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市場調查報告書

呼吸道融合瘤病毒(RSV) - 機會分析與預測

OpportunityAnalyzer: Respiratory Syncytial Virus (RSV) - Opportunity Analysis and Forecasts to 2024

出版商 GlobalData 商品編碼 355916
出版日期 內容資訊 英文 289 Pages
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呼吸道融合瘤病毒(RSV) - 機會分析與預測 OpportunityAnalyzer: Respiratory Syncytial Virus (RSV) - Opportunity Analysis and Forecasts to 2024
出版日期: 2016年01月01日 內容資訊: 英文 289 Pages
簡介

人類呼吸道融合瘤病毒(RSV)是1956年發現,上呼吸道感染 (一般的感冒) 的原因,在嬰幼兒中成為支氣管炎和肺炎等下呼吸道感染的最重要的原因。由於沒有RS病毒的有效抗病毒藥物,該疾病的治療只限於補充治療。可是今後由於呼吸道融合病毒(RSV)的預防和管理的新手法開發,該市場預計到2024年會有前所未有的成長。

本報告提供全球呼吸道融合瘤病毒(RSV)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

  • 病因及病理學
  • 症狀及預後
  • 生活品質
  • 疾病的管理

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
  • 呼吸道融合病毒(RSV)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:呼吸道融合病毒(RSV)預防藥
  • 產品簡介:呼吸道融合病毒(RSV)治療藥
  • 其他補充的方策

第6章 未滿足需求評估與機會分析

  • 概要
  • 有效治療性介入
  • 預防疫苗
  • 預防的單株抗體半衰期增加
  • 成人患者的呼吸道融合病毒(RSV)的就地檢驗
  • 成人的呼吸道融合病毒(RSV)感染的認識提高

第7章 研究開發策略

  • 概要
  • 提高成本效益的新預防抗體開發
  • 疫苗開發的技術性方法
  • FDA貿易快速審批計劃的利用
  • 呼吸道融合病毒(RSV)治療藥的開發
  • 臨床實驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發的潛力藥物:預防藥
  • 臨床開發的潛力藥物:治療藥
  • 創新的早期方法

第9章 開發平台價值分析

  • 概要
  • 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: GDHC041POA

Human respiratory syncytial virus (RSV) is an enveloped, single-stranded, negative-sense ribonucleic acid (RNA) pneumovirus belonging to the family of Paramyxoviridae. The virus was discovered in 1956, first as an isolate from a laboratory chimpanzee displaying symptoms of the common cold, and later from infants suffering from respiratory disease. RSV can cause upper respiratory tract infections (the common cold) and is the most important cause of lower respiratory tract infections, such as bronchiolitis and pneumonia, in infants. RSV is also an important cause of hospitalizations and deaths in elderly adults.

Today, Medimmune's Synagis (palivizumab) is the only licensed intervention for the prevention of RSV in infants at a high risk of severe infection. This humanized, mouse monoclonal antibody (mAb) was first approval in 1998, and while it is an efficacious prophylactic intervention, its short 20-day half-life necessitates monthly dosing during the RSV season. Moreover, the high cost of Synagis limits its use to certain subgroups of infants who are at high risk of severe RSV infection, and it is not indicated for use in elderly adults, leaving a key population of high-risk individuals unprotected. Furthermore, due to the absence of effective RSV-specific antivirals, the treatment of RSV infections is largely restricted to a number of supportive treatment options. GlobalData projects the global RSV marketplace - which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan) - to experience unprecedented growth from 2014-2024, driven by the arrival of novel approaches to prevention and management of RSV.

Highlights

Key Questions Answered

  • Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the RSV marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2014-2024)?
  • What research and development (R&D) strategies will companies leverage to compete in the future RSV marketplace?
  • Which patient population(s) are most likely to be targeted by novel RSV prophylactic and therapeutic agents?
  • What clinical and commercial factors are likely to influence RSV product uptake in the 7MM?

