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2024-2032 年按产品、製程、最终用户和地区分類的内视镜再处理市场报告Endoscope Reprocessing Market Report by Product, Process, End User, and Region 2024-2032 |
2023年,全球内视IMARC Group再处理市场规模达22亿美元。该市场主要是由微创手术需求的增长以及严格的感染控制法规的实施所推动的。此外,后处理设备的快速技术进步、对患者安全意识的增强以及内视镜检查程序的普及也进一步促进了市场的成长。
微创手术的需求不断增加
对微创手术的日益青睐是内视镜再处理市场成长的主要动力。与传统手术相比,这些使用内视镜的手术具有缩短恢復时间、降低感染风险以及减少术后疼痛等优点。根据美国国家生物技术中心公布的资料,美国每年进行约1,770万例胃肠(GI)内视镜手术,占所有内视镜手术的68%。胃肠道内视镜手术后的复合感染率为0.2%,特定手术的复合感染率较高:ERCP为0.8%,非ERCP上消化道内视镜为0.123%,下消化道内视镜为0.073%。因此,内视镜手术的频率不断增加,对有效的再处理解决方案以确保内视镜的安全性和使用寿命提出了更高的需求。
实施严格的感染控制规定
根据行业报告,柔性内视镜后处理失败与医院获得性感染 (HAI) 相关,这给患者和医疗保健系统带来了沉重负担。 HAI 是报告最多的影响患者的不良事件,整个欧洲的盛行率为 6.5%。手术部位感染占所有 HAI 的 18.3%,对患者的生活品质有负面影响,并增加发病率和死亡率。它们也给医疗保健系统带来了巨大的财务负担。在德国,手术部位感染可能导致平均住院时间延长 17.9 天,每位患者的额外医疗费用为 22,905 欧元。因此,世界各地的政府和医疗机构正在实施严格的法规来预防医院获得性感染 (HAI)。为了遵守这些法规并避免处罚,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。
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。自动再处理机、增强型消毒剂和复杂的追踪系统等创新提高了后处理过程的效率和可靠性。这些技术确保内视镜始终按照高标准进行清洁,降低人为错误的风险,并简化医疗机构的工作流程,使其成为采用和扩展内视镜再处理解决方案的关键因素。例如,2023 年 1 月,柔性机器人仪器的领先开发商 Agilis Robotics 以其专有的内视镜手术机器人完成了第二轮活体动物测试。结果表明,机器人系统在功效、准确性和安全性方面取得了良好的成果。因此,机器人在内视镜手术中的日益整合预计将增加执行的手术数量,从而推动市场成长。
IMARC Group提供了每个细分市场的主要趋势的分析,以及 2024-2032 年全球、区域和国家层面的预测。我们的报告根据产品、流程和最终用户对市场进行了分类。
高水平消毒剂和试纸占大部分市场份额
该报告根据产品提供了详细的市场细分和分析。这包括高强度消毒剂和试纸、清洁剂和湿纸巾、自动内视镜清洗机、内视镜干燥、储存和运输系统等。报导称,高强度消毒剂和试纸占了最大的份额。
高水准消毒剂和试纸条因其在确保患者安全方面的有效性和效率而正在提高内视镜再处理的市场价值。这些消毒剂专门设计用于消除广谱病原体,包括结核分枝桿菌和艰难梭菌等高度抗药性的生物体。它们的快速作用特性以及与自动洗消机的兼容性使它们成为繁忙的医疗保健环境中的首选。试纸在验证消毒过程的功效方面发挥着至关重要的作用,可以立即确认消毒剂是否达到最低建议浓度,从而确保符合安全标准并降低感染风险。例如,RAPICIDE 高水准消毒剂是一种基于戊二醛的快速起效、可重复使用的解决方案,适用于自动洗消机中的柔性内视镜,无需混合或活化。它可以在 DSD-201 等系统中对热敏感、半关键医疗设备进行再处理,在 95°F (35°C) 下接触 5 分钟即可灭活 TB、艰难梭菌和 CRE 等病原体。此消毒剂只需冲洗两次即可提高效率。 RAPICIDE(TM) 测试条可确认戊二醛的最低建议浓度,需要浸入 3 秒并读取 75 秒。这个例子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,从而增加内视镜再处理市场价值。
自动化清洁占据产业最大份额
报告还提供了基于流程的详细市场细分和分析。这包括手动清洁和自动清洁。报告称,自动化清洁占据最大的市场份额。
自动化清洁在内视镜再处理市场中占据主导地位,因为它能够确保一致和高水准的消毒,减少与手动清洁相关的人为错误风险。自动内视镜清洗机 (AER) 等自动化系统提供标准化、高效且有效的清洁和消毒流程,这对于病患安全至关重要。这些系统透过最大限度地减少内视镜再处理所涉及的时间和劳动力来提高医疗机构内的工作流程效率。此外,自动清洁系统专门设计用于适应现代内视镜的复杂设计,确保彻底净化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、高效的再处理方法的需求不断增长的推动下,自动化清洁解决方案的日益采用将继续塑造市场。
例如,2023 年 3 月,HOYA 集团旗下的 PENTAX Medical 因其创新的自动化预清洁解决方案 AquaTYPHOON 获得了 CE 标誌。该设备与 PlasmaBiotics 合作开发,为内视镜再处理中的传统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。
