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市場調查報告書

亞太地區的C型肝炎治療藥市場預測

Hepatitis C Therapeutics in Asia-Pacific Markets to 2023 - Presence of Outstanding Direct-Acting Antivirals and Late-Stage Pipeline to Transform the Clinical and Commercial Landscape

出版商 GBI Research 商品編碼 550297
出版日期 內容資訊 英文 138 Pages
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亞太地區的C型肝炎治療藥市場預測 Hepatitis C Therapeutics in Asia-Pacific Markets to 2023 - Presence of Outstanding Direct-Acting Antivirals and Late-Stage Pipeline to Transform the Clinical and Commercial Landscape
出版日期: 2017年08月01日 內容資訊: 英文 138 Pages
簡介

亞太地區的C型肝炎治療藥市場,預計2023年達到80億美元,2016年∼2023年以6.4%的年複合成長率成長。

本報告提供亞太地區的C型肝炎治療藥市場相關調查分析,上市產品,開發平台,市場預測,企業分析,策略性整合等系統性資訊。

第1章 目錄

第2章 簡介

第3章 上市產品

  • 概要
  • 單一成分直接作用抗病毒藥物
  • 多劑混合直接作用抗病毒藥物
  • Peginterferon、Ribavirin
  • 上市產品的有效性和安全性比較

第4章 開發平台分析

  • 概要
  • 開發平台:各開發階段,分子類型,給藥途徑,計劃類型
  • 開發平台:各分子標的
  • 有前途的開發平台候補藥
  • 開發中產品的有效性和安全性比較
  • 產品競爭力架構

第5章 臨床實驗分析

  • 失敗率
  • 臨床實驗的規模
  • 臨床實驗的期間
  • 臨床實驗標準的摘要

第6章 複數方案的預測

  • 概要
  • 亞太地區市場
  • 印度
  • 中國
  • 澳洲
  • 韓國
  • 日本

第7章 推動因素與阻礙

  • 推動因素
  • 障礙

第8章 交易與策略性整合

  • 授權交易
  • 共同開發交易

第9章 附錄

圖表

目錄
Product Code: GBIHC451MR

Executive Summary:

Recent years have seen a revolution in hepatitis C therapeutic development, and the treatment algorithms have rapidly shifted away from interferon-based therapies and towards interferon-free DAA combination therapies. Compared with the older treatments, DAA combination therapies have a favorable safety profile and excellent tolerability and efficacy, achieving cure rates of over 90%.

The recently approved all-oral interferon-free regimens have brought hepatitis C treatment options to a satisfactory level, and leave little space for any remarkable enhancement in clinical performance. Therefore, competition among drug producers will now focus on finer details such as efficacy and safety in niche patient populations, as well as environmental factors, including campaigns to improve treatment access.

The hepatitis C market is currently dominated by highly efficacious DAAs. Sovaldi (sofosbuvir), Gilead's pan-genotypic HCV polymerase (NS5B) inhibitor, has been the cornerstone of the market for the last two years in the Asia-Pacific region. This success illustrates the importance of providing a drug with an excellent efficacy profile for the majority of patient groups simultaneously.

Asia-Pacific is expected to grow at a compound annual growth rate (CAGR) of 6.4% to reach $8 billion plus in 2023. Despite an expected decline in prevalence due to increasing usage of DAAs that can effectively cure the disease, the overall market size is expected to grow due to increase in the treatment-receiving pool, and usage of costlier therapies.

While Japan, China and India are expected to see growth in market size during the forecast period, mainly due to increases in the treatment receiving pool and the usage of costlier DAAs, Australia and South Korea are likely to witness a decline, mainly due to diminishing treatment-receiving pools resulting from high cure rates.

Four pharmaceutical companies are heavily represented in the lucrative APAC DAA market space, namely AbbVie, Bristol-Myers Squibb, Gilead, and Merck and Co. In addition, each of these companies also has at least one novel DAA regimen under development. However, Bristol-Myers Squibb is the only market participant lacking a pan-genotypic drug combination in its pipeline - a consequence of its strategy of focusing on the Japanese HCV market.

Scope:

The hepatitis C Asia-Pacific market will be valued at $8.31 billion in 2023, growing from $5.38 billion in 2016 at a CAGR of 6.4%.

  • How will pan-genotypic therapies such as glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir contribute to growth?
  • What effect will the patent expiration of branded therapies have on market value?

The hepatitis C pipeline contains a range of molecule types and molecular targets, including those that are well established in hepatitis C, and novel target therapies.