Key Findings

  • The global RSV marketplace - which, for the purposes of this report, encompasses the sales of products for the prevention or treatment of RSV in the 7MM - was worth approximately $640m in 2014. GlobalData projects the market to surpass $2.3bn in sales by 2024, at a compound annual growth rate (CAGR) of 29.9% from 2014-2024. The sales are projected to originate predominantly from the US (a 62% market share), followed distantly by the 5EU (a 29% market share).
  • The anticipated arrival of novel prophylactic mAbs that boast improved dosing criteria compared with Synagis, led by MedImmune's MEDI8897, will be a principal driver of RSV market growth across the 7MM. The licensure of the first adult vaccine to offer protection against RSV, Novavax's RSV-F Vaccine, will also stimulate rapid growth in a previously untapped segment of the marketplace.
  • A persistent lack of patient and physician awareness of RSV in adult patients - specifically the infection's substantial impact on morbidity and mortality in the elderly - will serve as a key impediment to market growth from 2014-2024.

Scope

  • Overview of RSV infections, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline RSV market revenue from 2014-2024. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting RSV product sales in the 7MM.
  • 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.
  • Analysis of the current and future market competition in the global RSV 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

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 global RSV market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the RSV 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 and Prognosis
    • 3.2.1. Symptoms
    • 3.2.2. Prognosis
  • 3.3. Quality of Life
  • 3.4. Disease Management
    • 3.4.1. Diagnosis of RSV Infection
    • 3.4.2. Prevention of RSV Infection
    • 3.4.3. Treatment of RSV Infection

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. Preterm Infants and Children Born Preterm and Survived to Two Years of Age
    • 4.3.2. Infants with Neonatal CLD
    • 4.3.3. Children with Hemodynamically Significant Congenital Heart Disease
    • 4.3.4. Children with Congenital Respiratory or Neuromuscular Diseases That Compromise Respiratory Function
    • 4.3.5. Third-Trimester Pregnant Women
    • 4.3.6. Hospitalizations for RSV Infection
  • 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 RSV Infection (2014-2024)
    • 4.5.1. Risk Groups for Severe RSV Infection in Children Less than Two Years
    • 4.5.2. Preterm Births
    • 4.5.3. Neonatal CLD
    • 4.5.4. Third-Trimester Pregnant Women
    • 4.5.5. RSV Hospitalizations in Children
  • 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 - RSV Prophylactics
    • 5.2.1. Synagis (palivizumab)
  • 5.3. Product Profiles - RSV Therapeutics
    • 5.3.1. Virazole (aerosolized ribavirin)
  • 5.4. Other Supportive Measures

6. Unmet Needs and Opportunities

  • 6.1. Overview
  • 6.2. Effective Therapeutic Interventions
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Prophylactic Vaccines
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. A Prophylactic mAb with an Increased Half-Life
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Point-of-care Testing for RSV in Adult Patients
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Increased Awareness of RSV Infections in Adults
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity

7. Research and Development Strategies

  • 7.1. Overview
  • 7.2. Development of Novel Prophylactic Antibodies with Increased Cost-Effectiveness
  • 7.3. Technological Approaches to Vaccine Development
    • 7.3.1. Vaccine Antigen Selection
    • 7.3.2. Development of Maternal Vaccines
  • 7.4. Leveraging the FDA's Fast Track Program
  • 7.5. Development of RSV Therapeutics
  • 7.6. Clinical Trial Design
    • 7.6.1. Clinical Trial Design of Key Pipeline Prophylactics
    • 7.6.2. Demonstration of Protective Efficacy for Vaccines and Prophylactic Antibodies
    • 7.6.3. Clinical Trial Design of Key Pipeline Therapeutics
    • 7.6.4. Design and Limitations of Clinical Challenge Studies
    • 7.6.5. From Challenge Studies to Demonstrating Efficacy in Naturally Infected Patients

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development - Prophylactic Agents
    • 8.2.1. Novavax RSV F Vaccine
    • 8.2.2. GSK3003891A
    • 8.2.3. MEDI8897
    • 8.2.4. REGN2222
  • 8.3. Promising Drugs in Clinical Development - Therapeutic Agents
    • 8.3.1. ALS-8176
    • 8.3.2. ALX-0171
    • 8.3.3. GS-5806(presatovir)
    • 8.3.4. JNJ-678
  • 8.4. Innovative Early-Stage Approaches

