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OpportunityAnalyzer:アレルギー性鼻炎(アレルゲン特異的免疫療法)−−市場機会の分析と将来予測

OpportunityAnalyzer: Allergic Rhinitis: Allergen-Specific Immunotherapy - Opportunity Analysis and Forecast to 2018

発行 GlobalData 商品コード 320337
出版日 ページ情報 英文 209 Pages
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OpportunityAnalyzer:アレルギー性鼻炎(アレルゲン特異的免疫療法)−−市場機会の分析と将来予測 OpportunityAnalyzer: Allergic Rhinitis: Allergen-Specific Immunotherapy - Opportunity Analysis and Forecast to 2018
出版日: 2014年09月30日 ページ情報: 英文 209 Pages
概要

アレルギー性鼻炎(AR)向け特異的免疫療法(SIT)の世界市場は非常に細分化されています。米国・欧州・日本のそれぞれで別々の処方薬が上市されており、規制体制も異なるため、どの企業も自社製品を国際的に販売する段階にまで至っていません。欧州が最も研究が進んでおり、皮下免疫療法(SCIT)や舌下免疫療法(SLIT)、アレルゲン免疫療法用錠剤(AIT)などがすべて上市されています。しかし、経済危機に伴う医療費抑制が市場にも悪影響を与えているため、欧州企業は新たに米国・日本企業とのパートナー契約へと動き出しています。米国の場合、AITの上市により市場売上高が増加しつつあり、2013年に1億7250万だった市場規模は、2018年には6億8830万にまで拡大すると予想されています。これまでSITが活用されてこなかった日本の場合、イエダニ(HDM)・スギ花粉の2大アレルゲンを対象とした製品の需要が拡大しつつあり、全体的な市場規模も2018年には4億7090万米ドルに達する見通しです。

当レポートでは、全世界のアレルギー性鼻炎(以下AR)向け特異的免疫療法の市場について分析し、疾患の概要や現段階の治療法、アンメットニーズ・市場機会の評価、今後10年間の発症件数の予測値、治験の進行状況、新規パイプライン製品の評価、今後の市場動向などを調査・予測して、その結果を概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因と病態生理学
  • 分類
    • 季節性・通年性のAR
    • ARのARIA分類
  • 診断
  • 生活の質(QoL)
  • 症状

第4章 疫学

  • 疾患の背景
  • 危険因子と併存疾患
    • アレルギー性鼻炎の家族歴は、小児・成人のアレルギー性鼻炎の強力な予測因子である
    • 特定環境下でのアレルゲン曝露により、アレルギー性鼻炎のリスクが増大する
    • 都会生活は、アレルギー性鼻炎のリスクを増大させる
    • 共存症
  • 全世界および過去の動向
    • 米国
    • EU5ヶ国
    • 日本
  • 予測手法
    • 利用した情報源
    • 利用しなかった情報源
    • 予測の前提条件と手法
  • アレルギー性鼻炎の疫学的予測(今後11年間分)
    • アレルギー性鼻炎の総患者数
    • アレルギー性鼻炎の総患者数:年齢別
    • アレルギー性鼻炎の総患者数:男女別
    • アレルギー性鼻炎の年齢調整済みの総患者数
    • アレルギー性鼻炎の総患者数:重症度別の分布状況
    • アレルギー性鼻炎の総患者数:種類別の分布状況
    • 特異的アレルゲンに敏感なアレルギー性鼻炎の総患者数
  • 議論
    • 疫学予測に関する考察
    • 分析の限界
    • 分析の強み

第5章 競合評価

  • 概要
  • 治療法アルゴリズム
    • 第一・第二選択療法:
  • OTCおよび抗ヒスタミン剤、鼻腔内副腎皮質ステロイドおよび軽度の治療クラス
    • 第三選択療法:
  • 免疫療法
    • SIT販売承認の種類
  • 代表的な免疫療法メーカー
    • ALK-Abello
    • Stallergenes
    • Allergy Therapeutics
    • Allergopharma GmbH & Co. KG
    • HAL Allergy Group
    • 鳥居薬品
  • 米国市場
    • 米国で現在公認されている抗原エキスサプライヤー

