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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

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

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.


  • GBI Research Report Guidance
  • Executive Summary
  • Introduction
    • Disease Introduction
    • Epidemiology
    • Symptoms
    • HCV Life Cycle
      • NS3/NS4A Protease
      • NS5A
      • NS5B Polymerase
    • Etiology and Pathophysiology
      • Pathophysiology
        • Table Figure 1: Hepatitis C Therapeutics Market, HCV Genomic RNA, 2016
    • Diagnosis
    • Disease Progression
      • Acute Stage
      • Chronic Stage
      • End Stage
      • Factors Affecting Progression
        • Table Hepatitis C Therapeutics Market, Risk Factors for Fibrosis Progression, 2016
      • Co-morbidities and Complications
    • Prognosis
    • Treatment Options and Treatment Algorithm
      • Treatment Options
        • Table Hepatitis C Therapeutics Market, Global, Characteristics of DAAs, 2016
        • Table Hepatitis C Therapeutics Market, APAC, Categories of Approved DAA Therapies in Hepatitis C, 2016
      • Treatment Algorithm
        • Table Hepatitis C Therapeutics Market, Australia, GESA Hepatitis C Treatment Guidelines, 2016
      • Non-pharmacological Treatments
  • Marketed Products
    • Overview
    • Single Component Direct-Acting Antivirals
      • Sovaldi (Sofosbuvir) –Gilead Sciences
      • Daklinza (Daclatasvir) –Bristol-Myers Squibb
    • Fixed-Dose Combination Direct-Acting Antivirals
      • Harvoni (Sofosbuvir/Ledipasvir) –Gilead Sciences
      • Epclusa (Sofosbuvir/Velpatasvir) –Gilead Sciences
      • Zepatier (Elbasvir/Grazoprevir) –Merck & Co
      • Viekira Pak (Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir) and Technivie (Ombitasvir/Paritaprevir/Ritonavir) –AbbVie
      • Ximency (Asunaprevir/Beclabuvir/Daclatasvir) –Bristol-Myers Squibb
    • Peginterferon and Ribavirin
      • Pegasys (Peginterferon alpha-2a) –Roche
      • PegIntron (Peginterferon alpha-2b) –Merck & Co
      • Ribavirin
    • Comparative Efficacy and Safety of Marketed Products
      • Table Figure 2: Hepatitis C Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Hepatitis C Treatment
  • Pipeline Analysis
    • Overview
    • Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type
      • Table Figure 3: Hepatitis C Therapeutics Market, Global, Pipeline, 2017
    • Pipeline by Molecular Target
      • Table Figure 4: Hepatitis C Therapeutics Market, Global, Pipeline by Molecular Target, 2017
    • Promising Pipeline Candidates
      • Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) –Gilead Sciences
        • Table Figure 5: Hepatitis C Therapeutics Market, APAC, Sofosbuvir/Velpatasvir/Voxilaprevir Forecast ($m), 2018–2023
      • MAVIRET (Glecaprevir/Pibrentasvir) –AbbVie
        • Table Figure 6: Hepatitis C Therapeutics Market, APAC, Glecaprevir/Pibrentasvir Forecast ($m), 2018–2023
      • (Danoprevir/Ritonavir) –Roche
        • Table Figure 7: Hepatitis C Therapeutics Market, APAC, Danoprevir/Ritonavir Forecast ($m), 2018–2023
    • Comparative Efficacy and Safety of Pipeline Products
      • Table Figure 8: Hepatitis C Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Hepatitis C Treatment
    • Product Competitiveness Framework
      • Table Figure 9: Hepatitis C Therapeutics Market, Competitor Matrix for Hepatitis C Marketed and Pipeline Products, 2017
  • Clinical Trial Analysis
    • Failure Rate
      • Overall Failure Rate
        • Table Figure 10: Hepatitis C Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006–2016
      • Failure Rate by Phase and Molecule Type
        • Table Figure 11: Hepatitis C Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006–2016
      • Failure Rate by Phase and Molecular Target
        • Table Figure 12: Hepatitis C Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006–2016
    • Clinical Trial Size
      • Patient Enrollment per Product by Molecule Type and Stage of Development
        • Table Figure 13: Hepatitis C Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006–2016
      • Patient Enrollment per Product by Molecular Target and Stage of Development
        • Table Figure 14: Hepatitis C Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006–2016
      • Patient Enrollment per Trial by Molecule Type and Stage of Development
        • Table Figure 15: Hepatitis C Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006–2016
      • Patient Enrollment per Trial by Molecular Target and Stage of Development
        • Table Figure 16: Hepatitis C Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006–2016
    • Clinical Trial Duration
      • Trial Duration by Molecule Type and Stage of Development
        • Table Figure 17: Hepatitis C Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006–2016
      • Trial Duration by Molecular Target and Stage of Development
        • Table Figure 18: Hepatitis C Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006–2016
    • Summary of Clinical Trial Metrics
      • Table Figure 19: Hepatitis C Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
      • Table Figure 20: Hepatitis C Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target
  • Multi-scenario Forecast
    • Overview
    • Asia-Pacific Market
      • Table Figure 21: Hepatitis C Therapeutics Market, APAC, Treatment Patterns (`000), 2016–2023
      • Table Figure 22: Hepatitis C Therapeutics Market, APAC, Market Size ($bn), 2016–2023
    • India
      • Treatment Usage Patterns
        • Table Figure 23: Hepatitis C Therapeutics Market, India, Treatment Patterns (`000), 2016–2023
      • Annual Cost of Therapy
        • Table Figure 24: Hepatitis C Therapeutics Market, India, Annual Cost of Therapy ($), 2016–2023
      • Market Size
