An endoscope, an inspection device that can enter directly into the body's natural channels, can provide doctors with sufficient diagnostic information to treat diseases.
However, traditional endoscopes have complex structures and are difficult to thoroughly clean and sterilize. The application of the same endoscope between different patients can easily lead to cross-infection, which in turn causes serious damage to the health of the infected, and even death.
In December 2018, Olympus was fined nearly 600 million for duodenoscopy infections. It is reported that in the frequent infection incidents, Olympus did not ensure the scope of adequate cleaning of endoscopes, resulting in incomplete cleaning and disinfection by the hospital. Between 2012 and 2015, more than 190 people were infected with the bacteria.
According to relevant research, endoscopes rank first in the risk ranking of cross-infection of medical devices. More than 70% of endoscopes are not cleaned properly, and nearly three-quarters of commonly used endoscopes are contaminated by bacteria. Therefore, the safety of endoscope use has become an unavoidable problem.
After years of exploration by endoscope companies, disposable endoscopes have entered the "stage". Its appearance effectively solves the problem of cross-infection, and there is no loss of endoscopes in one-time use, which can ensure that the endoscopes are in the best condition every time they are unpacked, and the operation efficiency is improved to a certain extent. In addition, disposable endoscopes can also enable hospitals to effectively control the costs related to endoscopy and promote the promotion of endoscopic surgery in primary hospitals.
However, whether the disposable endoscope can release light on the stage of medical equipment is affected by many factors such as technology and cost.
In this article, we have sorted out 11 domestic companies in the field of disposable endoscopes, including their product development stages and application scenarios. In addition, we also introduced some foreign companies to get a glimpse of the development of disposable endoscopes. .
01. Technological updates lead to dramatic changes in cost, and one-time replacement can be achieved in many fields
Before formally introducing the disposable endoscope, let's briefly understand the structure of the endoscope. The traditional endoscope consists of three systems: image display system, lighting system and endoscope system.
Among them, the core of the endoscope system is image acquisition, and the core components include imaging lens, image sensor, acquisition and processing circuit. Endoscopes can be disposable, which is closely related to the technological change of image sensors.
The rise of CMOS brings opportunities for the disposable endoscope
On the market, image sensors can be divided into two categories: charge-coupled components (CCD) and metal-oxide-semiconductor components (CMOS). In the early days of the development of electronic endoscopes, CCDs were widely used. However, CCD is difficult to manufacture, and the core technology and export are restricted by foreign giants, which leads to the high price of CCD. However, with the rise of CMOS, endoscope manufacturers are gradually realizing the conversion from CCD to CMOS.
Compared with CCD, CMOS has the advantages of low power consumption and low noise. Although the image quality is slightly weaker, it is also approaching CCD. More importantly, the market of CMOS is fragmented, the technical barriers are relatively low, and domestic manufacturers can independently realize industrialization. At present, the price of CMOS is on a downward trend, bringing opportunities for disposable endoscopes.
In addition, the endoscope itself has both the attributes of medical equipment and consumables. The host part is not easy to be damaged, but the life of the mirror body ranges from 6 months to 10 years. When the one-time use really comes, the endoscope will no longer pursue repeated use, then the design and materials of the mirror body will develop towards the direction of simplification, and the cost control will be further improved.
Applicable to many fields, the market for disposable endoscopes is considerable
The possibility of high-volume and low-cost production brought about by technological updates has won the qualification for the debut of disposable endoscopes. So where is the market? This is another important issue for the "performance" of disposable endoscopes, and it is also an important consideration for enterprises to enter the market.
Considering the purchase cost, service life, turnover frequency, difficulty of sterilization, and maintenance cost of endoscopes, disposable endoscopes are more economical than traditional reusable endoscopes in many fields.
For hospitals, costs are more manageable. Taking flexible ureteroscope surgery as an example, from the perspective of equipment entry price, the hospital purchased 2 imported flexible scopes and a host, and the entry price was about 2 million yuan. For purchasing a number of domestic disposable soft mirrors and a host, the price can be controlled within 100,000 yuan. From the perspective of a single operation, the cost of traditional multiplex endoscopes (including decontamination, maintenance and other costs) exceeds 12,000 yuan, while the admission price of disposable flexible ureteroscopes is generally less than 10,000 yuan.
For patients, disposable endoscopes are currently more expensive than traditional endoscopes. However, disposable endoscopes can provide a safer inspection experience and avoid cross-infection. However, with the improvement of my country's consumption level and the strengthening of the trend of endoscope consumables, the competitiveness of disposable endoscopes will gradually increase.
According to statistics, the types of endoscopes suitable for disposable use mainly include cholangiopancreatoscope, gastroenteroscope, cystoscope, bronchoscope, nasopharyngoscope, hysteroscope, etc., involving gastroenterology, urology, respiratory, Gynecology and other department scenes. These mirror types correspond to the potential diagnosis and treatment volume of nearly 70 million cases in my country, which is a huge blue ocean market.
