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市場調查報告書

OpportunityAnalyzer:過敏性鼻炎(過敏原特異性免疫療法)--市場機會分析與未來預測

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

出版商 GlobalData 商品編碼 320337
出版日期 內容資訊 英文 209 Pages
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OpportunityAnalyzer:過敏性鼻炎(過敏原特異性免疫療法)--市場機會分析與未來預測 OpportunityAnalyzer: Allergic Rhinitis: Allergen-Specific Immunotherapy - Opportunity Analysis and Forecast to 2018
出版日期: 2014年09月30日 內容資訊: 英文 209 Pages
簡介

過敏性鼻炎(AR)的特異性免疫療法(SIT)的全球市場非常細分化。美國、歐洲、日本的各別處方藥上市,管理體制也不相同,每個企業都未達到將自家公司產品銷售到國際上的階段。歐洲研究最有進展,皮下免疫療法(SCIT)和舌下免疫療法(SLIT),過敏原免疫療法用藥丸(AIT)等全部上市。可是,由於經濟危機伴隨的醫療費抑制對市場也帶來不良影響,歐洲企業重新跟美國、日本企業開啟合作夥伴協議。美國的情況,AIT的上市造成市場銷售額逐漸增加,2013年是1億7250萬的市場規模,預計2018年擴大到6億8830萬。到現在為止沒有活用SIT的日本的情況,以塵蟎(HDM)、杉樹花粉2大過敏原為對象的產品需求逐漸擴大,整體市場規模2018年也達到4億7090萬美元。

本報告提供全球的過敏性鼻炎(以下AR)的特異性免疫療法的市場相關分析、疾病概要和目前的治療方法、未滿足需求、市場機會的評估、今後10年的發病數量的預測值、臨床實驗的進展、新開發中產品的評估、今後的市場趨勢等的調查預測,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病理學
  • 分類
    • 季節性、全年性的AR
    • AR的ARIA分類
  • 診斷
  • 生活品質(QoL)
  • 症狀

第4章 流行病學

  • 疾病的背景
  • 危險因素和共生病症
    • 過敏性鼻炎的家族病史,是兒童、成人的過敏性鼻炎的強力的預測因素
    • 由於在特定環境下暴露於過敏原,過敏性鼻炎的風險增大
    • 都市生活,增加過敏性鼻炎的風險
    • 共生病症
  • 全球及過去趨勢
    • 美國
    • EU5個國家
    • 日本
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的前提條件與手法
  • 過敏性鼻炎的流行病學的預測(今後11年份)
    • 過敏性鼻炎的總患者數
    • 過敏性鼻炎的總患者數:各年齡
    • 過敏性鼻炎的總患者數:男女
    • 過敏性鼻炎的年齡已調整的總患者數
    • 過敏性鼻炎的總患者數:各重症度的分佈情形
    • 過敏性鼻炎的總患者數:各種類的分佈情形
    • 對特異性過敏原敏感的過敏性鼻炎的總患者數
  • 議論
    • 流行病學預測相關考察
    • 分析的限制
    • 分析的優勢

第5章 競爭評估

  • 概要
  • 治療方法研究
    • 第一、第二選擇療法:
  • OTC及抗組織胺藥物,鼻腔內皮質類固醇及輕度的治療層級
    • 第三選擇療法:
  • 免疫療法
    • SIT銷售核準的種類
  • 代表性免疫療法廠商
    • ALK-Abello
    • Stallergenes
    • Allergy Therapeutics
    • Allergopharma GmbH & Co. KG
    • HAL Allergy Group
    • Torii
  • 美國市場
    • 美國現在受到公認的抗原萃取物供應商

第6章 未滿足需求評估及機會分析

  • 概要
  • 未滿足需求分析
    • 無全額償付的國家,合理價格的特異性免疫療法
    • 全部的過敏原的新世代片劑劑型
    • 診斷、免疫療法的開始相關,來自醫生對專家的介紹的增加
    • SIT相關遵守的嚴格化
    • 為了在Polysensitized實驗對象上使用靜電感應電晶體的臨床性證據
    • 日本的標準化抗原萃取物
  • 機會分析
    • 確定對過敏原終生免疫的實驗
    • 單劑量疫苗的過程
    • 在專業權限範圍內開處方的SIT
    • 顯示事業擴張,預防性地治療氣喘,降低氣喘的惡化

第7章 研究開發策略

  • 概要
    • SCIT過敏原修飾
    • 另外的給藥途徑
    • 在氣喘治療方法上的過敏原免疫療法
  • 臨床實驗設計
    • 目前臨床試驗設計
    • 臨床上重大的臨床實驗評估項目的選擇
    • 過敏原暴露的控制:環境暴露室

第8章 市場預測

  • 今後5年的銷售額的預測
    • 美國
    • EU5個國家
    • 日本

第9章 附錄

圖表一覽

目錄
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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