Introduction

Detailed analysis of the Asthma and COPD market. 10 year sales forecast for all major drugs brands in these indications, taking into account new treatment trends, clinical trial data, patent expirations and key new product launches in the 7 major markets.

Scope

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

Highlights

Asthma/COPD sales in the seven major markets are expected to grow to over $24 billion annually by 2010 and drop slightly thereafter 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. A once-daily LABA/LAMA product should become the top-selling single brand in the seven major markets in 2016, depending on which company launches such a combination product first. However, combined sales of the 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 IVAX's (now Teva) ProAir due to its favourable price compared with other marketed HFA SABAs.

Reasons to Purchase

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 future performance of key compounds Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development

ABOUT DATAMONITOR HEALTHCARE 2
About the respiratory pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the asthma/COPD market 3
Contributing experts 5
Related reports 5
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 7
Market definition for this report 7
Indication sales split 8
Current market situation 9
Strategic scoping and focus 13
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 14
Summary of environmental issues affecting the asthma/COPD market 14
Opportunities and threats in the seven major markets 15
Opportunities 15
Off-label prescribing is popular in the pediatric asthma market 15
EMEA harmonizes drug approval process 17
Smaller companies helped by European regulators 18
Threats 18
Governments try to stop increasing healthcare expenditure by controlling pricing and reimbursement 18
Parallel trading threatens return on investment 21
Asthma and COPD prevalence will remain stable 22
Non-compliance is particularly common in asthma 25
Difficulty in conducting clinical trials in COPD 27
US: opportunities and threats 27
Asthma/COPD market overview 27
Opportunities 28
New asthma clinical trial endpoints open doors 28
The CFC-HFA switch will lead to a branded salbutamol market 31
FDA initiatives to decrease product development times 31
US is the only country to allow direct-to-consumer (DTC) advertising of prescription medicines 32
Threats 34
Reimbursement controls are important in decreasing healthcare expenditure in the US 34
Implementation of Medicare Part D influences US healthcare market 35
Parallel trading could increase due to Medicare D's 'donut hole' 36
Prescription Drug User Fee Act (PDUFA) likely to increase fees 37
Reimbursement of nebulized beta2-agonists in COPD are under pressure 38
Japan: opportunities and threats 38
Asthma/COPD market overview 38
Opportunities 39
Characteristics of Japanese society impact the COPD market in particular 39
Separation of manufacturing and marketing entities benefits both Japanese and foreign companies 41
Japan shows initiatives to open their market 41
Threats 42
Price cuts still dominate pricing and reimbursement in Japan 42
Increasing uptake of generics 43
Lengthy approval process slows down access to the Japanese market 44
COPD remains underdiagnosed and undertreated 45
France: opportunities and threats 45
Asthma/COPD market overview 45
Opportunities 46
Generics use is still relatively low in France 46
Pricing and reimbursement negotiations to be shortened by new agency 47
Threats 47
France increases its pricing and reimbursement efforts 47
Varying formularies influence hospital prescribing 49
Germany: opportunities and threats 49
Asthma/COPD market overview 49
Opportunities 50
Encouraging environment for novel drug development 50
ePharmacy and mail-order drugs legalized 51
Disease management programs encourage patients to be more involved 51
Threats 52
Reimbursement controls are important in decreasing healthcare expenditure in Germany 52
Generic penetration in Germany is relatively high 54
Germany focuses attention on high doses of medicines for elderly patients 54
ICS/LABA combinations under scrutiny 55
Italy: opportunities and threats 55
Asthma/COPD market overview 55
Opportunities 56
Generic drugs play a small role in Italy 56
Reimbursement negotiations are less restrictive 57
Threats 58
Italy increases its pricing and reimbursement efforts 58
