Allergic Rhinitis Immunotherapy: Opportunity Analysis and Forecasts to 2028

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 GlobalData, 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 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?

GlobalData 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.

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.

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.

Companies mentioned

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

Table of Contents

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

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.3.10 Other General Assumptions

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.4.2 Payers

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Epidemiology Reviewers

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

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

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