A pharmaceutical excipient, also referred as bulking agent, filler, or diluent, is a natural or synthetic substance formulated with the active ingredient of a medication, included in a pharmaceutical dosage form to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability. They are also helpful in product identification and enhance the overall safety or functionality of the product during storage or use.
Thousands of different excipients are used in medicines and make up, on average, about 90% of each product. They represent a market value accounting about 0.5% of the total pharmaceutical market according to industry experts.The growth of the global market of pharmaceutical excipients is driven by the factors such as growing demand of functional excipients, increasing demand of generics, and emergence of new excipients in the market.
Excipients can be classified into 7 categories on the basis of the kind of function they perform: diluents, binders, disintegrants, glidants, lubricants, tablet coating & films and coloring agents.Diluents, which include sugar compounds such as lactose, dextrin, glucose, sucrose, sorbitol etc., and inorganic compounds such as silicates, salts of calcium & magnesium, sodium chloride etc., are used for providing bulk and enables accurate dosing of potent ingredients.
Binders are mainly natural or synthetic polymers such as starch, sugar alcohols and cellulose derivatives which are used to bind the tablet ingredients together to give form and mechanical strength.Disintegrants aids dispersion of the tablets in the gastrointestinal tract, releasing the active ingredient along with increasing the surface area for dissolution.
Glidants like colloidal anhydrous silicon, are used in reducing the friction and adhesion between particles and improves the flow of powders during tablet manufacturing. Coloring agents are mainly synthetic dyes used to improve patient acceptability, aid identification and prevent counterfeiting.
Global market of pharmaceutical excipients is sub-segmented into 7 key regions- North America, Latin America, East Europe, West Europe, Asia Pacific excluding japan and Middle East & Africa. Developed regions like North America and Europe are expected to experience a slow growth, due to already established excipients market, during the forecast period while the emerging market like Asia-Pacific is expected to record a strong growth during the same period owing to the availability of cheap labor, skills in abundance and comparatively lower cost of the raw materials. Countries like Brazil, India, and China are expected to be the major contributors in the growth of these emerging markets mainly due to the rising per capita income and increase in the number of companies from the developed regions willing to outsource their excipients manufacturing activities due to low manufacturing and labor costs in these regions.
The global pharmaceutical excipients market is expected to grow at a healthy CAGR during the forecast period due to increasing utilization of parenteral products owing to rise in the global burden of chronic and lifestyle diseases and heavy investments by the pharmaceutical industry on the development of biologics. Additionally, Adoption of modern science like nanotechnology to impart innovative functions to the excipients used for target specific functionality of the active ingredients, resulting in reduced drug toxicity, a major challenge faced by the pharmaceutical industry, is also propelling the global market during the forecast period. The product demand is increasing in the emerging markets like Asia-Pacific and Latin America, therefore proper expansion planning, focus on various R&D and innovations to launch new products would be a great opportunity. The growth of the market is hampered to a certain extent by the factors like declining investments in R&D by excipients producers, and increasing regulatory requirements leading to scarcity of U.S. FDA approved manufacturing sites.
Major players in the global market of pharmaceutical excipients are BASF (Germany) and Ashland, Inc. (U.S.) which dominate the market share with their diversified product portfolio and aggressive sales strategies. Some other key players include Avantor Performance Materials, Inc. (U.S.), The Dow Chemical Company (U.S.), FMC Corporation (U.S.), Evonik Industries (Germany), Lubrizol Corporation (U.S.), Roquette (France) and Colorcon, Inc. (U.S.)
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