Pharmaceutical excipients are substances, other than the pharmacologically active drug or prodrug, which are included in the manufacturing process or are contained in the finished pharmaceutical product dosage form. Excipients provide enhanced functionality to the pharmaceuticals, aid the innovations in the drug development and help improve patent life as well. Excipients make the products more functional at a lower cost, a benefit much desired by the pharmaceutical industry that is inundated with pressures to reduce costs.
All in all, excipients play a wide variety of functional roles in pharmaceutical dosage forms, including:
Modulating the solubility and bioavailability of active pharmaceutical ingredients (APIs).
Increasing the stability of active ingredients in dosage forms.
Helping active ingredients maintain preferred polymorphic forms or conformations.
Maintaining the pH and/or osmolarity of liquid formulations.
Acting as antioxidants, emulsifying agents, aerosol propellants, tablet binders, and tablet disintegrants.
Preventing aggregation or dissociation (e.g., of protein and polysaccharide actives).
Modulating immunogenic responses of active ingredients (e.g., adjuvants).
Excipient market comprises of five key segments including binders/fillers, coating agents, disintegrants, lubricants, sweeteners.
This report will address all the current trends in the sector that are reshaping the industry and making it more efficient from profitability perspective. This report will provide a comprehensive overview of the fine chemical/excipient industry, the pharmaceutical formulators industry, and the pharmaceutical finished drug industry. Based on the information, analysis provided in this report, the managers will be able to estimate the market size, forecasts, and prepare their development plans, budgets, and plan marketing, competitive strategies to improve their market power in the segments of their interest. As such, this report will be of particular interest and value to business, i.e. marketing managers, product managers, strategic planners, technical personnel, and R & D personnel.
Table of Contents
I. INTRODUCTION
Study Rationale
Study Goals
Scope and Structure
Methodology
Target Audience
II. PHARMACEUTICAL EXCIPIENTS: EXECUTIVE SUMMARY
Global Excipient Market: Background
Market Size and growth
Future market trends
Leading Players
Industry Structure, Margins and business models
Future prospects
III. PHARMACEUTICAL EXCIPIENTS: INDUSTRY OVERVIEW
Industry Overview
The Pharmaceutical Industry
The Chemical/Excipient Industry
Industry Trends
Issues
Challenges
Constraints
Trends (especially outsourcing and offshore manufacturing)
Business Opportunities
Excipient Regulations
CGMP Practices
FDA/CDER (Center for Drug Evaluation and Research) Regulations, USP (U.S. Pharmacopoeia) and IPEC (International Pharmaceutical Excipients Council) Monographs
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