The Worldwide Market for Prescription Generic Drugs- 4th Edition

 
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Published Nov 1, 2002 | 308 Pages | Pub ID: KLI769329

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The worldwide prescription generic drug market has evolved into a formidable and important participant in the complex world of healthcare. Generic drug manufacturers are poised for strong growth in the future as patent protection for a host of major pharmaceuticals are due to expire and new legislative reforms in the generic drug approval process may facilitate bringing products to market. Although the generic industry has stagnated since the late 1990s, that could change directly and the outlook for generic promotion is favorable in the next five years.

The landscape of generic companies is changing. Traditionally, generic companies developed a broad range of products that were easily manufactured, low-cost, and undifferentiated in the marketplace. However, a new breed of generic company is emerging, which will likely bring a greater threat to brand manufacturers than ever before. Many generic companies are using increased revenue generated from generic versions of a growing number of top-selling branded drugs to explore new drug targets, including specialty generics, generics with a distinction, generic biologicals, and proprietary molecules. Generic manufacturers have also been able to cross over into the brand name domain by establishing a foothold in specialty therapeutic areas.

This study is designed to provide a comprehensive look at the various strategies being used by generic companies in the marketplace, the issues and trends that are shaping the marketplace, and an individual look at the various markets within the prescription generic industry. This is the fourth time since 1995 that Kalorama Information has investigated the prescription generic market.

Scope and Methodology

For the purposes of this study, the prescription generic drug market was examined at the level of manufacturers’ revenues in each of the following product categories:

  • Allergy and respiratory drugs
  • Analgesic, NSAIDs, and anti-rheumatic drugs
  • Anesthesia
  • Anti-infectives
  • Cancer drugs
  • Cardiovascular drugs
  • CNS drugs
  • Gastrointestinal drugs
  • Hormones
  • Ophthalmic drugs

The information and analysis presented in this report are based on an extensive survey of senior management in the prescription generic drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals. Key information from published literature was used to conduct interviews with over 55 industry executives and product managers to validate and obtain expert opinion on current and future trends in the psychotherapeutic industry. Interviews were also used to confirm and/or adjust market size and market share estimates, as well as in formulating market projections.

Data are expressed in current U.S. dollars. The base year for data was 2001. Historical data are provided for each of the years 1996 through 2000, and forecast data are provided for each of the years 2002 through 2006. Historical, base year, and forecast data are provided for each market segment. Market shares are provided for each market segment for the 2001 base year. Geographically, revenues are reported for the world and then breakdown is given for U.S. and non-U.S. revenue.

Author
Mary Anne Crandall has been publishing market research in the life sciences for more than 10 years. She is a registered nurse and is the founder and CEO of Mountaintop Medical, LLC, a consulting firm in Oregon. She has been teaching at Southern Oregon University for over 12 years, and before joining Kalorama’s analytical team, she published with Frost & Sullivan, Theta Reports, FIND/SVP, MDI, FeedBack Research Services, Prognosis and Hall Enterprises. Ms. Crandall specializes in prescription pharmaceutical markets, with a particular focus on generic drug markets.

Executive Summary
  • Introduction
  • Scope and Methodology
  • Size and Growth of the Market
  • Trends Affecting the Market
  • Market Outlook

Introduction

    Industry Development
    • Generic Drug Industry Evolution
    • FDA Regulation
    • Development and Approval Process

    Industry Structure
    • Product Distribution
    • Patent Expirations

Allergy and Respiratory Drugs

    Product Categories
    • Asthma, Bronchodilators and Corticosteroids
    • Antihistamines, Decongestants, and Cough Preparations

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Analgesics, Nonsteroidal Anti-Inflammatory Drugs, And Antirheumatic Drugs

    Product Categories
    • Analgesics
    • Nonsteroidal Anti-inflammatory Drugs
    • Antirheumatics

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Anesthesia Drugs

    Product Categories
    • Anesthesia Agents

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Anti-Infectives

    Product Categories
    • Systemic Anti-Infectives
    • Topical Anti-Infectives

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Cancer Drugs

    Products

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

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

    • World Market and U.S. Market Analysis

    Competitive Analysis

Central Nervous System and Psychotherapeutic Drugs

    Product Categories
    • Antidepressants, Stimulants, and Antipsychotics
    • Anticonvulsants, Antispasmodics, and Muscle Relaxants
    • Parkinson’s Disease, Myasthenia Gravis, and Multiple Sclerosis
    • Sedatives, Hypnotics, and Antianxiety Drugs

