Author | Liu
The medical and health industry is one of the most promising industries in the future, which has basically been recognized in the circle of entrepreneurs. The "Healthy China 2030 Outline" issued by the State Council has defined the goal: the total scale of health service industry will exceed 8 trillion by 2020 and reach 16 trillion by 2030.
Among many medical sub-tracks, medical equipment is one of the important investment directions in the future. On the one hand, medical devices have broad development prospects and extremely high prosperity; On the other hand, medical devices are less affected by negative policies, unlike generic drugs, which are more affected by policies such as "purchasing with quantity".
According to the data of Prospective Industry Research Institute, the domestic medical device market reached 625.9 billion yuan in 20 19. In terms of profitability, according to the data of Zhongkang Industrial Capital Research Center, in 2065438+2009, the total operating income of 64 A-share listed companies of medical devices was11903.3 billion yuan, a year-on-year increase of 14.0 1%, and the total net profit attributable to the mother was/kloc.
In vitro diagnosis (IVD), as an important branch of medical devices, is developing rapidly under the background of aging population, increasing demand for medical services and domestic substitution trend. The main focus of today's daily financial report is in vitro diagnosis.
Chemiluminescence leads to in vitro diagnosis
Let's talk about knowledge popularization first. In vitro diagnosis (IVD) refers to products and services that obtain clinical diagnosis information by detecting human samples (blood, body fluids, tissues, etc.). ) outside the human body, and then judge the disease or body function.
According to the data of Evaluate Medtech, the global medical device market scale in 20 17 was US$ 405 billion, of which the IVD field was US$ 52.6 billion, accounting for about 13% of the medical device market. According to the statistics of China Medical Materials Association, in 20 18, the medical device market in China was 530.4 billion yuan, of which the IVD field was 71300 million yuan, accounting for more than 13% of the medical device market. From the end users' point of view, in 20 18 years, the inspection income of public hospitals, the main customers of domestic IVD products, reached 3 157 billion yuan, with a year-on-year growth rate of 12.48%, and the industry growth rate of ICL and physical examination centers of important customers was also around 20% or above.
Strong downstream demand has driven the rapid growth of the upstream market. In 20 18, the scale of IVD industry in China was 71300 million yuan, with a year-on-year increase of 25.6%, far exceeding the growth rate of 6.0% in the global IVD market. According to the different detection principles and methods, in vitro diagnosis market segments can be divided into biochemical diagnosis, immune diagnosis, molecular diagnosis, microbial diagnosis, blood diagnosis, POCT (instant diagnosis) and so on. Immunodiagnosis accounted for 38%, and molecular diagnosis surpassed biochemical diagnosis to become the second largest category, accounting for 20% and 19% respectively.
Immunodiagnosis focuses on the detection of trace substances in samples, with high sensitivity and low error rate, covering radioimmunoassay, enzyme-linked immunoassay, colloidal gold, chemiluminescence and other technologies. It has been widely used in infectious disease detection, endocrine, tumor and other fields, and has developed rapidly in recent years.
Chemiluminescence analysis in immunodiagnosis has systematic advantages such as high sensitivity, wide linear range, stable results, good safety and long service life. It has completely surpassed other immunodiagnosis methods in performance, so it has become the mainstream of immunodiagnosis, replacing qualitative/semi-quantitative products such as enzyme-linked immunosorbent assay, and its income growth rate has remained above 20%.
20 19 chemiluminescence in the field of immunodiagnosis accounts for 80%-90%. Chemiluminescence market is also the largest and fastest growing field in the field of in vitro diagnosis in China, and it has become a new growth point in the medical device industry. In recent years, the domestic market scale of chemiluminescence has increased by more than 20%, and Haitong Securities Research Institute expects to maintain the growth rate of 15%-20% in the next three years.
After the stage of manual preparation, technology introduction, independent production and standardization development in China, the technical level of domestic manufacturers has improved significantly since 2000, and some products have basically reached the international advanced level in the same period, such as blood cells and biochemistry. However, in the field of immunodiagnosis based on chemiluminescence, due to the late introduction of technology and high technical barriers, it is still monopolized by imported brands. The market share of four head enterprises (Roche, Abbott, Beckman and Siemens) exceeds 80%, the overall market share of foreign brands exceeds 85%, and the market share of domestic individual enterprises does not exceed 5%.
The local top three appeared.
According to the data of China Blue Book of Medical Devices (20 19 Edition), the in vitro diagnostic market is divided into three major areas from the perspective of industrial chain: upstream raw materials, midstream reagents and instruments, and downstream medical consumer terminals.
At present, most of the upstream raw materials for in vitro diagnosis are imported, which makes customers sticky. In recent years, midstream production enterprises have increased the research and development of upstream raw materials, and there are not many upstream enterprises with considerable scale at present. Midstream reagent and instrument manufacturers are still mainly imported products, and domestic enterprises such as mike biological, Antu Bio, Mindray Medical and other companies have already made arrangements in the fields of biochemistry and chemiluminescence, which is expected to continue to achieve product sales growth.
