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市場調査レポート

主要先進国におけるB型肝炎治療薬市場 〜2021年:罹患率の高い地域からの移民数の増加が市場の成長を牽引

Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth

発行 GBI Research 商品コード 340978
出版日 ページ情報 英文 72 Pages
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主要先進国におけるB型肝炎治療薬市場 〜2021年:罹患率の高い地域からの移民数の増加が市場の成長を牽引 Hepatitis B Therapeutics in Major Developed Markets to 2021 - Increasing Number of Migrants from High-Prevalence Regions to Drive Market Growth
出版日: 2015年09月01日 ページ情報: 英文 72 Pages
概要

世界でおよそ3億5,000万人が慢性のB型肝炎に感染しているとみられています。毎年78万人がB型肝炎で命を落としており、そのうち65万人は肝硬変や肝癌などの合併症によってなくなっています。2014〜2021年にかけて、主要8か国におけるB型肝炎市場は29億米ドルからCAGR2.3%で拡大し、35億米ドルになると予測されています。

当レポートでは、B型肝炎の概要と治療薬市場動向、上市済みおよびパイプラインの動向、2021年までの市場発展予測などをまとめています。

第1章 目次

第2章 イントロダクション

  • 分類
  • 病態生理学
  • 病因
  • 症状
  • 診断
  • 疫学
  • 治療と管理
  • 予後
  • 相互感染

第3章 上市済み製品

  • Viread
  • Entecavir
  • Pegasys (peg interferon α-2a)
  • Adefovir dipivoxil
  • Tyzeka per Sebivo
  • 有効性および安全性比較

第4章 パイプライン分析

  • パイプライン全体
  • 治療用ワクチンのパイプライン分析
  • 治験
    • 失敗率
    • 分子タイプ別失敗率
    • 作用機序別失敗率
    • 患者募集と治験規模
    • 期間
  • 治験競合指標分析
  • パイプラインにおける有望薬剤候補
  • パイプラインにある治療用ワクチン

第5章 2021年年までの市場予測

  • 地域別市場
  • 世界市場
  • 北米
  • 欧州5か国
  • 日本
  • 促進因子と障壁

第6章 契約および戦略的統合

  • ライセンシング
  • 共同開発

第7章 付録

図表

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目次
Product Code: GBIHC368MR

Executive Summary

Hepatitis B is an infectious liver disease caused by the Hepatitis B Virus (HBV) and characterized by acute or chronic inflammation of the liver. Despite its status as a vaccine-preventable disease, it remains a serious global health concern. Incidence tends to be higher in countries with a significant number of migrants from medium and high-prevalence countries. Approximately 350 million people worldwide are infected with chronic hepatitis B, which causes significant morbidity and mortality. Around 780,000 patients die from hepatitis B each year, of which 650,000 deaths are due to complications such as cirrhosis and liver cancer. Despite this, diagnosis and treatment rates are poor, stemming from its asymptomatic nature.

Globally, the hepatitis B therapeutics market is served moderately well by the available products, of which Baraclude and Viread are the most frequently prescribed. However, both have received black-box warnings from the US Food and Drug Administration (FDA), meaning that the market has a high level of unmet need.

Scope

The current hepatitis B market contains mainly nucleoside analog reverse transcriptase inhibitors, nucleotide analogs, and interferons.

Will these drugs continue to dominate hepatitis B treatment?

With 81 active pipeline molecules, most of the investigational drug candidates are small molecules and vaccines, comprising 64% of the pipeline.

What are the most prominent small molecules and vaccines in the pipeline?

Do the pipeline molecules offer advantages over commercially proven mechanisms?

Analysis of clinical trials since 2006 has identified a high rate of attrition in hepatitis B products.

How do failure rates vary by product stage of development, molecule type, and mechanism of action?

How do other factors such as average trial duration and trial size influence the costs and risks associated with product development?

Over the 2014-2021 forecast period, the hepatitis B market in the eight major markets is expected to increase in value at a CAGR of 2.3% from $2.9 billion to $3.5 billion.

Which markets make the most significant contribution to the current market size?

What are the epidemiology trends in these markets?

Which factors will influence growth rates in the different major markets?

Despite generic sales erosion resulting from patent expirations, the uptake of premium therapies tenofovir and entecavir will contribute to significant market growth over the forecast period.

Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?

Which patent expirations will have the most significant impact on the market?

