Abstract
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 v
- (International Pharmaceutical Excipients Council) Monographs
- Excipient Safety Regulations
- Participating Companies
- Research and Development
- Marketing and Distribution
- Pricing and Reimbursement
- Corporate Strategies/SWOT Analysis
IV. PHARMACEUTICAL EXCIPIENTS: TECHNICAL PERSPECTIVES
- Definition and Applications
- Oral delivery (Tablets, etc)
- Topical delivery (ointments and creams)
- Vaginal and Rectal delivery (suppositories)
- Excipient Formulations
- Tablets and Powders
- Capsules and Gels
- Liquid and Aqueous
- Excipient Drug Dissolution Types and Properties
- Immediate (fast-melt/quick dissolving)
- Time-released (sustained/extended release)
- Excipient Manufacturing Methods/Technologies
- Direct-compression/spray drying
- Freeze-drying
- Direct Granulation (wet/dry)
- Molding
- Sublimation
- Cotton-candy Process
- Major End-Uses
- Tablets/Caplets
- Aspirin
- Acetaminophen
- Ibuprofen
- Anti-acids
- Analgesics
- Vitamins
- Other
- Capsules
- Vitamins
- Anti-oxidants
- Other
- Liquid/Aqueous Preparations
- Cough Medications
- Anti-Acids
- Other
V. ORAL EXCIPIENTS: MARKETS AND PRODUCTS
- Global Excipient Market size, share, growth by segment (2007-2012)
- Fillers
- Emollients
- Vehicles
- Coatings
- Disintegrants
- Flavorants
- Osmotic agents
- Colorants
- Anti-caking Agents
- Magnesium Carbonate
- Mannitol
- Sorbitol
- Silica
- Talc
- Erythritol
- Isomalt
- Maltitol
- Tagatose
- Trehalose
- Xylitol
- Binders and Fillers
- Microcrystalline Cellulose (MCC)
- Hydrolyzed Gelatin
- Alginic Acid
- Dextrin
- Glucose (liquid)
- Lactose
- Sucrose
- Dibasic Calcium Phosphate (DCP)
- Coatings
- Enteric Coatings
- Polymer Coatings (acrylics, etc)
- Cellulosics
- Carbohydrates
- Microcrystalline cellulose
- Other
- Disintegrants
- Starches
- Corn Starch
- Dried Starch
- Modified Starch
- Gelatin
- Pregelatinized Starch
- Modified Cellulose
- Gums
- Guar Gum
- Xanthan Gum
- Polymers
- Acrylic Polymers
- Matrix (controlled-release) Polymers
- Alginates
- Other
- Enzymes
- Pepsin
- Trypsin
- Multifunctional Excipients (Co-processed Adjuvants)
- Synthetic Excipients
- Artificial Sweeteners
- Acesulfame-Potassium
- Aspartame
- Neotame
- Saccharin
- Sucralose
- Povidone
- Mineral Hydrocarbons
- Petrolatum
- Mineral Waxes
- Mineral Oils
- Colorants
- EDTA
- Flavors
- Glycine and Glycylglycine
- Vinyl Polymers
- Silicones
- Miscellaneous Synthetic Petrochemicals
- Oleochemicals
- Fatty Alcohols
- Glycerin
- Metal Stearate
- Others
- Natural Waxes
- Beeswax
- Candelilla Wax
- Carnauba Wax
- Cocoa and Shea Butters
- Lanolin
- Others
- Aroma agents
- Binders
- Buffers
- Chelating agents
- Glidants
- Humectants
- Lubricants
- Plasticizers
- Thickeners
VI. Company Profiles
- BASF Corporation
- Baxter Healthcare Corporation
- Chr Hansen
- Colorcon
- Cargill
- Degussa Corporation Rohm Pharma
- Dow Chemical Company
- Eastman Chemical Company
- FMC Corporation
- Fuji Chemical Industries
- Gattefosse Corporation
- International Specialty Products (ISP)
- JRS Pharma LP
- Mallinckrodt Group, Inc.
- Mutchler, Inc. Pharmaceutical Ingredients
- National Starch & Chemical Company
- Noviant, Inc
- Particle Dynamics
- Purac America
- Pharmaceutical Sourcing Group Americas (Janssen)
- Rhodia, Inc.
- Roquette America, Inc.
- Ruger Chemical Company
- SPI Pharma
- TIC Gums
- Tomita Pharmaceuticals
- Univar Company
- Wright Chemical Company
