天游国际

介凡社?密约 | “小眼睛，，，，，大天下”眼科黄金赛道，，，，，看谁领风流

2021年3月10日

行研 | 微流控手艺进入生长快车道，，，，，加速快速检测落地和升级

2021年3月16日

行研 | 医用内窥镜“耗材化”趋势已现，，，，，国产厂商弯道超车

前言

随着微创手术和癌症早诊早治的生长，，，，，内窥镜在诊疗中的应用一直增多。。。。。2020年我海内窥镜市场规模抵达254亿元，，，，，由于入口内窥镜厂商的手艺垄断，，，，，国产企业市占率低于10%。。。。。在内窥镜领域是否保存类似新能源汽车的弯道超车时机？？手艺前进给医用内窥镜行业带来哪些生长趋势？？

1. 中国医用内窥镜市场超250亿，，，，，入口厂商仍占有垄断态势

内窥镜通过人体的自然孔道或经手术爆发的小切口进入人体，，，，，使用时将内窥镜导入预检查的器官，，，，，并直接窥视有关部位的转变，，，，，是内、外科细腻检查和微创治疗的必备工具。。。。。按产品结构和形态划分，，，，，内窥镜可以分为软镜和硬镜。。。。。凭证使用科室和场景，，，，，再划分细分为腹腔镜、胸腔镜、枢纽镜，，，，，和胃镜、肠镜、输尿管软镜等。。。。。
凭证弗若斯特沙利文数据，，，，，2020年中海内窥镜市场规模抵达254亿人民币，，，，，2015-2020年复合增添率约14.2%。。。。。同期全球内窥镜市场规模从164亿美元增添至215亿美元，，，，，年复合增添率5.5%。。。。。中国市场增速远快于全球，，，，，在全球市场的占比一直提高。。。。。背后的潜在缘故原由是内窥镜兼具医疗装备与耗材属性，，，，，内窥镜主机不易损坏，，，，，镜体寿命从6个月至10年不等，，，，，西欧蓬勃国家已完成内窥镜的起源结构，，，，，如手艺没有大幅刷新，，，，，很难看到市场的显著增添。。。。。

天游国际(中国区)-官方网站

图：中海内窥镜市场规模（亿元，，，，，以出厂价计）

而中海内窥镜市场远未饱和，，，，，随着肿瘤早筛及微创治疗加速渗透，，，，，在外企的推广下，，，，，作为须要的检查和治疗工具，，，，，中国医院仍在加大对内窥镜的购置力度。。。。。同时，，，，，无论是用于早癌筛查的胃镜、肠镜检查，，，，，照旧提升有助于减轻患者痛苦、改善预后的腔镜手术、经自然腔道手术，，，，，都随着中国的老龄化加速，，，，，和逐渐提升的消耗水平，，，，，获得快速增添。。。。。

中海内窥镜市场按产品类型拆分，，，，，除了硬镜、软镜镜体，，，，，还包括相对应的装备、零备件，，，，，以及内窥镜专用的诊疗耗材。。。。。剔除手术耗材的影响，，，，，按科室细分，，，，，普外科占内窥镜市场比例最大，，，，，对应腹腔镜、胆道镜等，，，，，消化、泌尿比例次之，，，，，划分对应胃镜、肠镜、十二指肠镜及输尿管镜、经皮肾镜、膀胱镜等镜种。。。。。
天游国际(中国区)-官方网站

图：2020年中海内窥镜市场细分（亿元，，，，，以出厂价计）

在竞争名堂方面，，，，，我海内窥镜市场被日系、德系厂商垄断，，，，，国产厂商市占率~5%。。。。。由于古板软镜的感光元器件行业由日企推动生长，，，，，焦点手艺壁垒高，，，，，奥林巴斯、富士、宾得等日企基本垄断软镜市�。。。。。�；；；；；而德国公司卡尔史托斯最早掌握硬镜的柱状镜体手艺，，，，，德系厂商一直坚持在硬镜领域的领先职位。。。。。主要的国产软镜和硬镜厂商，，，，，如开立医疗、澳华内镜、迈瑞医疗等在高端市场上无法与入口厂商直接竞争，，，，，现在主要目的定位于二级医院以下医院，，，，，在已进院医院中，，，，，也较少作为主力内窥镜使用，，，，，仍在快速追赶入口偕行。。。。。

