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Peanut Allergy: Opportunity Analysis and Forecasts to 2027

Published By :

GlobalData

Published Date : Jun 2018

Category :

Pharmaceutical

No. of Pages : 124 Pages

Peanut Allergy: Opportunity Analysis and Forecasts to 2027

Summary

Peanut allergy is defined as a harmful health effect resulting from a specific and reproducible immune response following the ingestion of peanuts. While exposure to dietary antigens within the gastro-intestinal tract normally leads to oral tolerance, in certain individuals this mechanism fails. This results in sensitization and subsequent allergic responses towards innocuous food antigens. The most dangerous of these responses is an acute systemic reaction called anaphylaxis.

Peanut allergy has prevalence of 1-2.5% in developed nations and a low rate of remission-only around 20% in children. Though the specific etiology of peanut allergy is unclear, it is likely due to the interaction of genetic predisposition with environmental factors . Currently the only available strategy for managing peanut allergy long-term is avoidance and the treatment of acute reactions with injectable epinephrine. Some physicians have begun to offer their patients an investigational treatment known as experimental peanut oral immunotherapy. Though these grassroots efforts can be effective in desensitizing patients to peanut, they lack standardization and regulatory agency approval, thus making it difficult to ensure the safety of the treatment. With a complete absence of approved therapies available, peanut allergy is an indication with extremely high unmet need.

GlobalData projects the global peanut allergy marketplace - which, for the purposes of this report, comprises eight major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, Canada, and Australia) - to experience intense growth during the forecast period. GlobalData forecasts the peanut allergy market to grow over 1,700-fold between 2017 and 2027. This incredible growth stems from the projected entry of four new peanut immunotherapy products into a previously empty marketplace. These new therapies include three oral immunotherapy (OIT) products-Aimmune Therapeutics AR-101, Prota Therapeutics PPOIT, and Camallergys CA-002-and one epicutaneous immunotherapy product-DBV Technologies Viaskin Peanut.

Growing at a compound annual growth rate (CAGR) of 111% over the 10-year forecast period, in 2027 peanut allergy sales are projected to reach over $4.5 billion. The majority of sales (88%) will come from the US. This is mainly due to the US having a large population of potential patients (estimated 3,000,000 probable diagnosed prevalent cases), an elevated expected price tag for new therapies (nearly 5-7 times that of the other geographies), and a higher expected treatment rate (based on good accessibility to allergy specialists).

Aimmunes AR-101, is expected to be the market leader among the four peanut immunotherapy products released during the forecast, period, capturing over 67% of the peanut allergy market in 2027, worth an estimated $3.0B. Second in sales is DBV Technologies Viaskin Peanut, which is projected to capture 32% of the peanut allergy market in 2027, totaling nearly $1.4B in sales. Finally, sales for Prota Therapeutics and Camallergys products, PPOIT and CA-002, together are only expected to total 1%. This estimate is based on GlobalDatas assumption that within the forecast period these therapies will each only be released in one geography-Australia and the 5EU respectively.

Key Questions Answered

- The projected entry of four new peanut immunotherapy products during the forecast period is expected to spur intense growth within the peanut allergy market. How are these immunotherapy products similar and different? What are the strengths and weaknesses of the small biotech and start-up companies launching these therapies? Which of these drugs will have the highest peak sales, and why?
- Key Opinion Leaders (KOLs) interviewed by GlobalData have indicated that there are considerably high unmet needs within the peanut allergy indication. What are the main unmet needs in this market? How can the pharmaceutical industry address these needs? To what degree will the therapies under development fulfill these unmet needs?
- The peanut allergy market is likely to remain a dynamic, growing space throughout the forecast period and beyond. What are the main R&D trends in this market and which companies are leading the way? Are there major differences in the mechanisms of action used by therapies in late-stage versus early stage clinical development?

Scope

- Overview of peanut allergy including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized peanut allergy therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2017 and forecast for ten years to 2027.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the peanut allergy 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 peanut allergy 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

