Depth | Disposable endoscopes, the blue ocean market of tens of billions, who controls the ups and downs
It is classified according to the different parts reached by the endoscope: divided into ear nose, oral endoscope, dental endoscope, neuroscope, urethral cystoscope, ureteroscope, nephroscope, resectoscope, laparoscope, arthroscope, blood vessel Endoscopy, Sinusoscopy, Laryngoscopy, etc.
According to the clinical function of endoscopy, it is divided into diagnosis and treatment.
1.1.1 Hard mirror
The main supporting equipment of hard mirrors are camera system host, camera, cold light source, monitor, trolley, etc. Rigid endoscopes are mainly used to enter sterile human tissues and organs, or enter sterile human chambers through surgical incisions. The hard mirror is a prism optical system. The biggest advantage is that the image is clear, and it can be equipped with multiple working channels and select multiple viewing angles.
In the manufacturing process, the rigid mirror does not need to consider the flexibility and maneuverability of the mirror body, and the manufacturing process is relatively simple. In addition, the hard lens host only needs to capture the image displayed by the lens body and transmit it to the display screen, which is relatively independent from the lens body. And the requirements for image staining are not high, so it can be used with different brands of mirror bodies. Compared with soft mirrors, hard mirrors have fewer barriers, and it is expected to achieve domestic substitution first.
At present, in the field of hard mirrors, the technology iteration of imported brands is relatively slow, and the products have entered a period of technical silence. Domestic brands have already achieved "curve overtaking" in some technologies.
1.1.2 Soft mirror
Flexible endoscopy mainly completes inspection, diagnosis and treatment through the natural cavities of the human body, such as gastroscopy, colonoscopy, laryngoscopy, bronchoscopy, etc. However, gastroscope and colonoscopy are still the mainstays, and flexible scope has become the gold standard for gastrointestinal cancer screening. The optical system of the flexible mirror is mainly a fiber-optic optical system. The biggest feature of this fiber-optic endoscope is that the lens part can be manipulated by the operator to change the direction and expand the scope of application, but the imaging effect is not as good as that of the hard mirror.
▲ Source: Olympus
In terms of technology research and development, soft mirrors integrate optics, precision instruments, electronics, materials, camera processing and other disciplines, and require the cooperation of multiple professional fields. Among them, the optical fiber manufacturing process and CCD sensing technology are one of the most important technical barriers for soft mirrors, while Japan's optical technology is developed, and the technology of the early core component CCD sensor is monopolized by Japanese companies. In addition, the production of endoscopes involves more than 100 components, and many suppliers of precision core components are concentrated in Japan and Germany. In addition, although Japanese companies have multiple production bases around the world, their core manufacturing processes remain in Japan, effectively preventing technology leaks. In image processing technology, Japanese companies have also formed patent barriers and industry standards, building a solid moat.
1.1.3 Disposable endoscope
Due to the high purchase cost, short service life, low turnover frequency, difficult disinfection and high maintenance cost of endoscopes, disposable endoscopes are more economical than traditional reusable endoscopes in many fields. With the advancement of graded diagnosis and treatment, the grass-roots endoscope market will expand, and the "consumables" of endoscopes has become a trend.
▲Source: Ambu official website
For flexible ureteroscopic lithotripsy surgery, a hospital needs to purchase 2 imported flexible endoscopes and a main unit, and the admission price is about 2 million yuan; when choosing a disposable endoscope, only a few domestically produced endoscopes need to be purchased for the operation. For a disposable soft mirror and a host, the admission price can be controlled within 100,000 yuan. Disposable endoscopes are very beneficial to the promotion of endoscopic surgery in primary hospitals.
For cystoscopy, due to the high cost of imported cystoscopy, the penetration rate in China is very low, and optical rigid mirrors are still the mainstream. Disposable electronic bladder semi-rigid mirrors with smaller diameter and hydrophilic coating provide better patient experience. At the same time, due to the higher charging standard of electronic mirrors, the profit of a single surgical operation in the department has also been improved.
