Reviewing the development process of global API and generic industry chain, We can take 2015 as the watershed. In the first cycle of 1984-2015, the rise of generic drug market in Europe and the United States is the main source of industry dividends, and many  European and American enterprises enjoy a significant advantage. In the new cycle after 2015, with the increase of enterprises with quality system and registration and certification capabilities in European and American markets, the industry is gradually turning to the competition of comprehensive manufacturing capabilities and cost advantages. Chinese and Indian enterprises are expected to become the biggest beneficiaries by virtue of their resource endowment.

The main types of Chinese APIs are bulk products, such as vitamins, amino acids, amino glycosamines, antipyretic and analgesic drugs, etc. By the end of 2017, China had 1474 API production bases. With a complete industrial chain, China had a complete range of bulk API products, strong production capacity and low price. However, for high-end characteristic raw materials and the lack of R & D capacity in the early stage of domestic raw material pharmaceutical enterprises, the production technology is relatively backward, the industrial concentration is not high, and the production cost is high.

In addition, in recent years, the development of API industry is bound to usher in a great change, from the case of API monopoly being punished, to the prohibition of export because of impurity detection, to the increasingly stringent environment of the whole industry, to the reshuffle of pharmaceutical industry pattern by "consistency evaluation + procurement with quantity", and the redefinition of core competitive elements of generic drugs.

With the improvement of industry standards, the improvement of API industry is more important.How to develop the API industry?

The Ministry of industry and information technology, the Ministry of ecological environment, the National Health Commission and the State Drug Administration jointly issued the guidance on promoting green development of API industry, which clearly stated the future development goal, implementation path and basic requirements of API industry. The opinions pointed out that by 2025, the proportion of API produced by green process will be further increased, and the market share of high-end characteristic API will be significantly increased; the industrial layout will be more optimized, API will basically realize Park production, and a batch of API centralized production bases will be built; the clean production level will be significantly improved, and the energy consumption, carbon dioxide emission and water consumption per unit industrial added value will be increased The emission intensity of sulfur dioxide, nitrogen oxides, volatile organic compounds and other major pollutants gradually decreased. In order to achieve the above goals, the "opinions" said that through the adjustment of industrial structure, optimization of industrial layout, acceleration of technological innovation and layout, and implementation of green production standards, we can improve the proportion of green products of bulk API, accelerate the development of characteristic API and high-end customized API, eliminate backward technologies and products according to laws and regulations, and gradually improve the quality of raw materials The concentration degree and scale production level of raw material and medicine industry.