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市場調查報告書

OpportunityAnalyzer:全身性硬化症(硬皮症) - 市場機會分析與未來預測

OpportunityAnalyzer: Systemic Sclerosis (Scleroderma) - Opportunity Analysis and Forecast to 2024

出版商 GlobalData 商品編碼 354675
出版日期 內容資訊 英文 278 Pages
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OpportunityAnalyzer:全身性硬化症(硬皮症) - 市場機會分析與未來預測 OpportunityAnalyzer: Systemic Sclerosis (Scleroderma) - Opportunity Analysis and Forecast to 2024
出版日期: 2015年12月10日 內容資訊: 英文 278 Pages
簡介

所謂全身性硬化症(硬皮症) (SSc) 是複雜的自體免疫疾病的一種,會影響皮膚和各種內臟。常見的症狀有皮膚纖維症和肺纖維症,包含手指的血管障礙 (雷諾氏現象 (RP),手指潰瘍 (DU) 的) 等。關於全身性硬化症(硬皮症)的病因目前尚在探索,但一般認為遺傳性的易敏體質容易受到環境刺激而發病。雖然疾病臨床症狀因人而異,但尚未有大大改變病病惡化的全身性治療或疾病緩和治療法。現在用於治療全身性硬化症(硬皮症)的藥物,大部分是不適用的非標籤藥物產品 (皮膚·肺纖維症轉動免疫抑制劑,面向手指血管障礙血管擴張藥等) 。

本報告提供全身性硬化症(硬皮症) 的治療方法研究以及開發的最新趨勢調查,進行相關的市場預測,提供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年的患病人數預測值,臨床試驗的進展,新治療藥的開發平台評估,以及今後的市場趨勢等調查·預測。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病情生理
    • 病因
    • 病理生理學
  • 症狀
  • 疾病管理
    • 診斷
    • 治療

第4章 流行病學

  • 疾病的背景情況
  • 風險要素和共生病症
  • 全球的趨勢
  • 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
  • 全身性硬化症(硬皮症) (SSc) 的流行病學預測 (今後11年份)
    • 確診的患病人數 (全體)
    • 確診的患病人數 (各年齡)
    • 確診的患病人數 (男女)
    • 已調整年齡的確診患病人數
    • 確診患病人數:雷諾氏現象 (RP)/手指潰瘍 (DU) 的發病者
    • 限制型/進行性全身性硬化症(硬皮症)的比率
    • 限制型全身性硬化症(硬皮症) (lSSc) 的確診患病人數
    • 進行性全身性硬化症(硬皮症) (dSSc) 的確診患病人數
    • dSSc的確診患病人數:間質性肺部疾病 (ILD)·腎臟癌症的併發者數
  • 議論
    • 流行病學的趨勢相關考察
    • 分析的限制
    • 分析的優勢

第5章 目前治療選擇

  • 概要
  • 產品簡介:組織纖維症
    • Mycophenolate Mofetil
    • Methotrexate
    • Cyclophosphamide
    • 糖皮質激素
    • azachiopurin
  • 產品簡介:血管障礙
    • Tracleer (bosentan)
    • Calcium Channel Blockers
    • Phosphodiesterase 5 Inhibitors
    • Prostacyclins
    • Angiotensin Receptor Blockers
    • Selective Serotonin Reuptake Inhibitors
  • 其他治療方法

第6章 未滿足需求的評估與機會分析

  • 概要
  • 缺乏抗纖維症藥
    • 未滿足需求
    • 差距分析
    • 市場機會
  • 疾病緩和藥的缺乏
  • 預後生物標記的特定
  • 早期的詢問·治療
  • 缺乏安全有效的治療藥

第7章 研究開發 (R&D) 策略

  • 概要
    • 研究機關的臨床試驗
    • 針對自體免疫疾病·心血管疾病藥物的再利用
    • 小規模的生物科技企業的加入
    • 大型製藥企業的策略
    • 孤兒藥及其他的指定藥
  • 臨床實驗的設計

第8章 開發平台分析

  • 概要
  • 臨床實驗中的有潛力的藥劑
    • Rituxan (rituximab)
    • Actemra (tocilizumab)
    • Orencia (abatacept)
    • Botox
  • 早期階段的創新的方法
    • Adempas (riociguat)
    • Disitertide (P144 cream)
    • Resunab (JBT-101)
    • ARG201
    • Aimspro
    • Benlysta (belimumab)

