Abstract:In recent years, with the vigorous development of the domestic medical and health field, China's biodiagnostic reagent industry has also shown a rapid growth trend. Among them, in vitro diagnostics, as an important means of clinical diagnosis, continues to expand its market size. According to the data, the scale of the in vitro diagnostic market in mainland China will be about 148.49 billion yuan in 2023, a year-on-year increase of 16.55%.
1. Definitions and Classification
Biological diagnostic reagents are biological agents used to diagnose diseases, detect the immune status of the body, and identify pathogenic microorganisms. These reagents can determine disease or body function by detecting a part of the body taken from the body, such as serum. According to different uses, biological diagnostic reagents can be divided into two categories: in vivo diagnostic reagents and in vitro diagnostic reagents. Among them, in vivo diagnostic reagents are mainly used for intradermal diagnosis, which is used to diagnose by observing the body's response to specific antigens, while in vitro diagnostic reagents are mainly used for in vitro detection of human samples, and the diagnostic reagents react with specific substances in the sample by simulating the internal environment of the human body for diagnosis.
Second, industry policies
In recent years, the mainland government has paid great attention to the innovation and development of the biodiagnostic reagent industry, and has focused on supporting it as an important part of the biotechnology field. In order to promote the development of scientific research and innovation and industrialization of biotechnology, the government has issued a series of targeted industrial policies. Among them, in May 2022, the National Development and Reform Commission issued the "14th Five-Year Plan for the Development of the Bioeconomy", which not only carried out a comprehensive layout and planning of the bioeconomy, but also proposed to support innovative breakthroughs and industrial applications in key fields such as biodiagnostic technology. It is worth mentioning that for the middle-aged and elderly groups, in January 2024, the State Council issued the "Opinions on Developing the Silver Economy and Improving the Well-being of the Elderly", focusing on the development of the anti-aging industry, promoting the deep integration of biotechnology such as genetic testing and molecular diagnosis with delaying geriatric diseases, and developing early screening products and services for geriatric diseases. This provides a broad market space and development opportunities for the biodiagnostic reagent industry. These policies not only provide a clear development direction and goals for the industry, but also provide strong policy support and market guarantee for enterprises. Under a favorable policy environment, the biodiagnostic reagent industry is expected to achieve rapid development and breakthroughs, and make greater contributions to the medical and health undertakings of the mainland.
Third, the development process
Although China's biodiagnostic reagent industry started late, it has developed rapidly. At the beginning of the founding of the People's Republic of China, the domestic biological reagent industry was almost in a blank state. In the 50s of the 20th century, the national laboratory began to lead the research and development and production of reagents, although mainly focused on basic experimental reagents, but laid a preliminary foundation for the development of domestic reagents. From the mid-70s to the end of the 20th century, with the deepening of reform and opening up and the improvement of scientific research level, China's diagnostic reagent industry began to enter a preliminary stage of development. During this period, the establishment of the China Biological Products Industry Association marked the formation of the industry organization, and the R&D and production of reagents were gradually expanded and enriched in scale and category. After entering the 21st century, China's diagnostic reagent industry has ushered in a stage of rapid development. With the continuous improvement of domestic scientific research level and the increase of clinical demand, China's biological reagent industry has further developed, and product quality and technical level have been significantly improved. At the same time, the state has also issued a series of policies and regulations to further standardize the R&D, production and sales of biological reagents, and the industry has entered a stage of rapid development. At present, China's diagnostic reagent industry is in a stage of innovation and development. With the continuous progress of science and technology and the continuous change of clinical needs, domestic enterprises are increasing innovation efforts to promote the technological upgrading and product innovation of diagnostic reagents.
Fourth, industry barriers
1. Market access barriers
As a type of medical device, the R&D, production and sales of biodiagnostic reagents need to follow strict regulations and standards to ensure the safety and effectiveness of the product. Before entering the industry, enterprises must obtain approval and certification from the relevant departments before they can legally market and sell. Therefore, market access barriers are also an important barrier for the industry.
2. Technical barriers
The R&D and production of biological diagnostic reagents involve cutting-edge knowledge in many fields such as biotechnology, molecular biology, immunology, chemistry, etc., requiring enterprises to have a high-level R&D team and advanced technical equipment. These technologies and equipment are expensive to invest in, and they also require a long period of research and experimentation to achieve a breakthrough. There are obvious technical barriers in the industry.
3. Capital barriers
The R&D and production of biodiagnostic reagents require a large amount of capital investment, including R&D costs, production equipment, raw material procurement, clinical trials, etc., thus forming a high financial barrier. Among them, R&D cost is an important part of the financial barriers in the biological diagnostic reagent industry. The research and development of new products requires a lot of manpower, material and financial resources, including the remuneration of scientific researchers, the purchase and maintenance of laboratory equipment, and the procurement of experimental materials. In addition, the production of biodiagnostic reagents requires high-precision equipment and technical support, such as bioreactors, purification equipment, analytical instruments, etc. The acquisition and maintenance costs of these devices are high, and for new entrants, there is a lot of financial pressure.
4. Brand barriers
The brand barriers in the biological diagnostic reagent industry are significant, and multinational giants such as Roche and Abbott have been deeply cultivated in the domestic market for many years, establishing a solid brand foundation and a wide range of user groups. These well-known brands have won the wide trust and recognition of users by virtue of their excellent product quality, strong technical strength and deep market influence, thus occupying a large market share. It takes a long time and effort for new entrants to build their brand, which is also a difficult process.
Fifth, the industrial chain
1. Analysis of the industry chain
The upstream of the biodiagnostic reagent industry mainly includes raw material suppliers and equipment suppliers. Raw material suppliers mainly provide pharmaceutical and chemical raw materials, such as enzyme preparations, antigens, antibodies, fine chemicals, etc., as well as medical packaging materials. The midstream segment is mainly the manufacturer of biological diagnostic reagents. With the improvement of domestic scientific research level and the continuous change of clinical needs, the types and uses of biological diagnostic reagents are also expanding, covering biochemical diagnosis, immunodiagnosis, molecular diagnosis and other fields. The downstream mainly includes medical institutions, independent medical laboratories, blood screening market and food testing market, etc.
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