In the in vitro diagnostics (IVD) industry, reagent raw materials are the core element that determines the accuracy of diagnosis. However, the current IVD industry in China is facing a harsh reality: about 80% of IVD reagent raw materials rely on imports. This situation not only increases the production costs of enterprises, but also restricts the industry's ability to develop independently, and may even threaten the supply chain of medical diagnosis in special circumstances. In this context, domestic substitution has become an inevitable trend in the development of the industry, and Hubei Xindesheng Material Technology Co., Ltd. actively participates in it, striving to explore the development path of domestic IVD reagent raw materials.

 

(Chromogenic substrate MAOS)

 

The current situation of dependence on imported IVD reagent raw materials in China

 

（1） High proportion of imported key raw materials

 

In China's IVD reagent raw material market, key raw materials such as high-purity antigen antibodies, enzymes, and chemiluminescence reagents heavily rely on imports. Taking antigen antibodies as an example, highly specific antigen antibodies used for biomarker detection and infectious disease screening have a gap in research and production technology between domestic enterprises and some large enterprises, resulting in over 80% of products in the market relying on imports. The core raw materials in chemiluminescence reagents, such as acridine ester and luminol, are also dominated by imported products. The import sources of these raw materials are mainly concentrated in developed regions abroad, and their production enterprises have long monopolized the IVD reagent raw material market with technological advantages and brand effects.

 

（2） The problems caused by import dependence

 

The high dependence on imports has led domestic IVD enterprises to face many problems in raw material procurement. Firstly, significant price fluctuations, market supply and demand changes, exchange rate fluctuations, and other factors can lead to significant fluctuations in raw material prices, increasing production costs and operational risks for enterprises. Secondly, the supply cycle is long, often taking weeks or even months from placing an order to the arrival of raw materials, which seriously affects the production progress and market response speed of the enterprise. In addition, technological blockades and patent barriers also limit the technological innovation of domestic enterprises, making it difficult for China's IVD industry to break through in the field and remain downstream of the industry chain for a long time.

 

The need for domestic substitution of IVD reagent raw materials

 

（1） Ensure the supply chain

 

In recent years, the trade environment has been complex and ever-changing, and factors such as geopolitical conflicts and public health events may have an impact on the supply of imported raw materials. Once the import channels are blocked, domestic IVD enterprises will face the dilemma of raw material shortage, directly affecting the production and supply of diagnostic reagents, and thus threatening the normal development of medical diagnosis. Implementing domestic substitution can establish an independent and controllable supply chain system, reducing the impact of external risks on the industry.

 

（2） Reduce enterprise costs

 

The high prices of imported raw materials, coupled with transportation, tariffs, and other expenses, have resulted in high production costs for domestic IVD enterprises. The large-scale production and application of domestic raw materials can reduce the procurement costs of enterprises by reducing intermediate costs and improving supply chain efficiency. This not only helps companies improve their profitability, but also makes diagnostic reagent prices more affordable.

 

（3） Promote industry technological innovation

 

The process of domestic substitution is also a process of technological innovation and industrial upgrading for domestic enterprises. In order to produce IVD reagent raw materials that are comparable to imported products, enterprises need to increase research and development investment, introduce advanced technology and talents, and overcome technical difficulties. This will promote technological progress in raw material research and development, production processes, quality control, and other aspects of the domestic IVD industry, enhance the core competitiveness of the entire industry, and promote the development of China's IVD industry towards high-end and independent direction.

 

(Luminescent reagent acridine ester)

 

Exploration and Practice of Hubei Xindesheng in Domestic Substitution

 

（1） Increase R&D investment and break through technological bottlenecks

 

Hubei Xindesheng is well aware that technological innovation is the key to achieving domestic substitution. The company has established a professional R&D team, consisting of professionals from multiple fields such as biochemistry, organic synthesis, and analytical chemistry. In the research and development process, we focus on the core technical challenges of IVD reagent raw materials, such as the production of high-purity luminescent reagents and colorimetric reagents. Through years of effort, the company has achieved a series of technological breakthroughs in the fields of biological buffering agents, chemiluminescence reagents, enzyme substrates, and other raw materials. For example, in the research and development of the chemiluminescence reagent acridine ester, Xindesheng has improved the purity and luminescence efficiency of the product by optimizing the synthesis process, making its performance reach the level of similar overseas products.

 

（2） Strict quality control to ensure product performance

 

Quality is the lifeline of a product, especially for IVD reagent raw materials. Xindesheng has established a strict quality control system, with detailed standards and processes established for every link from raw material procurement, production process to finished product testing. The company is equipped with advanced testing equipment, such as liquid chromatography, mass spectrometry, etc., to conduct multi-faceted testing of product purity, activity, stability and other indicators.

 

Despite the challenges faced by domestic substitution of IVD reagent raw materials in China, achievements have been made through the efforts of companies like Hubei Xindesheng. With the continuous advancement of technology, policy support, and market recognition, domestic IVD reagent raw materials are expected to gradually break the import monopoly and achieve a transition from "dependence on imports" to "independent supply". In the future, Xindesheng will continue to uphold the spirit of innovation, increase investment in research and development and production, and continuously improve product performance and service levels. If you need IVD reagent raw materials, please feel free to contact us at any time!