Market Drivers of the Sterilization Technologies Market
Surgical interventions are crucial for addressing a variety of health issues, including injuries, cancers, infections, and cardiovascular ailments. To prevent potentially fatal infections, it is imperative that most medical and surgical instruments used in healthcare settings are properly sterilized. According to a 2020 publication by John Wiley & Sons, Inc., more than 313 million surgical procedures are performed globally each year. The rising incidence of surgeries and hospital-acquired infections highlights the critical role of sterilization services within the healthcare sector. Common surgical operations include cesarean sections, orthopedic surgeries (such as hip and knee replacements), neurosurgeries, and intra-abdominal surgeries. Additionally, an increase in road accidents and congenital disabilities has contributed to a higher volume of surgeries performed worldwide. The CDC reports that approximately 120,000 newborns in the United States are born with congenital disabilities annually.
The American Society for Aesthetic Plastic Surgery noted that around 15.6 million cosmetic surgeries and minimally invasive procedures were conducted in 2020. Furthermore, the American Society of Plastic Surgeons documented a remarkable 131% increase in cosmetic procedures from 2000 to 2020. In 2020, there was a 22% rise in total surgical procedures, while minimally invasive procedures surged by 174%. Medical devices that come into contact with bodily tissues or fluids, along with surgical instruments, biopsy forceps, and implanted devices, are deemed critical for sterilization. These items must be sterile upon use, as microbial contamination can lead to disease transmission to patients. Consequently, the growing number of surgical procedures is a significant factor driving the expansion of the sterilization technologies market. Moreover, ongoing advancements in sterilization technology are expected to introduce new trends in the market in the years ahead.
Restraints of the Sterilization Technologies Market
The sterilization technologies market has been experiencing rapid growth, particularly due to the increasing utilization of these technologies, especially chemical methods, in medical device and pharmaceutical manufacturing. Ethylene oxide (EtO) sterilization is a prevalent method in the medical device sector. The FDA reports that over 20 billion medical devices are sold annually in the United States, with approximately 50% of these devices being sterilized using EtO. However, growing concerns regarding the toxicity of EtO residues have led the Environmental Protection Agency to impose restrictions on its usage. Additionally, the closure of several sterilization facilities has created challenges for medical device manufacturers. For example, on January 21, 2020, Medline Industries temporarily shut down its Waukegan facility, which was responsible for manufacturing and decontaminating 16,000 custom surgical kits daily, to comply with state EtO emission regulations. Similarly, on June 2, 2021, Steril Milano S.R.L. in Italy announced the closure of its EtO sterilization facilities in Monza and Reggiolo due to improper sterilization practices that raised sterility concerns.
On the same date, Georgia State Authorities accused Becton Dickinson and Company of releasing excessive EtO, resulting in the closure of its medical device sterilization facility in Covington. This shutdown negatively impacted the supply of essential medical devices, including surgical kits, feeding tubes, and various types of catheters. The Lake County Health Department announced that the BD sterilization facility had been closed since December 13, 2019. Thus, the closure of medical device sterilization facilities poses a significant hindrance to the growth of the sterilization technologies market.
Sterilization Technologies Market: Segmental Overview
The sterilization technologies market is categorized by method into ethylene oxide sterilization, chlorine dioxide sterilization, gamma ray sterilization, electron beam sterilization, steam sterilization, and others. In 2022, the ethylene oxide sterilization segment held the largest market share, while the chlorine dioxide sterilization segment is expected to exhibit the highest CAGR from 2022 to 2030.
By end user, the sterilization technologies market is divided into medical device companies, pharmaceutical and biotechnology firms, hospitals and clinics, laboratories, and others. The medical device companies segment represented the largest market share in 2022 and is projected to achieve the highest CAGR during the forecast period.
Sterilization Technologies Market: Geographical Overview
The Asia Pacific region is anticipated to experience the highest CAGR from 2022 to 2030. Countries such as India and China present significant opportunities for the growth of the sterilization technologies market. In 2022, North America held the largest market share, driven by an increase in hospital-acquired infections (HAIs) due to contaminated instruments and insufficient preventive measures. According to the CDC, in 2022, approximately 1 in 31 patients in American hospitals and 1 in 43 nursing home residents contracted at least one HAI daily. The CDC estimates that HAIs result in over 1.7 million infections and approximately 99,000 deaths annually in the United States, underscoring the urgent need for enhanced patient care practices in healthcare facilities.
The demand for sterilization products is significantly increasing across the United States. In response to heightened awareness regarding sterilization, various market leaders are launching innovative products. For instance, in April 2020, Advanced Sterilization Products (US) received FDA Emergency Use Authorization (EUA) for its STERRAD sterilizers, which enable healthcare providers to decontaminate N95 respirators using STERRAD Sterilization Cycles in hospital environments.
Conclusion
Key sources referenced in the preparation of this report on the sterilization technologies market include the World Bank Data, National Health Service (NHS), FDA (Food and Drug Administration), EMA (European Medicines Agency), and WHO (World Health Organization).