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시장보고서
상품코드
1831894
내시경 리프로세싱 시장 보고서 : 제품, 프로세스, 최종사용자, 지역별(2025-2033년)Endoscope Reprocessing Market Report by Product, Process, End User, and Region 2025-2033 |
세계의 내시경 리프로세싱 시장 규모는 2024년에 23억 달러에 달했습니다. 향후 IMARC Group은 시장이 2033년까지 42억 달러에 달하며, 2025-2033년에 6.21%의 성장률(CAGR)을 보일 것으로 예측하고 있습니다. 이 시장은 주로 최소침습 수술에 대한 수요 증가와 감염 관리에 대한 엄격한 규제 시행에 의해 주도되고 있습니다. 또한 재처리 장비의 급속한 기술 발전, 환자 안전에 대한 인식 증가, 내시경 수술의 급격한 증가는 시장 성장에 더욱 기여하고 있습니다.
최소침습 수술에 대한 수요 증가
최소침습 수술에 대한 선호도가 높아지면서 내시경 재처리 시장 성장의 주요 촉진요인으로 작용하고 있습니다. 내시경을 이용한 이러한 수술은 기존 수술에 비해 회복 시간 단축, 감염 위험 감소, 수술 후 통증 감소 등의 장점이 있습니다. National Center for BIoTechnology에 게재된 데이터에 따르면 미국에서는 연간 약 1,770만 건의 소화관(GI) 내시경 수술이 이루어지고 있으며, 이는 전체 내시경 수술의 68%를 차지합니다. GI 내시경 시술 후 복합 감염률은 0.2%이며, 특정 시술의 경우 이보다 더 높은 것으로 나타났습니다. ERCP에서는 0.8%, ERCP를 제외한 상부위장관내시경에서는 0.123%, 하부위장관내시경에서는 0.073%였습니다. 그 결과, 내시경 시술 빈도가 증가함에 따라 내시경의 안전과 수명을 보장하기 위한 효과적인 재처리 솔루션에 대한 수요가 증가하고 있습니다.
엄격한 감염 관리 규정 시행
업계 보고에 따르면 연성 내시경의 재처리 실패는 병원내 감염(HAI)과 관련이 있으며, 환자와 의료 시스템에 큰 부담을 주고 있습니다. HAI는 환자에게 영향을 미치는 부작용 중 가장 많이 보고되는 부작용으로, 유럽 전체에서 6.5%의 유병률을 보이고 있습니다. 수술 부위 감염은 전체 HAI의 18.3%를 차지하며, 환자의 삶의 질에 악영향을 미치고 이환율과 사망률을 증가시킵니다. 또한 의료 시스템에 큰 경제적 부담을 주는 요인이 되기도 합니다. 독일에서 수술 부위 감염은 평균 17.9일의 입원 기간 연장과 환자 1인당 22,905 유로의 추가 의료비 지출로 이어집니다. 이에 따라 세계 각국 정부와 의료 기관은 병원내 감염(HAI)을 예방하기 위해 엄격한 규제를 시행하고 있습니다. 이러한 규정을 준수하고 처벌을 피하기 위해 의료 기관은 첨단 내시경 재처리 시스템에 투자하고 있습니다. 이를 통해 내시경을 철저히 세척, 소독, 멸균하여 HAI의 위험을 줄이고 환자의 안전을 향상시킵니다.
재처리 장비의 기술적 진보
기술의 발전은 내시경 재처리 시장의 성장을 크게 촉진하고 있습니다. 자동 재처리 장치, 강화된 소독제, 정교한 추적 시스템 등의 기술 혁신으로 재처리 공정의 효율성과 신뢰성이 향상되었습니다. 이러한 기술은 내시경이 항상 높은 수준의 세척을 보장하고, 인적 오류의 위험을 줄이며, 의료시설의 워크플로우를 간소화하기 위해 내시경 재처리 솔루션의 채택과 확대에 필수적인 요소로 작용하고 있습니다. 예를 들어 2023년 1월, 유연한 로봇기구의 선도적 개발 기업인 Agilis Robotics는 자체 개발한 내시경 수술용 로봇의 두 번째 동물실험을 완료했습니다. 그 결과, 로봇 시스템의 유효성, 정확성, 안전성 측면에서 유망 결과를 보여주었습니다. 그 결과 내시경 수술에 로봇공학의 통합이 진행됨에 따라 수술 건수가 증가하여 시장 성장의 원동력이 될 것으로 기대됩니다.
