In the context of economic integration, the supply chain of in vitro diagnostics (IVD) industry is closely intertwined. However, once the supply of IVD raw materials is cut off, the crisis it triggers will have a domino effect on the entire industry and even the medical system. From the obstruction of reagent production to the stagnation of testing services, from operational difficulties of enterprises to resource imbalance, every link is under tremendous pressure. In depth analysis of these crises is of great significance for the IVD industry to build a resilient supply chain and enhance its ability to resist risks.

Chromogenic substrate MAOS bottled

1、 Reagent production is stagnant and product supply is short

The production of IVD reagents highly relies on various raw materials, from core bioactive substances (such as antigens, antibodies, enzymes) to auxiliary materials (such as buffers, chromogenic substrates), all of which are indispensable. Once the raw material supply is cut off, the production line will be forced to press the pause button.

Taking biochemical diagnostic reagents as an example, the lack of key enzyme raw materials makes it impossible for the reagents to complete the construction of enzymatic reaction systems and accurately detect indicators such as blood glucose and blood lipids. According to statistics, in some small IVD reagent production enterprises, if the main raw material supply is cut off for more than one month, about 70% of the conventional reagent production capacity will stagnate. In the field of immunodiagnosis, interruptions in the supply of antigens and antibodies can lead to the inability to produce detection reagents such as chemiluminescence and colloidal gold, affecting the development of infectious disease screening, cancer biomarker testing, and other projects. This production stagnation directly leads to a shortage of IVD products in the market, and many institutions face the dilemma of no available reagents. Routine testing projects are forced to be reduced, and patient diagnosis and progress are severely delayed.

2、 Detection service is blocked, diagnosis is delayed

Medical institutions, as the main application terminals of IVD products, will directly impact testing services due to product shortages caused by raw material shortages. The laboratory department undertakes a large number of clinical sample testing tasks on a daily basis and relies on a stable supply of IVD reagents. When there is a shortage of reagents, testing projects have to be restricted or referred to other institutions.

At the grassroots level, the testing resources are limited and there is a high dependence on specific IVD products. For some townships, blood routine testing mainly relies on specific brands of blood analyzers and supporting reagents. If the reagent supply is cut off, it is difficult to find alternative solutions in the short term, and basic health screening for a large number of patients cannot be carried out, delaying early diagnosis of common diseases.

3、 Enterprise operational difficulties, soaring costs and declining profits

For IVD enterprises, the interruption of raw material supply brings multiple operational challenges. On the one hand, companies need to urgently seek alternative raw material suppliers, which often comes with high costs. New suppliers may increase prices due to limited production capacity, and there is uncertainty in the quality and adaptability of raw materials. Enterprises need to invest a large amount of funds in quality testing and process debugging.

On the other hand, production stagnation leads to an increase in the allocation of fixed costs (such as equipment depreciation and factory leasing), resulting in a significant rise in unit product costs. At the same time, insufficient product supply has led to customer loss, sharp decline in sales revenue, and severe compression of profit margins. Data shows that during the period of raw material supply interruption, the operating costs of some IVD enterprises have increased by an average of 30% -50%, while sales have decreased by 40% -60%. Some small and medium-sized enterprises even face bankruptcy risks. In order to alleviate financial pressure, companies may be forced to cut R&D investment, affecting their long-term innovation capabilities and falling into a vicious cycle of development.

4、 Industry trust damaged, market confidence frustrated

The interruption of IVD raw material supply has had an impact on the trust system of the entire industry, and many institutions have doubts about the supply stability of IVD products. They are more cautious in procurement decisions and tend to choose brands with reliable supply chains, which is extremely unfavorable for some enterprises that rely on imported raw materials and have poor supply stability.

As service recipients, patients may also lose confidence in IVD testing services due to testing delays or inaccurate results, which in turn affects the credibility of the entire medical industry. At the market level, investors' confidence in the IVD industry has been dampened, leading to a reduction in capital investment and constraining the industry's development and expansion. Industry associations and regulatory authorities also need to invest more effort in monitoring supply chain risks, which increases the hidden costs of industry operations. Over time, the development speed of the entire IVD industry will slow down and its competitiveness will decline.

The crisis caused by the interruption of IVD raw material supply runs through the upstream and downstream of the industrial chain, and no one is spared. To cope with these crises, the IVD industry needs to accelerate the process of domestic substitution, cultivate reliable local raw material suppliers, and build a diversified supply chain system; Enterprises should strengthen inventory management, establish emergency response mechanisms, and enhance their risk resistance capabilities; At the same time, industry associations and regulatory authorities should strengthen guidance and regulation, promote the coordinated development of the industrial chain, jointly enhance the resilience of the IVD industry in supply chain fluctuations, and ensure stable supply and quality improvement of services.

MOPS buffer raw material

As an upstream IVD reagent raw material manufacturer, Hubei Xindesheng Company can supply a variety of core raw materials, including biological buffering agents, luminescent reagents, chromogenic substrates, and enzyme substrates. The product is compatible with mainstream detection systems such as biochemical diagnosis, chemiluminescence, POCT, etc., and ensures continuous supply of raw materials through stable production capacity. It has established a comprehensive supply chain management mechanism that can quickly respond to customer needs and support flexible supply volume adjustments. The technical team can provide raw material adaptation suggestions and application guidance to help IVD enterprises reduce the risk of supply interruption and provide reliable support for the stable operation of the industrial chain. If you have any purchasing needs, please feel free to contact us at any time!