Spain: opportunities and threats 59
Asthma/COPD market overview 59
Opportunities 60
The pharmaceutical industry implements strategies to reduce parallel exportation 60
Health ministry introduces 'Spanish national formulary' 61
Threats 61
The introduction of a new medicines bill increases the focus on cost containment in Spain 61
The profile of generics is being raised in Spain 63
UK: opportunities and threats 64
Asthma/COPD market overview 64
Opportunities 65
The UK offers an attractive market 65
The pricing and reimbursement environment in the UK is relatively non-restrictive 66
Threats 67
The UK enjoys a strong generics market 67
The post-guidance and pre-guidance effects of NICE are a significant concern 68
CHAPTER 4 FORECAST ANALYSIS 69
Key events 69
Inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combinations 69
Advair/Seretide will lose first position in ICS/LABA class 71
Symbicort US approval and SMART approach will boost sales 72
Foster competes on price 75
New product launches 77
Major clinical trials 85
Additional indications 88
Patent expiries 89
Oral anti-inflammatories 90
Singulair will remain highest selling NSAID but will suffer from generic entry and new competitors 92
New product launches 94
Additional indications 98
Patent expiries 99
Long-acting anticholinergics (LAMAs) 99
BI tries to differentiate Spiriva before the entry of new competitors 101
New product launches 104
Major clinical trials 112
Additional indications 113
Patent expiries 113
Inhaled corticosteroids (ICS) 114
Pulmicort and Flixotide remain the highest-selling ICS products 115
New product launches 117
Additional indications 124
Patent expiries 125
Long-acting beta2-agonists (LABAs) 125
Serevent and Foradil lead the LABA class 126
New product launches 127
Major clinical trials 135
Patent expiries 137
Biologicals 137
Xolair to become blockbuster by 2014 138
New product launches 143
Additional indications 145
Patent expiries 145
Short-acting beta2-agonists (SABAs) 146
Sepracor's Xopenex franchise to reach revenues of over $1 billion 148
IVAX/Teva's ProAir set to make most out of CFC-HFA switch in the US 151
Combivent sales to decline slightly 152
Short-acting anticholinergics (SAMAs) 154
Other asthma and COPD therapies 155
Bronchial thermoplasty 155
Antibiotics 159
Immunotherapy 162
Data definitions, limitations and assumptions 164
Standard Units 164
Japanese Market Data 164
Derivation of Sales Forecasts and Pricing Trends 164
Regional launch dates for new products 165
Generic Erosion and Pricing Assumptions 165
The 'Others' class 167
Forecasts 167
Forecast methodology 167
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 168
The strategies behind combination products 168
Pricing 169
First-to-market advantage 169
Patent protection 170
Combinations are here to stay 171
The impact of the CFC-HFA switch in the US 172
HFA as alternative to CFC 173
3M's patents will prevent entry of other HFA SABAs 174
ProAir will be highest-selling SABA after 2009 with peak sales of $650m 175
The increasing importance of inhaler devices in the asthma/COPD market 177
Lack of detailed guidelines and physician skills 178
pMDIs versus DPIs 179
The ideal inhaler 180
The Novolizer and the Respimat SMI 181
The Novolizer - optimal patient feedback and fine particles 181
The Respimat SMI - slow moving mist with deep lung penetration 182
BIBLIOGRAPHY 184
Bibliography 184
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS 203
Summary asthma/COPD market data 203
ICS/LABA combinations market data 207
ICS/LABA combinations market data 207
Anticholinergics market data 210
Biologicals market data 215
Oral anti-inflammatories market data 216
Beta2-agonists market data 220
Inhaled corticosteroids (ICS) market data 226
APPENDIX B - MARKET FORECAST DATA 236
Market forecast data 236
APPENDIX C 258
Contributing experts 258
Report methodology 258
About Datamonitor 258
About Datamonitor Healthcare 259
About the respiratory and infectious disease analysis team 260
Disclaimer 261
List of Tables
Table 1: Prescription of off-label and unlicensed drugs in pediatrics 16
Table 2: Sales of ICS/LABA combination products in the seven major markets ($m), 2006-2016 70
Table 3: Price difference between launched ICS/LABA combination products in Germany, 2007 76
Table 4: Sales of oral anti-inflammatory products in the seven major markets ($m), 2006-2016 91
Table 5: Sales of long-acting anticholinergic products in the seven major markets ($m), 2006-2016 100
