PharmaPoint: Allergic Rhinitis - Global Drug Forecast and Market Analysis to 2024
Summary
Allergic Rhinitis (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.
Highlights
Key Questions Answered
- Allergic Rhinitis symptoms can be controlled in the majority of patients using the current standard therapies. Nevertheless, in around 20% of people with allergic rhinitis, the disease remains symptomatic and inadequately controlled. Therefore, there are considerably high unmet needs within the indication. What are the main unmet needs in this market?
- The current late-stage allergic rhinitis pipeline is sparse. Will the late-stage symptomatic drugs make a significant impact on the allergic rhinitis market? What strategies are drug developers undertaking to penetrate this difficult but potentially very lucrative market? How will immunotherapies affect the market landscape?
- The prevalence of environmental diseases, including allergic rhinitis, is increasing worldwide, with an estimated 46 million US citizens are likely to suffer from allergic rhinitis in 2024. How will epidemiological changes impact the growth of the future market?
Key Findings
- The main driver of growth in the AR market will be the introduction of several AIT tablets: Mercks Grastek (grass), Ragwitek (ragweed), and Mitizax (house dust mite [HDM]) tablets, as well as Greers Oralair (grass) in the US. These new products overcome the inconvenience of conventional subcutaneous immunotherapies (SCITs).
- The major global barrier for the AR market will be the increasing push for patients to self-medicate using OTC drugs will decrease the prescription AR drug market size.
- There is little room for new entrants, as the market is well-served by a wealth of symptomatic therapies. Since the competition is increasing, the market for AR therapies is becoming increasingly less lucrative. Also, there are currently no breakthrough symptomatic therapy products in clinical development.
- The remaining clinical unmet needs in this market include the requirement for more efficacious products, and the underserved area of causative therapies, such as immunotherapies, which target the underlying cause of the disease.
Scope
- Overview of AR, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized AR therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AR therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global AR therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global AR therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AR therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global AR therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table Of Contents
1 Table of Contents
1 Table of Contents 12
1.1 List of Tables 18
1.2 List of Figures 21
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.2 Symptoms 27
3.3 Classification 28
3.3.1 Seasonal and Perennial AR 28
3.3.2 ARIA Classification of AR 28
3.4 Diagnosis 29
3.5 Quality of Life 31
4 Epidemiology 32
4.1 Disease Background 32
4.2 Risk Factors and Comorbidities 33
4.2.1 A family history of AR is a strong predictor for AR in children and adults 34
4.2.2 Exposure to allergens in the environment increases the risk for AR 35
4.2.3 Urban living elevates the risk for AR 35
4.2.4 Comorbidities 36
4.3 Global and Historical Trends 38
4.3.1 US 38
4.3.2 5EU 39
4.3.3 Japan 40
4.4 Forecast Methodology 41
4.4.1 Sources Used 43
4.4.2 Sources Not Used 46
4.4.3 Forecast Assumptions and Methods 46
4.5 Epidemiological Forecast for AR (2013-2023) 49
4.5.1 Total Prevalent Cases of AR 49
4.5.2 Age-Specific Total Prevalent Cases of AR 51
4.5.3 Sex-Specific Total Prevalent Cases of AR 53
4.5.4 Age-Standardized Total Prevalence of AR 55
4.5.5 Distribution of Total Prevalent Cases of AR by Severity 57
4.5.6 Distribution of Total Prevalent Cases of AR by Type 58
4.5.7 Distribution of Total Prevalent Cases of AR Sensitized to Specific Allergens 59
4.6 Discussion 60
4.6.1 Epidemiological Forecast Insight 60
4.6.2 Limitations of the Analysis 60
4.6.3 Strengths of the Analysis 61
5 Disease Management 62
5.1 Diagnosis and Treatment Overview 62
5.1.1 Diagnosis 62
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 63
5.1.3 Clinical Practice 66
5.2 US 75
