- APIs are generally referred to as ‘bulk pharmaceuticals’ and are in fact usually made in places at relatively a remote place, where tablets, suspensions and liquids are manufactured.
- Today, the maximum concentrations of API manufacturers are located around Asia, specifically in India and China.
- This has led to more and more companies to outsource API manufacturing from India and China, which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure, which on the whole thing is a can also be problematical to install and maintain.
- A good example of API out sourcing is the Latin American countries, Australia, USA and UK who currently in the process of withdrawing from all API production in favour of outsourcing from Indian and Chinese API manufacturing companies.
- API outsourcing on the rise
Internationally, large innovator companies are also increasing their outsourcing requirements says Moorcroft, Coupled with the increasing use of generics, and additional opportunities for increased penetration in developing markets, thus the API industry will continue to experience strong growth.
- at present, API manufacturing is the largest business for pharmaceutical CDMOs, the operation most frequently outsourced by small-molecule manufacturers.
- On the commodity API side, an aging population and government spending caps are driving global demand for generic drugs and the APIs used to make them. Recently,
“Japan has been an area of high generics demand, according to a report by Nikkei Asian Review, as the Japanese government moves to boost use of generics from 50% to 80% of all prescription drugs by 2020″.
In Japan, a number of commodity APIs are in short supply, Nikkei Asian Review reported in February, and the pharmaceutical manufacturer, Eisai, plans to start selling APIs for allergy, high-cholesterol and other therapies to generic drug manufacturers in Japan. The company plans to double API production capacity at its plant in Andhra Pradesh, southern India (7), which had been previously used as a captive source. Eisai will use revenues to expand its R&D pipeline, the report says.