天游国际(中国区)-官方网站

图：中海内窥镜市场竞争名堂

2.成像元件更新换代，，，，，使内窥镜“耗材化”成为可能

国产厂商迟迟未在内窥镜领域破局反超，，，，，强手艺壁垒是导致国产渗透率低的直接缘故原由。。。。。内窥镜的研发和制造涉及多学科、多领域相互配合，，，，，以胃肠镜、输尿管镜为代表的软镜零部件多，，，，，供应链及其重大，，，，，制造办法繁杂，，，，，无法实现完全的自动化。。。。。以奥林巴斯为代表的的日系内窥镜厂商始终将生产制造工艺视为最高神秘，，，，，并只在日本本土举行焦点产品的生产。。。。。

天游国际(中国区)-官方网站

图：软性内窥镜结构示意

在感光元件方面，，，，，内窥镜的感光元件分为CCD（电荷耦合元件）和 CMOS（互补式金属氧化物半导体）两种手艺，，，，，CCD手艺由于影像质量更好，，，，，在电子内窥镜生长初期被普遍应用，，，，，然而，，，，，随着CMOS在色彩性能方面的提升，，，，，影像质量以及与CCD差别越来越小，，，，，而其低耗能、噪声小、可以大批量低本钱生产的特点为企业所浏览，，，，，主流内窥镜厂商在逐步实现从CCD到CMOS感光元件的转化。。。。。

天游国际(中国区)-官方网站

图：全球图像传感器出货量结构

在CCD时代，，，，，CCD是组成电子内镜本钱最主要的组成部分，，，，，CCD本钱约占整个内镜本钱的40%。。。。。由于CCD设计原理，，，，，导致信号输出易受单像素点影响，，，，，提高废品率，，，，，增添制造难度，，，，，本钱高昂。。。。。CCD全盛时期，，，，，仅有6家公司可以批量生产，，，，，划分为索尼、富士、柯达、飞利浦、松下和夏普，，，，，其中4家为日企，，，，，龙头索尼市占率超50%，，，，，而索尼为奥林巴斯股东，，，，，二者绑定关系亲近，，，，，其他CCD厂家对外洋内窥镜厂商的出口也多加限制。。。。。
由于CCD的价钱高企，，，，，一条寿命长、结实耐用的内窥镜，，，，，成为了厂家和医院方的配合选择。。。。。而软镜对操控性的极致追求，，，，，与多次使用后性能衰减的矛盾，，，，，极大提高了软镜的制造本钱。。。。。除CCD外其余细密焦点部件的要求也水涨船高，，，，，这部分零配件供应商集中在日本和德国，，，，，海内仍没有形成完整的工业链，，，，，使国产内窥镜的产品竞争力不强。。。。。
天游国际(中国区)-官方网站

图：医疗用CMOS全球出货量

新手艺CMOS的引入，，，，，在一定水平上挣脱了企业对CCD传感器的依赖，，，，，如开立医疗在2015 年研制出基于CMOS的海内首台200万像素的高清电子内窥镜系统 HD-500。。。。。更为欣喜的是，，，，，由于CMOS市场更疏散，，，，，手艺壁垒相对较低，，，，，适合大规模批量生产，，，，，CMOS的价钱更是泛起数目级下探趋势，，，，，从而使内窥镜的一次性化成为可能。。。。。
当内窥镜的设计使用寿命从数百次至数千次缩短为一次，，，，，且无需思量可维修性，，，，，内窥镜的本钱结构会爆发强烈的转变。。。。。整个镜体的设计思绪从一个细密的机械装备，，，，，转变为一条通俗的一次性医用导管，，，，，同时质料选用上也有大幅转变，，，，，金属材质被塑料材质所取代，，，，，零配件的数目大幅镌汰。。。。。古板的内窥镜厂商尚无暇应对一次性内镜的攻击，，，，，此后起之秀波士顿科学和丹麦Ambu，，，，，带着数百万件年产量医疗耗材的生产履历，，，，，登上了历史舞台，，，，，国产厂商也抖擞直追，，，，，在国际上占有了一席之地。。。。。
天游国际(中国区)-官方网站

