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