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OpportunityAnalyzer: Allergic Rhinitis: Allergen-Specific Immunotherapy - Opportunity Analysis and Forecast to 2018

Summary

The global specific immunotherapy (SIT) market for allergic rhinitis (AR) is highly fragmented, with the US, Europe, and Japan having different SIT formulations available, under different regulatory restrictions, with almost no historical company crossover between markets. Europe has the most developed market, with subcutaneous immunotherapy (SCIT), sublingual immunotherapy (SLIT), and allergen immunotherapy tablets (AITs) all being available. However, economy-driven healthcare expenditure restrictions have led to negative growth in European SIT sales for many companies, and in addition new German regulatory guidelines means now previously European-centric allergen extract manufacturers are partnering with US and Japanese pharmaceutical companies to distribute their therapies in the previously underdeveloped markets. In the US, the introduction of AITs will drive growth in the AR immunotherapies market, due to their high cost relative to standard subcutaneous allergen extracts. The total allergen extract immunotherapy market is expected to grow from $172.5m to $688.3m between 2013 and 2018. Japan, a market previously not widely treated with SIT, is set to see a new range of standardized, clinically-evaluated products containing the two most prevalent allergens, house dust mite (HDM) and Japanese cedar pollen. Available options will include AIT formulations previously unavailable in the market. GlobalData projects that the immunotherapy sales in Japan will reach $47.09m in 2018, with a CAGR of 70.24%.

Key Questions Answered

- Although SIT is the only therapy that targets the cause of AR, the drug treatment rate is low. The AR SIT market is still marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? What are the R&D approaches currently being explored?
- How will the requirement for SIT registration in Germany impact the AR SIT market in the 5MM? How will this process impact the market leaders in this space? Which of these companies will attain high sales revenues during 2013-2018? Which company will have the highest peak sales at the highest CAGR, and why?
- The current AR SIT market in the US and Japan is dominated by SCIT. How will the advent of allergen immunotherapy tablets change the drug treatment landscape for AR in these markets? How will the drug treatment rate change over the next five years? What are the key drivers and barriers to this change?

Key Findings

- A major driver to the US market will be the introduction of several allergen immunotherapy tablets (AITs): Merck’s Grastek (grass), Ragwitek (ragweed), and Mitizax (HDM) tablets, as well as Greer’s Oralair (grass). These new products overcome the inconvenience of conventional subcutaneous immunotherapies (SCIT). the higher profit margins associated with AIT compared with SCIT will boost the US market size, even if uptake is minimal.
- The main driver to an increase in the drug treatment rate and the expansion of the Japanese SIT market will be the launch of new sublingual immunotherapies (SLIT), by both Torii and Shionogi. Shionogi represents a new market entrant with brand power that will lead to increased awareness of SLITs in general and subsequent market growth.
- Primary research has indicated there is a number of unmet needs in the area, represented by the low drug treatment rate across all 7MM. This includes poor patient compliance, and a lack of affordable options or clinical evidence to support the use of SIT in polysensitized patients. The report highlights a number of novel R&D strategies aimed at reducing the barriers to this treatment.

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 2013 and forecast for seven years to 2018.
- 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 2013-2018.
- 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

OpportunityAnalyzer: Allergic Rhinitis: Allergen-Specific Immunotherapy - Opportunity Analysis and Forecast to 2018
1 Table of Contents