The report will enable you to -
- 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 peanut allergy therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global peanut allergy therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 peanut allergy therapeutics market from 2017-2027.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6
2 Peanut Allergy: Executive Summary 7
2.1 Intense Growth Expected for Peanut Allergy Market Following Launch of First-in-Class Targeted Therapies 8
2.2 The Peanut Allergy Market is Currently Dominated by Small Biotech and Start-Up Companies Using Immunotherapies to Desensitize Patients to Peanut 9
2.3 Vast Unmet Needs Exist in the Peanut Allergy Market 10
2.4 Abundant Opportunities Remain for New Entrants to Improve Upon and Transform Therapeutic Options for Peanut Allergy 11
2.5 Launches of Novel Pipeline Products Will Revolutionize the Peanut Allergy Treatment Landscape and Generate Significant Sales 11
2.6 What Do Physicians Think? 12
3 Introduction 16
3.1 Catalyst 16
3.2 Related Reports 17
3.3 Upcoming Related Reports 17
4 Disease Overview 18
4.1 Etiology and Pathophysiology 18
4.1.1 Etiology 18
4.1.2 Pathophysiology 19
4.2 Symptoms 20
4.3 Prognosis and Quality of Life 21
5 Epidemiology 22
5.1 Disease Background 22
5.2 Risk Factors and Comorbidities 23
5.3 Global and Historical Trends 23
5.4 Forecast Methodology 24
5.4.1 Sources 25
5.4.2 Forecast Assumptions and Methods 27
5.5 Epidemiological Forecast for Peanut Allergy (2017-2027) 31
5.5.1 Probable Diagnosed Prevalent Cases of Peanut Allergy 31
5.5.2 Age-Specific Probable Diagnosed Prevalent Cases of Peanut Allergy 32
5.5.3 Sex-Specific Diagnosed Prevalent Cases of Peanut Allergy 33
5.5.4 Probable Diagnosed Prevalent Cases of Peanut Allergy with Comorbid Condition 34
5.6 Discussion 35
5.6.1 Epidemiological Forecast Insight 35
5.6.2 Limitations of Analysis 36
5.6.3 Strengths of Analysis 37
6 Current Treatment Options 38
6.1 Overview 38
6.2 Diagnosis 38
6.3 Treatment 41
6.3.1 Guidelines 41
6.3.2 Avoidance and Prevention 42
6.3.3 Acute Reactions 44
6.3.4 Peanut Desensitization Using Experimental Oral Immunotherapy 50
7 Unmet Needs and Opportunity Assessment 52
7.1 Overview 52
7.2 Therapies Promoting Permanent Tolerance to Peanut 53
7.3 Biomarkers to Improve Diagnostic Sensitivity and Better Evaluate Patient Responses to Treatment 54
7.3.1 Improved Diagnostic Sensitivity 55
7.3.2 Biomarkers to Better Evaluate Patient Responses to Immunotherapy Treatment 57
7.4 Strategies to Minimize Side Effects in Immunotherapy Protocols 58
7.5 Strategies to Ensure Long-Term Compliance in Immunotherapy Protocols 59
7.6 Increased Access to Allergy Specialists 61
7.7 Enhanced Educational and Allergy Management Resources for a Broad Range of Audiences 62
8 R&D Strategies 64
8.1 Overview 64
8.1.1 Peanut Immunotherapies 64
8.1.2 Immuno-modulating Biologics Targeting Multiple Allergic Diseases 67
8.2 Clinical Trials Design 69
8.2.1 Current Clinical Trial Design 69
8.2.2 Biomarkers: Limitations and Future Outlook 72
8.2.3 Trial Design for Real-World Applicability 73
9 Pipeline Assessment 75
9.1 Overview 75
9.2 Innovative Early-Stage Approaches 80
9.3 Other Drugs in Development 83
10 Pipeline Valuation Analysis 84
10.1 Clinical Benchmark of Key Pipeline Drugs 84
10.2 Commercial Benchmark of Key Pipeline Drugs 86
10.3 Competitive Assessment 87
10.4 Top-Line 10-Year Forecast 88
10.4.1 US 94
10.4.2 5EU 95
10.4.3 Canada 97
10.4.4 Australia 98
11 Appendix 100
11.1 Bibliography 100
11.2 Abbreviations 107
11.3 Methodology 110
11.3.1 Forecasting Methodology 110
11.3.2 Diagnosed Patients 110
11.3.3 Drug Treated Population for Peanut Allergy 111
11.3.4 Drugs Included in Each Therapeutic Class 111
11.3.5 Launch and Patent Expiry Dates 111
11.3.6 General Pricing Assumptions 112
11.3.7 Individual Drug Assumptions 112
11.3.8 Pricing of Pipeline Agents 114
11.4 Primary Research - KOLs Interviewed for This Report 116
11.4.1 KOLs 116
11.4.2 Payers 118
11.4.3 Community Allergists 118
11.5 Primary Research - Prescriber Survey 119
11.6 About the Authors 120
11.6.1 Analyst 120
11.6.2 Therapy Area Director 120
11.6.3 Epidemiologist 120
11.6.4 Epidemiology Reviewers 120
11.6.5 Global Director of Therapy Analysis and Epidemiology 122
11.6.6 Global Head and EVP of Healthcare Operations and Strategy 122
11.7 About GlobalData 123
11.8 Contact Us 123
11.9 Disclaimer 124