第9章 開發平台評估分析

  • 主要的開發平台藥物臨床方面的比較分析
    • 纖維症的症狀
    • 手指的血管障礙
  • 在主要的開發平台藥物的商業方面的標準
    • 纖維症的症狀
    • 手指的血管障礙
  • 競爭力的評估
  • 今後5年的銷售額的預測
    • 美國
    • 歐洲主要5個國家
    • 日本

第10章 附錄

圖表一覽

目錄
Product Code: GDHC044POA

Systemic sclerosis (SSc) is a complex autoimmune disease that affects the skin and multiple internal organs. Common manifestations of SSc that are included in this report are skin fibrosis, lung fibrosis, and digital vasculopathy (including Raynaud's phenomenon [RP], and digital ulcers [DUs]). Although the etiology is not completely understood, it is believed to be caused by environmental triggers within genetically susceptible individuals. The clinical presentation of the disease varies between patients and treatment is mostly directed at managing its complications within each internal organ, as there are no systemic or disease-modifying treatments that significantly alter the course of the disease. Most drugs used to treat SSc are off-label and include immunosuppressive agents for skin and lung fibrosis and vasodilatory agents to treat digital vasculopathy. GlobalData expects the launch of three drugs during the 2014 to 2024 forecast period, including two biologic agents for fibrosis (Genentech/Roche's Actemra and BMS' Orencia) and Allergan's Botox to treat digital vasculopathy.

Highlights

Key Questions Answered

  • With three drug launches, two of which are biologics, which products are forecast to generate the highest sales over 2014-2024? How are product launches expected to affect immunosuppressants?
  • What do SSc specialists across the 7MM think about the evolving treatment landscape? How will the results from the Scleroderma Lung Study II and update to the 2009 EULAR guidelines affect the management of SSc?
  • What corporate strategies have been employed for recent product launches? What opportunities remain for new entrants?
  • According to KOLs, what are the most important unmet needs in SSc? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2024?
  • How do payers view the unmet needs for SSc and how do reimbursement practices affect drug availability?

Key Findings

  • Biologics are expected to account for nearly half of the SSc market in 2024, with Roche/Genentech's Actemra emerging as a market leader.
  • Reimbursement often poses a barrier to patients receiving proper therapy as evidence for use of off-label therapies in SSc is often lacking.
  • Unmet needs are expected to remain after the forecast period, as there are no antifibrotic or disease-modifying therapies expected to launch for SSc.
  • Several companies have been granted orphan designation and others from the European Medicines Agency (EMA), FDA, and Ministry of Health, Labour and Welfare (MHLW), which all provide incentives for drug development in this area.

Scope

  • Overview of SSc, including etiology, pathophysiology, symptoms, and treatment recommendations.
  • Annualized SSc 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 SSc market.
  • Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically Roche/Genentech's Actemra, Roche/Genentech's Rituxan, BMS's Orencia, and Allergan's Botox.
  • Analysis of the current and future market competition in the global SSc 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 identify companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the SSc market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SSc 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 SSc 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. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Disease Management
    • 3.3.1. Diagnosis
    • 3.3.2. Treatment

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 SSc (2014-2024)
    • 4.5.1. Diagnosed Prevalent Cases of SSc
    • 4.5.2. Age-Specific Diagnosed Prevalent Cases of SSc
    • 4.5.3. Sex-Specific Diagnosed Prevalent Cases of SSc
    • 4.5.4. Age-Standardized Prevalence of SSc
    • 4.5.5. Diagnosed Prevalent Cases of SSc with RP and SSc with DU
    • 4.5.6. SSc Segmented into lSSc and dSSc
    • 4.5.7. Sex-Specific Diagnosed Prevalent Cases of lSSc
    • 4.5.8. Sex-Specific Diagnosed Prevalent Cases of dSSc
    • 4.5.9. Diagnosed Prevalent Cases of dSSc with ILD and Cases with Kidney Disease
  • 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 - Tissue Fibrosis
    • 5.2.1. Mycophenolate Mofetil
    • 5.2.2. Methotrexate
    • 5.2.3. Cyclophosphamide
    • 5.2.4. Glucocorticoids
    • 5.2.5. Azathioprine
  • 5.3. Product Profiles - Vasculopathy
    • 5.3.1. Tracleer (bosentan)
    • 5.3.2. Calcium Channel Blockers
    • 5.3.3. Phosphodiesterase 5 Inhibitors
    • 5.3.4. Prostacyclins
    • 5.3.5. Angiotensin Receptor Blockers
    • 5.3.6. Selective Serotonin Reuptake Inhibitors
  • 5.4. Other Therapies

