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Global Markets for Asthma and COPD Drugs

  • August 2012
  • -
  • BCC Research
  • -
  • 136 pages

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This study is intended to provide readers with an understanding of the global market for asthma and chronic obstructive pulmonary disease (COPD) prescription drugs. The study outlines the industry structure, competitive aspects, current developments, and future trends in the market, to assist in identifying areas of commercial interest and potential in the asthma and COPD indications.

The objectives of the study include the assessment of current market status, the analysis of marketed drugs, market revenues, company shares, unmet market needs, market challenges, and future trends. Future market revenues are forecast for the global market, major drug classes, individual disease indication, and largest geographical regions. The study also reviews the compounds currently being investigated in clinical studies for the treatment of asthma and COPD.

REASONS FOR DOING THE STUDY

Asthma and COPD are two diseases experiencing increasing prevalence globally due to a combination of factors, including a globally aging population and increasing pollution levels. COPD is one of the top five causes of disability and death in industrialized countries and the fourth-leading cause of death globally.

The market for asthma and COPD drugs had global revenues in 2010 that exceeded $34 billion annually. These drugs enjoy tremendous commercial success, as illustrated by the presence of six currently marketed multibillion-dollar drugs in this market. However, there is a perceived high level of unmet need in this market in terms of treatment options for asthma and COPD patients.

With the loss of patent protection on several major COPD and asthma drugs between 2010 and 2017, the cost for some treatments is expected to decrease as generic versions gain market share. Additionally, several new drugs are projected to enter the market through 2017, and they will continue to drive growth of revenues for asthma and COPD drugs.

SCOPE OF REPORT

The report provides a current market overview and projects future developments in the asthma and COPD drugs market over the period from 2011 through 2017. The report describes existing drug classes approved for these indications, such as bronchodilators, anti-inflammatory drugs, and combination drugs of inhaled corticosteroids and bronchodilators. The pipeline of drugs in clinical trials for these indications is also presented and analyzed.

The report includes the following major sections:

Disease overview.
Industry structure and competitive analysis including tiers of competition; regulatory aspects; competitive factors; and market needs, challenges, and trends
Overall market revenue forecast and current market shares as well as revenue forecast by major drug classes, disease indication, and geographical regions.
In-depth analyses of current drug classes.
Reviews and analyses of compounds in clinical trials, with an emphasis on drugs in advanced stages of development.

The report will also analyze product sales and demographics in three regional markets: The Americas (U.S., Canada, Latin/South America); Europe, Middle East, Russia, Africa (EMRA); and Asia (Japan, Australia/New Zealand, other Asian nations, including India and China).

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. The analyses and data presented in this report are based on information collected from a variety of industry sources, including pharmaceutical manufacturers and end users. Secondary information sources include company financials and documentation, U.S. Securities and Exchange Commission (SEC) filings, the U.S. Patent and Trademark Office (USPTO), MEDCO Health, World Health Organization (WHO), trade organizations and their publications, online databases, and the medical and scientific literature.

The base year for analysis and forecast is 2011. Revenue forecasts are provided for the period 2012 to 2017. The forecasts are based on a comprehensive analysis of a variety of market and product-specific factors, including historical, current, and future trends; existing and undiagnosed patient populations; unmet market needs; existing product patent expiration dates; the impact of the generic market; and new market entrants and their value proposition and differentiation.

Values are given in U.S. dollars, forecasts are made in constant U.S. dollars, and growth rates are compounded. Currency conversions were made in June 2012. Growth rates were calculated based on existing and proposed device and equipment sales, at manufacturer pricing, during the forecast period.

INTENDED AUDIENCE

This report provides information that is useful for business planners, market researchers, marketers, business developers, investors, venture capitalists, consultants, and anyone who wants to understand or invest in this market. The information is also useful for technology licensing and scientific research and development purposes.

INFORMATION SOURCES

The analysis and data presented in this report are based on information collected from a variety of industry sources, including the pharmaceutical manufacturers that currently market prescription drugs in this therapeutic area and research- based companies that develop new drug candidates for these indications, as well as end users of prescription drugs. Secondary information sources include company websites, financials, and other literature; SEC filings; patents issued by the USPTO; trade organizations and publications; online databases; and medical and scientific literature.

