In 2025, the IVD (In Vitro Diagnostic) reagent raw material market is undergoing complex changes against the backdrop of rapid development in the health industry. The direction of this market is not only related to the improvement of medical diagnosis level, but also closely linked to the fate of upstream and downstream enterprises in the industry chain. The quality of its trend needs to be comprehensively analyzed from multiple perspectives.

bicine buffer

1、 Market size growth: opportunities contain challenges

The market size of IVD reagent raw materials is showing a continuous expansion trend both domestically and internationally. According to industry reports, the market size of in vitro diagnostic products at home and abroad is expected to reach approximately 81.7 billion US dollars in 2024, and is projected to climb to 109.2 billion US dollars by 2031, with a compound annual growth rate of 4.3% from 2025 to 2031. The position of the domestic market in the IVD market is becoming increasingly important. By 2024, the domestic IVD raw material market will reach 5.165 billion yuan, with a market size of 27.185 billion yuan. It is expected that the IVD raw material market at home and abroad will grow at a compound annual growth rate of 8.45% during the forecast period, and the total IVD raw material market size will reach 44.233 billion yuan by 2030.

From a positive perspective, the growth of market size is attributed to various factors. On the one hand, the aging process is accelerating, and the number of patients is rising, such as diabetes, cardiovascular disease, etc. The daily monitoring and diagnosis of these diseases have a great demand for IVD reagents, thus driving the reagent raw material market. On the other hand, the continuous demand for infectious disease prevention and control, the emergence of new infectious diseases, and the recurrence of some traditional infectious diseases have stabilized the demand for infectious disease diagnostic reagents and their raw materials.

However, there are also challenges hidden behind the growth of market size. With the expansion of the market and the influx of a large number of enterprises, competition has become increasingly fierce. Many enterprises compete for market share in terms of price, product quality, technological innovation, and other aspects. Especially in the field of mid to low end products, homogenization competition is severe, and some companies may compromise on product quality in order to reduce costs, which affects the overall product quality image of the market. At the same time, market growth brings higher requirements for raw material supply. If upstream raw material suppliers have insufficient production capacity or unstable supply, it will affect the normal production of IVD reagent raw material production enterprises and increase operational risks.

2、 Driven by technological innovation

In 2025, technological innovation in the field of IVD reagent raw materials will continue to be active, injecting new impetus into market development. In the field of molecular diagnostics, third-generation sequencing technology is gradually maturing and moving towards clinical applications. Compared with traditional sequencing technology, third-generation sequencing has advantages such as long read length and no need for PCR amplification, which can more accurately detect gene sequences. The development of this technology has greatly increased the demand for reagents and raw materials (such as DNA polymerase) that are compatible with it, promoting the development of the related raw material market.

Immunodiagnostic technology is constantly upgrading, moving from traditional enzyme-linked immunosorbent assay (ELISA) to more advanced technologies such as chemiluminescence immunoassay and time-resolved fluorescence immunoassay. Taking chemiluminescence immunoassay as an example, its detection process requires specific luminescent substrates, antibodies, and other raw materials. With the popularization of chemiluminescence immunoassay technology in clinical practice, the demand for these raw materials is showing a rapid growth trend.

But technological innovation also brings enormous pressure to enterprises. Developing new technologies and products requires a large amount of capital and manpower investment, and the research and development cycle is long with high risks. Some small and medium-sized enterprises may be eliminated in the market competition due to limited funds and insufficient research and development capabilities, making it difficult for them to keep up with the pace of technological innovation.         

3、 Domestic substitution process

In China, domestic substitution is an important trend in the IVD reagent raw material market. In the past, China heavily relied on imports for IVD reagent raw materials, especially in the fields of enzymes, magnetic beads, microspheres, etc., with imports accounting for over 80%. Imported raw materials are not only expensive, but also face the risk of supply chain instability.

In recent years, with the increasing attention of the country to the health industry and a series of policy supports, domestic enterprises have continuously increased their R&D investment and made breakthroughs in technology. For example, some enterprises have already gained strength in the research and production of raw materials such as antigen antibodies and biological buffering agents, and their product quality has gradually improved, leading to an expansion of their market share in the domestic market.

However, the path of domestic substitution is not smooth sailing. On the one hand, there is still a gap between domestic enterprises and top enterprises in terms of technological level and brand influence. The long-term accumulation of technological advantages, brand reputation, and well-established sales networks by some enterprises puts significant pressure on domestic enterprises in market competition. On the other hand, there are problems in the domestic IVD reagent raw material industry, such as small enterprise scale, insufficient R&D investment, and imperfect industry standardization system. The uneven quality of products from different enterprises has affected the overall image of domestic brands and increased the difficulty of domestic substitution.

Product packaging

The market trend of IVD reagent raw materials in 2025 is mixed. The growth of market size, technological innovation, domestic substitution, and policy environment have brought many development opportunities, as well as challenges such as fierce competition, research and development pressure, technological gaps, and policy risks.

Hubei Xindesheng Company, as a manufacturer of IVD reagent raw materials, focuses on core categories such as biological buffering agents, luminescent reagents, enzyme substrates, etc. Its products are suitable for multiple detection scenarios such as biochemical diagnosis, chemiluminescence, and molecular diagnosis. Relying on standardized production lines and a full process quality control system, we ensure high purity of raw materials and stable batches, which can meet the batch requirements from grams to tons. We provide customized services and complete quality inspection reports, and our technical team is deeply involved in downstream formula optimization to assist in solving application problems. If you have any purchasing needs, please feel free to contact us at any time!