Europe & Beyond
The quality of the European APIs is guaranteed by a strict application of Good Manufacturing Practices (GMPs), to which EU companies are totally committed, as is evidenced by the fact that the majority of the APIs used in the most developed pharmaceutical market, the US, are produced in Europe.
The API market’s outlook is positive with a healthy growth rate for the next years foreseen at 4.5% p.a. in the generic sector and 4.8% p.a. in the custom sector.
Despite the long-standing tradition in Europe and the outstanding quality of its APIs, Asian suppliers currently hold the lion’s share of the market in Europe (63%) whilst European suppliers dominate the US and Japanese markets.
European R&D should be promoted and effectively used to underpin the growth of the European API sector.
The strategic decision taken by some multinational pharmaceutical companies to return to Europe for their API sourcing due to quality and reliability reasons
The request by Chinese and Indian Authorities for a higher commitment from domestic API manufacturers to environment and safety, resulting in higher costs and delays in getting ready for the market
Asian manufacturers buying European APIs to export their dosage forms to the USA
The positive impact of the Falsified Medicines Directive (FMD) which triggered a structural change leading to a demand for reliable and well-established suppliers
The economic entry barrier to the US market created by the Generic Drug User Fee Amendments (GDUFA), leading to less API producers filing their products (correspondent Drug Master Files –DMFs-) with the US Food and Drug Administration
The growth opportunities offered to EU manufacturers in emerging markets which are rapidly embracing high quality standards and requiring high quality products to fulfill their demand