ANALYST CREDENTIALS

Peggy S. Lehr is the BCC Research analyst of this report. Ms. Lehr holds a BS in Journalism from the University of Colorado, Boulder, and an MS in Communication from the University of Denver. Ms. Lehr has worked within the publishing industry for both for-profit and not-for-profit organizations, and she has completed more than 20 reports for BCC.

Table Of Contents

Global Markets for Asthma and COPD Drugs
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 1
METHODOLOGY 2
INTENDED AUDIENCE 2
INFORMATION SOURCES 2
ANALYST CREDENTIALS 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER 2 SUMMARY 5
SUMMARY TABLE GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY
DISEASE, THROUGH 2017 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY
REGION, 2012 AND 2017 (%) 6
CHAPTER 3 OVERVIEW 9
PULMONARY DRUG DELIVERY 9
PULMONARY CONDITIONS AND THERAPIES 9
RESPIRATORY SYSTEM 9
LUNG 11
Particle Size, Toxicity and Drug Deposition 11
Systemic and Local Therapy 12
Pulmonary Drug Delivery-Devices 12
Device Characteristics 12
Manufacturing Techniques 14
ASTHMA 16
Symptoms of Asthma 17
Global Prevalence 17
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 17
Symptoms of COPD 17
Medication Treatment 18
Types of Medication Treatments 18
Classification of Asthma and COPD Medications 18
Bronchodilators 18
Quick-acting Bronchodilators 18
Two Classes of Long-Term Bronchodilators 19
Anti-inflammatory Drugs 19
Combination Inhaled Corticosteroids and Long-acting Beta-2 Agonists (ICS/LABA) 19
Advantages of ICS/LABA 20
TABLE 1 MARKETED ASTHMA AND COPD DRUG CLASSES 20
Drug Delivery Methods 20
Inhaled Drugs 21
Metered-dose Inhaler 21
Pressurized MDI Devices 21
Types of Metered-dose Inhalers 21
Breath-activated Inhalers 21
Types of Breath-activated Inhalers 22
Dry Powder Inhalers 22
Disadvantages of DPI 22
Types of DPI Inhalers 22
Nebulizers 22
Usage 23
Types of Nebulized Drugs 23
Oral and Injectable Drugs 23
Oral Drug Types 23
Injectable Drug Types 23
ADVANTAGES/DISADVANTAGES OF DRUG DELIVERY METHODS 23
DRUG DEVELOPMENT PROCESS 24
DEVELOPMENT OF DISEASE-MODIFYING DRUGS 24
New Drug Targets 24
TECHNICAL ASPECTS IN THE DEVELOPMENT OF INHALED DRUGS 25
INTELLECTUAL PROPERTY RIGHTS 25
DRUG DEVELOPMENT 25
COMPLEX REGULATORY DRUG APPROVAL PROCESS 26
Approval Times 26
REGULATORY ISSUES 26
REMOVAL OF CFC-PROPELLED INHALERS 26
FDA DRUG SAFETY WARNINGS 27
INDUSTRY PLAYERS 27
TIERS OF COMPETITION 27
MAJOR DRUG MANUFACTURERS 28
GlaxoSmithKline 28
Merck 28
Boehringer Ingelheim 28
TABLE 2 NET REVENUES FOR TOP SIX ASTHMA/COPD PRODUCT MANUFACTURERS, WITH
PRODUCT(S), 2010 AND 2011 ($ MILLIONS) 29
SPECIALTY PHARMACEUTICAL COMPANIES 29
Teva Pharmaceutical 29
Chiesi Farmaceutici 29
