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Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape

NEW YORK, Feb. 12, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape
http://www.reportlinker.com/p02015870/Hepatitis-C-Therapeutics-in-Major-Developed-Markets-to-2019---Outstanding-Recent-Approvals-and-Late-Stage-Pipeline-to-Transform-Clinical-and-Commercial-Landscape.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape

Summary

GBI Research, has released the pharma report, "Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape". The current Hepatitis C treatment landscape consists of a combination of pegylated interferon, ribavirin and, in patients infected with genotype 1 hepatitis C, one of two direct-acting antiviral agents (DAAs). Products with these mechanisms of action have performed strongly in the commercial setting, with the market leader Incivek (a DAA) having reached blockbuster sales.

However, these products are very poorly tolerated and only moderately efficacious. The approval of the DAA Sovaldi in December 2013 changed this, with a complete viral clearance being achieved in close to 100% of patients and a much improved adverse event profile compared to previous standards of therapy. In patients with genotype 2 and 3 hepatitis C, Sovaldi does not need to be administered with pegylated interferon. A number of products in the late-stage pipeline, which promise to be even more efficacious and safe are anticipated to enter the market over the forecast period, including several interferon-free therapies for genotype 1-infected patients. As a result of this, as well as an overall increase in the treated population, GBI Research believes the global market has the potential to grow to a value of $18.6 billion by 2019, more than tripling the 2012 market value of $5.8 billion.

Scope

- A brief introduction to hepatitis C, including the disease's pathogenesis, risk factors and diagnosis, and detailed analyses of disease epidemiology and treatment algorithms.
- In-depth analysis of the major antiviral drugs used in the treatment of hepatitis C, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map that compares marketed drugs in terms of safety and efficacy.
- A comprehensive review of the pipeline for hepatitis C therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline is analyzed by phase distribution, molecule type and molecular target.
- In-depth clinical trial enrolment, trial duration and program failure rate analyses for each molecule type and mechanism of action. Additionally, clinical trial endpoints and certain selection criteria are analyzed in great depth. This section also includes an additional heat map regarding pipeline products, and a direct cross-analysis against currently marketed products.
- Multi-scenario forecast data of the market to 2019, which takes into account the effects of the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets: US, Canada, Japan, Germany, UK, France, Italy and Spain.
- Discussion of the drivers and barriers for market growth.
- Analysis of licensing and co-development deals occurring in the hepatitis C market.

Reasons to buy

- Understand the different types of hepatitis C therapies and how treatment varies by genotype.
- Understand the treatment algorithms and guidelines related to hepatitis C, how they are anticipated to change during the forecast period and where opportunities and unmet needs lie.
- Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are most prominent.
- Observe trends in clinical trial duration and size as clinical phase and molecule type varies. Use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for hepatitis C therapeutics.
- Observe the shift in clinical trial endpoints with each clinical Phase, and use this data to potentially influence any future developmental programs. Additionally, understand the trends in enrolment by patient genotype.
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules and the points of opportunity which remain to be capitalized upon.

Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 10
2.1 Signs and Symptoms 10
2.2 Etiology and Risk Factors 11
2.3 Pathophysiology 11
2.4 Epidemiology 12
2.4.1 US and Canada 12
2.4.2 Europe 12
2.4.3 Japan 13
2.4.4 Regional Prevalence of Hepatitis C Genotypes 13
2.5 Prognosis 14
2.6 Diagnosis and Screening 16
2.7 Treatment 16
2.8 Treatment Algorithms 17
3 Marketed Products 21

