Low- and medium-price stents have great market potential

Business Club December 23 hearing If the future cost of installing stents in China can be controlled within 10,000 yuan, there may be a large number of potential coronary heart disease patients to install stents, when the domestic production and sales of blood vessel stents will at least more than double the current increase.

Vascular stents have been developed and marketed by foreign manufacturers in the late 1980s to “spread” blood vessels that have become narrow, thereby increasing blood flow and implantable medical devices that prevent myocardial infarction. The so-called stent refers to a hollow mesh tube formed by weaving a special metal wire (such as a titanium alloy wire or a stainless steel wire) having elasticity and strength. Commercially available vascular stents come in a variety of shapes. The most common stents are fishnet-like structures, followed by a variety of stents with various wire configurations.

Foreign markets are booming

The early development of vascular stents was essentially bare stents (referring to stents without any drugs). People in the industry call it the first generation of stents. The biggest drawback of naked stents is that after stenting in patients with coronary artery disease, there is no need for half a year, and a large number of lipid substances are re-deposited on the stent lumen surface and a new stenosis is formed (medically referred to as vascular restenosis).

In the mid-1990s, foreign manufacturers introduced a new type of blood vessel stent called a drug-coated stent, the surface of which was coated with drugs such as paclitaxel that could slowly dissolve out. Clinical trials have confirmed that the new type of vascular stent can effectively prevent the deposition of blood lipids in the lumen of the stent, thereby preventing the occurrence of restenosis. According to foreign medical circles, the incidence of restenosis in the second-generation stents currently used has dropped to less than 5%, which is a very good result (the incidence of restenosis in the first-generation stent products was as high as 50% or more).

A few years ago, U.S. and European manufacturers developed the third generation of stents - absorbable stents. According to the developer, this kind of stent is made of non-toxic macromolecule material such as polyglycolic acid, which can be automatically absorbed within 2 years after being implanted in blood vessels. (Polyglycolic acid can be slowly decomposed in human body. Become carbon dioxide and water). According to foreign reports, doctors in some European countries have followed up patients who use these absorbable stents. The results of the instrumental examination show that the wall of the vessel with the absorbable stent is smooth, and there is no deposition of lipids, and blood flow is unobstructed. This shows that Vascular stents are worth promoting.

It is understood that stents developed abroad not only have arterial stents suitable for use in patients with coronary artery disease, but also have renal vascular stents, celiac aneurysm stents, and newly-marketed biliary stents (which can open narrowed bile ducts and restore bile flow). Bracket new products. In the international market, there are dozens of varieties of coronary arterial stents. Foreign manufacturers are still developing new types of stents such as lightweight bio-ceramic material supports and engineering plastic stents using carbon fiber as the skeleton. In short, sales of stents in the Western market are extremely prosperous.

Domestic market quick start

For a long time, patients in our country have not understood the product of stents because the incidence of coronary heart disease in our country was extremely low. With the rising of national income, the improvement of people's living standards and the change of dietary structure, coronary heart disease has been gaining momentum in China in recent years. According to reports from foreign medical circles, coronary artery disease must be installed with stents to prevent myocardial infarction. In the mid-1990s, because stents could not be produced in the country at the time, the stents needed for clinical use were all imported from abroad. It was said that the total cost of doing a stent implantation at the time was as high as 60,000 to 100,000 yuan, not for ordinary patients. Can withstand. Therefore, in the 1990s, only tens of thousands of cases were implanted with stents each year.

After entering the 21st century, with the advent of home-made stents (its price is only half that of imported stents or even lower), the number of patients undergoing vascular stent implantation in China has increased dramatically. In patients with very severe symptoms of coronary heart disease, seven to eight stents have been implanted in the blood vessels. In recent years, hospitals in our country have performed more than 200,000 stent implantations each year. Annual sales of more than 300,000 sets of blood vessel stents are basically second-generation stent products, of which imported stents (including those produced by foreign companies in China) accounted for more than 80%, while domestic stents accounted for less than 20%. According to statistics from related departments, currently there are about 50 to 60 medical device manufacturers, including accessory parts, which produce stents in the domestic market, showing a small and scattered state, and there are about 10 manufacturers of whole sets of products that produce stents. Lepu (Beijing) Medical Devices Co., Ltd. is currently the largest manufacturer of vascular stents in China. The company mainly produces new products for the best-selling stents in the international market - rapamycin stents. Last year, the company sold 71,500 sets of vascular stents each year, accounting for about 24% of the total vascular stent sales in China. Because of promising development prospects for vascular stents in the Chinese market, Lepu Beijing has invested in expanding the production capacity of its drug-coated stents, resulting in a total stent production capacity of 170,000 units, equivalent to 55% of the total sales volume of vascular stent products in China last year.

