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Allergic Rhinitis Immunotherapy: Opportunity Analysis and Forecasts to 2028

  • ID: 4850687
  • Report
  • August 2019
  • Region: Global
  • 203 pages
  • GlobalData
1h Free Analyst Time

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FEATURED COMPANIES

  • ALK-Abello AS
  • Allergy Therapeutics Plc
  • Anergis SA
  • ASIT Biotech SA
  • HAL Allergy BV
  • LETIPharma GmbH
  • MORE
Allergic Rhinitis Immunotherapy: Opportunity Analysis and Forecasts to 2028

Summary

Allergic rhinitis (AR) is a common, IgE-mediated inflammatory disease in which an individual reacts to an otherwise innocuous inhaled substance in the environment with one or more of the following symptoms: rhinorrhea, sneezing, nasal congestion, and pruritus of the eyes, nose, and palate. Based on epidemiological analysis by the author, in 2018 there were over 70.5M 12-month diagnosed prevalent cases of AR among adults and adolescents throughout the seven major pharmaceutical markets (7MM) covered in this report, the US, 5EU (France, Germany, Italy, Spain, and UK) and Japan. This represents about 10% of all people twelve years of age or older. 12-month diagnosed prevalent cases of AR are expected to grow at an annual growth rate (AGR) of 0.17% throughout the course of the forecast period, reaching about 72.0 M in 2028.

Key Highlights

The greatest drivers of growth in the global AR ASIT market include the launch of five new pipeline therapies during the forecast period and a steadily climbing diagnosed prevalence in many 7MM countries.

The main barriers to growth in the AR ASIT market include persistently low treatment rates, low patient compliance and persistence, as well as shifting regulatory requirements in the 5EU, the largest market for these products.

Among the late-stage pipeline products, three are targeting grass pollen allergy using short-course preseasonal SCIT and two are targeting tree pollen allergies using SLIT tablets.

The most important unmet needs in the use of ASIT to treat AR included improved insurance coverage of ASIT products, increased access to allergy-specialists, changes to the way ASIT products are regulated, and strategies to improve ASIT compliance and persistence.

Key Questions Answered
  • Despite being the only disease-modifying treatment available for AR, throughout the 7MM, KOLs thought that the use of ASIT was far below what it should be and that this was due to an assortment of lingering unmet needs.
  • Which unmet needs are limiting the use of ASIT in the 7MM?
  • What strategies can the pharmaceutical industry employ to increase the use of ASIT in the treatment of AR?
  • How should these strategies differ across different geographical markets?
  • The AR ASIT market in the 5EU, comprising 80% of 7MM sales in 2018, is steadily shifting towards a different regulatory framework, creating new opportunities and threats for companies going forward.
  • What do 5EU KOLs think about the use of ASIT products regulated on a named patient basis versus those with formal market authorization?
  • How best can the pharmaceutical industry anticipate and respond to these regulatory changes?
  • The author expects that pipeline development of short-course pre-seasonal SCIT products and SLIT tablet products will powerfully shape the AR ASIT market going forward.
  • What are the main R&D trends in the AR ASIT 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 AR including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline AR ASIT market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting AR ASIT therapeutics sales in the 8MM.
  • 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 ASIT 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, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global AR ASIT therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AR ASIT market in the 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 AR ASIT therapeutics market from 2018-2028.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Note: Product cover images may vary from those shown
2 of 3

FEATURED COMPANIES

  • ALK-Abello AS
  • Allergy Therapeutics Plc
  • Anergis SA
  • ASIT Biotech SA
  • HAL Allergy BV
  • LETIPharma GmbH
  • MORE
1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Allergic Rhinitis Immunotherapy: Executive Summary
2.1 Modest Growth Expected for ASIT Market over Forecast Period (2018-2028)
2.2 ASIT Market Continues to Shift Toward SLIT and Short-Course SCIT Products
2.3 Lingering Unmet Needs Severely Limit ASIT Uptake and Persistence Among Patients with AR
2.4 Pipeline Short-Course, Preseasonal SCIT Products Utilize Both New and Old Approaches to Promote Allergen Desensitization
2.5 What Do Physicians Think?

