IVD raw materials are important materials for the research and production of in vitro diagnostic reagents, mainly including core reaction system materials such as antigens, antibodies, biochemical enzymes, nucleic acid amplification enzymes, primers, and probes, as well as non-core reaction system materials such as nano magnetic beads and chemical buffers. The rapid development of the IVD industry has driven the continuous expansion of the upstream raw material market, and the development of IVD raw materials is also of key significance in the entire in vitro diagnostic industry chain. For medical institutions covering thousands of testing items and serving a wide range of patients, the stability and reliability of IVD raw materials directly affect the accuracy of test results, clinical decision-making, and follow-up treatment. It can be said that upstream raw materials are undoubtedly the most critical link in the IVD industry chain, and their quality and brands affect the entire diagnostic and treatment chain.
The IVD industry chain includes upstream raw materials, midstream diagnostic products, and downstream application terminals, among which core upstream materials such as molecular detection enzymes, antigens, antibodies, immunoinhibitors, and biochemical diagnostic enzymes are the most important strategic nodes in product quality control. Midstream diagnostic products mainly include diagnostic equipment and reagents, and downstream application terminals include medical institutions, third-party diagnostic laboratories, and individual consumers.
Molecular diagnosis is a technique that uses molecular biology methods to detect changes in the structure or expression level of genetic materials in patients to make a diagnosis. Core materials commonly used in the molecular diagnostics market include DNA enzymes, reverse transcriptase, buffer solutions, proteases, and nucleotide enzyme inhibitors. In the field of molecular diagnostics, DNA amplification enzymes and reverse transcriptase are the core key materials in molecular detection reagents. Their performance and quality affect the amplification effect of the detection target fragment in the testing process, and further affect the success rate and accuracy of clinical molecular diagnostics.
Immunodiagnosis is currently the largest segment in the in vitro diagnostics market and the core competitive area for major in vitro diagnostic R&D and production companies. Antigens, antibodies, and high-quality immunoinhibitors are the core key materials for immunodetection, which have a decisive impact on the function implementation and performance of products. Therefore, the quality and performance of antigens and antibodies, as well as the elimination of common immune reactions, have a great impact on the sensitivity, specificity, and overall performance and quality of diagnostic reagents.
Biochemical diagnostic reagents are mainly aimed at the diagnosis of diseases such as blood routine, urine routine, liver function, renal function, pancreas, and diabetes. It is also one of the most commonly used in vitro diagnostic methods. Biochemical diagnosis has been developed for many years and has been a routine diagnostic testing item in hospitals. The accuracy and sensitivity of clinical biochemical diagnosis are derived from high-quality detection components.
Overall, IVD raw materials have a very important position in the field of in vitro diagnostics, and IVD raw materials are equivalent to the "core" of reagents, providing a solid foundation for the development of diagnostic reagent products and promoting the efficiency of reagent development. At the same time, during the reagent development process, screening and adaptation of raw materials will drive the demand for mature reagent projects in parallel.