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市場調查報告書

OpportunityAnalyzer:敗血症 - 機會分析與至2021年的預測

OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021

出版商 GlobalData 商品編碼 329820
出版日期 內容資訊 英文 255 Pages
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OpportunityAnalyzer:敗血症 - 機會分析與至2021年的預測 OpportunityAnalyzer: Sepsis - Opportunity Analysis and Forecasts to 2021
出版日期: 2015年03月01日 內容資訊: 英文 255 Pages
簡介

敗血症患者,苦於血液以及組織中的病原體及/或因毒素產生的一連串多種併發症。由於急速進行的過剩宿主免疫反應和細胞功能障礙,依重病度的不同,約有50%的死亡率。

本報告提供敗血症的治療藥市場相關調查分析、疾病概要、流行病學、目前治療選項、未滿足需求和機會、研究開發策略、開發平台評估等相關的系統性資訊。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病情生理
  • 症狀
  • 疾病的管理
  • 生活品質

第4章 流行病學

  • 疾病的背景
  • 危險因素和共生病症
  • 全球趨勢
    • 美國
    • EU5個國家
  • 預測手法
    • 利用之資訊來源
    • 預測的前提條件與手法
  • 敗血症的流行病學預測
    • 敗血症和確診的整體患者數
    • 敗血症和確診的整體患者數:各年齡
    • 敗血症和確診的整體患者數:性別
    • 敗血症的死亡案例等
  • 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 目前治療選項

  • 概要
  • 治療方法
  • 病原體標的法
  • 店主標的法
  • 依照各個國家而有所不同

第6章 未滿足需求和機會

  • 概要
  • 未滿足需求分析
  • 機會分析

第7章 研究開發 (R&D) 策略

  • 概要
  • 特異性治療
  • 臨床試驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發中的有前途藥物
  • 創新的初期階段的方法
  • 前臨床開發階段的產品

第9章 開發平台的評估分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • 銷售額的5年預測
    • 美國
    • EU5個國家

第10章 附錄

圖表

目錄
Product Code: GDHC032POA

Sepsis patients suffer from a series of diverse complications arising from the presence of pathogens and/or their toxins in the blood or tissues, which cause a rapidly progressing hyperactive host immune response and cellular dysfunction leading to mortality rates near 50% depending on disease severity. The syndrome places a major burden on the national healthcare systems of the global marketplace, which for the purposes of this report is comprised of the US, France, Germany, Italy, Spain, and the UK. There are currently no marketed drugs to treat sepsis and current treatment options are limited to careful monitoring, pathogen-targeting therapies, and supportive care and symptom management.

For the purposes of this report, GlobalData defines the sepsis market to include sales of sepsis-specific, host-directed products in patients 18 years and older. Therefore a detailed analysis and sales projections for antibiotics is beyond the scope of this report. The projection of annual sales for medical devices is also beyond the scope of this report, however anticipated launch dates and patient uptake estimates for these products is included in the forecast. GlobalData expects the market to experience modest growth that is primarily driven by the increased uptake of novel therapies - led by Asahi Kasei Pharma America Corporation's ART-123 - in select patients as the critical care community regains confidence in sepsis-specific products and as more data is generated on their overall efficacy and safety. Primary research revealed that skepticism, cynicism, and cautious optimism towards sepsis pipeline products is related to recent high profile failures of products in clinical development.

Highlights

Key Questions Answered

  • Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the sepsis marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2016-2021)?
  • What research and development (R&D) strategies will companies leverage to compete in the future sepsis marketplace?
  • Which patient population(s) are most likely to be targeted for sepsis-specific product development?
  • What clinical and commercial factors are likely to influence sepsis product uptake in the US and 5EU (France, Germany, Italy, Spain, and the UK)?

Key Findings

  • GlobalData projects the sepsis market in the US and 5EU to grow from approximately $26m in 2016 to $354m in 2021, at a compound annual growth rate (CAGR) of 69%. This solid growth will be driven by the increased uptake of novel therapies - led by AKP's anticoagulant ART-123 - in select patients as the critical care community regains confidence in sepsis-specific products and more data is generated on their overall efficacy and safety.
  • KOLs interviewed by GlobalData were cautiously optimistic regarding the clinical benefits of pipeline products in their currently selected trial participants and reiterated further improvements are necessary in an area with major unmet medical needs.
  • GlobalData anticipates that firms will increasingly turn to innovative R&D strategies, in particular the exploration of alternative approaches to clinical trial design and improved patient targeting - such as adaptive design trials and companion diagnostics - in order to increase developmental efficiency, minimize upfront risk, and gain a competitive advantage over rivals.