Sunovion/Sepracor 30
TABLE 3 NET REVENUES FOR TOP SPECIALTY ASTHMA/COPD MANUFACTURERS WITH
PRODUCT(S), 2010 AND 2011 ($ MILLIONS) 30
SMALLER COMPANIES 30
TABLE 4 NET REVENUES FOR SMALLER ASTHMA/COPD PRODUCT MANUFACTURER, WITH
PRODUCT, 2010 AND 2011 ($ MILLIONS) 30
ACQUISITIONS AND MERGERS 31
TABLE 5 ACQUISITIONS AND MERGERS IN THE ASTHMA AND COPD MARKET, JANUARY
2008 TO JUNE 2012 ($ MILLIONS) 31
COMPETITIVE FACTORS 31
SIX COMPETITIVE FACTORS 31
Delivery Mode and Convenience 32
Product Efficacy and Dosage Frequency 32
Safety 33
Combination Drugs 33
Drug Pricing 33
Sales and Marketing 33
SIGNIFICANT TRENDS 34
GLOBAL AGING POPULATION LEADS TO INCREASING ASTHMA AND COPD
PREVALENCE 34
NEW DRUG LAUNCHES OFFER ENHANCED TREATMENT OPTIONS 34
PATENT EXPIRATIONS OF MAJOR DRUGS AND GENERIC DRUG LAUNCHES WILL
CHANGE THE MARKET 34
TABLE 6 MAJOR ASTHMA/COPD DRUGS THAT LOSE PATENT PROTECTION BETWEEN 2008
AND 2024 35
MARKET CHALLENGES 36
TECHNICAL- AND MARKET-SPECIFIC EXPERTISE REQUIRED TO COMPETE IN THIS
THERAPEUTIC AREA 36
FILLING UNMET NEEDS 36
DISEASE-MODIFYING DRUGS 36
SUPERIOR EFFICACY DRUGS 37
IMPROVED SAFETY PROFILE DRUGS 37
IMPROVED DRUG DELIVERY MODALITIES 37
IMPROVED QUALITY OF LIFE FOR PATIENTS 37
REGIONAL ANALYSIS 38
THE AMERICAS 38
Demographic Findings 38
Asthma and Children in the Americas 38
Loss of Patent Protection 38
Product Usage 39
EMRA 39
Demographic Findings 39
Asthma and Children 39
Product Usage 39
ASIA 40
Demographic Findings 40
Asthma and Children in Asia 40
Product Usage 40
CHAPTER 4 DISEASE OVERVIEW 42
SYMPTOM COMPARISONS 42
TABLE 7 ASTHMA AND COPD SYMPTOM COMPARISONS 42
ASTHMA OVERVIEW 42
ASTHMA IN CHILDREN 42
ASTHMA IN ADULTS 43
GLOBAL ECONOMIC BURDEN OF ASTHMA 43
CLASSIFICATION OF ASTHMA 43
TABLE 8 CLASSIFICATION OF ASTHMA, BY SYMPTOMS 44
CAUSES AND RISK FACTORS 44
DIAGNOSIS 44
Diagnostic Tests 45
Spirometry 45
Peak Flow Test 45
Methacholine Bronchial Challenge Test 45
Nitric Oxide Test 45
Skin or Blood Test 46
DRUG CLASSES APPROVED IN THE TREATMENT OF ASTHMA AND COPD 46
TABLE 9 ASTHMA AND COPD DRUG CLASSES 46
Bronchodilators 46
Anti-inflammatory drugs 46
Combination Therapies of Bronchodilators and Anti-inflammatory Drugs 47
MEDICATION TREATMENT ALGORITHMS 47
First Line Therapy 47
Second Line Therapy 47
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 48
CLASSIFICATION OF COPD 48
TABLE 10 CLASSIFICATION OF COPD AND ASTHMA 49
CAUSES AND RISK FACTORS 49
DIAGNOSIS 49
COPD TREATMENT METHODS 49
Vaccine 49
Rehabilitation 50
Oxygen Therapy 50
Surgery 50
Medication Treatments 50
Drug Selection 51
REGIONAL STATISTICS 51
ACCESS TO CARE 51
AVAILABILITY OF TREATMENTS 52
NORTH AMERICA 52
Asthma in the U.S. 52
Adults and Asthma in the U.S. 52
Asthma in Canada 53
