Europe & Beyond

The API market is increasingly a global business integrated in the supply chain of pharmaceuticals, in which APIs constitute the most important components in terms of clinical efficacy and value.

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.

The growing trend towards new high tech therapeutics coupled with the emergence of novel and innovative delivery systems and the evolution of personalised medicines will only serve to further emphasise the growing demand for advanced APIs.

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.

The first aim of the European Authorities must always be to protect the patient by ensuring the access to secure medicines manufactured with high quality ingredients from proven sources.
The EU should actively promote and implement direct measures to allow European patients to take advantage of APIs produced within Europe, promoting this traditional high-value added industry and its high-skilled employment.

European R&D should be promoted and effectively used to underpin the growth of the European API sector.

Basic facts

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