Reasons to buy

  • This report will enable you to -
  • Understand the clinical context of hepatitis B by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
  • Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
  • Appreciate key pipeline trends by molecule type, route of administration, mechanism of action, and novelty.
  • Consider market opportunities and potential risks by looking at trends in clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
  • Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential by examining clinical trial data and multi-scenario product forecast projections.
  • Compare treatment usage patterns, annual therapy costs, and market growth projections for the US, Canada, the UK, France, Germany, Italy, Spain, and Japan.
  • Discover trends in licensing and co-development deals concerning hepatitis B products and identify the major strategic consolidations that have shaped the commercial landscape.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Disease Introduction
  • 2.2. Epidemiology
  • 2.3. Etiology and Pathophysiology
    • 2.3.1. Viral Genome
    • 2.3.2. Viral life cycle
    • 2.3.3. Genotypes and Global Distribution
  • 2.4. Symptoms
  • 2.5. Diagnosis
  • 2.6. Prognosis
  • 2.7. Treatment and Management
    • 2.7.1. First-Line Treatment
    • 2.7.2. Second-Line Treatment
  • 2.8. Co-infection
    • 2.8.1. HBV-HIV Co-infection
    • 2.8.2. HBV-HDV Co-infection
    • 2.8.3. HBV-HCV Co-infection

3. Marketed Products

  • 3.1. Viread
    • 3.1.1. Study 0102
    • 3.1.2. Study 0103
  • 3.2. Entecavir
    • 3.2.1. Study AI463022(HBeAg-Positive Subjects)
    • 3.2.2. Study AI463027(HBeAg-Negative Subjects)
    • 3.2.3. Study AI463026
    • 3.2.4. Study AI463048
  • 3.3. Pegasys(peg interferon α-2a)
  • 3.4. Adefovir dipivoxil
    • 3.4.1. Study 437(HBeAg-Positive)
    • 3.4.2. Study 438(HBeAg-Negative)
    • 3.4.3. Adefovir Treatment beyond 48 Weeks
    • 3.4.4. Study 435
    • 3.4.5. Study 461
  • 3.5. Tyzeka/Sebivo
    • 3.5.1. NV-02B-007 GLOBE Trial
    • 3.5.2. HBeAg-Positive Subjects
    • 3.5.3. HBeAg-Negative Subjects
  • 3.6. Comparative Efficacy and Safety

4. Pipeline Analysis

  • 4.1. Overview
  • 4.2. Pipeline Analysis of Therapeutic Vaccines
  • 4.3. Clinical Trials
    • 4.3.1. Failure Rate
    • 4.3.2. Clinical Trial Duration
    • 4.3.3. Clinical Trial Size
  • 4.4. Competitive Clinical Trials Metrics Analysis
  • 4.5. Promising Drug Candidates in Pipeline
    • 4.5.1. Tenofovir Alafenamide Fumarate(GS-7340)
  • 4.6. Therapeutic Vaccines in Pipeline
    • 4.6.1. GS-4774 Therapeutic Vaccine with Oral Antiviral Therapy
    • 4.6.2. ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B
    • 4.6.3. HB-110E Therapeutic DNA Vaccine
    • 4.6.4. INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients
    • 4.6.5. TG1050 Therapeutic Vaccine

5. Market Forecast to 2021

  • 5.1. Geographical Markets
  • 5.2. Global Market
  • 5.3. North America
    • 5.3.1. Treatment Usage Patterns
    • 5.3.2. Annual Cost of Therapy
    • 5.3.3. Market Size
  • 5.4. Top Five EU Markets
    • 5.4.1. Treatment Usage Patterns
    • 5.4.2. Annual Cost of Therapy
    • 5.4.3. Market Size
  • 5.5. Japan
    • 5.5.1. Treatment Usage Patterns
    • 5.5.2. Annual Cost of Therapy
    • 5.5.3. Market Size
  • 5.6. Drivers and Barriers in the Disease Market
    • 5.6.1. Drivers
    • 5.6.2. Barriers

6. Deals and Strategic Consolidations

  • 6.1. Licensing Deals
    • 6.1.1. OnCore Enters into Licensing Agreement with NeuroVive
    • 6.1.2. Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733
    • 6.1.3. Cytos Biotech Enters into Licensing Agreement with OnCore Biopharma
    • 6.1.4. NeuroVive Pharma Enters into Licensing Agreement with OnCore Biopharma for NVP018
  • 6.2. Co-development Deals
    • 6.2.1. Research agreement between OnCore Biopharma and Baruch S. Blumberg
    • 6.2.2. Vaccine Development Agreement between Artes Biotech and Bio Farma