The global endoscope reprocessing market size reached USD 2.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 4.2 Billion by 2033, exhibiting a growth rate (CAGR) of 6.21% during 2025-2033. The market is primarily being driven by the rising demand for minimally invasive surgeries, and the implementation of stringent regulations on infection control. Additionally, rapid technological advancements in reprocessing equipment, growing awareness about patient safety, and the surging prevalence of endoscopy procedures are further contributing to the market growth.
Increasing Demand for Minimally Invasive Surgeries
The rising preference for minimally invasive surgeries is acting as a major driver for the endoscope reprocessing market growth. These procedures, which use endoscopes, offer benefits such as reduced recovery time, lower risk of infection, and less postoperative pain compared to traditional surgeries. According to the data published on National Center for Biotechnology, approximately 17.7 million gastrointestinal (GI) endoscopic procedures are performed annually in the United States, accounting for 68% of all endoscopic procedures. The composite infection rate following GI endoscopic procedures was 0.2%, with higher rates for specific procedures: 0.8% for ERCP, 0.123% for non-ERCP upper GI endoscopies, and 0.073% for lower GI endoscopies. As a result, the frequency of endoscopic procedures is increasing, leading to a higher demand for effective reprocessing solutions to ensure the safety and longevity of endoscopes.
Implementation of Stringent Infection Control Regulations
As per industry reports, failures in reprocessing flexible endoscopes are associated with hospital-acquired infections (HAIs), which place a significant burden on patients and healthcare systems. HAIs are the most reported adverse events affecting patients, with a prevalence of 6.5% across Europe. Surgical site infections, comprising 18.3% of all HAIs, negatively affect patient quality of life and increase morbidity and mortality rates. They also contribute to a significant financial burden on healthcare systems. In Germany, surgical site infections can lead to an average hospital stay extension of 17.9 days and an additional healthcare cost of €22,905 per patient. As a result, governments and healthcare organizations worldwide are implementing stringent regulations to prevent hospital-acquired infections (HAIs). To comply with these regulations and avoid penalties, healthcare facilities are investing in advanced endoscope reprocessing systems. This ensures that endoscopes are thoroughly cleaned, disinfected, and sterilized, thereby reducing the risk of HAIs and improving patient safety.
Technological Advancements in Reprocessing Equipment
Advancements in technologies are significantly driving the endoscope reprocessing market growth. Innovations, such as automated reprocessing machines, enhanced disinfectants, and sophisticated tracking systems, have improved the efficiency and reliability of the reprocessing process. These technologies ensure that endoscopes are consistently cleaned to high standards, reduce the risk of human error, and streamline the workflow in healthcare facilities, making them a critical factor in the adoption and expansion of endoscope reprocessing solutions. For instance, in January 2023, Agilis Robotics, a leading developer of flexible robotic instruments, completed its second round of live animal testing with its proprietary robot for endoscopic surgery. The results demonstrated promising outcomes in terms of efficacy, accuracy, and safety of the robotic system. Consequently, the increasing integration of robotics in endoscopic surgery is expected to boost the number of procedures performed, thereby driving market growth.
