Frost & Sullivan releases the 'Blue Book on the Current Situation and Development Trends of the Endoscopy Industry' (with full-text access)

Medical endoscopes are a type of medical imaging device used to provide access, illumination during endoscopic diagnosis and treatment procedures, and to observe or operate on body cavities, hollow organs, and bodily ducts. The clinical application of medical endoscopes can be divided into diagnostic and therapeutic aspects. They enter the body through natural or surgical incisions, with diagnostic functions mainly helping doctors make disease diagnoses after observation or take tissue samples for pathological diagnosis. Therapeutic functions are used for specific surgeries or assist in implanting therapeutic artificial products.

As a medical device that provides images of the internal anatomical structures of the human body, medical endoscopes integrate optics, ergonomics, precision machinery, modern electronics, computer software, and more. They mainly consist of three parts: an image acquisition system, an image processing system, and a lighting system:

Source: Public information, analysis by Frost & Sullivan

Medical endoscopes have a wide range of uses and are diverse in type, which can be roughly classified from three dimensions: imaging principle, usage frequency, and product structure.

Classified by imaging principle, electronic medical endoscopes are based on photoelectric information conversion and image processing methods. They achieve imaging by applying electronic components combined with optical components. Optical medical endoscopes, on the other hand, are based on geometric optical imaging principles and achieve imaging functions through the application of an optical lens group and optical path design.

Classified by usage frequency, reusable medical endoscopes have the characteristic of being reusable but require long-term maintenance such as cleaning and disinfection. Disposable medical endoscopes are suitable for single diagnoses and treatments, single use, and generally do not need maintenance.

According to product structure, the insertion part of rigid medical endoscopes is made of hard metal materials and generally cannot be bent during operation. They are usually inserted into the human body through surgery for diagnosis and treatment. Typical categories include laparoscopes, hysteroscopes, and arthroscopes; whereas the insertion part of flexible medical endoscopes is made of soft, bendable high-strength materials and generally enters through natural body cavities for observation and diagnosis, such as gastroscopy, cholangioscopy, and bronchoscopy.

The 'Blue Book' details the product composition, development history, and technological evolution of each component of endoscopes. It also analyzes their clinical applications mainly in minimally invasive surgery and digestive tract diagnosis. The book sorts out relevant policies for the endoscopic industry in recent years from aspects such as independent innovation of medical devices, domestic substitution, and hierarchical diagnosis and treatment. For more detailed content, please refer to the full report.

Optical imaging technology is crucial for the brightness and clarity of images and is one of the most fundamental elements of endoscopic products. The global high-definition endoscopic technology based on CCD image sensor technology has long been dominated by a few manufacturers, but the rise of CMOS image sensor technology has broken this technological monopoly. With the replacement of CMOS sensors, domestic manufacturers have made significant breakthroughs in independently developing high-end flexible and rigid endoscopes. The imaging clarity of Chinese endoscopic products has gradually progressed from standard definition to high definition and is transitioning towards 4K.

Source: Public information, analysis by Frost & Sullivan

The 'Blue Book' details the product iteration process, technical advantages, and clinical application scenarios of 4K medical endoscopes. For more detailed content, please refer to the full report.

Early 2D endoscopic products provided two-dimensional planar images, but doctors lacked hand-eye coordination and relied on the movement and size of the endoscope to estimate the distance between anatomical regions and surgical instruments. This method could not be applied to complex surgical operations, and its scope of use was limited. At the same time, with the popularization of medical endoscopes in minimally invasive surgeries, doctors face higher clinical demands during diagnosis and treatment. In addition to clearly seeing the surface layer of human tissues, they need to see the depth relationships between tissues and organs to provide more accurate images for the surgical process. As a result, 3D medical electronic endoscopes have emerged and gradually evolved into the mainstream functional endoscopic type of application.

The 'Blue Book' details the development history, technical advantages, and clinical application scenarios of 3D medical endoscopes. For more detailed content, please refer to the full report.

The images of white light endoscopes are based on the visible light spectrum ranging from 400 to 700 nanometers. Due to the limited operating spectral range, they can only display images of the superficial layer of human tissue and cannot image deeper tissues. In the white light field of view, some lesions are hidden under the mucosa or mixed with other tissues, making it difficult for doctors to fully outline the current condition of the lesions based solely on experience.