5.3 France 78
5.4 Germany 80
5.5 Italy 84
5.6 Spain 86
5.7 UK 88
5.8 Japan 90
6 Competitive Assessment 93
6.1 Overview 93
6.2 Oral H1 Antihistamines 97
6.2.1 Overview 97
6.2.2 Efficacy 106
6.2.3 Safety 107
6.2.4 SWOT Analysis 109
6.2.5 Forecast 110
6.3 Intranasal Antihistamines 110
6.4 Intranasal Corticosteroids 113
6.4.1 Overview 113
6.4.2 Efficacy 120
6.4.3 Safety 122
6.4.4 SWOT Analysis 123
6.4.5 Forecast 124
6.5 Combination Intranasal Corticosteroids/Antihistamines 124
6.5.1 Dymista 124
6.6 Decongestants 133
6.6.1 Overview 133
6.7 Intranasal Anticholinergics 136
6.7.1 Overview 136
6.8 Leukotriene Receptor Antagonists 137
6.8.1 Overview 137
6.9 Cromones 140
6.9.1 Overview 140
6.10 Thromboxane A2 Receptor Antagonists 141
6.10.1 Overview 141
6.11 TH2 Cytokine Inhibitors 142
6.11.1 Overview 142
7 Unmet Need and Opportunity 143
7.1 Overview 143
7.2 Pharmacist Education 145
7.2.1 Unmet Need 145
7.2.2 Gap Analysis 147
7.2.3 Opportunity 148
7.3 Patient Compliance With Intranasal Corticosteroids and Antihistamines 150
7.3.1 Unmet Need 150
7.3.2 Gap Analysis 151
7.3.3 Opportunity 153
7.4 More Convenient and More Patient-Friendly Immunotherapies 156
7.4.1 Unmet Need 156
7.4.2 Gap Analysis 157
7.4.3 Opportunity 159
7.5 Primary Care Physician Education 160
7.5.1 Unmet Need 160
7.5.2 Gap Analysis 162
7.5.3 Opportunity 163
8 Pipeline Assessment 165
8.1 Promising Drugs in Clinical Development 166
8.1.1 S-555739 166
8.1.2 HP-3060 172
9 Current and Future Players 177
9.1 Overview 177
9.2 Trends in Corporate Strategy 179
9.3 Major Companies 180
9.3.1 Merck & Co. 180
9.3.2 GlaxoSmithKline 184
9.3.3 Sumitomo Dainippon Pharma 186
9.3.4 Sanofi 188
9.3.5 Teva 191
9.3.6 Meda AB 192
10 Market Outlook 195
10.1 Global Markets 195
10.1.1 Forecast 195
10.1.2 Drivers and Barriers - Global Issues 200
10.2 United States 205
10.2.1 Forecast 205
10.2.2 Key Events 210
10.2.3 Drivers and Barriers 210
10.3 5EU 212
10.3.1 Forecast 212
10.3.2 Key Events 217
10.3.3 Drivers and Barriers 217
10.4 Japan 225
10.4.1 Forecast 225
10.4.2 Key Events 230
10.4.3 Drivers and Barriers 230
11 Appendix 234
11.1 Bibliography 234
11.2 Abbreviations 247
11.3 Methodology 252
11.4 Forecasting Methodology 252
11.4.1 Pediatric Allergic Rhinitis Population 252
11.4.2 Diagnosed AR Patients 258
11.4.3 Percentage of Drug-Treated Patients 258
11.4.4 Drugs Included in Each Therapeutic Class 258
11.4.5 Launch and Patent Expiry Dates 261
11.4.6 1General Pricing Assumptions 262
11.4.7 Individual Drug Assumptions 263
11.4.8 Generic Erosion 272
11.4.9 Pricing of Pipeline Agents 272
11.5 Physicians and Specialists Included in This Study 273
11.6 About the Authors 277
11.6.1 Analyst 277
11.6.2 Therapy Area Director 277
11.6.3 Epidemiologist 278
11.6.4 Global Head of Healthcare 278
11.7 About GlobalData 279
11.8 Disclaimer 279
List Of Tables
1.1 List of Tables
Table 1: Airborne Allergens That Cause AR 24
Table 2: Common Symptoms of AR 27
Table 3: Classification of AR Based on Etiological Type and Severity 33
Table 4: Common Risk Factors and Comorbidities for AR 34
Table 5: Prevalence of the Most Frequently Occurring Comorbidities in People with AR 37
Table 6: Age-Specific Prevalence of Hay Fever from the 2011 NHIS Survey 39
Table 7: Self-Reported Total Prevalence (%) of AR in the 5EU, Age 20-44 Years 39
Table 8: Total Prevalence (%) of AR in the EU, Age 6-14 Years 40
Table 9: 7MM, Sources of Data Used to Forecast the Total Prevalent Cases of AR 42
Table 10: 7MM, Sources Excluded from the Epidemiological Forecast for the Total Prevalent Cases of AR 46
Table 11: 7MM, Total Prevalent Cases of AR, Both Sexes, Ages ?18 Years, N, 2013-2023 50
Table 12: 7MM, Age-Specific Total Prevalent Cases of AR, Both Sexes, N (Row %), 2013 52
Table 13: 7MM, Sex-Specific Total Prevalent Cases of AR, Ages ?18 Years, N (Row %), 2013 54
Table 14: 7MM, Distribution of Total Prevalent Cases of AR by Severity, Both Sexes, N (Row %), 2013 57
Table 15: 7MM, Distribution of Total Prevalent Cases of AR by Type, Both Sexes, N (Row %), 2013 58
Table 16: 7MM, Proportion of Total Prevalent AR Cases Sensitized to Specific Allergens, Both Sexes, %, 2013 59
Table 17: Treatment Guidelines for AR 64
Table 18: Most Commonly Prescribed Drugs for AR in the 7MM by Class, 2014 65
