In 2025, the domestic in vitro diagnostic (IVD) market is undergoing a period of deep transformation, with multiple factors intertwined to drive structural adjustments in the market landscape. From policy orientation, technological evolution to market demand transformation, the IVD industry is facing challenges and opportunities. Enterprises are constantly exploring new development paths in this transformation, and the market structure has also undergone significant changes.

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1、 The policy of centralized procurement reshapes the market competition pattern

Since the beginning of IVD centralized procurement in Anhui in 2021, the market landscape has undergone profound changes after multiple rounds of centralized procurement. As of now, a large number of testing projects in the fields of conventional biochemistry and luminescence have been included in the scope of centralized procurement. In terms of amount, the market size of about 7 billion yuan in the biochemical field and about 16 billion yuan in the immunological field has disappeared, resulting in a total market evaporation of 23 billion yuan. The financial report data of numerous IVD companies reflect this impact: in 2024, 25 out of 70 IVD related companies will suffer losses, and most companies will experience a double reduction in revenue and profit; In the first quarter of 2025, only 9 out of 60 listed domestic IVD companies achieved dual growth in revenue and net profit, with the industry's overall decline reaching a five-year peak.

Under the influence of the centralized procurement policy, the industry has shown a clear trend of head concentration. Top enterprises, with their scale advantage, cost control ability, and brand influence, are more competitive in centralized procurement and can maintain market share and revenue scale by exchanging price for quantity. For example, in the field of biochemical diagnosis, due to mature technology, high localization rate, and a large number of enterprises, the price competition after centralized procurement is fierce. Although the profit margin of top enterprises is squeezed, they can still maintain their position. Small and medium-sized enterprises, on the other hand, face greater survival pressure and find it difficult to compete with top enterprises in cost control, research and development investment, and some even face bankruptcy and closure.

According to statistics, it is expected that 50% of small and medium-sized enterprises will be eliminated in the next three years. Taking the 28 province IVD centralized procurement led by Anhui Province as an example, this centralized procurement has attracted much attention because it involves two large-scale projects in the market of cancer biomarkers and thyroid function chemiluminescence reagents, and has reached most of the markets. Enterprises face a trade-off between incremental and price reduction space in centralized procurement, which puts higher demands on their market strategy and profitability. In such a policy environment, enterprises need to continuously optimize their supply chain, reduce production costs, and improve product quality to adapt to market competition after centralized procurement.

2、 Reform of the Inspection Department to Compress Market Space

In 2025, a series of reform measures targeting the laboratory department are restructuring the survival environment of the IVD industry. The inspection fees will be lowered, and in October 2024, the medical insurance bureau will initiate two rounds of inspection price adjustments. In 2025, many medical insurance bureaus in different regions will follow suit. For example, the average price reduction for individual items such as glycated hemoglobin measurement exceeds 40 yuan; Regarding the testing items for cancer markers, the requirement is not to exceed 50 yuan per item, with a fluctuation of no more than 10% in different regions. This reduces the selling price of IVD products and further compresses their profit margins.

The accelerated promotion of mutual recognition of inspection results also has an impact on the IVD market. The mutual recognition of inspection results among provinces and cities will significantly accelerate by 2025, with over 100 projects recognized by 24 provinces currently. For example, the Beijing Tianjin Hebei Shandong region, Shaanxi Gansu Qinghai Ningxia Xinjiang Inner Mongolia and Xinjiang Production and Construction Corps, as well as Sichuan Chongqing, are actively promoting mutual recognition of inspection results. This reduces the need for repeated testing of some inspection items by institutions and compresses the stock market size of IVD enterprises.

3、 The acceleration of domestic substitution process

Despite facing many challenges in the domestic IVD market, the process of domestic substitution continues to accelerate. In the fields of biochemical diagnosis, blood cell analysis, molecular PCR detection, NGS (second-generation gene sequencing), and POCT (instant diagnosis), the proportion of domestic substitution has reached 60% -70%. With the continuous encouragement of policies and the improvement of industrial technological capabilities, related technologies are gradually approaching independence. Taking the chemiluminescence market in immunodiagnosis as an example, currently imported brands still occupy more than half of the domestic market share. However, with the continuous promotion of tariff adjustments and volume based procurement, local leading enterprises are expected to further expand their market share with their cost-effectiveness advantages. At the same time, domestic IVD companies are continuously making efforts in key technology research and development, material and process innovation, and large-scale production to narrow the gap with imported giants in equipment or components in fields such as molecular diagnostics, mass spectrometers, and POCT.

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The structural adjustment of the domestic IVD market in 2025 is the result of multiple factors working together. The policy of centralized procurement and the reform of inspection departments not only bring challenges, but also encourage enterprises to enhance their competitiveness and optimize market patterns. In this transformation, IVD enterprises need to adapt to market changes, adjust their business strategies, strengthen technological research and innovation, improve product quality and service levels, in order to achieve development in the fierce market competition. Hubei Xindesheng Company, as an upstream IVD reagent raw material supplier, can provide various core raw materials such as biological buffering agents, luminescent reagents, enzyme substrates, etc., covering commonly used products such as HEPES, Tris, luminol, acridine ester, TOOS, etc. Relying on mature synthesis processes and strict quality control systems, the product has high purity and strong batch stability, and is compatible with mainstream technology platforms such as chemiluminescence, enzyme-linked immunosorbent assay, and biochemical diagnosis. If you have any purchasing needs, please feel free to contact us at any time!