图：一次性软镜平均本钱示意

3.?一次性内窥镜解决了交织熏染、时间铺张、下层医院基建投入缺乏的问题

内窥镜是直接与患者的皮肤、黏膜及无菌组织亲近接触的医疗器械，，，，，但由于内窥镜结构中包括多个小而长的开放通道，，，，，为微生物、渗透物和血液的剩余与交织熏染提供了情形，，，，，交织熏染成为难以阻止的医疗事故危害。。。。。相关学术研究显示，，，，，内窥镜在医疗器械交织熏染危害排行榜中位列第一，，，，，70%以上的内镜保存洗濯不清洁的问题，，，，，靠近四分之三的常用内镜被细菌污染。。。。。
在海内，，，，，也常见到胃镜室消毒效果不达标、胃镜生物监测缺乏格的报道，，，，，同时有更多的院感由于发明不实时没有报出。。。。。在本轮新冠疫情中，，，，，多家医院的内镜室和口腔科、五官科一起停诊，，，，，也说明晰院方对内镜室院感危害的担心。。。。。
天游国际(中国区)-官方网站

图：美国抢救医学研究所ECRI 十大医疗手艺危害

2021年1月最新揭晓的研究显示，，，，，较量可重复使用和一次性使用的输尿管软镜，，，，，一次性内镜组的住院天数和抗生素治疗时间更短，，，，，总并发症爆发率和总体术后熏染率都更低；；；；；；在使用一次性内窥镜的90例患者中，，，，，没有患者泛起尿毒症或血液作育呈阳性，，，，，而比照组泛起了3例阳性。。。。。有力地证实晰一次性输尿管镜的使用具有显着降低术后并发症和熏染率的特点。。。。。
天游国际(中国区)-官方网站

图：一次性内窥镜降低输尿管软镜术后熏染率

同时，，，，，在海内医院的事情量下，，，，，多次、多支内窥镜的重复洗消会造成重复使用内窥镜的性能下降甚至损坏。。。。。而使用一次性内窥镜，，，，，可以包管每次拆开包装的内窥镜都在其最佳状态，，，，，一定水平上提高了手术效率。。。。。
天游国际(中国区)-官方网站

图：一次性内窥镜降低输尿管软镜手术耗时

同时，，，，，关于宽大的县级及以下下层医院，，，，，很是适合开展经自然腔道的检查和治疗术式，，，，，对麻醉、外科的要求也较开松手术更低。。。。。在蓬勃国家，，，，，相当比例的内镜检查和手术在门诊或专科内镜中心完成。。。。。而在海内下层医院，，，，，基建投入缺乏限制了内镜诊疗的生长。。。。。
同样以输尿管软镜取石手术为例，，，，，如一家医院要新开此术式，，，，，需采购2条入口软镜及一台主机，，，，，进院价约200万元；；；；；；而选择一次性内窥镜，，，，，开展手术仅需采购数条国产一次性软镜及一台主机，，，，，进院价可以控制在10万元以内。。。。。一次性内窥镜很是有利于内镜手术在下层医院的推广。。。。。

4. 一次性内窥镜市场展望：聚焦7,000万例微无创手术

经由外资与海内企业多年的探索，，，，，一次性内窥镜已在多个应用领域相比重复使用内镜更为经济。。。。。如古板输尿管软镜手术，，，，，思量到软镜的寿命、维修频率，，，，，单次手术的本钱凌驾1.2万元，，，，，而一次性输尿管软镜的海内入院价钱一样平常在万元以下，，，，，同时对医院来说，，，，，与内镜相关的本钱越发可控。。。。。