Asthma in Central America 53
Asthma in the Caribbean 53
ASTHMA IN SOUTH AMERICA 54
TABLE 11 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN THE
AMERICAS (%) 54
COPD IN THE U.S. 55
EMRA 55
Asthma in EMRA 55
Scandinavian/Baltic countries 55
Asthma in the UK and Ireland 55
Asthma in Western Europe 56
Asthma in Eastern Europe 56
Asthma in Russia 56
Asthma in the Middle East 57
TABLE 12 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN THE EMRA
(%) 57
COPD in EMRA 58
COPD in Russia 58
ASIA 58
Asthma in Asia 58
Asthma in Central Asia 58
Asthma in Southern Asia 59
Asthma in China/Taiwan/Mongolia 59
Asthma in Northeast Asia 59
Asthma in Southeast Asia 60
Asthma in Oceania 60
TABLE 13 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN ASIA 61
COPD in Asia 61
CHAPTER 5 MARKETS BY DRUG CLASS 63
TABLE 14 PROJECTED GLOBAL MARKET FOR ASTHMA AND COPD DRUG, BY DRUG CLASS,
THROUGH 2017 ($ MILLIONS) 63
BRONCHODILATORS 63
MARKET REVENUES AND FORECAST 63
FIGURE 1 GLOBAL BRONCHODILATOR MARKET, BY TYPE, 2012 AND 2017 (%) 64
TABLE 15 PROJECTED GLOBAL MARKET FOR BRONCHODILATORS, THROUGH 2017 ($
MILLIONS) 65
MANUFACTURERS' MARKET SHARE FOR BRONCHODILATORS 65
FIGURE 2 GLOBAL MARKET SHARE FOR BRONCHODILATORS BY COMPANY, 2011 (%) 65
SHORT-ACTING BETA-2 AGONISTS 66
TABLE 16 SHORT-ACTING BETA-2 AGONISTS, WITH APPROVAL AND PATENT EXPIRY DATES,
2011 67
Market Revenues and Forecast 67
Advantages/Disadvantages 68
TABLE 17 PROJECTED MARKET FOR SHORT-ACTING BETA-2 AGONIST BRONCHODILATORS,
THROUGH 2017 ($ MILLIONS) 68
LONG-ACTING BETA-2 AGONISTS 68
TABLE 18 LONG-ACTING BETA-2 AGONISTS, 2011 69
Market Revenues and Forecast 69
TABLE 19 PROJECTED GLOBAL MARKET FOR LABA PRODUCTS, THROUGH 2017 ($
MILLIONS) 70
FIGURE 3 MARKET SHARE FOR LABA BRONCHODILATORS BY COMPANY, 2011 (%) 70
ANTICHOLINERGICS AND COMBINATION ANTICHOLINERGICS/SABA 71
TABLE 20 ANTICHOLINERGICS AND COMBINATION ANTICHOLINERGICS/SABA BY
MANUFACTURER, 2011 71
Market Revenues and Forecast 71
TABLE 21 PROJECTED GLOBAL MARKET FOR ANTICHOLINERGICS, THROUGH 2017 ($
MILLIONS) 72
ANTI-INFLAMMATORY DRUGS 72
Market Revenues and Forecast 72
FIGURE 4 MARKET SHARE OF ANTI-INFLAMMATORY DRUGS BY TYPE, 2012 AND 2017 (%) 72
TABLE 22 PROJECTED GLOBAL MARKET FOR ANTI-INFLAMMATORY DRUGS BY TYPE,
THROUGH 2017 ($ MILLIONS) 74
Inhaled Corticosteroids 74
TABLE 23 INHALED CORTICOSTERIODS, 2011 75
FIGURE 5 MARKET SHARE OF LEADING MANUFACTURERS OF INHALED CORTICOSTERIODS,
2011 (%) 76
Competition in the ICS market 76
TABLE 24 PROJECTED GLOBAL MARKET FOR INHALED CORTICOSTEROIDS, THROUGH 2017
($ MILLIONS) 77
LEUKOTRIENE MODIFIERS 77
TABLE 25 LEUKOTRIENE MODIFIERS, 2011 77
Market Revenues and Forecast 78
TABLE 26 PROJECTED GLOBAL MARKET FOR LEUKOTRIENE MODIFIERS, THROUGH 2017 ($
