Forecast Insight: Asthma/COPD - Little long-term future for long-acting single-agent inhalers?

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 13
Market definition for this report 13
Indication sales split 14
Current seven major market assessment 15
The asthma/COPD market totaled almost $20 billion in 2007 16
Advair/Seretide tops the market with sales of $5.8 billion 17
Short-acting beta2-agonist (SABA) class reached highest number of standard units sold 17
The US was the largest market with most rapid growth between 2003 and 2007 18
Future seven major market assessment 19
Comparison with previous forecast 19
Datamonitor expects the asthma/COPD market to reach sales of almost $25 billion 21
Novartis/Schering-Plough’s once-daily ICS/LABA product predicted to be best-selling product 22
Short-acting beta2-agonist (SABA) class will continue selling highest number of standard units 23
Market growth in most countries to slow down, except in Japan 24
Rest of the World snapshot 29
Rest of the world sales account for one-fifth of the respiratory market 29
Advair/Seretide also best-selling product in small and emerging markets with sales of almost $1.3 billion 31

CHAPTER 3 BRAND DYNAMICS 37
Launch of generics continue to be difficult across the respiratory market 37
Nebulized drugs represent a small share of the overall respiratory market 37
Nebulized corticosteroids 40
Nebulized bronchodilators 41
Nebulized short-acting bronchodilator combinations 42
ICS/LABA combinations 43
Combination patents are under fire 43
LABA safety issues to threaten ICS/LABA combinations? 44
Advair/Seretide (fluticasone/salmeterol) 46
COPD indications are gained and expanded 46
Forecast assumptions for Advair/Seretide (7MM) 48
Symbicort (budesonide/formoterol) 50
Symbicort faces an uphill struggle in the US 50
Forecast assumptions for Symbicort (7MM) 52
Foster (beclometasone/formoterol) 53
Forecast assumptions for Foster (Europe only) 54
Overview of once-daily ICS/LABA combination products 55
GlaxoSmithKline and Novartis/Schering-Plough’s race to launch the first once-daily ICS/LABA combination product 55
QMF149 (mometasone/indacaterol) 55
Forecast assumptions for QMF149 (7MM) 56
Beyond Advair (fluticasone furoate/642444) 57
Forecast assumptions for Beyond Advair (7MM) 59
Overview of me-too ICS/LABA combination products 60
Two me-too ICS/LABA combination products are coming close to regulatory filing 60
Flutiform (fluticasone/formoterol) 61
Forecast assumptions for Flutiform (7MM) 62
MFF258 (mometasone/formoterol) 63
Forecast assumptions for MFF258 (US and Europe only) 64
Alvesco combo (ciclesonide/formoterol) 64
Oral anti-inflammatories 65
Singulair (montelukast) 65
Multiple setbacks for montelukast franchise 65
Forecast assumptions for Singulair (7MM) 67
Accolate (zafirlukast) 67
Forecast assumptions for Accolate (7MM) 68
Onon (pranlukast) 68
Forecast assumptions for Onon (Japan only) 69
Long-acting anticholinergics (LAMAs) 69
Spiriva (tiotropium bromide) 69
Spiriva Respimat has entered the market 69
Forecast assumptions for Spiriva (7MM) 71
Novel LAMA pipeline has not moved much since last forecast 73
Forecast assumptions for aclidinium bromide (US and Europe only) 74
Forecast assumptions for glycopyrrolate (7MM) 75
Inhaled corticosteroids (ICS) 76
Traditional inhaled corticosteroids 76
Forecast assumptions for Flixotide/Flovent (7MM) 78
Forecast assumptions for all beclometasone-based products and Azmacort (7MM) 80
New once-daily corticosteroids 81
Alvesco and Asmanex’s battle over the once-daily ICS market 81
Forecast assumptions for Alvesco (7MM) 83
Asmanex (mometasone) 84
Forecast assumptions for Asmanex (7MM) 85
Nebulized corticosteroids 86
Pulmicort Respules (budesonide) 86
Success of Pulmicort Respules under threat 86
Forecast assumptions for Pulmicort Respules (nebulized) (7MM) 87
Unit Dose Budesonide 87
Forecast assumptions for Unit Dose Budesonide (UDB) (US only) 88
Long-acting beta2-agonists (LABAs) 88
Serevent (salmeterol) and Foradil (formoterol) 89
Forecast assumptions for Foradil (US and Europe only) 90
Once-daily LABA pipeline has not moved much since last forecast 91
Forecast assumptions for indacaterol (7MM) 92
Forecast assumptions for GlaxoSmithKline’s LABA (7MM) 93
Forecast assumptions for carmoterol (Europe only) 94
Nebulized LABA products 94
Two nebulized LABA products were launched in 2007 94
Brovana’s new Medicare billing code may give the drug an advantage in the short term 95
Forecast assumptions for Brovana (US only) 96
Forecast assumptions for Perforomist (US only) 96
Biologics 97
Xolair (omalizumab) 97
Forecast assumptions for Xolair (7MM) 98
Short-acting bronchodilators (SABAs and SAMAs) 99
Short-acting anticholinergics (SAMAs) 99
Forecast assumptions for Atrovent (7MM) 99
Short-acting beta2-agonists (SABAs) 100
US CFC-HFA switch in full swing 100
Forecast assumptions for (levo)salbutamol HFA products (US and Europe only) 103
Xopenex nebulized (levosalbutamol) 105
Sales of nebulized Xopenex do not seem to be affected by launch of nebulized LABAs so far 105
Reduced Medicare reimbursement rate for Xopenex nebulized may impact sales in the US 105
Forecast assumptions for Xopenex nebulized (US only) 106
Short-acting beta-2 agonist/short-acting anticholinergic (SABA/SAMA) combinations 106
Combivent (Ipratropium bromide/salbutamol) 106
Forecast assumptions for Combivent and Duoneb (US and Europe only) 107
Long-acting beta2-agonist/long-acting anticholinergic (LABA/LAMA) combinations 108
QVA149 (indacaterol/glycopyrrolate) 109
Forecast assumptions for QVA149 (7MM) 110
Bifunctional muscarinic antagonist and beta2-agonist (MABA) 111

BIBLIOGRAPHY 112
Articles 112
Press releases 112
Guidelines 114
Datamonitor reports 115

APPENDIX A – MARKET ASSUMPTIONS 116
New product launches 116
Patent expiries 118
Data definitions, limitations and assumptions 120
Standard units 120
Japanese market data 120
Derivation of sales forecasts and pricing trends 120
Forecast methodology 120

APPENDIX B 122
Contributing experts 122
Report methodology 122
About Datamonitor 123
About Datamonitor Healthcare 123
About the Infectious Disease and Respiratory (ID&R) analysis team 124
Disclaimer 125