天游国际(中国区)-官方网站

图：重复使用输尿管软镜单台手术平均本钱（元）

类似的，，，，，关于膀胱镜，，，，，由于入口的膀胱电子镜本钱过于高昂，，，，，在海内普及率很低，，，，，光学硬镜仍是主流。。。。。一次性的电子膀胱半硬镜，，，，，直径更细，，，，，有亲水涂层，，，，，患者体验更好，，，，，同时由于电子镜有更高的收费标准，，，，，科室单次手术操作的利润也有了改善。。。。。

天游国际(中国区)-官方网站

图：古板光学膀胱镜与一次性膀胱镜收费与利润比照举例（元）

从一次性内窥镜的使用寿命、周转频率、消毒难度来思量，，，，，购置、维修、消毒本钱较高，，，，，单次使用时间较短，，，，，周转频率快的内窥镜，，，，，均有“耗材化”的潜力，，，，，这些镜种对应了中国近7,000万例的潜在诊疗量，，，，，给国产一次性内窥镜公司留下了一片蓝海市场。。。。。
天游国际(中国区)-官方网站

图：一次性内窥镜市场时机测算

5.?国际海内一次性内窥镜代表厂家

(一)国际巨头

美国波士顿科学

作为高值医疗器械巨头，，，，，波科的一次性内窥镜结构从与其营业最相关的泌尿和消化内镜最先。。。。。波科推出了天下首款一次性输尿管内镜LithoVue，，，，，现在的产品结构已经延伸到了EXALT十二指肠镜、支气管镜、胃镜，，，，，以及SpyGlass胆道镜。。。。。高端的市场定位，，，，，以及美国宽松的支付价钱，，，，，使得波科的一次性内窥镜产品普遍价钱高企。。。。。

丹麦Ambu

Ambu致力于开发、生产和销售医院及救援效劳需要的诊断和生命支持装备。。。。。2009年，，，，，Ambu推出宣布天下上第一个一次性支气管镜aScope，，，，，并成为一次性支气管镜领域的绝对王者。。。。。从支气管镜起身，，，，，Ambu逐步完成一次性内镜全工业结构。。。。。最近一个财年，，，，，公司一次性内窥镜销售额已突破100万支。。。。。

天游国际(中国区)-官方网站

图：Ambu一次性内窥镜生长史

(二)海内公司

阻止现在，，，，，海内已有4家公司总共获得了5张一次性内窥镜NMPA注册证，，，，，均在2020年获得。。。。。

普生医疗

普生医疗2014年建设于珠海，，，，，2020年6月获得一次性输尿管软镜注册证，，，，，前期已通过CE和FDA认证并开启外洋销售。。。。。公司未来产品线还包括一次性鼻咽喉镜、一次性支气管镜、一次性膀胱镜等。。。。。

瑞派医疗

瑞派医疗2015年建设于广州国际生物岛，，，，，是一家提供一次性微创手术整体解决计划的全球供应商，，，，，产品生长妄想笼罩泌尿外科、妇科、耳鼻喉科、消化科、呼吸科、普外科等。。。。。瑞派医疗在2020年获批了一次性输尿管软镜及一次性电子膀胱内窥镜注册证，，，，，同时也是现在在一次性内窥镜领域持有III类注册证最多的企业。。。。。

英诺伟

英诺伟2009年建设于上海，，，，，主要专注于消化内镜和泌尿外科相关高值耗材的研发和销售；；；；；；2014年，，，，，建设子公司安清医疗，，，，，聚焦于医疗内窥镜。。。。。期望内窥镜装备能与耗材形成闭环，，，，，为微创手术提供整体解决计划。。。。。2020年，，，，，安清医疗获批了一次性输尿管软镜，，，，，并已于前期开展外洋销售。。。。。

幸福工厂

安徽省幸福工厂医疗装备有限公司建设于2017年，，，，，企业在引进美国硅谷专利手艺基础上，，，，，通过消化吸收刷新，，，，，现拥有国际领先的一次性电子内窥镜研发手艺平台，，，，，主要从事一次性电子输尿管软镜、膀胱软镜等的研爆发产，，，，，2020年1月，，，，，公司获批了中国首张一次性输尿管软镜注册证。。。。。

