Gradually realize import substitution, in vitro diagnostics industry to open a market of hundreds of billions.

Release time:

2018-06-08

Translational Medicine Network 2018-06-08 Today, our "Looking for Real Growth in the Pharmaceutical Industry" series focuses on medical devices. Its largest subdivision is in vitro diagnosis. In vitro diagnosis refers to the extraction of patients' blood for testing and guiding treatment. At present, more than 70% of clinical diagnostic information comes from in vitro diagnosis, so it is also called "doctor's eyes". Let's take a look at the reporter survey. The import of medical devices relies heavily on multinational companies to monopolize the market. The West China Hospital of Sichuan University in Chengdu has to process about 18000 test specimens from all over the country every day. in the busy

Translational Medicine Network 2018-06-08
Today, our "Looking for Real Growth in the Pharmaceutical Industry" series focuses on medical devices, and its biggest segment is in vitro diagnostics. In vitro diagnosis refers to the extraction of patients' blood for testing and guiding treatment. At present, more than 70% of clinical diagnostic information comes from in vitro diagnosis, so it is also called "doctor's eyes". Let's take a look at the reporter survey.
 
Imports of medical devices rely heavily on multinational companies to monopolize the market.
West China Hospital of Sichuan University, located in Chengdu, processes about 18000 test specimens from all over the country every day. In the busy laboratory, we can see that most of the testing instruments used are imported.
Jiang Hong, deputy director of the Department of Experimental Medicine, West China Clinical Medical College, Sichuan University: Our hospital still imports a larger proportion, and a large number of foreign (testing) projects are still cited.
 

In fact, at present, in large tertiary hospitals such as West China Hospital, the equipment used by the laboratory is heavily dependent on imports. For a long time, the global in vitro diagnostics market has been dominated by multinational giants. Six major companies such as Roche, Siemens, Abbott, and Johnson & Johnson occupy nearly 60% of the in vitro diagnostics market, with obvious monopoly advantages. Although the domestic in vitro diagnostic industry has been catching up rapidly in recent years, the market concentration is relatively low.

Song Haibo, Secretary-General of the National Health Industry Enterprise Management Association: As of the end of 2017, there were more than 1,000 in-vitro diagnostic manufacturers in my country, and there were more than 20,000 circulation companies, that is, more than 20,000 operating companies. We have less than 1 billion yuan in-vitro diagnostic manufacturers. There are 15 companies, and the total market sales of these 15 companies are only equivalent to the total domestic market sales of a well-known international brand.
 
The reason why in vitro diagnosis relies on imports is generally attributed to two points in the industry. One is the lack of product stability caused by the immature industrial supporting facilities, and the more important reason is that the independent research and development capabilities of upstream raw materials such as enzymes, antigens and antibodies required for in vitro diagnosis are not strong., Too dependent on imports. At present, the domestic production rate of upstream raw materials for in vitro diagnosis in China is only 10% to 20%.
Chen Tielin, biomedical industry analyst at Southwest Securities: I think the gap in instruments is the biggest, especially in terms of overall quality and performance stability. I think it takes time to improve. Second, I think there is a very important thing, that is, in the control and production of raw materials, domestic enterprises should make greater efforts.
 
Mike Bio: From consignment to self-developed in vitro diagnostics to accelerate import substitution
Mike Bio is a leading enterprise in China's in vitro diagnostic industry. Chairman Tang Yong told reporters that in the past, most of the local in vitro diagnostic enterprises lived by selling imported instruments as agents, and their profits were not high and there were many foreign restrictions. Therefore, Tang Yong made up his mind to set up a team to independently develop core technologies.
Tang Yong, Chairman of Mike Biology Co., Ltd.: Because this technology is difficult, but talents are also scarce. When we began to introduce talents and invest in this project in 2006, in fact, many of our domestic counterparts were not optimistic. Many people said that Tang Yong, are you crazy? Your company is doing this kind of international work, only a few companies are doing it. thing.
There are many people like Tang Yong who are passionate about independent research and development. In the 1990 s, Tian Junxi, who had just graduated from university, went to Canada to work in the in vitro diagnostic industry for ten years. Ten years of work experience made him realize that the in vitro diagnostic industry started late in China and relied heavily on imports, and there will be greater development in the future, so he resolutely decided to return to China.
Reporter: When you came back, what attracted you most?

