Jinan Zhuocheng Bio-Tech Co., Ltd.

After years of development, China has become a core manufacturing base and leading exporter in the global active pharmaceutical ingredient (API) industry. Leveraging advantages in scale, cost, and technology, China occupies a pivotal position in the global pharmaceutical supply chain and plays an important role in ensuring stable supply and influencing global pharmaceutical pricing dynamics. The key manifestations are as follows:

(I) The world’s largest producer and exporter, with globally leading supply capacity
China accounts for approximately 35%–40% of global API production. In 2024, revenue from regulated chemical API manufacturers accounted for 35.4% of the global API market. The industry scale (including intermediates) is expected to exceed RMB 1.2 trillion in 2025, maintaining China’s position as the world’s largest producer and exporter of APIs.

In multiple sub-segments, China has achieved global dominance in capacity: bulk APIs such as ibuprofen, penicillin, and vitamin C account for over 60% of global capacity. Among them, XinHua Pharmaceutical accounts for nearly 40% of global ibuprofen capacity. More than 60 specialty APIs, including sartans and cephalosporins, account for over 70% of global capacity.

Among the global top 100 generic drugs, China supplies APIs for 76 products, making it one of the most critical upstream suppliers for the global generic drug industry and strongly supporting the stability of global generic drug supply.

Export scale continues to expand. From January to May 2025, China’s API exports reached USD 18.51 billion, up 4.9% year-on-year. Exports to Belt and Road countries totaled USD 7.74 billion, accounting for 41.8%. Export destinations cover more than 190 countries and regions, including the United States, the European Union, India, and Southeast Asia. The US and EU remain core export markets, accounting for over 40% of total exports. India is also a key importer of Chinese APIs; in 2023, 68.5% of India’s API imports were sourced from China, totaling USD 10.12 billion. Chinese APIs have become a critical pillar of the global pharmaceutical supply chain.

(II) Breakthroughs in international certification and globally recognized quality standards
As Chinese API manufacturers continue to upgrade technology and quality control systems, an increasing number of companies have obtained international certifications, gaining global recognition and breaking through regulatory barriers in developed markets.

As of Q2 2025, Chinese companies had accumulated 3,532 FDA DMF registrations and 1,182 EU CEP certificates, accounting for 13.3% and 17.9% of global totals, respectively. Leading companies such as XinHua Pharmaceutical, Huahai Pharmaceutical, and NHU Company have obtained certifications from FDA, EDQM, and WHO, becoming key suppliers for global pharmaceutical companies.

For example, XinHua Pharmaceutical is a core supplier of ibuprofen to multinational companies such as GSK and Johnson & Johnson. Huahai Pharmaceutical is a major global supplier of sartan APIs, with products exported to high-end markets in Europe and the United States. These developments have significantly reshaped the global perception of Chinese APIs, shifting from “low-end, low-quality” to reliable, high-quality supply.

(III) Influence on global API pricing and dominance in segmented markets
As a major global API producer and exporter, China holds a dominant position in multiple sub-segments and exerts strong influence on global API pricing.

For example, in bulk APIs such as vitamin C, vitamin E, and ibuprofen, China accounts for over 60% of global capacity. Leading enterprises leverage economies of scale and cost advantages to exert significant pricing influence in global markets. In specialty APIs such as sartans and statins, Chinese companies have gradually increased global market share through capacity and cost advantages, continuously shaping international price trends.

In addition, the production stability of Chinese API manufacturers is directly linked to global pharmaceutical supply chain security. During the COVID-19 pandemic, Chinese companies maintained orderly production and effectively filled global supply gaps, ensuring the stability of global pharmaceutical supply and further strengthening China’s influence in the global API market.

(IV) Participation in global industrial division of labor and supply chain integration
Chinese API companies are deeply integrated into the global pharmaceutical value chain, forming a “global R&D, China manufacturing, global sales” collaborative model. On one hand, they provide contract development and manufacturing (CDMO) services for innovative pharmaceutical companies, supporting drug development and commercialization while reducing R&D costs. On the other hand, they supply high-quality APIs to global generic drug manufacturers, supporting the development of the generic drug industry and improving global drug affordability and accessibility.

Meanwhile, Chinese API companies are actively expanding international cooperation through overseas acquisitions and production base expansion. For example, WuXi AppTec acquired Bayer’s API manufacturing facility in Germany, further strengthening its presence in Europe. These moves enhance China’s influence in the global API value chain and promote coordinated development of the global pharmaceutical supply system.