In the medical industry, the in vitro diagnostic (IVD) market occupies a pivotal position, and its development trend has always attracted much attention. Entering 2025, the IVD diagnostic market has shown many new changes and trends, and whether the demand for reagent raw materials will surge has become a hot topic in the industry. This issue is not only related to the production and operation of IVD companies, but also has a far-reaching impact on the development of the entire industry chain.
1. Growth of IVD diagnostic market size
The global IVD market size is in a steady expansion stage. In 2024, the global in vitro diagnostic product market size is about US$81.7 billion, and it is expected to climb to US$109.2 billion by 2031, with a compound annual growth rate of 4.3% during 2025-2031. The Chinese market is becoming more and more important in the global IVD market, and the domestic market size is growing strongly. In 2024, the market size of IVD raw materials in China will reach 5.165 billion yuan, and the global market size will be 27.185 billion yuan. The global IVD raw material market is expected to grow at a compound annual growth rate of 8.45% during the forecast period, and the total size of the global IVD raw material market will reach 44.233 billion yuan by 2030.
There are many driving factors behind the market growth. On the one hand, the prevalence of chronic diseases and infectious diseases is on the rise worldwide. Take diabetes as an example. With the change of people's lifestyles and the intensification of an aging society, the number of diabetic patients continues to increase, and the demand for related IVD diagnostic products such as blood sugar testing continues to rise, which in turn drives the growth of demand for reagent raw materials. On the other hand, the advancement of diagnostic technology is also a key factor. For example, molecular diagnostic technology has developed from traditional PCR technology to more advanced high-throughput sequencing technology. Every technological innovation has led to the birth of new diagnostic reagents, and the demand for new reagent raw materials has also been generated accordingly. The growth of personalized medical demand cannot be ignored either. Doctors need more accurate diagnostic results to formulate personalized treatment plans for patients, which has increased the use of IVD diagnostic reagents and driven the demand for reagent raw materials.
II. The impact of IVD diagnostic technology development on the demand for reagent raw materials
(I) Molecular diagnostic technology innovation
The field of molecular diagnosis has made significant progress in recent years, and third-generation sequencing technology has gradually matured. Compared with traditional sequencing technology, third-generation sequencing technology has advantages such as long read length and no need for PCR amplification. It can detect gene sequences more accurately and has broad applications in early cancer screening and genetic disease diagnosis. The development of this technology has greatly increased the demand for reagent raw materials that are compatible with it. For example, third-generation sequencing requires special raw materials such as DNA polymerase, and the research and development and production of these raw materials have become the key to meeting market demand. Moreover, with the promotion and application of technology, the clinical requirements for detection volume will increase, and the demand for the quantity of reagent raw materials will continue to rise.
(II) Immunodiagnostic technology upgrade
Immunodiagnostic technology has been continuously upgraded, from traditional enzyme-linked immunosorbent assay (ELISA) to more advanced technologies such as chemiluminescent immunoassay and time-resolved fluorescence immunoassay. These new technologies have higher sensitivity and specificity and are widely used in infectious disease diagnosis and tumor marker detection. Taking chemiluminescent immunoassay as an example, its detection process requires specific luminescent substrates, antibodies and other raw materials. With the popularization of chemiluminescent immunoassay technology in clinical practice, the demand for these raw materials has shown a rapid growth trend.
(III) Popularization of point-of-care testing (POCT) technology
POCT technology has been widely used in primary care, home testing and other fields due to its fast and convenient characteristics. The production of POCT products requires a variety of reagent raw materials, such as buffers, markers, antibodies, etc. With the continuous expansion of the POCT market, the demand for these reagent raw materials is also increasing. And as people pay more attention to health management, POCT products will be more widely used in the detection of chronic diseases such as blood sugar, blood lipids, and blood pressure in the future, which will further stimulate the growth of demand for reagent raw materials.
III. Market competition pattern and demand for reagent raw materials
(I) Scale effect and raw material demand of large enterprises
In the IVD market, large enterprises dominate the market competition with their brand advantages, technical strength and market share. These large enterprises usually have a complete industrial chain layout and large-scale production capacity. In order to maintain production stability and product quality consistency, large enterprises have a huge and relatively stable demand for reagent raw materials.
(II) Differentiated competition and raw material demand of SMEs
When facing competition from large enterprises, SMEs often seek development space through differentiated competition strategies. Some SMEs focus on niche markets and develop distinctive IVD diagnostic products, such as rapid detection reagents for specific diseases. The research and development and production of such differentiated products require specific reagent raw materials. In order to gain a foothold in the market, SMEs will continue to invest in research and development resources to improve product performance, which will also drive the growth of demand for related specialty reagent raw materials. However, due to the limited funds and scale of SMEs, they are more sensitive to raw material prices and prefer products with high cost performance when purchasing raw materials.
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