The Annual Report of China IVD Industry 2021 Part I-IV Changes in upstream, midstream and downstream of the industry

4.2    Midstream

4.2.1 Biochemistry: Biochemical tests accounted for about 20% of the IVD market share with a growth rate of less than 5% and a localization rate of more than 60%.

Biochemical diagnosis is to obtain clinical judgment information based on biochemical indexes in the human body, such as enzymes, lipids, saccharides, proteins and inorganic elements, which is applied to routine testing items in medical institutions, CDC and third-party laboratories, including liver function, kidney function, blood glucose, blood fat, cardiovascular, diabetes detection, etc. Biochemical industry is one of the earliest and most mature diagnostic means of IVD in China. Its market growth is mainly driven by the sales of instruments and the pipeline of biochemical immunity, while reagents grow slowly. The substitution rate of domestic biochemical reagents is about 70%. At present, there are more than 200 domestic biochemical reagent manufacturers and more than 100 biochemical detection projects. The industry barrier is low, and the competition has entered the red ocean model. Domestic high-speed biochemical instruments are developing rapidly. domestic biochemical analyzers with speeds below 800 account for 60%-70% of the market share. More than 10 domestic enterprises can produce analyzers with speed of 1000 and 2000. In the biochemical field, the enterprise can maintain stable development by adhering to the route of R&D of high-quality products and reducing the cost of upstream raw materials. The cooperative development of pipelines, biochemical closed systems and biochemical instruments with other products (such as immunization) is an important direction for the development of biochemical enterprises in the future.

4.2.2 Immunization: Driven by the chemiluminescence market, immunodiagnosis is a segment with the largest scale and most new varieties in the IVD field in recent years. At present, it accounts for more than 30% of the IVD market share with a growth rate of about 15%. The localization rate is 25% - 30%.

Immunodiagnosis is the largest sub-industry of IVD and is still developing rapidly. Immunodiagnosis can be classified into radioimmunoassay, ELISA, immunochromatography and chemiluminescence by methodological classification.

ELISA is still widely used because of its advantages such as fast detection and low cost. domestic products account for more than 70% of the ELISA market share. Multinational enterprises and more and more domestic enterprises have ELISA product lines, and the market competition is similar to the biochemistry market. In recent years, most of the patent applications of Roche and other global leading enterprises adopt chemiluminescence technology, and the domestic immunization market also shows a trend of chemiluminescence replacing ELISA.

The market share of domestic products in the field of chemiluminescence is more than 20%. The domestic laboratory market is dominated by tertiary hospital customers, and the future growth momentum will come from the secondary and tertiary hospital market, which accounts for 65%. Under the background of medical insurance cost control, domestic luminescence enterprises are facing the pressure of price reduction. The fundamental competitiveness to become bigger and stronger lies in continuous R&D innovation and powerful sales channels. At present, some domestic reagent kits are fairly mature, but some core reagent kits with high-performance requirements are still mostly imported products. Analysis of patent applications for immunochemical raw materials shows that these segments are dominated by foreign biomedical giants. Therefore, for domestic enterprises to realize import substitution, firstly, they should improve the product performance, enhance the R&D of raw materials and the quality control of instruments, and ensure the stability and high quality of raw materials and instruments. Secondly, they should, according to the clinical needs, provide menus of test items that meet the requirements of domesticusers and cannot be provided by foreign investors, and increase the number of installed instruments in hospitals through substantial test menus and complete supporting reagents. Thirdly, domestic instruments and reagents should be more cost-effective than imported products.

4.2.3    Molecular diagnostics: As one of the fastest growing segments of IVD, driven by the demand for nucleic acid testing for COVID-19, molecular diagnostics has a market share of about 20% with a growth rate of 20%. The localization rate is more than 50%.