  • What are the common targets and mechanisms of action of pipeline therapies?
  • Will the pipeline therapies fulfill the unmet needs of the hepatitis C market?
  • What implications will the increased focus on pan-genotypic therapies have on the future of hepatitis C treatment?

Late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period.

  • How have the late-stage therapies performed in clinical trials?
  • How will the approval of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir, which hold a key advantage in terms of reducing the treatment duration, affect the competitive landscape, with no therapy currently available to address this unmet need?

The market forecasts indicate that China and Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.

  • What will be the impact of available therapies with high cure rates on prevalence?
  • How will the annual cost of therapy and market size vary between the five Asia-Pacific markets?
  • Which countries are in the best situation currently for the eradication of HCV?

Various drivers and barriers will influence the hepatitis C market over the forecast period.

  • What are the barriers that will limit the uptake of available and upcoming therapies in the assessed countries?
  • Which factors are most likely to drive the market in these countries?

Licensing deals are the most common form of strategic alliance in hepatitis C, with total deal values ranging from under $10m to over $1.5 billion.

  • How do deal frequency and value compare between target families and molecule types?
  • What were the terms and conditions of key licensing deals?

Reasons to buy:

  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
  • Visualize the composition of the hepatitis C market in terms of dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the hepatitis C pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
  • Understand the potential of late-stage therapies, with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
  • Predict hepatitis C market growth in the five Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the hepatitis C deals landscape by analyzing trends in licensing and co-development deals.

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. Symptoms
  • 2.4. HCV Life Cycle
    • 2.4.1. NS3/NS4A Protease
    • 2.4.2. NS5A
    • 2.4.3. NS5B Polymerase
  • 2.5. Etiology and Pathophysiology
    • 2.5.1. Pathophysiology
  • 2.6. Diagnosis
  • 2.7. Disease Progression
    • 2.7.1. Acute Stage
    • 2.7.2. Chronic Stage
    • 2.7.3. End Stage
    • 2.7.4. Factors Affecting Progression
    • 2.7.5. Co-morbidities and Complications
  • 2.8. Prognosis
  • 2.9. Treatment Options and Treatment Algorithm
    • 2.9.1. Treatment Options
    • 2.9.2. Treatment Algorithm
    • 2.9.3. Non-pharmacological Treatments

3. Marketed Products

  • 3.1. Overview
  • 3.2. Single Component Direct-Acting Antivirals
    • 3.2.1. Sovaldi (Sofosbuvir) - Gilead Sciences
    • 3.2.2. Daklinza (Daclatasvir) - Bristol-Myers Squibb
  • 3.3. Fixed-Dose Combination Direct-Acting Antivirals
    • 3.3.1. Harvoni (Sofosbuvir/Ledipasvir) - Gilead Sciences
    • 3.3.2. Epclusa (Sofosbuvir/Velpatasvir) - Gilead Sciences
    • 3.3.3. Zepatier (Elbasvir/Grazoprevir) - Merck & Co
    • 3.3.4. Viekira Pak (Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir) and Technivie (Ombitasvir/Paritaprevir/Ritonavir) - AbbVie
    • 3.3.5. Ximency (Asunaprevir/Beclabuvir/Daclatasvir) - Bristol-Myers Squibb
  • 3.4. Peginterferon and Ribavirin
    • 3.4.1. Pegasys (Peginterferon alpha-2a) - Roche
    • 3.4.2. PegIntron (Peginterferon alpha-2b) - Merck & Co
    • 3.4.3. Ribavirin
  • 3.5. Comparative Efficacy and Safety of Marketed Products

4. Pipeline Analysis

  • 4.1. Overview
  • 4.2. Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type
  • 4.3. Pipeline by Molecular Target
  • 4.4. Promising Pipeline Candidates
    • 4.4.1. Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) - Gilead Sciences
    • 4.4.2. MAVIRET (Glecaprevir/Pibrentasvir) - AbbVie
    • 4.4.3. (Danoprevir/Ritonavir) - Roche
  • 4.5. Comparative Efficacy and Safety of Pipeline Products
  • 4.6. Product Competitiveness Framework

5. Clinical Trial Analysis

  • 5.1. Failure Rate
    • 5.1.1. Overall Failure Rate
    • 5.1.2. Failure Rate by Phase and Molecule Type
    • 5.1.3. Failure Rate by Phase and Molecular Target
  • 5.2. Clinical Trial Size
    • 5.2.1. Patient Enrollment per Product by Molecule Type and Stage of Development
    • 5.2.2. Patient Enrollment per Product by Molecular Target and Stage of Development
    • 5.2.3. Patient Enrollment per Trial by Molecule Type and Stage of Development
    • 5.2.4. Patient Enrollment per Trial by Molecular Target and Stage of Development
  • 5.3. Clinical Trial Duration
    • 5.3.1. Trial Duration by Molecule Type and Stage of Development
    • 5.3.2. Trial Duration by Molecular Target and Stage of Development
  • 5.4. Summary of Clinical Trial Metrics

