Abstract
Generics, so long the force that has shaken up the branded pharmaceutical industry, is now facing its own challenges as an industry. While growth indications are strong, there are challenges for generic companies. In the next two years, consolidation will most likely rise; the sector is expected to be rocked by increased competition from companies in Eastern Europe, India and China, as well as brand name companies seeking to protect their franchises by moving into generics.
Kalorama Information' s World Market for Prescription Generic Drugs, 6th Edition is your guide to this formidable and important participant in the complex world of healthcare. Included are market size and forecast revnues for:
- Allergy and Respiaratory Drugs
- Analgesics, NAIDS, and Antirheumatic Drugs
- Anesthesia Drugs
- Anti-Infectives
- Cancer Drugs
- Cardiovascular Drugs
- Central Nervous System and Psychotherapeutic Drugs
- Gastrointestinal Drugs
- Ophthalmic Drugs
This report is the result of primary research and secondary research. Interviews with experts in the generic industry form the basis of this report. Research was conducted from available company reports, trade publications and medical and government databases. Interviews with experts are the source of models.
For each drug segment, the report provides:
- Estimated Generic Market Size
- Forecast to 2012
- Recent ANDA Approvals
- World and US Market Share
- Company Profiles
Knowledge of the issues that face the generics industry is essential to understanding the market. The report discusses the following trends:
- Legislative Issues
- Big Pharma Tactics
- Authorized Generics
- Generic Biologics
- Medicaid Generic Drug Reimbursement
- The Elderly
- Confusion in Generic Names
- Broadening Generic Horizons
- International Generic Drug Issues
- Indian Drug Makers
- Industry Consolidation
- New Generic Giants
- Patent Issues
- Generic Companies Increasingly Aggressive
- Patent Reform
- Generic Growth
- Generic Statins
- Cost
- Generics Improve Compliance
- Generic Drug Sampling
Marketing executives, business development managers and brand and generic pharmaceutical companies, consultants and investors are among those who will benefit from this report.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Trends Affecting the Market
- Market Outlook
CHAPTER TWO:INTRODUCTION
- Industry Development
- Generic Drug Industry Evolution
- FDA Regulation
- Development and Approval Process
- Industry Structure
- Product Distribution
- Patent Expirations
CHAPTER THREE: ALLERGY AND RESPIRATORY DRUGS
- Product Categories
- Asthma, Bronchodilators and Corticosteroids
- Inhaled Corticosteroids
- Antiasthmatic Agents
- Bronchodilating Agents
- Antihistamines, Decongestants, and Cough Preparations
- Antihistamines
- Decongestants
- Cough Preparations
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
CHAPTER FOUR: ANALGESICS, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, AND ANTIRHEUMATIC DRUGS
- Product Categories
- Analgesics
- Nonsteroidal Anti-inflammatory Drugs
- Antirheumatics
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
CHAPTER FIVE: ANESTHESIA DRUGS
- Product Categories
- General
- Local
- Regional
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
CHAPTER SIX: ANTI-INFECTIVES
- Product Categories
- Systemic Anti-Infectives
- Topical Anti-Infectives
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market Competitive Analysis
CHAPTER SEVEN: CANCER DRUGS
- Products
- Product News
- Market Size and Forecast
- The World Marke
- The U.S. vs World Market
- Competitive Analysis
CHAPTER EIGHT: CARDIOVASCULAR DRUGS
- Product Categories
- Positive Inotropic Agents
- Antiadrenergics
- Beta-Adrenergic Blocking Agents
- Vasodilators
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Antiarrhythmics
- Antihyperlipidemic Agents
- Anticoagulants
- Diuretics
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs. World Market
- Competitive Analysis
CHAPTER NINE: CENTRAL NERVOUS SYSTEM AND PSYCHOTHERAPEUTIC DRUGS
- Product Categories
- Antidepressants, Stimulants, and Antipsychotics
- Antidepressants
