Strategic attention to the pharmaceutical “chip” - APIs

1. Overview of the API industry

An Active Pharmaceutical Ingredient (API) is any substance or mixture of substances used in the manufacture of a drug that, when used in pharmaceutical manufacturing, becomes an active ingredient of the drug. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, management of disease or disease prevention, or can affect the function or structure of the body.

From the upstream and downstream point of view, API is the final product obtained by using upstream basic chemicals or plants and animals as the basic raw materials, and obtaining pharmaceutical intermediates through chemical synthesis or biological fermentation or extraction, and then synthesizing them in 4-5 steps. And in the downstream, according to the actual function and use scenarios, APIs can also be used in the fields of pharmaceutical preparations, feed, health products and cosmetics, etc. The most important application scenario is still in the field of pharmaceutical preparations.
2. API sub-industry has its own characteristics

Sales of API products according to the downstream preparations of the patent period differences can be divided into three different periods overall, and also different APIs are divided into three categories of bulk, specialty and patent APIs.

(1) Patented APIs: downstream preparations for innovative drugs, product sales and innovative drugs / patented drugs single product sales are closely related to the R & D stage and approved within 2 years, sales are in the introductory period, slow growth, the absolute amount of small; within 3-8 years, sales are in the outbreak of the period of rapid growth; the later due to the emergence of new drugs, sales enter a period of recession.

(2) Specialty APIs: downstream preparations for the “new” generic drugs, before and after the expiration of the preparation patent, the market began to appear gradually generic, APIs into the registration of the introductory period; generic sales of about 2 years, due to the competition of a number of generic pharmaceutical enterprises in the amount of price drops, the rapid release of specialty APIs; patent expires 10 years later After 10 years of patent expiration, the “new” generic drug species enter the platform and decline period.

(3) Bulk APIs: downstream preparations patent expiration for a long time, generally more than 20 years of the “old” generic drugs, resulting in the preparation of its own sales growth into a bottleneck, the demand is basically stable and unchanged.