Fluorescence endoscopy technology can effectively overcome the limitations of white light endoscopy. Its working spectral range of 400 - 900 nm can provide clear images of both superficial and deep tissues simultaneously, enhancing the visibility of lesions and areas before lesions, which is conducive to precise intraoperative positioning. In addition, the accurate imaging results provided by fluorescence endoscopy assist doctors in quickly and effectively differentiating and removing diseased tissue, thereby reducing surgical difficulty and risk, minimizing iatrogenic injuries and postoperative complications.

The 'Blue Book' details the imaging principle, technical advantages, and clinical application scenarios of fluorescent medical endoscopes. For more detailed content, please refer to the full report.

The technical barriers in the field of medical endoscopes are mainly reflected in interdisciplinary R&D capabilities, a complete industrial chain layout capability, and precision manufacturing processes. Endoscope R&D integrates cross-disciplinary technologies such as optics, precision machinery, electronic materials, and image processing. Among them, optical imaging technology and image processing technology are the two core technologies of medical endoscopes, and they also determine whether a product can meet the industry's first-class standards. Therefore, the R&D process in the field of medical endoscopes requires a large number of talents with diverse backgrounds and rich experience in multiple fields.

At the supply chain level, many high-precision manufacturing components need to be purchased from manufacturers in numerous industries around the world, including image sensors, outer layers of mirrors, stainless steel cables, optical fibers, handles, and lubricants. R&D enterprises need to integrate resources from multiple industries and establish an efficient component supply chain.

In addition, the manufacturing of medical endoscopes involves multiple processes such as machining, welding, polymer material forming, heat treatment, and high-precision extrusion molding. Many of these processes cannot be fully automated at present and rely on manual fine processing and assembly. It is time-consuming and difficult to cultivate skilled manufacturing technicians in a short period, as it requires long training cycles and overcoming technical barriers through simple imitation is challenging.

The commercial barriers to the commercialization of medical endoscopes mainly include brand loyalty and distribution channel expansion. Endoscope hosts under the same brand are compatible with multiple endoscopes. When used for different procedures, only the corresponding endoscope needs to be replaced for operation, which also helps to solve compatibility issues in subsequent disinfection and maintenance procedures. Therefore, hospitals tend not to easily change endoscope brands, and early market entrants are more likely to build high product loyalty and expand multi-product line layouts. At the same time, doctors form personal preferences for specific brands during clinical use and do not easily change their clinical operation habits. Due to the wide coverage of clinical departments and high technical barriers for endoscope products, medical endoscope manufacturers tend to cooperate with distributors to promote products to medical institutions. Medical endoscope companies have a first-mover advantage in distribution channels and can establish stable cooperative relationships with distributors in advance.

Endoscopes are indispensable diagnostic and surgical equipment in departments such as general surgery, urology, otolaryngology, orthopedics, gynecology, etc., and are also one of the fastest-growing product categories in the global medical device industry. Developed countries overseas have a broad foundation for endoscopic applications, while the Chinese medical endoscope market is still in a stage of rapid development. Driven by factors such as the establishment of China's hierarchical diagnosis and treatment system, the development of minimally invasive surgery, and the gradual improvement of physician training systems, the scale of the Chinese medical endoscope market will expand rapidly at a rate higher than the global average.

At the same time, with the development of industries such as computers, big data, precision machinery, and the acceleration of medical technology progress, the clinical demand for high-definition and deep tissue imaging continues to increase, and the market scale of functional endoscopes in China will continue to expand.

The 'Blue Book' analyzes the global and Chinese market sizes for medical endoscopes, as well as the market penetration of functional endoscopes in China. It visually demonstrates the future development potential of the endoscope industry. For more detailed content, please refer to the full report.

The global endoscopic market is mainly dominated by American, Japanese, and German companies, with representative enterprises such as Karl Storz, German Wolfson, Olympus, Fujifilm, and Stryker. The leading firms have a significant effect, with their lenses and imaging systems covering the diagnostic and therapeutic needs of multiple departments. In the field of flexible endoscopes, the market competition pattern shows an oligopoly. However, overall, the market concentration of rigid endoscopes is relatively lower than that of flexible endoscopes, which can be attributed to the larger number of participants in the rigid endoscope sector. Moreover, rigid endoscopes have barriers such as lower technical complexity, clinical requirements, and patent monopolies compared to flexible endoscopes. The upstream supply chain is more flexible and open for downstream integration of complete machines.