- Stimulants
- Antipsychotics
- Anticonvulsants, Antispasmodics, and Muscle Relaxants
- Anticonvulsants
- Antispasmodics
- Muscle Relaxants
- Parkinson' s Disease, Myasthenia Gravis, and Multiple Sclerosis
- Parkinson' s Disease
- Myasthenia Gravis
- Multiple Sclerosis
- Sedatives, Hypnotics, and Antianxiety Drugs
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs World Market
- Competitive Analysis
CHAPTER TEN: GASTROINTESTINAL DRUGS
- Product Categories
- Antidiarrheals
- Antinauseants
- Antispasmodics
- Antiulcer
- Digestants
- Product News
- Market Size and Forecast
- The World Market
- The U.S. vs the World Market
- Competitive Analysis
CHAPTER ELEVEN: HORMONAL DRUGS
- Product Categories
- Male and Female Hormones
- Bone Metabolism Regulators
- Corticosteroids
- Diabetes Drugs
- Thyroid Drugs
- Product News
- Market Size and Forecast
- The World Market
- U.S. vs World Market
- Competitive Analysis
CHAPTER TWELVE: OPHTHALMIC DRUGS
- Product Categories
- Ophthalmic Anti-Infectives
- Ophthalmic Anti-Inflammatories and Mast Cell Inhibitors
- Glaucoma Agents
- Product News
- Market Size and Forecast
- The World Market
- U.S. vs World Market
- Competitive Analysis
CHAPTER THIRTEEN: WORLD MARKET SUMMARY
- Overview
- Total Market Size and Forecast
- Market and Competitive Analysis
CHAPTER FOURTEEN: ISSUES AND TRENDS
- Understanding Hatch-Waxman and Its Shortfalls
- The FDA, Funding and Review Times
- Big Pharma Tactics-Defensive and Offensive
- Authorized Generics
- Generic Biologics
- Medicaid Generic Drug Reimbursement Issues
- The Elderly
- Confusion in Generic Drug Names
- Broadening Generic Horizons
- International Generic Drug Issues
- Indian Drug Makers
- Industry Consolidation
- New Generic Giants
- Patent Issues: Filings and Challenges
- Generic Companies Increasingly Aggressive
- Patent Reform
- Generic Growth: Prescriptions, Approvals, Impact
- Generic Statins Countdown
- Prescription Drug Costs
- Generics Improve Compliance
- Generic Drug Sampling
CHAPTER FIFTEEN: COMPANY PROFILES
- Industry Structure and Participants
- Actavis Group
- APOTEX, Inc.
- Aurobindo Pharma, Ltd
- Barr Laboratories, Inc.
- Bedford Laboratories
- Dr Reddy' s Laboratories Limited
- Dragon Pharmaceuticals, Inc.
- Hospira Inc.
- Mylan Laboratories, Inc.
- Orchid Chemicals and Pharmaceuticals, Ltd.
- Par Pharmaceuticals, Inc.
- Perrigo Company
- PLIVA Pharmaceuticals, Inc.
- Ranbaxy Laboratories, Ltd.
- Roxane Laboratories, Inc.
- Sandoz
- Taro Pharmaceutical Industries Ltd.
- TEVA Pharmaceutical Industries, Ltd.
- Watson Pharmaceuticals, Inc.
- United Research Laboratories and Mutual Pharmaceutical Company
- Zydus Pharmaceuticals, Inc.
- APPENDIX: COMPANY DIRECTORY
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Figure 1-1: The World Market for Prescription Generic Drugs Revenues by Segment 2002-201
CHAPTER TWO: INTRODUCTION
- Figure 2-1: Abbreviated New Drug Application Review Flow Chart
- Table 2-1: Brand Name Companies with Generic Subsidiaries
- Table 2-2: Number of Best Selling Drugs with Patents Expiring in Years 2006-2012 Grouped by Treatment Category
- Table 2-3: Best Selling Prescription Drugs with Expected Patent Expiration (Year of Expiration, Brand, Manufacturer, Indication, 2007 Revenues) 2006-2012
CHAPTER THREE:ALLERGY AND RESPIRATORY DRUGS
- Table 3-1: Prescription Allergy and Respiratory ANDA Approvals, 2006-2007
- Table 3-2: The World Market for Prescription Generic Allergy and Respiratory Drugs by Type 2002-2012
- Figure 3-1: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues by Type 2002-2012
- Table 3-3: The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Type 2002-2012
- Table 3-4: The World Market for Prescription Generic Allergy and Respiratory Drugs, U.S. Revenues and Share 2002-2012
- Figure 3-2: The World Market for Prescription Generic Allergy and Respiratory Drugs, Displaying U.S. Revenues 2002-2012
- Table 3.5: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues and Market Share by Supplier 2007
- Figure 3-3: The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Leading Supplier 2005
