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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