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市場調查報告書

血管炎 - 機會分析與預測

OpportunityAnalyzer: Vasculitis - Opportunity Analysis and Forecast to 2024

出版商 GlobalData 商品編碼 355917
出版日期 內容資訊 英文 258 Pages
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血管炎 - 機會分析與預測 OpportunityAnalyzer: Vasculitis - Opportunity Analysis and Forecast to 2024
出版日期: 2016年01月01日 內容資訊: 英文 258 Pages
簡介

血管炎是稀少的自體免疫疾病,引起血管發炎的疾病。J&J是在血管炎市場的第一個生技藥品,日本2007年也受認可。2014∼2024年,6個藥物預定上市,隨著確診患者人數增加,將帶動血管炎市場擴大。

本報告提供全球血管炎市場相關調查,市場未滿足需求,企業的研究開發策略,開發平台趨勢,歐美及日本等的各地區趨勢,今後的預測,及打入市場的主要企業簡介等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 血管炎的種類
  • 病因及病理學
  • 症狀
  • 疾病管理

第4章 流行病學

  • 疾病的背景
  • 風險因素和合併症
  • 全球的趨勢
  • 預測方法
  • 血管炎的流行病學的預測
  • 考察

第5章 目前治療方法

  • 概要
  • 產品簡介

第6章 未滿足需求評估與機會分析

  • 概要
  • 引進治療中改良了有效性和安全性的藥物
  • 維持治療中改良了有效性和安全性的藥物
  • 為了預測對治療的反應的生物標記
  • 早期及非侵入性的診斷
  • 補充療法

第7章 研究開發策略

  • 概要
  • 自體免疫疾病藥物的擴大
  • 主要適應的血管炎的轉移
  • 臨床實驗設計
    • 目前臨床實驗設計
    • 血管炎臨床實驗設計的課題

第8章 開發平台評估

  • 概要
  • 臨床開發的潛力藥物
  • 血管炎發展的追加性藥物

第9章 開發平台價值分析

  • 主要開發平台藥物的臨床性基準
  • 主要開發平台藥物的商業性基準
  • 競爭評估
  • top line:10年預測

第10章 附錄

圖表

目錄
Product Code: GDHC045POA

Vasculitis is a family of rare autoimmune diseases, causing inflammation of the blood vessels, arteries, veins or capillaries. The different forms of vasculitis are classified by the size and location of the affected blood vessels . This report specifically covers large vessel vasculitis (LLV), Kawasaki disease (KD), antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), and Behcet's disease (BD). In 2014, there were 137,603 and 82,454 diagnosed prevalent and incident cases in the 7MM (US, France, Germany, Spain, Italy, UK, and Japan), respectively. Untreated, the organs and tissues affected by the damaged blood vessels do not get enough blood, which can lead to organ or tissue damage, or even death. J&J's Remicade was the first biologic in the vasculitis market, approved for BD in Japan in 2007. Other biologics approved for vasculitis include AbbVie's Humira for BD in Japan and Biogen/Roche's Rituxan for GPA/MPA in the 7MM. Several unmet needs still remain such as the development of drugs with improved safety and efficacy for use in both the induction and maintenance treatment settings . GlobalData expects the launch of six drugs during the 2014 to 2024 forecast period along with increased diagnosed patient numbers will drive the vasculitis market.

Highlights

Key Questions Answered

  • How large an impact will biosimilars have on the vasculitis market? What do vasculitis specialists and key opinion leaders across the 7MM think about the evolving treatment landscape?
  • What opportunities remain in the market for new product entrants?
  • With six drug launches, five of which are biologics, which products are forecast to generate the highest sales over 2014-2024? How are product launches expected to affect the sales of induction and maintenance therapies?
  • According to KOLs, what are the most important unmet needs in vasculitis? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2024?
  • What industry developments are likely to affect sales of the top-selling vasculitis drugs in the markets researched? Which is the largest growth market globally?

