From |Daily Finance News
By |Yuchen Liu
Medical and healthcare industry is one of the most promising industries in the future, which has basically reached a consensus among entrepreneurs, and the State Council previously issued the "Healthy China 2030" plan outline, which clearly defines the goal: the total scale of health service industry will exceed 8 trillion by 2020, and reach 16 trillion by 2030. In 2020, the total scale of health services exceeded 8 trillion, and by 2030 reached 16 trillion.
In many pharmaceutical sub-tracks, medical equipment is one of the important investment direction in the future, on the one hand, because of the broad prospects for the development of medical equipment, boom degree is very high; on the other hand, the medical equipment by the impact of short-term policy is relatively small, unlike the field of generic drugs by the "quantitative purchasing" and other policies are very big impact.
The data from the Foresight Industry Research Institute shows that the domestic market size of medical devices reached 625.9 billion yuan in 2019.
In-vitro diagnostics (IVD) as an important branch of medical devices, in the context of the aging population, the growth of demand for health care services and domestic substitution of the trend of factors such as the promotion of the development of a very fast, "Daily Finance" today focus on the protagonist of the in-vitro diagnostics.
Chemiluminescence to lead the in vitro diagnostics
First of all, let's do a bit of knowledge popularization, in vitro diagnostics (IVD) refers to the human body outside, through the human body samples (blood, body fluids, tissues, etc.) for testing and obtaining clinical diagnostic information, and then determine the disease or the function of the body's products and services.
According to Evaluate Medtech, the global medical device market was $405 billion in 2017, of which $52.6 billion was in the IVD sector, accounting for about 13% of the medical device market. According to China Pharmaceutical Materials Association, the size of China's medical device market in 2018 was $530.4 billion, of which $71.3 billion was in the IVD sector, accounting for more than 13% of the medical device market. From the end-user point of view, in 2018, the examination revenue of public hospitals, the main customer of domestic IVD products, reached 315.7 billion yuan, with a year-on-year growth rate of 12.48%, and the growth rate of ICL and medical examination center industry, an important customer, was also around 20% or more.
Strong downstream demand led to the rapid growth of the upstream market size, the size of China's IVD industry in 2018 71.3 billion yuan, an increase of 25.6% year-on-year, far exceeding the global IVD market growth rate of 6.0%. According to the different testing principles and methods, the in vitro diagnostics market segment can be mainly divided into biochemical diagnostics, immune diagnostics, molecular diagnostics, microbial diagnostics, blood diagnostics, POCT (instant diagnostics), and so on. Among them, immunodiagnostics accounted for the largest share of 38%, molecular diagnostics beyond biochemical diagnostics to become the second largest category, accounting for 20%, 19%.
Immuno-diagnosis focuses on the detection of trace substances in the sample, with high sensitivity and small error rate, covering technologies such as radioimmunoassay, enzyme immunoassay, colloidal gold, chemiluminescence, etc., which are massively applied in the fields of infectious disease detection, endocrinology, tumor, and other fields, and have developed rapidly in recent years.
The chemiluminescence analysis method in immunodiagnosis has the systematic advantages of high sensitivity, wide linear range, stable results, good safety and long service life, etc. It has formed a comprehensive transcendence of other immune methods in terms of performance, and therefore has become the mainstream of immunodiagnosis, and replaced qualitative/semi-quantitative products such as enzyme immunoassay, and the growth rate of the revenue has been maintained at more than 20%.
In 2019, chemiluminescence in the field of immunodiagnosis accounted for 80%-90%, the chemiluminescence market is also China's in vitro diagnostic field of the largest scale, the fastest growth rate of the field, has become a new growth point in the medical device industry. In recent years, the growth rate of chemiluminescence domestic market size is more than 20%, Haitong Securities Institute estimates that the next three years will still maintain a growth rate of 15%-20%.
China's in vitro diagnostics experienced manual preparation, technology introduction, independent production, standardized development and other stages, after 2000, the technical level of domestic manufacturers significantly improved, some products have basically reached the same period of the international advanced level, such as blood cells, biochemical field. The chemiluminescence-based immunodiagnostic field, due to the launch of the technology behind the time, high technical barriers, is still monopolized by imported brands, the four head of the enterprise (Roche, Abbott, Beckman, Siemens) market share of more than 80%, the overall market share of foreign brands of more than 85%, the market share of a single domestic enterprise is not more than 5%.
The Local Three Emerge
According to the data of China Medical Devices Blue Book (2019 Edition), the in vitro diagnostics market is divided into three major areas from the perspective of the industry chain: the upstream raw materials, the midstream reagents and instruments, and the downstream medical consumption terminals.
At present, most of the upstream raw materials for in vitro diagnostics are mainly imported, and the customers are sticky, and the midstream manufacturers have increased the layout of the research and development of the upstream raw materials in recent years, and there are not many upstream enterprises with a considerable scale at present. Midstream reagents and instrumentation manufacturers are still mainly imported products, domestic companies such as Mike Bio, AnTuBio, Myriad Medical and other companies have been in the biochemical and chemiluminescence and other areas of the layout, is expected to continue to achieve product sales growth.