02. 5 companies were approved by NMPA, and the application scenarios are concentrated in urology
Judging from the research and development stage of disposable endoscope products, the first products of most companies have been launched to the market, but they are still in the early stage of market development.
So far, 5 domestic companies have obtained 6 registration certificates from the National Medical Products Administration (NMPA), namely Ruipai Medical, Pusheng Medical, Innovax (subsidiary - Anqing Medical), Happiness Factory and Beifang Tenda. Among them, Ruipai Medical received two approvals, namely its disposable electronic cystoscope and disposable electronic flexible ureteroscope.
In addition, 6 of the 11 companies obtained CE or FDA certification. More than half of the products have been recognized by market regulators and allowed to be launched into the market, which is enough to prove that the research and development of disposable endoscopes has achieved preliminary results.
However, the products that have passed the approval and certification are limited to a single lens species. Taking the disposable endoscopes that obtained the NMPA registration certificate as an example, 6 are concentrated in the urology department, and 5 are disposable flexible ureteroscopes. In addition, the approval time is concentrated around 2020, and the market effect has not been fully feedback. Therefore, on the whole, disposable endoscopes have just emerged and are still in the early stages of development.
From the perspective of the use of disposable endoscopes, there is an obvious emphasis. Among them, urology has the largest number, followed by respiratory, gastroenterology and pulmonology, as shown in the figure below.
The future goal of Pusheng Medical, Ruipai Medical, Huaxin Medical and other companies is to build a full coverage of disposable endoscope products. It is conceivable that once the business model of their first product is available in the market, then there will be a huge "one-time revolution" of endoscopy.
However, in addition to diversified layouts, there are also companies that choose to focus on a certain field. For example, Lineset will focus on gastroenterology for the next 10 years. Leinsert said that the ultimate purpose of disposable endoscopes is not to reduce costs and prevent cross-infection, but to exert the functional value of products and solve the pain and difficulties faced by doctors in clinical practice. At present, it is building the second and third generation products to form multiple surgical solutions for gastroenterology around the endoscopic platform.
03. Concentrated in the eastern region, and financing was started at the beginning
We continue to focus on the company and see its characteristics in terms of its establishment time, distribution area and financing rounds.
First of all, in terms of their establishment time and distribution area, 11 companies were established in the 10 years from 2008 to 2018, and most of them are concentrated in the eastern region. The establishment time of the company was relatively concentrated in the four years from 2014 to 2017, and a total of 7 companies were established, namely Pusheng Medical, Innova-Anqing Medical, Ruipai Medical, Xinguangwei Medical, Hanmei Medical, and Lainsert.
Regional distribution characteristics In view of the imbalance between regions in the distribution of medical resources in my country, the eastern region has an advantage in the development and application of new technologies such as disposable endoscopes.
Secondly, from the perspective of financing rounds, most companies have completed their first financing, but most of them are in the stage of capital inspection. Of the 11 companies, 8 are known to have completed related financing, of which 2 have completed A round of financing, 3 have completed Pre-A financing, and 3 have completed equity financing.
The fact that most corporate financing is in the early stage roughly corresponds to the development of disposable endoscopes, that is, the product has been launched to match the market, but the specific satisfaction of market demand and product value still need to be verified.
Among them, Xinguangwei Medical completed a round of financing of nearly 400 million yuan in April this year. This is one of the projects with the highest financing amount in the domestic endoscopy field in recent years. It was jointly led by Hillhouse Ventures and Eli Lilly Asia Fund.
Xinguangwei Medical is an enterprise focusing on the research and development of image processing and the innovation of endoscope technology. Its products have unique advantages in the frontier technologies and productization directions of endoscopy, such as ultra-high-definition imaging technology, 3D imaging technology, and endoscopic consumables technology (disposable technology). It is reported that a number of single-use electronic endoscope products of Xinguangwei Medical have entered the clinical, or registration, or sales stage in China, the United States, Europe and other countries and regions, and have certain international competitiveness.
Ruipai Medical completed the A round of financing of nearly 100 million yuan in December 2020 to consolidate and expand product research and development pipelines, accelerate the promotion of automated production lines and brand market investment. In July and August 2020, Ruipai Medical obtained the registration certificate of the third type of medical device for two products, becoming the manufacturer with the most registration certificates of the third type of disposable endoscope products in China. Its self-developed single-use electronic cystoscope is also globally competitive.
04. Foreign endoscopy giants have entered the market, and there are already mature products
With the gradual emergence of "consumables" of endoscopes in recent years, many international companies have also begun to deploy disposable endoscopes. According to Boston Scientific's forecast, the disposable endoscope market will reach $2 billion in 2024.
Compared with the slow deployment of the major endoscopy companies in my country on disposable endoscopes; some foreign endoscopy giants have left the market and have developed mature products, such as Olympus, Pentax, Boston Scientific, etc.