Key Findings

  • Biosimilars are expected to change the landscape for vasculitis and create pricing pressure in the vasculitis market. However, questions from physicians and regulators regarding the appropriate use of biosimilars still lingers.
  • Sales of immunosuppressants are expected to decline due to the introduction of novel biologics and small molecules to treat vasculitis.
  • Several unmet needs are expected to remain after the forecast period, as all pipeline drugs are in development as induction therapies and maintenance therapies are lagging.
  • With several major pharmaceutical companies involved in development of vasculitis products, the market will be dominated by Big Pharma who will leverage their R&D, manufacturing, and distribution networks.

Scope

  • Overview of vasculitis, including etiology, pathophysiology, and country-specific diagnosis and treatment recommendations.
  • Annualized vasculitis market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the vasculitis market.
  • Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically BMS's Orencia, GSK's Benlysta and Nucala, Genentech/Roche's Actemra, Celgene's Otezla, J&J's Remicade, and biosimilars (such as Celltrion/Hospira/Alvogen's Inflectra/Remsima).
  • Analysis of the current and future market competition in the global vasculitis market. Insightful review of the key industry and governmental 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 through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the vasculitis market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global vasculitis 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 vasculitis market from 2014-2024.
  • 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. Types of Vasculitis
  • 3.2. Etiology and Pathophysiology
    • 3.2.1. Large Vessel Vasculitis
    • 3.2.2. Kawasaki Disease
    • 3.2.3. ANCA-Associated Small Vessel Vasculitis
    • 3.2.4. Beh?et's Disease
  • 3.3. Symptoms
  • 3.4. Disease Management
    • 3.4.1. Classification Criteria
    • 3.4.2. Disease Management Guidelines

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
  • 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 for Vasculitis, 2014-2024
    • 4.5.1. Diagnosed Incident Cases of AAV
    • 4.5.2. Diagnosed Prevalent Cases of AAV
    • 4.5.3. Age-Standardized Incidence of AAV
    • 4.5.4. Diagnosed Incident Cases of LVV - TA and GCA
    • 4.5.5. Diagnosed Prevalent Cases of TA
    • 4.5.6. Age-Standardized Incidence of LVV
    • 4.5.7. Diagnosed Incident Cases of BD
    • 4.5.8. Diagnosed Prevalent Cases of BD
    • 4.5.9. Age-Standardized Incidence of BD
    • 4.5.10. Diagnosed Incident Cases of KD
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Product Profiles
    • 5.2.1. Rituxan (Rituximab)
    • 5.2.2. Humira (Adalimumab)
    • 5.2.3. Remicade (Infliximab)
    • 5.2.4. Mycophenolate Mofetil
    • 5.2.5. Cyclophosphamide
    • 5.2.6. Azathioprine
    • 5.2.7. Methotrexate
    • 5.2.8. Glucocorticoids
    • 5.2.9. Intravenous Immunoglobulin

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Improved Drug Efficacy and Safety in the Induction Therapy Setting
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Improved Drug Efficacy and Safety in the Maintenance Therapy Setting
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Biomarkers to Predict Responsiveness to Therapy
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Biomarkers to Predict Disease Relapse
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Early and Non-invasive Diagnosis of Vasculitis
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity
  • 6.7. Adjunctive Therapy for the Treatment of KD
    • 6.7.1. Unmet Need
    • 6.7.2. Gap Analysis
    • 6.7.3. Opportunity

7. R&D Strategies

  • 7.1. Overview
  • 7.2. Expansion for Key Autoimmune Drugs
  • 7.3. Shift Towards Vasculitis as a Primary Indication
  • 7.4. Clinical Trial Design
    • 7.4.1. Current Clinical Trial Design
    • 7.4.2. Challenges in Vasculitis Clinical Trial Design

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Orencia (Abatacept)
    • 8.2.2. Benlysta (Belimumab)
    • 8.2.3. Actemra (Tocilizumab)
    • 8.2.4. Otezla (Apremilast)
    • 8.2.5. Nucala (Mepolizumab)
  • 8.3. Additional Drugs in Development for Vasculitis

