Reportlinker Adds Pipeline and Commercial Insight: Allergic Rhinitis - Immunotherapy Growth Surpassed by Generic Erosion

NEW YORK, Aug. 10 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Pipeline and Commercial Insight: Allergic Rhinitis - Immunotherapy growth surpassed by generic erosion

http://www.reportlinker.com/p0243819/Pipeline-and-Commercial-Insight-Allergic-Rhinitis---Immunotherapy-growth-surpassed-by-generic-erosion.html

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

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