2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 16
2.3 Upcoming Related Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.2 Classification 20
3.2.1 Seasonal and Perennial AR 20
3.2.2 ARIA Classification of AR 20
3.3 Diagnosis 21
3.4 Quality of Life 22
3.5 Symptoms 23
4 Epidemiology 24
4.1 Disease Background 24
4.2 Risk Factors and Comorbidities 25
4.2.1 Family history of allergic rhinitis is a strong predictor for allergic rhinitis in children and adults 26
4.2.2 Exposure to allergens in the environment increases the risk for allergic rhinitis 27
4.2.3 Urban living elevates the risk of allergic rhinitis 27
4.2.4 Comorbidities 28
4.3 Global and Historical Trends 29
4.3.1 US 30
4.3.2 5EU 31
4.3.3 Japan 32
4.4 Forecast Methodology 33
4.4.1 Sources Used 35
4.4.2 Sources Not Used 38
4.4.3 Forecast Assumptions and Methods 39
4.5 Epidemiological Forecast of Allergic Rhinitis (2013-2023) 43
4.5.1 Total Prevalent Cases of Allergic Rhinitis 43
4.5.2 Age-Specific Total Prevalent Cases of Allergic Rhinitis 44
4.5.3 Sex-Specific Total Prevalent Cases of Allergic Rhinitis 46
4.5.4 Age-Standardized Total Prevalence of Allergic Rhinitis 48
4.5.5 Distribution of Total Prevalent Cases of Allergic Rhinitis by Severity 49
4.5.6 Distribution of Total Prevalent Cases of Allergic Rhinitis by Type 50
4.5.7 Allergic Rhinitis Total Prevalent Cases Sensitized to Specific Allergens 51
4.6 Discussion 52
4.6.1 Epidemiological Forecast Insight 52
4.6.2 Limitations of the Analysis 53
4.6.3 Strengths of the Analysis 54
5 Competitive Assessment 55
5.1 Overview 55
5.2 Treatment Algorithm 55
5.2.1 First- and Second-Line Treatment: OTC and Prescription Antihistamines, Nasal Corticosteroids, and Minor Therapeutic Classes 57
5.2.2 Third-Line Treatment: Immunotherapy 59
5.2.3 Types of SIT Marketing Approval 64
5.3 Leading Immunotherapy Manufacturers 66
5.3.1 ALK-Abello 66
5.3.2 Stallergenes 79
5.3.3 Allergy Therapeutics 90
5.3.4 Allergopharma GmbH and Co. KG 99
5.3.5 HAL Allergy Group 106
5.3.6 Torii Pharmaceutical 111
5.4 US Market 117
5.4.1 Current Licensed US Allergen Extract Suppliers 121
6 Unmet Needs Assessment and Opportunity Analysis 124
6.1 Overview 124
6.2 Unmet Needs Analysis 126
6.2.1 Affordable Specific Immunotherapies in Countries Without Full Reimbursement 126
6.2.2 A New Generation Tablet Formulation for Every Allergen 128
6.2.3 Increased Physician Referral to Specialists for Diagnosis and Immunotherapy Initiation 130
6.2.4 Increased Compliance to SIT 133
6.2.5 Clinical Evidence for the Use of SIT in Polysensitized Patients 134
6.2.6 Standardized Allergen Extracts in Japan 135
6.3 Opportunity Analysis 136
6.3.1 A Test to Determine Lifetime Immunity to an Allergen 136
6.3.2 A Single-Dose Vaccine Course 136
6.3.3 SIT Prescribed by a Range of Specialists 137
6.3.4 Label Expansion to Prophylactically Treat Asthma and to Reduce Asthma Exacerbations 138
7 Research and Development Strategies 139
7.1 Overview 139
7.1.1 SCIT Allergen Modifications 139
7.1.2 Alternative Routes of Administration 145
7.1.3 Allergen Immunotherapy in the Treatment of Asthma 147
7.2 Clinical Trial Design 150
7.2.1 Current Clinical Trial Design 150
7.2.2 Selection of Clinically Relevant Trial Endpoints 151
7.2.3 Controlling Allergen Exposure: Environmental Exposure Chambers 154
8 Market Outlook 157
8.1 Top-Line, Five-Year Forecast 157
8.1.1 US 160
8.1.2 5EU 163
8.1.3 Japan 164
9 Appendix 167
9.1 Bibliography 167
9.2 Abbreviations 182
9.3 Methodology 188
9.4 Forecast Methodology 188
9.4.1 Pediatric Allergic Rhinitis Population 188
9.4.2 Specific Immunotherapy Drug-Treated Population 194
9.4.3 Companies Profiled 194
9.4.4 Launch Dates 195
9.4.5 General Pricing Assumptions 196
9.4.6 Individual Drug Class Assumptions 197
9.4.7 Company-Level Forecast Assumptions 201
9.5 Physicians and Specialists Included in This Study 205
9.6 About the Authors 206
9.6.1 Analyst, Cardiovascular and Metabolic Disorders 206
9.6.2 Therapy Director - CVMD and Acting Director of Epidemiology 206
9.6.3 Global Head of Healthcare 207
9.6.4 Epidemiologist 207
9.7 About GlobalData 208
9.8 Disclaimer 208