1.1 List of Tables
Table 1: Peanut Allergy: Key Metrics in the 8MM, 2017-2027 7
Table 2: Symptoms of Peanut-Induced Allergic Reactions 21
Table 3: Risk Factors and Comorbidities for Peanut Allergy 23
Table 4: SPT and sIgE Cutoffs for Peanut Allergy Diagnosis 40
Table 5: Popular Guidelines Available for Peanut Allergy, 2017 42
Table 6: Clinical Criteria for Diagnosing Anaphylaxis 45
Table 7: Pharmacologic Management of Anaphylaxis 49
Table 8: Comparative Assessment of Peanut Immunotherapy Strategies, 2017 65
Table 9: Clinical Trial Design for Key Immunotherapy Pipeline Agents in Late-stage Development, 2017 71
Table 10: Comparison of Therapeutic Classes in Late-stage Development for Peanut Allergy 76
Table 11: Innovative Early-Stage Approaches for Peanut Allergy, 2017 82
Table 12: Other Drugs in Development for Peanut Allergy, 2017 83
Table 13: Clinical Benchmark of Key Pipeline Drugs - Peanut Allergy, 2017 85
Table 14: Commercial Benchmark of Key Pipeline Drugs - Peanut Allergy, 2017 86
Table 15: Key Events Impacting Sales for Peanut Allergy, 2017-2027 93
Table 16: Peanut Allergy Market - Global Drivers and Barriers, 2017-2027 94
Table 17: Key Projected Launch Dates for Peanut Allergy, 2017-2027 111
Table 18: Key Projected Patent Expiry Dates for Peanut Allergy, 2017-2027 111
Table 19: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 119

1.2 List of Figures
Figure 1: Global (8MM) Sales Forecast by Geography for Peanut Allergy in 2017 and 2027 9
Figure 2: Competitive Assessment of Pipeline Drugs Benchmarked Against the SOC, Experimental Peanut OIT, 2017-2027 12
Figure 3: Hypersensitivity Reaction to Peanut Allergen and Therapeutic Targets 19
Figure 4: Sensitization to Peanut Allergen and Therapeutic Targets 20
Figure 5: 8MM, Age-Standardized Probable Diagnosed Prevalence of Peanut Allergy, All Ages, 2017 24
Figure 6: 8MM, Sources Used and Not Used to Forecast the Probable Diagnosed Prevalent Cases of Peanut Allergy 25
Figure 7: 8MM, Sources Used to Forecast the Probable Diagnosed Prevalent Cases of Peanut Allergy with Comorbidity of Asthma and AD 26
Figure 8: 8MM, Sources Used to Forecast the Probable Diagnosed Prevalent Cases of Peanut Allergy with Concomitant Food Allergy and Other Nut Allergy 27
Figure 9: 8MM, Probable Diagnosed Prevalent Cases of Peanut Allergy, Men and Women, All Ages, 2017 32
Figure 10: 8MM, Age-Specific Probable Diagnosed Prevalent Cases of Peanut Allergy, Men and Women, N, 2017 33
Figure 11: 8MM, Sex-Specific Probable Diagnosed Prevalent Cases of Peanut Allergy, All Ages, N, 2017 34
Figure 12: 8MM, Probable Diagnosed Prevalent Cases of Peanut Allergy with Comorbid Condition, Men and Women, All Ages, N, 2017 35
Figure 13: Typical Diagnostic Schemes for Peanut Allergy 39
Figure 14: Typical Management Scheme for an Individual Diagnosed with Peanut Allergy 43
Figure 15: Addendum Guidelines for Peanut Allergy Prevention 44
Figure 16: Global (8MM) Use of Different Branded and Generic Epinephrine Auto-injector Devices, 2017 46
Figure 17: Rates of Epinephrine Auto-injector Prescription to Peanut Allergy Patients in the 8MM, 2017 47
Figure 18: Unmet Needs and Opportunities in Peanut Allergy, 2017 53
Figure 19: Estimated Accessibility to Allergists Throughout the 8MM 61
Figure 20: Overview of the Development Pipeline in Peanut Allergy, 2017 75
Figure 21: Key Phase II/III Trials for the Pipeline Agents that GlobalData Expects be Licensed for Peanut Allergy in the 8MM During the Forecast Period, 2017 77
Figure 22:Competitive Assessment of the Pipeline Drugs Benchmarked Against the SOC, Experimental Peanut OIT, 2017 87
Figure 23: Global (8MM) Sales Forecast for Peanut Allergy, 2017-2027 88
Figure 24: Global (8MM) Sales Forecast by Geography for Peanut Allergy in 2017 and 2027 89
Figure 25: Global (8MM) Sales Forecast by Therapy for Peanut Allergy in 2017 and 2027 90
Figure 26: Global (8MM) Sales Forecast by Age for Viaskin Peanut and AR-101 in 2027 92
Figure 27: Sales Forecast by Therapy for Peanut Allergy in the US in 2017 and 2027 95
Figure 28: Sales Forecast by Therapy for Peanut Allergy in the 5EU in 2017 and 2027 97
Figure 29: Sales Forecast by Therapy for Peanut Allergy in Canada in 2017 and 2027 98
Figure 30: Sales Forecast by Therapy for Peanut Allergy in Australia in 2017 and 2027 99

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