Source: CAIVD, Annual Report of The In Vitro Diagnostic Industry in China (2019 edition)
The Annual Report of In vitro Diagnosis industry in China (2019 edition) was jointly released by The Medical Examination Industry Branch of National Health Industry Enterprise Management Association and the in vitro Diagnosis Branch of China Medical Device Industry Association.
From the perspective of the fine molecular industry, the biochemical diagnosis will develop towards closure. Chemiluminescence will gradually replace enzyme-linked immunity and realize the opportunity of import substitution; Molecular diagnosis With the popularization of second-generation sequencing technology and the development of multiple applications of liquid biopsy, the tumor field will bring new detection market. POCT is developing towards miniaturization, integration and quantification, and it extends to the new mode of family chronic disease monitoring and management with the help of the Internet. Pathological products will develop towards automation and high throughput.The upstream growth rate of in vitro diagnosis mainly depends on the growth rate of the industry in the middle and lower reaches, which is about 15%-20%.Upstream raw materials mainly include antigen antibody, enzyme, primers and probe, chemical products, consumables and core components (plus sample needle, sheath flow pool, laser), etc., in vitro diagnostic reagents in our country the upstream raw material market capacity up to 6 billion, combined with in vitro diagnostic instruments and key parts, the overall market capacity up to 10 billion yuan of above. At present, the majority of upstream raw materials are still monopolized by foreign enterprises, and the replacement of raw materials may lead to unstable product quality and the need for registration and declaration, so the customer stickiness is relatively high. In addition, the production process requirements are high, it is difficult to implement import substitution in the short term.Domestic has a considerable scale of upstream enterprises are not much, business is more stable, many are also in the middle and downstream development. At present, only a few enterprises can achieve partial raw material self-sufficiency, but some key raw materials still rely on imports.Localized raw material suppliers need to further improve their own innovation capabilities and product quality, continuously enhance their core competitiveness, and perform effective quality control more systematically and rigorously, from raw materials to final production purification and processes. Strictly check, do a solid backing for the production of in vitro diagnostic reagents and instruments, and jointly promote my country's in vitro diagnostic industry on a healthier development path.1. Biochemical: Biochemical testing accounts for about 25% of the in vitro diagnostic market, and the growth rate is expected to be 5%.The biochemical diagnostic market in China is very mature and can provide biochemical analyzers and biochemical reagents. The biochemical projects currently on the market mainly focus on more than 100 tests including enzymes, carbohydrates, lipids, protein and non-protein nitrogen, inorganic elements, liver function, and kidney function. The main detection platforms are chemical method, enzymatic method, immunoturbidimetric method and latex enhanced immunoturbidimetric method.Biochemical diagnosis has the characteristics of mature technology, simple operation, short analysis time, low test cost, etc. After more than 30 years of development, biochemical diagnostic reagents have become the most mature segment of the in vitro diagnostic industry in my country, and the domestic product share exceeds 50%, the overall technical level has basically reached the international level of the same period, and domestic products have a certain degree of competitiveness in biochemical detection analyzers with relatively high technical requirements, but they are still comparable to imported products in terms of detection accuracy and stability. A certain gap. With reference to the international recognition of closed systems, in the future, biochemical diagnostics will develop towards the closed-off of instruments and reagents. Domestic manufacturers should continue to improve the overall design, production technology and track functions of biochemical diagnostic instruments, and instruments and reagents will develop in concert.2. Immunization: Immunity diagnosis is promoted by the chemiluminescence market and is the segment with the largest scale and the most new varieties in the in vitro diagnosis field in recent years. It currently accounts for about 35% of the in vitro diagnostics market, and the growth rate is expected to reach more than 15%.Immunodiagnosis includes enzyme-linked immunoassay (ELISA), fluorescence immunity, time-resolved fluorescence, chemiluminescence and colloidal gold reagents. Among them, chemiluminescence immunoassay is mainly used for the detection of hormones, tumor markers, endocrine function, infectious diseases and other items. It has a large base of applicable populations, so it has a huge market space and a significant market growth rate. The main growth point of the diagnostic market. The current market share of domestic products in the immunization market is 20%-30%.The low cost advantage of enzyme immunoassay makes it still the main