Table 6: Sales of inhaled corticosteroid products in the seven major markets ($m), 2006-2016 115
Table 7: Sales of long-acting beta2-agonist products in the seven major markets ($m), 2006-2016 126
Table 8: GSK pool of LABA candidates in Phase II trials, 2006 129
Table 9: Sales of monoclonal antibody products in the seven major markets ($m), 2006-2016 138
Table 10: Sales of short-acting betas2-agonist products in the seven major markets ($m), 2006-2016 148
Table 11: Sales of short-acting anticholinergic products in the seven major markets ($m), 2006-2016 155
Table 12: Costs per bronchoscopy 158
Table 13: Launch forecast assumptions used in the asthma/COPD market, 2007 165
Table 14: Generic erosion in the seven major markets over 3 years (%) 166
Table 15: Generic price discounts in the seven major markets (%) 166
Table 16: Classes rolled up into the 'Others' category by country 167
Table 17: Prices of HFA (levo)salbutamol products in 2006 175
Table 18: US - Summary market data, 2006 and 2016 203
Table 19: Japan - Summary market data, 2006 and 2016 204
Table 20: France - Summary market data, 2006 and 2016 204
Table 21: Germany - Summary market data, 2006 and 2016 205
Table 22: Italy - Summary market data, 2006 and 2016 205
Table 23: Spain - Summary market data, 2006 and 2016 206
Table 24: UK - Summary market data, 2006 and 2016 206
Table 25: Advair/Seretide: key facts 207
Table 26: Symbicort: key facts 208
Table 27: Foster: key facts 209
Table 28: Spiriva: key facts 210
Table 29: Atrovent: key facts 211
Table 30: Combivent: key facts 212
Table 31: Duoneb: key facts 213
Table 32: Berodual: key facts 214
Table 33: Xolair: key facts 215
Table 34: Singulair: key facts 216
Table 35: Accolate: key facts 217
Table 36: Onon: key facts 218
Table 37: Zyflo: key facts 219
Table 38: Serevent: key facts 220
Table 39: Foradil: key facts 221
Table 40: Ventolin: key facts 222
Table 41: Proventil: key facts 223
Table 42: Xopenex: key facts 224
Table 43: ProAir: key facts 225
Table 44: Pulmicort: key facts 226
Table 45: Flixotide/Flovent: key facts 227
Table 46: Becotide: key facts 228
Table 47: Qvar: key facts 229
Table 48: Beclazone: key facts 230
Table 49: Clenil: key facts 231
Table 50: Azmacort: key facts 232
Table 51: Aerobid: key facts 233
Table 52: Alvesco: key facts 234
Table 53: Asmanex: key facts 235
Table 54: Seven major markets - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 236
Table 55: Five major European markets - forecast salesin the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 239
Table 56: US - forecast sales in the asthma/COPD amrket, 2006-2016 ($m; 2006 figures are actuals) 242
Table 57: Japan - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 245
Table 58: France - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 247
Table 59: Germany - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 249
Table 60: Italy - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 251
Table 61: Spain - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 253
Table 62: UK - forecast sales in the asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals) 255
List of Figures
Figure 1: Total sales in the seven major markets, by class ($bn), 2002-2006 10
Figure 2: Asthma/COPD market by class and value in the seven major markets, 2006 11
Figure 3: Top five brands by sales in seven major markets ($bn), 2006 12
Figure 4: Respiratory market sales split by country ($m), 2006-2016 13
Figure 5: Summary of environmental issues affecting the asthma/COPD market, 2007 14
Figure 6: Healthcare spending as a proportion of GDP in the seven major markets, 2004 20
Figure 7: Key pricing controls used globally, 2006 21
Figure 8: Trends in the prevalence of asthma symptoms according to the ISAAC Phase Three study, 2006 23
Figure 9: Percentage of daily smokers among adult population 24
Figure 10: US sales of asthma/COPD treatments by class ($bn), 2002-2006 28
Figure 11: Different endpoints show different profile of high versus low dose budesonide 29
Figure 12: Traditional and possible novel endpoints in asthma and COPD trials 30
Figure 13: Decrease of FDA's mean total approval time, 1995-2005 32
Figure 14: Japan sales of asthma/COPD treatments by class ($bn), 2002-2006 39
Figure 15: Increase in life expectancy between 1960 and 2003 across the seven major markets 40
Figure 16: France sales of asthma/COPD treatments by class ($bn), 2002-2006 46
