Albany, NY -- (SBWire) -- 12/19/2014 --According to a definition stated by the U.S. FDA, Active Pharmaceutical Ingredient (API) is referred to as any substance or a mixture of substances which are used in manufacturing of a drug and tends to become an active ingredient of the drug upon its production. These ingredients also refer to the central or prime ingredient in the product which affects disease diagnosis, prevention and cure. Excipients are the inactive substances present in the drug as compared to APIs. APIs are suspended in the pharmaceutically inert substance or the exciepients. Manufacturing activities of these substances are carried out in several locations across the globe, the United Kingdom being the significant location.
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API prequalification ensures that the API manufactured is of good quality and in accordance with the WHO stated Good Manufacturing Practices (GMP). This prequalification consists of two components, assessment of the sites of manufacturing to validate its compliance with WHO GMP requirements and assessment of API master file (APIMF) for its conformity with the standards and norms stated by WHO. The prequalification of API gives insights about the standard manufacturing processes and quality control issues. Henceforth, for each prequalified API, its relevant APIMF number is allotted and is included in the WHO's prequalified APIs list.
Global API market is expected to witness enormous growth prospects due to consistent rise in biotechnology and generic sectors. The market for APIs can be segmented by type of the synthesis, end users, technology and geography. The different types of synthesis adopted can be further categorized into synthetic and biotechnology based APIs. The major factors influencing the growth of the market are consistent growth in new medical technologies, patent expirations of branded drugs in near future, rigorous initiatives by regulatory authorities promoting the use of generic drugs and increased use of imported raw pharma ingredients from emerging economies. Increased market fragmentation and reduction in the overall research and development expenses are some of the factors which might hamper the growth of the market. Some of the major market players competing in API market are GlaxoSmithKline Pharmaceuticals Limited, AstraZeneca plc, Novartis AG, Pfizer, Inc. and F. Hoffmann-La Roche Ltd.
This research report analyzes this market depending on its market segments, major geographies, and current market trends.
- North America
- Asia Pacific
- Europe
- Rest of the World
This report provides comprehensive analysis of
- Market growth drivers
- Factors limiting market growth
- Current market trends
- Market structure
- Market projections for upcoming years
This report is a complete study of current trends in the market, industry growth drivers, and restraints. It provides market projections for the coming years. It includes analysis of recent developments in technology, Porter's five force model analysis and detailed profiles of top industry players. The report also includes a review of micro and macro factors essential for the existing market players and new entrants along with detailed value chain analysis.
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Active Pharmaceutical Ingredients (APIs) Market - Global Industry Segment, Trends and Forecast Up to 2019
Transparency Market Research (http://www.transparencymarketresearch.com) includes new market research report "Active Pharmaceutical Ingredients (APIs) Market" to its huge collection of research reports.