The Annual Report of China IVD Industry 2021 Part I-V General development trends of future technology and products

5    General development trends of future technology and products

Integration, high throughput, immediacy, portability and precision medicine are the future development direction of products and technologies in the diagnostics industry. At the same time, the constant inburst and upgrade and iteration of new technologies and new products such as mass spectrometry and mobile detection system have brought broader application prospects to the IVD field.

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5.1    Integration and high throughput

In the process of China's health system reform, based on the establishment of the universal medical security system, a large number of medical needs have been released, and the number of patients and specimens has increased. The medical laboratory department urgently needs to obtain more reliable test data and information in the shortest time, so it is particularly important to provide faster and more comprehensive diagnosis and treatment basis for the clinic. Therefore, medical laboratories have a strong demand for high-throughput, high-efficiency and high-safety pipeline products. Secondly, with the promotion of hierarchical medicare, the workload of outpatient services has been transferred to lower-level hospitals, and the sample size of primary medical institutions has gradually increased. Secondary hospitals, including a large number of county-level hospitals, also have potential demand for pipelines. In addition, the localization of pipeline products is an important way to reduce the cost of clinical laboratories. China's pipeline market has great potential. In the next 10-20 years, there will be a large number of intelligent pipelines in the upstream product side of the IVD industry. A large number of whole laboratory pipelines, biochemical immunity pipelines, blood cell pipelines, molecular pipelines, urine pipelines, blood coagulation pipelines and pipelines for other segments will enter the end market. The nucleic acid testing pipeline is undoubtedly another direction of future industry innovation. It is feasible to focus on the pipeline development of infectious disease diagnosis.

5.2    Immediacy and portability

POCT products are easy to operate, and can achieve spot sampling and timely results, which are very suitable for the application scenarios of primary medical institutions, emergency and critical wards and clinical departments. With the full implementation of the hierarchical medical policy, and the large-scale construction of five major emergency centers for pectoralgia, apoplexy, trauma, maternal near miss, and critical neonates with 4000 counties in China as the core units, POCT, as a representative of immediate and portable equipment, can release the needs of emergency and primary institutions and has a broad market. With the aging of the population and the prevalence of chronic diseases, especially in the prevention and control of public health, the conventional PCR nucleic acid testing technology cannot meet the needs of screening and detection due to its cumbersome process, complex operation, and the restrictions such as the need for centralized submission for testing. By contrast, by combining the characteristics of high sensitivity and specificity of molecular diagnosis and the advantages of the POCT platform, molecular POCT breaks through the restrictions of existing testing technologies on personnel and places, effectively shorting the testing time and improving convenience.Driven by the pandemic, molecular diagnostic POCT accelerated to the stage of clinical detection. In the future, the application of nucleic acid testing POCT will be able to detect a variety of pathogens and be applicable to multiple departments and a variety of application scenarios. At the same time, it can also detect human gene targets and promote precise and rational drug use.

5.3    Precision medicine and companion diagnostics

According to 2020 statistics, the number of cancer cases in China is 4.57 million, and the number of cancer deaths is 3 million. China has a large base of cancer patients and many new cancer patients; the number of new cancer cases and cancer deaths ranks first in the world. Both the number and the increment drive the patient's demand for companion diagnosis. At present, the top 10 sales of tumor drugs in China are tumor-targeting drugs, accounting for more than 50% of the global market share of anti-tumor prescription. More and more drugs used by pharmaceutical companies need diagnostic results as a reference, especially the introduction of many new drugs needs companion diagnostic testing. There is great potential for growth in companion diagnostics. In addition, with the deepening of the cooperation model of companion diagnostics and drug development, the R&D of diagnostic products will continue to accelerate.

Gene sequencing technology is the main technology of companion diagnosis, which is still in the development stage. With the research and development of sequencing technology, the development of the accompanying diagnostics market will change dramatically. The continuous investment of capital in recent years has provided "Logistics Support" for the field of companion diagnostics. To encourage the development of precision medicine in China, in 2015, the Ministry of Science and Technology determined to invest 60 billion CNY in developing the precision medicine strategy by 2030, providing strategic direction for the development of companion diagnostics.

5.4    Mass spectrometry

At present, many domestic IVD enterprises have entered the mass spectrometry field, which started late and developed slowly. Developed countries in Europe and the United States have widely carried out mass spectrometry clinical chemical test projects, including neonatal screening, detection of hormones and their metabolites, therapeutic drug monitoring, vitamin D detection and trace element detection. From 2004 to 2020, dozens of innovative clinical mass spectrometry enterprises emerged in China. Due to the restrictions of factors such as access to fee list, access to reagent registration, standardization of methodology, laboratory conditions, and lack of talents, the development of domesticenterprises is limited at present. With the constant improvement of such constraints, the mass spectrometry industry will enter the fast lane of development. Now more than 10 domestic mass spectrometers have obtained registration certificates. In addition, with the further development of LDT, many projects suitable for detection by mass spectrometers will continue to be launched, creating conditions for mass spectrometry to be extensively applied in clinical practice.

5.5    Mobile testing system

Mobile sampling and mobile testing schemes have been widely used in public health prevention and control, played an important role, and enhanced the emergency handling capacity of local authorities in public health emergencies. The mobile rapid nucleic acid testing vehicle is equipped with a low-throughput or medium-throughput nucleic acid tester and rapid virus inactivation equipment as well as mobile negative pressure disinfection chamber and 5G data real-time transmission function, which can be put into use in public places such as stations, squares, airports, etc. And it can provide timely and rapid testing services for remote areas and emergency scenes. This kind of testing system can meet urgent testing requirements under a variety of mobile scenarios. For example, on-site testing of multiple indicators can be realized in the ambulance in the future, and data can be transmitted to the first-aid consulting room in advance through the 5G network to improve treatment efficiency.

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Last：Changes in downstream of the industry

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