第6章 アンメットニーズ評価および機会分析

  • 概要
  • アンメットニーズ分析
    • 全額償還のない国での、手頃な価格での特異的免疫療法
    • すべてのアレルゲン向けの新世代タブレット剤形
    • 診断・免疫療法の開始に関する、専門家への医師からの紹介の増加
    • SITに関するコンプライアンスの厳格化
    • Polysensitized被験者での静電誘導トランジスタの使用のための臨床的証拠
    • 日本における標準化された抗原エキス
  • 機会分析
    • アレルゲンに生涯免疫を決定する試験
    • 単回投与ワクチンの経過
    • 専門職の権限の範囲内で処方されるSIT
    • 事業拡張を表示し、予防的に喘息を治療し、喘息の悪化を低減する

第7章 研究開発戦略

  • 概要
    • SCITアレルゲン修飾
    • 別の投与経路
    • 喘息の治療法でのアレルゲン免疫療法
  • 治験設計
    • 現在の臨床試験設計
    • 臨床上重大な治験評価項目の選択
    • アレルゲン曝露の制御:環境曝露室

第8章 市場の見通し

  • 今後5年間の売上高の予測
    • 米国
    • EU5ヶ国
    • 日本

第9章 付録

図表一覧

目次
Product Code: GDHC023POA

The global specific immunotherapy (SIT) market for allergic rhinitis (AR) is highly fragmented, with the US, Europe, and Japan having different SIT formulations available, under different regulatory restrictions, with almost no historical company crossover between markets. Europe has the most developed market, with subcutaneous immunotherapy (SCIT), sublingual immunotherapy (SLIT), and allergen immunotherapy tablets (AITs) all being available. However, economy-driven healthcare expenditure restrictions have led to negative growth in European SIT sales for many companies, and in addition new German regulatory guidelines means now previously European-centric allergen extract manufacturers are partnering with US and Japanese pharmaceutical companies to distribute their therapies in the previously underdeveloped markets. In the US, the introduction of AITs will drive growth in the AR immunotherapies market, due to their high cost relative to standard subcutaneous allergen extracts. The total allergen extract immunotherapy market is expected to grow from $172.5m to $688.3m between 2013 and 2018. Japan, a market previously not widely treated with SIT, is set to see a new range of standardized, clinically-evaluated products containing the two most prevalent allergens, house dust mite (HDM) and Japanese cedar pollen. Available options will include AIT formulations previously unavailable in the market. GlobalData projects that the immunotherapy sales in Japan will reach $47.09m in 2018, with a CAGR of 70.24%.

Highlights

Key Questions Answered

  • Although SIT is the only therapy that targets the cause of AR, the drug treatment rate is low. The AR SIT market is still marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market What are the R&D approaches currently being explored
  • How will the requirement for SIT registration in Germany impact the AR SIT market in the 5MM How will this process impact the market leaders in this space Which of these companies will attain high sales revenues during 2013-2018 Which company will have the highest peak sales at the highest CAGR, and why
  • The current AR SIT market in the US and Japan is dominated by SCIT. How will the advent of allergen immunotherapy tablets change the drug treatment landscape for AR in these markets How will the drug treatment rate change over the next five years What are the key drivers and barriers to this change

Key Findings

  • A major driver to the US market will be the introduction of several allergen immunotherapy tablets (AITs): Merck's Grastek (grass), Ragwitek (ragweed), and Mitizax (HDM) tablets, as well as Greer's Oralair (grass). These new products overcome the inconvenience of conventional subcutaneous immunotherapies (SCIT). the higher profit margins associated with AIT compared with SCIT will boost the US market size, even if uptake is minimal.
  • The main driver to an increase in the drug treatment rate and the expansion of the Japanese SIT market will be the launch of new sublingual immunotherapies (SLIT), by both Torii and Shionogi. Shionogi represents a new market entrant with brand power that will lead to increased awareness of SLITs in general and subsequent market growth.
  • Primary research has indicated there is a number of unmet needs in the area, represented by the low drug treatment rate across all 7MM. This includes poor patient compliance, and a lack of affordable options or clinical evidence to support the use of SIT in polysensitized patients. The report highlights a number of novel R&D strategies aimed at reducing the barriers to this treatment.

