Strategic Review – Global API Industry


A substance used in a finished pharmaceutical product, intended to furnish pharmacological activity or otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of a disease or to have direct effect in restoring, correcting or modifying psychological functions in human beings


The compound is generally defined as highly potent. If it has an occasional exposure limit (OEL) of less than 10 µg/m3, a daily therapeutic dosage of less than 10 mg/day or if one mg/kg/day dose produces serious toxicity in laboratory animals.

The API Market – Large & Rapidly Growing Business

  • Global sales of APIs are about $120 billion in 2016, including captive manufacturing and will grow to nearly $200 billion by 2021
  • Global sales of HPAPIs are estimated at $10 billion in 2016
  • While the API market is growing at a healthy rate of nearly 7% a year, HPAPIs are growing at a much faster rate in the low double digits