Active pharmaceutical ingredients (APIs) are also referred as ‘bulk pharmaceuticals’ and they are the base of the pharmaceutical industry. APIs are used in the manufacture of various pharmaceutical and drug products, intended to yield the desired pharmacological effect. APIs are produced through various processes such as chemical synthesis, fermentation process, isolation etc. Active pharmaceutical ingredient contract manufacturing market is one of the fastest growing markets of the pharmaceutical industry. Owing to the increasing number of contract manufacturing organizations (CMOs), the process of active pharmaceutical ingredient manufacturing is now being outsourced in order to reduce cost and increase product quality. Most of the pharmaceutical companies are increasingly concentrating on R&D and marketing activities, and therefore shifting their focus from non-core activities to the above core activities. The API contract manufacturing market is segmented as follows:
By state of matter:
By API content:
- Organic substances, isolated from animal origin
- Organic substances, isolated from microorganisms
- Inorganic substances
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Major driving factors for the growth of the API contract manufacturing market are reduced investment costs due to the availability of cheap labor in emerging Asia economies, easier access to gain new technology in the market, and better utilization of resources in such regions. Other factors such as increasing need to focus on core activities, increasing need to fasten the drug development process and considerable reduction in time-to-market will further provide growth opportunities towards this market.
Geographically, North America dominates the API contract manufacturing market, as the U.S. constitutes 45% of the world’s market share. The prime driving factors responsible for the growth of API contract manufacturing market are rapid technological innovations which are spurring the production of novel APIs, increasing demand for new bio-generic drugs and reduced cost of production of APIs. Asia-Pacific is also emerging as one of the fastest developing regions and is the most lucrative regional market for API contract manufacturing. Due to the higher costs associated with production of APIs in western countries, India and China have become the two most preferred regions for contract manufacturing outsourcing.
The major factors responsible for the growth of this market in the region are easy availability of required skilled labor at an effective cost, favorable government policies, tax benefits, better trade relationships, and this region constitutes some of the stable democracies, which is endowed with advanced technologies. Also, as several international pharmaceutical companies are gradually outsourcing API manufacture to Asia-Pacific region; this makes it an experienced market with regards to outsourcing and contracting as compared to other less experienced countries. Asia-Pacific has the largest manpower in technology and it is gaining advancement corresponding to technological development, which will in turn boost the growth of this market.
According to Boehringer Ingelheim GmbH, countries such as India and China, which now supply over 40% of APIs used in the U.S., will double that figure to a whopping 80% within the next 10 years. Some of the major players operating in the API contract manufacturing market Teva Pharmaceuticals Industries Ltd, Boehringer Ingelhein GmbH, Piramal Pharma Solutions, Dr. Reddy’s Laboratories Ltd, Sandoz-Lek-Biochemie, Novartis International AG, Ranbaxy Laboratories Ltd., Sun Pharmaceutical Industries Ltd., Merck & Co., Inc., AstraZeneca, GlaxoSmithKline Pharmaceuticals Ltd. and others.