From the perspective of the market structure of endoscopes in China, foreign manufacturers still dominate the market with their advanced manufacturing capabilities, leading innovation in technology, complete product lines, and strong brand effects, especially in mid-to-high-end application scenarios such as tertiary hospitals. In the field of flexible endoscopes, representative domestic manufacturers like Shenzhen Kaili and Shanghai Aohua have successively launched high-end product lines equipped with AI-assisted diagnosis and composite imaging technologies in recent years. In the field of rigid endoscopes, the pace of domestic substitution has accelerated significantly, with domestic brands such as Optomand, Nuoyuan Medical, Kangji Medical, Xin Guangwei, Haitai Xin Guang, and Mindray achieving technological breakthroughs one after another.

The 'Blue Book' details the product layout and industry competition landscape of Chinese endoscopic manufacturers in the field of functional endoscopes. For more detailed content, please refer to the full report.

Traditional endoscopes have a complex structure, consisting of many tiny and intricate parts that are difficult to disassemble individually for cleaning and disinfection. As a result, cross-infection may occur among patients. In addition to cross-infection, inadequate cleaning can also cause blockages in the inner cavity of the endoscope, as well as jamming of valves and movable parts. Moreover, complicated cleaning can lead to certain maintenance costs. Furthermore, flexible endoscopes cannot undergo the same disinfection process as rigid ones; high-temperature and high-pressure sterilization operations may damage core components and are expensive, making them unsuitable for disposal after single use.

Based on factors such as the need to reduce cross-infection risks and maintain costs, an emerging consumable disposable endoscope can avoid infection problems and high cleaning and disinfection expenses caused by repeated use of products, thereby improving patient safety and helping medical institutions save operating costs.

Source: Public information, analysis by Frost & Sullivan

The Blue Book details the technical advantages and clinical application scenarios of disposable medical endoscopes. For more detailed content, please refer to the full report.

The disposable endoscope product is equipped with a highly integrated host system, characterized by its compact size and high precision. The structural design and welding process of multiple components such as the endoscope handle, tip, and working channel pose significant technical barriers, requiring support from technologies like laser cutting and automatic adhesive bonding welding.

Secondly, the supply chain of disposable endoscopes involves hundreds of components such as image sensors, outer metal tubes, stainless steel traction wires, optical fibers, handles, and lubricants. A few domestic manufacturers possess large-scale production capabilities covering a series of processes from wafer cutting to chip packaging and integration of optoelectromechanical systems.

In addition, the product feature of disposable endoscopes is that they are discarded after use. Generally, costs are reduced through methods such as reducing materials, simplifying the internal structure of the product, and reducing parts. Therefore, disposable endoscope products need to balance cost and performance, achieving cost control without compromising performance requirements, which is the main difficulty faced by current disposable endoscope manufacturers.

Source: Public information, analysis by Frost & Sullivan

As of March 2023, 76 disposable medical endoscopic products have been approved for market launch. Due to the high cost of traditional cystoscopes and ureteroscopes, and the relatively high probability of damage during surgery with urological endoscopes, disposable products provide a more favorable price margin for subsequent promotion. Most companies choose to start with these two products. Therefore, urology is the department with the widest layout, with 27 companies deploying disposable cystoscopes and ureteroscopes, and 47 products having been approved for market launch, accounting for about 63.5% of the total. In addition, 16.2% of the products are used in respiratory medicine, 12.2% in gynecology, 6.8% in gastroenterology, and 1.4% in minimally invasive surgery.

Source: Public information, analysis by Frost & Sullivan

In recent years, the clinical advantages of disposable medical endoscopes have become increasingly clear, and related products have entered a peak period of market launch. The 'Blue Book' sorts out the approved disposable medical endoscope products and market competition landscape. For more detailed content, please refer to the full report.

