NEW YORK, Aug. 10 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Introduction
Datamonitor estimates 2009 allergic rhinitis sales of $5 billion in the seven major markets, and forecasts a decline to $4.2 billion by 2019. The greatest threat to the market is generics, with drug classes having differing vulnerability to generic erosion. While the symptomatic treatment sales will decrease, immunotherapy sales are on the rise, with changing regulations dictating development.
Scope
*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs
*Assessment of key drug classes for allergic rhinitis, with analysis of impacting events and a 10 year sales forecast split by indication
*In-depth discussion of the role of immunotherapy in allergic rhinitis, with analysis of developments, regulations, and pipeline products
*Interactive patient-based forecasts of 3 immunotherapy products, with a discussion of their relative strengths and weaknesses
Highlights
Datamonitor estimates 2009 allergic rhinitis sales in the seven major markets of $5 billion. This is forecast to drop to $4.2 billion in 2019, driven by the entrance of cheap generics, most notably in the US. Oral antihistamines are the more vulnerable to generic erosion, while nasal corticosteroids are partially protected by their device.
Reformulation of molecules and combinations are common, but timing is key. In 2009, Merck's Clarinex (desloratadine) had a quarter of Claritin's (loratadine) peak sales, having launched after generics. Meda Pharma's azelastine follow-on has seen more success launching prior to patent expiry and Meda Pharma is now combining the drug with a steroid.
Changing regulations are driving development of immunotherapies, with large-scale development programs seen in recent years. While immunotherapy is expected to remain a niche market, significant growth is forecast. Two sublingual grass tablets, Grazax (ALK-Abello) and Oralair (Stallergenes) forecast to have sales of $250m in the US and EU by 2019.
Reasons to Purchase
*Understand allergic rhinitis market trends, including life cycle management, current sales, and a 10 year sales forecast of symptomatic treatments
*Gain insight into the immunotherapy market and access patient based forecasts of three key immunotherapy products, with interactive assumptions
*Use analysis of key companies in the market and see how allergic rhinitis contributes to total brand sales
OVERVIEW 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Immunology & Inflammation pharmaceutical analysis team 2
EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the allergic rhinitis market 3
Related reports 4
Upcoming related reports 4
TABLE OF CONTENTS 4
1. PATIENT AND MARKET OVERVIEW 5
Key findings 5
Market definition for this report 6
Sales split by indication 6
Over- the-counter market impact 8
Patient potential 9
Disease definition 9
Patient segmentation 10
Seven major markets 11
Rest of World 17
Prevalence of key allergic diseases 18
Allergens 19
Market overview 20
Opportunities and threats 22
Seven major market opportunities and threats 23
Opportunity 1 - over-the-counter (OTC) status may extend revenue after patent expiry 23
Opportunity 2 - increasing awareness of allergic rhinitis 24
Opportunity 3 - allergy seasons start earlier, last longer and are more intense 25
Threat 1: governments reductions in healthcare expenditure through controlling pricing and reimbursement 26
Threat 2: key patent expires will change the allergic rhinitis market 27
US: opportunities and threats 27
Allergic rhinitis market overview 27
US formulary tier status for leading brands 28
Opportunities 30
Opportunity 1 - the OTC market is becoming more important in the US 30