结语

2020年，，，，，内窥镜巨头奥林巴斯仅凭简单产品线，，，，，以58.9亿美元的营收连任全球医疗器械公司100强第21名。。。。。令人羡慕的营收与利润背后，，，，，是日本巨头对古板内窥镜领域的垄断。。。。。中国一次性内窥镜创业者们，，，，，背靠中国重大的蓝海市场，，，，，迎来了在内窥镜领域最好的弯道超车时机。。。。。让我们拭目以待，，，，，国产立异战胜万难，，，，，成为天下一次性内窥镜领跑者，，，，，造福全球患者。。。。。[:en]

Abstract

With the development of minimally invasive surgery and early diagnosisand treatment of cancer, the application of endoscope in diagnosis andtreatment continues to increase.In 2020, thescale of domestic endoscope market has reached 25.4 billion RMB. Due to thetechnical monopoly of imported endoscope manufacturers, the market share ofdomestic players is less than 10%.Is there acounterattack opportunity similar to new-energy vehicles in the endoscopefield? What are the development trends of medical endoscope industry brought bytechnological progress?

I. China’s medical endoscopemarket exceeds 25 billion, and import manufacturers still occupy a monopoly

The endoscope enters the human body through the natural orifice or thesmall incision. It is a necessary tool for examination and minimally invasivetreatment. According to the structure and shape, endoscopes can be divided intoflexible endoscopes and rigid endoscopes.
According to Frost & Sullivan data, China’s medical endoscopemarket reached 25.4 billion RMB in 2020, with a CAGR of about 14.2% from 2015to 2020. Over the same period, the global endoscope market increased from US$16.4 billion to US $21.5 billion, with a CAGR of 5.5%. The growth rate ofChina’s market is much faster than that of the world, and its share in theglobal market is increasing. The underlying reason is that the endoscope hasthe attributes of both medical equipment and consumables, the endoscope consoleis not easy to damage, and the service life of the endoscope camera ranges from6 months to 10 years. Developed countries have completed the preliminary purchaseof the endoscopes. If there is no significant innovation in technology, itisn’t easy to see substantial growth in the market.
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Chart: China’s MedicalEndoscope Market Size (100 Million RMB, Based on Ex-factory Price)

The domestic endoscope market in China is far from saturated. With theaccelerated penetration of early tumor screening and minimally invasivetreatment, Chinese hospitals are still increasing their purchase of endoscopesas necessary inspection and treatment tools under the promotion of foreigncompanies. At the same time, gastroscopy and colonoscopy for early cancerscreening, endoscopic surgery, and transluminal surgery, which help reducepatients’ pain and improve prognosis, have achieved rapid growth with theacceleration of China’s aging and the gradual improvement of consumption level.
Divided by product type, in addition to rigid and flexible endoscopecameras, China’s domestic endoscope market also includes related equipment,spare parts, and therapeutic consumables for endoscopes. Excluding theinfluence of surgical consumables, subdivided by department, general surgeryaccounts for the most significant proportion of the endoscope market,corresponding to laparoscopy and choledochoscopy. The gastroenterology and urologydepartment takes the second and the third share, corresponding to gastroscopy,colonoscopy, duodenoscope and ureteroscopy, percutaneous nephroscope,cystoscopy, and other types of endoscopes, respectively.
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Figure: China’s Medical EndoscopeMarket Segmentation in 2020 (100 Million RMB, Based on Ex-factory Price)

Regarding competition, China’s medical endoscope market is monopolizedby Japanese and German manufacturers, and domestic manufacturers have a marketshare of ~5%. As the image sensor industry of traditional flexible endoscopesis promoted by Japanese companies, and the core technology barriers are high,Japanese companies such as Olympus, Fuji, and Pentax monopolize the flexibleendoscope market; German company Karl Storz was the first to master thecylindrical lens technology of rigid endoscopes, and German manufacturers havealways maintained a leading position in the field of rigid endoscopes. China’sdomestic rigid and flexible endoscope manufacturers, such as SonoScape Medical,Aohua Endoscopy, and Mindray Bio-Medical, cannot directly compete with importedmanufacturers in the high-end market. At present, their main target ishospitals below the second-level hospital. Among the hospitals that have beenadmitted, they are rarely used as the primary endoscope, and they are stillcatching up with their imported counterparts.
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Chart: China’s Medical EndoscopeCompetitive Landscape

