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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-Abelló) and Oralair (Stallergènes) 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
Table Of contents
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; Stallergènes) 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
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