Development status and future trend of in vitro diagnosis industry in China

In vitro diagnosis is the cornerstone of modern medical diagnosis, treatment, prevention, prognosis and other clinical decision-making, which can be called "medical scout". At present, the contribution of in vitro diagnosis to clinical medical decision-making has exceeded 70%. From a certain point of view, the 21st century is the century of biotechnology, in vitro diagnosis industry has become one of the most active and fastest growing industries in the world.

Although China's in vitro diagnosis industry started late, it developed rapidly, and the domestic market competition is becoming increasingly fierce. Throughout the current situation and atmosphere of domestic industrial development, in vitro diagnosis industry has the conditions for scale development. Although at this stage, local in vitro diagnostic enterprises are still facing many difficulties and challenges, driven by relevant national policies and aging population and other factors, in the future, China's in vitro diagnostic industry will have broad development space and rare opportunities, and in vitro diagnostic products will also develop in the direction of automation, integration, convenience, miniaturization, personalization and informatization.

Basic concepts

In vitro diagnosis refers to the process of obtaining clinical diagnosis information by detecting the samples (including blood, body fluid, tissue, etc.) obtained from human body in vitro. The in vitro diagnostic system is composed of the instruments, reagents and consumables needed in the detection process. The enterprises engaged in the R & D, production and marketing of these instruments, reagents and consumables have formed the in vitro diagnostic industry, which integrates biology, medicine, machinery, optics, electronics (Microelectronics), computer, engineering, industrial design and manufacturing and other related technologies.

Different from the international practice, there is no separate concept of IVD in China for a long time, and IVD products have not been defined independently. The products included in the common international concept of IVD have been scattered, and they belong to medical devices, IVD reagents and drugs respectively.

Development status

China's in vitro diagnosis industry started in the 1980s. After 30 years of development, it has the conditions for industrial scale development and is in a critical period of development. China's IVD industry is in a period of rapid development. China's population accounts for one fifth of the world's total population, but China's in vitro diagnosis industry accounts for less than 15% of the global share, and has a broad market space.

In recent years, with the hard work of local IVD enterprises, the level of production technology and product quality have been improved, and the variety of products has become increasingly rich. Domestic IVD equipment and reagents have been gradually accepted by users at home and abroad. The national medical service catalog has standardized the pricing of in vitro diagnosis and other items. IVD reagents are included in the list of charges by item. However, the prices of the products of the international mainstream IVD enterprises are generally 1-5 times higher than those of the domestic similar products, with obvious price disadvantages. This makes the advantages of high cost performance of domestic IVD products in the domestic market, especially in the middle and low-end markets such as secondary hospitals and primary hospitals More competitive.

At present, foreign IVD products (such as Roche, Abbott, etc.) are still dominant in high-end markets such as tertiary hospitals in first tier cities. Other markets have been generally occupied by local IVD enterprises. There is a trend that domestic products have replaced imported ones in some middle and low-end testing markets, which is more significant in terms of in vitro diagnostic testing reagents, especially domestic biochemical reagents. In foreign markets, domestic IVD products have achieved zero breakthrough and developed rapidly, showing a steady growth trend in product types and quality. In addition, from the perspective of market segments, molecular diagnosis and POCT will be the focus of industry development, and will also be the main areas of market competition in the future.

Future direction

In China's development plan, high-performance medical devices, biomedicine and medical informatization have been identified as key breakthrough areas. The market scale of in vitro diagnosis still has great potential. The market demand of in vitro diagnosis will be more diversified, the service mode will be more diversified, and the industry environment will be more standardized and orderly. Technological innovation will become the key to win in the industry. The development trend of in vitro diagnosis industry will present seven trends: systematization, integration, automation, informatization, individualization, miniaturization and convenience.

With the development of society, higher requirements will be put forward for in vitro diagnosis. It is necessary to achieve both rapid detection and consistent with the measurement results of complex technology and large-scale laboratory equipment, so as to strive for valuable time for clinical diagnosis and treatment. Therefore, the "convenience" of equipment is one of the problems that must be considered in in vitro diagnosis. While ensuring the accuracy and traceability of instruments, reagents, calibrators and quality control materials, it is very convenient and fast to use, such as POCT and wearable medical equipment, which will have a good prospect. At the same time, this kind of equipment also has broad application space outside medical institutions (such as home use). In the future, this kind of product will be one of the fastest growing varieties for quite a long time.

Finally, enough attention must be paid to mass spectrometry. At present, mass spectrometry technology has been more mature for microbial identification, small molecule detection, trace element determination, reference method establishment, etc. its unique technical advantages and cheap detection cost will bring unexpected development. In the future, the application of in vitro diagnosis will be beyond imagination.

Desheng biochemical is specialized in R & D, production and sales of vascular additives, in vitro diagnostic reagents, buffers and luminescent substrates. We have a wide range of products and sufficient inventory to provide customers with one-stop purchasing service. Desheng technology will continue to develop and research advanced biochemical reagents to meet the needs of the development of global medical laboratory technology and strive for human health. We hope that through the efforts of all Desheng employees, we can create a world that belongs to Desheng in the in vitro diagnosis industry.