Market Report Source

Overview

The market for respiratory disorder treatments is continuing to experience rapid expansion as healthcare payors increasingly acknowledge the high treatment costs associated with chronic indications. A shift in developmental focus has become the driving force for market transformation, with research efforts now targeting the causative disease pathway in an effort to prevent symptom presentation and pathological decline. In the short term, a number of impending product launches will satisfy unmet demand within high-value market niches by addressing issues of patient compliance and targeting patients at the more severe end of the disease spectrum.

‘Innovations and Pipelines for Respiratory Disorders’ is a new report published by Business Insights that examines the future of the respiratory disorders market and explores the dynamics and drivers for current and emerging treatments. This report assesses leading mechanisms of action in drug development pipelines based upon clinical/preclinical results, potential market positioning and sales success in addition to identifying associated investment opportunities. The major trends and issues affecting new product development are highlighted and the future potential of leading innovations is evaluated.

This report also identifies major areas of unmet market need and provides a detailed assessment of the currently marketed portfolios and developmental products of key companies within the sector. Explore the latest trends and innovations in respiratory treatments, assess the performances of currently marketed medications and evaluate the potential of leading pipeline candidates with this report.

Table of Contents

Executive Summary 10
Market introduction and outlook 10
Asthma 11
COPD 12
Cystic fibrosis 13
Pulmonary hypertension 13
Respiratory allergies 14
Respiratory tract infections 15
Key companies and pipelines 16

Chapter 1 Market introduction and outlook 18
Summary 18
Market introduction 19
Respiratory disease classification 19
Region-specific product sales revenues 21
Existing product pipeline 23
Leading marketed innovatives 25
Innovatives classification 25
Nasal preparations 26

• Nasonex 27

Anti-asthma and COPD preparations 28

• Seretide 31


• Singulair 32


• Spiriva 33

Cough and cold preparations 34

• Pulmozyme 35

Systemic antihistamines 36

• Xyzal 37

Key events to impact the respiratory market 37
Decreasing numbers of new product approvals 37
Regulatory affairs update 38
Emergence of molecular testing 39
Discontinued gene therapy research for cystic fibrosis 40
Patent challenge: Ivax vs Advair 40
Positive result for Seretide in COPD 41
Emergence of innovative drug classes 42

Chapter 2 Asthma 46
Summary 46
Market introduction 47
Etiology 47
Epidemiology 48
Unmet needs 50
Future drivers of growth and innovation 51
Combination therapies 52
Non-steroidal anti-inflammatories 52

• PG-D2 agonists 52


• CCR3 antagonists 53


• Targeting the mast cells directly 53

Monoclonal antibodies 55
Novel Anti-TNF targets 58
Inhaled immunostimulatory DNA 58
Novel therapies for severe neutrophilic asthma 59
Gene Therapy 59

Chapter 3 COPD Summary 62
Market introduction 63
Etiology 63
Epidemiology 65
Unmet needs 66
Future drivers of growth and innovation 68
Novel long-acting combination therapies 68
Triple combinations 69
Oral anti inflammatories 70
Phosphodiesterase inhibitors 71

• CXCR2 Agonists 72


• Proteinase targets 73

Other novel first in class mechanisms 73

Chapter 4 Cystic fibrosis 78
Summary 78
Market introduction 79
Etiology 79
Epidemiology 79
Unmet needs 80
Future drivers of growth and innovation 82
Gene therapy 82
Cystic fibrosis transmembrane regulator (CFTR) Protein Modulators 83
Targeting ion channel deficit 84
Anti-inflammatories 86
Anti-infectives 86
Active vaccines 87

Chapter 5 Pulmonary hypertension 94
Summary 94
Etiology 95
Epidemiology 96
Unmet needs 97
Future drivers of growth and innovation 99
Peptide hormones 99
Long-acting therapy 100
5 HT-2B Antagonists 100
Monoclonal Antibody therapy 100

Chapter 6 Respiratory allergies 104
Summary 104
Market introduction 105
Etiology 105
Epidemiology 105
Unmet needs 106
Future drivers of growth and innovation 108
Corticosteroids 108
Antihistamines 108
Anti-inflammatories 108
Nasal decongestants 109
Novel “immunodrug” approach 110

Chapter 7 Respiratory tract infections 114
Summary 114
Market introduction 115
Etiology 115
Epidemiology 119
Unmet needs 120
Future drivers of growth and innovation 121
Antibiotics 122
Anti-virals 122
Vaccine development 123
Monoclonal antibodies 123

Chapter 8 Key companies and pipelines 126
Summary 126
Introduction 127

GlaxoSmithKline 127
Leading market revenue drivers 128
Upcoming milestones 129
Leading Innovatives pipeline 129

