Since its inception in the 19th century, medical endoscopes have continued to develop, and now they have been used in general surgery, urology, gastroenterology, respiratory, orthopedics, otolaryngology, gynecology and other departments, becoming one of the most commonly used medical devices in modern medicine.
In recent years, technologies such as 4K, 3D, single-use technology, special light (such as fluorescence) imaging technology, ultra-fine medical endoscopy technology, big data, and artificial intelligence have developed rapidly, and have been successively applied in the field of endoscopy. At the same time, my country's endoscope industry is in a state of numerous pain points, numerous opportunities, and mixed players. The entire endoscopy industry is being subverted and reshaped by various factors such as technology, policy, and clinical practice.
In order to help industry colleagues keenly capture innovation trends and gain insight into the direction of change, Arterial Network Eggshell Research Institute will start from the details and will launch the "2021 Endoscopy Innovation Trend Report" for different demand directions and different innovation directions. This report focuses on the innovation drivers in the field of endoscopy, and analyzes the innovation opportunities of 4K, 3D, artificial intelligence, big data and other emerging technologies in the field of endoscopy.
The main points:
CMOS, 4K, 3D and computer technologies have achieved breakthroughs and are gradually applied in the field of endoscopy.
Giants such as Olympus monopolize the domestic endoscope market, and domestic companies are expected to overtake in corners by breaking the technological blockade.
The field of disposable endoscopy is one of the few endoscopy segments in my country that is at the leading level in the world.
4K ultra-high-definition endoscopy and 3D endoscopy are moving towards integration, and "4K+3D" will become the mainstream in the future.
The endoscopic AI-assisted diagnosis system focuses on the digestive tract, and the future broad market will be at the grassroots level.
The domestic endoscope field is hot in financing, and disposable endoscopes and 4K ultra-high-definition endoscopes have attracted much attention.
The history of endoscopy
Medical endoscope is a medical device commonly used in modern medicine. In terms of categories, there are many types of endoscopes, including gastroscope, colonoscope, laryngoscope, esophagoscope, laparoscope, thoracoscope, choledochoscope, cystoscope, ureteroscope, nephroscope, hysteroscope, vascular endoscope, joint Laparoscopic etc. In terms of functions, endoscopes have a variety of application scenarios. They can enter the human body through natural or surgically manufactured channels such as the oral cavity to help doctors screen and diagnose diseases. At this stage, they can also assist doctors in minimally invasive surgery.
In the 19th century, German scientists invented the rigid medical endoscope to examine the bladder and urethra. Early rigid medical endoscopes consisted of metal tube shells, optical components, and light sources. The optical elements include prisms, lenses, and reflectors; the light sources include candle light, tungsten filament external light reflection light sources, or small electric bead internal light sources.
Rigid medical endoscopes are not only difficult to insert into human orifices due to their rigid materials, structural defects and technical limitations, but also bring great pain to patients. At the same time, the illumination level of its light source is low, resulting in unclear images, many blind spots in observation and poor diagnosis.
In 1954, British scientists Hopkins and others jointly invented the optical fiber technology. Hirschowitz and his team developed the world's first fiber optic gastroduodenoscope based on optical fiber technology, which is also recognized as the world's first soft medical device product. The product uses optical fiber as the light guide and image transmission element, and uses an external strong cold light source for illumination, which can be used for photography. Since the optical fiber is a flexible element (the object is deformed by force, and the property that it cannot return to its original state after the force is lost is called flexibility), the Hirschowitz team added a bending mechanism to the lens, so that the flexible endoscope can control the bending direction, It is easy to insert into the human body and reduces the pain of the patient. In 1960, the American ACMI company commercialized it.
