全球針對主要疾病的固定量複合劑（FDC：Fixed Dose Combination）市場

Abstract

INTRODUCTION

OBJECTIVES AND GOALS OF STUDY

The aim of this report is to provide a range of information-from detailed market analyses through industry trends-to quantify and qualify the market for fixed-dose combination drugs for the treatment of selected major diseases. Forecasts and trends are gleaned from industry sources as well as from considered assessment of available and emerging technologies. The report develops forecasts for selected disease categories of the fixed-dose combination drug market from 2005 through 2012 and examines strategies employed by biotechnology companies and pharmaceutical firms to develop and market products in this market sector.

CONTRIBUTION OF THE STUDY AND FOR WHOM

Fixed-dose combination drugs have been used for some time in certain therapeutic categories such as antihypertensives, although they were often reserved for second- or third-line therapy. With the revolution in the survival rates of patients suffering from human immunodeficiency virus (HIV) infection that occurred with the implementation of fixed-drug combination products for this, this delivery technology received a boost of confidence as well as an influx of creative applications to other diseases. For the past several years, a number of fixed-dose combination drugs have been introduced for a variety of diseases, some for the first time in a particular disease category. This report discusses the impact of fixed-dose combination drug technology on these various therapeutic categories, as well as providing assessments and projections of this technology overall.

The information and analysis presented in this report on fixed-dose combination products are important assets in decision-making for managers involved in business development, marketing, market research, product development, mergers and acquisitions, licensing, business management, investment banking and deal creation, and to consultants to the pharmaceutical and biotechnology industry. The study provides a comprehensive analysis of the current markets for fixed-dose combination products and the market potential of promising drugs under development.

STUDY SCOPE AND FORMAT

This report analyzes products and applications of fixed-dose combination drugs utilized in the treatment of cardiovascular diseases (hypercholesterolemia and hypertension), diabetes, infectious diseases (bacterial infections, Helicobacter pylori, acquired immune deficiency syndrome-AIDS, HIV infection and tuberculosis), psychiatric disorders (depression and Alzheimer' s disease) and respiratory diseases (asthma and chronic obstructive pulmonary disease-COPD).

Not included in this report are combination products used as oral contraceptives, combinations of a drug (such as a monoclonal antibody) and a radioactive component, or combination vaccine products. Also not included are over-the-counter (OTC) and prescription nonsystemic fixed-dose combination products.

The scope of the study is worldwide. The Overview section provides a discussion of the history and advantages of fixed-dose combination drug products. Also described are the leading diseases for which fixed-dose combination products are available or are projected to be introduced during the forecast period. This section also discusses the various types of products available or in development within the categories included in this report.

The Products and Applications section provides synopses of more than 70 fixed-dose combination drug products, including those currently marketed and those in Phase II or later development. Comparative product and sales analyses are provided for individual products. Tables include current and forecasted sales by individual product, when possible, as well as worldwide market size and growth estimates for fixed-dose combination drug categories as a whole.

The section on Industry Structure provides an overview of strategies employed by Big Pharma in this decade of a high number of top-selling drug patent expirations, how this phenomenon relates to the overall pharmaceutical industry and biotechnology companies and, in particular, the role of fixed-dose combination drugs in the increasingly competitive pharmaceutical industry.

The section on Company Profiles emphasizes companies that lead the pharmaceutical and biotechnology industry in the research and development of fixed-dose combination drugs and the innovative products they have launched or have in development.