Scope

  • Overview of AR, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized AR therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for seven years to 2018.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AR 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 AR 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

  • 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 AR therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AR therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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 therapeutics market from 2013-2018.
  • 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. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
  • 3.2. Classification
    • 3.2.1. Seasonal and Perennial AR
    • 3.2.2. ARIA Classification of AR
  • 3.3. Diagnosis
  • 3.4. Quality of Life
  • 3.5. Symptoms

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
    • 4.2.1. Family history of allergic rhinitis is a strong predictor for allergic rhinitis in children and adults
    • 4.2.2. Exposure to allergens in the environment increases the risk for allergic rhinitis
    • 4.2.3. Urban living elevates the risk of allergic rhinitis
    • 4.2.4. Comorbidities
  • 4.3. Global and Historical Trends
    • 4.3.1. US
    • 4.3.2. 5EU
    • 4.3.3. Japan
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast of Allergic Rhinitis (2013-2023)
    • 4.5.1. Total Prevalent Cases of Allergic Rhinitis
    • 4.5.2. Age-Specific Total Prevalent Cases of Allergic Rhinitis
    • 4.5.3. Sex-Specific Total Prevalent Cases of Allergic Rhinitis
    • 4.5.4. Age-Standardized Total Prevalence of Allergic Rhinitis
    • 4.5.5. Distribution of Total Prevalent Cases of Allergic Rhinitis by Severity
    • 4.5.6. Distribution of Total Prevalent Cases of Allergic Rhinitis by Type
    • 4.5.7. Allergic Rhinitis Total Prevalent Cases Sensitized to Specific Allergens
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Treatment Algorithm
    • 5.2.1. First- and Second-Line Treatment: OTC and Prescription Antihistamines, Nasal Corticosteroids, and Minor Therapeutic Classes
    • 5.2.2. Third-Line Treatment: Immunotherapy
    • 5.2.3. Types of SIT Marketing Approval
  • 5.3. Leading Immunotherapy Manufacturers
    • 5.3.1. ALK-Abello
    • 5.3.2. Stallergenes
    • 5.3.3. Allergy Therapeutics
    • 5.3.4. Allergopharma GmbH & Co. KG
    • 5.3.5. HAL Allergy Group
    • 5.3.6. Torii Pharmaceutical
  • 5.4. US Market
    • 5.4.1. Current Licensed US Allergen Extract Suppliers

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Affordable Specific Immunotherapies in Countries Without Full Reimbursement
    • 6.2.2. A New Generation Tablet Formulation for Every Allergen
    • 6.2.3. Increased Physician Referral to Specialists for Diagnosis and Immunotherapy Initiation
    • 6.2.4. Increased Compliance to SIT
    • 6.2.5. Clinical Evidence for the Use of SIT in Polysensitized Patients
    • 6.2.6. Standardized Allergen Extracts in Japan
  • 6.3. Opportunity Analysis
    • 6.3.1. A Test to Determine Lifetime Immunity to an Allergen
    • 6.3.2. A Single-Dose Vaccine Course
    • 6.3.3. SIT Prescribed by a Range of Specialists
    • 6.3.4. Label Expansion to Prophylactically Treat Asthma and to Reduce Asthma Exacerbations

7. Research and Development Strategies

  • 7.1. Overview
    • 7.1.1. SCIT Allergen Modifications
    • 7.1.2. Alternative Routes of Administration
    • 7.1.3. Allergen Immunotherapy in the Treatment of Asthma
  • 7.2. Clinical Trial Design
    • 7.2.1. Current Clinical Trial Design
    • 7.2.2. Selection of Clinically Relevant Trial Endpoints
    • 7.2.3. Controlling Allergen Exposure: Environmental Exposure Chambers

8. Market Outlook

  • 8.1. Top-Line, Five-Year Forecast
    • 8.1.1. US
    • 8.1.2. 5EU
    • 8.1.3. Japan

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecast Methodology
    • 9.4.1. Pediatric Allergic Rhinitis Population
    • 9.4.2. Specific Immunotherapy Drug-Treated Population
    • 9.4.3. Companies Profiled
    • 9.4.4. Launch Dates
    • 9.4.5. General Pricing Assumptions
    • 9.4.6. Individual Drug Class Assumptions
    • 9.4.7. Company-Level Forecast Assumptions
  • 9.5. Physicians and Specialists Included in This Study
  • 9.6. About the Authors
    • 9.6.1. Analyst, Cardiovascular and Metabolic Disorders
    • 9.6.2. Therapy Director - CVMD and Acting Director of Epidemiology
    • 9.6.3. Global Head of Healthcare
    • 9.6.4. Epidemiologist
  • 9.7. About GlobalData
  • 9.8. Disclaimer