6. Unmet Needs Assessment and Oppportunity Analysis

  • 6.1. Overview
  • 6.2. Lack of Anti-Fibrotic Drugs
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Lack of Disease-Modifying Therapies
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Identification of Prognostic Biomarkers
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Earlier Referral and Treatment
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Lack of Safe and Effective Therapies
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Clinical Research Run by Academic Centers
    • 7.1.2. Repurposing of Drugs used for Autoimmune and Cardiovascular Diseases
    • 7.1.3. Small Biotech Companies Entering the Space
    • 7.1.4. Big Pharma Strategies
    • 7.1.5. Orphan Drug and Other Special Designations
  • 7.2. Clinical Trial Design

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Rituxan (rituximab)
    • 8.2.2. Actemra (tocilizumab)
    • 8.2.3. Orencia (abatacept)
    • 8.2.4. Botox
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. Adempas (riociguat)
    • 8.3.2. Disitertide (P144 cream)
    • 8.3.3. Resunab (JBT-101)
    • 8.3.4. ARG201
    • 8.3.5. Aimspro
    • 8.3.6. Benlysta (belimumab)

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmarking of Key Pipeline Drugs
    • 9.1.1. Fibrotic Manifestations
    • 9.1.2. Digital Vasculopathy
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
    • 9.2.1. Fibrotic Manifestations
    • 9.2.2. Digital Vasculopathy
  • 9.3. Competitive Assessment
  • 9.4. Top Line Ten Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU
    • 9.4.3. Japan

