Commercial and Pipeline Insight Allergic Rhinitis
ABOUT DATAMONITOR HEALTHCARE 2
About the Respiratory and Infectious Disease pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the allergic rhinitis market 3
Contributing experts 5
Related reports 6
Upcoming related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8
Market definition for this report 8
Allergic rhinitis disease background 9
Asthma is main and most important co-morbidity 10
Segmentation 11
Allergic rhinitis prevalence 13
Allergic rhinitis prevalence in children 19
Current market situation 21
Unmet needs in allergic rhinitis 25
Clinical unmet needs 25
Lack of a cure 25
Uncontrolled disease 26
Drugs do not impact co-morbidities sufficiently 27
Environmental unmet needs 28
Compliance is relatively low 28
Pipeline overview 29
Key companies involved in the allergic rhinitis market 30
Schering-Plough 31
Pfizer 33
Sanofi-Aventis 34
GlaxoSmithKline 35
Merck & Co 36
UCB 36
Sepracor 37
Companies involved in immunotherapy 37
Clinical trial design in allergic rhinitis 39
Endpoints 39
Symptom scores are most often used in clinical trials 39
Specific safety measures remain essential 41
Objective inflammatory endpoints are key for new anti-inflammatory therapies 41
Study population 42
Pediatric trials need some adaptation 43
Comparator drug 44
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 45
Summary of environmental issues affecting the allergic rhinitis market 45
Seven major market opportunities and threats 46
Opportunities 46
Over-the-counter (OTC) status may extend revenue after patent expiry 46
Increasing prevalence of allergic rhinitis 48
Allergy seasons start earlier, last longer and are more intense 49
EMEA harmonizes drug approval process 50
Smaller companies helped by European regulators 51
Threats 52
Governments try to stop increasing healthcare expenditure by controlling pricing
and reimbursement 52
Parallel trading threatens return on investment 54
US: opportunities and threats 55
Allergic rhinitis market overview 55
Opportunities 56
The OTC market is becoming more important in the US 56
FDA initiatives to decrease product development times 58
US is the only country to allow direct-to-consumer (DTC) advertising of
prescription medicines 58
Threats 60
Reimbursement controls decrease healthcare expenditure in the US 60
Implementation of Medicare Part D influences US healthcare market 61
Parallel trading could increase due to Medicare D's 'donut hole' 62
Prescription Drug User Fee Act (PDUFA) likely to increase fees 63
Japan: opportunities and threats 64
Allergic rhinitis market overview 64
Opportunities 66
Separation of manufacturing and marketing entities benefits both Japanese and
foreign companies 66
Japan shows initiatives to open its market 67
Threats 67
Price cuts still dominate pricing and reimbursement in Japan 67
Increasing uptake of generics 69
Lengthy approval process slows down access to the Japanese market 70
France: opportunities and threats 70
Allergic rhinitis market overview 70
Opportunities 72
Generics use is still relatively low in France 72
Pricing and reimbursement negotiations to be shortened by new agency 73
Threats 73
France increases its pricing and reimbursement efforts 73
Germany: opportunities and threats 75
Allergic rhinitis market overview 75
Opportunities 76
Encouraging environment for novel drug development 76
ePharmacy and mail-order drugs legalized 77
Threats 77
Reimbursement controls are important in decreasing healthcare expenditure in
Germany 77
Generic penetration in Germany is relatively high 79
Italy: opportunities and threats 79
Allergic rhinitis market overview 79
Opportunities 81
Generic drugs play a small role in Italy 81
Reimbursement negotiations are less restrictive 82
Threats 83
Italy increases its pricing and reimbursement efforts 83
Spain: opportunities and threats 84
Allergic rhinitis market overview 84
Opportunities 86
The pharmaceutical industry implements strategies to reduce parallel exportation
86
Health ministry introduces 'Spanish national formulary' 87
Threats 87
The introduction of a new medicines bill increases the focus on cost containment
in Spain 87
The profile of generics is being raised in Spain 89
UK: opportunities and threats 90
Allergic rhinitis market overview 90
Opportunities 91