        • Table Figure 25: Hepatitis C Therapeutics Market, India, Market Size ($m), 2016–2023
    • China
      • Treatment Usage Patterns
        • Table Figure 26: Hepatitis C Therapeutics Market, China, Treatment Patterns (`000), 2016–2023
      • Annual Cost of Therapy
        • Table Figure 27: Hepatitis C Therapeutics Market, China, Annual Cost of Therapy ($), 2016–2023
      • Market Size
        • Table Figure 28: Hepatitis C Therapeutics Market, China, Market Size ($m), 2016–2023
    • Australia
      • Treatment Usage Patterns
        • Table Figure 29: Hepatitis C Therapeutics Market, Australia, Treatment Patterns (`000), 2016–2023
      • Annual Cost of Therapy
        • Table Figure 30: Hepatitis C Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016–2023
      • Market Size
        • Table Figure 31: Hepatitis C Therapeutics Market, Australia, Market Size ($m), 2016–2023
    • South Korea
      • Treatment Usage Patterns
        • Table Figure 32: Hepatitis C Therapeutics Market, South Korea, Treatment Patterns (`000), 2016–2023
      • Annual Cost of Therapy
        • Table Figure 33: Hepatitis C Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016–2023
      • Market Size
        • Table Figure 34: Hepatitis C Therapeutics Market, South Korea, Market Size ($m), 2016–2023
    • Japan
      • Treatment Usage Patterns
        • Table Figure 35: Hepatitis C Therapeutics Market, Japan, Treatment Patterns (`000), 2016–2023
      • Annual Cost of Therapy
        • Table Figure 36: Hepatitis C Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016–2023
      • Market Size
        • Table Figure 37: Hepatitis C Therapeutics Market, Japan, Market Size ($bn), 2016–2023
  • Drivers and Barriers
    • Drivers
      • Increasing HCV Awareness and Screening Initiatives
      • Adoption of Preventative Care for HCV
      • Launch of Novel Pan-Genotypic DAAs
      • Expansion of Treatment Access
      • Clinical Evaluation of DAA Efficacy in Pediatric Patients
    • Barriers
      • Asymptomatic, Slowly Progressing Nature of HCV
      • High Prices of DAAs to Slow Down Market Growth
      • Stigma Associated with HCV
      • Rapidly Increasing Competition in the HCV Market
      • Limited Patient Awareness
      • Declining Prevalence Pool
      • Use of Traditional Medicines
  • Deals and Strategic Consolidations
    • Licensing Deals
      • Deals by Region and Value
        • Table Figure 38: Hepatitis C Therapeutics Market, Global, Licensing Deals by Region and Value, 2006–2016
      • Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
        • Table 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
      • Deal Value by Stage of Development, Molecule Type, and Molecular Target
        • Table Figure 40: Hepatitis C Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006–2016
        • Table Figure 41: Hepatitis C Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006–2016
        • Table Figure 42: Hepatitis C Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006–2016
      • Key Licensing Deals
        • Table Hepatitis C Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006–2016
    • Co-development Deals
      • Deals by Region and Value
        • Table Figure 43: Hepatitis C Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006–2016
      • Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
        • Table Figure 44: Hepatitis C Therapeutics Market, Global, Number of Disclosed and Undisclosed Codevelopment Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006–2016
      • Deal Value by Stage of Development, Molecule Type, and Molecular Target
        • Table Figure 45: Hepatitis C Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006–2016
        • Table Figure 46: Hepatitis C Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006–2016
        • Table Figure 47: Hepatitis C Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006–2016
      • Key Co-development Deals
        • Table Hepatitis C Therapeutics Market, Global, Co-development Deals Valued Above $5m, 2006–2016
  • Appendix
    • All Pipeline Drugs by Stage of Development
      • Discovery
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, Discovery, 2017
      • Preclinical
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017
      • Investigational New Drug/Clinical Trial Authorization-Filed
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2017
      • Phase I
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase I, 2017
      • Phase II
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase II, 2017
      • Phase III
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase III, 2017
      • Pre-registration
        • Table Hepatitis C Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017
    • Summary of Multi-scenario Market Forecasts to 2023
      • Asia-Pacific
        • Table Hepatitis C Therapeutics Market, APAC, Market Forecast, 2016–2023
      • India
        • Table Hepatitis C Therapeutics Market, India, Market Forecast, 2016–2023
      • China
        • Table Hepatitis C Therapeutics Market, China, Market Forecast, 2016–2023
      • Australia
        • Table Hepatitis C Therapeutics Market, Australia, Market Forecast, 2016–2023
      • South Korea
        • Table Hepatitis C Therapeutics Market, South Korea, Market Forecast, 2016–2023
      • Japan
        • Table Hepatitis C Therapeutics Market, Japan, Market Forecast, 2016–2023
    • Bibliography
    • Abbreviations
    • Research Methodology
      • Secondary Research
      • Marketed Product Profiles
      • Late-Stage Pipeline Candidates
      • Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
      • Product Competitiveness Framework
      • Pipeline Analysis
      • Forecasting Model
      • Deals Data Analysis
    • Contact Us
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