Market Report Source

Overview

The respiratory market will continue to grow with the same rate over the next few years, with a slight dip between 2012 and 2015 due to the patent expiries of leading products. Growth is driven by the expansion of sales in existing classes, the launch of major new products with safety and convenience advantages, and the results of several landmark trials.

Scope of this report:

• Indication based forecasts for asthma/COPD products and significant pipeline drugs
• Assessment of country-specific drivers and resistors likely to impact the market
• Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates
• Market overview by geographical area, with value analysis of clinical and commercial factors underlying product performance

Research and analysis highlights:

Datamonitor expects Asthma/COPD sales in the seven major markets to grow to about $25 billion annually by 2017, with a dip between 2012 and 2015 due to patent expiries of key products. The ICS/LABA class is set to remain the leading class by value throughout, while the LAMA market will experience the strongest growth, particularly in COPD.

Novartis/Schering-Plough’s once-daily ICS/LABA product will be the top-selling single brand in the seven major markets in 2017. However, the combined sales of GSK’s Advair franchise (Advair/Seretide and once-daily Beyond Advair) will dominate the asthma/COPD market over the next ten years.

The phase-out of CFC-containing inhalers in the US after 2008 will have a big impact on the market for short-acting beta2-agonists (SABAs), increasing this class’ size significantly. The main beneficiary is expected to be Teva/UCB’s Salamol/ProAir due to its favorable price compared with other marketed HFA SABAs.

Key reasons to read this report:

• Identify key opportunities and threats that will impact the use and uptake of new and existing products
• Quantify the future size and scope of the asthma/COPD market and predict the performance of key compounds
• Understand and capitalize on clinical unmet needs in the market through both lifecycle management of marketed drugs and new product development

Table of Contents

ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious Disease and Respiratory (ID&R) pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Contributing experts 4
Related reports 5

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 7
Market definition for this report 7
Indication sales split 8
Current seven major market assessment 9
The asthma/COPD market totaled almost $20 billion in 2007 10
Advair/Seretide tops the market with sales of $5.8 billion 11
Short-acting beta2-agonist (SABA) class reached highest number of standard units sold 11
The US was the largest market with most rapid growth between 2003 and 2007 12
Future seven major market assessment 13
Comparison with previous forecast 13
Datamonitor expects the asthma/COPD market to reach sales of almost $25 billion 15
Novartis/Schering-Plough’s once-daily ICS/LABA product predicted to be best-selling product 16
Short-acting beta2-agonist (SABA) class will continue selling highest number of standard units 17
Market growth in most countries to slow down, except in Japan 18
Rest of the World snapshot 23
Rest of the world sales account for one-fifth of the respiratory market 23
Advair/Seretide also best-selling product in small and emerging markets with sales of almost $1.3 billion 25

CHAPTER 3 BRAND DYNAMICS 31
Launch of generics continue to be difficult across the respiratory market 31
Nebulized drugs represent a small share of the overall respiratory market 31
Nebulized corticosteroids 34
Nebulized bronchodilators 35
Nebulized short-acting bronchodilator combinations 36

ICS/LABA combinations 37
Combination patents are under fire 37
LABA safety issues to threaten ICS/LABA combinations? 38
Advair/Seretide (fluticasone/salmeterol) 40
COPD indications are gained and expanded 40
Forecast assumptions for Advair/Seretide (7MM) 42
Symbicort (budesonide/formoterol) 44
Symbicort faces an uphill struggle in the US 44
Forecast assumptions for Symbicort (7MM) 46
Foster (beclometasone/formoterol) 47
Forecast assumptions for Foster (Europe only) 48
Overview of once-daily ICS/LABA combination products 49
GlaxoSmithKline and Novartis/Schering-Plough’s race to launch the first once-daily ICS/LABA combination product 49
QMF149 (mometasone/indacaterol) 49
Forecast assumptions for QMF149 (7MM) 50
Beyond Advair (fluticasone furoate/642444) 51
Forecast assumptions for Beyond Advair (7MM) 53
Overview of me-too ICS/LABA combination products 54
Two me-too ICS/LABA combination products are coming close to regulatory filing 54
Flutiform (fluticasone/formoterol) 55
Forecast assumptions for Flutiform (7MM) 56
MFF258 (mometasone/formoterol) 57
Forecast assumptions for MFF258 (US and Europe only) 58
Alvesco combo (ciclesonide/formoterol) 58