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
    • 9.1.1. AAV
    • 9.1.2. LVV
    • 9.1.3. KD
    • 9.1.4. BD
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
    • 9.2.1. AAV
    • 9.2.2. LVV
    • 9.2.3. KD
    • 9.2.4. BD
  • 9.3. Competitive Assessment
    • 9.3.1. AAV
    • 9.3.2. LVV
    • 9.3.3. KD
    • 9.3.4. BD
  • 9.4. Top Line Ten Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU
    • 9.4.3. Japan

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Percent Drug-treated Patients
    • 10.4.2. Drugs Included in Each Therapeutic Class
    • 10.4.3. Launch and Patent Expiry Dates
    • 10.4.4. General Pricing Assumptions
    • 10.4.5. Individual Drug Assumptions
    • 10.4.6. Generic Erosion
    • 10.4.7. Pricing of Pipeline Agents
  • 10.5. Primary Research
    • 10.5.1. Physicians and Specialists Included in this Study
    • 10.5.2. Online Survey of High Prescribing Physicians
  • 10.6. About the Authors
    • 10.6.1. Author
    • 10.6.2. Reviewer
    • 10.6.3. Epidemiologist
    • 10.6.4. Global Director of Therapy Analysis and Epidemiology
    • 10.6.5. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Symptoms of Selected Types of Vasculitis
  • Table 2: Nine Recommendations for the Management of BD
  • Table 3: Clinical and Laboratory Features of KD
  • Table 4: Risk Factors and Comorbidities for Vasculitis
  • Table 5: 2012 Revised CHCC Definitions of Vasculitides
  • Table 6: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of MPA
  • Table 7: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of MPA
  • Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of GPA
  • Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of GPA
  • Table 10: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of eGPA
  • Table 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of eGPA
  • Table 12: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of GCA
  • Table 13: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of TA
  • Table 14: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of TA
  • Table 15: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of BD
  • Table 16: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of BD
  • Table 17: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of KD
  • Table 18: 7MM, Sources Not Used in Epidemiological Analysis of AAV, LVV, BD, and KD
  • Table 19: 7MM, Diagnosed Incident Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Table 20: 7MM, Diagnosed Prevalent Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Table 21: 7MM, Diagnosed Incident Cases of LVV, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Table 22: 7MM, Diagnosed Prevalent Cases of TA, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Table 23: 7MM, Diagnosed Incident Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Table 24: 7MM, Diagnosed Prevalent Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Table 25: 7MM, Diagnosed Incident Cases of KD, Ages ≤5 Years, Both Sexes, N, 2014-2024
  • Table 26: Leading Treatments for Vasculitis, 2015
  • Table 27: Current Treatment Options for Vasculitis Across the 7MM, November 2015
  • Table 28: Product Profile - Rituxan
  • Table 29: Rituxan SWOT Analysis, 2015
  • Table 30: Product Profile - Humira
  • Table 31: Humira SWOT Analysis, 2015
  • Table 32: Product Profile - Remicade
  • Table 33: Completed trials demonstrating Remicade as a potential treatment for vasculitis
  • Table 34: Remicade SWOT Analysis, 2015
  • Table 35: Product Profile - Mycophenolate Mofetil
  • Table 36: Evidence for Mycophenolate Mofetil Treatment Therapy in Vasculitis
  • Table 37: MMF SWOT Analysis, 2015
  • Table 38: Product Profile - CYC
  • Table 39: Evidence for cyclophosphamide treatment therapy in vasculitis
  • Table 40: CYC SWOT Analysis, 2014
