The Global Market for Fixed-Dose Combination Drugs for Leading Diseases

  • ID: 604497
  • Report
  • Region: Global
  • 116 Pages
  • STIX Market Research
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FEATURED COMPANIES

  • Abbott Laboratories
  • Axcan Pharma, Inc.
  • Gilead Sciences Inc.
  • Horizon Therapeutics
  • Merck & Company, Inc.
  • Pfizer Corporation
  • MORE
“The Global Market for Fixed-Dose Combination Drugs for Leading Diseases” 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 non-systemic fixed-dose combination products.

The scope of this report is worldwide. The Overview section provides a discussion of the history and advantages of fixed-dose combination drug products. 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 a synopsis 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 a discussion of strategies employed by big pharmaceutical companies in this decade for 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.

The information and analysis presented in “The Global Market for Fixed-Dose Combination Drugs for Leading Diseases” 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.
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FEATURED COMPANIES

  • Abbott Laboratories
  • Axcan Pharma, Inc.
  • Gilead Sciences Inc.
  • Horizon Therapeutics
  • Merck & Company, Inc.
  • Pfizer Corporation
  • MORE
INTRODUCTION 1

OBJECTIVES AND GOALS OF STUDY 1

CONTRIBUTION OF THE STUDY AND FOR WHOM 1

STUDY SCOPE AND FORMAT 1

METHODOLOGY 2

INFORMATION SOURCES 2

OTHER MARKET RESEARCH REPORTS RECENTLY PUBLISHED BY THE AUTHOR 3

EXECUTIVE SUMMARY 4

OVERVIEW 6

DEFINITION OF A COMBINATION DRUG 6

ADVANTAGES OF FIXED-DOSE COMBINATION DRUGS 6

POTENTIATION AND CANCELLATION 7

DECREASED DOSING MEANS BETTER COMPLIANCE AND LOWER ADMINISTRATIVE COSTS 7

COMBINATION DRUGS TARGETING INFECTIOUS AGENTS RATHER THAN BODY TISSUES 8

THE DISADVANTAGES OF FIXED-DOSE COMBINATION DRUGS 9

REGULATIONS RELATING TO FIXED-DOSE COMBINATION DRUGS 10

INCENTIVES AND BARRIERS TO THE DEVELOPMENT OF FIXED-DOSE COMBINATION DRUGS 11

MARKET-RELATED ADVANTAGES OF FIXED-DOSE

COMBINATION DRUGS 11

THE CHALLENGES OF MANUFACTURING FIXED-DOSE COMBINATION DRUGS 11

LEGAL/INTELLECTUAL PROPERTY ISSUES RELATING TO FIXED-DOSE COMBINATION PRODUCTS 13

PRODUCTS AND APPLICATIONS 15

CARDIOVASCULAR DISEASES 15

INFECTIOUS DISEASES 17

PSYCHIATRIC DISEASES 19

CARDIOVASCULAR DISEASES 20

HYPERTENSION 21
Prevalence of Hypertension Worldwide 21
Improved Control of Hypertension Needed 22
The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure 23
The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure 25
Leading Single-Compound Antihypertensive Agents 26
Fixed-Dose Combination Antihypertensive Drugs 26
Drug Categories Commonly Used in Fixed-Dose
Combination Antihypertensive Drugs 27
Angiotensin-Converting Enzyme Inhibitors 28
Angiotensin II Receptor Blockers 28
Beta Blockers 29
Calcium Channel Blockers 29
Diuretics 30
The Market for Fixed-Dose Combination Antihypertensive Products 30
Fixed-Dose Combination Drug Products in Phase II or Later Development
for the Treatment of Hypertension 31
Daiichi Sankyo Files NDA with FDA for New Fixed-Dose Combination Antihypertensive Drug 31
Toprol-XL/HCTZ 32

HYPERCHOLESTEROLEMIA 32
Relationship of Cholesterol to Cardiovascular Disease 35
Fixed-Dose Combination Lipid-Lowering Drugs 36
Marketed Statin Drugs 37
The First Fixed-Dose Combination Product to Treat Hypercholesterolemia Introduced 37
The Market for Fixed-Dose Combination Drugs to Treat Hypercholesterolemia 38
A Potential Blockbuster Fails Late-Stage Trials 38
Another Statin Fixed-Dose Combination Product Hits a Snag 39
Products in Development 39
Combination of Crestor and TriCor for the Treatment of Hypercholesterolemia 39
Simcor 40
Three-Drug “Polypill” in Development 40
DIABETES 41

FIXED-DOSE COMBINATION DRUGS FOR DIABETES INTRODUCED 42
Avandamet 42
Glucovance 42
Metaglip 43

THREE NEW FIXED-DOSE COMBINATION PRODUCTS INTRODUCED IN 2005 AND 2006 43

THE MARKET FOR FIXED-DOSE COMBINATION DRUGS TO TREAT DIABETES 44

FIXED-DOSE COMBINATION DRUGS IN DEVELOPMENT 44

INFECTIOUS DISEASES 45

LEADING FIXED-DOSE COMBINATION ANTIBIOTIC DRUGS 46
Augmentin 46
Bactrim 46
Primaxin 47
Synercid 47
Zosyn 47

