Albany, NY -- (SBWIRE) -- 03/26/2015 -- The U.S. Food and Drug Administration describes active pharmaceutical ingredients as substances or mixture of substances that are used in the manufacturing of drugs. Upon production, active pharmaceutical ingredients generally become integral ingredients in these drugs.

The global active pharmaceutical ingredients market is primarily driven by factors such as greater application of raw pharma imports from developing economies, gradual growth in newer medical technologies, strong initiatives taken by regulatory bodies advocating greater application of generic drugs, and expiry of patents of branded drugs.

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Active pharmaceutical ingredients are the main ingredients that have a direct impact on disease diagnosis, its prevention, and even cure. Unlike active pharmaceutical ingredients, excipients refer to substances present in drugs that are essentially inactive and play a neutral role. Active pharmaceutical ingredients are the substances that are suspended in excipients, which are pharmaceutically inert materials. The growth of the active pharmaceutical ingredients market is also fueled by the development of high potency active pharmaceutical ingredient and biogeneric drugs.

WHO Norms - The Basis for Manufacturing Active Pharmaceutical Ingredients

Segmentation of the global active pharmaceutical ingredients market is mainly on the basis of parameters such as synthesis type, technology, end users, and geography. On the basis of synthesis type, the active pharmaceutical ingredients market is classified into biotechnology-based active pharmaceutical ingredients and synthetic active pharmaceutical ingredients. The biotechnology-based active pharmaceutical ingredients segment is further classified into vaccines, monoclonal antibodies, and recombinant proteins. The sub-segments of the synthetic active pharmaceutical ingredients segment are generic and innovative. Active pharmaceutical ingredients prequalification aims at ensuring that the active pharmaceutical ingredients being manufactured are of high quality and conform to Good Manufacturing Practices (GMP) as stated by the World Health Organization.

There are two main components in this prequalification: The assessment of the master file of active pharmaceutical ingredients in order to check the conformity with norms and standards as put forth by the WHO, and manufacturing sites' assessment for validating its conformity with the GMP requirements of the WHO. The active pharmaceutical ingredients prequalification sheds light on issues pertaining to quality control and standard processes of manufacturing. Therefore, each and every prequalified active pharmaceutical ingredients is highlighted in the prequalified active pharmaceutical ingredients list developed by WHO and is also allotted a relevant active pharmaceutical ingredients master file number.

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Entry of New Market Players a Glaring Threat in the Global Active Pharmaceutical Ingredients Market

Geographically, the global active pharmaceutical ingredients market is categorized into Europe, North America, Asia Pacific, and Rest of the World. In terms of manufacturing, the U.K. is the main hub of the global active pharmaceutical ingredients market. Presently, several European economies such as Germany, the U.K., and France are promoting greater use of generics to doctors via incentives so that they write prescriptions that relate to generic drugs. Incentives are offered even to pharmacists so that they start offering the generic equivalents of the drugs that are mostly prescribed. As a result, it is anticipated that the generic active pharmaceutical ingredients market will witness higher growth rate as against the innovative active pharmaceutical ingredients market.

The largest share in the global active pharmaceutical ingredients market is held by North America, with Europe following suit. However, it is the Asia Pacific active pharmaceutical ingredients market that is forecast to witness highest growth rate from 2013 to 2019.

Some of the prominent business expansion strategies that are being observed in the global active pharmaceutical ingredients market are business collaborations and mergers. A major threat being witnessed by existing medium and small vendors in the overall active pharmaceutical ingredients market is the entry of new market players. This leads to stiff competition in the global market for active pharmaceutical ingredients. The main market restraints are declining expenditure on research and development and greater market fragmentation.

F. Hoffmann-La Roche Ltd., Pfizer, Inc., Novartis AG, AstraZeneca plc, and GlaxoSmithKline Pharmaceuticals Limited are few of the prominent companies in the global active pharmaceutical ingredients market.

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