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市場調查報告書

生殖器皰疹 - 機會分析與至2023年的預測

OpportunityAnalyzer: Genital Herpes - Opportunity Analysis and Forecasts to 2023

出版商 GlobalData 商品編碼 341944
出版日期 內容資訊 英文 223 Pages
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生殖器皰疹 - 機會分析與至2023年的預測 OpportunityAnalyzer: Genital Herpes - Opportunity Analysis and Forecasts to 2023
出版日期: 2015年07月10日 內容資訊: 英文 223 Pages
簡介

美國、歐洲5個國家及日本的生殖器皰疹市場預計從2013年的4億9,000萬美元以3.1%的年複合成長率擴大,到2023年達6億6,800萬美元。是由美國、歐洲5個國家的治療用疫苗等開發平台的上市所促進,和由於學名藥的普及。

本報告提供生殖器皰疹的概要與2013∼2023年的市場收益、市場競爭、研究開發策略、開發平台分析、現在及未來市場預測等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因及病理學
  • 生活品質
  • 症狀
  • 疾病的管理
    • 診斷
    • 抗病毒治療
    • 特定患者的生殖器皰疹的管理
    • 補充對策

第4章 流行病學

  • 疾病的背景
  • 風險因素及並用疾病
  • 全球的趨勢
  • 預測方法
  • 流行病學的預測
  • 考察

第5章 目前治療方法

  • 概要
  • 產品簡介:抗病毒藥物

第6章 未滿足需求評估與機會分析

  • 概要
  • 未滿足需求分析
  • 機會分析

第7章 研究開發策略

  • 概要
  • 疫苗開發的技術性方法
  • 抗病毒藥物的開發成為新作用機制
  • 聯合、授權、夥伴關係
  • 臨床實驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發的潛力產品
  • 早期臨床開發的潛力產品
  • 其他的創新方法

第9章 開發平台價值分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業性基準
  • 競爭評估
  • 主要國家的5年預測

第10章 附錄

目錄
Product Code: GDHC025POA

Genital herpes (GH) is a life-long viral infection of the genitalia and urogenital tract. It is one of the most common sexually transmitted infections (STIs) and is a leading cause of genital ulcers around the world. Patients with GH can suffer from recurring episodes of symptom outbreaks, which usually involve painful ulcerations. The prevalence of GH in the seven major pharmaceutical markets (7MM) covered in this report (US, France, Germany, Italy, Spain, UK, and Japan) has been increasing, and GH is beginning to be viewed as a significant global public health problem, especially because the infection can assist the transmission of human immunodeficiency virus 1 (HIV-1).

There is currently no effective preventative vaccine or cure for GH, and the treatment landscape is dominated by generic nucleoside analogues. Despite the effectiveness of these drugs in managing the symptoms in the majority of patients, the lack of treatment alternatives and the shortcomings of the current treatments have stimulated investments in new treatment options for this vast patient population.

For the purposes of this report, GlobalData defines the GH market to include sales of GH-specific medication in patients 18 years and older. GlobalData expects the market to experience moderate growth that is primarily driven by the uptake of novel therapies - led by Agenus's HerpV and Genocea's GEN-003 - in the US and 5EU (France, Germany, Italy, Spain and UK).

Highlights

Key Questions Answered

  • Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the GH marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2013-2023)?
  • What research and development (R&D) strategies will companies leverage to compete in the future GH marketplace?
  • Which patient population(s) are most likely to be targeted for GH -specific product development?
  • What clinical and commercial factors are likely to influence GH uptake in the US, 5EU and Japan?

Key Findings

  • GlobalData projects the GH market in the US, 5EU and Japan to grow from approximately $490m in 2013 to $668m in 2023, at a compound annual growth rate (CAGR) of 3.1%. This growth across the 7MM will primarily be driven by the launch of pipeline agents, especially the therapeutic vaccines in the US and 5EU, while continued generic erosion across the 7MM, particularly in the 5EU and Japan, is expected to curtail market growth over the forecast period.
  • While pipeline agents have the potential to address some of the unmet needs in the GH treatment, available data do not demonstrate that they will be able to fully address these issues, according to interviewed KOLs.
  • GlobalData anticipates that opportunities centered on the development of therapeutic and/or prophylactic vaccines, as well as antivirals with novel MOAs, will exist for current and future players in the GH marketplace for the duration of the forecast period.