Scope

  • Overview of sepsis, severe sepsis, and septic shock, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
  • Topline sepsis market revenue from 2016-2021. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included*.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the sepsis market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
  • Analysis of the current and future market competition in the global sepsis 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.
  • Develop business strategies by understanding the trends shaping and driving the global sepsis market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the sepsis 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.
  • 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 Guidelines
    • 3.3.3. Clinical Practice
  • 3.4. Quality of Life Post Sepsis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Forecast Assumptions and Methods - Diagnosed Incident Cases of Sepsis
    • 4.4.3. Forecast Assumptions and Methods - Sepsis Mortality Cases
    • 4.4.4. Forecast Assumptions and Methods - Diagnosed Incident Cases of Sepsis by Severity
    • 4.4.5. Forecast Assumptions and Methods - Sepsis Mortality Cases by Severity
    • 4.4.6. Forecast Assumptions and Methods - Diagnosed Incident Cases of Sepsis by Causative Organism
    • 4.4.7. Forecast Assumptions and Methods - Sepsis Mortality Cases by Causative Pathogen
    • 4.4.8. Forecast Assumptions and Methods - Diagnosed Incident Cases of Sepsis by Comorbid Condition
  • 4.5. Epidemiological Forecast for Sepsis (2013-2023)
    • 4.5.1. Diagnosed Incident Cases of Sepsis
    • 4.5.2. Age-Specific Diagnosed Incident Cases of Sepsis
    • 4.5.3. Sex-Specific Diagnosed Incident Cases of Sepsis
    • 4.5.4. Sepsis Mortality Cases
    • 4.5.5. Age-Specific Sepsis Mortality Cases
    • 4.5.6. Sex-Specific Sepsis Mortality Cases
    • 4.5.7. Diagnosed Incident Cases of Sepsis by Severity
    • 4.5.8. Sepsis Mortality Cases by Severity
    • 4.5.9. Diagnosed Incident Cases of Sepsis by Causative Organism
    • 4.5.10. Sepsis Mortality Cases by Causative Organism
    • 4.5.11. Diagnosed Incident Cases of Sepsis with a Comorbid Condition
  • 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. Treatment Bundles
  • 5.3. Pathogen-Targeting Approaches to Treating Sepsis
    • 5.3.1. Antimicrobial Therapy
    • 5.3.2. Other Therapies - Antivirals, Antifungals and Antiparasitics
  • 5.4. Host-Targeting Approaches to Treating Sepsis
    • 5.4.1. Overview of Current Supportive Care
  • 5.5. Country Differences

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Unmet Need: Sepsis-Specific Therapies
    • 6.2.2. Unmet Need: An Improved Understanding of Sepsis Pathophysiology
    • 6.2.3. Unmet Need: Clinically Relevant Biomarkers to Guide Clinical Trial Enrollment and Inform Physician Treatment Decisions
    • 6.2.4. Unmet Need: Rapid, Accurate, and Sensitive Diagnostic Tools
    • 6.2.5. Unmet Need: Refined Sepsis Definitions and Diagnoses
    • 6.2.6. Unmet Need: Improved Sepsis Education and Awareness for the Public and Healthcare Professionals
  • 6.3. Opportunity Analysis
    • 6.3.1. Opportunity: Develop Innovative Immunomodulatory Agents that Target Sepsis-Specific Pathophysiology
    • 6.3.2. Opportunity: Improved Supportive Care for Sepsis-Induced Comorbidities and Combination Therapies
    • 6.3.3. Opportunity: Identify and Leverage Novel Biomarkers to Streamline Patient Identification and Better Demonstrate Efficacy
    • 6.3.4. Opportunity: Leverage Diagnostics to Help Streamline Clinical Development and Improve Patient Care
    • 6.3.5. Opportunity: Recruit Experts to Improve Company Insight on Sepsis Pathophysiology
    • 6.3.6. Opportunity: Implement Sepsis Awareness Campaigns and Roll Out Educational Tools for Healthcare Professionals

7. Research and Development Strategies

  • 7.1. Overview
  • 7.2. Approaches to Sepsis-specific Therapy Development
    • 7.2.1. Novel Targets
    • 7.2.2. Immunomodulatory Agents
    • 7.2.3. Leverage Novel Biomarkers and Companion Diagnostics
    • 7.2.4. Solve Funding Issues and Potential Partnerships
  • 7.3. Clinical Trial Design
    • 7.3.1. Current Clinical Trial Design
    • 7.3.2. Accurate and Efficient Patient Selection and Enrollment Criteria
    • 7.3.3. Alternative Efficacy Endpoints
    • 7.3.4. Biomarker-Driven Adaptive Design Trials
    • 7.3.5. Standardization of Background Care in Multicenter Trials