MILLIONS) 78
FIGURE 6 GLOBAL MARKET FOR LEUKOTRIENE MODIFIERS, BY MANUFACTURER, 2012
AND 2017 (%) 79
PDE-4 INHIBITORS 80
TABLE 27 PROJECTED GLOBAL MARKET FOR PDE-4 DRUGS, THROUGH 2017 ($ MILLIONS) 80
BIOLOGICAL DRUGS 80
MARKET REVENUES AND FORECAST 80
Increasing Market for Biological Drugs to Treat Asthma 80
TABLE 28 PROJECTED GLOBAL MARKET FOR ASTHMA BIOLOGICAL DRUGS, THROUGH 2017
($ MILLIONS) 81
COMBINATION ICS/LABA DRUGS 81
TABLE 29 COMBINATION ICS/LABA DRUGS, 2011 81
MARKET REVENUES AND FORECAST 82
TABLE 30 PROJECTED GLOBAL MARKET FOR COMBINATION ICS/LABA DRUGS, THROUGH
2017 ($ MILLIONS) 82
FIGURE 7 MARKET SHARE OF MANUFACTURERS OF ICS/LABA, 2011 (%) 83
Market Dynamics 83
Flutiform 84
Dulera 84
Relovair 84
REGIONAL ANALYSIS 84
TABLE 31 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS BY REGION, THROUGH
2017 ($ MILLIONS) 85
The Americas 85
TABLE 32 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE AMERICAS REGION,
THROUGH 2017 ($ MILLIONS) 85
Projected Use of Asthma/COPD Drugs, by Americas' Regions 85
TABLE 33 PROJECTED USE OF ASTHMA/COPD DRUGS IN THE AMERICAS' REGION,
THROUGH 2017 ($ MILLIONS) 86
FIGURE 8 MARKET PERCENT OF ASTHMA/COPD DRUGS IN THE AMERICAS REGION, 2012
AND 2017 (%) 86
EMRA 87
TABLE 34 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE EMRA, THROUGH
2017 ($ MILLIONS) 87
TABLE 35 PROJECTED USE OF ASTHMA/COPD DRUGS IN THE EMRA REGION, THROUGH
2017 ($ MILLIONS) 87
FIGURE 9 MARKET PERCENT OF ASTHMA/COPD DRUGS IN THE EMRA, 2012 AND 2017 (%) 88
Asia 89
TABLE 36 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE ASIAN REGION,
THROUGH 2017 ($ MILLIONS) 89
TABLE 37 PROJECTED USE OF ASTHMA/COPD DRUGS, BY REGION IN ASIA, THROUGH 2017
($ MILLIONS) 89
FIGURE 10 MARKET PERCENTAGE OF ASTHMA/COPD DRUGS, BY REGION IN ASIA, 2012
AND 2017 (%) 89
CHAPTER 6 MARKETS BY DISEASE 92
FIGURE 11 GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY DISEASE,
2011 (%) 92
ASTHMA DRUGS 92
MARKET REVENUES FOR ASTHMA DRUGS 93
MARKET SHARES, BY COMPANY 93
FIGURE 12 MARKET SHARES OF LEADING MANUFACTURERS OF ASTHMA DRUGS, 2011 (%) 93
NEW BRANDED ASTHMA DRUGS LAUNCHES 95
GENERIC DRUG LAUNCHES 95
TABLE 38 PROJECTED GLOBAL MARKET FOR ASTHMA PRESCRIPTION DRUGS, THROUGH
2017 ($ MILLIONS) 96
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 96
FIGURE 13 MARKET SHARES OF LEADING MANUFACTURERS OF COPD DRUGS, 2011 (%) 96
TABLE 39 PROJECTED GLOBAL MARKET FOR COPD PRESCRIPTION DRUGS, THROUGH 2017
($ MILLIONS) 97
BRANDED COPD PRODUCT LAUNCHES 97
COMBINATION ASTHMA/COPD DRUGS 97
TABLE 40 PROJECTED GLOBAL MARKET FOR COMBINATION ASTHMA/COPD DRUGS,
THROUGH 2017 ($ MILLIONS) 98
FIGURE 14 MARKET SHARES OF LEADING MANUFACTURERS OF COMBINATION
ASTHMA/COPD DRUGS, 2011 (%) 98