According to different technology platforms, molecular detection can be divided into polymerase chain nucleic acid amplification (PCR), gene sequencing (NGS), fluorescence in situ hybridization, gene chip and nucleic acid mass spectrometry. Molecular diagnostics is mainly used in infectious diseases, tumor diagnosis, genetic disease diagnosis, eugenics, personalized medication, etc. Multinational companies focus on high-end instruments, represented by ThermoFisher, Bio-rad, Roche Quantitative PCR and Illumina Sequencer. In the field of mid-range instruments that it is easy to make a breakthrough in technology, such as nucleic acid extractors, PCR amplifiers, nucleic acid hybridization ovens and gene chip instruments, localization has been achieved and domestic products have occupied the leading market, while the localization of gene sequencer is breaking through, mainly in three ways: (1) merge and acquire a foreign sequencer company, and launch its own-brand sequencers based on the core technologies of the acquired company, such as BGI; (2) develop independently with internal research capacity; (3) cooperate with a well-known foreign sequencer manufacturer, and transform its sequencer prototype to form the company's own-brand sequencers with special purposes, such as Berry, Daan, etc. During the COVID-19 pandemic, the market size of China's molecular detection industry has surged, and the demand for nucleic acid testing has led to a doubling of the sales of domestic PCR amplifiers and nucleic acid extractors. According to the report of China Insights Consultancy, the market size of PCR amplifiers in China was 6.6 billion CNY in 2020, which is expected to reach 20.6 billion CNY by 2030, with a CAGR of 12.0% from 2020 to 2030[2]. In the post-COVID-19 era, PCR technology will advance towards high precision, high throughput and automation by improving the performance of polymerase and the processing capacity of PCR equipment. The development of molecular diagnostics will largely depend on the process of substitution with domestic products of upstream equipment. With policy support and more excellent enterprises moving to the upstream instrument side, molecular diagnostic instruments are expected to be substituted with domestic products faster.

Looking forward to the future, the largest application market of molecular diagnostics will be in the tumor field, including tumor susceptibility gene screening, early diagnostics of tumors, companion diagnostics of tumors and drug guidance, and monitoring after tumor recovery, forming a whole course and life cycle management model. Among them, companion diagnostics is the fastest-growing sub-industry in the molecular segment. Micromolecule targeting drugs, macromolecular mAb drugs, immunoassay therapy and CART therapy all require gene screening for maximum efficacy. With the rise of precision medicine, based on AI, big data and Internet platforms, molecular diagnostics will be used more and more widely.

4.2.4 Blood and Body Fluid: The blood and body fluid test market mainly includes coagulation tests, blood cell analysis, urinalysis, urinary sediment analysis, etc. The overall market accounts for less than 10% of the IVD market with a growth rate of 10% and a localization rate of more than 50%.

Blood and body fluid test mainly involves blood cell, urine and blood coagulation test, including blood analyzer, coagulation analyzer, urine analyzer and other equipment, detection reagents and consumables. The basic principle is mainly to apply various physical and chemical methods, involving technologies such as flow cytometry, electrical impedance, and photoelectric colorimetry, as well as the detection of routine blood tests, thrombus and hemostasis, routine urine tests and other items.

Blood coagulation: At present, domestic enterprises have less than 20% of the market share in the coagulation market, and foreign enterprises have absolute advantages, accounting for more than 80% of the market share. The three foreign giants of blood coagulation are IL (Werfen Group), Sysmex and Stago. With the deepening of hierarchical medical policy and the constant promotion of community hospitals and other related concepts in recent two years, the market for mid-range and low-end coagulation analyzers will increase significantly;

Blood cell: After decades of development in the field of blood cell tests, two blood cell giants have emerged, namely Sysmex and Mindray, accounting for 60% of the market share; at the same time, rising stars like Dymind have also emerged, and Maccura has also stepped up its layout in the high-end blood cell market in recent years. Blood cell analysis has also been upgraded from manual method to the current blood cell pipeline.

