Market Report Source

Overview

Introduction
The allergic rhinitis market will continue to decline over the next few years, after which it will resume limited growth due to the introduction of new compounds and combination products. These will drive the expansion of sales in existing classes as they exhibit safety and convenience advantages. Meanwhile, immunotherapy is expected to move from its niche position into mainstream therapy.

Scope of this report

• Indication-based forecasts for allergic rhinitis 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
• Assessment of the remaining unmet clinical needs in allergic rhinitis, analyzing the potential of new targeted therapies

Research and analysis highlights
The allergic rhinitis market was worth about $10 billion in 2006 and has been decreasing in value over the last few years due to patent expiries and limited levels of innovation. The top 2 drug classes prescribed for the treatment of allergic rhinitisoral antihistamines and nasal corticosteroidsaccounted for 77% of the total sales in this market.

At least 3 major allergic rhinitis players have developed and launched an oral antihistamine/decongestant fixed dose combination. However, several practical concerns have limited the use of these treatments and none of the products have reached sales as high as their single antihistamine component.

The immunotherapy market is moving from a niche position towards baseline therapy. Datamonitor expects a sublingual tablet for the treatment of grass allergy (such as Grazax) to be able to reach annual sales of $780m to $1.3 billion, depending on the patient population targeted, the length of administration and price of the product.

Key reasons to read this report

• 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 allergic rhinitis 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

Table of Contents

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

Stallergènes 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

About Datamonitor Healthcare 306

About the Infectious Disease and Respiratory analysis team 307

Disclaimer 308

List of Tables

Table 1: The diagnosed AR population aged over 20 years old according to severity and allergen in the seven major markets (million), 2006 and 2016 15

Table 2: The diagnosed AR population aged over 20 years old according to severity and allergen in the US (million), 2006 and 2016 16

Table 3: The diagnosed AR population aged over 20 years old according to severity and allergen in Europe (million), 2006 and 2016 17

Table 4: The diagnosed AR population aged over 20 years old according to severity and allergen in Japan (million), 2006 and 2016 18

Table 5: Prevalence of allergic rhinitis symptoms and hay fever in patients aged 6-7 and 13-14 in the seven major markets, 2007 20

Table 6: Prevalence of allergic rhinitis symptoms and hay fever in patients aged 0-19 in the seven major markets, millions, 2007 20

Table 7: Key products in late-stage R&D pipeline for the treatment of allergic rhinitis, 2007 30

Table 8: Overview of types of immunotherapy products on the market, 2007 39

Table 9: Time trends in hay fever or allergic rhinitis in school-age children in the UK, Finland, and Germany, 1973-1996 49

Table 10: Effect of oral antihistamines on allergic rhinitis symptoms 100

Table 11: Overview of the top five oral antihistamines, 2006 102

Table 12: Sales forecasts of oral antihistamines, seven major markets ($m), 2006-2016 103

Table 13: Key products in the late-stage R&D pipeline for oral antihistamines in AR, 2007 104

Table 14: Clinical trial summary cetirizine versus fexofenadine 108

Table 15: Comparative safety data for bilastine, 2007 126

Table 16: Effect of nasal corticosteroids on allergic rhinitis symptoms 129

Table 17: Overview of the top four nasal corticosteroids, 2006 131

Table 18: Sales forecasts of nasal corticosteroids across the seven major markets ($m), 2006-2016 132

Table 19: Key products in the late-stage R&D pipeline for nasal corticosteroids in AR, 2007 133

Table 20: Clinical trial data of Veramyst versus placebo, 2007 152

Table 21: Clinical trial data of Omnair versus placebo in PAR and SAR, 2007 156

Table 22: Overview of the top oral antihistamine/decongestant combinations, 2006 170

Table 23: Sales forecasts of nasal corticosteroids across the seven major markets ($m) 2006-2016 171

Table 24: Effect of nasal antihistamines on allergic rhinitis symptoms 181

Table 25: Key products in the late-stage R&D pipeline for nasal antihistamines in AR, 2007 182

Table 26: Clinical trial summary of the safety and efficacy of olopatadine, 2007 189

Table 27: Effect of antileukotrienes on allergic rhinitis symptoms 191

Table 28: Key products in the late-stage R&D pipeline for antileukotrienes in AR, 2007 192