6. Multi-scenario Forecast

  • 6.1. Overview
  • 6.2. Asia-Pacific Market
  • 6.3. India
    • 6.3.1. Treatment Usage Patterns
    • 6.3.2. Annual Cost of Therapy
    • 6.3.3. Market Size
  • 6.4. China
    • 6.4.1. Treatment Usage Patterns
    • 6.4.2. Annual Cost of Therapy
    • 6.4.3. Market Size
  • 6.5. Australia
    • 6.5.1. Treatment Usage Patterns
    • 6.5.2. Annual Cost of Therapy
    • 6.5.3. Market Size
  • 6.6. South Korea
    • 6.6.1. Treatment Usage Patterns
    • 6.6.2. Annual Cost of Therapy
    • 6.6.3. Market Size
  • 6.7. Japan
    • 6.7.1. Treatment Usage Patterns
    • 6.7.2. Annual Cost of Therapy
    • 6.7.3. Market Size

7. Drivers and Barriers

  • 7.1. Drivers
    • 7.1.1. Increasing HCV Awareness and Screening Initiatives
    • 7.1.2. Adoption of Preventative Care for HCV
    • 7.1.3. Launch of Novel Pan-Genotypic DAAs
    • 7.1.4. Expansion of Treatment Access
    • 7.1.5. Clinical Evaluation of DAA Efficacy in Pediatric Patients
  • 7.2. Barriers
    • 7.2.1. Asymptomatic, Slowly Progressing Nature of HCV
    • 7.2.2. High Prices of DAAs to Slow Down Market Growth
    • 7.2.3. Stigma Associated with HCV
    • 7.2.4. Rapidly Increasing Competition in the HCV Market
    • 7.2.5. Limited Patient Awareness
    • 7.2.6. Declining Prevalence Pool
    • 7.2.7. Use of Traditional Medicines

8. Deals and Strategic Consolidations

  • 8.1. Licensing Deals
    • 8.1.1. Deals by Region and Value
    • 8.1.2. Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
    • 8.1.3. Deal Value by Stage of Development, Molecule Type, and Molecular Target
    • 8.1.4. Key Licensing Deals
  • 8.2. Co-development Deals
    • 8.2.1. Deals by Region and Value
    • 8.2.2. Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
    • 8.2.3. Deal Value by Stage of Development, Molecule Type, and Molecular Target
    • 8.2.4. Key Co-development Deals

9. Appendix

  • 9.1. All Pipeline Drugs by Stage of Development
    • 9.1.1. Discovery
    • 9.1.2. Preclinical
    • 9.1.3. Investigational New Drug/Clinical Trial Authorization-Filed
    • 9.1.4. Phase I
    • 9.1.5. Phase II
    • 9.1.6. Phase III
    • 9.1.7. Pre-registration
  • 9.2. Summary of Multi-scenario Market Forecasts to 2023
    • 9.2.1. Asia-Pacific
    • 9.2.2. India
    • 9.2.3. China
    • 9.2.4. Australia
    • 9.2.5. South Korea
    • 9.2.6. Japan
  • 9.3. Bibliography
  • 9.4. Abbreviations
  • 9.5. Research Methodology
    • 9.5.1. Secondary Research
    • 9.5.2. Marketed Product Profiles
    • 9.5.3. Late-Stage Pipeline Candidates
    • 9.5.4. Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
    • 9.5.5. Product Competitiveness Framework
    • 9.5.6. Pipeline Analysis
    • 9.5.7. Forecasting Model
    • 9.5.8. Deals Data Analysis
  • 9.6. Contact Us
  • 9.7. Disclaimer

