Intelligent innovation development  basic market heavy volume   localization rate increase

The stapler is a medical device that replaces traditional manual sutures in surgical operations. It is mainly used for cutting, resection, and anastomosis of various cavities and diseased tissues in the human body, as well as the reconstruction of organ functions. With the development of minimally invasive surgery, in the reconstruction of the digestive tract, stapler anastomosis has gradually replaced manual suture as the main method of abdominal anastomosis. In recent years, with the wide application and popularization of staplers in clinical practice, the stapler industry has ushered in rapid development.

The stapler has a wide range of clinical applications

The stapler is a commonly used medical device in surgical operations, with a wide range of clinical applications and various types, but its basic working principle is based on the B-shaped staple mode. Taking the endoscopic stapler as an example, it is mainly composed of a nail box, a handle, a transmission component, etc., in which a blade is in the nail box, and the tissue is separated while the staple is anastomosed. There are 6 rows of staples in the nail box. After the tissue is cut, 3 rows of staples on both sides are bent into a "B" shape under the action of the staple seat to complete the tissue staple.

With the development of modern technology and the advancement of processing technology, disposable staplers have gradually replaced reusable staplers, and the types have also evolved from a single digestive tract stapler to a series of staplers that can be applied to different operations and different parts. According to the structure and function, the stapler can be divided into 8 types: linear stapler, circular stapler, and anorectal stapler. According to different surgical methods, staplers can be divided into open staplers and endoscopic staplers. Among them, the endoscopic stapler has the advantages of small surgical local trauma, light stress response, and quick postoperative recovery, etc., and is more and more highly praised by clinical surgeons at home and abroad.

The stapler market is growing at a considerable rate

According to data from the National Drug Administration and the Stapler Industry Association, in 2017, the global stapler market was worth 3.38 billion U.S. dollars and is expected to reach 4.78 billion U.S. dollars in 2022, with a compound annual growth rate of 7.2%. The sales of the stapler market in my country increased from 3.6 billion yuan in 2014 to 10.7 billion yuan in 2019 (see figure), with a compound annual growth rate of 17%. Among them, the growth rate of endoscopic stapler sales exceeded 30%. It can be seen from the figure that my country's stapler market has expanded year by year, and the sales volume of endoscopic staplers has surpassed that of open staplers. With the rapid development of minimally invasive surgery technology, the endoscopic stapler market will continue to accelerate its expansion.

In terms of market structure, in recent years, the domestic stapler market has been dominated by foreign brands. In 2019, imported staplers accounted for about 70% of the domestic stapler market. In terms of stapler types, the localization rate of open staplers is higher than that of endoscopic staplers. The domestic open stapler has gained 50% market share after years of development. The current market structure is relatively stable, but the competition is fierce. Due to the high technical barriers of endoscopic staplers, the market is mainly dominated by foreign brands, and the market for imported products accounts for 85%.

At present, there are more than 250 stapler-related business companies in my country, of which less than 100 companies have R&D capabilities. The overall concentration of the stapler industry in my country is low, showing a small and scattered state, and has not yet formed a large-scale development pattern. In addition, the innovation capability of my country's stapler industry needs to be improved. Taking high-tech endoscopic staplers as an example, foreign brands are mainly Johnson & Johnson and Medtronic, and these two brands also represent two different stapler technologies. Most domestic stapler manufacturers produce Medtronic staplers, such as Frankman, Tianjin Ricky, Beijing Peerte, etc. The products are homogenized and the competition is fierce; there are few domestic manufacturers of Johnson & Johnson staplers, and they have Jiangsu style. He, Changzhou Huasen, Shandong Weirui, etc.

In recent years, with the support of domestically-made alternative policies, a number of high-quality stapler companies have emerged in China, such as Shanghai Yisi Medical. The company’s endoscopic stapler products have the world’s first 60° super-large rotation angle, and titanium nails The shape of the nails is changed to an arc shape, which is different from the rectangular-like of the traditional Johnson & Johnson series; Changzhou Jianruibao’s new generation of endoscope cutting stapler and staple cartridge adopts the patented technology of "non-contour staple forming", which improves Improve the suture and hemostatic properties of the product.