3.1 Ribavirin 21
3.2 Pegasys (Peginterferon alfa 2a) and PegIntron (Peginterferon alfa 2b) – Hoffmann La Roche and Merck & Co 22
3.2.1 Pegasys – Hoffmann La Roche 24
3.2.2 PegIntron – Merck & Co 24
3.3 Incivek (telaprevir) – Vertex Pharmaceuticals and Janssen-Cilag 25
3.4 Victrelis (boceprevir) – Merck & Co 26
3.5 Olysio (simeprevir) – Johnson and Johnson 27
3.6 Sovaldi (sofosbuvir) – Gilead Sciences 28
3.7 Heat Map for Marketed Products 29
4 Developmental Pipeline 31
4.1 Overall Pipeline 31
4.2 Mechanisms of Action 33
4.3 Clinical Trials 35
4.3.1 Clinical Trial Failure Rates 36
4.3.2 Clinical Trial Enrollment 37
4.3.3 Clinical Trial Duration 39
4.3.4 Clinical Trial Design 41
4.4 Promising Pipeline Drugs 44
4.4.1 Sovaldi plus Ledipasvir – Gilead Sciences 44
4.4.2 Daclatasvir – Bristol-Myers Squibb 46
4.4.3 Faldaprevir – Boehringer-Ingelheim 49
4.4.4 Peginterferon lambda 1a – Bristol-Myers Squibb 50
4.4.5 ABT-450 – AbbVie and Enanta 52
4.4.6 Vaniprevir – Merck & Co 54
4.5 Heat Map and Competitor Matrix for Pipeline Products 55
4.6 Conclusion 59
5 Market Forecast to 2019 61

5.1 Global Market 62
5.1.1 Treatment Usage Patterns 62
5.1.2 Market Size 63
5.2 US 65
5.2.1 Treatment Usage Patterns 65
5.2.2 Market Size 66
5.3 Canada 67
5.3.1 Treatment Usage Patterns 67
5.3.2 Market Size 68
5.4 Top Five European Markets 69
5.4.1 Treatment Usage Patterns 69
5.4.2 Annual Cost of Therapy 72
5.4.3 Market Size 74
5.5 Japan 76
5.5.1 Treatment Usage Patterns 76
5.5.2 Market Size 77
6 Drivers and Barriers 78
6.1 Drivers 78
6.1.1 Approval of Sovaldi and Olysio in 2013 78
6.1.2 Large and Exceptionally Promising Late-Stage Pipeline 78
6.1.3 Favorable Pricing Structure in the US 78
6.1.4 Weak Exposure to Generics and Biosimilars during the Forecast Period 79
6.1.5 Increasing Volume of Treated Patients 79
6.1.6 Rapid Incorporation of Novel Products into Treatment Guidelines 79
6.2 Barriers 80
6.2.1 Low Rates of Diagnosis and Treatment in Certain Markets 80
6.2.2 Unfavorable Pricing Structures in the EU and Japan 80
6.2.3 Rapidly Increasing Competition in the Market 80
7 Licensing and Co-development deals 82
7.1 Licensing Deals 82
7.1.1 Vertex Pharma Enters into Licensing Agreement with Alios BioPharma for ALS-2200 and ALS-2158 85
7.1.2 Bristol-Myers Squibb Company Enters into Licensing Agreement with ZymoGenetics 85
7.1.3 Human Genome Sciences Enters Into Licensing Agreement With Novartis 85
7.1.4 Roche Signs Licensing Agreement With InterMune 85

7.1.5 Idenix Enters Into A Licensing Agreement With Novartis Pharma 86
7.1.6 Enanta Pharma Enters into Licensing Agreement with Novartis for Hepatitis C Program 86
7.1.7 Medivir Enters into Licensing Agreement with Tibotec 86
7.1.8 Metabasis Therapeutics Enters Into Collaboration And Licensing Agreement With Roche 86
7.1.9 Schering-Plough And PTC Therapeutics Enter Into A Collaboration And Licensing Agreement 87
7.1.10 Presidio Pharma Enters into Licensing Agreement with XTL BioPharma 87
7.2 Co-development Deals 88
7.2.1 Vertex Pharma Enters into Co-Development Agreement with Janssen Pharmaceutica 89
7.2.2 Abbott Labs Enters into Agreement with Enanta Pharma 89
7.2.3 Genelabs Enters into Collaboration with Novartis 89
7.2.4 Regulus Therapeutics Enters into an Agreement with GlaxoSmithKline 90
7.2.5 Tacere Therapeutics Enters into Agreement with Pfizer 90
7.2.6 Biota Holdings Enters into an Agreement with Boehringer Ingelheim 90
8 Appendix 91
8.1 Sources 91
8.2 Sources for Heat Maps 98
8.3 All Pipeline Products, by Stage of Development 99
8.3.1 Discovery 99
8.3.2 Preclinical and IND/CTA-filed 102
8.3.3 Phase I 106
8.3.4 Phase II 107
8.3.5 Phase III and Pre-registration 110