3 Introduction
3.1 Catalyst
3.2 Related Reports

4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Classification
4.2.1 Seasonal and Perennial AR
4.2.2 ARIA Classification of AR

5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources Used
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for AR (2018-2028)
5.5.1 Diagnosed Incident Cases of AR
5.5.2 Age-Specific Diagnosed Incident Cases of AR
5.5.3 Sex-Specific Diagnosed Incident Cases of AR
5.5.4 12-Month Diagnosed Prevalent Cases of AR
5.5.5 Age-Specific 12-Month Diagnosed Prevalent Cases of AR
5.5.6 Sex-Specific 12-Month Diagnosed Prevalent Cases of AR
5.5.7 12-Month Diagnosed Prevalent Cases of AR by Severity
5.5.8 12-Month Diagnosed Prevalent Cases of AR by Type of Allergen
5.5.9 12-Month Total Prevalent Cases of AR
5.5.10 Age-Specific 12-Month Total Prevalent Cases of AR
5.5.11 Sex-Specific 12-Month Total Prevalent Cases of AR
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitations of Analysis
5.6.3 Strengths of Analysis

6 Current Treatment Options
6.1 Overview
6.2 Diagnosis
6.3 Treatment Algorithm
6.3.1 Guidelines
6.3.2 OTC and Prescription Symptomatic Therapies
6.3.3 ASIT

7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Increased Patient Access to ASIT
7.2.1 Improved Insurance Coverage for ASIT Products
7.2.2 Increased Access to Physicians Trained to Administer ASIT
7.3 Changes to ASIT Regulation
7.4 Improved ASIT Compliance and Persistence

8 R&D Strategies
8.1 Overview
8.1.1 Improve Safety and Convenience Through Increased Use of SLIT
8.1.2 Speed Up SCIT While Maintaining Efficacy and Safety
8.1.3 Expand Product Use to New Indications: Asthma Treatment and Prophylaxis
8.2 Clinical Trials Design
8.2.1 Current Clinical Trial Design
8.2.2 Strategies for Study Participant Selection
8.2.3 Use of Controlled Challenge Endpoints in Earlier-Stage Trials
8.2.4 Clinically Relevant Trial Endpoints for Phase III Studies

9 Pipeline Assessment
9.1 Overview
9.2 Innovative Early-Stage Approaches
9.2.1 Mannan-Conjugated Allergoids
9.2.2 Contiguous Overlapping Peptides Allergy Vaccines
9.2.3 New Therapies for Cat Allergy
9.3 Other Drugs in Development

10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.1.1 Grass Pollen SCIT
10.1.2 Tree Pollen SLIT
10.2 Commercial Benchmark of Key Pipeline Drugs
10.2.1 Grass Pollen SCIT
10.2.2 Tree Pollen SLIT
10.3 Competitive Assessment
10.3.1 Grass Pollen SCIT
10.3.2 Tree Pollen SLIT
10.4 Top-Line 10-Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan

