Chinese API Companies Accelerate Global Expansion, with Efficiency as a Key Challenge
The latest data shows that between 2022 and 2025, the number of Chinese API companies submitting DMFs to the US FDA surged, surpassing both the US and India in total, demonstrating strong expansion momentum. However, compared with India and the US, the average number of DMFs held by Chinese companies is lower, reflecting a structural problem of increasing quantity but not quality.
In recent years, Chinese API companies have seen rapid expansion in the international market. The latest statistics show that between 2022 and 2025, the number of Chinese companies submitting DMFs to the US FDA will reach 422, far exceeding India (191) and US companies (84). By 2025, the total number of Chinese companies with DMF certification will reach 708, surpassing both the US and India for the first time. However, these impressive figures belie concerns. Industry analysis shows that the average number of DMFs held by Chinese companies is only 3.96, lagging behind both India's 17.49 and the US's 4.41. This gap reflects the ongoing development dilemma facing China's API industry, where "quantity increases but quality doesn't."
From a development perspective, China's API industry has experienced explosive growth, with the number of companies increasing by 74% over the past five years, but the output efficiency of individual companies has stagnated. India, on the other hand, has maintained steady development, with a high level of industry concentration and a clear advantage for leading companies. Meanwhile, the US industry has continued to contract, with the number of companies declining by 32% over the past five years, and the trend of manufacturing outflow is difficult to reverse.
In-depth analysis shows that the efficiency level of China's API industry still lags behind that of India. The main reasons for this gap include severe competition from homogeneous low-end products, insufficient R&D and innovation capabilities, and a need to improve international operational capabilities. For the Chinese API industry to achieve sustainable development, it must focus on the following areas: increasing investment in innovation, transitioning to high-value-added products, improving international management systems, and enhancing registration and filing efficiency.
Against the backdrop of the restructuring of the global pharmaceutical industry chain, Chinese API companies must shift from "quantity expansion" to "quality improvement." Only by breaking through efficiency bottlenecks can China truly achieve the transformation from a pharmaceutical powerhouse to a pharmaceutical powerhouse. Future industry competition will focus not only on the number of companies but also on technological innovation capabilities and international competitiveness.