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Allergic Rhinitis-US Drug Forecast and Market Analysis to 2024

Allergic Rhinitis-US Drug Forecast and Market Analysis to 2024

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Executive Summary

Allergic Rhinitis-US Drug Forecast and Market Analysis to 2024


AR is becoming an increasingly prevalent condition, with the most common form being moderate to severe in nature (Baena-Cagnani et al., 2015). According to the European Academy of Allergy and Clinical Immunology (EAACI), 50% of Europeans will suffer from an allergy by 2027 (Papadopoulos et al., 2012). The allergic rhinitis (AR) market has declined very slowly over the past decade, as has it become saturated with relatively efficacious standard therapies, such as antihistamines (AHs), intranasal corticosteroids (INCS), and leukotriene receptor antagonists (LRAs), and has also been facing increasing generic competition. Despite the rising prevalence of AR, and a large patient population that is dissatisfied with the current treatment options, the market size for symptomatic therapies alone is set to shrink, as the remaining branded products lose patent protection. There is an increasing shift in the transfer of prescription AR products to over-the-counter (OTC) status, which is driving patients to pharmacies rather than to physicians, further diluting the prescription AR market. The immense, crowded generic AR market has been largely unappealing to drug manufacturers. Consequently, only two symptomatic therapies are expected to launch before 2024.

In 2014, the base year of the forecast period, AR sales in the US were around USD 2.8 billion. As in the global markets, this decrease will be fueled mainly by the patent expiries of numerous INCS, and the launch of the first OTC INCS in US pharmacies. Despite the fact that the prevalence of AR patients is set to increase over the forecast period, only one drug will be launched during this time, which is expected to face stiff competition upon entry and capture little market share.

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Overview of Allergic Rhinitis including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the US from 2014-2024.

Analysis of the impact of key events as well the drivers and restraints affecting the US Allergic Rhinitis market.

Reasons To Buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for Allergic Rhinitis.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2014-2024 in the US.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 8