Scope

  • Overview of GH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
  • Topline GH market revenue from 2013-2023. 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 genital herpes 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 genital herpes 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 genital herpes market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the genital herpes 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. Quality of Life
  • 3.3. Symptoms
  • 3.4. Disease Management
    • 3.4.1. Diagnosis
    • 3.4.2. Antiviral Therapy
    • 3.4.3. Management of GH in Specific Patient Populations
    • 3.4.4. Supportive Measures

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 of GH (2013-2023)
    • 4.5.1. Diagnosed Incident Cases of GH
    • 4.5.2. Diagnosed Incident Cases of GH Segmented by Strain
    • 4.5.3. Diagnosed Incident Cases of GH Segmented by Sex
    • 4.5.4. Number of Persons Diagnosed with Herpes Simplex Virus-1 GH Experiencing Recurrences During the First Year of Diagnosis
    • 4.5.5. Number of Persons Diagnosed with Herpes Simplex Virus-2 GH Experiencing Recurrences During the First Year of Diagnosis
    • 4.5.6. Diagnosed Prevalent Cases of Herpes Simplex Virus-1 Only GH
    • 4.5.7. Diagnosed Prevalent Cases of Herpes Simplex Virus-2 Only GH
    • 4.5.8. Diagnosed Prevalent Cases of Herpes Simplex Virus-1 and Herpes Simplex Virus-2 Co-infection GH
  • 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 - Antivirals
    • 5.2.1. Acyclovir
    • 5.2.2. Valacyclovir
    • 5.2.3. Famciclovir
    • 5.2.4. Other Marketed Products

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Unmet Need: Novel Treatment Options That Reduce GH Transmission and Recurrence
    • 6.2.2. Unmet Need: Therapies with More Convenient Dosing Schedules
    • 6.2.3. Unmet Need: Safe and Efficacious Therapeutic Interventions for Difficult-to-Treat Patient Populations
    • 6.2.4. Unmet Need: Increased Public Awareness and Acceptance of GH
    • 6.2.5. Unmet Need: Improved Physician Education on the Importance of Proactively Diagnosing and Treating GH
  • 6.3. Opportunity Analysis
    • 6.3.1. Opportunity: Develop Therapeutic GH Vaccines
    • 6.3.2. Opportunity: Develop Prophylactic GH Vaccines
    • 6.3.3. Opportunity: Develop Novel Antiviral Treatments that Possess Novel Mechanisms of Action
    • 6.3.4. Opportunity: Leverage Novel Diagnostic Tools alongside Public Awareness Initiatives to Improve GH Diagnosis Rates

7. Research and Development Strategies

  • 7.1. Overview
  • 7.2. Technological Approaches to Vaccine Development
    • 7.2.1. Vaccine Antigen Selection
    • 7.2.2. Selection of Adjuvants and Co-stimulants
    • 7.2.3. Prioritizing Therapeutic Vaccines that Target Herpes Simplex Virus-2
  • 7.3. Development of Antivirals that Possess Novel Mechanisms of Action
  • 7.4. Collaboration, Licensing, and Partnerships
  • 7.5. Clinical Trial Design
    • 7.5.1. Current Clinical Trial Design
    • 7.5.2. Selection and Enrollment of Clinical Trial Participants
    • 7.5.3. Efficacy Endpoint Selection
    • 7.5.4. Genital Swabbing Test

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Products in Clinical Development
    • 8.2.1. Amenamevir
    • 8.2.2. HerpV
    • 8.2.3. GEN-003
  • 8.3. Promising Products in Early-Stage Clinical Development
    • 8.3.1. VCL-HB01 and VCL-HM01
    • 8.3.2. HSV529
    • 8.3.3. HSV-2 DNA Vaccine
    • 8.3.4. Brincidofovir
    • 8.3.5. G103
    • 8.3.6. Pritelivir
  • 8.4. Other Innovative Approaches
    • 8.4.1. Vaccines in Preclinical Development
    • 8.4.2. Other Products in Preclinical Development

