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市場調查報告書
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915013

過敏性鼻炎免疫治療:機會分析與2028年為止的預測

Allergic Rhinitis Immunotherapy: Opportunity Analysis and Forecasts to 2028

出版日期: | 出版商: GlobalData | 英文 203 Pages | 訂單完成後即時交付

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  • 全貌
  • 簡介
  • 目錄
簡介

根據流行病學的分析,2018年的12個月的世界7大醫藥品市場上成人、未成年的過敏性鼻炎罹患數量為7,050萬件,這成為12歲以上人口的10%。

本報告提供過敏性鼻炎免疫治療市場相關調查,疾病的概要與目前治療方法,未滿足需求與機會評估,研究開發策略等相關資訊彙整。

第1章 圖表

第2章 摘要整理

第3章 簡介

第4章 疾病概要

  • 病因與病理學
  • 分類

第5章 流行病學

第6章 目前治療方法

  • 概要
  • 診斷
  • 治療流程

第7章 未滿足需求與機會評估

  • 概要
  • 對ASIT的患者獲取的擴大
  • ASIT法規的修改
  • 改善ASIT的合規性和存活率

第8章 研究開發策略

  • 概要
  • 臨床實驗設計

第9章 開發平台評估

  • 概要
  • 創新的早期方法
  • 開發中的其他藥物

第10章 開發平台價值評估

  • 臨床基準
  • 商業基準
  • 競爭評估
  • top line10年預測

第11章 附錄

目錄
Product Code: GDHC100POA

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 -

  • 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.

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