Table of Contents

• INTRODUCTION
  • OBJECTIVES AND GOALS OF STUDY
  • CONTRIBUTION OF THE STUDY AND FOR WHOM
  • STUDY SCOPE AND FORMAT
  • METHODOLOGY
  • INFORMATION SOURCES
  • OTHER MARKET RESEARCH REPORTS RECENTLY PUBLISHED BY THE AUTHOR
• EXECUTIVE SUMMARY
• OVERVIEW
  • DEFINITION OF A COMBINATION DRUG
  • ADVANTAGES OF FIXED-DOSE COMBINATION DRUGS
  • POTENTIATION AND CANCELLATION
  • DECREASED DOSING MEANS BETTER COMPLIANCE AND LOWER ADMINISTRATIVE COSTS
  • COMBINATION DRUGS TARGETING INFECTIOUS AGENTS RATHER THAN BODY TISSUES
  • THE DISADVANTAGES OF FIXED-DOSE COMBINATION DRUGS
  • REGULATIONS RELATING TO FIXED-DOSE COMBINATION DRUGS
  • INCENTIVES AND BARRIERS TO THE DEVELOPMENT OF FIXED-DOSE COMBINATION DRUGS
  • MARKET-RELATED ADVANTAGES OF FIXED-DOSE COMBINATION DRUGS
  • THE CHALLENGES OF MANUFACTURING FIXED-DOSE COMBINATION DRUGS
  • LEGAL/INTELLECTUAL PROPERTY ISSUES RELATING TO FIXED-DOSE COMBINATION PRODUCTS
• PRODUCTS AND APPLICATIONS
  • CARDIOVASCULAR DISEASES
  • INFECTIOUS DISEASES
  • PSYCHIATRIC DISEASES
  • CARDIOVASCULAR DISEASES
    • HYPERTENSION
      • Prevalence of Hypertension Worldwide
      • Improved Control of Hypertension Needed
      • The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure
      • The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure
      • Leading Single-Compound Antihypertensive Agents
      • Fixed-Dose Combination Antihypertensive Drugs
      • Drug Categories Commonly Used in Fixed-Dose Combination Antihypertensive Drugs
        • Angiotensin-Converting Enzyme Inhibitors
        • Angiotensin II Receptor Blockers
        • Beta Blockers
        • Calcium Channel Blockers
        • Diuretics
      • The Market for Fixed-Dose Combination Antihypertensive Products
      • Fixed-Dose Combination Drug Products in Phase II or Later Development for the Treatment of Hypertension
        • Daiichi Sankyo Files NDA with FDA for New Fixed-Dose Combination Antihypertensive Drug
        • Toprol-XL/HCTZ
    • HYPERCHOLESTEROLEMIA
      • Relationship of Cholesterol to Cardiovascular Disease
      • Fixed-Dose Combination Lipid-Lowering Drugs
      • Marketed Statin Drugs
      • The First Fixed-Dose Combination Product to Treat Hypercholesterolemia Introduced
      • The Market for Fixed-Dose Combination Drugs to Treat Hypercholesterolemia
      • A Potential Blockbuster Fails Late-Stage Trials
      • Another Statin Fixed-Dose Combination Product Hits a Snag
      • Products in Development
        • Combination of Crestor and TriCor for the Treatment of Hypercholesterolemia
        • Simcor
        • Three-Drug "Polypill" in Development
  • DIABETES
    • FIXED-DOSE COMBINATION DRUGS FOR DIABETES INTRODUCED
      • Avandamet
      • Glucovance
      • Metaglip
    • THREE NEW FIXED-DOSE COMBINATION PRODUCTS INTRODUCED IN 2005 AND 2006
    • THE MARKET FOR FIXED-DOSE COMBINATION DRUGS TO TREAT DIABETES
    • FIXED-DOSE COMBINATION DRUGS IN DEVELOPMENT
  • INFECTIOUS DISEASES
    • LEADING FIXED-DOSE COMBINATION ANTIBIOTIC DRUGS
      • Augmentin
      • Bactrim
      • Primaxin
      • Synercid
      • Zosyn
    • THE MARKET FOR FIXED-DOSE COMBINATION DRUGS TO TREAT BACTERIAL INFECTIONS
    • HELICOBACTER PYLORI INFECTION
      • Fixed-Dose Combination Therapy for the Treatment of Helicobacter Pylori Infections/Duodenal Ulcers
        • OD-PEP
        • Pylera