9. Pipeline Valuation

  • 9.1. Overview
  • 9.2. Clinical Benchmark of Key Pipeline Products
    • 9.2.1. Prophylactic Agents
    • 9.2.2. Therapeutic Agents
  • 9.3. Commcercial Benchmark of Key Pipeline Products
    • 9.3.1. Prophylactic Agents
    • 9.3.2. Therapeutic Agents
  • 9.4. Competitive Assessment
    • 9.4.1. Prophylactic Agents
    • 9.4.2. Therapeutic Agents
  • 9.5. Top-Line 10-Year Forecast
    • 9.5.1. US
    • 9.5.2. 5EU
    • 9.5.3. Japan

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. RSV Patient Population Segmentation
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Products 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. Pricing of Pipeline Agents
  • 10.5. Primary Research - KOLs and Payers Interviewed for this Report
    • 10.5.1. KOLs
    • 10.5.2. Payers
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Analyst
    • 10.7.2. Epidemiologist
    • 10.7.3. Therapy Area Director
    • 10.7.4. Global Director of Therapy Analysis and Epidemiology
    • 10.7.5. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Symptoms of RSV Infection in Infants
  • Table 2: Symptoms of RSV Infection in Elderly and High-Risk Adults
  • Table 3: Guidelines for the Prevention of RSV
  • Table 4: Risk Factors and Comorbidities for Severe RSV Infection
  • Table 5: 7MM, Sources Used to Determine the Preterm Infant Population, 2014
  • Table 6: 7MM, Sources Used to Determine the Incidence of Neonatal CLD, 2014
  • Table 7: 7MM, Sources Used to Determine the Incidence of Hemodynamically Significant Heart Disease in Children, 2014
  • Table 8: 7MM, Sources Used to Determine the Diagnosed Prevalence of Congenital Respiratory and Neuromuscular Diseases That Compromise Respiratory Function in Children, 2014
  • Table 9: 7MM, Sources Used to Determine the Third-Trimester Pregnant Women Population, 2014
  • Table 10: NICHD Neonatal CLD Severity Categorization
  • Table 11: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ≤2 Years, N, 2014
  • Table 12: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ≤2 Years, N, 2024
  • Table 13: 7MM, Preterm Births, Boys and Girls, <37 Weeks' GA, N (Row %), 2014
  • Table 14: 7MM, Incident Cases of Neonatal CLD by Severity, Boys and Girls, <32 Weeks GA, N (Row %), 2014
  • Table 15: 7MM, Third-Trimester Pregnant Women, N, 2014 and 2024
  • Table 16: 7MM, Confirmed RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014
  • Table 17: 7MM, Estimated RSV Hospitalizations in Children, Ages 0-2 Years, N, 2014
  • Table 18: Leading Drug-Based Interventions for RSV, 2015
  • Table 19: Product Profile - Synagis
  • Table 20: Synagis' Efficacy in the Impact-RSV Study
  • Table 21: Synagis SWOT Analysis, 2015
  • Table 22: Product Profile - Virazole
  • Table 23: Virazole's Efficacy in Mechanically Ventilated Infants with Severe RSV LRTI
  • Table 24: Serious Cardiovascular and Pulmonary AEs Associated with Virazole Treatment
  • Table 25: Virazole SWOT Analysis, 2015
  • Table 26: Unmet Needs and Opportunities in RSV, 2015
  • Table 27: FDA Regulatory Decisions Accelerating the Development of RSV Pipeline Agents, 2015
  • Table 28: Key Phase III and Phase II Clinical Trials of Pipeline Prophylactics
  • Table 29: Key Phase I Clinical Trials of Pipeline Prophylactics
  • Table 30: Key Phase II Clinical Trials of Pipeline Therapeutics
