![]() |
市場調查報告書
商品編碼
1831894
2025-2033年內視鏡再處理市場報告(依產品、製程、最終用戶及地區)Endoscope Reprocessing Market Report by Product, Process, End User, and Region 2025-2033 |
2024年,全球內視鏡後處理市場規模達23億美元。展望未來, IMARC Group預計到2033年,該市場規模將達到42億美元,2025-2033年期間的複合年成長率(CAGR)為6.21%。市場成長主要受微創手術需求的不斷成長以及嚴格的感染控制法規的實施所推動。此外,後處理設備的快速技術進步、患者安全意識的不斷增強以及內視鏡檢查的普及率的飆升也進一步促進了市場的成長。
微創手術需求不斷成長
人們對微創手術的日益青睞是內視鏡再處理市場成長的主要驅動力。與傳統手術相比,這些使用內視鏡的手術具有恢復時間短、感染風險低、術後疼痛少等優點。根據美國國家生物技術中心發布的資料,美國每年約進行 1,770 萬例胃腸道 (GI) 內視鏡檢查,佔所有內視鏡檢查的 68%。胃腸道內視鏡檢查後的綜合感染率為 0.2%,特定手術的感染率較高:ERCP 為 0.8%,非 ERCP 上消化道內視鏡檢查為 0.123%,下消化道內視鏡檢查為 0.073%。因此,內視鏡檢查的頻率正在增加,對有效的再處理解決方案的需求也隨之增加,以確保內視鏡的安全性和使用壽命。
實施嚴格的感染控制法規
根據行業報告,軟性內視鏡再處理失敗與院內感染 (HAI) 有關,這給患者和醫療保健系統帶來了沉重的負擔。 HAI 是通報最多的病患不良事件,在歐洲的盛行率為 6.5%。手術部位感染佔所有 HAI 的 18.3%,會對患者的生活品質產生負面影響,並增加發病率和死亡率。此外,手術部位感染也會給醫療保健系統帶來沉重的財務負擔。在德國,手術部位感染平均會導致住院時間延長 17.9 天,每位患者的醫療費用增加 22,905 歐元。因此,世界各地的政府和醫療保健組織都在實施嚴格的法規,以預防院內感染 (HAI)。為了遵守這些法規並避免受到處罰,醫療機構正在投資先進的內視鏡再處理系統。這可確保內視鏡已徹底清潔、消毒和滅菌,從而降低 HAI 風險並提高病患安全性。
後處理設備的技術進步
技術進步極大地推動了內視鏡再處理市場的成長。自動化再處理機、增強型消毒劑和先進的追蹤系統等創新技術提高了再處理流程的效率和可靠性。這些技術確保內視鏡始終保持高標準清潔,降低人為失誤風險,並簡化醫療機構的工作流程,使其成為內視鏡再處理解決方案推廣和應用的關鍵因素。例如,2023年1月,領先的軟性機器人器械開發商Agilis Robotics利用其專有的內視鏡手術機器人完成了第二輪活體動物測試。測試結果顯示,該機器人系統在功效、準確性和安全性方面均表現出色。因此,機器人技術在內視鏡手術中的日益普及預計將增加手術數量,從而推動市場成長。
高水平消毒劑和試紙佔大部分市場佔有率
高效消毒劑和試紙因其在保障病人安全方面的有效性和效率,正在提升內視鏡再處理市場的價值。這些消毒劑專為殺死多種病原體而設計,包括結核分枝桿菌和艱難梭菌等高抗藥性病原體。其快速起效的特性以及與自動再處理機的兼容性,使其成為繁忙醫療環境中的首選。試紙在驗證消毒過程的有效性方面發揮著至關重要的作用,可立即確認消毒劑的最低建議濃度已達到,從而確保符合安全標準並降低感染風險。例如,RAPICIDE 高效能消毒劑是一種基於戊二醛的快速起效、可重複使用的溶液,適用於自動再處理機中的軟性內視鏡,無需混合或活化。它可在DSD-201等系統中對熱敏感、半關鍵醫療器材進行再處理,在95°F(35°C)的溫度下,只需5分鐘的接觸時間即可去活化結核菌、艱難梭菌和抗藥性腸球菌(CRE)等病原體。此消毒劑只需沖洗兩次即可提高消毒效率。 RAPICIDE™ 試紙可確認戊二醛的最低建議濃度,只需浸泡3秒,讀取時間為75秒。此範例說明了特定產品如何推動市場對高水準消毒劑和試紙的需求,從而提升內視鏡再處理的市場價值。