The market drivers of medical endoscopes mainly include technological innovation, clinical demand, favorable policies, and grassroots penetration.

The future development trends of medical endoscopes include continuous product upgrades and iterations, deep integration of multiple technologies and processes, the extension and construction of the entire industrial chain, and acceleration of domestic substitution under independent technological breakthroughs.

The 'Blue Book' summarizes and presents the market drivers and future development trends of the medical endoscopy industry. For more detailed content, please refer to the full report.

The 'Blue Book' details the financing events of companies in the domestic endoscopic field, as well as mergers and acquisitions in the domestic and international endoscopic industries. For more detailed content, please refer to the full report.

Guangdong Opemend Technology Co., Ltd. was established in 2013 and is a national high-tech enterprise with a full range of functional endoscopic products. After years of innovation and development, the company has mastered core technologies in multiple areas such as fluorescence endoscope design and manufacturing technology, optical 3D endoscope design technology, endoscope imaging technology, flexible endoscope system design technology, and platform integration technology. Adhering to the business philosophy of "building a global leading endoscope platform innovation enterprise in functional imaging," the company is committed to applying world-leading optical technology to the medical field, providing customers with high-level and high-quality medical products and services.

Nanjing Nuoyuan Medical Devices Co., Ltd. was established in 2011 and is a national high-tech enterprise integrating the research, development, production, and sales of high-end medical devices and innovative targeted probes. The company has established an innovative model of 'combining medicine and devices' to provide a full-chain solution for precise tumor diagnosis and treatment; it possesses continuous innovation capabilities, develops multiple series of medical devices and contrast agents with international advanced levels, focuses on core technologies such as molecular fluorescence, Raman spectroscopy, artificial intelligence, and AI-assisted drug design, has a rich product pipeline, and is committed to becoming a leader in precision medical technology.

Hangzhou Kangji Medical Devices Co., Ltd. (hereinafter referred to as Kangji Medical) was established in 2004 and has been deeply involved in the field of minimally invasive surgery for nearly two decades. It provides comprehensive, high-quality, reliable, and accessible overall solutions for minimally invasive surgeries to doctors and patients in China and around the world. The company has now become the largest platform for minimally invasive surgical instruments and supporting consumables in China, serving more than 3,500 hospitals nationwide, including over 1,000 Class III Grade A hospitals, with its business scope covering nearly 50 countries and regions globally.

UroViu was established in 2016 as a portable, disposable endoscope research and development manufacturer with its headquarters located in California. It has offices and production facilities in North America and Asia. The products developed cover urology and gynecology, and the platform is protected by 30 granted patents and numerous patent applications in progress. The company's development mission is to innovate cystoscopy and hysteroscopy platforms to improve patient care and efficiency, with the vision of simplifying the scope of patient care.

Shenyang ShenDa Endoscopy Co., Ltd. was established in 1985 and is one of the earliest domestic companies to develop, produce, and sell medical rigid endoscopes, minimally invasive surgical instruments, and medical electrical products. The company is moving forward with solid and steady steps towards internationalization, intelligence, scale, and industrialization.

Shanghai Aohua Endoscope Co., Ltd. was established in 1994 and is a technology enterprise mainly engaged in the research, development, production, and sales of electronic endoscope equipment and consumables for endoscopic diagnosis and treatment. The company's products have been applied in multiple clinical departments such as gastroenterology, respiratory medicine, otolaryngology, gynecology, and emergency medicine.

Shenzhen Kaile Biomedical Technology Co., Ltd. adheres to the concept of "setting a precedent in the industry and establishing a national brand." Since its establishment, it has been dedicated to the independent research and development and manufacturing of medical equipment. Its products cover fields such as ultrasonic medical imaging, endoscopic diagnosis and treatment, minimally invasive surgery, and cardiovascular intervention, providing clinical solutions for different departments in hospitals at all levels.

Midea Medical Group Co., Ltd. was established in 1991 with its headquarters in Shenzhen, China. It is a leading manufacturer of high-tech medical equipment in China and one of the global innovators in medical devices. Since its inception in 1991, Midea has been dedicated to the research, development, and manufacturing of clinical medical equipment. Its products cover four major areas: life information and support, clinical testing and reagents, digital ultrasound, and radiological imaging.