Multiple sales plan needs to cooperate

According to a cardiovascular expert from Beijing Fuwai Hospital, in the past few years, the total number of patients who die from acute exacerbations of coronary heart disease each year in China exceeds 1 million. If these people install vascular stents early, they can at least reduce mortality by 50%. Therefore, the application of vascular stents is imminent. Since vascular stents can save the lives of patients with coronary heart disease, why do our country's patients with coronary heart disease (estimated about tens of millions of people in the country) rarely ask to install stents? In Western countries, at least one-quarter of patients with coronary heart disease have stents installed. The problem lies in the fact that stenting surgery is a high-cost operation in China. In most domestic hospitals, the installation of a domestically-made stent needs to cost between 16,000 and 18,000 yuan. If an imported stent is installed, it needs 40,000 to 50,000 yuan. This high price is undoubtedly a big expense for patients who must install stents at their own expense. In developed countries, it takes only 500-600 US dollars to install a common bracket (second-generation product). It can be seen that the installation cost of hospital stents in China is extremely high. It is said that the stent products provided by the manufacturer to the hospital cost only a few thousand yuan each (the price of domestic products is even lower). High prices limit the internal needs of our patient-mounted stents. In the developed countries, installing stents is the most common surgery. Many European countries do stent implantation surgery can be reimbursed most of the cost, and our country to do a vascular stent implantation surgery has become a heavy burden on patients. This is why there are tens of millions of patients with coronary heart disease in our country, but less than 1% of patients request the installation of stents every year.

According to the prediction of the Chinese Medical Insurance Association, according to the current development trend, by 2012, the total sales of the vascular stent market in China will surely exceed the 10 billion yuan mark, reaching a scale of 11 billion yuan, and the total sales of blood vessel stents in the international market will reach 70. Billion US dollars, but the premise is that domestic medical device companies must accelerate the development of high-intensity, low-cost, suitable for many low-income patients in the domestic use of vascular stent products (such as the use of titanium-magnesium alloy wire and other materials for stent production). There is a big gap between China's enterprises and Western developed countries in the development of materials for low-cost, high-strength stents. The cost of each vascular stent produced by American counterparts is controlled below $50, and it is still doubtful whether the country can achieve the same level of materials as developed countries. In addition, there is still a big gap between China's drug coating stent technology and foreign manufacturers. In Europe and the United States, drug coated stents have become one of the most commonly used medical device products. Due to the high quality and low price of foreign stent products, there are many users, and the domestic stents not only have the problem of unstable quality, but also the cost of installing the stent is much higher than that of foreign countries. If the cost of installing a stent in the country can be controlled within 10,000 yuan in the future, there will certainly be a large number of potential coronary patients with stents installed. At that time, the production and sales volume of domestic blood vessel stents will at least increase by more than twice the current level.

It is understood that the annual growth rate of the vascular stent market in developed countries is 10% to 12%, while the growth rate of the vascular stent market in China has reached 30% in recent years. According to the forecast of Datamonitor, a consulting company in the United States, by 2015, sales of the world's blood vessel stents (excluding newly-developed stents such as biliary stents) will reach 7.8 billion to 8 billion US dollars, of which US stenting market accounts for world sales. 45% of the market, Europe accounted for 32%, Japan accounted for 12%, and other countries and regions in the world accounted for the remaining 11% of the total. If the production and sales volume of vascular stents in China is to reach a new level, we must first reduce the retail price of the stents, and try to produce as much low-to-medium-sized stent products as the European and American markets on the developed countries; secondly, the hospital must reduce the cost of surgery; It is the best for stent products to be included in the scope of medical insurance. Otherwise, it will affect China's stent production and sales doubling plan.