Opportunity 2 - direct-to-consumer (DTC) advertising of prescription medicines highly influential in the US 31
Threats 32
Threat 1 - reimbursement controls reduce healthcare expenditure in the US 32
Threat 2 - generic entry to shrink the allergic rhinitis market 32
Japan: opportunities and threats 33
Allergic rhinitis market overview 33
Opportunity 1 - new regulation of OTC drugs 34
Opportunity 2 - no gatekeeper system 35
Threat 1 - generic influence to grow 35
Threat 2 - long approval process dampens access to Japanese market 35
EU: opportunities and threats 36
Allergic rhinitis market overview 36
Opportunity 1 - generic markets less developed than in the US 37
Threat 1 - cost containment policies to impact drug prices 38
Threat 2 - reimbursement policies impact allergic rhinitis drug classes 38
Unmet needs 38
Clinical unmet needs 39
Lack of a cure 39
Uncontrolled disease 40
Suboptimal therapy 40
Environmental unmet needs 40
Patient behavior 40
Lack of public attention 42
Clinical trial design in allergic rhinitis 42
New trends in endpoints 42
Challenges with seasonality of disease 44
Study populations 44
Comparator drugs 45
Guidelines in immunotherapy 45
Key companies involved in the allergic rhinitis market 46
2. ORAL ANTIHISTAMINE FRANCHISES 50
Key findings 50
Overview of oral antihistamines 50
Oral antihistamine market size 52
Allegra/Allegra-D franchise (fexofenadine, Sanofi-Aventis) 53
Franchise profile 55
Product positioning 55
Telfast/Allegra (fexofenadine; Sanofi-Aventis) 55
Allegra-D (fexofenadine/pseudoephedrine; Sanofi-Aventis) 56
SWOT analysis 57
Brand forecast to 2019 58
Telfast/Allegra forecast assumptions 58
Allegra-D forecast assumptions 59
Zyrtec/Zyrtec-D/Xyzal franchise (levocetirizine, UCB/Sepracor/Sanofi-Aventis) 62
Franchise profile 64
Product positioning 65
Zyrtec (cetirizine; UCB) 65
Zyrtec-D (cetirizine/pseudoephedrine; UCB/Pfizer) 66
Xyzal (levocetirizine; UCB and Sepracor) 66
SWOT analysis 67
Brand forecast to 2019 68
Zyrtec forecast assumptions 69
Zyrtec-D forecast assumptions 69
Xyzal forecast assumptions 69
Claritin/Clarinex/Clarinex-D franchise (loratadine/desloratadine; Merck) 72
Franchise profile 74
Product positioning 75
Claritin (loratadine; Merck) 75
Aerius/Clarinex (desloratadine; Merck) 75
Clarinex-D (desloratadine/pseudoephedrine; Merck) 76
SWOT analysis 76
Brand forecast to 2019 77
Late-stage development compounds recently discontinued 81
Epinastine (Inspire) 81
3. NASAL CORTICOSTEROIDS 82
Key findings 82
Overview for nasal corticosteroids 82
Nasal corticosteroid market size 83
Nasonex (mometasone; Merck) 85
Drug profile 86
Product positioning 86
SWOT analysis 87
Brand forecast to 2019 88
Flixonase/Flonase/Veramyst franchise (fluticasone) GlaxoSmithKline 90
Drug profile 91
Product positioning 92
Flixonase/Flonase (fluticasone propionate; GlaxoSmithKline) 92
Veramyst (fluticasone furoate; GlaxoSmithKline) 92
SWOT analysis 94
Brand forecast to 2019 94
Rhinocort (budesonide; AstraZeneca) 96
Drug profile 97
Product positioning 97
SWOT analysis 98
Brand forecast to 2019 98
Omnair/Omnaris (ciclesonide; Nycomed/Sepracor) 100
Drug profile 101
Product positioning 101
SWOT analysis 103
Brand forecast to 2019 104
4. NASAL ANTIHISTAMINES 107
Key findings 107
Overview for nasal antihistamines 107
Nasal antihistamine market size 107
Astelin/Astepro (azelastine); Meda Pharma 109
Franchise profile 111
Product positioning 111
Astelin (azelastine, Meda Pharma) 111
Astepro (azelastine; Meda Pharma) 112
SWOT analysis 113
Brand forecast to 2019 114
Patanase (olopatadine; Alcon) 116
Drug profile 117
Product positioning 117
SWOT analysis 118