II. The renewal of imagesensors makes it possible to “disposable” endoscope

Domestic manufacturers have been slow to breakthrough in the field ofendoscopy, and solid technical barriers directly cause the low domesticpenetration rate. The R&D and manufacturing of endoscopes involvemulti-disciplinary and multi-field cooperation. Gastrointestinal endoscopes andureteroscopes are made of many parts, and the supply chain is highlycomplicated. The manufacturing steps are complex and cannot be fully automated.Japanese endoscope manufacturers represented by Olympus always regard the manufacturingprocess as the top secret and only produce core products in Japan.
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Figure: Schematic Diagram ofthe Flexible Endoscope

The image sensors are divided into two technologies: CCD (ChargeCoupled Device) and CMOS (Complementary Metal Oxide Semiconductor). CCDtechnology was widely used in the early development of electronic endoscopesdue to its better image quality. However, with the improvement of CMOS in termsof color performance, the image quality and the gap with CCD are gettingsmaller and smaller, and its low energy consumption, low noise, and low-costmass production characteristics are appreciated by enterprises. Major endoscopemanufacturers gradually realize the conversion from CCD to CMOS image sensors.
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Chart: Global Image Sensor ShipmentsSegmentation

In the CCD era, CCD is an essential part of the cost of electronicendoscopes. The cost of CCD accounts for about 40% of the price of the entireendoscope. Due to the CCD design principle, the signal output is easilyaffected by a single pixel, which increases the defect rate, increases thedifficulty of manufacturing, and is costly. During the heyday of CCD, only sixcompanies could mass-produce them, namely Sony, Fuji, Kodak, Philips,Panasonic, and Sharp, four of which were Japanese companies. The leader Sonyhas a market share of over 50%, and Sony is a shareholder of Olympus, and thetwo are closely tied together. Other CCD manufacturers also impose restrictionson the export to overseas endoscope manufacturers.
Due to the high price of CCD, a long-life, sturdy and durable endoscopehas become the common choice of manufacturers and hospitals. The extremepursuit of the flexible endoscopes for maneuverability, and the contradictionbetween the performance degradation after repeated use, dramatically increasesthe manufacturing cost of the flexible endoscopes. Except for CCD, therequirements for other precision core components are also rising. These partssuppliers are concentrated in Japan and Germany. The domestic industry has notyet formed a complete industrial chain, making the competitiveness of domesticendoscope products weak.
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Chart: Global Shipments of MedicalCMOS

The introduction of the new technology CMOS has gotten rid ofenterprises’ dependence on CCD sensors. For example, in 2015, SonoScapedeveloped the first domestic 2-megapixel high-definition electronic endoscopesystem, HD-500, based on CMOS. What’s more gratifying is that because the CMOSmarket is more fragmented and the technical barriers are relatively low, it issuitable for large-scale mass production. The price of CMOS is showing an orderof magnitude downward trend, making the disposable endoscope possible.
When the designed service life of the endoscope is shortened fromhundreds to thousands of times to one time, and there is no need to considerthe maintainability, the cost structure of the endoscope will changedrastically. The design idea of the entire camera has changed from a precisionmechanical device to an ordinary disposable medical catheter. At the same time,the material has also changed significantly. Plastic materials replace metalmaterials, and the number of parts is reduced dramatically. Traditionalendoscope manufacturers have no time to deal with the impact of disposableendoscopes. Then Boston Scientific and Ambu, with the production experience ofmillions of annual medical consumables, have stepped on the historical stage.Domestic manufacturers have also caught up and have a role to play in theworld.
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Figure: Schematic of the AverageCost of a Disposable Flexible Endoscope

III. Disposable endoscopessolve the problems of cross-infection, waste of time, and insufficientinvestment in basic hospital infrastructure