10. Appendix

  • 10.1. Abbreviations
  • 10.2. Bibliography
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch and Patent Expiry Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Drug Assumptions
    • 10.4.7. Generic Erosion
    • 10.4.8. Pricing of Pipeline Agents
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Author
    • 10.7.2. Therapy Area Director
    • 10.7.3. Epidemiologist
    • 10.7.4. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Symptoms of Systemic Sclerosis
  • Table 2: 2013 ACR/EULAR Criteria for the Classification of SSc (Scleroderma)
  • Table 3: Treatments for Skin Involvement
  • Table 4: Treatments for Digital Vasculopathy
  • Table 5: Treatments for SSc-ILD
  • Table 6: Treatments for SSc-PAH
  • Table 7: Risk Factors and Comorbidities for SSc
  • Table 8: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc
  • Table 9: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc with RP
  • Table 10: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc with DU
  • Table 11: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc, Segmented by lSSc and dSSc
  • Table 12: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of dSSc with ILD
  • Table 13: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of dSSc with Kidney Disease
  • Table 14: 7MM, Diagnosed Prevalent Cases of SSc, Both Sexes, Ages ≥18 Years, Select Years, 2014-2024
  • Table 15: 7MM, Age-Specific Diagnosed Prevalent Cases of SSc, Both Sexes, N (Row%), 2014
  • Table 16: 7MM, Sex-Specific Diagnosed Prevalent Cases of SSc, Ages ≥18 Years, N (Row %), 2014
  • Table 17: 7MM, Diagnosed Prevalent Cases of SSc with RP, and SSc with DU, Both Sexes, Ages ≥18 Years, N (% of Diagnosed Prevalent SSc Cases), 2014
  • Table 18: 7MM, Sex-Specific Diagnosed Prevalent Cases of lSSc, Ages ≥18 Years, N (Row %), 2014
  • Table 19: 7MM, Sex-Specific Diagnosed Prevalent Cases of dSSc, Ages ≥18 Years, N (Row %), 2014
  • Table 20: 7MM, Diagnosed Prevalent Cases of dSSc with ILD and dSSc with Kidney Disease, Both Sexes, Ages ≥15 Years, N (% of Diagnosed Prevalent dSSc Cases), 2014
  • Table 21: Leading Treatments for SSc, 2015
  • Table 22: Product Profile - Mycophenolate mofetil
  • Table 23: Clinical Trials for MMF in SSc
  • Table 24: Product Profile - Methotrexate
  • Table 25: Clinical Trials for MTX in SSc
  • Table 26: Product Profile - Cyclophosphamide
  • Table 27: Clinical Trials for Cyclophosphamide in SSc
  • Table 28: AEs in SSc-ILD Patients Treated with Cyclophosphamide
  • Table 29: Product Profile - Glucocorticoids
  • Table 30: Clinical Trials for Glucocorticoids in SSc
  • Table 31: Product Profile - Azathioprine
  • Table 32: Product Profile - Tracleer
  • Table 33: Clinical Trials for Tracleer in SSc
  • Table 34: AEs Reported in Tracleer Label
  • Table 35: Tracleer SWOT Analysis, 2015
  • Table 36: Product Profile - Calcium Channel Blockers
  • Table 37: AEs Reported in Procardia Label
  • Table 38: Product Profile - Phosphodiesterase Inhibitors
  • Table 39: Clinical Trials for Sildenafil in SSc patients with RP and DUs
  • Table 40: Product Profile - Prostacyclins
  • Table 41: Clinical Trials for IV Prostanoids in SSc
  • Table 42: Adverse Reactions in an RCT of IV Iloprost
  • Table 43: Product Profile - Angiotensin Receptor Blockers
  • Table 44: Product Profile - Selective Serotonin Reuptake Inhibitors
  • Table 45: Frequency of Adverse Effects for Fluoxetine and Nifedipine in Primary and Secondary Raynaud's
  • Table 46: Summary of Minor Therapeutic Drug Classes Used to Treat SSc, 2015
  • Table 47: Unmet Needs and Opportunities in SSc, 2015
  • Table 48: SSc - Late Stage Pipeline, October 2015
  • Table 49: Product Profile - Rituxan
  • Table 50: Clinical Investigations of Rituxan for SSc
  • Table 51: Rituxan SWOT Analysis, 2015
  • Table 52: Product Profile - Actemra
  • Table 53: Results of the FaSScinate Trial in dSSc
  • Table 54: Clinical Investigations of Actemra for SSc
  • Table 55: Actemra SWOT Analysis, 2015
  • Table 56: Product Profile - Orencia
  • Table 57: Orencia SWOT Analysis, 2015
  • Table 58: Product Profile - Botox
  • Table 59: Hand Strength in SSc Patients with Secondary RP Treated with BTX-A
  • Table 60: Clinical Investigations of Botox for SSc, October 2015
  • Table 61: Botox SWOT Analysis, 2015
  • Table 62: Early-Stage Pipeline Products in SSc, October 2015
  • Table 63: Clinical Benchmark of Key Drugs for Fibrosis in SSc
  • Table 64: Clinical Benchmark of Key Digital Vasculopathy Drugs for SSc
  • Table 65: Commercial Benchmark of Key Drugs for Fibrosis in SSc
  • Table 66: Commercial Benchmark of Key Digital Vasculopathy Drugs for SSc
  • Table 67: Top-Line Sales Forecasts ($m) for SSc, 2014-2024
  • Table 68: Key Events Impacting Sales for SSc, 2014-2024
  • Table 69: Global SSc Disease Market - Drivers and Barriers, 2014-2024
  • Table 70: Key Launch Dates
  • Table 71: Key Patent Expiries
  • Table 72: Average Body Weight and Surface Area Across the 7MM
  • Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: Scleroderma Classification
  • Figure 2: Pathogenesis of SSc
  • Figure 3: Case Flow Map of the Diagnosed Prevalent Cases of SSc
  • Figure 4: 7MM, Diagnosed Prevalent Cases of SSc, Both Sexes, Ages ≥18 Years, Selected Years, 2014-2024
  • Figure 5: 7MM, Age-Specific Diagnosed Prevalent Cases of SSc, Both Sexes, 2014
  • Figure 6: 7MM, Sex-Specific Diagnosed Prevalent Cases of SSc, Ages ≥18 Years, 2014
  • Figure 7: 7MM, Age-Standardized Diagnosed Prevalence of SSc, 2014
  • Figure 8: 7MM, Diagnosed Prevalent Cases of SSc with RP and SSc with DU, Both Sexes, Ages ≥18 Years, N, 2014
  • Figure 9: 7MM, Diagnosed Prevalent Cases of SSc Classified as lSSc and dSSc, Both Sexes, Ages ≥18 Years, N, 2014
  • Figure 10: Mediators of Vascular Tone and MOAs that Promote Vasodilation
  • Figure 11: Competitive Assessment of SSc Pipeline Therapies for Fibrosis, 2014-2024
  • Figure 12: Competitive Assessment of SSc Pipeline Therapies for Digital Vasculopathy, 2014-2024
  • Figure 13: Global Sales for SSc by Region, 2014-2024
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