  • Table 31: Key Phase I Clinical Trials of Pipeline Therapeutics
  • Table 32: RSV Therapies and Prophylactics - Late-Stage Pipeline, 2015
  • Table 33: Product Profile - Novavax RSV F Vaccine
  • Table 34: A Phase II Clinical Trial Of Novavax's RSV F Vaccine in Third-Trimester Pregnant Women
  • Table 35: Novavax RSV F Vaccine SWOT Analysis, 2015
  • Table 36: Product Profile - GSK3003891A
  • Table 37: GSK3003891A SWOT Analysis, 2015
  • Table 38: Product Profile - MEDI8897
  • Table 39: Clinical Trials Assessing MEDI8897's Safety
  • Table 40: MEDI8897 SWOT Analysis, 2015
  • Table 41: Product Profile - REGN2222
  • Table 42: REGN2222 SWOT Analysis, 2015
  • Table 43: Product Profile - ALS-8176
  • Table 44: ALS-8176 SWOT Analysis, 2015
  • Table 45: Product Profile - ALX-0171
  • Table 46: ALX-0171 SWOT Analysis, 2015
  • Table 47: Product Profile - GS-5806
  • Table 48: GS-5806 Dosing Cohorts in a Phase IIa Challenge Study
  • Table 49: GS-5806 SWOT Analysis, 2015
  • Table 50: Product Profile - JNJ-678
  • Table 51: JNJ-678 SWOT Analysis, 2015
  • Table 52: RSV Therapies and Prophylactics - Early-Stage Clinical Pipeline, 2015
  • Table 53: Clinical Benchmarking of Key RSV Prophylactic Agents, 2015
  • Table 54: Clinical Benchmarking of Key RSV Therapeutic Agents, 2015
  • Table 55: Commercial Benchmarking of Key RSV Prophylactic Agents, 2015
  • Table 56: Commercial Benchmarking of Key RSV Therapeutic Agents, 2015
  • Table 57: Top-Line Global Sales ($m) Forecasts for RSV, 2014-2024
  • Table 58: 7MM, Key Events Impacting Sales for RSV, 2014-2024
  • Table 59: Global RSV Market - Drivers and Barriers, 2014-2024
  • Table 60: Key Historical and Projected Launch Dates for RSV Across the 7MM
  • Table 61: Key Historical and Projected Patent Expiry Dates for RSV Across the 7MM
  • Table 62: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: The RSV Virion
  • Figure 2: Life Cycle of RSV
  • Figure 3: Case Flow Map for RSV Prophylactic and Therapeutic Populations
  • Figure 4: Population Estimates and Births Forecast for the US, Boys and Girls, 1997-2024
  • Figure 5: 7MM, Children Born Preterm (<37 Weeks' GA) Surviving to Ages 0-2 Years, Boys and Girls, N, 2014 and 2024
  • Figure 6: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ≤2 Years, N, 2014
  • Figure 7: 7MM, Children at Risk for Severe RSV Infection, Boys and Girls, Ages ≤2 Years, N, 2024
  • Figure 8: Competitive Assessment of Key RSV Prophylactic Agents, 2014-2024
  • Figure 9: Competitive Assessment of Key RSV Therapeutic Agents, 2014-2024
  • Figure 10: Global Sales ($m) for RSV Therapeutics and Prophylactics by Region, 2014 and 2024
  • Figure 11: Global Sales ($m) for RSV Therapeutics and Prophylactics by Region, 2014-2024
  • Figure 12: Global Sales ($m) for RSV Therapeutics and Prophylactics by Product Class, 2014-2024
  • Figure 13: Sales ($m) for RSV Prophylactics in the US, 2014-2024
  • Figure 14: Sales ($m) for RSV Therapeutics in the US, 2024
  • Figure 15: Sales ($m) for RSV Prophylactics in the 5EU, 2014-2024
  • Figure 16: Sales ($m) for RSV Therapeutics in the 5EU, 2024
  • Figure 17: Sales ($m) for RSV Prophylactics in Japan, 2014-2024
  • Figure 18: Sales ($m) for RSV Therapeutics in Japan, 2024
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