An endoscope is a medical device that directly contacts the patient’sskin, mucous membrane and sterile tissues. However, because the endoscopestructure contains multiple small and long lumens, it provides an environmentfor the survival and cross-infection of microorganisms, secretions and blood. Cross-infectionbecomes an inevitable risk of medical accidents. Related academic researchshows that endoscopes rank first in the list of cross-infection risks formedical devices. More than 70% of endoscopes are not cleaned, and bacteriacontaminate nearly three-quarters of commonly used endoscopes.
In China, it is also common to report that the disinfection effect ofthe gastroscope room is not up to standard, and the biomonitoring of thegastroscope is not qualified. At the same time, more nosocomial infections arenot reported in time because they are not found. In the COVID-19 pandemic, theendoscopy rooms of many hospitals, stomatology, and ENT clinics were closedtogether, which also explained the hospital’s concern about the risk of nosocomialinfection in the endoscopy room.
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Figure: 2019 Top 10 HealthTechnology Hazards by ECRI

The latest study published in January 2021 showed that compared withreusable ureteroscopes, the length of hospital stay and antibiotic treatmenttime in the disposable endoscopy group were shorter, and the incidence of totalcomplications and the overall postoperative infection rate was lower. Among the90 patients under the treatment of disposable endoscopes, no uremia or bloodcultures were positive, while the control group had three positives. Itstrongly proves that disposable ureteroscope has the characteristics ofsignificantly reducing postoperative complications and infection rates.
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Figure: Disposable EndoscopeReduces Infection Rate After Ureteroscopy

At the same time，，，，，under the workload of domestic hospitals, repeateddecontamination of endoscopes will cause the performance of reusable endoscopesto decrease or even damage. Using a disposable endoscope can ensure that theendoscope is in its best condition every time the package is unpacked, whichimproves the efficiency of the operation to a certain extent.
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Figure: Disposable EndoscopeReduces the Operation Time of Ureteroscopy

At the same time, it is very suitable for carrying out Natural orificetransluminal endoscopic surgery for the vast county-level and lower-levelhospitals. The requirements for anesthesia and surgery are lower than that ofopen surgery. In developed countries, many endoscopies and surgeries areperformed in clinics or specialized endoscopy centers. In domestic primaryhospitals, insufficient investment in infrastructure has restricted thedevelopment of endoscopic diagnosis and treatment.
Similarly, taking ureteroscopic lithotomy as an example, if a hospitalwants to carry out this operation, it needs to purchase two imported flexibleendoscope cameras and a console, which costs about 2 million RMB. As fordisposable endoscopes, only a few domestic disposable flexible endoscope camerasand a console need to be purchased, and the price is within 100 thousand RMB. Adisposable endoscope is very conducive to the promotion of endoscopic surgeryin grass-roots hospitals.

IV. Market outlook of disposableendoscopy: Target 70 million cases of minimally invasive surgery

After years of exploration by foreign and domestic companies,disposable endoscopes have become more cost-effective than durable endoscopesin many scenarios. For example, considering the life span and maintenancefrequency of the ureteroscope, a traditional reusable ureteroscopy surgerywould cost more than 12,000 RMB. The purchase price of a disposable ureteroscopefor a hospital under the same circumstance is usually less than 10,000 RMB, andthe related spending is more controllable.
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Chart: Average Cost Structureof a Traditional Reusable Ureteroscopy Surgery (RMB)

The same cost-saving benefit also applies to disposable cystoscopy. Dueto the high cost of imported electronic flexible cystoscopy, the domesticmarket is largely occupied by optical rigid cystoscopy, and hospitals usuallysuffered a 500 RMB loss per surgery on average. The disposable electronicsemi-rigid cystoscope has a smaller diameter and hydrophilic coating, offeringpatients a more expensive but comfortable surgical option, which helpscontribute to considerable net profits for hospitals.
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Chart: Comparison of ProfitsBetween Traditional Optical Cystoscope and Disposable Cystoscope (RMB)

Considering the longevity, turnover, and disinfection of disposableendoscopes, endoscopes with high purchasing price, maintenance and disinfectioncosts, short usage time, and high turnover frequency are more likely to become“consumables”. These potential “consumables” indicate an incredible market of70 million diagnosis and treatment cases in China, bringing blue oceans to domesticdisposable endoscope companies.
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V. Leading international anddomestic manufacturers of disposable medical endoscope

