Quality first -- raw materials for in vitro diagnostic reagents

IVD raw materials are important raw materials for the R & D and production of in vitro diagnostic reagents, mainly including core reaction system raw materials such as antigens, antibodies, biochemical enzymes, nucleic acid amplification enzymes and primer probes, as well as non core reaction system raw materials such as nano magnetic beads and chemical buffers. The rapid development of IVD industry drives the continuous expansion of upstream raw material market. The development of IVD raw materials is also of key significance in the whole in vitro diagnosis industry chain. For medical institutions whose service scenarios are for patients and cover thousands of detection menus, the stability and reliability of IVD raw material quality are directly related to the accuracy of test results, and also affect the judgment of clinicians and subsequent diagnosis and treatment. It can be said that upstream raw materials are undoubtedly one of the most critical links in the IVD industry chain, and their quality and quality affect the whole diagnosis and treatment chain.
IVD industry accelerates development
The "quality" of upstream raw materials has attracted much attention
The IVD industry chain includes upstream raw materials, midstream diagnostic products and downstream applications. Among them, the upstream core raw materials such as molecular detection enzymes, antigens, antibodies, immune interference blockers and biochemical diagnostic enzymes are the most important strategic nodes for the quality control of in vitro diagnostic reagents; Midstream diagnostic products mainly include diagnostic equipment and reagents; Downstream applications include medical institutions, third-party diagnostic laboratories and individual consumers.
From the demand side of IVD market, the detection menu of clinical laboratory institutions involves a variety of diagnostic methodologies, including molecular diagnosis, immune diagnosis, biochemical diagnosis, etc. There will be hundreds or thousands of reagent products for patients to use in these subdivided inspection fields. The key to determining the "fate" of these hundreds or thousands of detection reagents is the quality of IVD raw materials. According to frost Sullivan's data, the scale of China's in vitro diagnostic reagent raw material market will be about 12.2 billion yuan in 2020. In the future, with the normalization of epidemic prevention and control, the scale of the in vitro diagnostic reagent raw material market will be further expanded. It is expected that the scale of the raw material market will reach about 20billion yuan in 2024.
Application scenario of core raw materials - molecular diagnosis: molecular diagnosis is a technology that uses molecular biological methods to detect changes in the structure or expression level of genetic material in patients. The core raw materials commonly used in the molecular diagnosis market include DNase, reverse transcriptase, buffer, mastermix, dNTP, protease K, nuclease inhibitor, etc. In the field of molecular diagnosis, DNA amplification enzyme and reverse transcriptase are the key raw materials in the core of molecular detection reagents. Their performance and quality affect the amplification effect of detection target fragments in the detection process, and then affect the success rate and accuracy of clinical detection of molecular diagnostic reagents.
Core raw material application scenario - immunodiagnosis: immunodiagnosis is the largest segment in the domestic in vitro diagnosis market at present, and it is also the core competitive field of major in vitro diagnosis R & D and production enterprises. Antigens, antibodies and high-quality immune interference blockers are the core and key raw materials of immune detection, which play a decisive role in the functional realization and performance of products. Therefore, the performance and quality of antigens and antibodies and the elimination of common immune reaction interference have a great impact on the sensitivity, specificity and other indicators of diagnostic reagents, as well as the overall performance and quality of diagnostic reagents.
Application scenario of core raw materials - biochemical diagnosis: biochemical diagnostic reagents are mainly diagnostic reagents for blood routine, urine routine, liver function, kidney function, pancreas, diabetes and other diseases. They are also one of the most commonly used in vitro diagnostic methods at present. Biochemical diagnosis developed early in China and has been a routine diagnostic test item in hospitals for many years. The accuracy and sensitivity of clinical biochemical diagnosis are derived from high-quality detection components.
On the whole, IVD raw materials play a very important role in the field of in vitro diagnosis. IVD raw materials are equivalent to the "core" of reagents, which provides a solid foundation for the development of diagnostic reagents and promotes the efficiency of reagent development. Meanwhile, in the process of reagent development, raw materials are screened and adapted, and mature reagent projects will synchronously drive the demand for raw materials.
Source innovation!
Opportunities and challenges coexist in upstream raw materials
From the perspective of the scale distribution of the industrial chain, the upstream raw materials of the IVD industry belong to the link of high technical barriers, which is also the key to the establishment of core barriers at the product end and the supply end. Its market scale corresponds to the users in the IVD middle and downstream markets, and the supply capacity directly affects the business performance of enterprises in the industrial chain. For the development and production of the midstream market and channel integration, as well as the downstream market for end users, the quality of raw materials is undoubtedly the absolute guarantee for the quality of its diagnosis and treatment.
With the rapid development of IVD industry, the demand for upstream raw materials continues to expand. The scale of China's IVD raw material market is expected to reach 20billion yuan by 2024. The research and development of IVD raw materials is difficult and the production process is complex. However, the IVD raw material industry in China started late. Only around 2000 did there be a special R & D and production enterprise for raw materials of in vitro diagnostic reagents. From the perspective of raw material import and domestic market scale, most of the domestic IVD raw material market is still dominated by imported enterprises. However, in recent years, with the national policy incentives, domestic IVD raw material enterprises are also accelerating their pace, and the representative enterprises are also actively tackling key raw material R & D core technologies and optimizing the supply chain layout.
Molecular diagnostic raw materials: from sample preparation to amplification reaction detection, high-quality molecular diagnostic products are based on professional design, high-quality raw materials and strict production process.
Immunoassay raw materials: in the field of immunoassay, ensuring the reliability, stability and consistency of product test results is the key to market success and good reputation.
Biochemical test materials: the accuracy and sensitivity of clinical biochemical diagnosis are derived from high-quality test components.
epilogue
At present, the "reform" era of IVD raw material industry has come. As the source and guarantee of in vitro diagnostic technology innovation, the quality of IVD raw materials directly determines the quality of reagents and the accuracy of final diagnostic results. In combination with the general environment of precision diagnosis and treatment in China, the requirements of reagent raw materials and products on the technology platform will continue to rise. In the long run, the conversion costs of downstream customers are high, and domestic large-scale production enterprises specializing in the development of reagent core raw materials and with certain technical strength are still relatively small.
In short, the benign development of the IVD industry requires more local enterprises to assume the main responsibility for product quality, improve the R & D capacity of diagnostic reagents, improve and ensure the supply capacity of raw material products, so as to jointly promote the high-quality development of the industry.