testing platform in basic hospitals and many basic projects. The domestically produced enzyme immunity products account for a relatively large proportion, about 60%-70%. However, with the further expansion of the scale of chemiluminescence enterprises and the acceleration of project research and development, the future will inevitably be accompanied by the price reduction of instruments and reagents. Chemiluminescence will further replace enzyme-linked immunoassay and qualitative products. At present, chemiluminescence is still mainly imported products. Accounted for 70%-80%.With the increasing pressure of medical insurance control fees and terminal charges, my country is establishing an incentive mechanism to actively use domestic medical equipment, focusing on promoting the use of domestic medical equipment in large tertiary hospitals. Domestic chemiluminescence will also further expand import substitution. Companies with good instrument compatibility, large testing volume and rich testing projects have strong competitive advantages. In the future, chemiluminescence instruments will develop toward high-throughput, modular, and assembly lines.3. Molecular diagnostics: Molecular diagnostics is one of the fastest growing segments of in vitro diagnostics, accounting for 10% of the total in vitro diagnostics market, with a growth rate of about 20%.Molecular diagnosis has the following technology platforms: PCR (amplification technology), FISH (fluorescence in situ hybridization), nucleic acid mass spectrometry, gene chip and gene sequencing. Mainly used in infectious diseases, tumor diagnosis, genetic disease diagnosis, prenatal and postnatal care, etc. The molecular diagnostics market is still dominated by imported products, and domestic products account for only 20%-30%, mainly concentrated in PCR products.The PCR instruments and gene chip instruments in the midstream of molecular diagnostics have been partially localized. Fluorescence quantitative PCR is currently the mainstream platform, and digital PCR with ultra-high sensitivity is still in the introduction phase. The PCR diagnostics market accounts for more than 30% of the molecular diagnostics market, and PCR is expected to remain the mainstream molecular diagnostics technology in the next 3-5 years.At present, the nucleic acid mass spectrometry technology mainly uses ESI and MALDI. Compared with other detection technologies, mass spectrometry has the advantages of rapidness, accuracy, high sensitivity, and high throughput. In recent years, it has been widely used in the fields of advanced nucleic acid structure identification, oligonucleotide and small molecule interaction, DNA damage and modification, etc. Applications. Due to the complexity of biological samples, mass spectrometry technology still faces some challenges and difficulties. However, biological mass spectrometry technology is a powerful tool for scientific research. With the continuous deepening of the understanding and application of mass spectrometry in clinical laboratories, the detection platform may become Indispensable standard equipment for standardizing laboratories.Compared with traditional chromosome karyotype analysis technology, gene chip has higher resolution and can identify subtle chromosome imbalances above Kb level. Gene chip has now become a routine technology in clinical genetic diagnosis at home and abroad, and it has shown broad application prospects in genetic disease detection, disease screening, disease typing, pathogen detection, and personalized medicine.The emergence and continuous optimization of second-generation sequencing have reduced the cost of gene sequencing, and the speed and data volume have continued to rise. Domestic gene sequencing is currently mainly used in the field of reproductive health and oncology, among which NIPT is the largest and most mature field in the current market.Looking forward to the future, the largest application market for molecular diagnostics will be in the field of tumors, specifically including tumor susceptibility gene screening, early tumor diagnosis, tumor companion diagnosis and medication guidance, and tumor post-treatment monitoring.With the rise of precision medicine and the development of medical models towards personalized and targeted therapy, the application scope of molecular diagnosis will become wider and wider. At present, domestic molecular diagnostics is still in its infancy, but under the promotion of national policies, the molecular diagnostics industry will usher in rapid development.4. Blood and body fluids: The blood and body fluid testing market mainly includes coagulation testing, blood cell analysis, urinalysis, and urine physical analysis. The overall market accounts for about 10% of the in vitro diagnostic market, maintaining a 10% growth.At present, foreign-funded enterprises have an absolute advantage in the Chinese hemagglutination market, and are expected to occupy more than 80% of the market share. With the continuous deepening of the hierarchical diagnosis and treatment policy in the past two years and the continuous promotion of related concepts such as community hospitals, the market for middle and low-end blood coagulation instruments will increase significantly; on the other hand, with the introduction of the concept of automated blood coagulation, the high-end market Will gradually integrate and upgrade, and