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

 Published On: Aug, 2017 |    No of Pages: 138 |  Published By: GBI Research | Format: PDF
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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 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 12
2.4 HCV Life Cycle 13
2.4.1 NS3/NS4A Protease 13
2.4.2 NS5A 13
2.4.3 NS5B Polymerase 13
2.5 Etiology and Pathophysiology 13
2.5.1 Pathophysiology 14
2.6 Diagnosis 18
2.7 Disease Progression 18
2.7.1 Acute Stage 18
2.7.2 Chronic Stage 19
2.7.3 End Stage 19
2.7.4 Factors Affecting Progression 19
2.7.5 Co-morbidities and Complications 20
2.8 Prognosis 20
2.9 Treatment Options and Treatment Algorithm 21
2.9.1 Treatment Options 21
2.9.2 Treatment Algorithm 25
2.9.3 Non-pharmacological Treatments 27
3 Marketed Products 29
3.1 Overview 29
3.2 Single Component Direct-Acting Antivirals 30
3.2.1 Sovaldi (Sofosbuvir) - Gilead Sciences 30
3.2.2 Daklinza (Daclatasvir) - Bristol-Myers Squibb 31
3.3 Fixed-Dose Combination Direct-Acting Antivirals 32
3.3.1 Harvoni (Sofosbuvir/Ledipasvir) - Gilead Sciences 32
3.3.2 Epclusa (Sofosbuvir/Velpatasvir) - Gilead Sciences 34
3.3.3 Zepatier (Elbasvir/Grazoprevir) - Merck & Co 35
3.3.4 Viekira Pak (Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir) and Technivie (Ombitasvir/Paritaprevir/Ritonavir) - AbbVie 37
3.3.5 Ximency (Asunaprevir/Beclabuvir/Daclatasvir) - Bristol-Myers Squibb 38
3.4 Peginterferon and Ribavirin 39
3.4.1 Pegasys (Peginterferon alpha-2a) - Roche 39
3.4.2 PegIntron (Peginterferon alpha-2b) - Merck & Co 40
3.4.3 Ribavirin 41
3.5 Comparative Efficacy and Safety of Marketed Products 42
4 Pipeline Analysis 44
4.1 Overview 44
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 45
4.3 Pipeline by Molecular Target 46
4.4 Promising Pipeline Candidates 48
4.4.1 Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) - Gilead Sciences 48
4.4.2 MAVIRET (Glecaprevir/Pibrentasvir) - AbbVie 51
4.4.3 (Danoprevir/Ritonavir) - Roche 53
4.5 Comparative Efficacy and Safety of Pipeline Products 55
4.6 Product Competitiveness Framework 56
5 Clinical Trial Analysis 58
5.1 Failure Rate 58
5.1.1 Overall Failure Rate 58
5.1.2 Failure Rate by Phase and Molecule Type 60
5.1.3 Failure Rate by Phase and Molecular Target 62
5.2 Clinical Trial Size 64
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 64
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 65
5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 65
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 67
5.3 Clinical Trial Duration 69
5.3.1 Trial Duration by Molecule Type and Stage of Development 69
5.3.2 Trial Duration by Molecular Target and Stage of Development 70
5.4 Summary of Clinical Trial Metrics 71
6 Multi-scenario Forecast 73
6.1 Overview 73
6.2 Asia-Pacific Market 74
6.3 India 76
6.3.1 Treatment Usage Patterns 76
6.3.2 Annual Cost of Therapy 77
6.3.3 Market Size 78
6.4 China 80
6.4.1 Treatment Usage Patterns 80
6.4.2 Annual Cost of Therapy 81
6.4.3 Market Size 82
6.5 Australia 84
6.5.1 Treatment Usage Patterns 84
6.5.2 Annual Cost of Therapy 85
6.5.3 Market Size 86
6.6 South Korea 87
6.6.1 Treatment Usage Patterns 87
6.6.2 Annual Cost of Therapy 88
6.6.3 Market Size 89
6.7 Japan 91
6.7.1 Treatment Usage Patterns 91
6.7.2 Annual Cost of Therapy 92
6.7.3 Market Size 93
7 Drivers and Barriers 95
7.1 Drivers 95
7.1.1 Increasing HCV Awareness and Screening Initiatives 95
7.1.2 Adoption of Preventative Care for HCV 95
7.1.3 Launch of Novel Pan-Genotypic DAAs 95
7.1.4 Expansion of Treatment Access 96
7.1.5 Clinical Evaluation of DAA Efficacy in Pediatric Patients 96
7.2 Barriers 96
7.2.1 Asymptomatic, Slowly Progressing Nature of HCV 96
7.2.2 High Prices of DAAs to Slow Down Market Growth 96
7.2.3 Stigma Associated with HCV 96
7.2.4 Rapidly Increasing Competition in the HCV Market 97
7.2.5 Limited Patient Awareness 97
7.2.6 Declining Prevalence Pool 97
7.2.7 Use of Traditional Medicines 97
8 Deals and Strategic Consolidations 98
8.1 Licensing Deals 98
8.1.1 Deals by Region and Value 98
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 99
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 100
8.1.4 Key Licensing Deals 103
8.2 Co-development Deals 107
8.2.1 Deals by Region and Value 107
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 108
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 109
8.2.4 Key Co-development Deals 111
9 Appendix 114
9.1 All Pipeline Drugs by Stage of Development 114
9.1.1 Discovery 114
9.1.2 Preclinical 117
9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 119
9.1.4 Phase I 119
9.1.5 Phase II 120
9.1.6 Phase III 121
9.1.7 Pre-registration 121
9.2 Summary of Multi-scenario Market Forecasts to 2023 121
9.2.1 Asia-Pacific 121
9.2.2 India 122
9.2.3 China 122
9.2.4 Australia 122
9.2.5 South Korea 123
9.2.6 Japan 123
9.3 Bibliography 124
9.4 Abbreviations 132
9.5 Research Methodology 134
9.5.1 Secondary Research 134
9.5.2 Marketed Product Profiles 135
9.5.3 Late-Stage Pipeline Candidates 135
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 135
9.5.5 Product Competitiveness Framework 135
9.5.6 Pipeline Analysis 136
9.5.7 Forecasting Model 137
9.5.8 Deals Data Analysis 137
9.6 Contact Us 138
9.7 Disclaimer 138

