At present, most of the global medical decision-making is based on diagnosis, and in vitro diagnosis is an important part of the prevention and treatment of diseases. Since 2015, the compound annual growth rate of China's in vitro diagnostics market has remained above 15%. In 2019, the scale of China's IVD market exceeded RMB 90 billion. After the baptism of the epidemic in 2020, the market has reached a scale of 100 billion. China has become one of the fastest growing markets for IVD in the world.

|Domestic modern IVD core technology system|

High-end immune import substitution, molecular diagnostic technology upgrades and POCT convenience are the three major directions for future development. IVD belongs to a high-tech industry, and the core lies in the technical platform and response system of diagnostic testing. The core competitiveness of an enterprise mainly lies in its technical level.

China's population accounts for one-fifth of the world's total population, but China's in vitro diagnostic industry has a low share of the global market and has broad room for development.

|Domestic IVD industry technology development|

In the 1980s, the first batch of in vitro diagnostic product manufacturers appeared in China, which opened the prelude to the in vitro diagnostic industry. In the early stages of development, there was a big gap between domestic technology and product quality and foreign products, and the main focus was on learning and imitating foreign products. After 30 years of development and growth, the conditions for large-scale industrial development are now available, and it is in a critical period of rapid development.

A breakthrough was made in product import substitution, and the quality of mid- and low-end products improved significantly

According to statistics, in 2019, the State Food and Drug Administration approved and registered a total of 524 domestic IVD and imported IVD products, including 352 domestic IVD products and 172 imported IVD products. Import substitution increased significantly.

my country's promotion of the localization of biochemical instruments is conducive to breakthroughs in the company's instrument research and development capabilities, and promotes product differentiation in the industry; chemiluminescence technology has played a significant role in the field of infectious diseases, and the door to import substitution has been opened. In the field of molecular diagnostics, the cost of sequencing has dropped rapidly; emerging technologies such as microfluidics and PCR have also strongly promoted the innovative development of POCT at the technical level.

Although most of the domestically developed IVD products are still in the low-end market in the field of immunodiagnosis and molecular diagnosis, high-end products such as high-throughput automatic biochemical analyzers, automatic chemiluminescence, real-time PCR, and smart POCT have begun to be localized.

The bottleneck of my country's in vitro diagnostic industry

IVD is a high-tech industry, and the competition in the industry is ultimately the competition of technology. Domestic IVD companies started with reagents and have mature technology. Therefore, the current hot spot in IVD competition is instruments. The ecological environment of my country's in vitro diagnostic industry has undesirable conditions such as backward research technology, mismatch between supply and demand of research products, and poor product sales. Mainly reflected in the following three aspects:

01

The scale of the enterprise is relatively small and the industry concentration is low

my country is mainly dominated by small IVD companies, and there are few large-scale mature R&D companies. Although the arrival of the epidemic has brought many business opportunities to many IVD companies and achieved rapid development in the short term, it has reached the turnover of leading global IVD companies. There is a certain gap in comparison. Most enterprises have limited technical content, few products, single business scope, small and scattered enterprises, and fierce competition. Although large listed in vitro diagnostic companies related to epidemic prevention and control emerged last year and began to dominate the domestic diagnostic market, overall, the domestic market concentration needs to be further improved.

02

The mismatch between scientific research results and market demand

Judging from the results of current research retrievals, the transformation of scientific research results of scientific research institutions is not active, the transformation rate of technology and products is not high, technology is useless, enterprises have no innovation ability, and there is no demand for technology. The disconnection between research and application, and the disconnection between products and needs, ultimately leads to a pathological environment that new technology products and instrument testing departments are unwilling to use, and clinical departments cannot use them.

03

Core technologies such as engineering and fluids are backward

In vitro diagnostics is a typical high-tech industry, with significant features such as intensive high-tech applications, extensive interdisciplinary, and technological integration. With the rapid development of my country's economy, in vitro diagnostic technology is also constantly developing and innovating. But in terms of core technology, there is still a certain gap between domestic and foreign. The innovation and application of core technologies such as optics, fluids, and computing are weak. IVD giants and high-end products are almost all occupied by foreign countries. New technology discovery and transformation capabilities are low, technological platform innovation and transformation capabilities are low, precision manufacturing and large-scale production capabilities are low.

|Research on my country's IVD Industry Innovation and Development Strategy|

Focus on the development of innovative products to meet new medical needs

Use nanotechnology, artificial intelligence, Internet and other technologies to transform and reshape the POCT technology system. Through computing and cloud big data processing, POCT can obtain health data, guide health monitoring, and promote the transformation from traditional POCT to iPOCT (Intelligent and Timely Detection). Testing, decision-making, communication, and learning are integrated to enable IVD to go deep into community hospitals, into families, and support hierarchical diagnosis and treatment, so that people get less sick, see fewer doctors, and make it easier to see a doctor.

Promote revolutionary new technology innovation and strengthen platform technology research

Strengthen the innovation research of core technologies such as droplet technology and nanotechnology, and improve the innovation ability of in vitro diagnostic technology; focus on breakthroughs in the research and development of important technologies such as molecular diagnostics, biochips, nanotechnology, and accelerate domestic research and development to replace imports; establish microfluidic engineering, liquids Innovative technology platforms such as biopsy and biosensors will establish important decision-making systems such as chronic disease management, early tumor diagnosis and microbiological diagnosis systems to meet the urgent needs of medical and health care.

Develop high-throughput and high-end digital testing instruments

Integrate high-end technology, reshape the IVD technology system, make breakthroughs in automation, intelligence, integration, and standardization, and develop fully automated medical digital testing instruments and fully automated mobile laboratory production lines. Realize the import substitution of high-end instruments, support efficient diagnosis and treatment and precision medicine, and relieve the pressure on hospitals.

Strengthen related software development and improve IVD decision-making capabilities

In the era of big data, comprehensive use of multi-dimensional, multi-angle production data and information data, develop identification and diagnosis software and diagnosis and treatment equipment, realize the transformation and upgrade from in vitro testing to in vitro diagnosis, endow in vitro diagnostic decision-making capabilities, and realize intelligent detection functions.

Encourage domestic enterprises to innovate and provide policy support

In order to allow enterprises and research institutes to give full play to their advantages, the state promotes industry-university-research cooperation, publishes relevant policies to support local industries, mobilizes the enthusiasm of enterprises in innovation, highlights the dominant position of enterprises in technological innovation, and strives to resolve the disconnect between scientific research and market, production and cooperation Disconnected demands, disconnected products and applications, and other issues.

As the country gradually implements the "Healthy China 2030" strategy, the concept of "early diagnosis, early treatment, early recovery, and achieving universal health" has been continuously strengthened, coupled with the outbreak of the 2020 epidemic, people’s demand for diagnosis and accuracy The demand for highly easy-to-use instruments is also increasing. However, domestic IVD companies started late and need to be improved in terms of scale, strength, technology, and innovation capabilities. Therefore, they use external resources to improve their corporate strength, innovate and develop localized products, solve the current supply and demand mismatch difficulties, and lay out product lines in advance. Seize the market.

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