sterigenics International expanded its global service capabilities in 2015 by acquiring the top sterilisation company in Latin America, Companhia Brasileira De Esterilizaço (CBE).

Sterigenics also acquired the largest supplier of cobalt-60, an essential element of the gamma sterilisation process, and an isotope that creates gamma radiation, Nordion, in 2014.

The global market is thus likely to show high growth over the coming years at a CAGR of 6.8% and reach a global market size of US$ 7.1 Bn by 2033.

How Can the Global Market Grow?

“Presence of Established Service Portfolio and Rising Adoption of Single-Use Devices”

The need for single-use, disposable medical equipment has grown over time in the healthcare sector. Many businesses that manufacture medical equipment and devices use sterilising technologies including gamma, steam, x-rays, and ethylene oxide in their design and manufacturing processes.

With an increase in the use of single-use devices, sterilisation methods for the production of medical devices have increased. These practises involve performing validation and quality checks on the packaging as well as additional revalidation using sterilisation services.

Many healthcare regulatory agencies are worried about cutting healthcare expenses by accelerating the licencing of new equipment and medications. Faster approvals will also increase demand for novel sterility evaluation methods, prompting forward-thinking market firms to invest more in cutting-edge technologies.

Recent advancements in sterilisation technologies that are applicable to healthcare facilities have followed the trend that concentrates on low temperature sterilisation systems, including shorter cycles, increased material compatibility, extended instrument capabilities, environmental friendliness, and lower prices.

Enhancements have been made to low-temperature sterilisation systems that are now on the market, and more recent technologies are inching closer to being implemented.

For the steam sterilisation procedure, new biological indicators (BIs) with quicker readout times have been developed. Such advancements are set to propel the overall growth of the global market throughout the forecast period.

Can the Sterilization Services Market Growth Be Affected in Any Way?

“Regulatory Impositions and Cost Constraints”

Traditional cleaning and disinfection techniques are still used in some healthcare facilities, particularly in MEA and Asian nations.

According to current hospital standards, less than 50% of the environmental surfaces in patient care rooms are being cleaned properly, according to research.

The contact time recommended on the label of the disinfectant product is often too long for practical implementation, which contributes to insufficient environmental surface disinfection. Such procedures hinder the development and spread of sterilising services and procedures in such settings.

When multiple healthcare service provider companies offer their services abroad, regulatory approval becomes more difficult.

Each nation might have its own regulatory bodies and procedures. Many, however, have their own approval processes and adhere to the laws of major nations like the US FDA. In such cases, one provider is prohibited from introducing new or enhanced products and services before receiving all necessary permissions.

Before commencing to provide their services, the corporations will hold off until they have secured all necessary regulatory approvals. Evidently, the cost of fragmented service distribution is so high that it will take a service provider years to obtain all necessary regulatory permits. Such circumstances impede the market expansion for sterilising services.

Country-wise Insights

Why is the U.S. Market Booming?

“Rising Disease Burden and Adoption of Infection Prevention Guidelines”

The U.S. accounted for around 92.0% market share in the North America market in 2022.

Growing number of surgical procedural volumes have given way to the adoption of infection prevention guidelines within a medical or healthcare system. With a large population base suffering from chronic and infectious disease conditions, the market within the country observes a propulsion brought on by strategies to minimize the risk of infection from healthcare personnel to patient or from patient to the personnel. Moreover, the presence of major players, such as Steris Plc., have further promoted the stance of the U.S. with a large market share, within the global market.

Will Germany Be a Lucrative Market for Sterilization Services?

“High Incidence of Hospital Acquired Infections”

Germany held around 34.7% market share of the Europe market in 2022. The government has launched a number of programmes nationwide to combat hospital-acquired infections. The key driver of the German sterilisation systems market is the high incidence of surgical site infections and illnesses brought on by medical equipment. Hospital acquired diseases affect many people annually, increasing the demand for products that can prevent the spread of such infections.

This will further increase the need for sterilising equipment, accelerating the development of the German market under study.

How is Japan Emerging as a Prominent Market?