Brand forecast to 2019 118
5. ANTILEUKOTRIENES 120
Key findings 120
Overview of antileukotrienes 120
Antileukotriene market size 120
Singulair (montelukast; Merck and Kyorin Pharmaceuticals) 122
Drug profile 123
Product positioning 123
SWOT analysis 125
Brand forecast to 2019 125
Onon (pranlukast; Ono Pharmaceuticals) 127
Drug profile 128
Product positioning 128
SWOT analysis 128
Onon forecast assumptions 129
Late-stage development compounds recently discontinued 131
Loratadine/montelukast (Merck) 131
6. IMMUNOTHERAPY 133
Key findings 133
Overview of immunotherapy 133
Developments in immunotherapy for allergic rhinitis 135
Methodology and comparative forecasts 144
Sensitivity analysis 146
Grazax (ALK-Abelló) 147
Drug profile 149
Product positioning 149
Clinical trial data 150
EU clinical trial results 150
US clinical trial results 152
SWOT analysis 154
Brand forecast to 2019 154
Stalair Program (Stallergènes) 156
Product profile 158
Product positioning 158
Oralair Grasses (pollen; Stallergenes) 158
Clinical trial data 159
EU clinical trial results 159
US clinical trial results 161
Stalair Betv1 (pollen, Stallergènes) 161
Actair (dust mite; Stallergènes) 163
SWOT analysis 163
Brand forecast to 2019 164
Pollinex Quattro (Allergy Therapeutics) 166
Product profile 167
Product positioning 167
Clinical trial data 168
SWOT analysis 169
Brand forecast to 2019 170
Fornix's sells allergy division to ALK-Abelló 172
Allergopharma moving into sublingual immunotherapy 173
Roxall and Dr. Beckman collaboration 173
Greer developing sublingual immunotherapy 173
7. PIPELINE DYNAMICS 175
Key findings 175
Pipeline overview 175
Azelastine/Fluticasone (MP2902; Meda/Cipla) 179
Drug profile 179
Clinical trial data 179
Product positioning 181
SWOT analysis 182
Brand forecast to 2019 182
CDX-313 (azelastine/budesonide; CyDex) 184
Drug profile 184
Clinical trial data 184
Product positioning 185
8. CASE STUDY 186
Introduction 186
Nasal corticosteroids 187
Antihistamines 191
BIBLIOGRAPHY 198
Journal papers 198
Websites 202
Datamonitor reports 210
APPENDIX A - MARKET ASSUMPTIONS 211
Forecasting assumptions 211
New product launches 211
Patent expiries 211
Data definitions, limitations and assumptions 212
Standard units 212
Derivation of sales forecasts and pricing trends 212
Exchange rates 213
APPENDIX B - ALLERGIES PREVALENCE SOURCES 214
APPENDIX C 215
Contributing experts 215
Conferences attended 215
Report methodology 215
About Datamonitor 215
About Datamonitor Healthcare 215
About the Disease analysis team 216
Datamonitor consulting 216
Disclaimer 216
LIST OF TABLES
Table 1: MIDAS Prescribing Insights Physician Coverage, 2010 7
Table 2: Adult and pediatric allergic rhinitis prevalent populations in the seven major markets, 2010 13
Table 3: Allergic rhinitis prevalence literature review, 2010 15
Table 4: BRIC nations allergic rhinitis population, 2010 18
Table 5: Most common allergens in the US and EU 20
Table 6: Time trends in hay fever or allergic rhinitis in school-age children in the UK, Finland, and Germany, 1973-1996 25
Table 7: US formulary tier status for leading brands in allergic rhinitis, 2010 29
Table 8: Telfast/Allegra and Allegra-D - franchise profile, 2010 55
Table 9: Sales forecasts for Telfast/Allegra, Allegra-D in allergic rhinitis in the seven major markets ($ 000), 2009-2019 61
Table 10: Zyrtec/Zyrtec-D/Xyzal (levocetirizine; UCB) - franchise profile, 2010 64
Table 11: Sales forecasts for Zyrtec, Xyzal and Zyrtec-D for allergic rhinitis in the seven major markets ($ 000s), 2009-2019 71
Table 12: Claritin/Clarinex/Clarinex-D (des/loratadine/pseudoephedrine; Merck - franchise profile, 2010 74