High-level disinfectants and test strips account for the majority of the market share
High-level disinfectants and test strips are enhancing the endoscope reprocessing market value due to their effectiveness and efficiency in ensuring patient safety. These disinfectants are specifically designed to eliminate a broad spectrum of pathogens, including highly resistant organisms such as Mycobacterium tuberculosis and Clostridium difficile. Their fast-acting nature and compatibility with automated reprocessors make them a preferred choice in busy healthcare settings. Test strips play a crucial role in validating the efficacy of the disinfection process, providing immediate confirmation that the minimum recommended concentration of the disinfectant is met, thus ensuring compliance with safety standards and reducing the risk of infections. For instance, RAPICIDE high-level disinfectant is a glutaraldehyde-based, fast-acting, reusable solution for flexible endoscopes in automated reprocessors, requiring no mixing or activation. It reprocesses heat-sensitive, semi-critical medical devices in systems like the DSD-201, inactivating pathogens such as TB, C-diff, and CRE with a 5-minute contact time at 95°F (35°C). The disinfectant enhances efficiency with only two rinses needed. RAPICIDE(TM) Test Strips confirm the minimum recommended concentration of glutaraldehyde, requiring a 3-second dip and a 75-second read time. This example illustrates how specific products drive the demand for high-level disinfectants and test strips in the market, thereby increasing the endoscope reprocessing market value.
Automated cleaning holds the largest share of the industry
Automated cleaning dominates the endoscope reprocessing market due to its ability to ensure consistent and high-level disinfection, reducing the risk of human error associated with manual cleaning. Automated systems, such as automated endoscope reprocessors (AERs), provide standardized, efficient, and effective cleaning and disinfecting processes, which are critical for patient safety. These systems enhance workflow efficiency within healthcare facilities by minimizing both the time and labor involved in reprocessing endoscopes. Additionally, automated cleaning systems are specifically designed to accommodate the intricate designs of modern endoscopes, ensuring thorough decontamination and adherence to stringent regulatory standards. As part of the endoscope reprocessing market forecast, it is expected that the growing adoption of automated cleaning solutions will continue to shape the market, driven by advancements in technology and the increasing demand for reliable and efficient reprocessing methods.
For instance, in March 2023, PENTAX Medical, a division of the HOYA Group, was awarded the CE mark for its innovative automated pre-cleaning solution, the AquaTYPHOON. Developed in collaboration with PlasmaBiotics, this device offers a robust alternative to the traditional manual pre-cleaning step in endoscope reprocessing, effectively addressing the hygiene challenges healthcare providers encounter in daily clinical practice.
Hospitals and clinics represent the leading market segment
The endoscope reprocessing market research report highlights that hospitals and clinics are the dominant segment in the market, attributed to the large volume of endoscopic procedures conducted within these facilities. According to industry reports, the number of bariatric surgery procedures in Ireland reached 219 in 2023, significantly surpassing the revised target of 200 set by the Health Service Executive (HSE). This marked a substantial increase from the 109 procedures performed in 2022. These surgeries were conducted at three HSE sites: St Vincent's University Hospital in Dublin, St Michael's Hospital in Dun Laoghaire, and University Hospital Galway. Additionally, University Hospital Galway alone performed 49 surgeries in 2023, up from 19 in the previous year.
These facilities require stringent infection control measures to prevent hospital-acquired infections, making effective reprocessing essential. The increasing prevalence of minimally invasive surgeries, which frequently utilize endoscopes, further drives demand. Additionally, regulatory requirements and guidelines mandate rigorous reprocessing protocols to ensure patient safety. The combination of high procedural volume, regulatory compliance, and the critical need for infection prevention establishes hospitals and clinics as the primary market segment for endoscope reprocessing.
North America leads the market, accounting for the largest endoscope reprocessing market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for endoscope reprocessing.
North America's dominance in the endoscope reprocessing market can be attributed to its advanced healthcare infrastructure, increasing prevalence of chronic diseases, stringent regulatory standards, and high frequency of endoscopic procedures. For example, a 2024 article by the American Society of Anesthesiologists indicates that approximately 6.1 million upper endoscopies are performed annually in the U.S. Furthermore, the CDC reports that around 129 million Americans suffer from at least one major chronic condition, significantly driving the need for endoscope reprocessing solutions. As endoscopic procedures become more common for both diagnostic and therapeutic purposes, the endoscope reprocessing market outlook reflects a growing demand for effective reprocessing technologies. The region's healthcare systems, equipped with sophisticated technologies and protocols, ensure effective endoscope reprocessing to prevent infections. Additionally, heightened awareness of infection control among healthcare providers and patients, along with continuous technological advancements and a focus on patient safety, further solidify North America's leading position in the market.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)