Before the 1990s, Europe and the United States were the world's major producers of APIs, featuring large industrial scales and advanced technological capabilities. Subsequently, driven by factors such as rising production costs and mounting environmental pressure, API manufacturing and supply in Europe and the US gradually shifted to the Asia-Pacific region. At present, global chemical API production is mainly concentrated in five regions: Western Europe, North America, Japan, China, and India. Among them, Europe and the United States have been scaling down their API production capacities. The United States, in particular, sees most of its generic drug manufacturers without in-house API production facilities, relying heavily on imports. In contrast, emerging markets represented by China and India have risen rapidly to become major API producers and exporters. According to relevant data, the combined global share of API supply from China and India increased from 16.7% in 2008 to 47% in 2019.
Geographically, in Europe, apart from a small number of API manufacturing facilities in France, the Netherlands, Germany, Switzerland, Spain, Italy, Ireland, Russia, and several Eastern European countries, most European nations have long ceased API production. In the Americas, the United States, Mexico, Brazil, and Cuba retain some API plants, though in limited numbers, with API enterprises in some of these countries on a downward trend. In Asia, besides China and India, Israel, Japan, and South Korea maintain a certain number of API and intermediate production facilities, but their scale remains relatively modest. Africa has a near-negligible API industry.
In terms of product categories, developed regions such as the United States and Europe hold a dominant position in the high value-added patented API segment, supported by advantages in R&D, production processes, and intellectual property protection. China focuses primarily on bulk APIs, while India's specialty API production is driven by its robust generic drug industry.
China and India have secured important positions in the global API market thanks to their cost advantages. As specialty API manufacturers in these developing countries continuously increase R&D investment, upgrade production technologies, refine manufacturing processes, and invest in specialized production lines, Chinese and Indian API enterprises are gradually moving up the high-end value chain of API production.
Prior to the COVID-19 pandemic, the five major API-producing regions had already exhibited a pattern of relative growth and decline. Benefiting from the rapid development of their domestic pharmaceutical industries and surging global demand for APIs, the API sectors in China and India achieved remarkable growth. Moreover, compared with the other three producing regions, the future development prospects of the API industries in China and India are widely optimistic. Meanwhile, given the similarities between India's and China's pharmaceutical sectors, India's API industry is well-established and is expected to maintain fierce competition with Chinese API manufacturers for a considerable period to come.
