In the current booming in vitro diagnostics (IVD) industry, the upstream raw material market is experiencing significant expansion. From 2015 to 2019, the domestic in vitro diagnostic market grew from approximately 42.75 billion yuan to 80.57 billion yuan, with an annualized compound growth rate of 17.2%. It is expected to climb to 288.15 billion yuan by 2030, increasing its market share to 33.2%. Such rapid market growth undoubtedly brings broad development space for the upstream raw material market. However, in this seemingly promising blue ocean, enterprises should not blindly pursue scale expansion, but rather focus on doing a good job in "precision, specialization, and sharpness".

(Chromogenic substrate TOOS)

Amidst the expansion of the industry, chaos is rampant

At present, the upstream raw material market of IVD is showing a prosperous but hidden crisis scene. From the perspective of the number of enterprises, according to the "IVD Reagent Raw Material Supplier List (2024)" compiled by IVD Research Society, there are over 300 domestic raw material enterprises, which is quite considerable. In sharp contrast, the industry structure is very fragmented, with monopolies and internal competition coexisting. Some foreign companies dominate the market, especially in key raw materials such as antibody antigens and diagnostic enzymes, and have long controlled core technologies and market share. Domestic enterprises are mostly concentrated in the mid to low end market, with severe product homogenization, leading to competition falling into the quagmire of low prices and forming a vicious cycle of "low price competition weak profits weak innovation". The generally small scale of enterprises results in a severe lack of research and development investment, making it difficult to break through technological barriers and further limiting the pace of enterprises entering the market.

In terms of market supply and demand, although the market continues to expand, the problem of core raw material dependence on imports is very prominent. The proportion of imported key raw materials in China exceeds 80%, and in the fields of enzymes, magnetic beads, microspheres, etc., they are almost controlled by others. Imported raw materials are not only expensive, but also face the risk of supply chain instability.

 'Precision, specialization and sharpness' is a good way to break the deadlock

1. Focus on segmented fields and build professional brands

IVD raw material suppliers should abandon a broad and comprehensive development approach, learn successful business models, and focus on segmented fields. In vitro diagnosis involves numerous fields, with infectious diseases, cardiovascular diseases, metabolism, and other diseases representing independent disciplines. As a supplier of antigen antibody raw materials, only through long-term and in-depth research on specific diseases and biomarkers can reliable raw materials be developed for accurate disease diagnosis. Domestic enterprises can select niche areas where they have accumulated technology or resource advantages, and concentrate their efforts on deepening and refining their work. In the field of cancer biomarker detection raw materials, if enterprises can improve the sensitivity and specificity of raw materials through continuous research and development investment, accurately identify cancer-related antigens or antibodies, and provide more accurate detection basis for downstream diagnostic reagents, they can establish a professional brand image in this niche field and attract customers in related fields.

2. Driven by technological innovation, breaking through barriers

In terms of technological innovation, enterprises need to increase their R&D investment. Taking the field of molecular diagnostics as an example, although some degree of domestic substitution has been achieved in primers, probes, labeled nucleotides, etc., there is still a gap between domestic raw materials and foreign ones in key sequencing library enzymes. The efficiency of library enzymes directly affects the capture quantity of sample sequences, which in turn affects data integrity and analysis accuracy. Domestic enterprises need to invest in adaptive technology platforms, starting from molecular structure design, production process optimization, and other aspects, to improve the performance of library enzymes. We can cooperate with universities and research institutions to jointly carry out technological breakthroughs, utilize the cutting-edge research results of research institutions, and combine them with the production practice experience of enterprises to accelerate the pace of technological innovation, and improve product quality through technological innovation.

3. Strict quality control to enhance product quality

Quality is the lifeline of enterprises, especially for IVD upstream raw material enterprises. Due to the varying quality standards of different raw material production enterprises, there are significant differences in the performance and stability of the raw materials circulating in the market, which has brought many difficulties to the midstream IVD reagent and instrument production enterprises, affecting the quality and performance of their products. Enterprises need to establish a strict quality control system, from raw material procurement, production process monitoring to finished product inspection, with strict standards and specifications established at every stage.

(Enzyme substrate)

With the continuous development of the IVD industry, the emergence of new technologies, and the diversification of diagnostic scenarios, higher requirements have been put forward for upstream raw materials. In emerging diagnostic scenarios such as home check ups, pet diagnosis, etc., raw materials need to be able to adapt to the demand for miniaturized, portable, and fast diagnostic products. As an upstream IVD reagent raw material manufacturer, Hubei Xindesheng Company has established a complete R&D and production system in the sub fields of biological buffering agents, color reagents, luminescent reagents, etc. With the model of "specialized research in sub scenes+strict quality control chain", Xindesheng has provided raw material supply to more than 100 IVD enterprises at home and abroad. If you have any purchasing needs, please feel free to contact us at any time!