• Preclinical 130


• Phase II 131

Boehringer Ingelheim 132
Leading market revenue drivers 132
Leading innovatives pipeline 132

• Preclinical 133


• Phase II 133

Merck & Co. 134
Upcoming milestones 134
Leading Innovatives pipeline 134

AstraZeneca 135
Leading market revenue drivers 135
Upcoming milestones 136
Leading Innovatives pipeline 138

• Preclinical 139


• Phase I 139


• Phase II 140

Chapter 9 Appendix 142

Index 144

List of Figures
Figure 1.1: Growth in global respiratory product sales revenues, 2003-2007 ($m) 22
Figure 1.2: Share of respiratory product global sales revenues by ATC2 classification, 2007 ($m)
23
Figure 1.3: Global respiratory and pulmonary product pipeline, May 2008 24
Figure 1.4: Total respiratory market, growth metrics and sales revenues by therapy area, global,
2003-2007 25
Figure 1.5: Global sales by drug class, 2007 ($m) 26
Figure 1.6: Global revenues for asthma and COPD related drug classes, 2007 ($m) 29
Figure 1.7: NDAs for novel respiratory drugs, FDA, 2003-2008 38
Figure 1.8: Key disease pathways, emerging drug targets and company-specific areas of interest
for respiratory disorders 43
Figure 1.9: Lung alveolar epithelial cell – Key biochemical pathways and respiratory drug targets
44
Figure 2.10: Comparative etiology of an asthmatic bronchiole 47
Figure 2.11: The Asthma Innovatives R&D Pipeline 60
Figure 3.12: The COPD Innovatives R&D pipeline 75
Figure 4.13: The cystic fibrosis innovatives R&D pipeline 91
Figure 5.14: The PAH Innovatives R&D Pipeline 101
Figure 6.15: The respiratory allergies innovatives pipeline 111
Figure 7.16: Etiology of common respiratory tract infections 118
Figure 8.17: Top 10 companies by sales revenue, total respiratory product sales growth metrics
2003-2007, global 127
Figure 8.18: GlaxoSmithKline respiratory and pulmonary product pipeline, July 2008 130
Figure 8.19: Boehringer Ingelheim respiratory and pulmonary product pipeline, July 2008 133
Figure 8.20: Merck & Co respiratory and pulmonary product pipeline, July 2008 135
Figure 8.21: AstraZeneca respiratory and pulmonary product pipeline, July 2008 139

List of Tables
Table 1.1: Estimated Annual Incidence for selected respiratory diseases by WHO sub region,
2002, ‘000’s 20
Table 1.2: Estimated annual incidence for selected respiratory diseases by sex, 2002, ‘000s 21
Table 1.3: Global sales of innovatives by drug class, 2007 ($m) 26
Table 1.4: Top five diagnoses – share of total nasal preparations Rx market (EU5, US and Japan),
2007 27
Table 1.5: Key anti-asthma and COPD growth drivers, global, 2007 ($m) 30
Table 1.6: Global sales of Leading anti-asthma and COPD brands, 2003-2007 ($m) 31
Table 1.7: Singulair; major product milestones 33
Table 1.8: Leading branded systemic antihistamines, global, 2007 ($m) 36
Table 2.9: Asthma prevalence and diagnosed populations, EU5, US and Japan, 2007 49
Table 2.10: Anti-asthma Monoclonal Antibodies, June 2008 56
Table 3.11: Estimated prevalence of COPD, EU5, US and Japan, 2006 (‘000s) 66
Table 4.12: Annual incidence estimates of Cystic fibrosis in the 7MM, 2008 80
Table 4.13: P aeruginosa pipeline vaccine candidates 89
Table 5.14: Estimated prevalence of PAH by region, 2005 (millions) 96
Table 5.15: Current breakdown of presenting PAH patients by severity 97
Table 5.16: Strengths and weaknesses, currently marketed pulmonary hypertension therapies 98
Table 6.17: Total diagnosed AR population aged over 20 years according to severity (%) and
allergen (millions) in the 7 MM, 2006 106
Table 7.18: Incidence of RTI diagnoses, US, 2006, millions 119
Table 8.19: GlaxoSmithKline; Leading drug class sales for respiratory disorders, global, 2003-
2007 ($m) 128
Table 8.20: Boehringer Ingelheim; Leading drug class sales for respiratory disorders, global, 2003-
2007 ($m) 132
Table 8.21: AstraZeneca; Leading drug class sales for respiratory disorders, global, 2003-2007
($m) 136
Table 9.22: Measurement of severity amongst COPD sufferers 142