In recent years, the domestic IVD (in vitro diagnostic) reagent raw material industry has developed rapidly, accumulating advantages in technological innovation and cost control. Expanding the market overseas has become an important strategic direction for many enterprises seeking further development. However, the overseas market environment is complex and ever-changing, and the road for domestic IVD reagent raw materials to go global by 2025 is still full of thorns and hidden risks, which require companies to pay attention to and respond cautiously.

Regulatory and policy risks

There are significant differences in regulations and policies regarding IVD reagent raw materials among different countries and regions. In developed markets such as Europe and America, the regulatory system is extremely strict, with detailed and high requirements for product quality standards. In the United States, products need to follow a series of complex FDA approval processes, from registration and application to approval, which often take a long time and involve numerous uncertain factors. Some regions regulate the market through regulations such as the Medical Device Regulation (MDR), which imposes extremely strict audits on the quality management system and product technical documents of enterprises. Emerging markets such as Latin America have enormous market potential, but their regulatory construction is not yet perfect and policy stability is poor. Sudden changes in policies may lead to a significant increase in compliance costs for enterprises. Some countries may temporarily increase import tariffs, set up trade barriers, and restrict the entry of foreign products. If a company does not thoroughly study the regulations and policies of its target market and rashly goes abroad, it may lead to the inability of its products to enter the market smoothly, and even face serious consequences such as recalls and fines.

Market competition risk

The competition in the IVD reagent raw material market is extremely fierce. Foreign established enterprises dominate the market with their long-term accumulated technological advantages, brand reputation, and well-established sales networks. These enterprises continue to maintain high levels of research and development investment, constantly launching innovative products and consolidating their market position. Domestic enterprises still have a gap with giants in terms of technological level, product quality stability, and face enormous pressure in competing for market share. At the same time, local enterprises in emerging economies are also rapidly rising, relying on their local cost advantages and market resources to compete fiercely with domestic enterprises in the mid to low end market. Some overseas companies have seized market share through low price strategies, which have impacted the pricing system of domestic IVD reagent raw material enterprises and compressed profit margins.

intellectual property risk

The IVD reagent raw material industry has high technological content, and intellectual property protection is crucial. During the process of going global, domestic enterprises may face patent infringement risks due to unfamiliarity with intellectual property rules. Some companies may inadvertently infringe on the patent rights of foreign companies if they fail to conduct sufficient patent searches and design avoidance during the product development process. When selling in overseas markets, if sued for infringement, the company will face high compensation and the brand image will also be severely damaged. In terms of patent application, trademark registration, etc., if a company lacks a professional legal team and a sound intellectual property strategy, its innovative achievements may be maliciously imitated or stolen by others, damaging the interests of the company.

supply chain risk

Building a stable and reliable supply chain is another challenge faced by IVD reagent raw material enterprises going global. In terms of raw material supply, some key raw materials may rely on specific countries or regions. Once there is political turmoil, natural disasters, trade frictions, etc. in the local area, the supply of raw materials may be interrupted, affecting the production progress of enterprises. There are also many uncertainties in the logistics transportation process, with large fluctuations in logistics costs and the impact of factors such as shipping market capacity and port congestion. The transportation time of goods is difficult to guarantee, which may lead to delivery delays and customer dissatisfaction. When establishing localized production and service networks in different countries and regions, enterprises also need to deal with complex issues such as local labor markets, tax policies, and land resources. If the supply chain management is poor, it will significantly increase operating costs and reduce the competitiveness of the enterprise.

Faced with numerous risks, domestic IVD reagent raw material enterprises can adopt the following strategies to cope:

1. Conduct in-depth research on target market regulations and policies, lay out in advance, and strictly design and produce products in accordance with local regulatory requirements during the product development stage to ensure product compliance.

2. Strengthen cooperation with professional regulatory consulting agencies, timely grasp the dynamics of regulations and policies, and adjust corporate strategies.

3. Continuously increase research and development investment, improve product technology content and quality stability, create products with independent intellectual property rights through differentiated competition, and enhance brand value.

4. Strengthen intellectual property management, establish a professional legal team, carry out patent search, application, and rights protection work, and protect enterprise innovation achievements within a specific scope.

5. Optimize supply chain management, establish long-term stable cooperative relationships with suppliers, expand raw material procurement channels, and reduce supply risks.

In the journey of domestic IVD reagent raw materials going abroad, Xindesheng has been deeply involved in the field of in vitro diagnostic raw materials for many years. With mature technology in the research and development of biological buffering agents, enzyme preparations, antigen antibodies and other products, the product quality is stable and reliable, meets standards, and can meet different market requirements. It has a professional R&D team, constantly innovating in technology, providing differentiated raw material solutions for enterprises, and enhancing product competitiveness. If you have any purchasing needs, you can contact Xindesheng at any time!