8.3.6 Undisclosed 111
8.4 Tabular Forecast Data 112
8.4.1 Global 112
8.4.2 US 113
8.4.3 Canada 113
8.4.4 UK 113
8.4.5 France 114
8.4.6 Germany 114
8.4.7 Italy 114
8.4.8 Spain 115
8.4.9 Japan 115
8.5 Market Definition 115
8.6 Abbreviations 115
8.7 Methodology 116
8.7.1 Coverage 116
8.7.2 Secondary Research 117
8.7.3 Primary Research 117
8.7.4 Therapeutic Landscape 117
8.7.5 Epidemiology-Based Forecasting 118
8.7.6 Market Size by Geography 119
8.7.7 Geographical Landscape 120
8.7.8 Pipeline Analysis 120
8.8 Contact Us 120
8.9 Disclaimer 120

List of Tables

Table 1: Hepatitis C, Top Five European Countries, Disease Prevalence (%), 2011 13
Table 2: Hepatitis C, Top Five European Markets, Most Common Risk Factors for Infection (%), 2011 13
Table 3: Hepatitis C, Global, Estimated Distribution of Hepatitis C Genotypes (%), 2013 14
Table 4: Market for Hepatitis C, Sources for Heat Maps 98
Table 5: Hepatitis C Therapeutics, Global, All Pipeline Products (Discovery), 2013 99
Table 6: Hepatitis C Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013 102
Table 7: Hepatitis C, Global, All Pipeline Products (Phase I), 2013 106
Table 8: Hepatitis C Therapeutics, Global, All Pipeline Products (Phase II), 2013 107
Table 9: Hepatitis C Therapeutics, Global, All Pipeline Products (Phase III), 2013 110
Table 10: Hepatitis C Therapeutics, Global, All Pipeline Products (Undisclosed), 2013 111
Table 11: Market for Hepatitis C, Global, Forecast Data, 2012–2019 112
Table 12: Market for Hepatitis C, US, Forecast Data, 2012–2019 113
Table 13: Market for Hepatitis C, Canada, Forecast Data, 2012–2019 113
Table 14: Market for Hepatitis C, UK, Forecast Data, 2012–2019 113
Table 15: Market for Hepatitis C, France, Forecast Data, 2012–2019 114
Table 16: Market for Hepatitis C, Germany, Forecast Data, 2012–2019 114
Table 17: Market for Hepatitis C, Italy, Forecast Data, 2012–2019 114
Table 18: Market for Hepatitis C, Spain, Forecast Data, 2012–2019 115
Table 19: Market for Hepatitis C, Japan, Forecast Data, 2012–2019 115

List of Figures

Figure 1: Market for Hepatitis C, Global, Treatment Algorithm (Genotype 1, Triple Therapy with Incivek), 2013 18
Figure 2: Market for Hepatitis C, Global, Treatment Algorithm (Genotype 1, Triple Therapy with Victrelis), 2013 19
Figure 3: Market for Hepatitis C, Global, Treatment Algorithm (Genotypes 2 to 7), 2013 20
Figure 4: Market for Hepatitis C, Global, Sales of Pegasys and PegIntron ($m), 2002–2012 22
Figure 5: Market for Hepatitis C, Global, Heat Map for Marketed Products, 2013 30
Figure 6: Market for Hepatitis C, Global, Developmental Pipeline, 2013 32
Figure 7: Market for Hepatitis C, Global, Pipeline by Mechanism of Action and Molecule Type, 2013 33
Figure 8: Market for Hepatitis C, Global, Clinical Trial Failure Rate by Molecule Type, 2006–2013 36
Figure 9: Market for Hepatitis C, Global, Clinical Trial Failure Rates by Mechanism of Action, 2006–2013 37
Figure 10: Market for Hepatitis C, Global, Clinical Trial Enrollment by Molecule Type, 2006–2013 38
Figure 11: Market for Hepatitis C, Global, Clinical Trial Enrollment by Mechanism of Action, 2006–2013 39
Figure 12: Market for Hepatitis C, Clinical Trial Duration by Molecule Type, 2006–2013 40
Figure 13: Market for Hepatitis C, Global, Clinical Trial Duration by Mechanism of Action, 2006–2013 41
Figure 14: Market for Hepatitis C, Global, Frequency of Clinical Trial Primary Endpoints Per Clinical Trial, 2006–2013 42
Figure 15: Market for Hepatitis C, Global, Frequency of Clinical Trial Endpoints Primary within Clinical Development Programs, 2006–2013 43
Figure 16: Market for Hepatitis C, Global, Usage of HCV Genotypes as Clinical Trial Inclusion Criteria, 2006–2013 44
Figure 17: Market for Hepatitis C, Global, Sales Forecast for Sovaldi plus ledipasvir ($m), 2015–2019 45