List of Tables

  • Table 1: Hepatitis C Therapeutics Market, Risk Factors for Fibrosis Progression, 2016
  • Table 2: Hepatitis C Therapeutics Market, Global, Characteristics of DAAs, 2016
  • Table 3: Hepatitis C Therapeutics Market, APAC, Categories of Approved DAA Therapies in Hepatitis C, 2016
  • Table 4: Hepatitis C Therapeutics Market, Australia, GESA Hepatitis C Treatment Guidelines, 2016
  • Table 5: Hepatitis C Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006-2016
  • Table 6: Hepatitis C Therapeutics Market, Global, Co-development Deals Valued Above $5m, 2006-2016
  • Table 7: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Discovery, 2017
  • Table 8: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017
  • Table 9: Hepatitis C Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2017
  • Table 10: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase I, 2017
  • Table 11: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase II, 2017
  • Table 12: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase III, 2017
  • Table 13: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017
  • Table 14: Hepatitis C Therapeutics Market, APAC, Market Forecast, 2016-2023
  • Table 15: Hepatitis C Therapeutics Market, India, Market Forecast, 2016-2023
  • Table 16: Hepatitis C Therapeutics Market, China, Market Forecast, 2016-2023
  • Table 17: Hepatitis C Therapeutics Market, Australia, Market Forecast, 2016-2023
  • Table 18: Hepatitis C Therapeutics Market, South Korea, Market Forecast, 2016-2023
  • Table 19: Hepatitis C Therapeutics Market, Japan, Market Forecast, 2016-2023

List of Figures

  • Figure 1: Hepatitis C Therapeutics Market, HCV Genomic RNA, 2016
  • Figure 2: Hepatitis C Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Hepatitis C Treatment
  • Figure 3: Hepatitis C Therapeutics Market, Global, Pipeline, 2017
  • Figure 4: Hepatitis C Therapeutics Market, Global, Pipeline by Molecular Target, 2017
  • Figure 5: Hepatitis C Therapeutics Market, APAC, Sofosbuvir/Velpatasvir/Voxilaprevir Forecast ($m), 2018-2023
  • Figure 6: Hepatitis C Therapeutics Market, APAC, Glecaprevir/Pibrentasvir Forecast ($m), 2018-2023
  • Figure 7: Hepatitis C Therapeutics Market, APAC, Danoprevir/Ritonavir Forecast ($m), 2018-2023
  • Figure 8: Hepatitis C Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Hepatitis C Treatment
  • Figure 9: Hepatitis C Therapeutics Market, Competitor Matrix for Hepatitis C Marketed and Pipeline Products, 2017
  • Figure 10: Hepatitis C Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016
  • Figure 11: Hepatitis C Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016
  • Figure 12: Hepatitis C Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016
  • Figure 13: Hepatitis C Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016
  • Figure 14: Hepatitis C Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016
  • Figure 15: Hepatitis C Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016
  • Figure 16: Hepatitis C Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016
  • Figure 17: Hepatitis C Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016
  • Figure 18: Hepatitis C Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016
  • Figure 19: Hepatitis C Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
  • Figure 20: Hepatitis C Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target
  • Figure 21: Hepatitis C Therapeutics Market, APAC, Treatment Patterns ('000), 2016-2023
  • Figure 22: Hepatitis C Therapeutics Market, APAC, Market Size ($bn), 2016-2023
  • Figure 23: Hepatitis C Therapeutics Market, India, Treatment Patterns ('000), 2016-2023
  • Figure 24: Hepatitis C Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023
  • Figure 25: Hepatitis C Therapeutics Market, India, Market Size ($m), 2016-2023
  • Figure 26: Hepatitis C Therapeutics Market, China, Treatment Patterns ('000), 2016-2023
  • Figure 27: Hepatitis C Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023
  • Figure 28: Hepatitis C Therapeutics Market, China, Market Size ($m), 2016-2023
  • Figure 29: Hepatitis C Therapeutics Market, Australia, Treatment Patterns ('000), 2016-2023
  • Figure 30: Hepatitis C Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023
  • Figure 31: Hepatitis C Therapeutics Market, Australia, Market Size ($m), 2016-2023
  • Figure 32: Hepatitis C Therapeutics Market, South Korea, Treatment Patterns ('000), 2016-2023
  • Figure 33: Hepatitis C Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023
  • Figure 34: Hepatitis C Therapeutics Market, South Korea, Market Size ($m), 2016-2023
  • Figure 35: Hepatitis C Therapeutics Market, Japan, Treatment Patterns ('000), 2016-2023
  • Figure 36: Hepatitis C Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023
  • Figure 37: Hepatitis C Therapeutics Market, Japan, Market Size ($bn), 2016-2023
  • Figure 38: Hepatitis C Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016
  • Figure 39: Hepatitis C Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016
  • Figure 40: Hepatitis C Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016
  • Figure 41: Hepatitis C Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016
  • Figure 42: Hepatitis C Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2016
  • Figure 43: Hepatitis C Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2016
  • Figure 44: Hepatitis C Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016
  • Figure 45: Hepatitis C Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016
  • Figure 46: Hepatitis C Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2016
  • Figure 47: Hepatitis C Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016
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