      • The Market for Fixed-Dose Combination Drugs to Treat H. Pylori Infections
    • HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)
      • HIV and AIDS Statistics
      • HIV Infection and AIDS Cases in the U.S.
      • Treatments for HIV Infection/AIDS
      • Categories of Drugs Used in Fixed-Dose Combination Products for the Treatment of HIV/AIDS
        • Transcriptase Inhibitors
          • Nonnucleoside Reverse Transcriptase Inhibitors
          • Nucleoside Reverse Transcriptase Inhibitors
          • Nucleotide Reverse Transcriptase Inhibitors
          • Protease Inhibitors
      • Side Effects of Marketed HIV Drugs
      • HIV/AIDS Drugs Introduced to the U.S. Market from 2003 through 2006
      • Leading Marketers of HIV/AIDS Drugs
        • Leaders in the Nucleoside Reverse Transcriptase Inhibitor Class
      • Dosing and Compliance Challenges
      • The Ideal Dosing Regimen and the Role of Fixed-Dose Combination Products
      • The Number of Salvage Patients Continues to Increase
      • Fixed-Dose Combination Drugs to Treat HIV/AIDS
        • Combination Products Emerge as Preferred Treatment
        • Atripla
        • Combivir
        • Epzicom
        • Kaletra
        • Trizivir
        • Truvada
        • FDA Approves Aurobindo Three-in-One Fixed-Dose Combination Drug for AIDS Relief Program
      • The Market for Fixed-Dose Combination Drugs for the Treatment of HIV Infection/AIDS
      • Fixed-Dose Combination Drugs in Phase II Development for the Treatment and/or Prevention of HIV Infection/AIDS
    • TUBERCULOSIS
      • Fixed-Dose Combination Drugs Used to Treat Tuberculosis
  • PSYCHIATRIC DISORDERS
    • DEPRESSION
      • Recently Introduced Fixed-Dose Combination Products for the Treatment of Depression
    • THE MARKET FOR FIXED-DOSE COMBINATION PRODUCTS TO TREAT PSYCHIATRIC DISORDERS
    • FIXED-DOSE COMBINATION PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF PSYCHIATRIC DISORDERS
      • 372475
      • 773812
      • Contrave
      • Excalia
      • Symbyax
    • FIXED-DOSE COMBINATION PRODUCTS FOR THE TREATMENT OF ALZHEIMER' S DISEASE
  • RESPIRATORY DISEASES
    • ASTHMA
    • CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    • CURRENTLY MARKETED PRODUCTS FOR THE TREATMENT OF ASTHMA
      • Anti-Inflammatory Drugs Used to Treat Asthma
        • Corticosteroids
        • Leukotriene Modifiers
        • IgE Inhibitors
        • Phosphodiesterase Inhibitors
        • Mast-Cell Inhibitors
      • Efficacy of Available Drugs
      • Fixed-Dose Combination Asthma Treatments
        • Advair/Seretide
        • Foster
        • Symbicort
    • THE MARKET FOR DRUGS TO TREAT ASTHMA AND COPD
      • The Market for Drugs to Treat Asthma
      • The Market Drugs to Treat COPD
      • The Market For Fixed-Dose Combination Drugs To Treat Asthma/COPD
    • FIXED-DOSE COMBINATION PRODUCTS IN PHASE II OR LATER DEVELOPMENT TO TREAT ASTHMA AND COPD
      • Alvesco Combo
      • Flutiform
      • Mometasone/Formoterol
      • Super Advair
      • VR315
  • INDUSTRY
    • THE NUMBER OF BLOCKBUSTER DRUGS ON THE WORLDWIDE PHARMACEUTICAL MARKET APPROACHES 100
    • U.S. PHARMACEUTICAL INDUSTRY GROWTH EXPECTED TO INCREASE SLIGHTLY
    • MORE MERGERS, ACQUISITIONS AND LICENSING
    • POTENTIAL FIXED-DOSE COMBINATION DRUGS LEAD THE MARKET
    • LEADING MANUFACTURERS IN THE FIXED-DOSE COMBINATION DRUG MARKET
  • COMPANY PROFILES