Urinalysis: In the past market share of urine test analyzers, foreign brands have been occupying a high proportion. With the increasing maturity of the technology of domestic brands, domestic brands have gradually replaced imported products with a market share of more than 50%. Many domestic enterprises have started the ball rolling in the secondary and tertiary markets, such as Dirui, Urit, etc. In the future, urinalysis will require higher speed, portability and accuracy to meet the needs of families, individuals and primary care; at the same time, in large hospitals and independent third-party laboratories, automatic pipelines for urinalysis will be more widely used.

With the continuous upgrading and improvement of automated instruments in the blood and body fluid market, another key competitive advantage in the future is the refinement and diversification of parameters. With the increasingly diversified demands for blood and body fluid test items in the Grade-A tertiary and Grade-A secondary hospitals, routine items obviously do not meet the clinical needs of the high-end market. Therefore, diversified parameters and reliable test results will be the key technologies for manufacturers to compete in the high-end market.

4.2.5 POCT: The current market size of POCT accounts for about 15% of the overall IVD market with a growth rate of about 15%. The localization rate is more than 50%.

From the perspective of the application field, POCT products can be used in clinical tests, chronic disease monitoring, emergency anti-terrorism, disaster medical rescue, infectious disease monitoring, inspection and quarantine, food safety, drug examination and other public health fields. From the perspective of application sites, POCT products can be used in a variety of occasions, including wards, outpatient departments, emergency departments, laboratories, operating rooms, and care units in large hospitals; primary hospitals, community clinics and private clinics; health service centers, disease prevention and control centers, medical rescue sites for disasters, food safety testing sites, environmental protection sites; customs quarantine control, fast screening of illegal drugs; forensic medicine sites; biological anti-terrorism sites, etc.

From the perspective of the growth rate of segments, POCT products for cardiac markers and infectious diseases are in a rapid growth period with rapid demand growth and large development space in the future. This is because saving cardiovascular patients requires much higher timeliness than treating other diseases, and POCT meets this demand with its high detection speed. Therefore, cardiovascular detection has become the fastest-growing application of POCT. POCT for infectious diseases is mainly a product for primary field screening and rapid detection of various common infectious diseases and major infectious diseases, including AIDS, syphilis, viral hepatitis, malaria, influenza, etc. Infectious diseases have attracted different degrees of attention worldwide because of their characteristics of infectivity, epidemicity, territoriality and seasonality. China has also gradually increased the prevention and monitoring of major infectious diseases. POCT products have become an important tool for the prevention and control of related infectious diseases. As in this pandemic, COVID-19-related POCT detection products are widely used in the domestic detection field abroad.

POCT is one of the fastest-growing fields in the IVD industry. Due to the increasing degree of aging and uneven distribution of medical resources, and thanks to the advancement of hierarchical medical policy and medicare reform policy, China's POCT industry will still maintain rapid growth in the next few years. With the development of precision medicine in recent years, there are higher requirements for the precision of medical detection instruments. Biochip, microfluidics, mass spectrometer, reverse transcription polymerase chain reaction, isothermal amplification, CRISPR gene editing and other technologies are combined with the POCT platform to promote the rapid development of POCT towards refinement. In addition, the combination of artificial intelligence, mobile intelligent devices, intelligent APP, wearable devices, biosensors and POCT detection technology can realize remote patient monitoring and home medical services, which is of great significance for chronic disease and health monitoring.

In the field of POCT, which is widely used and extensively demanded by the market, Chinese enterprises have made continuous progress in technology. They are not very far behind foreign enterprises and are more cost-effective. In the future, it is more and more likely to realize substitution with domestic products. "Miniaturization", "Integration", "Informatization" and "Intelligence" have become higher requirements for the technical development and integration of POCT. In the future, enterprises with the ability of upstream innovation and R&D and downstream channel promotion as well as the resources of industry-university-research collaboration will be more competitive.