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Gastrointestinal Drugs

    Product Categories
    • Antidiarrheals
    • Antinauseants
    • Antispasmodics
    • Antiulcer
    • Digestants

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Hormonal Drugs

    Product Categories
    • Male and Female Hormones
    • Corticosteroids
    • Diabetes Drugs
    • Thyroid Drugs

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

Ophthalmic Drugs

    Product Categories
    • Ophthalmic Anti-Infectives
    • Ophthalmic Anti-inflammatories and Mast Cell Inhibitors
    • Glaucoma Agents

    Product News

    Market Size and Forecast

    • World Market and U.S. Market Analysis

    Competitive Analysis

World Market Summary

  • Overview
  • Total Market Size and Forecast
  • Market and Competitive Analysis

Issues and Trends

  • Generic Biologics
  • Anticompetitive Agreements
  • Legal and Legislative Issues
  • The Elderly
  • Generic Drug Rebates
  • Direct-to-Consumer Advertising
  • Broadening Generic Horizons
  • Pharmacists Role
  • International Generic Drug Issues
  • Industry Consolidation
  • Cost
  • Patent Issues and Expirations

Competitor Profiles

  • Industry Structure and Participants
  • Abbott Laboratories
  • Akorn, Inc.
  • Andrx Corporation
  • Alpharma, Inc.
  • Barr Laboratories, Inc.
  • Bausch & Lomb, Inc.
  • Bedford Laboratories
  • Bigmar Inc.
  • Dey, Inc.
  • Falcon Pharmaceuticals
  • Geneva Pharmaceuticals, Inc.
  • IVAX Corporation
  • Mylan Laboratories, Inc.
  • Ranbaxy Laboratories, Ltd.
  • Roxane Laboratories, Inc.
  • Sicor, Inc.
  • TEVA Pharmaceutical Industries, Ltd.
  • Watson Pharmaceuticals, Inc.
  • Wyeth/ESI Lederle

