It is time to open up the industrial chain of in vitro diagnostic reagent raw materials to accelerate the localization of raw materials

In vitro diagnostic reagents can be used to test blood, urine and other samples outside the human body to provide a basis for disease diagnosis and health assessment.
The test results directly affect medical decision-making
.
The in vitro diagnostic reagent industry chain consists of upstream raw material suppliers, midstream reagent manufacturers and downstream reagent users (such as hospital laboratory, third-party laboratories, etc.
)
.
Among them, the upstream raw material industry mainly provides basic raw materials for midstream reagent manufacturers, such as enzymes, coenzymes, substrates, antigens, antibodies, magnetic beads, microspheres, etc.
, which belong to the discipline of basic materials
.
At present, China's in vitro diagnostic reagent raw material market is dominated by imported products, and the domestic in vitro diagnostic raw material industry is in its infancy, with great development potential and optimistic prospects
.
Industry Bottlenecks in vitro diagnostic reagents for the raw material is prepared in vitro diagnostic reagent products, including antigens and antibodies, enzymes and coenzymes, probes, primers, microspheres and the like
.
Among them, antigens and antibodies, enzymes and coenzymes are the key active substances in the reagents, which determine the core performance of the product
.
The author estimates based on public data and survey questionnaires that the size of China's in vitro diagnostic reagent raw materials market will be about 10 billion yuan in 2020, an increase of more than 30% from 2019
.
Among them, the antigen and antibody market accounted for nearly 50%, the enzyme, coenzyme, and enzyme substrate market accounted for nearly 30%, the probe and primer market accounted for about 10%, and the magnetic beads, microspheres and other raw materials market accounted for about 10%
.
The raw materials of in vitro diagnostic reagents are the basis for the research and development and innovation of in vitro diagnostic reagents, and belong to the basic disciplines that require long-term investment
.
The raw material industry of in vitro diagnostic reagents in China started late.
At present, imported products account for more than 80% of the domestic in vitro diagnostic reagent raw materials market
.
At present, China's in vitro diagnostic reagent raw material industry is facing four main development bottlenecks
.
First of all, there are shortcomings in the domestic in vitro diagnostic reagent raw material industry.
The company's innovative research and development capabilities, large-scale production capabilities, and quality control processes need to be improved, and there is a gap between product performance and imported brands.

.
Secondly, due to the large variety of in vitro diagnostic reagent raw materials, a wide range of professional fields, and a long research and development cycle, the domestic in vitro diagnostic reagent raw material companies are generally small in scale and weak in market influence
.
Third, in vitro diagnostic raw material companies and academia are not synergistic enough, and the transformation of scientific and technological achievements is not smooth
.
On the one hand, the academic community lacks timely and accurate information on technical requirements, and it is difficult to determine the direction of basic research; basic research teams lack industrialization and engineering management experience, insufficient research on the process of transforming R&D results into mass production; lack of R&D results transformation The resources necessary for large-scale industrialization, the hardware and software conditions do not meet the requirements of industrialization, making it difficult for a large number of academic research results to achieve industrialization, and the research results cannot be fully utilized
.
On the other hand, professional and forward-looking sources of technical information and high-end R&D talents are the key to the R&D and innovation of in vitro diagnostic reagent raw materials enterprises.
Both of them are often concentrated in universities and research institutions and are rarely used by enterprises.
Enterprise product R&D lacks high-end research.
Equipment
.
The research of in vitro diagnostic reagent raw materials requires more high-end research equipment and covers a wide range of fields.
Under the circumstance that the income cannot be estimated, it is difficult for companies to invest in such equipment on a large scale, leading to the lag in innovation and research and development
.
Finally, the domestic in vitro diagnostic reagent raw material industry is scattered geographically, and local policy support is less
.
China's in vitro diagnostic reagent raw material companies are concentrated in the Yangtze River Delta, Pearl River Delta, Beijing-Tianjin-Hebei region, and scattered in other regions
.
Due to the small overall market size of in vitro diagnostic reagent raw materials, it is difficult for local support policies to tilt toward the raw material industry
.
In addition, it takes a long time for the in vitro diagnostic reagent raw material company to realize its profitability from its establishment to the realization of profitability, and it will take a long time for the contribution to the growth of local tax revenue to be reflected, and the local government does not pay enough attention to the industry
.
The combination of multiple factors has resulted in less support for the in vitro diagnostic reagent raw material industry in local industrial policies
.
Favorable factors promote the improvement In recent years, with the increase in the number of in vitro diagnostic reagent raw materials enterprises in my country, the improvement of product quality, and the increase in the capital market’s attention to raw materials, the industry has gradually improved.