  • Table 41: Product Profile - Azathioprine
  • Table 42: Evidence for azathioprine treatment therapy in vasculitis
  • Table 43: Azathioprine SWOT Analysis, 2015
  • Table 44: Product Profile - Methotrexate
  • Table 45: Evidence for Methotrexate treatment therapy in vasculitis
  • Table 46: Methotrexate SWOT Analysis, 2015
  • Table 47: Product Profile - Glucocorticoids
  • Table 48: Evidence for Glucocorticoid Treatment Therapy in Vasculitis
  • Table 49: GC SWOT Analysis, 2015
  • Table 50: Product Profile - Intravenous Immunoglobulin
  • Table 51: Evidence for Intravenous Immunoglobulin Therapy in Vasculitis
  • Table 52: GC SWOT Analysis, 2015
  • Table 53: Unmet Need and Opportunity in Vasculitis, 2015
  • Table 54: Vasculitis - Late Stage Pipeline, December 2015
  • Table 55: Product Profile - Orencia
  • Table 56: Orencia SWOT Analysis, 2015
  • Table 57: Product Profile - Benlysta
  • Table 58: Benlysta SWOT Analysis, 2015
  • Table 59: Product Profile - Actemra
  • Table 60: Clinical Trials Demonstrating Actemra as a Potential Treatment for Vasculitis
  • Table 61: Actemra SWOT Analysis, 2015
  • Table 62: Product Profile - Otezla
  • Table 63: Otezla SWOT Analysis, 2015
  • Table 64: Product Profile - Nucala
  • Table 65: Completed Trials Demonstrating Nucala as a Potential Treatment for eGPA
  • Table 66: Nucala SWOT Analysis, 2015
  • Table 67: Early-Stage Pipeline Products in Vasculitis, November 2015
  • Table 68: Clinical Benchmark of Key Pipeline Drugs for AAV
  • Table 69: Clinical Benchmark of Key Pipeline Drugs for LVV, KD, and BD
  • Table 70: Commercial Benchmark of Key Pipeline Drugs for AAV
  • Table 71: Commercial Benchmark of Key Pipeline Drugs for LVV, KD, and BD
  • Table 72: Top-Line Sales Forecasts ($m) for Vasculitis, 2014-2024
  • Table 73: Key Events Impacting Sales for Vasculitis, 2014-2024
  • Table 74: Global Vasculitis Disease Market - Drivers and Barriers, 2014-2024
  • Table 75: Key Launch Dates
  • Table 76: Key Patent Expiries
  • Table 77: Average Body Weight and Surface Area Across the 7MM
  • Table 78: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Classification of Systemic Vasculitides as Defined by CHCC 2012
  • Figure 2: 7MM, Diagnosed Incident Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Figure 3: 7MM, Diagnosed Prevalent Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Figure 4: 7MM, Age-Standardized Diagnosed Incidence of MPA, Ages ≥15 Years, Both Sexes, N, 2014
  • Figure 5: 7MM, Age-Standardized Diagnosed Incidence of GPA, Ages ≥15 Years, Both Sexes, N, 2014
  • Figure 6: 7MM, Age-Standardized Incidence of eGPA, Ages ≥15 Years, Both Sexes, N, 2014
  • Figure 7: 7MM, Diagnosed Incident Cases of LVV, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Figure 8: 7MM, Diagnosed Prevalent Cases of TA, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Figure 9: 7MM, Age-Standardized Diagnosed Incidence of GCA, Ages ≥15 Years, Both Sexes, N, 2014
  • Figure 10: 7MM, Age-Standardized Diagnosed Incidence of TA, Ages ≥15 Years, Both Sexes, N, 2014
  • Figure 11: 7MM, Diagnosed Incident Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Figure 12: 7MM, Diagnosed Prevalent Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014-2024
  • Figure 13: 7MM, Age-Standardized Incidence of BD, Ages ≥15 Years, Both Sexes, N, 2014
  • Figure 14: 7MM, Diagnosed Incident Cases of KD, Ages ≤5 Years, Both Sexes, N, 2014-2024
  • Figure 15: Competitive Assessment of AAV Pipeline Therapies, 2014-2024
  • Figure 16: Competitive Assessment of LVV, KD, and BD Pipeline Therapies, 2014-2024
  • Figure 17: Global Sales for Vasculitis by Region, 2014-2024
  • Figure 18: Global Sales for Vasculitis by Indication, 2014-2024
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