Oral anti-inflammatories 59
Singulair (montelukast) 59
Multiple setbacks for montelukast franchise 59
Forecast assumptions for Singulair (7MM) 61
Accolate (zafirlukast) 61
Forecast assumptions for Accolate (7MM) 62
Onon (pranlukast) 62
Forecast assumptions for Onon (Japan only) 63

Long-acting anticholinergics (LAMAs) 63
Spiriva (tiotropium bromide) 63
Spiriva Respimat has entered the market 63
Forecast assumptions for Spiriva (7MM) 65
Novel LAMA pipeline has not moved much since last forecast 67
Forecast assumptions for aclidinium bromide (US and Europe only) 68
Forecast assumptions for glycopyrrolate (7MM) 69

Inhaled corticosteroids (ICS) 70
Traditional inhaled corticosteroids 70
Forecast assumptions for Flixotide/Flovent (7MM) 72
Forecast assumptions for all beclometasone-based products and Azmacort (7MM) 74
New once-daily corticosteroids 75
Alvesco and Asmanex’s battle over the once-daily ICS market 75
Forecast assumptions for Alvesco (7MM) 77
Asmanex (mometasone) 78
Forecast assumptions for Asmanex (7MM) 79
Nebulized corticosteroids 80
Pulmicort Respules (budesonide) 80
Success of Pulmicort Respules under threat 80
Forecast assumptions for Pulmicort Respules (nebulized) (7MM) 81
Unit Dose Budesonide 81
Forecast assumptions for Unit Dose Budesonide (UDB) (US only) 82

Long-acting beta2-agonists (LABAs) 82
Serevent (salmeterol) and Foradil (formoterol) 83
Forecast assumptions for Foradil (US and Europe only) 84
Once-daily LABA pipeline has not moved much since last forecast 85
Forecast assumptions for indacaterol (7MM) 86
Forecast assumptions for GlaxoSmithKline’s LABA (7MM) 87
Forecast assumptions for carmoterol (Europe only) 88
Nebulized LABA products 88
Two nebulized LABA products were launched in 2007 88
Brovana’s new Medicare billing code may give the drug an advantage in the short term 89
Forecast assumptions for Brovana (US only) 90
Forecast assumptions for Perforomist (US only) 90

Biologics 91
Xolair (omalizumab) 91
Forecast assumptions for Xolair (7MM) 92

Short-acting bronchodilators (SABAs and SAMAs) 93
Short-acting anticholinergics (SAMAs) 93
Forecast assumptions for Atrovent (7MM) 93
Short-acting beta2-agonists (SABAs) 94
US CFC-HFA switch in full swing 94
Forecast assumptions for (levo)salbutamol HFA products (US and Europe only) 97
Xopenex nebulized (levosalbutamol) 99
Sales of nebulized Xopenex do not seem to be affected by launch of nebulized LABAs so far 99
Reduced Medicare reimbursement rate for Xopenex nebulized may impact sales in the US 99
Forecast assumptions for Xopenex nebulized (US only) 100
Short-acting beta-2 agonist/short-acting anticholinergic (SABA/SAMA) combinations 100
Combivent (Ipratropium bromide/salbutamol) 100
Forecast assumptions for Combivent and Duoneb (US and Europe only) 101

Long-acting beta2-agonist/long-acting anticholinergic (LABA/LAMA) combinations 102
QVA149 (indacaterol/glycopyrrolate) 103
Forecast assumptions for QVA149 (7MM) 104
Bifunctional muscarinic antagonist and beta2-agonist (MABA) 105

BIBLIOGRAPHY 106
Articles 106
Press releases 106
Guidelines 108
Datamonitor reports 109

APPENDIX A – MARKET ASSUMPTIONS 110
New product launches 110
Patent expiries 112
Data definitions, limitations and assumptions 114

• Standard units 114
• Japanese market data 114
• Derivation of sales forecasts and pricing trends 114

Forecast methodology 114

APPENDIX B 116
Contributing experts 116
Report methodology 116
About Datamonitor 117

• About Datamonitor Healthcare 117
• About the Infectious Disease and Respiratory (ID&R) analysis team 118

Disclaimer 119

List of Tables

Table 1: ATC classes included in the definition of the asthma/COPD market 7

Table 2: Sales forecasts in asthma and COPD in the seven major markets ($m), 2007-2017 20

Table 3: Sales of the respiratory market in small and emerging markets in 2007 and CAGR, 2003-07 25