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Products in Late-Stage Clinical Development
    • 8.2.1. ART-123
    • 8.2.2. Toraymyxin
  • 8.3. Promising Products in Early-Stage Clinical Development
    • 8.3.1. Selepressin
    • 8.3.2. ALT-836
    • 8.3.3. LB-1148
    • 8.3.4. recAP
    • 8.3.5. IFX-1
    • 8.3.6. Other Innovative Early-Stage Approaches
  • 8.4. Products in Preclinical Development

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Therapies
  • 9.2. Commercial Benchmark of Key Pipeline Therapies
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Five-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Sepsis Patient Population Segmentation
    • 10.4.2. Percent Product-Treated Patients
    • 10.4.3. Products Included in Each Therapeutic Class
    • 10.4.4. Product Launch Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Product Assumptions
    • 10.4.7. Pricing of Pipeline Products
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Analyst
    • 10.6.2. Epidemiologist
    • 10.6.3. Therapy Area Director
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Summary of Temporal Pathophysiological Events Causing Sepsis
  • Table 2: Mediators of the Pro-inflammatory and Anti-inflammatory responses
  • Table 3: Major Biological Events Characteristic to the Hyper-inflammatory Response
  • Table 4: Major Biological Events Characteristic to the Excessive Anti-inflammatory Response
  • Table 5: Symptoms Associated with SIRS, Sepsis, Severe Sepsis, and Septic Shock
  • Table 6: SIRS, Sepsis, Severe Sepsis, and Septic Shock Diagnostic Criteria
  • Table 7: Guidelines for Stratification of Patients with SIRS, Sepsis, Severe Sepsis, and Septic Shock
  • Table 8: Common Comorbidities within Sepsis Patients
  • Table 9: Comorbid Conditions of Sepsis
  • Table 10: ACCP/SCCM Criteria for Classification of Sepsis by Severity
  • Table 11: 6MM, Sources of Diagnosed Incidence Data of Sepsis
  • Table 12: 6MM, Sources of Mortality Data of Sepsis
  • Table 13: 6MM, Sources of Diagnosed Incidence Data of Sepsis by Severity
  • Table 14: 6MM, Sources of Mortality Data of Sepsis by Severity
  • Table 15: 6MM, Sources of Diagnosed Incidence Data of Sepsis by Causative Organism
  • Table 16: 6MM, Sources of Mortality Data of Sepsis by Causative Organism
  • Table 17: 6MM, Sources of Diagnosed Incident Cases of Sepsis with DIC
  • Table 18: 6MM, Sources of Diagnosed Incident Cases of Sepsis with ARDS
  • Table 19: 6MM, Sources of Diagnosed Incident Cases of Sepsis with ALI
  • Table 20: 6MM, Sources of Diagnosed Incident Cases of Sepsis with AKI
  • Table 21: 6MM, Diagnosed Incident Cases of Sepsis, All Ages, Both Sexes, N, 2013-2023
  • Table 22: 6MM, Diagnosed Incident Cases of Sepsis, by Age, Both Sexes, N, (Row %), 2013
  • Table 23: 6MM, Diagnosed Incident Cases of Sepsis, by Sex, All Ages, N (Row %), 2013
  • Table 24: 6MM, Sepsis Mortality Cases, All Ages, Both Sexes, N, 2013-2023
  • Table 25: 6MM, Sepsis Mortality Cases, by Age, Both Sexes, N, (Row %), 2013
  • Table 26: 6MM, Sepsis Mortality Cases, by Sex, All Ages, N (Row %), 2013
  • Table 27: 6MM, Diagnosed Incident Cases of Sepsis by Severity, All Ages, Both Sexes, N (Row %), 2013
  • Table 28: 6MM, Sepsis Mortality Cases by Severity, All Ages, Both Sexes, N, (Row %), 2013
  • Table 29: 6MM, Diagnosed Incident Cases of Sepsis by Causative Organism, All Ages, Both Sexes, N (Row %), 2013
  • Table 30: 6MM, Sepsis Mortality Cases by Causative Organism, All Ages, Both Sexes, N (Row %), 2013
  • Table 31: 6MM, Diagnosed Incident Cases of Sepsis with a Comorbid Condition, All Ages, Both Sexes, N, 2013
  • Table 32: Treatment Bundles for Sepsis Patients
  • Table 33: Commonly Used Antibiotics in Sepsis and Important Gaps in Coverage
  • Table 34: Other Supportive Therapies to be Implemented When Clinically Relevant
  • Table 35: Unmet Need and Opportunity in Sepsis
  • Table 36: Recent High-Profile Failures in the Sepsis Market
  • Table 37: Key Companies in the Sepsis Market, 2014
  • Table 38: Design of Pipeline Clinical Trials in Sepsis
  • Table 39: Sepsis Therapies - Late-Stage Pipeline, 2014
  • Table 40: Product Profile - ART-123
  • Table 41: ART-123 Phase IIb Trial Summary of 28-Day Mortality Rates by Overall Patients and Subgroups
  • Table 42: ART-123 Phase IIb Trial Event-Free and Alive Days
  • Table 43: ART-123 Phase IIb Trial Important Treatment Emergent AEs and SAEs Monitored
  • Table 44: ART-123 SWOT Analysis, 2015
  • Table 45: Product Profile - Toraymyxin
  • Table 46: EUPHAS Trial - Toraymyxin Physiological End Points by Treatment Group at Baseline and 72 Hours
  • Table 47: EUPHAS Trial - Change in SOFA Scores by Treatment Group After 72 hours
  • Table 48: EUPHAS Trial - Event-free Days and Days Spent in Hospital by Treatment Group
  • Table 49: Toraymyxin SWOT Analysis, 2014
  • Table 50: Sepsis Therapies - Innovative Early-Stage Approaches, 2015
  • Table 51: Product Profile - Selepressin
  • Table 52: Product Profile - ALT-836
  • Table 53: Hospital Indices - ALT-836
  • Table 54: Safety Profile - ALT-836
  • Table 55: Product Profile - LB-1148
  • Table 56: Product Profile - recAP
  • Table 57: Safety Profile of BIAP
  • Table 58: Product Profile - IFX-1
  • Table 59: Product Profile - Levosimendan
  • Table 60: Product Profile - Cx-611
  • Table 61: Sepsis Products in Preclinical Development, 2014
  • Table 62: Clinical Benchmark of Key Sepsis Pipeline Products, 2016-2021
  • Table 63: Commercial Benchmark of Key Sepsis Pipeline Products, 2016-2021
  • Table 64: Top-Line Sales Forecasts ($m) for Sepsis Pipeline Products, 2016-2021
  • Table 65: Key Events Impacting Sales for Sepsis Products, 2016-2021
  • Table 66: Sepsis Products Market - Drivers and Barriers, 2016-2021
  • Table 67: Sepsis Patient Population Segmentation - Secondary Sources Leveraged
  • Table 68: Patient Populations Targeted by Sepsis Pipeline Product Developers
  • Table 69: Sepsis Pipeline Products Broken Down by Therapeutic Class
  • Table 70: Key Product Launch Dates by Region

