Analysis of China’s chemical API industry-Overview of API industry

Chemical drug APIs are raw materials used in the production of pharmaceutical preparations. They are compounds with certain pharmacological effects and are located in the upstream of preparation production in the industrial chain. As one of the strategic pillars of China’s pharmaceutical industry, the chemical API industry has formed a relatively complete industrial system through decades of development, and has the characteristics of large scale, low cost and high output. At present, China’s chemical API industry is constantly upgrading, the products are gradually changing from medium and low-end to medium and high-end, and the standardization of industry development is constantly improving.

1. Overview of API industry

Chemical drug APIs are raw materials used in the production of pharmaceutical preparations. They are compounds with certain pharmacological effects. They are located in the upstream of preparation production in the industrial chain. Most of them are produced by means of microbial fermentation, DNA recombination technology, chemical synthesis and a few are directly extracted from driven plants. Because the compound can not be used directly, it needs to be transformed into medicine through processing and production with the help of various excipients and dosage forms. According to different product values and product characteristics, chemical drug APIs can be divided into bulk APIs and characteristic APIs. Among them, bulk APIs refer to traditional chemical APIs with large tonnage such as penicillin, vitamins and hormones, which do not involve patent issues. The product is characterized by large output, many production enterprises, fierce market competition and low product price and added value. Characteristic APIs mainly refer to some drugs whose patents are about to expire or have just expired, with reasonable imitation technology and international certification number. Compared with bulk APIs, characteristic APIs have high added value and broad industry prospects, but only some enterprises with strong research and development strength, advanced production facilities and large-scale production experience can obtain high profits in the competition.

After years of development, China’s chemical drug API industry, with the intensification of market competition, most API enterprises have changed from extensive low-end bulk APIs to fine medium and high-end characteristic APIs. The deep processing capacity of enterprises has been continuously enhanced, and the drug quality has been improved accordingly.