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Hepatitis C Therapeutics Market to 2018 - Expected Launch of GS-7977 in 2015 will Pave the Way for an Oral Interferon-free Combination Therapy

Executive Summary

Incivek and Victrelis to Kick-Start Huge Hepatitis C Market Growth

The approval of the US Food and Drug Administration in May of last year for two drugs, Incivek and Victrelis, has sparked explosive pharmaceutical industry revenue gains that will see the hepatitis C market grow exponentially in size by 2018, predicts new research by healthcare sector analysts GBI Research.

The firm's latest report* states that the market for hepatitis C will climb from a 2011 value of $2.6 billion to just under $15 billion by the end of 2018, at a Compound Annual Growth Rate (CAGR) of 28%.

According to GBI Research, last year's introduction of Incivek (co-developed by Vertex and Johnson & Johnson) and Victrelis (from US firm, Merck & Co.) marked the beginning of a boom period for the global hepatitis C market following years of sliding revenues.

Both of these highly influential treatments will be subject to large-scale marketing across the US, Europe and Japan in the coming years and will contribute significantly to the industry's value.

Drug manufacturer profits are expected to be further bolstered by the imminent launch of oral DAA molecules (the first of which should be on the market in 2015) and the increased reliance on prescribing DAA drug combinations within the healthcare community.

Almost 8 million people worldwide were estimated to have chronic hepatitis C virus (HCV) in 2011, climbing from 7.6 million in 2004. Thanks to improving treatments and an increasing awareness within the general population, GBI Research expects this figure to drop below the 7 million mark by 2018.

Hepatitis C Therapeutics Market to 2018 - Expected Launch of GS-7977 in 2015 will Pave the Way for an Oral Interferon-free Combination Therapy

This report provides insights into the global hepatitis C therapeutics market up to 2018.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Abstract

Hepatitis C Therapeutics Market to 2018 - Expected Launch of GS-7977 in 2015 will Pave the Way for an Oral Interferon-free Combination Therapy

Summary

GBI Research, the leading business intelligence provider, has released its latest research "Hepatitis C Therapeutics Market to 2018 - Expected Launch of GS-7977 in 2015 will Pave the Way for an Oral Interferon-free Combination Therapy", which provides insights into the global hepatitis C therapeutics market up to 2018. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts. The report examines the global hepatitis C treatment usage patterns, and the geographical distribution of hepatitis C therapeutics and markets across the US, the top five countries of Europe and Japan. The report also includes insights into the hepatitis C therapeutics R&D product pipeline and explores the competitive landscape, including major players in the hepatitis C therapeutics market. Finally, the report also includes analysis of the Mergers and Acquisitions (M&As) and licensing agreements that took place in the hepatitis C therapeutics market from 2010 to 2012.

In 2011, the hepatitis C therapeutics market was estimated at $2.6 billion. From 2004 to 2011, the market grew at the CAGR of 2.7%, with the launch of Incivek and Victrelis in 2011 boosting positive growth. The market had seen a significant decline in value due to the low uptake of Pegylated Interferon (PI) therapies and subsequent patient warehousing in anticipation of more effective drugs being launched. The launch of the two PIs added a billion dollars to the market in 2011 and helped to achieve a positive CAGR. GBI Research analyses estimate that the hepatitis C therapeutics market in the top seven markets will be valued at $14.9 billion in 2018, with a CAGR of 28.3% over the forecast period. These estimates are based on the continued adoption of PIs as the gold standard treatment option for hepatitis C, and the imminent launch of oral DAA molecules, the first of which should be in the market in 2015. Further, combinations of DAA drugs will improve the overall effectiveness of treatment and will have less side-effects than PIs. This should result in a significant increase in diagnosis and treatment rates over the forecast period.

Scope

  • Data and analysis on the hepatitis C therapeutics market in the leading geographies of the world - the US, Japan, the UK, Germany, France, Italy and Spain.
  • Annualized market data for the hepatitis C therapeutics market from 2004 to 2011, with forecasts to 2018.
  • Market data on the geographical landscape and therapeutic landscape, including market size, market share, annual cost of therapy, sales volume and treatment usage patterns such as disease population, treatment seeking population, diagnosis population and prescription population.
  • Key drivers and restraints that have had a significant impact on the market.
  • The competitive landscape of the global hepatitis C therapeutics market including top companies benchmarking. The key companies studied in this report are Vertex Pharmaceuticals, Inc., Merck & Co., Inc., Gilead Sciences, Inc., Bristol-Myers Squibb Company (BMS), Abbott Laboratories, F. Hoffmann-La Roche Ltd., Johnson & Johnson / Tibotec BVBA, Boehringer Ingelheim GmbH, Novartis AG, Achillion Pharmaceuticals, Inc., and Idenix Pharmaceuticals, Inc.
  • Key M&A activities and licensing agreements that took place in the years 2010 to 2012 in the hepatitis C therapeutics market.

Reasons to buy

  • Align their product portfolios to markets with high growth potential.
  • Build effective strategies to launch their pipeline products by identifying potential geographies.
  • Exploit in-licensing and out-licensing opportunities by identifying products that might fill their portfolio gaps.
  • Develop key strategic initiatives by studying the key strategies of top competitors.
  • Devise a more tailored strategy through the understanding of key drivers and barriers and market potential of each indication.
  • Develop market-entry and market expansion strategies by identifying the geographic markets poised for strong growth.
  • Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules which are safer and more efficacious.

