China is the world's largest producer and consumer of chemical products. In 2020, the output of dozens of bulk chemicals ranked first worldwide. Benefiting from a complete upstream industrial chain of basic chemical raw materials and strong advantages in industrial and supply chains, China's API industry has evolved into an active player in the global API sector through years of sustained development. Especially since 2010, China has become the world's largest API manufacturing base. It not only effectively meets domestic demand but also exports APIs in large quantities to nearly 200 countries and regions worldwide. Its API export value has ranked first globally for many years, securing an extremely important position in the global pharmaceutical industrial chain.
According to Clarivate data, China is capable of producing approximately 1,650 API varieties, with a production capacity accounting for around 30% of the global total. Its comparative advantages lie in fermentation-based products, cost control capabilities, and compliance with international standards. A considerable number of APIs and intermediates manufactured in China hold substantial global market shares and possess certain pricing power. For instance, China's antibiotic production is internationally advanced, with antibiotic APIs accounting for 30% of the global market; the output of antipyretic and analgesic drugs such as paracetamol, aspirin and analgin is substantial, among which paracetamol alone makes up 50% of the world's total production; most vitamin APIs rank among the top globally except for a very few varieties; and corticosteroid APIs also lead the world in market share. Furthermore, China is the largest supplier, and in some cases the sole global supplier, of active pharmaceutical ingredients for certain key drugs, such as vancomycin. China also dominates the global supply of heparin.
Data from the China Chamber of Commerce for Import and Export of Medicines and Health Products show that China's exports of chemical APIs have maintained continuous growth over the years, except for slight declines of 1%–2% in 2015 and 2016. Export value rose from $15.98 billion in 2010 to $41.77 billion in 2021, with export volume exceeding 10 million tonnes, and dozens of products achieving annual export values of over $100 million. Statistics indicate that Chinese-made APIs account for approximately one-third of the global API market, making China a deserved global leader in API production. In recent years, the number of EU CEP (Certificate of Suitability to the European Pharmacopoeia) and US DMF (Drug Master File) certifications applied for by Chinese enterprises has increased rapidly. Taking the European market as an example, as of July 11, 2022, Chinese companies held 899 valid CEP certificates, with more than 900 API varieties sold in Europe, making China the largest API supplier to the European market.
