Against the backdrop of sustained global market development, the in vitro diagnostics (IVD) industry, as an important component of the medical field, has shown significant growth in recent years. After experiencing fierce competition and honing in the local market, many domestic IVD production enterprises have turned their attention to overseas markets, seeking broader development opportunities. The road to going global is not smooth. Domestic IVD production enterprises not only have their own advantages, but also face many challenges.

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Advantages of domestic IVD production enterprises going global

（1） Product cost-effectiveness advantage

Domestic IVD production enterprises have significant advantages in cost control by relying on a relatively complete domestic industrial chain and mature manufacturing capabilities. Taking biochemical diagnostic reagents as an example, from raw material procurement to finished product production, the complete chemical and biological product industry system in China can provide abundant and reasonably priced raw materials, enabling enterprises to significantly reduce production costs while ensuring product quality. Compared to similar products in Europe, America, and other regions, domestic IVD products are often priced 20% -50% lower. In some price sensitive developing markets, such as Southeast Asia and some African countries, this high cost-effectiveness advantage can quickly attract the attention of local institutions and distributors, helping domestic enterprises quickly open up the market and gain market share.

（2） Technological innovation and diversified product development

In recent years, domestic IVD enterprises have continuously increased their R&D investment and achieved remarkable results in technological innovation. In the field of immunodiagnosis, some companies have developed chemiluminescence immunoassay technology, which has reached the international advanced level in key indicators such as detection speed and sensitivity, and can meet the needs of rapid and accurate clinical diagnosis. At the same time, domestic enterprises, with their keen insight into the market, can quickly develop diversified products according to different market demands, meeting the rapid detection needs of local grassroots markets.

（3） Capacity and supply chain advantages

In terms of supply chain, a complete IVD industry chain has been formed in China, from upstream raw material and component production, to midstream product manufacturing, and then to downstream sales and services, with close coordination in each link. Even in the face of fluctuations in raw material supply and logistics disruptions, enterprises can ensure the stability of product production and supply through flexible resource allocation and collaborative cooperation with suppliers.

（4） National policy support

The country attaches great importance to the development of the medical equipment industry and has introduced a series of policies to encourage enterprises to "go global". In terms of taxation, export tax rebates will be given to IVD products that meet the conditions, reducing the export costs of enterprises; In the financial field, policy tools such as export credit and credit insurance are used to provide financial support and risk protection for enterprises to expand into overseas markets. The government actively promotes the construction of the "the Belt and Road", strengthens cooperation with countries along the line in the medical and health field, and creates favorable conditions for domestic IVD enterprises to enter the markets of countries along the line. Many companies have taken advantage of this opportunity to register their products and establish sales channels in Southeast Asia, the Middle East, and other regions, gradually opening up overseas markets.

Disadvantages of domestic IVD production enterprises going global

（1） High market access threshold

Different countries and regions have established strict regulations and standards for IVD products. Higher requirements have been put forward for product classification, clinical evaluation, quality management system, and other aspects. The registration cycle has been significantly extended, and the registration time for some high-risk products can reach 2-3 years, with high registration fees, increasing the market entry and time costs for enterprises. Domestic enterprises need to invest a large amount of manpower, material resources, and financial resources to cope with different market access requirements.

（2） Insufficient brand influence

The IVD market at home and abroad has long been dominated by giants such as Roche, Abbott, Siemens, etc. After decades or even centuries of development, these companies have established extensive brand awareness and customer loyalty within the domestic market. Its products have been highly recognized by the international market in terms of quality, performance and progressiveness technology, forming a strong brand barrier. In contrast, domestic IVD enterprises started brand building relatively late, have lower visibility, and face greater difficulties in market expansion.

（3） Difficulty in channel construction and market promotion

There is a significant difference in sales channels between overseas markets and domestic markets, and domestic IVD companies have relatively limited experience in overseas channel construction. In mature markets, stable sales networks have been formed locally, and some giant companies have firmly controlled channel resources through long-term cooperation and market layout. Domestic enterprises entering these markets find it difficult to establish sales channels in the short term. In emerging markets, although there are market gaps and development opportunities, problems such as market dispersion, incomplete infrastructure, and inadequate logistics and distribution systems have increased the difficulty of channel construction.

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Although domestic IVD production enterprises face many challenges in going global, with their own advantages, if they can continue to make efforts in product research and development, brand building, channel expansion, after-sales service, and continuously improve their core competitiveness, they are still expected to occupy a place in the global IVD market.