Company Directory

  • Industry Participants
  • Related Companies

List of Exhibits

  • Table 1-1: The World Market for Prescription Generic Drugs Revenues by Segment 1996-2006
  • Figure 1-1: The World Market for Prescription Generic Drugs Revenues by Segment 1996-2006
  • Figure 2-1: Abbreviated New Drug Application Review Flow Chart
  • Table 2-1: Brand Name Companies with Generic Subsidiaries
  • Table 2-2: Number of Drugs with Potential Approval in the United States within the Next 5 Years by Therapeutic Category
  • Table 2-3: Number of NDA and Generic Drug Approvals and First Generic Entrant by Year
  • Table 2-4: Number of Drugs with Patents Expiring in Years 2001-2004 Grouped by Treatment Category
  • Table 3-1: Prescription Allergy and Respiratory ANDA Approvals, 2001
  • Table 3-2: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues by Type 1996-2006
  • Figure 3-1: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues by Type 1996-2006
  • Table 3-3: The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Type 1996-2006
  • Table 3-4: The World Market for Prescription Generic Allergy and Respiratory Drugs, U.S. Revenues and Share 1996-2006
  • Figure 3-2: The World Market for Prescription Generic Allergy and Respiratory Drugs, Displaying U.S. Revenues 1996-2006
  • Table 3-5: The World Market for Prescription Generic Allergy and Respiratory Drugs, Revenues and Market Share by Supplier 2001
  • Figure 3-3: The World Market for Prescription Generic Allergy and Respiratory Drugs, Market Share by Leading Supplier 2001
  • Table 4-1: Prescription Generic Analgesic, NSAID, and Antirheumatic ANDA Approvals, 2001
  • Table 4-2: The World Market for Prescription Generic Analgesics, NSAIDs and Antirheumatic Drugs by Type 1996-2006
  • Figure 4-1: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Revenues by Type 1996-2006
  • Table 4-3: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, Market Share by Type 1996-2006
  • Table 4-4: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs, U.S. Revenues and Share 1996-2006
  • Figure 4-2: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Displaying U.S. Revenues 1996-2006
  • Table 4-5: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Revenues and Market Share by Supplier 2001
  • Figure 4-3: The World Market for Prescription Generic Analgesics, NSAIDs, and Antirheumatic Drugs Market Share by Leading Supplier 2001
  • Table 5-1: Prescription Generic Anesthesia Drug ANDA Approvals, 2001
  • Table 5-2: The World Market for Prescription Generic Anesthesia Drugs Revenues 1996-2006
  • Figure 5-1: The World Market for Prescription Generic Anesthesia Drugs Revenues 1996-2006
  • Table 5-3: The World Market for Prescription Generic Anesthesia Drugs, U.S. Revenues and Share 1996-2006
  • Figure 5-2: The World Market for Prescription Generic Anesthesia Drugs Displaying U.S. Revenues 1996-2006
  • Table 5-4: The World Market for Prescription Generic Anesthesia Drugs, Revenues and Market Share by Supplier 2001
  • Figure 5-3: The World Market for Prescription Generic Anesthesia Drugs Market Share by Leading Supplier 2001
  • Table 6-1: Prescription Generic Anti-infective Drug ANDA Approvals, 2001
  • Table 6-2: The World Market for Prescription Generic Anti-Infective Drugs, Revenues by Type 1996-2006
  • Figure 6-1: The World Market for Prescription Generic Anti-Infective Drugs, Revenues by Type 1996-2006
  • Table 6-3: The World Market for Prescription Generic Anti-Infective Drugs, Market Share by Type 1996-2006
  • Table 6-4: The World Market for Prescription Generic Anti-Infective Drugs, U.S. Revenues and Share 1996-2006
  • Figure 6-2: The World Market for Prescription Generic Anti-Infective Drugs Displaying U.S. Revenues 1996-2006
  • Table 6-5: The World Market for Prescription Generic Anti-Infective Drugs, Revenues and Market Share by Supplier 2001
  • Figure 6-3: The World Market for Prescription Generic Anti-Infective Drugs Market Share by Leading Supplier 2001
  • Table 7-1: Prescription Generic Cancer Drug ANDA Approvals 2001
  • Table 7-2: The World Market for Prescription Generic Cancer Drugs Revenues by Type 1996-2006
  • Figure 7-1: The World Market for Prescription Generic Cancer Drugs Revenues by Type 1996-2006
  • Table 7-3: The World Market for Prescription Generic Cancer Drugs, U.S. Revenues and Share 1996-2006
  • Figure 7-2: The World Market for Prescription Generic Cancer Drugs Displaying U.S. Revenues 1996-2006
  • Table 7-4: The World Market for Prescription Generic Cancer Drugs, Revenues and Market Share by Supplier 2001
  • Figure 7-3: The World Market for Prescription Generic Cancer Drugs Market Share by Leading Supplier 2001
  • Table 8-1: Prescription Generic Cardiovascular Drug ANDA Approvals. 2001
  • Table 8-2: The World Market for Prescription Generic Cardiovascular Drugs, Revenues by Type 1996-2006
  • Figure 8-1: The World Market for Prescription Generic Cardiovascular Drugs, Revenues by Type 1996-2006
