Global API Market to be hampered by Stern Regulatory Policies in European Union

Global API Market to be hampered by Stern Regulatory Policies in European Union

The recent patent expiry of several blockbuster drugs has presented specialized active pharmaceutical ingredients (API) manufacturers with ample opportunities for expansion all over the world. The bioactive portions of any drug are made up of APIs. The U.S. FDA defines APIs as a material or an amalgam of materials utilized in the manufacture of a drug and one that becomes an active ingredient of the drug upon production. APIs present patients with health benefits and assist in diagnosing, preventing, and curing diseases, though the result of and reactions to the drug vary from patient to patient depending on the dosage consumed.

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In the recent past, the increase in abbreviated new drug applications has stimulated the demand for APIs. Additionally, several Indian pharmaceutical companies are joining the rapidly growing global API market. However, the stern regulatory policies in the European Union are restricting the rise of this market.

In 2013, the global API market had reached a value of US$119.7 billion. By 2020, the market is estimated to be worth US$185.9 billion, developing at a CAGR of 6.5% during the period from 2014 to 2020.

In-house API manufacturing Market in Declining Phase Due to High Level of Competition

The captive or in-house API manufacturing market and the API contract manufacturing market are the segments of the global API market based on the type of manufacturing. Hitherto, the captive API manufacturing market was the dominant segment, but, at present, the market is losing ground owing to the high level of competition coupled with decreased profitability. Correspondingly, the API contract manufacturing market is registering impressive growth.

Based on the types of API, this market is classified into the synthetic chemical API market and the biological API market, in which the biological...

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