continue to move towards automation.The blood cell counting product consists of a blood cell analyzer, reagents, calibrators and quality control products. Blood cell analyzer is one of the most widely used instruments in hospital clinical testing. With the rapid development of computer technology in recent years, the technology of blood cell analysis has also shifted from three groups to five groups. As a key implementation of the sinking of medical and health resources, five-category blood cell analyzers are gradually popularized in primary medical institutions. However, the clinical testing laboratories of primary medical institutions are small in area, many instruments, and limited space. Therefore, miniaturization will be five-category blood cell analysis. The development direction of the instrument. The blood analyzer product market is the most successful segment of the entire China's IVD industry market for Chinese product brand substitution. It is relatively mature, with domestic production accounting for more than 50%. The three-category instruments are mainly domestically produced, and the imported products are concentrated in the five-category.As one of the routine medical testing methods, urine analyzers play a prominent role in medical equipment. In the past, foreign brands have always accounted for a relatively high proportion of the market share in this field, and at the same time they are in a leading position in R&D and technology.With the increasingly mature technology of domestic brands and numerous domestic suppliers, the market share of imported brands has declined. Domestic brands have gradually replaced imports, with a market share of over 50%.5. POCT: The overall market size of POCT currently accounts for more than 10% of the total in vitro diagnostic market, with a growth rate of more than 15%.POCT is one of the fastest growing areas in the in vitro diagnostic industry. The most representative technologies on the market are colloidal gold and fluorescence immunochromatography. Traditional immunochromatographic test strips are limited by their own methodology. Generally, they can only achieve qualitative diagnosis and cannot meet the quantitative needs of doctors. In addition, because the test strips are difficult to achieve uniform structure, the materials, thickness, and density are also difficult. Exactly the same, which will make the sample test results have poor repeatability on different test cards.With the development of precision medicine in recent years, there are higher requirements for the accuracy of medical testing instruments. Biochip technology and microfluidic technology are developing rapidly in the POCT field. Microfluidic technology integrates cell lysis, nucleic acid extraction and amplification, and final detection on a chip. The reaction process is in a closed environment, which reduces the burden on the operator and the possibility of pollution, and achieves rapid speed anytime, anywhere The demand for testing has brought tremendous help to medical testing and disease prevention and control, and has a key role in realizing the miniaturization, integration, portability, and disposal of testing devices. The sensitivity and repeatability of future products will be the competitive advantages of POCT companies, and the prospects of POCT based on immune platform detection and molecular diagnosis are promising. At present, domestically produced products in the POCT market account for about 50%.Thanks to the gradual implementation of graded diagnosis and treatment and the construction of chest pain centers, POCT products will have more opportunities in departments such as primary hospitals and heart failure centers. In addition, in the Internet+ era of big data, cloud computing, and the Internet of Things, the big POCT platform with smart POCT as the core will bring good news to patients.6. Microbiology: The field of microbiological diagnosis in my country started late, with a share of about 5% and an increase of about 10%.Microbial diagnosis provides evidence for the prevention, diagnosis, treatment and efficacy observation of clinical infectious diseases through pathogenic diagnosis and drug sensitivity analysis. In terms of microbial detection in the past two years, the most influential in the industry has been the technological breakthroughs in matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF) and drug susceptibility detection. Although the mass spectrometry market is still dominated by two companies, BioMérieux and Bruker, domestic mass spectrometers continue to develop rapidly, breaking the monopoly of foreign companies at lower prices on the basis of guaranteed performance.Currently, microbial testing is developing in two directions. On the one hand, microbial detection is advancing rapidly on the road of integration and intelligence. Major manufacturers have introduced a series of overall solutions for each project of microbial detection through process optimization and information integration; on the other hand, bedside diagnostic products are quick and easy. The advantages of high efficiency, low cost, short inspection cycle, and small amount of specimens have attracted more and more clinical attention. At present, the microbiology market is still mainly imported, and the share of imported products is more than 80%.7. Pathology: China's pathology market accounts for