Japanese companies started late in endoscopy, but their innovation speed is fast. In 1962, Japan's Olympus added a biopsy device and a camera on the basis of the fiberoptic gastroscope, which significantly improved the detection capability of the endoscope. In 1966, Olympus innovatively developed the front end angle structure of the endoscope to further improve the observation field of the endoscope. In 1967, the Japanese company Machida adopted an external cold light source, which greatly increased the amount of light. Based on technological breakthroughs and continuous innovation, Japanese companies have occupied a pivotal position in the field of international endoscopy. At present, Japanese company Olympus has occupied 34% of the global endoscope market share.
In 1970, the charge-coupled device was born. Due to the dual characteristics of photoelectric conversion and scanning, charge-coupled devices have quickly become popular in the field of medical endoscopy. In 1983, Welch Allyn of the United States took the lead in launching the world's first electronic endoscope. Afterwards, Western European and Japanese companies quickly followed up and increased investment in the research and development of electronic endoscopes, setting off an upsurge in the development and application of electronic endoscopes. Compared with fiberoptic endoscopes, electronic endoscopes have many advantages such as clearer images, more realistic colors, higher resolution, and can be observed by multiple people at the same time, and they have become the mainstream of the market.
Data source: public data statistics, produced by Eggshell Research Institute
Throughout the development history of medical endoscopes, from rigid endoscopes to fiber endoscopes to electronic endoscopes, the shape and structure of endoscopes have undergone tremendous changes, and their image quality has also steadily improved with product iterations.
At the same time, we can see that every leap-forward development of endoscope products stems from the bottom-level technological innovation. For example, based on optical fiber technology, endoscope companies have innovated flexible endoscopes and fiber endoscopes; based on charge-coupled device technology, endoscope companies have innovated electronic endoscopes and gradually replaced fiber endoscopes. On the other hand, innovations in structures, materials, and procedures have expanded more application scenarios for endoscopes, saved more patients, and spawned a larger endoscope market.
The Pattern and Opportunity of Endoscopy
Driven by various factors such as policies, enterprises, technology, and patient needs, my country's endoscopic industry is accelerating its development. In 2019, the size of my country's endoscope market was 22.5 billion yuan, and it is expected to grow to 42.3 billion yuan in 2024.
Data source: Frost & Sullivan, produced by Eggshell Research Institute
According to "China Endoscope Market Scale and Forecast 2015-2024", the proportion of my country's endoscope market in the global market continues to rise. In 2015, my country's endoscopic device market accounted for 12.7% of the global market, and it accounted for 16.1% in 2019 and is expected to increase to 22.7% in 2024.
On the other hand, as a large country with a population of 1.4 billion, China is one of the countries with the fastest growth rate of the endoscope market, and the market growth rate is much higher than the average growth rate of the global market. From 2015 to 2019, the compound annual growth rate of the global endoscope market size was only 5.4%, while the compound annual growth rate of the Chinese endoscope market was as high as 14.5%. Huge market space and fast-growing market have brought development opportunities for domestic endoscopy companies, but at present, the domestic endoscopy field is still dominated by multinational giants. In the competition pattern of soft endoscopes in my country, three Japanese companies dominate the market, and other brands account for less than 2%. Among them, Olympus accounted for 71%, Fuji accounted for 15%, and Pentax accounted for 12%.
Data source: Frost & Sullivan, produced by Eggshell Research Institute
In the field of hard mirrors, companies from Germany, Japan and the United States dominate the market, accounting for over 80% of the market. Among them, Karl Stoss, Olympus, Stryker, and Wolf occupied the top four in my country's hard mirror market.
Data source: Frost & Sullivan, produced by Eggshell Research Institute
Both hard and soft mirrors have extremely high technical barriers. For domestic enterprises, factors such as talents, technology, patents, production processes, and brands are all pain points: overseas giants do not set up R&D centers in China, which makes the domestic lack of relevant talents; early layout of patent barriers makes it more difficult for domestic enterprises to break through patents .
At present, domestic enterprises have achieved breakthroughs in core components. The core components of an endoscope include a lens, an image sensor, an image processor, and a light source. In terms of cold light sources, 116 products in my country have been approved by the State Food and Drug Administration; in terms of image processors, 47 products have been approved.