Tian Junxi, R & D Manager of Immunization Department of Reagent R & D Center of Mike Biology Co., Ltd.: What attracts (me) most is to be able to make a career. Enterprises can develop, and individuals can develop. Our chemiluminescence immunity has grown from scratch. Now we have made more than 50 products, and more than 100 products are under research and development. Many of them have been put on the market. There are economic and social benefits.

Insisting on independent research and development means a lot of investment. Tang Yong told reporters that after developing his own products, some foreign products could not continue to act as agents, which meant tens of millions of losses every year. However, in the query of peers, Tang Yong still recruited a group of high-end scientific research talents with a much higher annual salary than his chairman, and successfully launched the first single tube automatic chemiluminescence analyzer with independent intellectual property rights in China. At present, the installed capacity of this machine in the country has reached 1500 units, and it is widely used in secondary hospitals and some township hospitals.
 
Liu Ping, director of the clinical laboratory of Pixian Hospital of Integrated traditional Chinese and Western Medicine in Chengdu City, Sichuan Province: we are a grass-roots hospital. We have introduced this instrument, and we have gradually carried out some projects that could not be carried out before, such as (thyroid function) T3 T4, some tumor markers. We can gradually carry out these projects, but manual operation was not possible before.
Patient Ms. Yu: Because it feels more convenient here, their equipment feels similar to that of hospitals in the city, and then it is more convenient and fast, and the price is more appropriate.
Independent research and development has brought stable performance returns to the enterprise. According to the annual report of Mike Bio -2017, the company's self-produced products achieved sales revenue of 0.777 billion billion yuan in 2017, up 32.61 percent from the same period last year. Independent research and development products have higher profit margins than agency products.


Tang Yong, Chairman of Mike Biology Co., Ltd.: The replacement speed of each plate is very fast now. Of course, the largest plate should be the chemiluminescence plate. The localization rate of this plate is about 10%, and 90% still depends on imports. Moreover, this plate is the largest plate in vitro diagnosis. Our goal is to hope that in the next 10 years, we can achieve a localization rate of 60% and 70% like biochemical reagents.

The more important significance of import substitution is to reduce testing costs and benefit hospitals and patients. It is understood that the current chemiluminescence detection equipment, instruments and reagents on the domestic and foreign markets must be matched. If you use a foreign brand of equipment, you must use the same brand of reagents. For tertiary hospitals with a huge amount of consumables, high The cost of consumables is not a small burden.

Bao Yong, Director of the Laboratory Department of Chengdu Second People's Hospital, Sichuan Province: For inspection of this department, the amount of consumables in one year is probably. The data for 2017 should be close to 50 million (yuan). If our equipment, As long as the quality standard meets the requirements, then we will all replace domestic products. If we say that my department will replace all domestic products, the 30% reduction will be no problem.
 
Mike Bio: Research and development investment in precision and stability to improve
In vitro diagnostics industry is gradually realizing import substitution, Mike Bio as the industry leader, by the attention of investors, in the Shenzhen Stock Exchange Interactive Easy, Oriental Wealth Stock Bar and other platforms, investors on Mike Bio in cash flow, growth and other aspects of the question.
 
Investor Wang Yang: I was wondering what advantages the company has with other companies in the same industry in terms of core competencies? The second is that the company is investing in research and development to a very large extent over the past few years because of its constant investment in research and development, and what is the highlight of the product // and why is its cash flow much worse than some other companies in the same industry?
Shi Wei, Director of Strategic Investment of Mike Biology Co., Ltd.: We have invested a lot in research and development. On the other hand, we will also invest a lot in channel expansion. Therefore, in the past two years, our operating cash flow will not perform so well, but in 2017, we will improve. In terms of the company's future growth space, we think more is, in the process of promoting the new business model, the biochemical products brought by ourselves are higher than the growth rate of the industry, and the chemiluminescent products are also showing a gradient of rapid growth.

During the interview, the reporter found that for domestic testing equipment to replace imports, the vast majority of hospitals said that as long as domestic products are stable and accurate enough, they are ready to replace them at any time. The relevant person in charge of Mike Biology told the reporter that in the past, when they entrusted various parts of the product to an external enterprise for processing, the other party could only refer to the drawings, and there were often cases of "not being able to do it" or "the goods were not on the board", which greatly affected the efficiency and the stability.
 