List of Tables

  • Table 1: Types of AR-Causing Allergens
  • Table 2: Common Symptoms of AR
  • Table 3: Classification of Allergic Rhinitis
  • Table 4: Risk Factors and Comorbidities for Allergic Rhinitis
  • Table 5: Prevalence of Most Frequently Occurring Comorbidities in People with Allergic Rhinitis
  • Table 6: Age-Specific Prevalence of Hay Fever from the NHIS Survey in 2011
  • Table 7: Age- and Sex-Standardized Self-Reported Total Prevalence (%) of Allergic Rhinitis, Ages 20-44 Years, 5EU
  • Table 8: Total Prevalence (%) of Allergic Rhinitis in the EU, Ages 6-14 Years
  • Table 9: 7MM, Sources of Data Used for the Total Prevalence and the Segmentations for Allergic Rhinitis
  • Table 10: 7MM, Sources Excluded for the Epidemiological Forecast of Total Prevalent Cases of Allergic Rhinitis
  • Table 11: 7MM, Total Prevalent Cases of Allergic Rhinitis, Both Sexes, Ages ≥18 Years, N, 2013-2023
  • Table 12: 7MM, Age-Specific Total Prevalent Cases of Allergic Rhinitis, Both Sexes, N (Row %), 2013
  • Table 13: 7MM, Sex-Specific Total Prevalent Cases of Allergic Rhinitis, Ages ≥18 Years, N (Row %), 2013
  • Table 14: 7MM, Distribution of Total Prevalent Cases of Allergic Rhinitis by Severity, Both Sexes, N (Row %), 2013
  • Table 15: 7MM, Distribution of Total Prevalent Cases of Allergic Rhinitis by Type, Both Sexes, N (Row %), 2013
  • Table 16: 7MM, Proportion of Allergic Rhinitis Total Prevalent Cases Sensitized to Specific Allergens, Both Sexes, %, 2013
  • Table 17: AR Treatment Guidelines Available
  • Table 18: Product Profile - Grazax
  • Table 19: ALK-Abello SWOT Analysis
  • Table 20: Product Profile - Oralair
  • Table 21: Stallergenes SWOT Analysis
  • Table 22: Product Profile - Pollinex Quattro Grass
  • Table 23: Allergy Therapuetics' SWOT Analysis
  • Table 24: Product Profile - Allergovit
  • Table 25: Allergopharma SWOT Analysis
  • Table 26: Product Profile - Purethal
  • Table 27: HAL's SWOT Analysis
  • Table 28: Product Profile - Cedartolen
  • Table 29: Torii SWOT Analysis
  • Table 30: Overall Unmet Needs - Current Level of Attainment
  • Table 31: Top-Line Sales Forecasts ($m) for AR , Specific Immunotherapies 2013-2018
  • Table 32: Key Events Impacting Sales for AR, Specific Immunotherapies 2013-2018
  • Table 33: AR Market - Drivers and Barriers, 2013-2018

List of Figures

  • Figure 1: AR: Mechanisms of Allergic Response
  • Figure 2: ARIA Classification of AR Symptoms
  • Figure 3: 7MM, Total Prevalent Cases of Allergic Rhinitis, Both Sexes, Ages ≥18 Years, N, 2013-2023
  • Figure 4: 7MM, Age-Specific Total Prevalent Cases of Allergic Rhinitis, Both Sexes, N, 2013
  • Figure 5: 7MM, Sex-Specific Total Prevalent Cases of Allergic Rhinitis, Ages ≥18 Years, N, 2013
  • Figure 6: 7MM, Age-Standardized Total Prevalence (%) of Allergic Rhinitis, Ages ≥18 Years, by Sex, 2013
  • Figure 7: ARIA Guidelines for the Treatment of AR
  • Figure 8: ALK-Abello Product Pipeline
  • Figure 9: Stallergenes' Product Pipeline
  • Figure 10: Allergy Therapeutics' Product Pipeline
  • Figure 11: Allergopharma's Product Pipeline
  • Figure 12: HAL Allergy Group's Product Pipeline
  • Figure 13: Torii's Product Pipeline
  • Figure 14: Sales of AR, Specific Immunotherapies 2013-2018
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