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市场调查报告书
商品编码
1831894
2025-2033年内视镜再处理市场报告(依产品、製程、最终用户及地区)Endoscope Reprocessing Market Report by Product, Process, End User, and Region 2025-2033 |
2024年,全球内视镜后处理市场规模达23亿美元。展望未来, IMARC Group预计到2033年,该市场规模将达到42亿美元,2025-2033年期间的复合年增长率(CAGR)为6.21%。市场成长主要受微创手术需求的不断增长以及严格的感染控制法规的实施所推动。此外,后处理设备的快速技术进步、患者安全意识的不断增强以及内视镜检查的普及率的飙升也进一步促进了市场的成长。
微创手术需求不断成长
人们对微创手术的日益青睐是内视镜再处理市场成长的主要驱动力。与传统手术相比,这些使用内视镜的手术具有恢復时间短、感染风险低、术后疼痛少等优点。根据美国国家生物技术中心发布的资料,美国每年约进行 1,770 万例胃肠道 (GI) 内视镜检查,占所有内视镜检查的 68%。胃肠道内视镜检查后的综合感染率为 0.2%,特定手术的感染率较高:ERCP 为 0.8%,非 ERCP 上消化道内视镜检查为 0.123%,下消化道内视镜检查为 0.073%。因此,内视镜检查的频率正在增加,对有效的再处理解决方案的需求也随之增加,以确保内视镜的安全性和使用寿命。
实施严格的感染控制法规
根据行业报告,柔性内视镜再处理失败与医院获得性感染 (HAI) 有关,这给患者和医疗保健系统带来了沉重的负担。 HAI 是通报最多的病患不良事件,在欧洲的盛行率为 6.5%。手术部位感染占所有 HAI 的 18.3%,会对患者的生活品质产生负面影响,并增加发病率和死亡率。此外,手术部位感染也会给医疗保健系统带来沉重的财务负担。在德国,手术部位感染平均会导致住院时间延长 17.9 天,每位患者的医疗费用增加 22,905 欧元。因此,世界各地的政府和医疗保健组织都在实施严格的法规,以预防医院获得性感染 (HAI)。为了遵守这些法规并避免受到处罚,医疗机构正在投资先进的内视镜再处理系统。这可确保内视镜已彻底清洁、消毒和灭菌,从而降低 HAI 风险并提高病患安全性。
后处理设备的技术进步
技术进步极大地推动了内视镜再处理市场的成长。自动化再处理机、增强型消毒剂和先进的追踪系统等创新技术提高了再处理流程的效率和可靠性。这些技术确保内视镜始终保持高标准清洁,降低人为失误风险,并简化医疗机构的工作流程,使其成为内视镜再处理解决方案推广和应用的关键因素。例如,2023年1月,领先的柔性机器人器械开发商Agilis Robotics利用其专有的内视镜手术机器人完成了第二轮活体动物测试。测试结果显示,该机器人系统在功效、准确性和安全性方面均表现出色。因此,机器人技术在内视镜手术中的日益普及预计将增加手术数量,从而推动市场成长。
高水平消毒剂和试纸占大部分市场份额
高效消毒剂和试纸因其在保障病人安全方面的有效性和效率,正在提升内视镜再处理市场的价值。这些消毒剂专为杀死多种病原体而设计,包括结核分枝桿菌和艰难梭菌等高抗药性病原体。其快速起效的特性以及与自动再处理机的兼容性,使其成为繁忙医疗环境中的首选。试纸在验证消毒过程的有效性方面发挥着至关重要的作用,可立即确认消毒剂的最低建议浓度已达到,从而确保符合安全标准并降低感染风险。例如,RAPICIDE 高效能消毒剂是一种基于戊二醛的快速起效、可重复使用的溶液,适用于自动再处理机中的柔性内视镜,无需混合或活化。它可在DSD-201等系统中对热敏感、半关键医疗器材进行再处理,在95°F(35°C)的温度下,只需5分钟的接触时间即可灭活结核菌、艰难梭菌和抗药性肠球菌(CRE)等病原体。此消毒剂只需冲洗两次即可提高消毒效率。 RAPICIDE™ 试纸可确认戊二醛的最低建议浓度,只需浸泡3秒,读取时间为75秒。此范例说明了特定产品如何推动市场对高水准消毒剂和试纸的需求,从而提升内视镜再处理的市场价值。
自动化清洁占据产业最大份额
自动化清洁技术在内视镜再处理市场占据主导地位,因为它能够确保一致且高水准的消毒,从而降低手动清洁相关的人为错误风险。自动化系统,例如自动内视镜再处理器 (AER),提供标准化、高效且有效的清洁和消毒流程,这对病人安全至关重要。这些系统透过最大限度地减少内视镜再处理所需的时间和人力,提高了医疗机构的工作流程效率。此外,自动化清洁系统专为适应现代内视镜的复杂设计而设计,确保彻底消毒并遵守严格的监管标准。作为内视镜再处理市场预测的一部分,预计在技术进步和对可靠高效再处理方法日益增长的需求的推动下,自动化清洁解决方案的日益普及将继续塑造市场。
例如,2023年3月,豪雅集团旗下的宾得医疗 (PENTAX Medical) 凭藉其创新的自动化预清洁解决方案 AquaTYPHOON 荣获 CE 标誌。该设备由宾得医疗与 PlasmaBiotics 合作开发,为内视镜再处理中传统的手动预清洁步骤提供了强大的替代方案,有效解决了医疗保健提供者在日常临床实践中遇到的卫生挑战。
医院和诊所是主要的细分市场
内视镜后处理市场研究报告强调,医院和诊所是市场的主要组成部分,因为这些机构内进行的内视镜手术数量庞大。根据业界报告,2023年爱尔兰的减重手术数量将达到219例,大大超过了爱尔兰卫生服务执行局(HSE)设定的200例的修订目标。这比2022年的109例手术数量大幅增加。这些手术在HSE的三个机构进行:都柏林的圣文森大学医院、敦莱里市的圣迈克尔医院和戈尔韦大学医院。此外,光是戈尔韦大学医院一所医院在2023年就进行了49例手术,高于前一年的19例。
这些机构需要采取严格的感染控制措施来预防医院内感染,因此有效的再处理至关重要。微创手术(通常使用内视镜)的日益普及进一步推动了需求。此外,监管要求和指南规定了严格的再处理方案,以确保病人安全。高手术量、合规性以及对感染预防的迫切需求,使得医院和诊所成为内视镜再处理的主要市场。
北美引领市场,占据最大的内视镜再处理市场份额
该报告还对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告指出,北美是内视镜再处理最大的区域市场。
北美在内视镜再处理市场的主导地位可归因于其先进的医疗基础设施、日益增长的慢性病盛行率、严格的监管标准以及高频率的内视镜检查。例如,美国麻醉医师协会 2024 年的一篇文章指出,美国每年进行约 610 万例上消化道内视镜检查。此外,美国疾病管制与预防中心报告称,约有 1.29 亿美国人患有至少一种主要慢性病,这极大地推动了对内视镜再处理解决方案的需求。随着内视镜检查在诊断和治疗目的中的越来越普遍,内视镜再处理市场前景反映出对有效再处理技术日益增长的需求。该地区的医疗保健系统配备了先进的技术和协议,可确保有效的内视镜再处理以防止感染。此外,医疗服务提供者和患者对感染控制的认识不断提高,加上技术的不断进步和对患者安全的关注,进一步巩固了北美在该市场的领先地位。
(请注意,这只是关键参与者的部分名单,完整名单将在报告中提供。)
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.)