Figure 17: Germany sales of asthma/COPD treatments by class ($bn), 2002-2006 50
Figure 18: Italy sales of asthma/COPD treatments by class ($bn), 2002-2006 56
Figure 19: Spain sales of asthma/COPD treatments by class ($bn), 2002-2006 60
Figure 20: UK sales of asthma/COPD treatments by class ($bn), 2002-2006 65
Figure 21: Sales of the ICS/LABA combination class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 70
Figure 22: Sales of Advair/Seretide, Symbicort and Foster in the seven major markets ($bn), 2006-2016 77
Figure 23: Once daily QAB149 is comparable to twice-daily formoterol 79
Figure 24: Sales of Advair/Seretide, Beyond Advair, Advair family and QMF149 in the seven major markets ($bn), 2006-2016 81
Figure 25: Sales of Alvesco Combo, Flutiform and MFF258 in the seven major markets ($m), 2006-2016 85
Figure 26: Sales of the oral anti-inflammatories class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 91
Figure 27: Sales of Singulair, Onon and Accolate in the seven major markets ($m), 2006-2016 94
Figure 28: Sales of Zyflo, Zileuton CR and MN-001 in the seven major markets ($m), 2006-2016 97
Figure 29: Sales of the long-acting anticholinergic class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 100
Figure 30: The Respimat Soft Mist Inhaler 102
Figure 31: Sales of Spiriva in the seven major markets ($bn), 2006-2016 104
Figure 32: Sales of LAS 34273, NVA237 and GSK's LAMA in the seven major markets ($m), 2006-2016 108
Figure 33: Sales of QVA149 in the seven major markets ($m), 2006-2016 111
Figure 34: Sales of the inhaled corticosteroid class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 114
Figure 35: Sales of Pulmicort and Flixotide/Flovent in the seven major markets ($m), 2006-2016 116
Figure 36: Sales of beclometasone-based inhalers in the seven major markets ($m), 2006-2016 117
Figure 37: Sales of Asmanex and Alvesco in Germany ($m), 2003-2006 119
Figure 38: Sales of Asmanex and Alvesco in the seven major markets ($m), 2006-2016 122
Figure 39: Patient potential for a once-daily anti-inflammatory for the treatment of COPD in the seven major markets, 2007 124
Figure 40: Sales of the long-acting beta2-agonist class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 126
Figure 41: Sales of Serevent and Foradil in the seven major markets ($m), 2006-2016 127
Figure 42: Sales of QAB149, GSK's LABA and CHF 4226 in the seven major markets ($m), 2006-2016 132
Figure 43: Trials on safety and efficacy of Brovana and Perforomist, 2007 134
Figure 44: Sales of Brovana and Perforomist in the seven major markets ($m), 2006-2016 135
Figure 45: Sales of the biologicals class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 138
Figure 46: Patient potential for Xolair in the US, 2007 141
Figure 47: Patient potential for Xolair in Europe, 2007 142
Figure 48: Sales of Xolair in the seven major markets ($m), 2006-2016 143
Figure 49: Patient potential for a once-daily monoclonal antibody for the treatment of severe/refractory asthma in the seven major markets, 2007 144
Figure 50: Sales of the short-acting beta2-agonist class compared to overall asthma/COPD sales in the seven major markets ($bn), 2006-2016 147
Figure 51: Sales of Xopenex Nebulized and HFA in the seven major markets ($m), 2006-2016 151
Figure 52: Sales of Ventolin, Proventil and ProAir in the seven major markets ($m), 2006-2016 152
Figure 53: Sales of Combivent and Duoneb in the seven major markets ($m), 2006-2016 154
Figure 54: Sales of Atrovent in the seven major markets ($m), 2006-2016 155
Figure 55: Possible patient potential for bronchial thermoplasty in the US, 2007 157
Figure 56: Possible revenues for Asthmatx in the US 159
Figure 57: The roles of viral and bacterial infections in asthma 160
Figure 58: Cannibalization versus expansion strategy 169
Figure 59: Sales of Advair/Seretide versus its components in the US ($bn), 2002-2006 170
Figure 60: First-year of launch and 2016 sales of marketed and pipeline combination products 172
Figure 61: Generic CFC salbutamol market will revert to branded HFA salbutamol market in the US after December 2008 175
Figure 62: Overview of the salbutamol and levosalbutamol market, HFA versus other, and the impact of the CFC-HFA switch, 2006-2008 176
Figure 63: Sales of HFA (levo)salbutamol products, 2006-2016 177
Figure 64: The Novolizer has the characteristics of an ideal inhaler device 182
Figure 65: Respimat SMI demonstrates better lung deposition compared with conventional MDIs 183