.
On the one hand, the importance of in vitro diagnostic reagent manufacturers to the raw material industry has increased significantly
.
Due to the impact of the new crown pneumonia epidemic, many in-vitro diagnostic reagents raw materials are out of stock, prompting in-vitro diagnostic reagent manufacturers to pay attention to the supply of raw materials, and more in-vitro diagnostic reagent manufacturers are open to domestic raw material companies as alternative suppliers.
The development of domestic in vitro diagnostic reagent raw material enterprises brings more opportunities
.
At the same time, in-vitro diagnostic reagent manufacturers are facing central procurement cost pressure, and their willingness to cooperate with raw material companies has strengthened, and they have even actively deployed the raw material industry, thus promoting the rapid development of the raw material industry
.
On the other hand, the capital market has paid more attention to the in vitro diagnostic reagent raw material industry
.
According to statistics published by the author, in 2020, in vitro diagnostic reagent raw material companies have raised more than 2.
5 billion yuan in financing, covering areas such as antigens, antibodies, molecular diagnostics, magnetic beads, and microspheres
.
Financial capital's favor for in vitro diagnostic reagent raw material companies has provided sufficient financial support for the industry, and has played a positive role in promoting raw material innovation and research and development, large-scale production, and a sound quality management system
.
In addition, the promulgation of relevant policies has also brought benefits to the development of the in vitro diagnostic reagent raw material industry
.
In recent years, the country has issued a number of policies to encourage the development of the in vitro diagnostic reagent industry, and issues such as the safety of the raw material supply chain will subsequently be effectively resolved.
The in vitro diagnostic reagent raw material industry has ushered in major development opportunities
.
Achieving leapfrog development requires concerted efforts
.
To break through the bottleneck and achieve leapfrog development of domestic in vitro diagnostic reagent raw materials enterprises requires the joint efforts of multiple parties .
The first is to give full play to the leading role of industry associations to promote the coordinated development of industries
.
The in vitro diagnostic reagent raw material industry involves many fields and technology platforms, and it is difficult for a single company to achieve full coverage of product lines.
It is necessary to give full play to the leading role of industry associations to connect enterprises to achieve complementary advantages and coordinated development, and promote the formation of a good Market atmosphere
.
Especially in terms of product line layout and division of labor, guidance will be given to companies with different technological advantages to promote the rational allocation of R&D resources and avoid duplication of construction
.
The second is to organize a new type of "no courtyard wall" research and development institutions to increase the success rate of innovation results transformation
.
Create a six-in-one coordinated development system of "government, industry, university, research and funding" through relevant industrial policies, and establish R&D institutions without academic research and industrial enterprise "academic walls"
.
On the one hand, let the experts and scholars of universities and research institutions understand the status quo of industrial development and market demand, and clarify the direction of basic research
.
On the other hand, enterprises can make good use of the high-end R&D talents and equipment of universities and research institutions, accelerate the pace of innovative research and development, and better realize the industrialization of basic research results
.
At the same time, raw material companies can also introduce new product research and development needs of production companies, and carry out joint application evaluations with downstream product users such as hospitals and CDCs.
In this way, the success rate of transformation of innovation results will be greatly improved
.
The third is to improve the raw material standard system for in vitro diagnostic reagents
.
At present, the raw materials of in-vitro diagnostic reagents lack industry or national standards, and the evaluation of the performance is only at the level of whether the application is compatible
.
Whether it is enzyme activity determination, substrate purity analysis and antibody titer testing, different companies have different methods and standards, which make it difficult to evaluate the quality of raw materials and products
.
The early establishment and improvement of industry and national standards is conducive to the development of industry standardization and standardization, and avoids the occurrence of "bad money driving out good money"
.
Fourth, in vitro diagnostic reagent raw material companies must actively "go global
.
" At present, the target market of domestic in vitro diagnostic reagent raw materials companies is mainly domestic, and actively expanding overseas markets will be an important development direction in the future, which puts forward a higher level of capabilities for companies in R&D, production, quality management, marketing, and technical support.
Require
.
In general, with the rapid development of the in vitro diagnostic industry and the intensified competition among in vitro diagnostic reagent manufacturers, the coordinated development of in vitro diagnostic reagent manufacturers and raw material companies will become the future trend; improve product quality, increase investment in innovative R&D, and strengthen " "Government-industry-university-research funding" cooperation is a key breakthrough direction for raw material companies in the future; industrial layout and capacity building for overseas markets will become the next hot spot of competition
.
The development trend of the in-vitro diagnostic reagent raw material industry is improving, but opportunities and challenges coexist.
It requires the joint efforts of the entire industry chain to maintain healthy and stable growth
.
[This article is selected from the "Medical Device Blue Book: China's Medical Device Industry Development Report (2021)" edited by Wang Baoting and Geng Hongwu]