less than 5% of the overall in vitro diagnostic market, with a growth rate of about 10%.Pathology generally includes histopathology, cytopathology and molecular pathology.As the most commonly used method of pathological diagnosis, immunohistochemistry technology has important and extensive clinical application value in tumor diagnosis, identification, and treatment. Most of the key raw materials for immunohistochemistry, especially secondary antibodies, rely on imports. A small number of domestic companies that have the ability to develop and produce specific pathological antibodies have become the leaders in the subdivisions. At present, domestic products account for 20%-30% of the pathology market. The original pathology detection mostly relies on manual operation, which takes a long time, and the automatic staining instrument realizes the automatic operation from the baking sheet to the counterstaining process, which can effectively avoid human error, highly simulate the manual immunohistochemical staining procedure, and change the manual operation using reagents. In order to automate operation and ensure stable and reliable experimental results, it has been widely used in domestic top three hospitals.The traditional method of cytopathology is the Pap smear technique, but the detection sensitivity is poor due to cell loss and poor film quality. Liquid-based cell technology puts the exfoliated cells in the preservation solution, which can better preserve DNA information and greatly increase the positive detection rate.At present, the commonly used molecular pathology detection techniques are chromosome karyotype analysis, fluorescence in situ hybridization, PCR method, gene chip and first-generation sequencing. Under the general trend of precision medicine, molecular pathology has important applications in the detection of tumors, infectious diseases and genetic diseases. High throughput will become the main trend in molecular pathology.In 2018, the Health Commission's "Notice on Printing and Distributing the Work Plan for Comprehensively Improving the Comprehensive Capability of County-level Hospitals (2018-2020)" proposed that the construction of the pathology department and the medical laboratory department should be strengthened. With the advancement of national graded diagnosis and treatment, the pathological diagnosis capabilities of primary medical care will inevitably be improved, which will bring sustained and steady growth momentum to the development of the pathological diagnosis industry, which is conducive to the development of domestic brands.The main downstream users of in vitro diagnostics include medical institutions, independent medical laboratories, blood stations, physical examination centers, and food testing markets. With the improvement of living standards, people's emphasis on health has been increasing, medical care expenditure has also increased correspondingly, and the demand in the downstream market has continued to increase. The growth of the downstream market remained at double digits.Medical institutions: According to the 2018 Statistical Communiqué on the Development of China's Health Services, at the end of 2018, there were 997,434, an increase of 10,785 over the previous year. Among them: 33,009 hospitals, 943,639 primary medical and health institutions, and 18,034 professional public health institutions.Third-party medical laboratories : In recent years, benefiting from national policies such as graded diagnosis and treatment and medical insurance control fees, China's third-party medical diagnosis industry has a large room for growth, and the market size is expected to maintain a rapid growth trend in the short term. As of the end of 2018, my country had 1,495 medical testing laboratories, a year-on-year increase of 73.4% over 2017, and the market size increased by more than 20% year-on-year. In 2019, China's third-party medical market is expected to reach 18.8 billion yuan. By 2024, the market size is expected to exceed 80 billion, with a compound annual growth rate of about 35%, accounting for about 14% of the medical laboratory industry's revenue. The operating income of independent laboratories in the United States, Europe, and Japan accounted for approximately 44%, 53% and 67% of the entire medical laboratory industry's income, respectively. In contrast, China still does not exceed 5%. At present, my country is still in the initial stage of third-party medical inspection, and there is still a big gap between the inspection market of such developed countries, and there is huge room for growth. At present, multiple models of inspection services (centralized procurement, special inspection, co-construction, etc.) have coexisted and developed over a period of time. From a long-term trend, independent third-party laboratories and regional third-party laboratories are expected to eventually win.Physical examination center : Physical examination institutions are mainly divided into public hospitals and non-public institutions. In 2018, the number of health examinations in China reached 575 million, accounting for 42% of the total population. In 2018, the size of the health check-up market reached 151.1 billion yuan, a year-on-year increase of about 16%. As my country's consumption upgrades and health awareness increase, the demand for health checkups and the market scale will further increase.