11 Appendix

List of Tables
Table 1: Allergic Rhinitis Immunotherapy: Key Metrics in the 7MM
Table 2: Risk Factors and Comorbid Conditions Associated with AR
Table 3: 7MM, 12-Month Diagnosed Prevalent Cases of AR by Type of Allergen, N, Both Sexes, Ages ≥5 Years, 2018
Table 4: Popular Guidelines Available for Allergic Rhinitis and the Use of ASIT, 2019
Table 5: Examples of ASIT Product Up-Dosing Profiles, 2019
Table 6: NPT Protocols
Table 7: CPT Protocol - TOSS
Table 8: Standardized Scoring System for the CSMS
Table 9: Comparison of Pipeline Short Course SCIT Products for Grass Pollen
Table 10: Comparison of Pipeline SLIT Tablets for Tree Pollen Allergy
Table 11: Early-Stage Allergen Immunotherapy Candidates for Allergic Rhinitis, 2019
Table 12: Other ASIT Products in Development for AR, 2019
Table 13: Clinical Benchmark of Key SCIT Pipeline Drugs for Grass Pollen Allergy
Table 14: Clinical Benchmark of Key SLIT Pipeline Drugs for Tree Pollen Allergy
Table 15: Commercial Benchmark of Key SCIT Pipeline Drugs for Grass Pollen Allergy
Table 16: Commercial Benchmark of Key SLIT Pipeline Drugs for Tree Pollen Allergy
Table 17: Key Events Impacting Sales for Allergic Rhinitis Immunotherapy, 2018-2028
Table 18: Allergic Rhinitis Immunotherapy Market - Global Drivers and Barriers, 2018-2028
Table 19: Key Historical and Projected Launch Dates for Allergic Rhinitis Immunotherapy
Table 20: Key Historical and Projected Patent/Exclusivity Expiry Dates for Allergic Rhinitis Immunotherapy
Table 21: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures
Figure 1: Global (7MM) Sales Forecast by Country for Allergic Rhinitis Immunotherapy in 2018 and 2028
Figure 2: Competitive Assessment of Grass Pollen SCIT Pipeline Drugs Benchmarked Against SOCs, Grass Pollen Bulk Extracts and Allergovit Grasses
Figure 3: Competitive Assessment of Tree Pollen SLIT Pipeline Drugs Benchmarked Against SOCs, Cedarcure and Staloral Birch
Figure 4: Examples of Inhaled Allergens that Can Cause AR
Figure 5: The Atopic March - Age at Diagnosis of Common Allergic Conditions
Figure 6: Hypersensitivity Reaction to Inhaled Allergens and Therapeutic Targets
Figure 7: Desensitization to Aeroallergens using ASIT
Figure 8: ARIA Classification of AR
Figure 9: 7MM, Diagnosed Incidence of AR (Cases per 100,000 Population), Men and Women, Ages ≥5 Years, 2018
Figure 10: 7MM, 12-Month Diagnosed Prevalence of AR (%), Men and Women, Ages ≥5 Years, 2018
Figure 11: 7MM, 12-Month Total Prevalence of AR (%), Men and Women, Ages ≥5 Years, 2018
Figure 12: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of AR
Figure 13: 7MM, Sources Used to Forecast the 12-Month Diagnosed Prevalent Cases of AR
Figure 14: 7MM, Sources Used to Forecast the 12-Month Total Prevalent Cases of AR
Figure 15: 7MM, Sources Used to Forecast the 12-Month Diagnosed Prevalent Cases of AR by Severity
Figure 16: 7MM, Diagnosed Incident Cases of AR, N, Both Sexes, ≥5 Years, 2018
Figure 17: 7MM, Age-Specific Diagnosed Incident Cases of AR, N, Both Sexes, Ages ≥5 Years, 2018
Figure 18: 7MM, Sex-Specific Diagnosed Incident Cases of AR, N, Ages ≥5 Years, 2018
Figure 19: 7MM, 12-Month Diagnosed Prevalent Cases of AR, N, Both Sexes, Ages ≥5 Years, 2018
Figure 20: 7MM, Age-Specific 12-Month Diagnosed Prevalent Cases of AR, N, Both Sexes, Ages ≥5 Years, 2018
Figure 21: 7MM, Sex-Specific 12-Month Diagnosed Prevalent Cases of AR, N, Ages ≥5 Years, 2018
