In recent years, with the intensification of competition in the domestic in vitro diagnostic (IVD) market and the normalization of centralized procurement and price reduction, more and more companies have turned their attention to overseas markets. Going global has become an important path for IVD companies to seek growth and enhance brand influence. However, moving from the domestic market to the global market is not simply a matter of "copy and paste". The differences in language, regulations, culture, and channels constitute numerous barriers. How to effectively address these challenges and develop practical and feasible strategies for going global is the key to determining whether a company can stand firm.

Luminol reagent

The Three Core Challenges Faced by Going Global

1. High regulatory barriers to entry and long certification cycles

There are significant differences in the regulatory systems for IVD products among different countries and regions. The European and American markets implement strict classification management, such as FDA 510 (k) or PMA certification in the United States and CE-IVDR certification in the European Union, with complex processes, high technical document requirements, and long audit cycles. Although emerging markets have relatively relaxed access, they are gradually establishing localized registration systems. If a company lacks a professional regulatory registration team or has insufficient understanding of target market regulations, it is highly likely to be hindered in the certification process and delay the timing of listing.

2. Diversified market demand makes product adaptation difficult

There are differences in disease spectrum, medical level, and testing habits among different regions. For example, developed countries pay more attention to high value-added projects such as early screening and accompanying diagnosis of tumors; However, some developing countries have a greater demand for infectious disease testing and basic biochemical projects. In addition, climatic conditions such as high temperature and humidity may also affect the stability of reagents. If a company only exports domestic products directly, it may face difficulties in adapting to local clinical needs.

3. Weak channel construction and brand awareness

In overseas markets, especially in Europe and America, end customers (hospitals, laboratories) generally rely on mature distribution networks. New entrants lack local channel resources and find it difficult to quickly open up the market. Meanwhile, the international recognition of Chinese IVD brands still needs to be improved, and some customers have quality doubts about "Made in China". Establishing brand trust and expanding sales networks require long-term investment and localized operational capabilities.

Three major strategies for breaking through the dilemma of going global

1. Promote in stages, focusing on key markets

Enterprises should avoid "full bloom" and prioritize target areas with clear regulatory systems, high market potential, and matching with their own product lines. We can first enter markets with relatively low entry barriers such as Southeast Asia, Latin America, and the Middle East, accumulate experience, and establish brand reputation; Gradually expanding into high-end markets such as Europe and America. At the same time, overseas exhibitions and international certifications (such as CE and FDA) can be utilized to enhance product credibility.

2. Strengthen localization adaptation and technical support

Optimize product design for different market demands. For example, developing high-temperature resistant reagents, adapting test kits to local mainstream detection platforms, or providing multilingual instructions and software interfaces. At the same time, establish a local technical support team or collaborate with local service providers to provide timely installation, training, and after-sales response, enhancing customer loyalty.

3. Build an independent and controllable supply chain system

International competition is essentially a competition between comprehensive costs and stability. Having a stable and high-quality supply of upstream raw materials is the foundation for ensuring consistency in reagent performance and cost control. Especially in key raw materials such as buffering agents, enzymes, antibodies, etc., achieving independent controllability can not only reduce external dependence, but also enhance product differentiation competitiveness.

 Product packaging

Hubei Xindesheng: Assisting IVD Enterprises in Consolidating the Raw Material Foundation for Going Global

In market layout, the stability and compliance of upstream raw materials cannot be ignored. Hubei Xindesheng Material Technology Co., Ltd. focuses on the research and production of biological buffering agents such as Tris, HEPES, MOPS, CAPS, etc. The products have high purity and stable batches. The company's Huanggang new factory production base is accelerating construction and will achieve higher production capacity and better quality control in the future, further ensuring production capacity and delivery. We are willing to work together with IVD enterprises to enhance product competitiveness from the source and jointly explore the global market.