Table 13: Sales forecasts for Aerius/Clarinex, Clarinex-D, and Claritin in allergic rhinitis in the seven major markets ($ 000s), 2009-2019 80
Table 14: Nasonex - drug profile, 2010 86
Table 15: Sales forecasts for Nasonex in allergic rhinitis in the seven major markets ($ 000s), 2009-2019 90
Table 16: Flixonase/Flonase/Veramyst - franchise profile, 2010 91
Table 17: Sales forecasts for Flixonase/Flonase and Veramyst in allergic rhinitis in the seven major markets ($ 000s), 2009-2019 96
Table 18: Rhinocort - drug profile, 2010 97
Table 19: Sales forecasts for Rhinocort in allergic rhinitis in the US and five major EU markets ($ 000s), 2009-2019 100
Table 20: Omnair/Omnaris - drug profile, 2010 101
Table 21: Omnair HFA nasal aerosol formulation, ongoing clinical trials for perennial allergic rhinitis, 2010 102
Table 22: Sales forecasts for Omnair/Omnaris in allergic rhinitis in the seven major markets ($ 000s), 2009-2019 106
Table 23: Astelin/Astepro - franchise profile, 2010 111
Table 24: Sales forecasts for Astelin and Astepro in allergic rhinitis in the US and five major EU markets ($ 000s), 2009-2019 116
Table 25: Patanase - drug profile, 2010 117
Table 26: Sales forecasts for Patanase in allergic rhinitis in the US ($ 000s), 2009-2019 119
Table 27: Singulair - drug profile, 2010 123
Table 28: Sales forecasts for Singulair in allergic rhinitis in the seven major markets ($ 000s), 2009-2019 127
Table 29: Onon - drug profile, 2010 128
Table 30: Sales forecasts for Onon in allergic rhinitis in Japan ($ 000s), 2009-2019 130
Table 31: Grazax - drug profile, 2010 149
Table 32: Grazax patient-based forecast assumptions, 2010 155
Table 33: Sales forecasts for Grazax in allergic rhinitis in the US and five major EU markets ($ 000s), 2009-2019 156
Table 34: Stalair - franchise profile, 2010 158
Table 35: Oralair - Three year results 161
Table 36: Oralair patient-based forecast assumptions, 2010 165
Table 37: Sales forecasts for Oralair in allergic rhinitis in the US and five major EU markets ($ 000s), 2009-2019 166
Table 38: Pollinex Quattro grass - drug profile, 2010 167
Table 39: Pollinex Quattro Grass patient based forecast assumptions, 2010 171
Table 40: Sales forecasts for Pollinex Quattro for allergic rhinitis in the five major EU markets ($ 000s), 2009-2019 172
Table 41: Products in development for allergic rhinitis, 2010 177
Table 42: Azelastine/fluticasone - drug profile, 2010 179
Table 43: Azelastine/fluticasone - completed Phase III trials 181
Table 44: Azelastine/fluticasone price/standard unit in the US and the five major EU markets, 2010 183
Table 45: Sales forecasts for azelastine/fluticasone in allergic rhinitis in the US and five major EU markets ($ 000s), 2009-2019 183
Table 46: CDX-313- drug profile, 2010 184
Table 47: Generic erosion of selected allergic rhinitis treatments in the seven major markets 187
Table 48: Datamonitor's estimated launch dates for key late-stage pipeline allergic rhinitis in the seven major markets, 2010-2019 211
Table 49: Estimated generic launch dates for allergic rhinitis products in the seven major markets, 2010-2019 212
Table 50: Prevalence of allergic diseases in selected countries, 2010 214
List of Figures
Figure 1: Key classes in allergic rhinitis split by indication, 2009 8
Figure 2: The impact of patent expiries and over-the-counter shifts on branded prescription sales, 2010 9
Figure 3: Allergic rhinitis and its impact on asthma (ARIA) classification, 2008 10
Figure 4: Distribution of severity of diagnosed allergic rhinitis patients 11
Figure 5: Allergic rhinitis prevalent population in the seven major markets, 2010 12
Figure 6: Prevalent populations of key allergic diseases in the seven major markets and BRIC nations, 2010 19
