2025-07-11
SenovaTech Team at CPHI 2025 i
Chinese API Manufacturers Accelerate Overseas Expansion, Yet Efficiency Bottlenecks Remain
Release Time: 2025-07-25
News Source: SenovaTech
Author: SENOVA—Lucas
In recent years, Chinese active pharmaceutical ingredient (API) manufacturers have been rapidly expanding into international markets. Latest statistics show that from 2022 to 2025, 422 Chinese companies newly submitted Drug Master Files (DMFs) to the U.S. FDA, far surpassing India (191) and the U.S. (84). By 2025, the total number of Chinese companies with DMF qualifications reached 708, marking the first time China has surpassed both the U.S. and India in this regard.
However, behind these impressive figures lie hidden concerns. Industry analysis reveals that the average number of DMFs held by Chinese companies is only 3.96, lagging behind India's 17.49 and even slightly below the U.S.'s 4.41. This gap highlights the "quantity over quality" dilemma in China's API sector.
The development trajectories of the three countries show distinct characteristics:
China: Exhibits "explosive growth," with a 74% increase in the number of companies over the past five years, but stagnant per-company output efficiency.
India: Maintains "steady development," with high industry concentration and dominant leading enterprises.
U.S.: Experiences "industrial contraction," with a 32% decline in the number of companies over the past five years, reflecting an irreversible trend of manufacturing outflow.
Further analysis indicates that China's API industry still lags behind India in terms of efficiency. Key reasons for this gap include:
Severe homogenized competition in low-end products
Insufficient R&D innovation capabilities
Room for improvement in international operational capabilities
To achieve sustainable development, China's API industry must focus on:
Increasing innovation investment to shift toward high-value-added products
Improving international management systems to enhance registration and submission efficiency
Amid the restructuring of the global pharmaceutical supply chain, Chinese API manufacturers must transition from "quantity expansion" to "quality improvement." Only by overcoming efficiency bottlenecks can China truly evolve from a major pharmaceutical producer to a global leader. The future of industry competition will depend not just on the number of companies but on technological innovation and international competitiveness.
