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Aug 9, 2010

Pipeline and Commercial Insight: Allergic Rhinitis - Immunotherapy growth surpassed by generic erosion now available at ReportsandReports

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Browse complete Pipeline and Commercial Insight: Allergic Rhinitis – Immunotherapy growth surpassed by generic erosion Report

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.


  • 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


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


Catalyst 1

Summary 1

About Datamonitor healthcare 2

About the Immunology & Inflammation pharmaceutical analysis team 2


Strategic scoping and focus 3

Datamonitor insight into the allergic rhinitis market 3

Related reports 4

Upcoming related reports 4

Table of Contents 4


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


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


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


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


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


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


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


Introduction 186

Nasal corticosteroids 187

Antihistamines 191


Journal papers 198

Websites 202

Datamonitor reports 210


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



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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