Myriad Medical Natural needless to say, the leading local in vitro diagnostic enterprises, last year the plate realized operating income of 5.814 billion yuan, up 25.69%. As a whole, the in vitro diagnostic instruments of Myriad Medical in the domestic laboratory equipment category market share of 15.3%, and Beckman tied for second place, Hyson Mecom's market share of 26.10%, ranked first. Expanding view, the company's blood cell analyzer in the international and domestic markets occupy a dominant position in the domestic market share of more than 30%, ranked second, and ranked first HysonMedicom about 10% difference.
The blood cell analyzer category is divided into three classified and five classified, three classified to meet the low-end market for grass-roots hospitals, the price is low, the market competition is fierce, the gross profit margin is relatively low. Domestic tertiary hospitals mostly use five-classified blood cell analyzers, with a lifespan of about 10 years. The company's blood cell analyzer has launched high-end models, the current level of technology and foreign leading enterprises, has been among the three hospitals in the high-end market.
The blood cell analysis market is relatively mature, Myriad and Heath McComb **** with more than 70% of the market share, in the high-end market is also squeezing Heath McComb space, overall stable and rising. In the field of chemiluminescence, instruments and reagents are the two most important aspects, Myriad Medical represents the top level of domestic chemiluminescent instruments, and is constantly moving towards high-end, from 120 speed to 480 speed, the fastest single CL-6000i detection speed of up to 480T/h, has been gradually accepted by the Tertiary hospitals, and at present one-third of the top 100 Tertiary hospitals in the Department of Laboratory Medicine has been used Myriad of the chemiluminescent immunology products. The chemiluminescent immunoassay products are used by one-third of the top 100 hospitals' laboratory departments.
Compared to the rich product line of the leader, AnTuBio focuses on the development and production of in vitro diagnostic reagents, and has a leading edge in the field of chemiluminescence, and of course, also produces some related instruments. Antalis has been in the field of immunodiagnostics for many years, and has mastered a number of immunological technologies such as enzyme immunoassay, plate luminescence, and magnetic particle luminescence, and has formed a technological system from raw material research to product development and production. Infectious disease-related products are the company's most advantageous items, and are generally well recognized by hospitals at all levels, accounting for approximately 50% of magnetic particle chemiluminescence, followed by oncology accounting for approximately 20%, and the rest of the items are more dispersed, including thyroid function, hormones, hypertension, and TORCH, which account for approximately 30% in total. The company obtained two registration certificates for Mycoplasma pneumoniae IgM antibody detection kit and Chlamydia pneumoniae IgM antibody detection kit (magnetic particle chemiluminescence) in November 2019, the project is more high-quality and is the second domestic establishment on the luminescence platform, and it is expected to be a gradual substitution of the same foreign-funded project based on the manual platform in the future.
Mike Bio was founded in 1994, from the in vitro diagnostic products agent, since 2004 to independent R & D and production as the core and in vitro diagnostic full chain layout, now covers biochemical, immunity, blood, molecular diagnostics, rapid detection, pathology, raw materials and other technology platforms, to become the domestic in vitro diagnostic production enterprises in the product range of one of the most abundant enterprises, the company biochemical, immunity, clinical testing three segments, the company's products and services, and the company's products and services. The company's biochemistry, immunization and clinical examination three plates can meet the needs of more than 80% of the testing projects in medical laboratories, and has a strong competitive advantage in the overall solution of medical laboratories.
In the fourth quarter of 2018, the company launched the high-end product i3000 automatic chemiluminescence immunoassay analyzer, formally stepped into the first echelon of domestic chemiluminescence, in 2019, the company's chemiluminescence immunoassay business to achieve sales revenue of 479 million yuan, an increase of 29.48%. In addition, Mike biology in the field of biochemical diagnostics also has a strong strength, the current domestic market biochemical diagnostic reagents have been relatively mature, the overall level of technology has basically reached the international level of the same period, accounting for about 2/3 of the market share, Mike biology industry already has the strength to compete with the international giants.
In the 2018 International Medical Reference Laboratory Inter-Room Quality Evaluation (RELA) test published in 2019, which represents the highest level of clinical chemistry and laboratory medicine, Mike's Bio*** had 30 items passed the evaluation, which is the most passed items, the most complete analytical methods, and covers all analyte categories of RELA among all participating laboratories. According to the latest news, Mack Bio has nearly 70 items of biochemical diagnostic reagents, covering the major clinical needs.
Finally, we need to say that China's population accounts for about 1/5 of the world's population, but the size of the in vitro diagnostics market is only 3% of the global market, and at the same time, China's per capita consumption of in vitro diagnostic products is $4.6 per annum, which is only half of the global average consumption level, and there is a large room for improvement.
In the future, with the improvement of health care awareness, per capita consumption ability to improve (per capita diagnosis and treatment costs increase), the public for early diagnosis, early screening needs will gradually rise, on the other hand, the policy requirements of independent control, the local company is bound to catch up.
In terms of price, foreign-funded products are generally more than 30% more expensive than the average level of domestic enterprises, in the health insurance fee control and DRGs to implement the general trend, the Department of Laboratory by the original profit side into the cost side, the second level of hospitals and some tertiary hospitals to control cost pressures have increased significantly, and are more inclined to use the more cost-effective domestic products. Although there is a certain amount of foreign-funded products to reduce the price of space, but because it has a systematic price system in the world, the willingness to reduce prices in the short term is very low, which provides a once-in-a-lifetime strategic opportunity for local enterprises.
Under the dual role of market expansion and domestic substitution, the industry will continue to grow, which is the core reason for optimizing the future of in vitro diagnostics.