Analysis of Development Status and Future Prospect of API

1. Development Status of API Medicine

API medicine refers to the active ingredient of a drug, which is the basic substance that constitutes the pharmacological action of a drug. The API cannot be used directly by patients, and it must be further processed into preparation by adding auxiliary materials before patients can take it. An intermediate is a material produced in the process of an API that must undergo further molecular modification or refinement before becoming an API. The broader API medicine industry includes APIS and intermediates.

There are two main sources of upstream raw materials for APIS medicine, one is the basic chemical industry, the other is the planting industry. The former is mainly produced through the chemical synthesis process, while the latter is made into related intermediates through biological fermentation and then modified. The fermentation process is mainly used for antibiotics, vitamins and other raw materials, which has advantages of low pollution, high efficiency and low cost compared with the chemical synthesis process.

The main downstream application fields of API medicine are pharmaceutical preparations, which are still dominated by chemical drugs. Secondly, API is also widely used in feed, health care products, food and other fields.

At present, the geographical and variety distribution of raw material API manufacturers is not balanced. Manufacturers of APIS and related intermediates are mainly concentrated in regions with traditionally strong chemical industries.

2. Policy Analysis of the Pharmaceutical Bulk Drugs Industry

According to the analysis of the pharmaceutical raw materials industry, the characteristics of the chemical raw materials industry include large scale, low cost, and high output, which are an important driving force for the upgrading of the pharmaceutical industry. Chemical raw materials are one of the important raw materials in the production of chemical-pharmaceutical preparations, and the sales of raw materials are mainly for preparation manufacturers.

Intermediate chemical products are mainly divided into bulk APIS and characteristic APIS. Bulk APIS medicine mainly refers to traditional chemical APIS with large tonnage and no patent issues, such as penicillin, vitamins and hormones. Their market demand is relatively stable and their application is relatively common. The featured API mainly refers to the drug in the patent protection period or in a period of time after the end of the patent protection period.

In recent years, as the number of patented drugs with expired patents has been increasing, the variety and quantity of generic drugs have also risen rapidly, which has brought huge market opportunities to the API market, and the output of APIS medicine has continued to grow.