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Global API Market to Be Hampered by Stern Regulatory Policies in European Union

Active Pharmaceutical Ingredients (API) Market: (Branded/Generic/Over-the-counter, Chemical/Biological, Captive/Contract Manufactured, by Geography, and by Therapeutic Area) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020


Albany, NY -- (SBWIRE) -- 07/08/2015 -- 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 API market is undergoing major expansion on account of the attention giant pharma companies have started to pay to this market segment.

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The API market is dominated by generic prescriptions drugs based on the types of drugs and, owing to the global volume rise in generic prescription drugs, the demand for APIs is expected to witness a swift increase across the globe.

Apart from this, the oncology drugs market is likely to report the fastest growth in the global API market in terms of therapeutic area. The growth of this market is expected to boost demand for APIs to a large extent.

API market in North America to Maintain its Dominance

The global market for API is spread across North America, Europe, Asia Pacific, and Rest of the World, wherein the market is led by North America on the account of the increasing demand for APIs in drug formulations and the rise in R&D programs. Analysts expect the region to maintain its dominance in the near future. In response to high medical and healthcare costs in the U.S., the preference for generic medicines is on the rise, fueling growth of the API market in this region. The API market in Asia Pacific stands at the second position in the geographical hierarchy of the global market, due to the presence of generic medicine producers in large numbers.

The major players in the global API market are Actavis plc, Boehringer Ingelheim Group, BASF SE, Cambrex Corporation, Hospira, Inc., Dr. Reddy's Laboratories Ltd., Lonza Group, Novartis International AG, Mylan, Inc., Pfizer, Inc., WuXi Apptec, and Teva Pharmaceutical Industries Ltd. However, the market consists of more than 2,500 participants, making it highly fragmented in nature. The recent approval of ZarxioTM (first biosimilar in the U.S.) of Sandoz – the generic pharma division of Novartis – is expected to add significantly to overall revenue generated in the global API market.

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