医院和诊所是领先的细分市场
该报告提供了基于最终用户的详细市场细分和分析。这包括医院和诊所、门诊手术中心等。报告称,医院和诊所是最大的部分。
内视镜再处理市场研究报告强调,医院和诊所是市场的主导部分,因为这些设施内进行了大量的内视镜手术。据业界报告称,2023年爱尔兰减肥手术数量将达到219例,大大超过卫生服务执行局(HSE)设定的200例的修订目标。这标誌着比 2022 年进行的 109 例手术大幅增加。此外,光是戈尔韦大学医院在 2023 年就进行了 49 例手术,高于前一年的 19 例。
这些设施需要采取严格的感染控制措施,以防止医院获得性感染,因此有效的再处理至关重要。经常使用内视镜的微创手术日益普及,进一步推动了需求。此外,监管要求和指南要求严格的再处理方案,以确保病人安全。高程序量、法规遵从性以及感染预防的迫切需求相结合,使医院和诊所成为内视镜再处理的主要细分市场。
北美市场领先,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,其中包括北美(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。报告称,北美是内视镜再处理的最大区域市场。
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、慢性病盛行率的增加、严格的监管标准以及内视镜手术的高频率。例如,美国麻醉医师协会2024 年发表的一篇文章表明,美国每年进行约610 万例上消化道内视镜检查。大地推动了对内视镜的需求再处理解决方案。随着内视镜手术在诊断和治疗方面变得越来越普遍,内视镜再处理市场前景反映出对有效再处理技术的需求不断增长。该地区的医疗保健系统配备了先进的技术和方案,可确保有效的内视镜再处理以预防感染。此外,医疗保健提供者和患者对感染控制意识的提高,以及不断的技术进步和对患者安全的关注,进一步巩固了北美在市场上的领先地位。
(请注意,这只是关键参与者的部分列表,报告中提供了完整列表。)
The global endoscope reprocessing market size reached US$ 2.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 4.0 Billion by 2032, exhibiting a growth rate (CAGR) of 6.8% during 2024-2032. 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.
IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on product, process, and end user.
High-level disinfectants and test strips account for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the product. This includes high-level disinfectants and test strips, detergents and wipes, automated endoscope reprocessors, endoscope drying, storage and transport systems, and others. According to the report, high-level disinfectants and test strips represented the largest segment.
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
A detailed breakup and analysis of the market based on the process have also been provided in the report. This includes manual cleaning and automated cleaning. According to the report, automated cleaning accounted for the largest market share.
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 report has provided a detailed breakup and analysis of the market based on the end user. This includes hospitals and clinics, ambulatory surgery centers, and others. According to the report, hospitals and clinics represented the largest 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.)