As a core technology in the field of in vitro diagnostics (IVD), chemiluminescence is widely used in clinical testing due to its high sensitivity and strong specificity, and occupies an important position in the immunodiagnosis market. In recent years, the domestic chemiluminescence market has performed outstandingly, with a market share successfully exceeding 50%. This achievement is the result of multiple factors such as technological innovation, policy support, and market strategy.

Acridine ester NSP-SA-NHS

1、 Technological breakthrough: the core driving force for breaking the import monopoly

For a long time, the field of chemiluminescence has been monopolized by multinational giants, and technological barriers have become obstacles to the development of domestic enterprises. Domestic enterprises continue to increase their R&D investment and make breakthroughs in core technologies. Taking the luminescence system as an example, enterprises in the Yangtze River Delta and Pearl River Delta regions are continuously deepening their cultivation in mainstream technology paths such as direct chemiluminescence and enzymatic chemiluminescence, optimizing the performance of markers such as acridine ester and luminol, and improving luminescence efficiency and detection sensitivity. Domestic chemiluminescence analyzers have reached the forefront level in parameters such as sample position, reagent position, and sample extraction time, and some products even surpass imported brands in single point indicators. Progress has also been made in the research and development of instruments and reagents, by optimizing reagent formulas and reaction systems, improving detection accuracy, reducing inter batch differences, and gradually narrowing the gap with imported products.

2、 Policy promotion: Centralized procurement accelerates the process of domestic substitution

The centralized procurement policy has played a key role in promoting the increase of domestic chemiluminescence market share. Taking the multi province chemiluminescence centralized procurement led by Anhui as an example, the scope of centralized procurement covers chemiluminescence related reagents such as infectious diseases, sex hormones, and glucose metabolism. The intended purchase quantity reaches 640 million people, and the demand for eight infectious diseases (chemiluminescence method) is 350 million people, accounting for over 55.4% of the total. Centralized procurement no longer distinguishes between domestic and foreign investment, and is uniformly included in the price system for ranking of price reductions. Domestic manufacturers are more likely to obtain top choices in centralized procurement based on their price advantages and product quality.

Under natural growth conditions, the market share of domestically produced in vitro diagnostic reagents has been slowly increasing. However, after the implementation of the centralized procurement policy, it is expected to achieve the level of domestic market share that would only be reached by 2030 under natural growth within 2 years of policy implementation, greatly accelerating the process of domestic substitution.

3、 Cost effectiveness advantage: meeting diverse market demands

Domestic brands have significant advantages in terms of product cost-effectiveness. In terms of instrument prices, compared to imported brands, domestically produced chemiluminescence instruments are more affordable. According to industry data, among the top 10 sales models of chemiluminescence instruments in China in the first half of 2024, a certain imported brand had a market share of 6.82% and an average price of 482000 yuan; The market share of a certain model of a domestic brand is 6.70%, with an average price of 359000 yuan; Another domestic brand model ranks third with a market share of 4.93% and an average price of only 221000 yuan.

In terms of reagents, domestic reagents also have competitive prices, and some companies have further improved their cost-effectiveness by optimizing production processes to reduce costs. For some primary healthcare institutions and private hospitals that are sensitive to testing costs, the cost-effectiveness advantage of domestically produced chemiluminescence products makes them an ideal choice.

4、 Industrial synergy: improving the industrial chain to ensure stable supply

The development of chemiluminescence industry cannot be separated from the synergy of upstream and downstream industrial chains. In recent years, the domestic chemiluminescence industry chain has been continuously improved, with close cooperation between enterprises in various links from raw material supply to instrument and equipment manufacturing. In the field of raw materials, domestic enterprises have made progress in the research and production of key raw materials such as antibodies and antigens. Some enterprises have achieved self research and self production of raw materials, reducing dependence on imported raw materials and improving product quality stability.

The development of supporting industries such as mechanical processing and electronic components in the instrument manufacturing process provides support for the production of chemiluminescence instruments. Industrial collaboration is also reflected in the cooperation between industry, academia, and research institutions. The technological achievements of universities and research institutions are accelerating their transformation into enterprises, promoting the overall technological level of the industry and ensuring the stable supply and continuous innovation capability of domestic chemiluminescence products.

The market share of domestically produced chemiluminescence exceeding 50% is the result of the resonance of multiple factors such as technology, policies, and markets. In the future, as domestic enterprises continue to make efforts in technological innovation, closely follow policy guidance to optimize product structure, further consolidate cost-effectiveness and market service advantages, and improve the coordinated development of the industrial chain, they are expected to occupy a more important position in the chemiluminescence market.

luminol powder

Hubei Xindesheng Company, as a research and development manufacturer of chemiluminescence reagents such as acridine ester and luminol, focuses on optimizing the performance of two core raw materials. The acridine ester produced by it has stable luminescence efficiency, high photon yield after labeling, and is suitable for direct chemiluminescence systems; Luminol has high purity and good solubility, suitable for enzymatic chemiluminescence scenes. Through refined production control, ensure consistency between batches and reduce detection interference. Multiple specifications of products can be provided. If you have any purchasing needs, please feel free to contact us at any time!