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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

July 2017 | 138 pages | ID: H91189978B5EN
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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

SUMMARY

Hepatitis C is a blood-borne liver disease caused by the hepatitis C virus (HCV), which can lead to acute and chronic hepatitis infection. According to the World Health Organization (WHO), in 2015 there were 1.75 million new HCV infections globally, and approximately 399,000 people die each year from hepatitis C, mostly due to cirrhosis and hepatocellular carcinoma. The APAC region has diverse HCV epidemiology, with prevalence ranging from 0.1% to 4.7%, and a unique genotype (GT) distribution. Acute HCV infection is usually asymptomatic, and 15-45% of people spontaneously clear the virus within six months of infection without any treatment, while the remaining 55-85% develop chronic HCV infection.

The hepatitis C market is currently dominated by high-performance regimens comprising new-generation DAAs. The treatment algorithms have shifted away rapidly from interferon-based therapies, and towards interferon-free DAA combination therapies that can cure most patients in as little as eight to 12 weeks, without ribavirin. In the highly competitive hepatitis C treatment landscape, where new combination therapies match each other closely in terms of safety and efficacy, one key differential is patient segment coverage. A number of factors that have conventionally been used to predict treatment outcome, including HCV genotypes, previous treatment history, and a patient’s liver and kidney conditions, are also used to define target patient populations for new therapies.

The late-stage hepatitis C pipeline is predominantly composed of DAA regimens targeting HCV NS5A, NS5B polymerase, and NS3/4A protease. The most advanced of the promising pipeline agents are Gilead’s sofosbuvir/velpatasvir/voxilaprevir and AbbVie’s glecaprevir/pibrentasvir, which have been studied in Phase III clinical trials. Due to the highly effective late-stage pipeline drugs and marketed products, developers of HCV NS5A, NS5B polymerase and NS3/4A protease in earlier stages of clinical development are not aiming to dominate the market, but rather to earn a place as a ‘me too’ product.

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.
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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