Against the backdrop of limited growth in the domestic IVD market due to factors such as centralized procurement and laboratory reform, going global has become an important strategic choice for many companies seeking new growth opportunities. According to statistics, there will be over 2000 IVD production enterprises registered domestically in 2023, and the market competition is fierce. The size of the domestic and international IVD market is expected to grow from 94.75 billion US dollars in 2021 to 142.89 billion US dollars in 2030, with a compound annual growth rate of 4.7%. The vast market space is attracting domestic IVD companies to actively layout. However, the road for IVD companies to go global is not smooth sailing, and in the process of expanding into overseas markets, they need to face many complex challenges.

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1、 Complex and stringent regulatory entry barriers

Different regions have their own independent and complex regulatory standards and admission procedures for IVD products. Taking the new version of IVDR, which will be officially implemented in May 2022, as an example, it can be called the "earthquake of the IVD industry". The regulation has adjusted the product classification system, requiring the intervention of notified bodies for approximately 80% of IVD products; Significantly improved performance evaluation and post market regulatory requirements, and introduced a Unique Identifier (UDI) system. This series of changes has led to the failure of many companies' existing compliance strategies. As of May 2023, only about 1600 IVD products have obtained IVDR certification, far below market expectations.

The FDA also has strict approval requirements for IVD products, requiring companies to provide a large amount of detailed clinical data, product performance verification information, etc. The approval cycle is long and the uncertainty is high. Although the overall registration requirements in other regions are relatively relaxed, countries are gradually establishing and improving relevant markets

2、 Intense market competition

The IVD market at home and abroad has long been dominated by multinational giants. In 2021, Roche's market share in the IVD field reached as high as 20% both domestically and internationally. These giants hold a solid position in the market with their strong brand influence, strong research and development capabilities, extensive sales networks, and long-term accumulated customer trust. They continuously introduce new technologies and products through research and development innovation, consolidating their competitive advantage. In the market competition, some domestic IVD companies not only have to confront these multinational enterprises head-on, but also need to cope with competition from enterprises in other emerging market countries. In this fierce competitive landscape, domestic enterprises need to highlight their product advantages and enhance their brand awareness in order to potentially gain a share of the market.

3、 Market demand and cultural differences pose challenges

Due to differences in race, socio-cultural environment, and conditions, different countries and regions overseas have varying demands for the functionality, price, packaging, and other aspects of IVD products. In developed countries, the medical system is well-established, with higher requirements for product automation, ease of operation, and more emphasis on brand and product quality; In some developing countries, due to relatively scarce resources, the cost-effectiveness of products is more valued, and products may need to have stronger environmental adaptability and easy operability.

4、 Challenges in after-sales service and technical support

The use of IVD products involves professional knowledge and technical operations. In overseas markets, there are differences in the degree of demand, response time, and service focus for after-sales service and technical support in different countries. In some technologically advanced countries, customers may prefer companies to provide remote technical guidance, software upgrades, and other services; In areas with relatively weak infrastructure, companies may need to provide on-site training, equipment maintenance, and other support.

Language barriers, different social and cultural customs, and interpersonal communication preferences also increase the difficulty of after-sales service and technical support. Enterprises need to establish localized service teams or collaborate with local professional organizations to ensure timely resolution of customer issues, enhance customer satisfaction, and maintain brand image. Otherwise, if the after-sales service is not in place, it may lead to customers losing confidence in the product, affecting market reputation and subsequent sales.

5、 Logistics and supply chain risks

IVD products have strict requirements for transportation conditions, such as some reagents requiring full cold chain transportation to ensure product quality and stable performance. In the process of cross-border logistics, there are problems such as long transportation distances, multiple links, and complex transportation environments, which increase the risk of product damage and deterioration. At the same time, the logistics market fluctuates frequently and freight prices are unstable, which may lead to a significant increase in logistics costs due to factors such as rising fuel prices and adjustments in trade policies.

In terms of supply chain, geopolitical instability and rising trade protectionism pose a risk of raw material supply disruptions. For example, some countries may implement export controls on key raw materials or components, which may affect the normal production of enterprises. Enterprises need to optimize their logistics plans, select reliable logistics partners, strengthen supply chain risk management, establish emergency supply mechanisms, ensure stable raw material supply, and reduce the impact of logistics and supply chain links on their overseas business.

Although domestic IVD companies have broad prospects for going global, they face numerous challenges. When formulating an overseas strategy, enterprises need to fully evaluate their own strength, deeply understand the target market situation, and plan ahead to deal with various problems.

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As an upstream IVD raw material enterprise, Hubei Xindesheng actively formulates overseas strategies, relying on mature production processes and stable product quality to expand overseas markets. The company optimizes product quality inspection standards in response to different national regulatory requirements, ensuring that raw materials such as biological buffering agents, luminol, and acridine esters meet admission standards. By participating in exhibitions and establishing cooperation with overseas IVD reagent manufacturers, we provide guidance on raw material application and after-sales support to ensure the stability of cross-border supply. At present, the product has entered the overseas market, providing high-purity raw material support for overseas customers and gradually increasing overseas market share. If you need it, please feel free to contact us anytime!