Mindray Medical naturally needless to say, the local leading enterprises in in vitro diagnosis achieved an operating income of 58140,000 yuan last year, a year-on-year increase of 25.69%. On the whole, Mindray medical in vitro diagnostic instruments account for 15.3% of the domestic laboratory equipment market, which is tied for second place with Beckman, and Haisen Meikang ranks first with a market share of 26. 10%. From the development point of view, the company's blood cell analyzer occupies a dominant position in the international and domestic markets, ranking second in the domestic market, with a market share of over 30%, which is about 10% different from the number one Himsen Kangmei.
Blood cell analyzers are divided into three categories and five categories. The third category is satisfied with the low-end market and oriented to primary hospitals, with low prices, fierce market competition and relatively low gross profit margin. Most domestic tertiary hospitals use five types of blood analyzers, and their service life is about 10 years. The company's blood cell analyzer has launched a high-end model, and its current technical level is equivalent to that of foreign leading enterprises, and it has become one of the high-end markets of tertiary hospitals.
The market for blood cell analysis is relatively mature, with Mindray and Hismecon * * * accounting for more than 70% of the market. In the high-end market, the market is constantly squeezing the space of Hismecon, and generally speaking, it is steady and rising. In the field of chemiluminescence, instruments and reagents are the two most important aspects. Mindray Medical represents the top level of domestic chemiluminescence instruments, and keeps moving towards the high end, from 120 speed to 480 speed, and the fastest single-machine CL-6000i detection speed is as high as 480T/h, which has been gradually accepted by the top three hospitals. At present, one third of the top 100 hospitals have used Mindray.
Compared with Mindray Medical's rich product line, Antu Bio mainly focuses on the research and development of in vitro diagnostic reagents, has a leading edge in the field of chemiluminescence, and of course produces some related instruments. Antu Bio has been deeply involved in the field of immunodiagnosis for many years, and has mastered many immune technologies, such as enzyme-linked immunoassay, plate luminescence, magnetic particle luminescence and so on, forming a technical system from raw material research to product development and production. Infectious disease-related products are the company's most advantageous projects, generally recognized by hospitals at all levels, accounting for about 50% of magnetic particle chemiluminescence, followed by tumors, accounting for about 20%, and other projects are scattered, including manicure, hormone, hypertension and torch, accounting for about 30% in total. On October 20 19, 165438 10, the company obtained two registration certificates of mycoplasma pneumoniae IgM antibody detection kit and chlamydia pneumoniae IgM antibody detection kit (magnetic particle chemiluminescence method). The project is of high quality, and it is the second project built on the luminous platform in China, and it is expected to gradually replace foreign-funded projects based on artificial platforms in the future.
Mike biological was founded in 1994, and started as an agent of in vitro diagnostic products. Since 2004, we have focused on independent research and development and production, and laid out the whole production chain of in vitro diagnosis. Now it has covered many technical platforms, such as biochemistry, immunology, hematology, molecular diagnosis, rapid detection, pathology, raw materials, etc., and has become one of the most abundant products in domestic in-vitro diagnosis production enterprises. The company's three sections, biochemistry, immunology and clinical examination, can meet the needs of 80 medical laboratories.
20 18 in the fourth quarter, the company launched the high-end product i3000 automatic chemiluminescence immunoassay analyzer, which officially entered the first echelon of domestic chemiluminescence. In 20 19, the company's chemiluminescence immunoassay business achieved sales revenue of 479 million yuan, up 29.48% year-on-year. In addition, mike biological also has strong strength in the field of biochemical diagnosis. At present, the biochemical diagnostic reagents in the domestic market are relatively mature, and the overall technical level has basically reached the international level, accounting for about two-thirds of the market. Mike biological already has the strength to compete with international giants.
Mike biological * * * has passed 30 items in the 20 18 international medical reference laboratory's external quality evaluation (RELA) test, representing the highest level of clinical chemistry and laboratory medicine. It is the unit with the most projects and the most comprehensive analytical methods in all participating laboratories, covering all analyte categories of RELA. The latest news shows that there are nearly 70 kinds of biochemical diagnostic reagents in mike biological, covering the main clinical needs.
Finally, the population of China accounts for about15 of the world, but the in vitro diagnosis market accounts for only 3% of the world. At the same time, the per capita annual consumption of in vitro diagnostic products in China is US$ 4.6, which is only half of the global average consumption level, and there is a lot of room for improvement.
In the future, with the improvement of health care awareness and per capita consumption capacity (the increase of per capita medical expenses), the public's demand for early diagnosis and screening will gradually increase. On the other hand, under the requirements of self-made policies, local companies are bound to catch up.
In terms of price, foreign products are generally more than 30% more expensive than the average level of domestic enterprises. Under the general trend of medical insurance cost control and DRGs implementation, the laboratory has changed from the original profit end to the cost end, and the pressure of cost control in secondary hospitals and some tertiary hospitals has increased significantly, preferring to use domestic products with higher cost performance. Although there is some room for foreign products to reduce prices, due to its systematic price system in the world, the willingness to reduce prices in the short term is very low, which provides a golden strategic opportunity for local enterprises.
Under the dual effects of market expansion and domestic substitution, the industry will continue to grow, which is the core reason for optimistic about the future of in vitro diagnosis.