The UK offers an attractive market 91
The pricing and reimbursement environment in the UK is relatively
non-restrictive 91
Threats 93
Lack of allergy knowledge in primary care setting 93
Lack of allergy specialists 95
The UK enjoys a strong generics market 96
The post-guidance and pre-guidance effects of NICE are a significant concern 96
CHAPTER 4 DRUG ANALYSIS & FORECASTS 98
Overview for oral antihistamines 99
Patient potential 101
Comparative forecasts 102
Pipeline summary 104
Zyrtec 104
Zyrtec forecast assumptions 106
Trial data 107
Xyzal 109
Xyzal forecast assumptions 110
Trial data 111
Telfast/Allegra 112
Telfast/Allegra forecast assumptions 114
Trial data 115
Claritin 117
Claritin forecast assumptions 120
Trial data 120
Aerius/Clarinex 121
Aerius/Clarinex forecast assumptions 123
Trial data 123
Pipeline drugs in the antihistamines class 124
Bilastine 125
CP-118 126
Late-stage development compounds recently discontinued 127
Overview for nasal corticosteroids 128
Patient potential 129
Comparative forecasts 131
Pipeline summary 133
Nasonex 133
Nasonex forecast assumptions 134
Trial data 135
Flixonase/Flonase 137
Flixonase/Flonase forecast assumptions 139
Trial data 140
Nasacort 141
Nasacort forecast assumptions 142
Trial data 143
Rhinocort 144
Rhinocort forecast assumptions 145
Trial data 146
Pipeline drugs in the nasal corticosteroid class 147
Veramyst 148
Omnair 153
Nasal steroid/antihistamine combination 157
Innovative anti-inflammatory projects 160
Late-stage development compounds recently discontinued 164
Overview for oral antihistamine/decongestant combinations 166
Patient potential 167
Comparative forecasts 170
Zyrtec-D 171
Zyrtec-D forecast assumptions 173
Trial data 173
Allegra-D 174
Allegra-D forecast assumptions 176
Trial data 177
Clarinex-D 177
Clarinex-D forecast assumptions 178
Trial data 179
Overview for nasal antihistamines 180
Patient potential 181
Pipeline summary 182
Astelin 182
Astelin forecast assumptions 184
Trial data 185
Pipeline drugs in the nasal antihistamine class 186
Patanase 186
Other pipeline drugs in the nasal antihistamine class 190
Overview for antileukotrienes 190
Patient potential 191
Pipeline summary 192
Singulair 192
Singulair forecast assumptions 193
Trial data 194
Onon 195
Onon forecast assumptions 196
Trial data 197
Pipeline drugs in the antileukotrienes class 198
Loratadine/montelukast combination 198
Overview for nasal decongestants 200
Overview for immunotherapy 202
Current market overview 206
Patient potential 207
Moving towards baseline therapy 209
Immunotherapy is shown to be effective and safe 210
Studies show long-term relief after discontinuation of immunotherapy 211
Immunotherapy is thought to prevent new sensitizations 211
Studies suggest role for immunotherapy in the prevention of asthma 213
More studies needed to evaluate the safety of immunotherapy in asthma 215
Showing safety of immunotherapy in children is an important step for expanding
the market 216
Immunotherapy can be cost-effective 217
Significant commercial opportunity 218
Pipeline summary 221
Companies involved in immunotherapy 223
ALK-Abelló 224
Stallergčnes 227
Allergy Therapeutics 229
Dynavax 231
Fornix Biosciences 232
Curalogic 232
Greer Laboratories 233
Allergopharma 233
HAL Allergy 233
Non allergen-based immunotherapy 233
Cytos Biotechnology 233
CMP Therapeutics 234
Cobalis 234
Data definitions, limitations and assumptions 235
Over-the-counter (OTC) sales 235
Standard units 235
Japanese market data 235
Derivation of sales forecasts and pricing trends 235
Regional launch dates for new products 236
Generic erosion and pricing assumptions 236
Forecasts 237
Forecast methodology 238
Strategic scoping and focus 238
BIBLIOGRAPHY 239
Papers 239
Websites 262
Datamonitor reports 263
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS 264
Summary allergic rhinitis market data 264
Antihistamines market data 268
Nasal corticosteroids market data 274
Antihistamine/decongestant combination market data 278
Antileukotrienes market data 281
Nasal anti-allergic agents market data 283
APPENDIX B - MARKET FORECAST DATA 284
Seven major markets 284
M5EU 287
US 289
Japan 292
France 294
Germany 296
Italy 298
Spain 300
UK 303
APPENDIX C 305
Contributing experts 305
Report methodology 305
About Datamonitor 305