CHAPTER FOUR: ANALGESICS, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, AND ANTIRHEUMATIC DRUGS
- Table 4-1: Prescription Generic Analgesic, NSAID, and Antirheumatic ANDA Approvals, 2005
- Table 4-2: The World Market for Prescription Generic Analgesics, NSAIDs and Antirheumatic Drugs by Type 2002-2012
- Figure 4-1: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Revenues by Type 2002-2012
- Table 4-3: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Market Share by Type 2002-2012
- Table 4-4: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, U.S. Revenues and Share 2002-2012
- Figure 4-2: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Displaying U.S. Revenues 2002-2012
- Table 4-5: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Revenues and Market Share by Supplier 2007
- Figure 4-3: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Market Share by Leading Supplier 2007
CHAPTER FIVE: ANESTHESIA DRUGS
- Table 5-1: Prescription Generic Anesthesia Drug ANDA Approvals, 2006
- Table 5-2: The World Market for Prescription Generic Anesthesia Drugs 2002-2012
- Figure 5-1: The World Market for Prescription Generic Anesthesia Drugs Revenues 2002-2012
- Table 5-3: The World Market for Prescription Generic Anesthesia Drugs, U.S. Revenues and Share 2002-2012
- Figure 5-2: The World Market for Prescription Generic Anesthesia Drugs Displaying U.S. Revenues 2002-2012
- Table 5-4: The World Market for Prescription Generic Anesthesia Drugs, Revenues and Market Share by Supplier 2007
- Figure 5-3: The World Market for Prescription Generic Anesthesia Drugs Market Share by Leading Supplier 2007
CHAPTER SIX: ANTI-INFECTIVES
- Table 6-1: Prescription Generic Anti-infective Drug ANDA Approvals, 2005
- Table 6-2: The World Market for Prescription Generic Anti-Infective Drugs by Type 2002-2012
- Figure 6-1: The World Market for Prescription Generic Anti-Infective Drugs, Revenues by Type 2002-2012
- Table 6-3: The World Market for Prescription Generic Anti-Infective Drugs, Market Share by Type 2002-2012
- Table 6-4: The World Market for Prescription Generic Anti-Infective Drugs U.S. Revenues and Share 2002-2012
- Figure 6-2: The World Market for Prescription Generic Anti-Infective Drugs Displaying U.S. Revenues 2002-2012
- Table 6-5: The World Market for Prescription Generic Anti-Infective Drugs, Revenues and Market Share by Supplier 2007
- Figure 6-3: The World Market for Prescription Generic Anti-Infective Drugs Market Share by Leading Supplier 2007
CHAPTER SEVEN: CANCER DRUGS
- Table 7-1: Prescription Generic Cancer Drug ANDA Approvals 2006-2007
- Table 7-2: The World Market for Prescription Generic Cancer Drugs 2002-2012
- Figure 7-1: The World Market for Prescription Generic Cancer Drugs Revenues 2002-2012
- Table 7-3: The World Market for Prescription Generic Cancer Drugs, U.S. Revenues and Share 2002-2012
- Figure 7-2: The World Market for Prescription Generic Cancer Drugs Displaying U.S. Revenues 2002-2012
- Table 7-4: The World Market for Prescription Generic Cancer Drugs, Revenues and Market Share by Supplier 2007
- Figure 7-3: The World Market for Prescription Generic Cancer Drugs Market Share by Leading Supplier 2007
CHAPTER EIGHT: CARDIOVASCULAR DRUGS
- Table 8-1: Prescription Generic Cardiovascular Drug ANDA Approvals. 2006-2007
- Table 8-2: The World Market for Prescription Generic Cardiovascular Drugs by Type 2002-2012
- Figure 8-1: The World Market for Prescription Generic Cardiovascular Drugs Revenues by Type 2002-2012
- Table 8-3: The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Type 2002-2012
- Figure 8-2: The World Market for Prescription Generic Cardiovascular Drugs, Share by Type 2007 and 2012
- Table 8-4: The World Market for Prescription Generic Cardiovascular Drugs U.S. Revenues and Share 2002-2012
- Figure 8-3: The World Market for Prescription Generic Cardiovascular Drugs Displaying U.S. Revenues 2002-2012
- Table 8-5: The World Market for Prescription Generic Cardiovascular Drugs, Revenues and Market Share by Supplier 2007
- Figure 8-4: The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Leading Supplier 2007
