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

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 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 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?
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.

Reasons to buy

The report will enable you to -
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