List of Figures

  • Figure 1: Pathogens Responsible for Causing Sepsis, Severe Sepsis, and Septic Shock
  • Figure 2: The Diagnostic Pathway for SIRS, Sepsis, Severe Sepsis, and Septic Shock
  • Figure 3: Common Causes and Origins of Sepsis
  • Figure 4: Effects of Excessive Specific Mediators on the Host Immune System
  • Figure 5: Competing Theories of the Host Immune Response - the Inflammatory and Anti-inflammatory Response
  • Figure 6: International Treatment Algorithm Overview for Sepsis, Severe Sepsis, and Septic Shock
  • Figure 7: 6MM, Diagnosed Incident Cases of Sepsis, All Ages, Both Sexes, N, 2013-2023
  • Figure 8: 6MM, Diagnosed Incident Cases of Sepsis, by Age, Both Sexes, N, 2013
  • Figure 9: 6MM, Diagnosed Incident Cases of Sepsis, by Sex, All Ages, N, 2013
  • Figure 10: 6MM, Sepsis Mortality Cases, All Ages, Both Sexes, N, 2013-2023
  • Figure 11: 6MM, Sepsis Mortality Cases, by Age, Both Sexes, N, 2013
  • Figure 12: 6MM, Sepsis Mortality Cases, by Sex, All Ages, N, 2013
  • Figure 13: 6MM, Diagnosed Incident Cases of Sepsis by Severity, All Ages, Both Sexes, N, 2013
  • Figure 14: 6MM, Sepsis Mortality Cases by Severity, All Ages, Both Sexes, N, 2013
  • Figure 15: 6MM, Diagnosed Incident Cases of Sepsis by Causative Organism, All Ages, Both Sexes, N, 2013
  • Figure 16: 6MM, Sepsis Mortality Cases by Causative Organism, All Ages, Both Sexes, N, 2013
  • Figure 17: 6MM, Diagnosed Incident Cases of Sepsis with a Comorbid Condition, All Ages, Both Sexes, N, 2013
  • Figure 18: Current Treatment Options for Sepsis, Severe Sepsis, and Septic Shock
  • Figure 19: Competitive Assessment of Sepsis Pipeline Products, 2016-2021
  • Figure 20: Global Sales for Sepsis Products by Region, 2016-2021
  • Figure 21: US Sales for Sepsis Products, 2016-2021
  • Figure 22: 5EU Sales for Sepsis Products, 2016-2021
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