Figure 7: Total branded sales for all allergic rhinitis drug classes in the seven major markets by indication ($ billion), 2006-2019 21
Figure 8: Total brand volume for all allergic rhinitis drug classes in the seven major markets by indication (standard units), 2006-2019 22
Figure 9: Opportunities and threats in the allergic rhinitis market, 2010 23
Figure 10: Drivers and resistors of prescription to OTC switch, 2010 24
Figure 11: Healthcare spending in the seven major markets, 2007 27
Figure 12: US: total sales for allergic rhinitis by class ($ billion), 2006-09 28
Figure 13: New Drug Applications versus monographs 31
Figure 14: Japan: total sales for allergic rhinitis by class ($ billion), 2006-09 34
Figure 15: Five major EU markets: total sales for allergic rhinitis market by class ($ billion), 2006-09 37
Figure 16: Unmet needs in allergic rhinitis, 2010 39
Figure 17: Average adjusted symptom score example 43
Figure 18: Allergic rhinitis-specific market share by company in the seven major markets, 2009 and 2019 47
Figure 19: Merck's respiratory franchise, 2010 48
Figure 20: Allergic rhinitis sales in the seven major markets, 2009 and 2019 49
Figure 21: Oral antihistamine sales in the seven major markets by indication ($ billion), 2006-2019 52
Figure 22: Allergic rhinitis sales of oral antihistamines in the seven major markets by country ($ billion), 2009-2019 53
Figure 23: Telfast/Allegra and Allegra-D: US launch timeline, 1996-2005 54
Figure 24: Sanofi-Aventis Allegra/Allegra-D franchise - SWOT analysis, 2010 58
Figure 25: Telfast/Allegra and Allegra-D allergic rhinitis sales in the seven major markets ($m), 2009-2019 60
Figure 26: Zyrtec, Zyrtec-D and Xyzal: US launch timeline, 1996-2007 63
Figure 27: UCB Zyrtec/Zyrtec-D/Xyzal franchise - SWOT analysis for allergic rhinitis, 2010 68
Figure 28: Zyrtec/Zyrtec-D/ Xyzal allergic rhinitis sales by country in the seven major markets ($m), 2009-2019 70
Figure 29: Claritin, Aerius/Clarinex and Clarinex-D: US launch timeline, 1988-2005 73
Figure 30: Merck Claritin/Clarinex/Clarinex-D franchise - SWOT analysis for allergic rhinitis, 2010 77
Figure 31: Aerius/Clarinex/Claritin/Clarinex-D allergic rhinitis sales in the seven major markets ($m), 2009-2019 79
Figure 32: Nasal corticosteroid sales in the seven major markets by indication, 2006-2019 84
Figure 33: Allergic rhinitis sales of nasal corticosteroids in the seven major markets by country ($ billion), 2009-2019 85
Figure 34: Nasonex - SWOT analysis for allergic rhinitis, 2010 88
Figure 35: Nasonex sales in the seven major markets ($m), 2009-2019 89
Figure 36: GlaxoSmithKline's Flixonase/Flonase/Veramyst franchise - SWOT analysis for allergic rhinitis, 2010 94
Figure 37: Flixonase/Flonase/Veramyst sales in the seven major markets ($m), 2009-2019 95
Figure 38: Rhinocort - SWOT analysis for allergic rhinitis, 2010 98
Figure 39: Rhinocort allergic rhinitis sales in the US and five major EU markets ($m), 2009-2019 99
Figure 40: Omnair/Omnaris - SWOT analysis for allergic rhinitis, 2010 103
Figure 41: Omnair/Omnaris allergic rhinitis sales in the seven major markets ($m), 2008-2019 105
Figure 42: Nasal antihistamine sales in the seven major markets, by indication ($ billion), 2006-2019 108
Figure 43: Allergic rhinitis sales of nasal antihistamines in the seven major markets by country ($ billion), 2009-2019 109
Figure 44: US: Astelin and Astepro share of azelastine sales , %, Q3 2008-Q4 2009 112
Figure 45: Astelin/Astepro franchise - SWOT analysis for allergic rhinitis, 2010 114
Figure 46: Astelin/Astepro sales in the US and five major EU markets ($m), 2009-2019 115