1.2 Endoscope market (potential market exceeds 40 billion yuan, with a growth rate of 15%, and domestic production is less than 5%)
In 2019, the scale of China's endoscope market was 22.5 billion yuan, with a growth rate of about 15%. It is expected that by 2024, the market size of China's endoscope equipment will grow to 42.3 billion yuan, which is in a stage of rapid growth and has broad market prospects.
▲Source: Frost & Sullivan
In 2018, the three Japanese companies, Olympus, Fujifilm and Pentax Medical, had a combined market share of about 95% (21 billion), of which Olympus dominated the market with a market share of more than 80%. Among domestic enterprises, Aohua has a market share of about 2.5% (552.5 million), ranking first among domestic brands.
(1) Hard mirror market (nearly 20 billion yuan, domestic 8%)
Rigid endoscopes have a wide range of applications. Rigid endoscopes represented by laparoscopy have achieved rapid development in recent years as an important tool for minimally invasive surgery. In 2019, the sales volume of China's rigid endoscope market was about 18.66 billion yuan.
In the field of hard mirrors, the market is highly concentrated, mainly monopolized by German and Japanese companies.
Among them, Karl Stoss of Germany and Olympus of Japan occupy 47% and 23% of the first echelon respectively, with absolute leading advantages; the second echelon of American Stryker and Wolf brand occupy 13% and 9% of the market share respectively. .
Domestic brands mainly include Shenyang Shenda, Zhejiang Tiansong, Qingdao Haitai Xinguang, etc., mainly concentrated in the low-end market.
(2) Soft endoscope market (over 5 billion yuan, accounting for 22% of the total endoscope market, within 10% of domestic production)
In 2019, the global soft mirror equipment market size was US$6 billion and consumables were US$5.9 billion, still in the popularization period.
The development of flexible mirrors is driven by the market demand and the development of endoscope manufacturing technology, and has entered a period of rapid development. According to statistics, the sales volume of China's flexible endoscope market in 2019 is about 5.34 billion yuan, with a growth rate of more than 12%. Flexible endoscopes account for about 22% of the total endoscope market, and domestic production accounts for less than 10%. Endoscopy business revenue is about 200 million yuan, accounting for about 4%.
(3) Disposable endoscope market
The popularity of disposable endoscopes will inevitably increase the consumption of endoscope consumables exponentially. According to statistics, the use of endoscopes in a tertiary hospital is about 600,000 times a year. The national hospitals are classified according to their grades: there are 1192 tertiary hospitals, of which 722 are tertiary hospitals. There are 6,780 second-level hospitals, 4,989 first-level hospitals, and 6,751 unrated hospitals. Excluding some department endoscopes that cannot be used as disposable consumables for the time being, the potential diagnosis and treatment volume of over 60 million cases in my country. Boston Scientific predicts that the global disposable endoscope market will reach $2 billion in 2024.
my country's Endoscopy Challenge
2.1 "Stuck neck" technique
The technical barriers in the field of endoscopy are extremely high. Japanese and German brands have a long history of development, and they have accumulated huge technical advantages in the industry. There is still a gap between domestic brands. The key technologies of medical endoscope mainly include image acquisition, image post-processing and lighting methods.
▲Data source: Prospective Information Network and public data collation
(1) Image acquisition
The image acquisition system generally consists of imaging lens, miniature image sensor, acquisition and processing circuit and other parts. The image sensor is a sensor that senses optical image information and converts it into a usable output signal. It is an important part of a digital camera. It can be divided into two categories: charge-coupled components (CCD) and metal-oxide-semiconductor components (CMOS).
▲Source: Prospective Research Institute
(2) Image post-processing
There are still many gaps between domestic brands in terms of image delicacy and color reproduction. At present, the Japanese brand Olympus has stronger image processing and information extraction technology, and has many patented technologies, including bifocal magnification technology, Narrow Band Imaging (NBI), autofluorescence technology (AFI), Far infrared imaging technology (IRI), etc. Noise reduction algorithms play a key role in improving image quality and help resolve motion blur issues; edge enhancement is also a very important image processing technique that helps doctors see abnormalities in tissue more comprehensively , such as generating a higher contrast vascular view, improving the view quality of tissue texture images and mucosal surface images, etc.