TABLE 41 PROJECTED GLOBAL MARKET FOR COMBINATION ASTHMA/COPD PRESCRIPTION
DRUGS, THROUGH 2017 ($ MILLIONS) 99
CHAPTER 7 EMERGING TRENDS AND PRODUCT PIPELINE REVIEW 101
THE "ASTHMA GENE" 101
ORAL DRUGS FOR ASTHMA 101
LEUKOTRIENE ORAL DRUGS 101
Masitinib 101
Oral Antifungal Treatment for Severe Asthma 101
DISEASE MODIFYING DRUGS 102
ASTHMA FORMULATIONS 102
COPD FORMULATIONS 102
BOEHRINGER INGELHEIM 102
FOREST LABORATORIES/AMIRALL SA 102
ELEVATION PHARMACEUTICALS 103
PEARL THERAPEUTICS 103
NOVEL BIOLOGICS 103
AMG 157 103
AMG 176 103
MEPOLIZUMAB 103
ULTRA LONG-ACTING MUSCARINIC ANTAGONISTS 103
ULTRA LONG-ACTING B2 AGONISTS (ULTRA-LABA) 104
LAMA AND LABA COMBINATION DRUGS 104
ANTI-INFLAMMATORY DRUGS 105
ANTI-PROTEASE 105
CHEMOKINE ANTAGONISTS 105
PPAR AGONISTS 105
ASTHMA/COPD DRUG DEVELOPMENT, BY COMPANY 105
TABLE 42 ASTHMA/COPD PRODUCTS UNDER DEVELOPMENT, BY COMPANY, 2012 106
ASTHMA DEVICES 108
CHAPTER 8 APPROVED DRUGS AND PATENT REVIEW 110
TABLE 43 APPROVED DRUGS TO TREAT ASTHMA AND COPD, 1996 THROUGH 2011 110
TABLE 44 DRUGS SEEKING APPROVAL TO TREAT ASTHMA AND COPD 2012 THROUGH 2013 111
PATENT REVIEW 111
TABLE 45 ASTHMA/COPD TREATMENT PATENTS, BY COMPANY, DISEASE, PATENT NUMBER,
YEAR FILED, 2011 THROUGH 2012 112
FIGURE 15 PERCENT OF REVIEWED PATENTS FOR ASTHMA, COPD, AND COMBINATION
USE, JANUARY 2011 TO MAY 2012 (%) 114
TABLE 46 ASTHMA/COPD TREATMENT PATENTS, BY NUMBER, COMPANY, DESCRIPTION,
AND DATE ISSUED, 2011 THROUGH 2012 115
TABLE 47 ASTHMA/COPD DRUG TREATMENT PATENTS ISSUED BETWEEN JANUARY 2011
AND MAY 2012, BY COMPANY 123
FIGURE 16 ASTHMA/COPD PATENTS, BY COUNTRY, 2011 THROUGH 2012 (%) 125
CHAPTER 9 COMPANY PROFILES 127
ACTIENT PHARMACEUTICALS 127
AEROVANCE, INC. 127
ALMIRALL, S.A. 128
AMGEN INC. 128
APTAR PHARMA 129
ARGENTA DISCOVERY, LTD. 129
ASTRAZENECA 130
ASTRAZENECA PHARMACEUTICALS, LP 130
BOEHRINGER INGELHEIM GMBH 131
CHIESI FARMACEUTICI SPA 131
CORNERSTONE THERAPEUTICS 132
CYTOS BIOTECHNOLOGY AG 132
DEY PHARMA (MYLAN SPECIALTY L.P.) 133
FOREST LABORATORIES, INC. 133
GENENTECH, INC. (ROCHE) 133
GLAXO WELLCOME U.K., LTD. 134
GLAXOSMITHKLINE U.S. 134
MEDICINOVA 135
MEDICIS PHARMACEUTICAL 136
MEDIMMUNE 136
MERCK and CO., INC. 136
NOVARTIS PHARMA 137
NOVARTIS CORPORATION 137
NOVARTIS PHARMACEUTICALS CORPORATION 137
NYCOMED INTERNATIONAL (TAKEDA INTERNATIONAL) 138
OSIRIS THERAPEUTICS, INC. 139
PFIZER, INC. 139
SEPRACOR, INC. (SUNOVION) 140
SKYEPHARMA PLC 140
TEVA PHARMACEUTICAL INDUSTRIES, LTD. 141
TEVA PHARMACEUTICALS USA 141
THERAVANCE 142
RELOVAIR 142
LAMA/LABA (GSK573719/VILANTROL) 142
BIFUNCTIONAL MUSCARINIC ANTAGONIST-BETA2 AGONIST PROGRAM 142
INHALED LONG-ACTING MUSCARINIC ANTAGONIST (LAMA) 142
TOPIGEN PHARMACEUTICALS, INC. (PHARMAXIS LTD) 143
VECTURA GROUP PLC 143