Table 4: Comparison of leading branded drug sales ($m) for asthma and COPD in the seven major markets and the small and emerging markets, 2007 26

Table 5: Overview of the top three small and emerging markets for each asthma/COPD-specific brand sales ($m), 2007 27

Table 6: Sales forecast ($m) for Advair/Seretide for asthma and COPD in the seven major markets, 2007-17 43

Table 7: Sales forecast ($m) for Symbicort for asthma and COPD in the seven major markets, 2007-17 47

Table 8: Sales forecast ($m) for Foster for asthma and COPD in the seven major markets, 2007-17 48

Table 9: Key once-daily ICS/LABA combination products in late-stage R&D pipeline for asthma/COPD, 2008 49

Table 10: Sales forecast ($m) for QMF149 for asthma and COPD in the seven major markets, 2007-2017 51

Table 11: Sales forecast ($m) for Beyond Advair for asthma and COPD in the seven major markets, 2013-17 53

Table 12: Key me-too ICS/LABA combination products in late-stage R&D pipeline for asthma/COPD, 2008 54

Table 13: Sales forecast ($m) for Flutiform for asthma in the seven major markets, 2007-2017 56

Table 14: Sales forecast ($m) for MFF258 for asthma and COPD in the US and 5EU, 2007-2017 58

Table 15: Sales forecast ($m) for Singulair for asthma and COPD in the seven major markets, 2007-17 61

Table 16: Sales forecast ($m) for Accolate for asthma and COPD in the seven major markets, 2007-17 62

Table 17: Sales forecast ($m) for Onon for asthma and COPD in Japan, 2007-17 63

Table 18: Sales forecast ($m) for Spiriva for asthma and COPD in the seven major markets, 2007-17 66

Table 19: Key LAMA products in the late-stage R&D pipeline for COPD, 2008 67

Table 20: Sales forecast ($m) for aclidinium bromide for COPD in the US and 5EU, 2007-17 68

Table 21: Sales forecast ($m) for glycopyrrolate for COPD in the seven major markets, 2007-17 69

Table 22: Sales forecast ($m) for darotropium for COPD in the seven major markets, 2007-17 70

Table 23: Sales forecast ($m) for Pulmicort (inhaled) for asthma and COPD in the seven major markets, 2007-17 71

Table 24: Sales forecast ($m) for Flixotide/Flovent for asthma and COPD in the seven major markets, 2007-17 72

Table 25: Sales forecast ($m) for Becotide for asthma and COPD in the 5EU, 2007-17 74

Table 26: Sales forecast ($m) for Beclazone for asthma and COPD in the US and 5EU, 2007-17 74

Table 27: Sales forecast ($m) for Qvar for asthma and COPD in Japan, 2007-17 75

Table 28: Sales forecast ($m) for Azmacort for asthma and COPD in the US, 2007-17 75

Table 29: Sales forecast ($m) for Alvesco for asthma and COPD in the seven major markets, 2007-17 78

Table 30: Sales forecast ($m) for Asmanex for asthma and COPD in the seven major markets, 2007-17 79

Table 31: Sales forecast ($m) for Pulmicort Respules (nebulized) for asthma and COPD in the seven major markets, 2007-17 81

Table 32: Sales forecast ($m) for MAP Pharma’s unit dose budesonide for asthma and COPD in the US, 2007-17 82

Table 33: Sales forecast ($m) for Serevent for asthma and COPD in the seven major markets, 2007-17 83

Table 34: Sales forecast ($m) for Foradil for asthma and COPD in the seven major markets, 2007-17 84

Table 35: Key once-daily LABA products in late-stage R&D pipeline for asthma/COPD, 2008 86

Table 36: Sales forecast ($m) for indacaterol for COPD in the seven major markets, 2007-17 86

Table 37: Sales forecast ($m) for 642444 for COPD in the seven major markets, 2007-17 87

Table 38: Sales forecast ($m) for carmoterol for COPD in the 5EU, 2007-17 88

Table 39: Sales forecast ($m) for Brovana for COPD in the US, 2007-17 90

Table 40: Sales forecast ($m) for Perforomist for COPD in the US, 2007-17 90

Table 41: Sales forecast ($m) for Xolair for asthma and COPD in the seven major markets, 2007-17 92

Table 42: Sales forecast ($m) for Atrovent for asthma and COPD in the seven major markets, 2007-17 93

Table 43: Price per standard unit (SU) for HFA salbutamol products in the US, 2005-07 95