Xinguangwei Medical Technology (Suzhou) Co., Ltd. was established in 2016 and is a minimally invasive diagnosis and treatment enterprise dedicated to the research, development, and commercialization of medical endoscopes and related innovative products. The company has set up R&D centers in China and Japan, creating a comprehensive portfolio of medical endoscope products and research products, covering all types of endoscopic surgeries performed in various clinical departments of hospitals, and capable of meeting diverse medical needs.

Haitai Xin Guang was established in 2003 and is mainly engaged in the research, development, production, and sales of medical endoscopic instruments and optical products. The company has established four major technical platforms of 'optics, precision machinery, electronics, and digital imaging', possessing a complete industrial chain from system design to optical processing, component assembly, and system integration. In the medical field, the company is committed to developing and manufacturing high-performance medical device products, providing core components and complete systems such as surgical external viewing systems and endoscopic systems for surgical operations, and offering a full set of optical imaging solutions for clinical medicine.

DPM Company (including Beijing Digital Precision Medical Technology Co., Ltd. and Zhuhai Dipu Medical Technology Co., Ltd.) was established in 2016 and is the crystallization of research and accumulation from major projects in multiple countries. Currently, DPM's business scope covers the independent research and development and production of a variety of high-end intraoperative optical molecular imaging surgical navigation devices and contrast agents, creating a closed-loop of 'equipment + consumables'. In the future, relying on new magnetic nanoparticle disease screening imaging technology, the company will further advance from the field of precision surgery into the field of precision health.

Shanghai Yisi Medical Technology Co., Ltd. was established in 2011 and is a high-tech company focusing on the research, development, and industrialization of advanced minimally invasive surgical medical devices for tumors. It is a national high-tech enterprise, a demonstration unit for brand cultivation by the Ministry of Industry and Information Technology, and a brand cultivation demonstration unit in Shanghai. The company provides complete minimally invasive surgical solutions for tumors globally, with product applications covering minimally invasive surgeries in the fields of digestive system, respiratory system, urological system, etc., including tumor surgery, bariatric surgery, and pneumothorax surgery.

Pusan Medical was established in 2014 and is an innovative medical technology enterprise integrating R&D, production, sales, and service. It focuses on providing clinical with innovative and high-quality medical products. As a pioneer of disposable endoscopes, while establishing its product line in urology, it actively expands into medical fields such as ICU, respiratory anesthesia, otolaryngology, etc., adhering to technological innovation as the leading force for development, and providing more, better, more diversified, and cost-effective products and services for clinical practice.

Anhui Xingfu Industrial Park Medical Equipment Co., Ltd. was established in 2017 and is a high-tech enterprise engaged in the research, development, manufacturing, and sales of disposable endoscopic systematic diagnosis and treatment products. The company has formed an internationally leading research and development technology platform for disposable electronic endoscopes, developing products such as disposable electronic ureteral flexible endoscopes, bladder flexible endoscopes, pressure-measuring control endoscopes, etc. Products such as disposable hysteroscopes, disposable gastroscopes, intelligent perfusion and suction platforms, and laser equipment will also be launched on the market one after another.

Founded in 2017, Lienserth has been focusing on the development of disposable endoscopes and auxiliary instruments for the digestive system since its inception. Adhering to the concept of focused innovation and independent intellectual property research and development combined with clinical practice, it fully considers the integration of clinical needs and regulations. Especially in terms of low-cost control, it has a very deep understanding and experience. Currently, some products have obtained certifications such as CE MDR, MDD, FDA, NMPA, and those from other countries and regions. By combining its own globally innovative products and commercialization paths, it has carried out global layout, and its series of products have been successively launched globally.

Ruipai Medical was founded in 2015 and is located on Guangzhou International Bio Island. It is a national high-tech enterprise. As a global supplier of disposable endoscopes with high cost-effectiveness, its product development plan covers urology, gynecology, otolaryngology, respiratory medicine, general surgery, etc. The company is committed to improving the medical environment, enhancing the accessibility of medical services, integrating clinical needs with the development trends of medical technology. With cutting-edge R&D technologies and advanced service concepts, it provides and formulates innovative and comprehensive medical solutions from detection, diagnosis to treatment.