CHAPTER NINE: CENTRAL NERVOUS SYSTEM AND PSYCHOTHERAPEUTIC DRUGS
- Table 9-1: Prescription Generic Central Nervous System/Psychotherapeutic Drug ANDA Approvals 2006-2007 Table 9-2: The World Market for Prescription Generic Central Nervous System Drugs by Type 2002-2012
- Figure 9-1: The World Market for Prescription Generic Central Nervous System Drugs Revenues by Type 2002-2012
- Table 9-3: The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Type 2002-2012
- Table 9-4: The World Market for Prescription Generic Central Nervous System Drugs, U.S. Revenues and Share 2002-2012
- Figure 9-2 : The World Market for Prescription Generic Central Nervous System Drugs Displaying U.S. Revenues 2002-2012
- Table 9-5 : The World Market for Prescription Generic Central Nervous System Drugs, Revenues and Market Share by Supplier 2007
- Figure 9-3 : The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Leading Supplier 2007
CHAPTER TEN: GASTROINTESTINAL DRUGS
- Table 10-1: Prescription Generic Gastrointestinal Drug ANDA Approvals 2006-2007
- Table 10-2: The World Market for Prescription Generic Gastrointestinal Drugs by Type, 2002-2012
- Figure 10-1: The World Market for Prescription Generic Gastrointestinal Drugs Revenues by Type 2002-2012
- Table 10-3: The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Type 2002-2012
- Figure 10-2: The World Market for Prescription Generic Gastrointestinal Drugs, Share by Type 2007 and 2012
- Table 10-4: The World Market for Prescription Generic Gastrointestinal Drugs, U.S. Revenues and Share 2002-2012
- Figure 10-3: The World Market for Prescription Generic Gastrointestinal Drugs, Displaying U.S. Revenues 2002-2012
- Table 10-5: The World Market for Prescription Generic Gastrointestinal Drugs, Revenues and Market Share by Supplier 2007
- Figure 10-4: The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Leading Supplier 2007
CHAPTER ELEVEN: HORMONAL DRUGS
- Table 11-1: Prescription Generic Hormone Drug ANDA Approvals 2006-2007
- Table 11-2: The World Market for Prescription Generic Hormone Drugs by Type 2002-2012
- Figure 11-1: The World Market for Prescription Generic Hormone Drugs Revenues by Type 2002-2012
- Table 11-3: The World Market for Prescription Generic Hormone Drugs, Market Share by Type 2002-2012
- Figure 11-2: The World Market for Prescription Generic Hormone Drugs Share by Type 2007 and 2012
- Table 11-4: The World Market for Prescription Generic Hormone Drugs U.S. Revenues and Share 2002-2012
- Figure 11-3: The World Market for Prescription Generic Hormone Drugs Displaying U.S. Revenues 2002-2012
- Table 11-5: The World Market for Prescription Generic Hormone Drugs, Revenues and Market Share by Supplier 2007
- Figure 11-4: The World Market for Prescription Generic Hormone Drugs Market Share by Leading Supplier 2007
CHAPTER TWELVE: OPHTHALMIC DRUGS
- Table 12-1: Prescription Generic Ophthalmic Drug ANDA Approvals 2006-2007
- Table 12-2: The World Market for Prescription Generic Ophthalmic Drugs by Type 2002-2012
- Figure 12-1: The World Market for Prescription Generic Ophthalmic Drugs Revenues by Type 2002-2012
- Table 12-3: The World Market for Prescription Generic Ophthalmic Drugs, Market Share by Type 2002-2012
- Table 12-4: The World Market for Prescription Generic Ophthalmic Drugs, U.S. Revenues and Share 2002-2012
- Figure 12-2: The World Market for Prescription Generic Ophthalmic Drugs Displaying U.S. Revenues 2002-2012
- Table 12-5: The World Market for Prescription Generic Ophthalmic Drugs, Revenues and Market Share by Supplier 2007
- Figure 12-3: The World Market for Prescription Generic Ophthalmic Drugs Market Share by Leading Supplier 2007
CHAPTER THIRTEEN: WORLD MARKET SUMMARY
- Table 13-1: The World Market for Prescription Generic Drugs Revenues by Segment 2002-2012
- Figure 13-1: The World Market for Prescription Generic Drugs Revenues by Segment 2002-2012
- Figure 13-2: The World Market for Generic Drugs Market Share by Type 2007 and 2012
- Table 13-2: World Market for Prescription Generic Drugs Revenues and Segments of Participation by Leading Player 2007