1.1 List of Tables
Table 1: Hepatitis C Therapeutics Market, Risk Factors for Fibrosis Progression, 2016 20
Table 2: Hepatitis C Therapeutics Market, Global, Characteristics of DAAs, 2016 22
Table 3: Hepatitis C Therapeutics Market, APAC, Categories of Approved DAA Therapies in Hepatitis C, 2016 25
Table 4: Hepatitis C Therapeutics Market, Australia, GESA Hepatitis C Treatment Guidelines, 2016 26
Table 5: Hepatitis C Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006-2016 106
Table 6: Hepatitis C Therapeutics Market, Global, Co-development Deals Valued Above $5m, 2006-2016 113
Table 7: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 114
Table 8: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017 117
Table 9: Hepatitis C Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2017 119
Table 10: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 119
Table 11: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 120
Table 12: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 121
Table 13: Hepatitis C Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017 121
Table 14: Hepatitis C Therapeutics Market, APAC, Market Forecast, 2016-2023 121
Table 15: Hepatitis C Therapeutics Market, India, Market Forecast, 2016-2023 122
Table 16: Hepatitis C Therapeutics Market, China, Market Forecast, 2016-2023 122
Table 17: Hepatitis C Therapeutics Market, Australia, Market Forecast, 2016-2023 122
Table 18: Hepatitis C Therapeutics Market, South Korea, Market Forecast, 2016-2023 123
Table 19: Hepatitis C Therapeutics Market, Japan, Market Forecast, 2016-2023 123

1.2 List of Figures
Figure 1: Hepatitis C Therapeutics Market, HCV Genomic RNA, 2016 16
Figure 2: Hepatitis C Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Hepatitis C Treatment 43
Figure 3: Hepatitis C Therapeutics Market, Global, Pipeline, 2017 46
Figure 4: Hepatitis C Therapeutics Market, Global, Pipeline by Molecular Target, 2017 48
Figure 5: Hepatitis C Therapeutics Market, APAC, Sofosbuvir/Velpatasvir/Voxilaprevir Forecast ($m), 2018-2023 50
Figure 6: Hepatitis C Therapeutics Market, APAC, Glecaprevir/Pibrentasvir Forecast ($m), 2018-2023 53
Figure 7: Hepatitis C Therapeutics Market, APAC, Danoprevir/Ritonavir Forecast ($m), 2018-2023 55
Figure 8: Hepatitis C Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Hepatitis C Treatment 56
Figure 9: Hepatitis C Therapeutics Market, Competitor Matrix for Hepatitis C Marketed and Pipeline Products, 2017 57
Figure 10: Hepatitis C Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 59
Figure 11: Hepatitis C Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 61
Figure 12: Hepatitis C Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 63
Figure 13: Hepatitis C Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 64
Figure 14: Hepatitis C Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 65
Figure 15: Hepatitis C Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 66
Figure 16: Hepatitis C Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 68
Figure 17: Hepatitis C Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 70
Figure 18: Hepatitis C Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 71
Figure 19: Hepatitis C Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 71
Figure 20: Hepatitis C Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 72
Figure 21: Hepatitis C Therapeutics Market, APAC, Treatment Patterns (‘000), 2016-2023 75
Figure 22: Hepatitis C Therapeutics Market, APAC, Market Size ($bn), 2016-2023 76
Figure 23: Hepatitis C Therapeutics Market, India, Treatment Patterns (‘000), 2016-2023 77
Figure 24: Hepatitis C Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 78
Figure 25: Hepatitis C Therapeutics Market, India, Market Size ($m), 2016-2023 79
Figure 26: Hepatitis C Therapeutics Market, China, Treatment Patterns (‘000), 2016-2023 81
Figure 27: Hepatitis C Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 82
Figure 28: Hepatitis C Therapeutics Market, China, Market Size ($m), 2016-2023 83
Figure 29: Hepatitis C Therapeutics Market, Australia, Treatment Patterns (‘000), 2016-2023 85
Figure 30: Hepatitis C Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 86
Figure 31: Hepatitis C Therapeutics Market, Australia, Market Size ($m), 2016-2023 87
Figure 32: Hepatitis C Therapeutics Market, South Korea, Treatment Patterns (‘000), 2016-2023 88
Figure 33: Hepatitis C Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 89
Figure 34: Hepatitis C Therapeutics Market, South Korea, Market Size ($m), 2016-2023 90
Figure 35: Hepatitis C Therapeutics Market, Japan, Treatment Patterns (‘000), 2016-2023 92
Figure 36: Hepatitis C Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 93
Figure 37: Hepatitis C Therapeutics Market, Japan, Market Size ($bn), 2016-2023 94
Figure 38: Hepatitis C Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 99
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 100
Figure 40: Hepatitis C Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 101
Figure 41: Hepatitis C Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016 102
Figure 42: Hepatitis C Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2016 103
Figure 43: Hepatitis C Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2016 107
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 108
Figure 45: Hepatitis C Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 109
Figure 46: Hepatitis C Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2016 110
Figure 47: Hepatitis C Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 111

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