Table 44: Sales forecast ($m) for ProAir/Salamol for asthma and COPD in the US and 5EU, 2007-17 97

Table 45: Sales forecast ($m) for Proventil for asthma and COPD in the US, 2007-17 97

Table 46: Sales forecast ($m) for Ventolin for asthma and COPD in the seven major markets, 2007-17 98

Table 47: Sales forecast ($m) for Xopenex (inhaled) for asthma and COPD in the US, 2007-17 98

Table 48: Sales forecast ($m) for Xopenex (nebulized) for asthma and COPD in the US, 2007-17 100

Table 49: Sales forecast ($m) for Combivent for asthma and COPD in the US and 5EU, 2007-17 102

Table 50: Sales forecast ($m) for Duoneb for asthma and COPD in the US, 2007-17 102

Table 51: Key LABA/LAMA combination products in late-stage R&D pipeline for COPD, 2008 103

Table 52: Sales forecast ($m) for QVA149 for COPD in the seven major markets, 2007-17 104

Table 53: Datamonitor’s launch dates for asthma and COPD products in the seven major markets, 2007-17 110

Table 54: Generic entry dates for asthma and COPD products in the seven major markets, 2007-17 112

List of Figures
Figure 1: Asthma/COPD-specific sales by class in the seven major markets ($ billions), 2003-07 10

Figure 2: Asthma/COPD-specific volume per class in the seven major markets (standard units, billions), 2003-07 12

Figure 3: Asthma/COPD-specific sales by country in the seven major markets, 2003-07 13

Figure 4: Asthma/COPD-specific sales by class in the seven major markets ($ billions), 2007-17 16

Figure 5: Asthma/COPD-specific volume per class in the seven major markets (standard units, billions), 2007-17 18

Figure 6: Asthma/COPD-specific sales by country in the seven major markets, 2007-17 19

Figure 7: Seven major markets versus rest of the world sales split for the respiratory market, 2003 and 2007 23

Figure 8: Indexed annual global sales of the respiratory market in small and emerging markets, 2003-07 24

Figure 9: Sales of the respiratory market by method of drug delivery, in the US and 5EU, 2007 33

Figure 10: Asthma/COPD-specific sales of nebulized inhaled corticosteroids in the US and 5EU ($m), 2003-07 35

Figure 11: Asthma/COPD-specific sales of nebulized bronchodilators in the US and 5EU ($m), 2003-07 36

Figure 12: Asthma/COPD-specific sales of nebulized short-acting bronchodilator combinations in the US and 5EU ($m), 2003-07 37

Figure 13: Asthma/COPD-specific sales of long-acting beta2-agonists in the seven major markets by country ($m), 2003-07 39

Figure 14: Overview of developments of Symbicort and Advair/Seretide in 2007-08 41

Figure 15: Asthma/COPD-specific sales ($ billion) for Advair/Seretide and Symbicort in the seven major markets, 2003-07 42

Figure 16: Market share in terms of sales of Advair/Seretide, Symbicort and Foster in the US and 5EU, 2003-07 45

Figure 17: Overview of developments for Flutiform in 2007-08 56

Figure 18: Asthma- and allergic rhinitis-specific sales ($ billions) for Singulair in the seven major markets, 2003-07 60

Figure 19: Asthma/COPD-specific sales ($m) for Spiriva HandiHaler and Spiriva Respimat in Germany and the UK, 2003-07 64

Figure 20: Asthma/COPD-specific sales ($m) for Berodual in Germany, 2003-07 65

Figure 21: Asthma/COPD-specific sales ($m) for Pulmicort and Flixotide/Flovent in the seven major markets, 2003-07 71

Figure 22: Asthma/COPD-specific sales ($m) for Beclazone, Azmacort, Qvar and Becotide in the seven major markets, 2003-07 73

Figure 23: Asthma/COPD-specific sales ($m) for Alvesco and Asmanex in the seven major markets, 2003-07 76

Figure 24: Overview of developments regarding Pulmicort Respules’s patent challenge by IVAX, 2005-07 80

Figure 25: Asthma/COPD-specific sales ($m) for Serevent, Foradil and generic formoterol in the seven major markets, 2003-07 83

Figure 26: Asthma/COPD-specific sales ($m) for HFA and CFC containing short-acting beta2-agonists in the US, 2003-07 96

Figure 27: Asthma/COPD-specific sales ($m) for Xopenex, Perforomist and Brovana in the US, 2003-07 99