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top Line Five 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. Diagnosed GH Patients
    • 10.4.2. Drug-Treated GH 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. Pricing of Pipeline Agents
  • 10.5. Primary Research - Key Opinion Leaders Interviewed for this Report
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Author
    • 10.7.2. Epidemiologist
    • 10.7.3. Therapy Area Director
    • 10.7.4. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Symptoms of GH
  • Table 2: Laboratory-Based Diagnostic Tests for HSV Infection
  • Table 3: Recommended Antiviral Regimens for the Management of GH in Immunocompetent Patients
  • Table 4: Recommended Antiviral Regimens for the Management of GH in Immunocompromised Patients
  • Table 5: Risk Factors and Comorbidities for GH
  • Table 6: Sources of Epidemiological Data Used for the Forecast of the Diagnosed Incident Cases of GH in the 7MM
  • Table 7: Sources of Epidemiological Data Used for the Forecast of the Total Prevalent Cases of HSV-1 Infections in the 7MM
  • Table 8: Sources of Epidemiological Data Used for the Forecast of the Total Prevalent Cases of HSV-2 Infection in the 7MM
  • Table 9: Sources of Epidemiological Data Used for the Forecast of the Total Prevalent Cases of HSV-1 and HSV-2 Co-infections in the 7MM
  • Table 10: Sources of Epidemiological Data Used for the Forecast of the Diagnosis Rate of HSV-1 Only GH in the 7MM
  • Table 11: Sources of Epidemiological Data Used for the Forecast of the Diagnosis Rate of HSV-2 Only GH in the 7MM
  • Table 12: Sources of Epidemiological Data Used for the Forecast of the Diagnosis Rate of HSV-1 and HSV-2 Co-infection GH in the 7MM
  • Table 13: 7MM, Sources Not Used in the Epidemiological Analysis of GH
  • Table 14: 7MM, Diagnosed Incident Cases of GH, Both Sexes, Ages ≥18 Years, Select Years 2013-2023
  • Table 15: 7MM, Diagnosed Incident Cases of GH Segmented by Strain, Both Sexes, Ages ≥18 Years, 2013
  • Table 16: 7MM, Diagnosed Incident Cases of GH Segmented by Sex, Ages ≥18 Years, N (Row %) 2013
  • Table 17: 7MM, Number of Persons Diagnosed with HSV-1 Experiencing Recurrences During the First Year of Diagnosis, Both Sexes, Ages ≥18 Years, 2013
  • Table 18: 7MM, Number of Persons Diagnosed with HSV-2 Experiencing Recurrences During the First Year of Diagnosis, Both Sexes, Ages ≥18 Years, 2013
  • Table 19: 7MM, Diagnosed Prevalent Cases of HSV-1 Only GH, Both Sexes, Ages ≥18 Years, N, Select Years, 2013-2023
  • Table 20: 7MM, Diagnosed Prevalent Cases of HSV-2 Only GH, Both Sexes, Ages ≥18 Years, N, Select Years, 2013-2023
  • Table 21: 7MM, Diagnosed Prevalent Cases of HSV-1 and HSV-2 Co-infection GH, Both Sexes, Ages ≥18 Years, Select Years, 2013-2023
  • Table 22: Leading Treatments for GH
  • Table 23: Product Profile - Acyclovir
  • Table 24: Summary of Key Clinical Trials of Acyclovir
  • Table 25: Result from a Clinical Trial with Oral Acyclovir
  • Table 26: Result from a Clinical Trial with Oral Acyclovir
  • Table 27: Acyclovir SWOT Analysis, 2014
  • Table 28: Product Profile - Valacyclovir
  • Table 29: Summary of Key Clinical Trials of Valacyclovir
  • Table 30: Valacyclovir SWOT Analysis, 2014
  • Table 31: Product Profile - Famciclovir
  • Table 32: Summary of Key Clinical Trials of Famciclovir
  • Table 33: Famciclovir SWOT Analysis, 2014
  • Table 34: Other Drugs Used to Treat HSV Infections
  • Table 35: Overall Unmet Needs - Current Level of Attainment
  • Table 36: Collaboration and Partnership in the Development of GH Vaccines
  • Table 37: Key Clinical Trials of Pipeline Antiviral Treatments
  • Table 38: Key Clinical Trials of Pipeline Vaccines
  • Table 39: Late-Stage Pipeline for GH, 2014
  • Table 40: Product Profile - Amenamevir
  • Table 41: Amenamevir - Key Efficacy End Point Result in a Phase II Clinical Trial
  • Table 42: Amenamevir SWOT Analysis, 2014
  • Table 43: Product Profile - HerpV
  • Table 44: HerpV SWOT Analysis, 2014
  • Table 45: Product Profile - GEN-003
  • Table 46: GEN-003 - Clinical Data from a Phase I/IIa Clinical Trial
  • Table 47: GEN-003 - Clinical Data from a Phase II Dose Optimization Clinical Trial
  • Table 48: GEN-003 SWOT Analysis, 2014
  • Table 49: Early-stage Pipeline for GH, 2014
  • Table 50: Preclinical and Discovery Stage Vaccines for GH
  • Table 51: Preclinical and Discovery Stage Non-vaccine Products for GH
  • Table 52: Clinical Benchmarking of Key Marketed & Pipeline Antivirals
  • Table 53: Clinical Benchmarking of Key Pipeline Vaccines
  • Table 54: Commercial Benchmarking of Key Marketed & Pipeline Products
  • Table 55: Top Line Sales Forecasts ($m) for GH, 2013-2023
  • Table 56: Key Events Impacting Sales for GH, 2013-2023
  • Table 57: GH Market - Drivers and Barriers, 2013-2023
  • Table 58: Key Historical and Projected Launch Dates
  • Table 59: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: HSV Virion Structure
  • Figure 2: 7MM, Diagnosed Incident Cases of GH, Both Sexes, Ages ≥18 Years, Select Years, 2013-2023
  • Figure 3: Diagnosed incident Cases of GH Segmented by Strain, Both Sexes, Ages ≥18 Years, 2013
  • Figure 4: 7MM, Diagnosed Incident Cases of GH Segmented by Sex, Ages ≥18 Years, 2013
  • Figure 5: 7MM, Diagnosed Prevalent Cases of HSV-1 Only GH, Both Sexes, Ages ≥18 Years, N, 2013-2023
  • Figure 6: 7MM, Diagnosed Prevalent Cases of HSV-2 Only GH, Both Sexes, Ages ≥18 Years, N, 2013-2023
  • Figure 7: 7MM, Diagnosed Prevalent Cases of HSV-1 and HSV-2 Co-infection GH, Both Sexes, Ages ≥18 Years, Select Years, 2013-2023
  • Figure 8: Competitive Assessment of Late-stage Pipeline Agents for GH, 2013-2023
  • Figure 9: Sales for GH by Region, 2013-2023
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