Figure 18: Market for Hepatitis C, Global, Sales Forecast for daclatasvir (monotherapy) ($m), 2015–2019 47
Figure 19: Market for Hepatitis C, Global, Sales Forecast for daclatasvir plus asunaprevir plus BMS-791325 ($m), 2015–2019 48
Figure 20: Market for Hepatitis C, Global, Sales Forecast for faldaprevir ($m), 2015–2019 50
Figure 21: Market for Hepatitis C, Global, Sales Forecast for peginterferon lambda 1a ($m), 2015–2019 51
Figure 22: Market for Hepatitis C, Global, Sales Forecast for ABT-450 ($m), 2015–2019 52
Figure 23: Market for Hepatitis C, Global, Sales Forecast for ABT-450 plus ABT-333 plus ABT-267 ($m), 2015–2019 54
Figure 24: Market for Hepatitis C, Global, Sales Forecast for vaniprevir, 2015–2019 55
Figure 25: Market for Hepatitis C, Global, Heat Map for Pipeline Products, 2013 57
Figure 26: Market for Hepatitis C, Global, Competitor Matrix, 2013 58
Figure 27: Market for Hepatitis C, Global, Market Growth and Size, 2012–2019 61
Figure 28: Market for Hepatitis C, Global, Treatment Patterns, 2012–2019 63

Figure 29: Market for Hepatitis C, Global, Market Size ($bn), 2012–2019 64
Figure 30: Market for Hepatitis C, US, Treatment Usage Patterns, 2012–2019 65
Figure 31: Market for Hepatitis C, US, Market Size ($bn), 2012–2019 66
Figure 32: Market for Hepatitis C, Canada, Treatment Usage Patterns, 2012–2019 67
Figure 33: Market for Hepatitis C, Canada, Market Size ($m), 2012–2019 68
Figure 34: Market for Hepatitis C, Top Five European Markets, Treatment Patterns, 2012–2019 69
Figure 35: Market for Hepatitis C, Top Five European Markets, Annual Cost of Therapy ($), 2012–2019 72
Figure 36: Market for Hepatitis C, Top Five European Markets, Market Size ($m), 2012–2019 74
Figure 37: Market for Hepatitis C, Japan, Treatment Usage Patterns, 2012–2019 76
Figure 38: Market for Hepatitis C, Japan, Market Size ($m), 2012–2019 77
Figure 39: Market for Hepatitis C, Global, Network of Licensing Deals, 2006–2013 82
Figure 40: Market for Hepatitis C, Global, Licensing Deals by Year, 2006–2013 83
Figure 41: Market for Hepatitis C, Global, Licensing Deals, 2006–2013 84
Figure 42: Market for Hepatitis C, Global, Network of Co-Development Deals, 2006–2013 88
Figure 43: Market for Hepatitis C, Global, Co-Development Deals by Year, 2006–2013 89
Figure 44: GBI Research Market Forecasting Model 119

To order this report: Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape
http://www.reportlinker.com/p02015870/Hepatitis-C-Therapeutics-in-Major-Developed-Markets-to-2019---Outstanding-Recent-Approvals-and-Late-Stage-Pipeline-to-Transform-Clinical-and-Commercial-Landscape.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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