As for image sensors, domestic companies also have solutions. Endoscopic image sensors can be classified into charge-coupled elements (CCD) and metal-oxide-semiconductor elements (CMOS). Among them, CCD technology is monopolized by a few foreign companies, while CMOS technology is emerging globally. From a technical point of view, CMOS has the advantages of small size, low power consumption, low cost, and high system integration, and is considered to be more likely to become the mainstream technology of endoscopic sensors. At present, many companies around the world have applied CMOS technology to medical endoscopes and launched a number of innovative endoscope products. At the same time, domestic companies have made rapid progress in CMOS technology, and the gap with overseas technologies is small, and there is a greater opportunity to achieve technological breakthroughs with CMOS image sensors.
From the perspective of domestic endoscopy companies, the industry is relatively scattered, and there is no leading company that can challenge foreign giants. At the same time, domestic endoscope products are currently mainly competing for the low-end endoscope market, and the high-end endoscope market is still dominated by import companies. In the field of soft mirrors, domestic enterprises mainly include Shenzhen Kaili, Shanghai Aohua, etc.; in the field of hard mirrors, mainly include Xinguangwei Medical, Shenyang Shenda, Tiansong Medical, Mindray Medical, Haitai Xinguang, etc.
Judging from the history of localization of a single instrument, there is a large domestic alternative space in the field of endoscopy. Especially with the emergence of new technologies, the localization process of endoscopes will be greatly accelerated. For example, in optical imaging technology, the rise of CMOS image sensors broke the monopoly of Japanese CCDs; in dyeing technology, in addition to Olympus' NBI technology, various brands have developed their own dyeing technologies, such as Pentax I-Scan technology, Medical VIST technology, etc.; in the manufacture of mirror bodies, the trend of mirror body consumables is becoming more and more obvious, and disposable endoscopes have made breakthroughs.
At present, combined with a variety of technological innovations, disposable endoscopes, compound endoscopes (ultrasound endoscopes, optical coherence tomography endoscopes, fluorescence endoscopes, confocal endoscopes, etc.), endoscopes, etc. Robots, endoscope AI-aided diagnosis systems, 4K ultra-high-definition endoscopes, 3D endoscopes, capsule endoscopes and other innovative products.
On the traditional endoscopy track, domestic companies need to spend a lot of energy to catch up with technology. However, with the emergence of new technologies and the silence of traditional technologies, domestic enterprises and multinational giants are standing on the same starting line in terms of innovative endoscopes, and this is also a rare opportunity for domestic endoscope companies to overtake in corners.
Innovation driver for endoscopy
According to the development history of endoscope, the leap-forward iteration of endoscope originated from the most primitive technological breakthrough. Today, various cutting-edge technologies such as CMOS technology, 4K technology, 3D technology, artificial intelligence technology, big data technology, and deep learning technology are becoming more and more mature and gradually applied in the field of endoscopy, laying a technical foundation for the innovation of endoscopy.
On the other hand, the continuous growth of the endoscope market size provides a broad space for endoscope companies to seize the market, gain profits and create wealth, while the demand for profit and wealth creation drives endoscope companies to continuously innovate products. Make it take the initiative in the market competition.
At the same time, a variety of factors, such as changes in consumer behavior, clinical demand upgrades, capital bets, policy support, and corporate competition, drive endoscopy companies to continue to innovate.
Compared to two decades ago, clinical needs have changed dramatically. For doctors, they need clearer, more three-dimensional (three-dimensional) images with more parameters; for patients, they need safe, painless, and timely feedback endoscopic diagnosis and treatment.
