In the fiercely competitive field of in vitro diagnostics (IVD), market dynamics constantly attract the attention of practitioners. In the first half of March, many events intertwined in the IVD market, and every change, whether it was policy adjustments or market fluctuations caused by disease outbreaks, had a profound impact on various links in the IVD industry chain. As a pioneer in the field of IVD reagent raw materials, Hubei Xindesheng has been closely monitoring these trends and will now interpret the key information one by one for you.

Company Building

Market changes driven by policies continue to deepen

（1） The impact of centralized procurement in the fields of biochemistry and immunology is intensifying

From a policy perspective, the Jiangxi Provincial Alliance's biochemical centralized procurement is continuously deepening in its ongoing promotion. The field of biochemical testing shows a significant decline in 2024 compared to the entire year of 2023. This is mainly due to the centralized procurement policy, which has led to a significant decrease in the prices of related products, compressing the profit margins of enterprises, and even causing survival difficulties for some small and medium-sized enterprises. In some common biochemical testing projects, reagent prices have been halved, forcing companies to maintain operations by optimizing costs and improving production efficiency. Starting from September 2024, the centralized procurement of Anhui Provincial Alliance immune reagents has gradually been implemented in various provinces and cities. In addition, the combined impact of factors such as inspection price and fee management has led to a significant shrinkage of the immune market. Entering 2025, the implementation of centralized procurement of tumor markers and thyroid function reagents is expected to further shrink the immune market. For IVD raw material suppliers, this means unstable downstream market demand and the need to adjust product strategies and market layouts in a timely manner to cope with market changes.

（2） Opportunities and challenges coexist in the field of bedside diagnosis

The field of bedside diagnosis has decreased by 0.6% year-on-year in 2024 compared to 2023. This is mainly due to the gradual expansion of the coverage and impact of DRG/DIP and other control measures, resulting in varying degrees of decline in testing volume and fees. However, with the deepening of population aging, the overall demand for bedside diagnosis is actually still increasing. Moreover, the future expansion of ICU and the sinking of medical resources have brought growth potential to the bedside diagnosis market by 2025. In this context, IVD raw material small factories can focus on developing characteristic raw material products that meet the needs of primary healthcare, such as high-quality raw materials for bedside rapid detection reagents, to meet the needs of primary institutions for convenient and accurate diagnosis. By accurately positioning the market, small factories are expected to occupy a place in the segmented field.

Disease outbreaks drive fluctuations in segmented markets

（1） The field of molecular diagnostics is affected by the detection of infectious diseases

The field of molecular diagnostics has undergone significant changes in the fourth quarter of 2024. Due to the increase in respiratory infectious diseases, there has been a significant increase in the detection of corresponding molecules and NGS pathogens. At the same time, cancer gene testing is also maintaining a high-speed upward trend. However, HPV testing has significantly decreased due to the impact of the Anhui Provincial Alliance's centralized procurement and implementation. Entering 2025, as the decline in PCR equipment stops, it is expected that the overall market will rebound with the increase in diagnostic volume. For small IVD raw material factories, this means that in the research and development of molecular diagnostic raw materials, it is important to keep up with the trend. Increase research and development investment in respiratory infectious diseases and genetic testing related materials, improve product quality and performance, and meet the market's demand for high-quality molecular diagnostic materials.

（2） Stable growth in demand for pathological tissue diagnosis

In the field of pathological tissue diagnosis, immunohistochemistry will mainly drive market growth in 2024 due to the sustained increase in patient testing demand. In the pre-processing market, although facing intensified domestic competition, the conventional dyeing field has maintained relatively stable demand. It is expected that organizational diagnosis will continue to maintain a high single digit upward trend in 2025. This provides a development opportunity for small IVD raw material factories, which can focus on developing characteristic raw materials for immunohistochemistry and conventional staining, and stand out in the fiercely competitive market through technological innovation and quality improvement.

Enzyme preparation

Behind these major events in the IVD market in the first half of March, there are new opportunities and challenges for industry development. Just like Hubei Xindesheng Company, as a supplier of IVD reagent raw materials, we always adhere to the principle of quality first, strictly control the production process, and ensure that every batch of products is stable and reliable. In the research and production of various IVD reagent raw materials such as biological buffering agents, enzyme preparations, and chromogenic substrates, we provide high-quality raw materials for the industry with profound technological accumulation and continuous innovation spirit. If you have any purchasing needs, please feel free to contact Xindesheng at any time.