  • Table 8-3: The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Type 1996-2006
  • Figure 8-2: The World Market for Prescription Generic Cardiovascular Drugs, Share by Type 2001 and 2006
  • Table 8-4: The World Market for Prescription Generic Cardiovascular Drugs, U.S. Revenues and Share 1996-2006
  • Figure 8-3: The World Market for Prescription Generic Cardiovascular Drugs Displaying U.S. Revenues 1996-2006
  • Table 8-5: The World Market for Prescription Generic Cardiovascular Drugs, Revenues and Market Share by Supplier 2001
  • Figure 8-4: The World Market for Prescription Generic Cardiovascular Drugs, Market Share by Leading Supplier 2001
  • Table 9-1: Prescription Generic Central Nervous System/Psychotherapeutic Drug ANDA Approvals 2001
  • Table 9-2: The World Market for Prescription Generic Central Nervous System Drugs, Revenues by Type 1996-2006
  • Figure 9-1: The World Market for Prescription Generic Central Nervous System Drugs, Revenues by Type 1996-2006
  • Table 9-3: The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Type 1996-2006
  • Table 9-4: The World Market for Prescription Generic Central Nervous System Drugs, U.S. Revenues and Share 1996-2006
  • Figure 9-2: The World Market for Prescription Generic Central Nervous System Drugs Displaying U.S. Revenues 1996-2006
  • Table 9-5: The World Market for Prescription Generic Central Nervous System Drugs, Revenues and Market Share by Supplier 2001
  • Figure 9-3: The World Market for Prescription Generic Central Nervous System Drugs, Market Share by Leading Supplier 2001
  • Table 10-1: Prescription Generic Gastrointestinal Drug ANDA Approvals 2001
  • Table 10-2: The World Market for Prescription Generic Gastrointestinal Drugs, Revenues by Type, 1996-2006
  • Figure 10-1: The World Market for Prescription Generic Gastrointestinal Drugs, Revenues by Type 1996-2006
  • Table 10-3: The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Type 1996-2006
  • Figure 10-2: The World Market for Prescription Generic Gastrointestinal Drugs, Share by Type 2001 and 2006
  • Table 10-4: The World Market for Prescription Generic Gastrointestinal Drugs, U.S. Revenues and Share 1996-2006
  • Figure 10-3: The World Market for Prescription Generic Gastrointestinal Drugs, Displaying U.S. Revenues 1996-2006
  • Table 10-5: The World Market for Prescription Generic Gastrointestinal Drugs, Revenues and Market Share by Supplier 2001
  • Figure 10-4: The World Market for Prescription Generic Gastrointestinal Drugs, Market Share by Leading Supplier 2001
  • Table 11-1: Prescription Generic Hormone Drug ANDA Approvals 2001
  • Table 11-2: The World Market for Prescription Generic Hormone Drugs, Revenues by Type 1996-2006
  • Figure 11-1: The World Market for Prescription Generic Hormone Drugs, Revenues by Type 1996-2006
  • Table 11-3: The World Market for Prescription Generic Hormone Drugs, Market Share by Type 1996-2006
  • Figure 11-2: The World Market for Prescription Generic Hormone Drugs, Share by Type 2001 and 2006
  • Table 11-4: The World Market for Prescription Generic Hormone Drugs, U.S. Revenues and Share 1996-2006
  • Figure 11-3: The World Market for Prescription Generic Hormone Drugs Displaying U.S. Revenues 1996-2006
  • Table 11-5: The World Market for Prescription Generic Hormone Drugs, Revenues and Market Share by Supplier 2001
  • Figure 11-4: The World Market for Prescription Generic Hormone Drugs, Market Share by Leading Supplier 2001
  • Table 12-1: Prescription Generic Ophthalmic Drug ANDA Approvals 2001
  • Table 12-2: The World Market for Prescription Generic Ophthalmic Drugs, Revenues by Type 1996-2006
  • Figure 12-1: The World Market for Prescription Generic Ophthalmic Drugs, Revenues by Type 1996-2006
  • Table 12-3: The World Market for Prescription Generic Ophthalmic Drugs, Market Share by Type 1996-2006
  • Table 12-4: The World Market for Prescription Generic Ophthalmic Drugs, U.S. Revenues and Share 1996-2006
  • Figure 12-2: The World Market for Prescription Generic Ophthalmic Drugs Displaying U.S. Revenues 1996-2006
  • Table 12-5: The World Market for Prescription Generic Ophthalmic Drugs, Revenues and Market Share by Supplier 2001
  • Figure 12-3: The World Market for Prescription Generic Ophthalmic Drugs Market Share by Leading Supplier 2001
  • Table 13-1: The World Market for Prescription Generic Drugs, Revenues by Segment 1996-2006
  • Figure 13-1: The World Market for Prescription Generic Drugs, Revenues by Segment 1996-2006
  • Table 13-2: The World for Prescription Generic Drugs, Market Share by Segment 1996-2006
  • Figure 13-2: The World Market for Generic Drugs, Market Share by Type 2001 and 2006
  • Table 13-3: World Market for Prescription Generic Drugs Revenues and Segments of Participation by Leading Market Participants 2001
  • Table 14-1: Selected products losing patent protection 2001-2006

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