Comparison of mainstream endoscopic image processing techniques
▲Data source: public information
(3) Lighting method
Whether the reproducibility of the illumination color is good is directly related to the performance of the entire endoscope. The light unit usually consists of xenon lamps or metal halide bulbs, mainly composed of power electronic systems.
(4) Mirror body maneuverability
The maneuverability of the endoscope body directly affects the doctor's operating feel and the patient's intraoperative experience. Judging from the lens parameter data, the performance of domestic brands has reached international standards. However, according to some clinical feedbacks, in terms of intraoperative experience of patients, domestic endoscopes are used, and there are many feedbacks from patients with throat discomfort. In addition, in the design and manufacture of the mirror body, Olympus has extremely high requirements, which are composed of more than 100 parts, which also directly leads to the difference in the maneuverability of the mirror body.
2.2 There is a shortage of endoscopists, and a training system needs to be established urgently
Endoscopic clinical diagnosis and treatment has high technical and safety requirements, and requires experienced practitioners to operate. According to the 2012 National Digestive Endoscopy Census, there are 26,203 gastrointestinal endoscopy doctors in my country, accounting for 1.06% of all practicing doctors in the country. It is less than one-tenth of that in developed countries such as Japan, and there is a large gap in endoscopists. Coupled with the long training cycle of endoscopists, it is understood that in the United States, gastrointestinal endoscopists need to receive 10 years or more of education and training after completing an undergraduate degree.
In addition, the operation of endoscopes is complicated, and there are certain differences in the field of view, edge light effect, angular resolution and quality of the field of view of different brands of endoscopes. At present, the endoscopes that endoscopists contact during training are Japanese brands, forming a usage habit. Switching to other brands later, the cost is higher, and the doctor needs some time to get used to it again.
2.3 It is difficult to realize automation and mass production
Many production links of endoscopes (including disposable endoscopes) rely on manual fine work, and most parts are manufactured and assembled by hand. It is understood that most domestic enterprises that have obtained certificates of disposable endoscopes require manual welding to package CMOS. It is difficult to mass-produce, and the product yield is very low. In order to prevent the outflow of technology, Olympus' soft lens manufacturing plant has not moved out of Japan so far. The manufacturing process of soft mirrors is very demanding, and it is difficult to train skilled technicians. It is difficult for new entrants to achieve breakthroughs in technical barriers through imitation.
2.4 Low cost and high quality are difficult to achieve
The entry of disposable endoscope products into hospitals needs to be based on clarity and user-friendliness, and the widespread promotion needs to rely on the cost of single-use endoscopes being lower than that of multiplexed endoscopes. This determines that the core of disposable endoscopes is to play a game between cost and performance, that is, at a terminal price lower than the average cost of use of multiplexed endoscopes, to achieve the basic requirements of the department Requirements. In the game between cost and performance of disposable endoscopes, cost often receives more attention.
Traditional endoscope manufacturers design and manufacture disposable endoscopes from the path of reusable endoscopes. The result will be the same as Karl Storz. The design is simple, the mechanism is efficient, and the products are comparable to reusable endoscopes. In terms of control, it can't compete with Ambu. This makes KZ's product positioning slightly embarrassing: internally it may have an impact on the existing rich production line; externally, it is difficult to avoid the edge of competitive products that have been recognized by the market. Although KZ has done a lot of articles on the specification setting, it seems to avoid two embarrassing points, but it is still difficult to actually sell.
Domestically and even globally, the players of disposable endoscopes tell the most stories about the rapid cost reduction after mass production. The reality is that even if the terminal price is sold at $400, the average cost of use is still higher than that of multiplexed in most regions of the world.