2 Introduction 9

2.1 Catalyst 9

2.2 Related Reports 10

2.3 Upcoming Related Reports 10

3 Disease Overview 11

3.1 Etiology and Pathophysiology 11

3.2 Symptoms 14

3.3 Classification 15

3.3.1 Seasonal and Perennial AR 15

3.3.2 ARIA Classification of AR 15

3.4 Diagnosis 16

3.5 Quality of Life 18

4 Disease Management 19

4.1 Diagnosis and Treatment Overview 19

4.1.1 Diagnosis 19

4.1.2 Treatment Guidelines and Leading Prescribed Drugs 20

4.1.3 Clinical Practice 23

4.2 US 32

5 Competitive Assessment 35

5.1 Overview 35

5.2 Oral H1 Antihistamines 39

5.2.1 Overview 39

5.2.2 Efficacy 48

5.2.3 Safety 49

5.2.4 SWOT Analysis 51

5.2.5 Forecast 52

5.3 Intranasal Antihistamines 52

5.4 Intranasal Corticosteroids 55

5.4.1 Overview 55

5.4.2 Efficacy 62

5.4.3 Safety 64

5.4.4 SWOT Analysis 65

5.4.5 Forecast 66

5.5 Combination Intranasal Corticosteroids/Antihistamines 66

5.5.1 Dymista 66

5.6 Decongestants 75

5.6.1 Overview 75

5.7 Intranasal Anticholinergics 78

5.7.1 Overview 78

5.8 Leukotriene Receptor Antagonists 79

5.8.1 Overview 79

5.9 Cromones 82

5.9.1 Overview 82

5.10 Thromboxane A2 Receptor Antagonists 83

5.10.1 Overview 83

5.11 TH2 Cytokine Inhibitors 84

5.11.1 Overview 84

6 Unmet Need and Opportunity 85

6.1 Overview 85

6.2 Pharmacist Education 87

6.2.1 Unmet Need 87

6.2.2 Gap Analysis 89

6.2.3 Opportunity 90

6.3 Patient Compliance With Intranasal Corticosteroids and Antihistamines 92

6.3.1 Unmet Need 92

6.3.2 Gap Analysis 93

6.3.3 Opportunity 95

6.4 More Convenient and More Patient-Friendly Immunotherapies 98

6.4.1 Unmet Need 98

6.4.2 Gap Analysis 99

6.4.3 Opportunity 101

6.5 Primary Care Physician Education 102

6.5.1 Unmet Need 102

6.5.2 Gap Analysis 104

6.5.3 Opportunity 105

7 Pipeline Assessment 107

7.1 Promising Drugs in Clinical Development 108

7.1.1 S-555739 108

7.1.2 HP-3060 114

8 Market Outlook 119

8.1 United States 119

8.1.1 Forecast 119

8.1.2 Key Events 124

8.1.3 Drivers and Barriers 124

9 Appendix 127

9.1 Bibliography 127

9.2 Abbreviations 140

9.3 Methodology 145

9.4 Forecasting Methodology 145

9.4.1 Pediatric Allergic Rhinitis Population 145

9.4.2 Diagnosed AR Patients 151

9.4.3 Percentage of Drug-Treated Patients 151

9.4.4 Drugs Included in Each Therapeutic Class 151

9.4.5 Launch and Patent Expiry Dates 154

9.4.6 1General Pricing Assumptions 155

9.4.7 Individual Drug Assumptions 156

9.4.8 Generic Erosion 165

9.4.9 Pricing of Pipeline Agents 165

9.5 Physicians and Specialists Included in This Study 166

9.6 About the Authors 170

9.6.1 Analyst 170

9.6.2 Therapy Area Director 170

9.6.3 Epidemiologist 171

9.6.4 Global Head of Healthcare 171

9.7 About GlobalData 172

9.8 Disclaimer 172

1.2 List of Figures

Figure 1: Immunological Mechanisms Involved in the Early- and Late-Phase Allergic Response 13

Figure 2: ARIA Classification of AR by Duration of Symptoms and Severity 16

Figure 3: Algorithm Used for the Management of AR in the 7MM* 25

Figure 4: Sales for AR in the US by Drug Class, 2014-2024 123

1.1 List of Tables

Table 1: Airborne Allergens That Cause AR 11

Table 2: Common Symptoms of AR 14

Table 3: Treatment Guidelines for AR 21

Table 4: Most Commonly Prescribed Drugs for AR in the 7MM by Class, 2014 22

Table 5: Major Brands of INCS 28

Table 6: Management of AR, Country Profile-US 34

Table 7: Effects of Main Drug Classes on AR Symptoms 37

Table 8: Leading Branded Drugs Used to Treat AR, 2014 39

Table 9: Major Brands of Second- and Third-Generation Non-Sedating AHs 45

Table 10: Product Profile-AHs 48

Table 11: Efficacy of Bilastine in Symptomatic SAR Patients Age 12-70 Years 49

Table 12: Safety of Bilastine in Symptomatic SAR Patients Age 12-70 Years 50

Table 13: Oral AHs SWOT Analysis, 2014 51

Table 14: Global Sales Forecasts (USD m) for Oral AHs, 2014-2024 52

Table 15: Major Brands of Intranasal Ahs 54

Table 16: Major Brands of INCS 60

Table 17: Product Profile-INCS 62

Table 18: Efficacy of FP ANS and BDP ANS in AR Patients Age 18-72 Years 63

Table 19: Safety Profile of FP ANS and BDP ANS in AR Patients Age 18-72 Years 64

Table 20: INCS SWOT Analysis, 2014 65

Table 21: Global Sales Forecasts (USD m) for INCS, 2014-2024 66

Table 22: Product Profile-Dymista 71

Table 23: Efficacy of Dymista 72

Table 24: Safety of Dymista 73

Table 25: Dymista SWOT Analysis, 2014 74

Table 26: Global Sales Forecasts (USD m) for Dymista, 2014-2024 75

Table 27: Unmet Need and Opportunity in AR 86

Table 28: Late-Stage Pipeline for AR, 2014 108

Table 29: Product Profile-S-555739 109

Table 30: Completed Clinical Trials of S-555739 in AR Patients 111

Table 31: S-555739 SWOT Analysis, 2014 113

Table 32: Global Sales Forecasts (USD ) for S-555739, 2014-2024 114

Table 33: Product Profile-HP-3060 115

Table 34: HP-3060 SWOT Analysis, 2014 117

Table 35: Global Sales Forecasts (USD ) for HP-3060, 2014-2024 118

Table 36: Sales Forecasts (USD m) for AR in the US, 2014-2024 122

Table 37: Key Events Impacting Sales for AR in the US, 2014-2024 124

Table 38: AR Market-Drivers and Barriers in the US, 2014-2024 124

Table 39: Abbreviations 140

Table 40: Key Launch Dates of the Currently Available AR Therapies 154

Table 41: Key Loss of Exclusivity Dates of the Currently Available AR Therapies 155

Table 42: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 169

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