7. Appendix

  • 7.1. All Pipeline Drugs by Phase of Development
    • 7.1.1. Discovery
    • 7.1.2. Preclinical
    • 7.1.3. Phase I
    • 7.1.4. Phase II
    • 7.1.5. Phase III
  • 7.2. Market Forecasts to 2021
    • 7.2.1. Global
    • 7.2.2. US
    • 7.2.3. Canada
    • 7.2.4. UK
    • 7.2.5. France
    • 7.2.6. Germany
    • 7.2.7. Italy
    • 7.2.8. Spain
    • 7.2.9. Japan
  • 7.3. Bibliography
  • 7.4. Abbreviations
  • 7.5. Research Methodology
    • 7.5.1. Secondary Research
    • 7.5.2. Marketed Product Profiles
    • 7.5.3. Late-Stage Pipeline Candidates
    • 7.5.4. Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
    • 7.5.5. Forecasting Model
    • 7.5.6. Deals Data Analysis
  • 7.6. Contact Us
  • 7.7. Disclaimer

List of Tables

  • Table 1: Chronic Hepatitis B Prevalence in Countries that are Main Sources of Migration to US
  • Table 2: Comparison of Drugs that Treat Hepatitis B
  • Table 3: Immigration from High-Prevalence Regions to US, 2010 and 2013
  • Table 4: Hepatitis B Therapeutics Market, Global, Pipeline Products, Discovery, 2015
  • Table 5: Hepatitis B Therapeutics Market, Global, Pipeline Products, Preclinical, 2015
  • Table 6: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase I, 2015
  • Table 7: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase II, 2015
  • Table 8: Hepatitis B Therapeutics Market, Global, Pipeline Products, Phase III, 2015
  • Table 9: Hepatitis B Therapeutics Market, Global, Market Forecast, 2014-2021
  • Table 10: Hepatitis B Therapeutics Market, US, Market Forecast, 2014-2021
  • Table 11: Hepatitis B Therapeutics Market, Canada, Market Forecast, 2014-2021
  • Table 12: Hepatitis B Therapeutics Market, UK, Market Forecast, 2014-2021
  • Table 13: Hepatitis B Therapeutics Market, France, Market Forecast, 2014-2021
  • Table 14: Hepatitis B Therapeutics Market, Germany, Market Forecast, 2014-2021
  • Table 15: Hepatitis B Therapeutics Market, Italy, Market Forecast, 2014-2021
  • Table 16: Hepatitis B Therapeutics Market, Spain, Market Forecast, 2014-2021
  • Table 17: Hepatitis B Therapeutics Market, Japan, Market Forecast, 2014-2021
  • Table 18: Abbreviations

List of Figures

  • Figure 1: Hepatitis B Disease Classification
  • Figure 2: Hepatitis B Virus Life Cycle
  • Figure 3: Management of Hepatitis B Infection
  • Figure 4: Hepatitis B Therapeutics Market, Global, Comparative Efficacy and Safety of Marketed Products Heatmap, 2015
  • Figure 5: Hepatitis B Therapeutics Market, Global, Overview of Pipeline Products
  • Figure 6: Hepatitis B Therapeutics Market, Global, Therapeutic Vaccines in Pipeline by Molecule Type
  • Figure 7: Hepatitis B Market, Global, Clinical Trial Failure Rate (%), 2015
  • Figure 8: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015
  • Figure 9: Hepatitis B Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2015
  • Figure 10: Hepatitis B Market, Global, Clinical Trial Duration by Molecule Type (months), 2015
  • Figure 11: Hepatitis B Market, Global, Clinical Trial Size by Molecule Type, 2015
  • Figure 12: Multiple Myeloma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
  • Figure 13: Hepatitis B Therapeutics Market, Vaccine Technology by Genexine
  • Figure 14: Hepatitis B Therapeutics Market, Global, Treatment Patterns (million) and Market Size ($bn), 2014-2021
  • Figure 15: Hepatitis B Therapeutics Market, North America, Treatment Patterns ('000), 2014-2021
  • Figure 16: Hepatitis B Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021
  • Figure 17: Hepatitis B Therapeutics Market, North America, Market Size ($m), 2014-2021
  • Figure 18: Hepatitis B Therapeutics Market, EU, Treatment Patterns ('000), 2014-2021
  • Figure 19: Hepatitis B Therapeutics Market, EU, Annual Cost of Therapy ($), 2014-2021
  • Figure 20: Hepatitis B Therapeutics Market, EU, Market Size ($), 2014-2021
  • Figure 21: Hepatitis B Therapeutics Market, Japan, Treatment Usage Patterns ('000), 2014-2021
  • Figure 22: Hepatitis B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021
  • Figure 23: Hepatitis B Therapeutics Market, Japan, Market Size ($m), 2014-2021
  • Figure 24: Hepatitis B Market, Global, Licensing Deals by Region, 2006-2015
  • Figure 25: Hepatitis B Market, Global, Licensing Deals by Region, Value and Year, 2006-2015
  • Figure 26: Hepatitis B Market, Global, Licensing Deals by Phase and Value, 2006-2015
  • Figure 27: Hepatitis B Market, Global, Co-development Deals by Region and Stage of Development, 2006-2015
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