Table 29: Effect of nasal decongestants on allergic rhinitis symptoms 201

Table 30: Overview of immunotherapy products in development, 2007 222

Table 31: Launch forecast assumptions used in the asthma/COPD market, 2007 236

Table 32: Generic erosion in the seven major markets over 3 years (%) 237

Table 33: Generic price discounts in the seven major markets (%) 237

Table 34: US summary market data, 2006 264

Table 35: Japan summary market data 2006 264

Table 36: France summary market data, 2006 265

Table 37: Germany summary market data, 2006 265

Table 38: Italy summary market data, 2006 266

Table 39: Spain summary market data, 2006 266

Table 40: UK summary market data, 2006 267

Table 41: Zyrtec: key facts 268

Table 42: Telfast/Allegra: key facts 270

Table 43: Claritin: key facts 271

Table 44: Aerius/Clarinex: key facts 272

Table 45: Xyzal: key facts 273

Table 46: Nasonex: key facts 274

Table 47: Flixonase/Flonase: key facts 275

Table 48: Nasacort: key facts 276

Table 49: Rhinocort: key facts 277

Table 50: Zyrtec-D: key facts 278

Table 51: Allegra-D: key facts 279

Table 52: Clarinex-D: key facts 280

Table 53: Singulair: key facts 281

Table 54: Onon: key facts 282

Table 55: Astelin: key facts 283

Table 56: Seven major markets allergic rhinitis drug sales ($m) forecasts, 2006-2016 284

Table 57: 5EU allergic rhinitis drug sales ($m) forecasts, 2006-2016 287

Table 58: US allergic rhinitis drug sales ($m) forecasts, 2006-2016 289

Table 59: Japan allergic rhinitis drug sales ($m) forecasts, 2006-2016 292

Table 60: France allergic rhinitis drug sales ($000) forecasts, 2006-2016 294

Table 61: Germany allergic rhinitis drug sales ($000) forecasts, 2006-2016 296

Table 62: Italy allergic rhinitis drug sales ($000) forecasts, 2006-2016 298

Table 63: Spain allergic rhinitis drug sales ($000) forecasts, 2006-2016 300

Table 64: UK allergic rhinitis drug sales ($000) forecasts, 2006-2016 303

List of Figures

Figure 1: Concept of minimal persistent inflammation 10

Figure 2: Classification of allergic rhinitis based on duration and severity of symptoms 12

Figure 3: Distribution of severity of diagnosed allergic rhinitis patients, 2006 13

Figure 4: Total sales in the seven major markets by class ($ billion), 2003-06 21

Figure 5: Allergic rhinitis market by class and value in the seven major markets, 2006 and 2016 22

Figure 6: Top five brands by sales in seven major markets ($ billion), 2006 24

Figure 7: Allergic rhinitis market sales split by country, CAGR 2003-2006 (%), sales ($m) and market share (%), 2006 25

Figure 8: Key players in the allergic rhinitis market, 2002-06 31

Figure 9: Sales of top five companies involved in immunotherapy, 2006 38

Figure 10: Advantages and disadvantages of objective inflammatory endpoints 42

Figure 11: Opportunities and threats in the seven major markets, 2007 45

Figure 12: Drivers and resistors of prescription-to-OTC switching 47

Figure 13: Sales in Japan during a high pollen season ($ billion), 2004-06 50

Figure 14: Healthcare spending as a proportion of GDP in the seven major markets, 2004 53

Figure 15: Key pharmaceutical pricing controls used globally, 2006 54

Figure 16: US: total sales in the AR market, by class ($ billion), 2003-06 55

Figure 17: US: prescriptions of AR treatment per sex and age group, 2006 56

Figure 18: Differences and similarities of NDAs and monographs 57

Figure 19: Decrease of FDA’s mean total approval time, 1995-2005 58

Figure 20: Japan: total sales in the AR market, by class ($ billion), 2003-2006 65

Figure 21: Japan: prescriptions of AR treatment per sex and age group, 2006 66

Figure 22: France: total sales in the AR market, by class ($m), 2003-06 71

Figure 23: France: prescriptions of AR treatment per sex and age group, 2006 72

Figure 24: Germany: total sales in the AR market, by class ($m), 2003-06 75

Figure 25: Germany: prescriptions of AR treatment per sex and age group, 2006 76

Figure 26: Italy: total sales in the AR market by class ($m), 2003-06 80

Figure 27: Italy: prescriptions of AR treatment per sex and age group, 2006 81

Figure 28: Spain: total sales in the AR market, by class ($m), 2003-06 85

Figure 29: Spanish prescriptions of AR treatment per sex and age group, 2006 86

Figure 30: UK: total sales in the AR market by class ($m), 2003-06 90

Figure 31: UK: prescriptions of AR treatment per sex and age group, 2006 91

Figure 32: ARIA treatment guidelines for allergic rhinitis, 2001 98

Figure 33: Sales forecasts of oral antihistamines, seven major markets ($m), 2006-2016 103

Figure 34: Sales of Zyrtec in allergic rhinitis per age group, 2006 105

Figure 35: Sales forecasts for Zyrtec, generic cetirizine and Xyzal , seven major markets ($m), 2006-2016 106

Figure 36: Sales of Xyzal in allergic rhinitis per age group, 2006 109

Figure 37: Sales forecasts for Xyzal, generic levocetirizine and Zyrtec in the seven major markets ($m), 2006-2016 111