Figure 22: 7MM, 12-Month Diagnosed Prevalent Cases of AR by Severity, N, Both Sexes, Ages ≥5 Years, 2018
Figure 23: 7MM, 12-Month Total Prevalent Cases of AR, N, Both Sexes, Ages ≥5 Years, 2018
Figure 24: 7MM, Age-Specific 12-Month Total Prevalent Cases of AR, N, Both Sexes, Ages ≥5 Years, 2018
Figure 25: 7MM, Sex-Specific 12-Month Total Prevalent Cases of AR, N, Ages ≥5 Years, 2018
Figure 26: ARIA Guidelines for the Treatment of AR
Figure 27: Projections for Future SCIT Use in the 7MM
Figure 28: Projections for Future SLIT Use in the 7MM
Figure 29: Common Allergens Targeted by ASIT Throughout the 7MM (Normalized to 100%)
Figure 30: ASIT - Line of Therapy
Figure 31: Comparing SCIT and SLIT - Preferred Therapy
Figure 32: Unmet Needs and Opportunities in Allergic Rhinitis Immunotherapy
Figure 33: Comparing SCIT and SLIT - Efficacy and Safety
Figure 34: Overview of the Development Pipeline of ASIT Products for AR
Figure 35: Key Phase II/III Trials for Promising Pipeline ASIT Products that GlobalData Expects to Be Licensed for AR in the 7MM During the Forecast Period, 2019
Figure 36: Opinions of US Physicians Regarding Use of Pre-formulated, Single-Allergen ASIT Products
Figure 37: Competitive Assessment of Grass Pollen SCIT Pipeline Drugs Benchmarked Against SOCs, Grass Pollen Bulk Extracts and Allergovit Grasses
Figure 38: Competitive Assessment of Tree Pollen SLIT Pipeline Drugs Benchmarked Against SOCs, Cedarcure and Staloral Birch
Figure 39: Global (7MM) Sales Forecast for Allergic Rhinitis Immunotherapy, 2018-2028
Figure 40: Global (7MM) Sales Forecast by Country for Allergic Rhinitis Immunotherapy in 2018 and 2028
Figure 41: Global Sales Forecast by Administration Method for Allergic Rhinitis Immunotherapy in 2018 and 2028
Figure 42: Global Sales Forecast by Company for Allergic Rhinitis Immunotherapy in 2018 and 2028
Figure 43: Sales Forecast by Administration Method for Allergic Rhinitis Immunotherapy in the US in 2018 and 2028
Figure 44: Sales Forecast by Company for Allergic Rhinitis Immunotherapy in the US in 2018 and 2028
Figure 45: Sales Forecast by Product for Allergic Rhinitis Immunotherapy in the US in 2018 and 2028
Figure 46: Sales Forecast by Country for Allergic Rhinitis Immunotherapy in the 5EU in 2018 and 2028
Figure 47: Sales Forecast by Administration Method for Allergic Rhinitis Immunotherapy in the 5EU in 2018 and 2028
Figure 48: Sales Forecast by Company for Allergic Rhinitis Immunotherapy in the 5EU in 2018 and 2028
Figure 49: Sales Forecast by Administration Method for Allergic Rhinitis Immunotherapy in Japan in 2018 and 2028
Figure 50: Sales Forecast by Company for Allergic Rhinitis Immunotherapy in Japan in 2018 and 2028
Figure 51: Sales Forecast by Product for Allergic Rhinitis Immunotherapy in Japan in 2018 and 2028
Note: Product cover images may vary from those shown
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  • ALK-Abello AS
  • Stallergenes Greer Plc
  • Jubilant HollisterStier LLC
  • Allermed Laboratories
  • Antigen Laboratories
  • Allergy Laboratories
  • Allergy Therapeutics Plc
  • Allergopharma GmbH & Co. KG
  • Torii Pharmaceutical Co Ltd
  • Shionogi & Co Ltd
  • Biomay AG
  • ASIT Biotech SA
  • LETIPharma GmbH
  • HAL Allergy BV
  • Inmunotek SL
  • Anergis SA
  • Sementis Ltd
Note: Product cover images may vary from those shown
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