自動化清潔佔據產業最大佔有率
自動化清潔技術在內視鏡再處理市場佔據主導地位,因為它能夠確保一致且高水準的消毒,從而降低手動清潔相關的人為錯誤風險。自動化系統,例如自動內視鏡再處理器 (AER),提供標準化、高效且有效的清潔和消毒流程,這對病人安全至關重要。這些系統透過最大限度地減少內視鏡再處理所需的時間和人力,提高了醫療機構的工作流程效率。此外,自動化清潔系統專為適應現代內視鏡的複雜設計而設計,確保徹底消毒並遵守嚴格的監管標準。作為內視鏡再處理市場預測的一部分,預計在技術進步和對可靠高效再處理方法日益成長的需求的推動下,自動化清潔解決方案的日益普及將繼續塑造市場。
例如,2023年3月,豪雅集團旗下的賓得醫療 (PENTAX Medical) 憑藉其創新的自動化預清潔解決方案 AquaTYPHOON 榮獲 CE 標誌。該設備由賓得醫療與 PlasmaBiotics 合作開發,為內視鏡再處理中傳統的手動預清潔步驟提供了強大的替代方案,有效解決了醫療保健提供者在日常臨床實踐中遇到的衛生挑戰。
醫院和診所是主要的細分市場
內視鏡後處理市場研究報告強調,醫院和診所是市場的主要組成部分,因為這些機構內進行的內視鏡手術數量龐大。根據業界報告,2023年愛爾蘭的減重手術數量將達到219例,大大超過了愛爾蘭衛生服務執行局(HSE)設定的200例的修訂目標。這比2022年的109例手術數量大幅增加。這些手術在HSE的三個機構進行:都柏林的聖文森大學醫院、敦萊里市的聖邁克爾醫院和戈爾韋大學醫院。此外,光是戈爾韋大學醫院一所醫院在2023年就進行了49例手術,高於前一年的19例。
這些機構需要採取嚴格的感染控制措施來預防醫院內感染,因此有效的再處理至關重要。微創手術(通常使用內視鏡)的日益普及進一步推動了需求。此外,監管要求和指南規定了嚴格的再處理方案,以確保病人安全。高手術量、合規性以及對感染預防的迫切需求,使得醫院和診所成為內視鏡再處理的主要市場。
北美引領市場,佔據最大的內視鏡再處理市場佔有率
該報告還對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告指出,北美是內視鏡再處理最大的區域市場。
北美在內視鏡再處理市場的主導地位可歸因於其先進的醫療基礎設施、日益成長的慢性病盛行率、嚴格的監管標準以及高頻率的內視鏡檢查。例如,美國麻醉醫師協會 2024 年的一篇文章指出,美國每年進行約 610 萬例上消化道內視鏡檢查。此外,美國疾病管制與預防中心報告稱,約有 1.29 億美國人患有至少一種主要慢性病,這極大地推動了對內視鏡再處理解決方案的需求。隨著內視鏡檢查在診斷和治療目的中的越來越普遍,內視鏡再處理市場前景反映出對有效再處理技術日益成長的需求。該地區的醫療保健系統配備了先進的技術和協議,可確保有效的內視鏡再處理以防止感染。此外,醫療服務提供者和患者對感染控制的認知不斷提高,加上技術的不斷進步和對患者安全的關注,進一步鞏固了北美在該市場的領先地位。
(請注意,這只是關鍵參與者的部分名單,完整名單將在報告中提供。)
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.)