Intelligent development is the trend

The emergence of the stapler has benefited doctors and patients, but there is still a risk of postoperative complications. Complications such as anastomotic leakage, anastomotic stenosis, and anastomotic bleeding can even threaten the life of patients. Relevant studies have shown that postoperative complications are related to many factors, including the patient's physique, doctor's professionalism, and operating level. At present, most of the mechanical staplers used in clinical practice require manual pressing and manual firing. The doctor needs to judge the pressing time, pressing strength, and cutting speed required for anastomosis based on personal experience, and select the corresponding staples according to the thickness of the tissue. The effect largely depends on the doctor's level of operation.

In order to establish a safer and more effective anastomosis, it is necessary to ensure uniform force during the use of the stapler, the strength of the pressed tissue is appropriate, the pressing time is appropriate, and the selected staple cartridge is suitable for the thickness of the tissue. All of these require higher requirements for the surgeon. , And the electrification and intelligence of the stapler are effective methods to solve these problems.

At present, some companies have conducted research on the electric and intelligent stapler, such as Johnson & Johnson Powered Echelon Flex series stapler and Beijing Peerte's disposable electric endoscopic stapler, which have effectively improved the quality of the anastomosis, which is beneficial to patients. The wound recovered after the operation. Medtronic’s SigniaTM Stapling System laparoscopic stapler can automatically adjust the firing speed. It can also feed back the matching degree of the tissue and the staple cartridge when the tissue is pressed, reminding the doctor to use a more suitable staple cartridge, effectively improving the safety of anastomosis, and has a certain number of people. Machine interaction capability, in addition to one-handed operation, convenient for doctors to operate.

In the future, the stapler technology will further innovate through the combination of artificial intelligence and robotics technology to accelerate the stapler to the intelligent era. At present, there are already some semi-intelligent anastomosis platforms on the market, but these anastomosis platforms are more inclined to automation, and there is still a big gap between true intelligence. In the future, the fully intelligent stapler will be integrated into the surgical robot together with the intelligent feedback system. When performing an anastomosis operation on the tissue, it can feed back parameters such as the thickness of the tissue and the pressing and cutting strength in real time, so that the doctor can update the patient's operation status. For a comprehensive grasp, make the operation more intelligent and simple.

With the continuous enhancement of my country's economic strength and the continuous deepening of the reform of the medical system, the ability of Chinese residents to pay for medical services has been continuously improved. At present, the trend of population aging in our country is obvious. In the context of more and more patients with cardiovascular diseases, cancer and diabetes, it is expected that the growth rate of stapler usage in our country will exceed the global average. Combining with the key factors that promote the development of the surgical stapler industry, it is predicted that my country's stapler industry will have the following development trends in the future.

First of all, minimally invasive surgery and intelligent instrument operation are the general trend. The proportion of minimally invasive surgery in developed countries and regions has reached 80% to 90%, while the proportion of minimally invasive surgery in my country's top hospitals is only 70%, and the proportion in second- and third-tier hospitals is even lower. Domestic minimally invasive surgery has much room for development. The popularity of minimally invasive surgery will drive the continuous growth of the stapler market.

Secondly, the increased volume of primary hospitals and the coverage of regional medical insurance will promote the rapid development of the stapler market. With the deepening of my country's medical system reform, the new medical reform encourages general operations to be carried out in county-level and lower-level hospitals as much as possible, which will promote the continuous increase of the stapler market in the primary medical market. Judging from the use of staplers in hospitals at various levels, the use rate of staplers in county-level hospitals in my country is significantly lower than that in provincial hospitals, and the use rates vary greatly among different regions. It is expected that in the next 3 to 5 years, with the popularization of staplers in county-level hospitals and the increase in the proportion of people covered by insurance, the stapler market will usher in rapid development.

Finally, increased policy support will speed up the substitution of domestic staplers into imports. In recent years, the state has strongly supported the development of the medical industry. From “encouraging domestic production” in 2015 to “prioritizing domestic production” in 2016, and then to “restricting imports and purchasing domestic products” in 2017, support for domestic devices has been implemented in procurement Executive level. In addition, some regions have begun to carry out centralized procurement of medical devices at the provincial level, and support for domestically-made devices will rise to a new level, which will greatly stimulate the enthusiasm of domestic stapler companies for research and development and accelerate import substitution.