LIST OF TABLES
SUMMARY TABLE GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY
DISEASE, THROUGH 2017 ($ MILLIONS) 6
TABLE 1 MARKETED ASTHMA AND COPD DRUG CLASSES 20
TABLE 2 NET REVENUES FOR TOP SIX ASTHMA/COPD PRODUCT MANUFACTURERS, WITH
PRODUCT(S), 2010 AND 2011 ($ MILLIONS) 29
TABLE 3 NET REVENUES FOR TOP SPECIALTY ASTHMA/COPD MANUFACTURERS WITH
PRODUCT(S), 2010 AND 2011 ($ MILLIONS) 30
TABLE 4 NET REVENUES FOR SMALLER ASTHMA/COPD PRODUCT MANUFACTURER, WITH
PRODUCT, 2010 AND 2011 ($ MILLIONS) 30
TABLE 5 ACQUISITIONS AND MERGERS IN THE ASTHMA AND COPD MARKET, JANUARY 2008
TO JUNE 2012 ($ MILLIONS) 31
TABLE 6 MAJOR ASTHMA/COPD DRUGS THAT LOSE PATENT PROTECTION BETWEEN 2008
AND 2024 35
TABLE 7 ASTHMA AND COPD SYMPTOM COMPARISONS 42
TABLE 8 CLASSIFICATION OF ASTHMA, BY SYMPTOMS 44
TABLE 9 ASTHMA AND COPD DRUG CLASSES 46
TABLE 10 CLASSIFICATION OF COPD AND ASTHMA 49
TABLE 11 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN THE
AMERICAS (%) 54
TABLE 12 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN THE EMRA
(%) 57
TABLE 13 PERCENT OF SELECTED POPULATIONS WITH DIAGNOSED ASTHMA IN ASIA 61
TABLE 14 PROJECTED GLOBAL MARKET FOR ASTHMA AND COPD DRUG, BY DRUG CLASS,
THROUGH 2017 ($ MILLIONS) 63
TABLE 15 PROJECTED GLOBAL MARKET FOR BRONCHODILATORS, THROUGH 2017 ($
MILLIONS) 65
TABLE 16 SHORT-ACTING BETA-2 AGONISTS, WITH APPROVAL AND PATENT EXPIRY DATES,
2011 67
TABLE 17 PROJECTED MARKET FOR SHORT-ACTING BETA-2 AGONIST BRONCHODILATORS,
THROUGH 2017 ($ MILLIONS) 68
TABLE 18 LONG-ACTING BETA-2 AGONISTS, 2011 69
TABLE 19 PROJECTED GLOBAL MARKET FOR LABA PRODUCTS, THROUGH 2017 ($ MILLIONS) 70
TABLE 20 ANTICHOLINERGICS AND COMBINATION ANTICHOLINERGICS/SABA BY
MANUFACTURER, 2011 71
TABLE 21 PROJECTED GLOBAL MARKET FOR ANTICHOLINERGICS, THROUGH 2017 ($
MILLIONS) 72
TABLE 22 PROJECTED GLOBAL MARKET FOR ANTI-INFLAMMATORY DRUGS BY TYPE,
THROUGH 2017 ($ MILLIONS) 74
TABLE 23 INHALED CORTICOSTERIODS, 2011 75
TABLE 24 PROJECTED GLOBAL MARKET FOR INHALED CORTICOSTEROIDS, THROUGH 2017
($ MILLIONS) 77
TABLE 25 LEUKOTRIENE MODIFIERS, 2011 77
TABLE 26 PROJECTED GLOBAL MARKET FOR LEUKOTRIENE MODIFIERS, THROUGH 2017 ($
MILLIONS) 78
TABLE 27 PROJECTED GLOBAL MARKET FOR PDE-4 DRUGS, THROUGH 2017 ($ MILLIONS) 80
TABLE 28 PROJECTED GLOBAL MARKET FOR ASTHMA BIOLOGICAL DRUGS, THROUGH 2017
($ MILLIONS) 81
TABLE 29 COMBINATION ICS/LABA DRUGS, 2011 81
TABLE 30 PROJECTED GLOBAL MARKET FOR COMBINATION ICS/LABA DRUGS, THROUGH
2017 ($ MILLIONS) 82
TABLE 31 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS BY REGION, THROUGH 2017
($ MILLIONS) 85
TABLE 32 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE AMERICAS REGION,
THROUGH 2017 ($ MILLIONS) 85
TABLE 33 PROJECTED USE OF ASTHMA/COPD DRUGS IN THE AMERICAS' REGION, THROUGH
2017 ($ MILLIONS) 86
TABLE 34 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE EMRA, THROUGH
2017 ($ MILLIONS) 87
TABLE 35 PROJECTED USE OF ASTHMA/COPD DRUGS IN THE EMRA REGION, THROUGH 2017
($ MILLIONS) 87
TABLE 36 PROJECTED REVENUES FROM ASTHMA/COPD DRUGS IN THE ASIAN REGION,
THROUGH 2017 ($ MILLIONS) 89
TABLE 37 PROJECTED USE OF ASTHMA/COPD DRUGS, BY REGION IN ASIA, THROUGH 2017 ($
MILLIONS) 89
TABLE 38 PROJECTED GLOBAL MARKET FOR ASTHMA PRESCRIPTION DRUGS, THROUGH
2017 ($ MILLIONS) 96
TABLE 39 PROJECTED GLOBAL MARKET FOR COPD PRESCRIPTION DRUGS, THROUGH 2017
($ MILLIONS) 97
TABLE 40 PROJECTED GLOBAL MARKET FOR COMBINATION ASTHMA/COPD DRUGS,
THROUGH 2017 ($ MILLIONS) 98
TABLE 41 PROJECTED GLOBAL MARKET FOR COMBINATION ASTHMA/COPD PRESCRIPTION
DRUGS, THROUGH 2017 ($ MILLIONS) 99
TABLE 42 ASTHMA/COPD PRODUCTS UNDER DEVELOPMENT, BY COMPANY, 2012 106
TABLE 43 APPROVED DRUGS TO TREAT ASTHMA AND COPD, 1996 THROUGH 2011 110
TABLE 44 DRUGS SEEKING APPROVAL TO TREAT ASTHMA AND COPD 2012 THROUGH 2013 111
TABLE 45 ASTHMA/COPD TREATMENT PATENTS, BY COMPANY, DISEASE, PATENT NUMBER,
YEAR FILED, 2011 THROUGH 2012 112
TABLE 46 ASTHMA/COPD TREATMENT PATENTS, BY NUMBER, COMPANY, DESCRIPTION,
AND DATE ISSUED, 2011 THROUGH 2012 115
TABLE 47 ASTHMA/COPD DRUG TREATMENT PATENTS ISSUED BETWEEN JANUARY 2011
AND MAY 2012, BY COMPANY 123