THE MARKET FOR FIXED-DOSE COMBINATION DRUGS TO TREAT BACTERIAL INFECTIONS 48

HELICOBACTER PYLORI INFECTION 48
Fixed-Dose Combination Therapy for the Treatment of Helicobacter Pylori Infections/Duodenal Ulcers 49
OD-PEP 49
Pylera 50
The Market for Fixed-Dose Combination Drugs to Treat H. Pylori Infections 50

HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS) 51
HIV and AIDS Statistics 51
HIV Infection and AIDS Cases in the U.S. 54
Treatments for HIV Infection/AIDS 55
Categories of Drugs Used in Fixed-Dose Combination Products for the
Treatment of HIV/AIDS 56
Transcriptase Inhibitors 57
Nonnucleoside Reverse Transcriptase Inhibitors 57
Nucleoside Reverse Transcriptase Inhibitors 58
Nucleotide Reverse Transcriptase Inhibitors 58
Protease Inhibitors 59
Side Effects of Marketed HIV Drugs 60
HIV/AIDS Drugs Introduced to the U.S. Market from 2003 through 2006 60
Leading Marketers of HIV/AIDS Drugs 62
Leaders in the Nucleoside Reverse Transcriptase Inhibitor Class 62
Dosing and Compliance Challenges 63
The Ideal Dosing Regimen and the Role of Fixed-Dose Combination Products 64
The Number of Salvage Patients Continues to Increase 64
Fixed-Dose Combination Drugs to Treat HIV/AIDS 65
Combination Products Emerge as Preferred Treatment 66
Atripla 66
Combivir 67
Epzicom 67
Kaletra 67
Trizivir 67
Truvada 67
FDA Approves Aurobindo Three-in-One Fixed-Dose Combination
Drug for AIDS Relief Program 67
The Market for Fixed-Dose Combination Drugs for the Treatment of HIV Infection/AIDS 68
Fixed-Dose Combination Drugs in Phase II Development for the Treatment and/or Prevention of HIV Infection/AIDS 69

TUBERCULOSIS 69
Fixed-Dose Combination Drugs Used to Treat Tuberculosis 71

PSYCHIATRIC DISORDERS 74

DEPRESSION 74
Recently Introduced Fixed-Dose Combination Products for the
Treatment of Depression 75

THE MARKET FOR FIXED-DOSE COMBINATION PRODUCTS TO TREAT PSYCHIATRIC DISORDERS 76

FIXED-DOSE COMBINATION PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF

PSYCHIATRIC DISORDERS 76
372475 76
773812 76
Contrave 77
Excalia 77
Symbyax 78

FIXED-DOSE COMBINATION PRODUCTS FOR THE TREATMENT OF ALZHEIMER’S DISEASE 78

RESPIRATORY DISEASES 80

ASTHMA 80

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) 81

CURRENTLY MARKETED PRODUCTS FOR THE TREATMENT OF ASTHMA 82
Anti-Inflammatory Drugs Used to Treat Asthma 85
Corticosteroids 85
Leukotriene Modifiers 86
IgE Inhibitors 86
Phosphodiesterase Inhibitors 86
Mast-Cell Inhibitors 87
Efficacy of Available Drugs 87
Fixed-Dose Combination Asthma Treatments 87
Advair/Seretide 87
Foster 88
Symbicort 88

THE MARKET FOR DRUGS TO TREAT ASTHMA AND COPD 89
The Market for Drugs to Treat Asthma 89
The Market Drugs to Treat COPD 90
The Market For Fixed-Dose Combination Drugs To Treat Asthma/COPD 93

FIXED-DOSE COMBINATION PRODUCTS IN PHASE II OR LATER DEVELOPMENT TO TREAT ASTHMA AND COPD 93
Alvesco Combo 94
Flutiform 94
Mometasone/Formoterol 95
Super Advair 95

VR315 95

INDUSTRY 96

THE NUMBER OF BLOCKBUSTER DRUGS ON THE WORLDWIDE PHARMACEUTICAL MARKET APPROACHES 100 96

U.S. PHARMACEUTICAL INDUSTRY GROWTH EXPECTED TO INCREASE SLIGHTLY 97

MORE MERGERS, ACQUISITIONS AND LICENSING 97

POTENTIAL FIXED-DOSE COMBINATION DRUGS LEAD THE MARKET 98

LEADING MANUFACTURERS IN THE FIXED-DOSE COMBINATION

DRUG MARKET 98

COMPANY PROFILES 99

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

21Brand-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
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FEATURED COMPANIES

  • Abbott Laboratories
  • Axcan Pharma, Inc.
  • Gilead Sciences Inc.
  • Horizon Therapeutics
  • Merck & Company, Inc.
  • Pfizer Corporation
  • MORE
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 indication, 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.
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Abbott Laboratories
Astrazeneca Plc
Axcan Pharma, Inc.
Bristol-Myers Squibb
Gilead Sciences Inc.
Glaxosmithkline Plc
Horizon Therapeutics
Kos Pharmaceuticals, Inc.
Merck & Company, Inc.
Novartis Ag
Orexigen Therapeutics, Inc.
Pfizer Corporation
Skyepharma Plc
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