Table 19: Major Brands of INCS 71
Table 20: Management of AR, Country Profile - US 77
Table 21: Management of AR, Country Profile - France 79
Table 22: Management of AR, Country Profile - Germany 83
Table 23: Management of AR, Country Profile - Italy 85
Table 24: Management of AR Country Profile - Spain 87
Table 25: Management of AR Country Profile - UK 89
Table 26: Management of AR, Country Profile - Japan 92
Table 27: Effects of Main Drug Classes on AR Symptoms 95
Table 28: Leading Branded Drugs Used to Treat AR, 2014 97
Table 29: Major Brands of Second- and Third-Generation Non-Sedating AHs 103
Table 30: Product Profile - AHs 106
Table 31: Efficacy of Bilastine in Symptomatic SAR Patients Age 12-70 Years 107
Table 32: Safety of Bilastine in Symptomatic SAR Patients Age 12-70 Years 108
Table 33: Oral AHs SWOT Analysis, 2014 109
Table 34: Global Sales Forecasts ($m) for Oral AHs, 2014-2024 110
Table 35: Major Brands of Intranasal Ahs 112
Table 36: Major Brands of INCS 118
Table 37: Product Profile - INCS 120
Table 38: Efficacy of FP ANS and BDP ANS in AR Patients Age 18-72 Years 121
Table 39: Safety Profile of FP ANS and BDP ANS in AR Patients Age 18-72 Years 122
Table 40: INCS SWOT Analysis, 2014 123
Table 41: Global Sales Forecasts ($m) for INCS, 2014-2024 124
Table 42: Product Profile - Dymista 129
Table 43: Efficacy of Dymista 130
Table 44: Safety of Dymista 131
Table 45: Dymista SWOT Analysis, 2014 132
Table 46: Global Sales Forecasts ($m) for Dymista, 2014-2024 133
Table 47: Unmet Need and Opportunity in AR 144
Table 48: Late-Stage Pipeline for AR, 2014 166
Table 49: Product Profile - S-555739 167
Table 50: Completed Clinical Trials of S-555739 in AR Patients 169
Table 51: S-555739 SWOT Analysis, 2014 171
Table 52: Global Sales Forecasts ($) for S-555739, 2014-2024 172
Table 53: Product Profile - HP-3060 173
Table 54: HP-3060 SWOT Analysis, 2014 175
Table 55: Global Sales Forecasts ($) for HP-3060, 2014-2024 176
Table 56: Major Companies in the AR Market and Their Portfolios, 2014 178
Table 57: Mercks AR Portfolio Assessment, 2014 183
Table 58: GSKs AR Portfolio Assessment, 2014 185
Table 59: Sumitomo Dainippon Pharmas AR Portfolio Assessment, 2014 187
Table 60: Sanofis AR Portfolio Assessment, 2014 190
Table 61: Tevas AR Portfolio Assessment, 2014 191
Table 62: Medas AR Portfolio Assessment, 2014 194
Table 63: Global Sales Forecasts ($m) for AR, 2014-2024 197
Table 64: Global AR Market - Drivers and Barriers, 2014-2024 200
Table 65: Sales Forecasts ($m) for AR in the US, 2014-2024 208
Table 66: Key Events Impacting Sales for AR in the US, 2014-2024 210
Table 67: AR Market - Drivers and Barriers in the US, 2014-2024 210
Table 68: Sales Forecasts ($m) for AR in the 5EU, 2014-2024 215
Table 69: Key Events Impacting Sales for AR in the 5EU, 2014-2024 217
Table 70: AR Market - Drivers and Barriers in the 5EU, 2014 217
Table 71: Sales Forecasts ($) for AR in Japan, 2014-2024 228
Table 72: Key Events Impacting Sales for AR in Japan, 2014-2024 230
Table 73: AR Market - Drivers and Barriers in Japan, 2014-2024 230
Table 74: Abbreviations 247
Table 75: Key Launch Dates of the Currently Available AR Therapies 261
Table 76: Key Loss of Exclusivity Dates of the Currently Available AR Therapies 262
Table 77: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 276
List Of Figures
1.2 List of Figures
Figure 1: Immunological Mechanisms Involved in the Early- and Late-Phase Allergic Response 26
Figure 2: ARIA Classification of AR by Duration of Symptoms and Severity 29
Figure 3: 7MM, Total Prevalent Cases of AR, Both Sexes, Age ?18 Years, N, 2013-2023 51
Figure 4: 7MM, Age-Specific Total Prevalent Cases of AR, Both Sexes, N, 2013 53
Figure 5: 7MM, Sex-Specific Total Prevalent Cases of AR, Ages ?18 Years, N, 2013 55
Figure 6: 7MM, Age-Standardized Total Prevalence (%) of AR, Ages ?18 Years, by Sex, 2013 56
Figure 7: Algorithm Used for the Management of AR in the 7MM* 68
Figure 8: Company Portfolio Gap Analysis in AR, 2014-2024 179
Figure 9: Global Sales for AR by Region, 2014-2024 199
Figure 10: Sales for AR in the US by Drug Class, 2014-2024 209
Figure 11: Sales for AR in the 5EU by Drug Class, 2014-2024 216
Figure 12: Sales for AR in Japan by Drug Class, 2014-2024 229