LIST OF FIGURES
SUMMARY FIGURE GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY
REGION, 2012 AND 2017 (%) 6
FIGURE 1 GLOBAL BRONCHODILATOR MARKET, BY TYPE, 2012 AND 2017 (%) 64
FIGURE 2 GLOBAL MARKET SHARE FOR BRONCHODILATORS BY COMPANY, 2011 (%) 65
FIGURE 3 MARKET SHARE FOR LABA BRONCHODILATORS BY COMPANY, 2011 (%) 70
FIGURE 4 MARKET SHARE OF ANTI-INFLAMMATORY DRUGS BY TYPE, 2012 AND 2017 (%) 72
FIGURE 5 MARKET SHARE OF LEADING MANUFACTURERS OF INHALED CORTICOSTERIODS,
2011 (%) 76
FIGURE 6 GLOBAL MARKET FOR LEUKOTRIENE MODIFIERS, BY MANUFACTURER, 2012 AND
2017 (%) 79
FIGURE 7 MARKET SHARE OF MANUFACTURERS OF ICS/LABA, 2011 (%) 83
FIGURE 8 MARKET PERCENT OF ASTHMA/COPD DRUGS IN THE AMERICAS REGION, 2012
AND 2017 (%) 86
FIGURE 9 MARKET PERCENT OF ASTHMA/COPD DRUGS IN THE EMRA, 2012 AND 2017 (%) 88
FIGURE 10 MARKET PERCENTAGE OF ASTHMA/COPD DRUGS, BY REGION IN ASIA, 2012 AND
2017 (%) 89
FIGURE 11 GLOBAL MARKET FOR ASTHMA AND COPD PRESCRIPTION DRUGS BY DISEASE,
2011 (%) 92
FIGURE 12 MARKET SHARES OF LEADING MANUFACTURERS OF ASTHMA DRUGS, 2011 (%) 93
FIGURE 13 MARKET SHARES OF LEADING MANUFACTURERS OF COPD DRUGS, 2011 (%) 96
FIGURE 14 MARKET SHARES OF LEADING MANUFACTURERS OF COMBINATION
ASTHMA/COPD DRUGS, 2011 (%) 98
FIGURE 15 PERCENT OF REVIEWED PATENTS FOR ASTHMA, COPD, AND COMBINATION USE,
JANUARY 2011 TO MAY 2012 (%) 114
FIGURE 16 ASTHMA/COPD PATENTS, BY COUNTRY, 2011 THROUGH 2012 (%) 125

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