4.2.6    Microorganism: China's microbiological diagnostics field started late with a share of no more than 5% and a growth rate of 10%. At present, the microorganism market is still dominated by imported products, and domestic products account for about 20%.

At present, the main microorganism detection platforms include conventional technologies, serum immunology, molecular diagnostics and mass spectrometry. Conventional methods and serum immunology are relatively mature. immunoassay can only detect antibodies against known types of bacteria, which has high sensitivity, specificity and convenience, but the types of pathogenic bacteria that can be detected are not complete. Mass spectrometry and molecular diagnostics are new technologies. The core barrier of mass spectrometry is the traceability of bacteria banks. A cloud database of microbial protein fingerprints needs to be established. The representative domestic enterprises of mass spectrometry are Bioyong and Autobio, and the representative foreign enterprises are Bruker, Mérieux and BD; the core of gene test method lies in the establishment of bacterial gene databases and the selection of detection method. The cost of macro genome sequencing is high, and only known bacteria can be detected by PCR. The representative enterprises in molecular diagnostics are BGI, Jiangxi PrecisionGene, and Dynamiker Biotech, which focuses on the field of fungus detection. In the international market, Mérieux is a leading enterprise in the global microbiological diagnostics industry, covering all technical platforms in the field of microbiological diagnostics and accounting for 60% of the global market share of microbiological diagnostics.

Automation and intelligence are the future development direction of microorganism detection: due to emerging infectious diseases, nosocomial infection and increased antibiotic resistance, there will be an increasing demand for microbiology and virology in the next five years. Automated and intelligent microorganism detection equipment can improve the efficiency of testing microbial content of the sample, reduce the time required in routine testing, and detect the number and types of microorganisms in a short time; at the same time, the testing technology should guarantee the test results and improve the precision and scientific nature of the test.

4.2.7    Pathology: China's pathology market accounts for about 3% of the overall IVD market with a growth rate of 10%. The localization rate is about 20%.

Pathology usually includes histopathology, cytopathology and molecular pathology. Immunohistochemical technique is the most widely used in clinical practice, which can be used for the diagnosis and differential diagnosis of malignant tumors, the determination of the primary site of metastatic tumors, the further pathological typing of tumors, the determination of histological classification of soft tissue tumors, the discovery of micrometastases, and the provision of a basis for clinical treatment.

At present, the commonly used molecular pathological examination techniques include chromosome karyotype analysis, fluorescence in situ hybridization, PCR, gene chip and first-generation sequencing. In the general trend of precision medicine, molecular pathology plays an important role in the detection of tumors, infectious diseases and genetic diseases. At present, molecular pathological examination equipment is dominated by international brands.

In China, cytopathology is mainly used for cervical cancer screening. TCT screening of cervical cancer accounts for 80% of the total cytopathology market, while there are too few examination items for other types of cancer. 

The pain points of pathological diagnosis lie in the scarcity of pathologists and technicians and the seriously uneven distribution of resources. However, with the vigorous development of artificial intelligence, digital section scanning technology and the Internet, digital remote pathological consultation + AI-assisted diagnosis have taken root all over the country, and become increasingly complete and mature, which could effectively give play to the technical advantages of the pathology department of superior hospitals, promote the subsidence of good pathologists, and help promote hierarchical medicare.

The market size of immunohistochemical pathology in China is growing steadily. According to the data of Market & Market, the global immunohistochemistry market size was about 1.9 billion USD in 2020, and it is expected to grow to 2.7 billion USD in 2025 with a CAGR of 6.6%[3]. According to the data of Intelligence Research Group, the CAGR of China's immunohistochemistry market from 2012 to 2017 was 14.27%, which was significantly higher than the global average. With the promotion of national hierarchical medicare, the pathological diagnosis ability of primary care is bound to improve, which will bring a sustained and steady growth momentum to the development of the pathological diagnostics industry, and is conducive to the development of domestic brands.

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