1.1 List of Tables

Table 1: Types of AR-Causing Allergens 17
Table 2: Common Symptoms of AR 23
Table 3: Classification of Allergic Rhinitis 25
Table 4: Risk Factors and Comorbidities for Allergic Rhinitis 26
Table 5: Prevalence of Most Frequently Occurring Comorbidities in People with Allergic Rhinitis 29
Table 6: Age-Specific Prevalence of Hay Fever from the NHIS Survey in 2011 31
Table 7: Age- and Sex-Standardized Self-Reported Total Prevalence (%) of Allergic Rhinitis, Ages 20-44 Years, 5EU 31
Table 8: Total Prevalence (%) of Allergic Rhinitis in the EU, Ages 6-14 Years 32
Table 9: 7MM, Sources of Data Used for the Total Prevalence and the Segmentations for Allergic Rhinitis 34
Table 10: 7MM, Sources Excluded for the Epidemiological Forecast of Total Prevalent Cases of Allergic Rhinitis 39
Table 11: 7MM, Total Prevalent Cases of Allergic Rhinitis, Both Sexes, Ages ?18 Years, N, 2013-2023 43
Table 12: 7MM, Age-Specific Total Prevalent Cases of Allergic Rhinitis, Both Sexes, N (Row %), 2013 45
Table 13: 7MM, Sex-Specific Total Prevalent Cases of Allergic Rhinitis, Ages ?18 Years, N (Row %), 2013 47
Table 14: 7MM, Distribution of Total Prevalent Cases of Allergic Rhinitis by Severity, Both Sexes, N (Row %), 2013 50
Table 15: 7MM, Distribution of Total Prevalent Cases of Allergic Rhinitis by Type, Both Sexes, N (Row %), 2013 51
Table 16: 7MM, Proportion of Allergic Rhinitis Total Prevalent Cases Sensitized to Specific Allergens, Both Sexes, %, 2013 52
Table 17: AR Treatment Guidelines Available 56
Table 18: Product Profile - Grazax 74
Table 19: ALK-Abello SWOT Analysis 76
Table 20: Product Profile - Oralair 86
Table 21: Stallergenes SWOT Analysis 88
Table 22: Product Profile - Pollinex Quattro Grass 96
Table 23: Allergy Therapuetics' SWOT Analysis 98
Table 24: Product Profile - Allergovit 103
Table 25: Allergopharma SWOT Analysis 105
Table 26: Product Profile - Purethal 109
Table 27: HAL's SWOT Analysis 110
Table 28: Product Profile - Cedartolen 114
Table 29: Torii SWOT Analysis 116
Table 30: Overall Unmet Needs - Current Level of Attainment 126
Table 31: Top-Line Sales Forecasts ($m) for AR , Specific Immunotherapies 2013-2018 158
Table 32: Key Events Impacting Sales for AR, Specific Immunotherapies 2013-2018 160
Table 33: AR Market - Drivers and Barriers, 2013-2018 166

1.2 List of Figures

Figure 1: AR: Mechanisms of Allergic Response 19
Figure 2: ARIA Classification of AR Symptoms 21
Figure 3: 7MM, Total Prevalent Cases of Allergic Rhinitis, Both Sexes, Ages ?18 Years, N, 2013-2023 44
Figure 4: 7MM, Age-Specific Total Prevalent Cases of Allergic Rhinitis, Both Sexes, N, 2013 46
Figure 5: 7MM, Sex-Specific Total Prevalent Cases of Allergic Rhinitis, Ages ?18 Years, N, 2013 48
Figure 6: 7MM, Age-Standardized Total Prevalence (%) of Allergic Rhinitis, Ages ?18 Years, by Sex, 2013 49
Figure 7: ARIA Guidelines for the Treatment of AR 57
Figure 8: ALK-Abello Product Pipeline 72
Figure 9: Stallergenes' Product Pipeline 83
Figure 10: Allergy Therapeutics' Product Pipeline 93
Figure 11: Allergopharma's Product Pipeline 101
Figure 12: HAL Allergy Group's Product Pipeline 107
Figure 13: Torii's Product Pipeline 114
Figure 14: Sales of AR, Specific Immunotherapies 2013-2018 159

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