“Growing Awareness of Infection Prevention, and Rising Geriatric Population”

Japan held a market share of about 5.9% of the global market in 2022. The overall expansion of the market in Japan is being attributed to rising cases of communicable diseases as well as heightened public awareness of hospital-acquired infections.

Due to an increase in the number of elderly people, healthcare supply demand is also rising. The elderly population is more vulnerable to infections and illnesses; hence, this aspect is anticipated to have a beneficial effect on the market in Japan. Japan is a developed country that engages in commerce with other developed countries. The majority of the major international businesses are thus present in the Japan market, which is a benefit for it.

Additionally, a few domestic Japanese businesses are active on the market. As a result, the Japanese market for sterilisation systems is now competitive due to the existence of several international players.

Category-wise Insights

Which Service is Driving Demand within the Global Market?

“Reduction of Production Costs”

The contract sterilization service segment held around 70.3% of the total market in 2022. When a business provides a contractual service intended to sterilise a product subject to FDA regulation, this is referred to as contract sterilisation. The contract sterilisation facilities operate continuously, with little downtime, and to full capacity. On-site contract steam sterilisation services are provided by a number of businesses for products such medical equipment, diagnostics, drug delivery systems, and individual components.

Regulatory requirements for the equipment to be certified sterile and the adaptability of the medical device with the sterilisation process influence contract sterilisation management. Contract sterilization offers clients with services that reduce their production costs, thus propelling the value of the segment within the global market.

Which Technique for Sterilization Services is Largely of Focus within the Global Market?

“High Adoption of Ethylene Oxide for Routine Sterilization in Medical Facilities”

Ethylene oxide sterilization held a share of about 41.3% in 2022. To make medical devices safe, manufacturers frequently employ the fundamental sterilization method of ethylene oxide. In healthcare facilities, ethylene oxide (EO) sterilization is used to sterilize vital (and occasionally semi-vital) items that are heat- or moisture-sensitive and cannot be disinfected by steam sterilization.

One of the most popular methods for sterilizing medical equipment is the use of ethylene oxide gas. This technique is extremely safe, strictly regulated, and important for preventing infections and ensuring that patients receive safe surgeries and medical treatments.

The advantages of ethylene oxide sterilization include the fact that no extreme heat, moisture, or radiation is used to sterilize materials when using EO. As a result, EO can sterilize a wide range of materials, especially polymeric components frequently found in medical devices.

Which End User Provides the Global Market With a Large Share?

“Presence of Established Guidelines and Adoption of Good Manufacturing Practices”

The medical device companies segment held a share of about 34.7% in 2022 globally. Regulatory requirements for the equipment to be designated sterile and the interoperability of the medical equipment with the sterilizing technique impact contract sterilizing management.

Due to regulations set forth by governments and regulatory agencies in the healthcare business to ensure compliance with good manufacturing practices (GMP), end users such as hospitals and medical device manufacturers are increasingly using sterilization services throughout their production lines.

In addition, the expansion of pharmaceutical and medical device firms in emerging economies, the expansion of E-beam sterilization, the return of ethylene oxide sterilization, the expansion of the healthcare sector, and the outsourcing of operations to developing nations are anticipated to present market participants with high-growth possibilities throughout the projection period.

Competition Landscape

The timing of the introduction of new services on the market is crucial for staying competitive. The ability of businesses to offer infection prevention sterilisation services promptly and complete the regulatory clearance processes is essential for them to achieve market success.

Moreover, competitors are expanding business partnerships based on contract-based services between service providers and academic institutions for low-cost, high-quality services.

Some key instances of development include:

• According to STERIS plc's announcement in April 2020, the US Food and Drug Administration (FDA) approved an Emergency Use Authorization for respirator decontamination. The authorization allows health practitioners to sanitize N95 Respirators on-site by installing customised STERIS V-PRO® Low Temperature Sterilization Systems.
• A subsidiary of Stryker Corporation acquired TSO3, a pioneer in low-temperature sterilising technology for medical devices, in November 2019.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies in the sterilization services market, which are available in the full report.

Sterilization Services Market Report Scope

Key Segments Covered in Global Sterilization Services Market Research

Service:

• Contract Sterilization Service
• Validation Sterilization Services

Technique:

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

End User:

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

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

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