Data source: Frost & Sullivan, produced by Eggshell Research Institute
For clearer needs, domestic and foreign companies have been researching or developing 4K ultra-clear endoscopes. For example, Xinguangwei Medical has launched a 4K medical endoscope camera system; the AIENDO-4K ultra-high-definition endoscope system developed by Tuge Medical is the first domestic 4K endoscope product purchased by a hospital in China. In addition, the fluoroscope (working spectrum is 400-900nm) has a wider working spectrum than the traditional white light microscope (working spectrum is 400-700nm), so it can show the image of the surface layer of human tissue and the fluorescence imaging of the tissue below the surface, such as the gallbladder Vessels, lymphatic vessels, and blood vessels are visualized; white light microscopy mainly displays surface images of human tissues. Therefore, fluoroscopy has become more and more widely used in clinical practice. Today, OPMANDI has broken the continuous leadership of overseas companies, and took the lead in launching the world's first 4K fluorescence laparoscopic system; at the same time, other domestic companies have launched related products. Ultra HD Fluorescence Endoscopy System.
For more three-dimensional needs, 3D endoscopes can provide doctors with three-dimensional images. At present, Sino Micro Medical has launched a 3D electronic thoracic and laparoscopic system; Surui Medical's 3D electronic laparoscopic endoscope has been approved by the State Food and Drug Administration. However, 3D endoscopes also have the problem of clarity, and how to realize the combination of 3D and 4K will be the next difficult problem for such enterprises to consider.
In response to the demand for more parameters, Kaili Medical has launched the first ultrasound endoscope in China, which can provide endoscopic images and ultrasound images; Nanwei Medical has developed an endoscopic optical coherence tomography system (EOCT), which is used in It is the first time in China to apply optical coherence tomography to the diagnosis of early cancer in the digestive tract, and it is also the second commercialized EOCT system in the world; MicroVision is the first to create confocal pancreaticobiliary endoscopy, which can be used for clinicians. It provides real-time in vivo pathological-level image information, and can help doctors see real-time microscopic images of cells at the stenosis during surgery.
In response to the need for more safety, many companies have developed disposable endoscopes, which solve the problem of cross-infection in endoscopy and treatment, and improve safety. For example, Ruipai Medical's single-use electronic cystoscope and disposable electronic uretero-pyeloscope catheter have been approved in 2020, and its product line plans to cover urology, gynecology, ENT, respiratory, General surgery, etc.; and Xinguangwei Medical, Pusheng Medical, Anqing Medical, Happiness Factory, Northern Tenda and other companies have also approved the listing of disposable endoscope products. For single-use endoscope companies, what needs to be innovatively solved is how to ensure the imaging quality and function of existing endoscopes at low cost.
In response to the demand for painless endoscopy, the emergence of capsule endoscopy has brought hope to patients. At present, Ankon Medical, Kingsoft Technology, Zifu Medical and other companies have launched a variety of capsule endoscopes, which can be used for gastrointestinal disease inspection and early cancer screening. The product is shaped like a capsule, and the user can start the inspection after swallowing, and one person, one mirror, avoids the risk of cross-infection. For capsule endoscopy companies, expanding indications, ensuring inspection accuracy, and assisting in image reading are their innovative directions.
In response to the need for timely feedback, the AI-assisted diagnosis system can help doctors diagnose more efficiently, quickly and accurately. The distribution of medical resources in my country is uneven, and endoscopic picture reading doctors are scarce. The artificial intelligence-assisted diagnosis system can help doctors with less experience to reach the "expert level", and the reading time is shorter and the diagnosis report is issued faster.
In addition, the domestic substitution trend and national policy support have promoted innovation in the endoscopy industry to a certain extent. The financial support of many investment institutions has provided a boost for corporate innovation. It is believed that under the combined forces of technology, market, policy, capital and other factors, the endoscopy industry will usher in a new wave of innovation.
Disposable endoscope
Disposable endoscopes address the risk of cross-infection common to traditional endoscopes.
As a precision instrument that penetrates deep into the human cavity, endoscopes can easily lead to cross-infection events. For example, in the Top 10 Medical Technology Hazards, published annually by the American Institute of Emergency Medicine, endoscopic