LIST OF TABLES

• SUMMARY: FIXED-DOSE COMBINATION THERAPEUTICS, MARKET SHARE BY CATEGORY: 2006 AND 2012
• 1. SELECTED BRAND-NAME FIXED-DOSE COMBINATION PRODUCTS, BY THERAPEUTIC CATEGORY
• 2. THE MARKET FOR FIXED-DOSE COMBINATION THERAPEUTICS, BY CATEGORY: WORLDWIDE SALES: 2005-2012
• 3. EFFECTS OF ANTIHYPERTENSIVE AGENTS ON SELECTED CORONARY RISK FACTORS
• 4. CLASSIFICATION OF BLOOD PRESSURE FOR ADULTS AGED 18 YEARS AND OLDER
• 5. BRAND-NAME FIXED-DOSE COMBINATION ANTIHYPERTENSIVE DRUGS: WORLDWIDE MARKET, 2005, 2006, 2007 AND 2012
• 6. STATIN DRUGS AVAILABLE GLOBALLY AND THEIR GENERIC AVAILABILITY IN THE U.S.
• 7. BRAND-NAME FIXED-DOSE COMBINATION DRUGS TO TREAT HYPERCHOLESTEROLEMIA, BY PRODUCT: WORLDWIDE SALES, 2005, 2006, 2007 AND 2012
• 8. BRAND-NAME FIXED-DOSE COMBINATION DRUGS TO TREAT DIABETES: WORLDWIDE SALES, 2005, 2006, 2007 AND 2012
• 9. SELECTED FIXED-DOSE COMBINATION DRUGS TO TREAT INFECTIOUS BACTERIAL DISEASES, BY PRODUCT: WORLDWIDE SALES, 2005, 2006, 2007 AND 2012
• 10. BRAND-NAME FIXED-DOSE COMBINATION DRUGS TO TREAT H. PYLORI INFECTIONS: WORLDWIDE SALES, 2005, 2006, 2007 & 2012
• 11. ESTIMATED NUMBER OF PERSONS INFECTED WITH HIV/LIVING WITH AIDS, ADULTS AND CHILDREN, BY GEOGRAPHIC REGION: 2005
• 12. PERCENT OF GLOBAL HIV CASES BY GEOGRAPHIC REGION: 2005
• 13. ESTIMATED NUMBER OF PEOPLE NEWLY INFECTED WITH HIV, ADULTS AND CHILDREN, BY GEOGRAPHIC REGION: 2005
• 14. ESTIMATED NUMBER OF DEATHS FROM AIDS, ADULTS AND CHILDREN, BY GEOGRAPHIC REGION: 2005
• 15. ESTIMATED NUMBER OF PEOPLE INFECTED WITH HIV IN SELECTED COUNTRIES: 2002 AND 2010
• 16. NUMBER OF DEATHS FROM AIDS IN THE U.S., 1987-2005
• 17. PRODUCT INTRODUCTIONS FOR THE TREATMENT OF HIV INFECTION, U.S.: 2002-2005
• 18. DAILY DOSAGE REQUIREMENTS FOR SELECTED HIV/AIDS THERAPIES
• 19. RELATIONSHIP BETWEEN COMPLIANCE AND DOSING FREQUENCY
• 20. FDA-APPROVED FIXED DOSE COMBINATION DRUGS FOR THE TREATMENT OF HIV INFECTION/AIDS
• 21. BRAND-NAME FIXED-DOSE HIV/AIDS THERAPEUTICS: WORLDWIDE SALES, BY PRODUCT: 2005-2012
• 22. HIV/AIDS THERAPEUTICS BY PRODUCT CATEGORY: WORLDWIDE SALES, 2005-2012
• 23. FIRST-LINE FIXED-DOSE COMBINATION DRUGS FOR THE TREATMENT OF TUBERCULOSIS
• 24. BRAND-NAME FIXED-DOSE PSYCHIATRIC THERAPEUTICS: WORLDWIDE SALES: 2005-2012
• 25. DRUG COMBINATIONS STUDIED IN THE TREATMENT OF ALZHEIMER' S DISEASE
• 26. ASTHMA DRUG CATEGORIES AND SELECTED PRODUCTS
• 27. SELECTED BRANDED ANTI-INFLAMMATORY AND BRONCHODILATING DRUGS USED TO TREAT ASTHMA
• 28. DRUGS USED TO TREAT ASTHMA, BY CATEGORY: WORLDWIDE SALES, 2005, 2006, 2007 AND 2012
• 29. DRUGS USED TO TREAT COPD, BY CATEGORY, 2005, 2006, 2007 AND 2012
• 30. BRAND-NAME FIXED-DOSE COMBINATION DRUGS TO TREAT ASTHMA/COPD, BY PRODUCT: WORLDWIDE SALES, 2005, 2006, 2007 AND 2012
• 31. FIXED-DOSE COMBINATION PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF ASTHMA AND/OR COPD

LIST OF FIGURES

• SUMMARY FIGURES
• 1. MARKET SHARE FOR DRUGS TO TREAT ASTHMA, BY CATEGORY OF DRUG, WORLDWIDE, 2006 AND 2012
• 2. MARKET SHARE FOR DRUGS TO TREAT COPD, BY CATEGORY OF DRUG, WORLDWIDE, 2006 AND 2012