(1) International Giant

Boston Scientific

Boston Scientific, the high-value medical device giant, successfullyleveraged its experience in the urinary and digestive sectors by firstestablishing its disposable endoscope business from those two sectors. Thecompany launched?LithoVue, theworld’s first disposable ureteroscope on Jan 12^th, 2016. The industry-leadingpipeline has later been extended to?EXALTD?duodenoscope (approved by FDA on Dec 13^th,2019),?EXALT B?bronchoscope (received CE Markon May 26^th, 2021), gastroscope, and?SpyGlass?choledochoscope, etc. Boston Scientific’s high-end marketpositioning and adequate reimbursement environment in the U.S. have jointlyresulted in those products’ relative-high prices.

?Ambu

Ambu A/S, founded in 1937, is a Danish company that develops, producesand markets disposable endoscopy solutions, diagnostic and life-supportingequipment to hospitals, private practices, and rescue services. In 2009, Ambulaunched aScope, the world’s first disposable bronchoscope, and later theindustry has witnessed the coronation of a long-lived king in the field ofdisposable bronchoscopy. Starting from bronchoscopy, Ambu gradually expandedits disposable endoscope kingdom’s territory, and the sales of disposable productsexceeded 1 million in the most recent fiscal year.

(2) Domestic Company

Up to now, 5 domestic companies have obtained a total of 6 disposableendoscope NMPA registration certificates, most of which were obtained in 2020.

Pusen Medical

Founded in 2014, Pusen Medical is located in Zhuhai, China. The companyobtained the NMPA registration certificate of disposable ureteroscope in June2020, and had built its overseas business with CE Mark and FDA approval evenearlier. The company’s pipeline also includes disposable rhino-laryngoscopes,bronchoscopes, and cystoscopes, etc.

Redpine

Redpine was established in Guangzhou International Biological Island in2015 and aims to provide its global clients with comprehensive solutions forone-time minimally invasive surgery. Its products cover several departmentsincluding urology, gynecology, otolaryngology, gastroenterology, respiratory,and general surgery, etc. Redpine has two products currently approved, its ureteroscopeand cystoscope, both in 2020. It is also the company that holds the most ClassIII registration certificates in the field of disposable endoscopy so far.

Anqing Medical, Innovex Group

Innovex Group is composed of three independently operated enterprises,each one is active in minimal invasive consumables, disposable digitalendoscopes, and surgical energy equipment & consumables. Its disposableendoscope branch, Anqing Medical was established in 2014 and is expected tohelp form a closed-loop with both low- and high-value consumables. AnqingMedical’s disposable ureteroscope received NMPA approval in 2020, and same asPusen Medical, entered overseas markets prior to that.

Happiness Workshop

Anhui Happiness Workshop Medical Instruments Co., Ltd. was establishedin 2017. The company in-licensed technology from Silicon Valley and integratedthem into an international leading disposable endoscope R&D platform. Thecompany manufactures disposable ureteroscopes and cystoscopes, and obtainedNMPA’s first approval of disposable ureteroscopy in China in Jan 2020.

North Tengda

Beijing North Tengda Technology Development Co., Ltd. was founded in2018. The company mainly engaged in domestic sales and after-sales service ofimported medical equipment, like MiroCam capsule endoscope and E.G.Scandisposable tube endoscope from South Korea. The company’s disposable ureteroscopyobtained NMPA approval in May 2021.

Conclusion

In 2020, the global endoscope leader Olympus realized $5.89 billion insales and continuously ranked 21^st among the top 100 medical devicecompanies worldwide, with only endoscope products. Behind Olympus’s enviableperformance is the strong monopoly of Japanese giants in the field of the coretechnology of traditional endoscopes. As listed above, it is the best time nowfor Chinese disposable endoscope startups to seize the opportunity and overtakeforeign conventional competitors. We are looking forward to seeing the greatvictory of domestic innovations and more and more global patients benefit from Chineseleading disposable endoscope technology.

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