Figure 38: Sales of Telfast/Allegra in allergic rhinitis per age group, 2006 113

Figure 39: Impact of patent expiry on sales of Telfast/Allegra in the US, 2003-06 114

Figure 40: Sales forecasts of Telfast/Allegra and generic fexofenadine, seven major markets ($m), 2006-2016 115

Figure 41: Sales of Claritin in allergic rhinitis per age group, 2006 118

Figure 42: Impact of patent expiry on sales of Claritin in the US, 2002-06 119

Figure 43: Sales forecasts of Claritin and generic loratadine, seven major markets ($m), 2006-2016 120

Figure 44: Sales of Aerius/Clarinex in allergic rhinitis per age group, 2006 122

Figure 45: Sales forecasts of Aerius/Clarinex and generic desloratadine, seven major markets ($m), 2006-2016 123

Figure 46: Sales forecasts of nasal corticosteroids across the seven major markets ($m), 2006-2016 132

Figure 47: Sales of Nasonex in allergic rhinitis per age group, 2006 134

Figure 48: Sales forecasts of Nasonex and generic mometasone in the seven major markets ($m), 2006-2016 135

Figure 49: Sales of Flixonase/Flonase in allergic rhinitis per age group, 2006 137

Figure 50: Impact of patent expiry on sales of Flixonase/Flonase in the seven major markets, 2003-06 138

Figure 51: Sales forecasts of Flixonase/Flonase, generic fluticasone propionate and Veramyst across the seven major markets ($m), 2006-2016 139

Figure 52: Sales of Nasacort in allergic rhinitis per age group, 2006 141

Figure 53: Sales forecasts of Nasacort and generic triamcinolone across the seven major markets ($m), 2006-2016 143

Figure 54: Sales of Rhinocort in allergic rhinitis per age group, 2006 145

Figure 55: Sales forecasts of Rhinocort and generic budesonide across the six major markets ($m), 2006-2016 146

Figure 56: GSK’s Veramyst device (fluticasone furoate) 149

Figure 57: Sales forecasts of Veramyst, Flixonase/Flonase and generic fluticasone across the seven major markets ($m), 2006-2016 150

Figure 58: Sales forecasts of Omnair across the seven major markets ($m), 2006-2016 155

Figure 59: Sales forecasts of a nasal steroid/antihistamine combination across the six major markets ($m), 2006-2016 159

Figure 60: Sales of oral antihistamine/decongestant combinations in Europe and the US (%), 2006 168

Figure 61: Sales forecasts of oral antihistamine/decongestant combinations across the seven major markets ($m), 2006-2016 171

Figure 62: Sales of Zyrtec-D in allergic rhinitis per age group, 2006 172

Figure 63: Sales forecasts of Zyrtec-D, Zyrtec and generic cetirizine across the seven major markets ($m), 2006-2016 173

Figure 64: Sales of Allegra-D in allergic rhinitis per age group, 2006 175

Figure 65: Sales forecasts of Allegra-D, Telfast/Allegra and generic fexofenadine across the seven major markets ($m), 2006-2016 176

Figure 66: Sales of Clarinex-D in allergic rhinitis per age group, 2006 178

Figure 67: Sales forecasts of Clarinex-D, Aerius/Clarinex and generic desloratadine, 7MM ($m), 2006-2016 179

Figure 68: Sales of Astelin in allergic rhinitis per age group, 2006 183

Figure 69: Sales forecasts of Astelin and generic azelastine across the seven major markets ($m), 2006-2016 184

Figure 70: Sales forecasts of Patanase in the US and Japan ($m), 2006-2016 188

Figure 71: Sales of Singulair in allergic rhinitis per age group, 2006 193

Figure 72: Sales forecasts of Singulair and generic montelukast across the seven major markets ($m), 2006-2016 194

Figure 73: Sales of Onon in allergic rhinitis per age group, 2006 196

Figure 74: Sales forecasts of Onon and generic pranlukast, across the seven major markets ($m), 2006-2016 197

Figure 75: Sales forecasts of loratadine/montelukast fixed dose combination in the US ($m), 2006-2016 199

Figure 76: Sales forecasts of the nasal decongestant class, US ($m), 2006-2016 202

Figure 77: Key players in the immunotherapy market, 2007 206

Figure 78: Sales of immunotherapy per type of administration, 2006 207

Figure 79: Current limitations of immunotherapy in allergic rhinitis 208

Figure 80: The allergic march 214

Figure 81: Minimum and maximum cost of treatment with immunotherapy per patient per year 219

Figure 82: Patient potential for a tablet-based grass allergen immunotherapy in the seven major markets, 2007 220

Figure 83: Immunotherapy market in the treatment of allergic rhinitis has opportunities to expand 221

Figure 84: Distribution of pipeline products according to allergen, 2007 223

Figure 85: Overview of non-subcutaneous immunotherapy products in development, 2007 224