Figure 47: Patanase - SWOT analysis for allergic rhinitis, 2010 118
Figure 48: Patanase allergic rhinitis sales in the US ($m), 2009-2019 119
Figure 49: Antileukotriene sales in the seven major markets by indication ($ billion), 2006-2019 121
Figure 50: Allergic rhinitis sales of antileukotrienes in the seven major markets by country ($ billion), 2009-2019 122
Figure 51: Singulair sales by indication, 2009 124
Figure 52: Singulair - SWOT analysis for allergic rhinitis, 2010 125
Figure 53: Singulair allergic rhinitis sales in the seven major markets ($m), 2009-2019 126
Figure 54: Onon - SWOT analysis for allergic rhinitis, 2010 129
Figure 55: Onon allergic rhinitis sales in Japan, 2009-2019 130
Figure 56: Approaches to treating allergic rhinitis 134
Figure 57: Symptomatic treatments versus immunotherapy, 2010 136
Figure 58: History of sublingual immunotherapy, 1986-2009 138
Figure 59: Advantages and disadvantages of sublingual and subcutaneous immunotherapy, 2010 140
Figure 60: Antihistamine versus immunotherapy cost analysis in allergic rhinitis, Germany, 2009 143
Figure 61: Patient-based forecast methodology for immunotherapy in allergic rhinitis, 2010 145
Figure 62: Grazax, Oralair, and Pollinex Quattro sales in the US and five major EU markets ($m), 2009-2019 146
Figure 63: Datamonitor's sensitivity analysis for immunotherapy sales ($m) in the US and 5EU, 2019 147
Figure 64: ALK-Abelló tablet program development stages, 2010 148
Figure 65: Grazax: EU adult Phase III results 151
Figure 66: Grazax: US pediatric Phase III results 153
Figure 67: Grazax - SWOT analysis for allergic rhinitis, 2010 154
Figure 68: Stalair program development stages, 2010 157
Figure 69: Oralair Grasses: Phase III adult and pediatric results 160
Figure 70: Stalair Betv1: Phase IIb/III trial results 162
Figure 71: Stalair Program - SWOT analysis for allergic rhinitis, 2010 164
Figure 72: Pollinex Quattro Grass - Phase III trial results 169
Figure 73: Pollinex Quattro Grass - SWOT analysis for allergic rhinitis, 2010 170
Figure 74: Products in development for allergic rhinitis by class/target, 2010 176
Figure 75: Azelastine/fluticasone - Phase III trial results 180
Figure 76: Azelastine/fluticasone - SWOT analysis for allergic rhinitis, 2010 182
Figure 77: Generic erosion of Flixonase/Flonase, in the US, Q4 2005-Q4 2009 188
Figure 78: Generic erosion of Flixonase/Flonase in Japan, Q2 2006-Q4 2009 189
Figure 79: Generic erosion of Flixonase/Flonase in Germany, Q4 2006-Q4 2009 189
Figure 80: Generic erosion of Flixonase/Flonase in Italy, Q3 2006-Q4 2009 190
Figure 81: Generic erosion of Flixonase/Flonase in Spain, Q1 2007-Q4 2009 190
Figure 82: Generic erosion of Flixonase/Flonase in the UK, Q1 2005-Q4 2009 191
Figure 83: Generic erosion of antihistamines in the US, Q4 2002-Q4 2005 and Q2 2005-Q4 2009 192
Figure 84: Generic erosion of antihistamines in France, Q1 2007-Q4 2009 and Q1 2008-Q4 2009 193
Figure 85: Generic erosion of antihistamines in Germany, Q4 2008-Q4 2009 and Q1 2001-Q4 2005 194
Figure 86: Generic erosion of antihistamines in Italy, , Q1 2009-Q4 2009 and Q2 2007-Q4 2009 195
Figure 87: Generic erosion of antihistamines in Spain, , Q3 2008-Q4 2009 and Q1 2001-Q4 2005 196
Figure 88: Generic erosion of antihistamines in the UK, , Q3 2006-Q4 2009 and Q3 2002-Q4 2005 197
Figure 89: Methodology for forecasting price to remove impact of currency fluctuations on trend 213
To order this report:
Drug Discovery and Development Industry: Pipeline and Commercial Insight: Allergic Rhinitis - Immunotherapy growth surpassed by generic erosion
Drug Discovery and Development Business News
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