Kong Chaocheng, chief engineer of the instrument and technology department of Mike Biology Co., Ltd.: the main gap is actually the problem of supporting our industry, because from the design level, from the design level of the whole machine, we think that it is very close to the foreign level, but the processing and manufacturing are still far away.
In order to strengthen the standardization of product manufacturing and improve stability, Mike Bio purchased such a production line. Now, they have the ability to "sample" the parts that need to be outsourced, which makes up for the immature shortcomings of the industry and improves the stability of the instrument.
Wang Zhen, Director of Instrument Production of Mike Biology Co., Ltd.: Passively accepting the standard provided by the supplier has become that we can formulate this standard. Then this accessory solves the first thing and can improve our performance and quality. Stability, the second one improves the efficiency of research and development, we can do it, we will tell (the processor) the standard, we will tell it how to do it.

In terms of import substitution of raw materials, Mike Bio also has its own layout. In front of these jars are stored cell strains used to produce biological raw materials, which are the most important raw materials for in vitro diagnostic products. The accuracy of all tests is closely related to the raw materials. In the past, they had to spend a lot of money to buy raw materials from the United States and Japan every year, but now more than 60% of the raw materials can be produced for their own use, and the cost is only 20% of the imported raw materials.

Long Tengxi, Director of Reagent Research and Development of Mike Biology Co., Ltd.: If others want to sell it to you, they can sell it to you. Maybe you have money, and there is also the possibility that others will not sell it to you. In addition, there is a delivery cycle and the safety of supply. It is possible that he satisfies his biggest foreign customers. Although he produces the same raw materials, he will not sell it to us. There is a possibility, therefore, based on the cost of the product, the delivery cycle, and the safety of our supply, we must control it in our own hands.
 
In vitro diagnostics hundreds of billions of market will open chemical luminescence is a battleground
China's in vitro diagnostics industry has achieved rapid development in the past few years, the industry scale from 10.8 billion in 2009 to 36.9 billion in 2016, the average annual compound growth rate of 16.6. However, at present, the per capita annual consumption of in vitro diagnosis in China is only 5 US dollars, which has great growth potential compared with the level of 30 US dollars per capita annual consumption in developed countries. For investment opportunities in various segments of the in vitro diagnostics industry, industry analysts pointed out that they can focus on faster-growing areas such as chemiluminescence and molecular diagnostics.

Southwest Securities Biopharmaceutical Industry Analyst Chen Tielin: In vitro diagnostics industry, we think it is a A- share, which is an area worthy of attention. For professional laboratory laboratories, we are optimistic about chemiluminescence and molecular diagnostics, which are more advanced technologies. This area is also the current domestic industry with a relatively fast growth rate. Chemical luminescence industry at present we estimate the factory caliber, a domestic market size, should be in the early 20 billion s, the industry growth rate is expected to be in 20% to 25% of the appearance, the proportion of domestic should be about 15%, we believe that chemical luminescence is a domestic in vitro diagnostic enterprises a must.

Regarding the development prospects of the in vitro diagnostic industry, analysts pointed out that my country's population aging problem is becoming more and more serious. The proportion of people aged 65 and over in the total population has increased from 8.3 in 2008 to 10.8 in 2016. The aging stage is the stage of high incidence of chronic diseases, and the diagnosis of many chronic diseases requires in vitro diagnostic products, which objectively increases the demand for in vitro diagnostic products. In the future, with the growth of per capita medical expenses and technological progress, China's in vitro diagnostic industry is expected to maintain sustained and rapid development in the next five years, and the 100 billion market is worth looking forward.
 
Song Haibo, Secretary-General of the National Health Industry Enterprise Management Association: There is still huge room for the development of in vitro diagnostics in China in the future. This is because of the following factors: First, China has a demographic dividend of a 1.3 billion population, and second, China's aging society is gradually Increasing, the demand for health will increase, and third, with the deepening of medical reform and the establishment of the National Medical Insurance Bureau, how to choose appropriate technologies and low cost, products that can also ensure normal medical treatment will definitely be on the agenda.
(Translational Medicine Network360zhyx.com)