Sterilization Services Market
The sterilization services market is projected to reach USD 5.9 billion by 2030, at a CAGR of 5.5% during the forecast period. Strict mandates imposed by governments and regulatory bodies in the healthcare industry to maintain GMP compliance, an increase in the number of surgical procedures, and increased outsourcing of sterilisation services by pharmaceutical companies, hospitals, and medical device manufacturers are factors driving the growth of this market.
Sterilization Services Market Dynamics
Growth Drivers: Growing prevalence of hospital acquired infections (HAIs)
According to the World Health Organization's (WHO) report on Infection Prevention and Control in 2022, seven patients in high-income countries and approximately 15 patients in low- and middle-income countries will contract at least one healthcare-associated infection (HAI) during their hospital stay. They are nosocomial infections that arise during a patient's stay in a hospital or other healthcare facility and are not detected at the time of admission. Central line-associated bloodstream infections, surgical-site infections, catheter-associated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and Clostridium difficile infections are examples of these illnesses. The most common bacteria associated with HAIs include C. difficile, MRSA, Klebsiella, E. coli, Enterococcus, and Pseudomonas species. HAIs are frequently disseminated through the use of infected medical equipment during diagnostic and therapeutic procedures.
Growth Opportunities: Emerging-market medical device and pharmaceutical businesses are expanding.
Emerging economies such as India, China, Brazil, Russia, and countries in Latin America and Southeast Asia are expected to provide significant growth opportunities for players operating in this market. More than half of the world's population resides in India and China, making these markets home to a large patient population. Public pressure to improve the quality of hospital care, rising cost of HAIs in healthcare systems, emergence of multi-resistant microorganisms, and initiatives by government authorities are playing a significant role in the growth of the global market in these country. Over the past few years, medical device manufacturing has witnessed significant growth in the Asia-Pacific region. Current development trends among players point to even greater potential in the coming years. This can be attributed to advances in technology, increasing disease burden, and increasing number of surgeries being performed in this region.
Restraints: Concerns regarding the safety of reprocessed instruments
Some reusable medical devices include surgical forceps, endoscopes, and stethoscopes. However, there are concerns about the safety and performance of reprocessed devices. There has been a paradigm shift in the reprocessing of medical devices, with an increased emphasis on the quality management systems approach which requires manufacturer-validated sterilization instructions and continuous monitoring by reprocessing personnel to ensure the adequacy of sterilization. The FDA takes steps to reduce the risk of infection from reprocessed reusable devices by conducting pre-market and post-market information reviews of all manufacturers and types of reprocessed devices.
Challenges: Sterilization of advanced medical instruments
Some concerns relate to cleaning, disinfection and sterilization of advanced medical devices. Inadequate sterilization of these devices could put patients at risk of contracting HAIs. Additionally, with the introduction of technologically advanced instruments such as endoscopes and analyzers to the market, there is a growing need for advanced sterilizers compatible with Automated Endoscope Reprocessors (AERs) used to clean and disinfect flexible endoscopes. after each procedure. Failure to properly sterilize critical medical devices for various endoscopy procedures such as bronchoscopy, cystoscopy and duodenoscopy has led to numerous outbreaks of multiple resistance pathogens (MDR) with serious consequences for patients. Currently, reprocessing these instruments after each use is a major challenge facing healthcare providers to comply with sterilization standards.
The sterilisation services market was dominated by the ethylene oxide (EtO) sterilisation sector.
Based on the method, the market has been categorized into ethylene oxide (EtO) sterilization, gamma sterilization, electron beam (e-beam) radiation sterilization, steam sterilization, radiation irradiation X and other methods of sterilization. The ethylene oxide (EtO) sterilization segment accounted for the largest share of the global market. The high material compatibility with radiation sterilization methods and the cost effectiveness associated with the use of EtO sterilization methods are attributable to the large share of this segment.
The sterilisation validation services sector has the second biggest market share in the sterilisation services industry.
Based on type, the global market has been segmented into contract sterilization services and sterilization validation services. The sterilization validation services segment accounted for the second largest share of this market, in 2021. Growing preference for biological indicators by central sterilization services (CSSDs), stringent regulatory standards for validation of sterilization processes and the launch of advanced biological indicators are the key factors supporting the growth of sterilization validation services.
The sterilisation services market was dominated by the off-site sterilisation services sector.
By mode of delivery, the market has been segmented into offsite sterilization services and onsite sterilization services. The offsite sterilization services segment accounted for the largest share of the global market. Limited space availability in in-house sterile processing departments and cost reduction benefits are the key factors supporting the largest share of the segment.
The sector of hospitals and clinics held the second highest proportion of the sterilisation services market.
On the basis of end user, the global market has been segmented into hospitals and clinics, medical device companies, pharmaceutical and biotechnology companies and others (food and beverage industry, cosmetics industry, dietary supplement manufacturers, veterinary industry and others health care providers, such as long-term care facilities and diagnostic and imaging centers). Hospitals and clinics segment accounted for the second largest market share in 2021. The growth of this segment is mainly attributed to increase in government initiatives to reduce HAIs in hospitals, growth of hospital sector in countries emerging countries such as China, India and Brazil. due to growing awareness and increase in medical tourism.
North America accounted for the largest share of the sterilization services market in 2021
In 2021, North America accounted for the largest share of the global market. The large share of the region can be attributed to the increase in the geriatric population in the coming years, the subsequent increase in the prevalence of chronic diseases and the adoption of sterilization services due to the growing emphasis focused on healthy lifestyles and disease prevention among consumers.
Sterilization Services Market Key Players
The prominent players in This market are STERIS plc (US) Sotera Health Company (US) Stryker Corporation (US) Advanced Sterilization Products (ASP, US) E-BEAM Services, Inc. (US), MMM Group (Germany), Belimed AG (Switzerland), BGS Beta-Gamma-Service GmbH & Co. KG (Germany), Medistri SA (Switzerland), and Noxilizer, Inc. (US).
Sterilization Services Market Scope
The study categorizes the Sterilization Services Market based on method, type, mode of delivery, end user, and regional and global level.
By Method
- X-ray Irradiation
- EtO Sterilization
- Gamma Sterilization
- E-beam Sterilization
- Steam Sterilization
- Other Methods
By Type
- Sterilization Validation Services
- Contract Sterilization Services
By Mode of Delivery
- On-Site Sterilization Services
- Off-Site Sterilization Services
By End User
- Medical Device Companies
- Hospitals & Clinics
- Pharmaceutical & Biotechnology Companies
- Other End Users
By Region
- North America
- Canada
- US
- Europe
- UK
- Germany
- Italy
- France
- Switzerland
- Rest of Europe
- Spain
- Asia Pacific
- India
- China
- Southeast Asia
- Rest of APAC
- Japan
- Latin America
- Mexico
- Rest of Latin America
- Brazil
- Middle East & Africa
Recent Developments:
- In 2022, BGS Beta-Gamma-Service GmbH & Co. KG enlarged its laboratory in Wiehl to satisfy the rising demand for radiation crosslinking sterilisation services in the biotechnology, medical, and diagnostics industries.
- In 2022, Sterigenics will expand its electron beam facility in Columbia, Indiana. This facility offers critical electron beam sterilisation services to aid in the safety of medical equipment and medications.
- In 2021, STERIS purchased Cantel, a supplier of infection prevention services, which will improve STERIS' infection prevention leadership by bringing together two complementary companies.
- In 2020, STERIS expanded its Thailand operation to include X-rays to its current gamma irradiation product offering.