TOC

1 Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 7
  • 1.2 List of Figures 8

2 Introduction 10

3 Market Overview 11

  • 3.1 Introduction 11
    • 3.1.1 HCV Classification 11
    • 3.1.2 HCV Genome 12
    • 3.1.3 HCV Diagnosis 13
    • 3.1.4 HCV Treatment Goals 13
    • 3.1.5 Current HCV Treatment Options 15
    • 3.1.6 Future HCV Treatment Paradigm 16
  • 3.2 Global Hepatitis C Therapeutics Market 18
    • 3.2.1 Revenue 18
    • 3.2.2 Annual Cost of Therapy 22
    • 3.2.3 Treatment Usage Pattern 23
    • 3.2.4 Market Trends 26

4 Geographic Landscape 27

  • 4.1 The US 27
    • 4.1.1 Revenue 27
    • 4.1.2 Annual Cost of Therapy 28
    • 4.1.3 Treatment Usage Pattern 29
  • 4.2 Top Five Countries of Europe 31
    • 4.2.1 Revenue 31
    • 4.2.2 Revenue by Country 33
    • 4.2.3 Annual Cost of Therapy 35
    • 4.2.4 Treatment Usage Pattern 36
  • 4.3 Japan 38
    • 4.3.1 Revenue 38
    • 4.3.2 Annual Cost of Therapy 39
    • 4.3.3 Treatment Usage Pattern 40
  • 4.4 Other Markets 42
    • 4.4.1 Australia 42
    • 4.4.2 China 46
    • 4.4.3 India 49

5 Pipeline Analysis 52

  • 5.1 Research and Development Pipeline 52
  • 5.2 Highlights from the International Liver Congress 2012, European Association for the Study of the Liver 53
  • 5.3 Recently Launched 55
    • 5.3.1 Incivek/Telavic/Incivo (telaprevir) 55
    • 5.3.2 Victrelis 58
    • 5.3.3 Perspective on Incivek and Victrelis 59
  • 5.4 Most Promising Molecules in Phase III 61
    • 5.4.1 GS-7977 61
    • 5.4.2 BMS-790052 (daclatasvir) 67
    • 5.4.3 TMC-435 68
    • 5.4.4 BI-201335 70
  • 5.5 Most Promising Molecules in Phase II 73
    • 5.5.1 ABT-450 73
    • 5.5.2 GS-5885 74
    • 5.5.3 RG7128 (mericitabine) 74
    • 5.5.4 ACH-1625 75
  • 5.6 Combination Therapy Development 76
    • 5.6.1 With PEG-IFN and RBV 76
    • 5.6.2 With RBV only 77
    • 5.6.3 Without PEG-IFN and RBV 78

6 Competitive Landscape 80

  • 6.1 Market Share Analysis 80
  • 6.2 Competitive Profiling 81
    • 6.2.1 Vertex Pharmaceuticals, Inc. 81
    • 6.2.2 Merck & Co., Inc. 82
    • 6.2.3 Gilead Sciences, Inc. 84
    • 6.2.4 Bristol-Myers Squibb Company 85
    • 6.2.5 Abbott Laboratories 87
    • 6.2.6 F. Hoffmann-La Roche Ltd. 88
    • 6.2.7 Johnson & Johnson/Tibotec BVBA 89
    • 6.2.8 Boehringer Ingelheim GmbH 91
    • 6.2.9 Novartis AG 92
    • 6.2.10 Achillion Pharmaceuticals, Inc. 93
    • 6.2.11 Idenix Pharmaceuticals, Inc. 94

7 Strategic Consolidations 95

  • 7.1 Deals by Year 96
  • 7.2 Deals by Type 97
  • 7.3 Deals by Value 98
  • 7.4 Deals by Region 99
  • 7.5 Mergers and Acquisitions 100
    • 7.5.1 Major M&A Deals 101
  • 7.6 Licensing Agreements 102
    • 7.6.1 Major Licensing Agreements 103
  • 7.7 Partnerships 104
    • 7.7.1 Major Partnership Deals 105

8 Appendix 106

  • 8.1 Market Definitions 106
  • 8.2 Abbreviations 106
  • 8.3 Bibliography 107
  • 8.4 Research Methodology 108
    • 8.4.1 Coverage 108
    • 8.4.2 Secondary Research 109
    • 8.4.3 Primary Research 109
    • 8.4.4 Therapeutic Landscape 110
    • 8.4.5 Market Size by Geography 112
    • 8.4.6 Geographical Landscape 113
    • 8.4.7 Pipeline Analysis 113
    • 8.4.8 Competitive Landscape 113
    • 8.4.9 Expert Panel Validation 113
  • 8.5 Contact Us 113
  • 8.6 Disclaimer 113

List of Tables

1.1 List of Tables

  • Table 1: Characteristics of HCV Genotypes 1-3 12
  • Table 2: Functions of HCV Proteins and Therapeutic Approach 12
  • Table 3: Clinical Endpoints for HCV Therapy 14
  • Table 4: Patient Classification Based on Viral Response to Therapy 14
  • Table 5: Direct-acting Antiviral Therapies in Development 16
  • Table 6: Host-Targeting Antiviral Therapies in Development 17
  • Table 7: Novel Interferons in Development 17
  • Table 8: Hepatitis C Therapeutics Market, Global, Revenues ($m), 2004-2011 18
  • Table 9: Hepatitis C Therapeutics Market, Global, Revenue Forecasts ($m), 2011-2018 18
  • Table 10: Hepatitis C Therapeutics Market, Global, Revenues by Geography ($m), 2004-2011 20
  • Table 11: Hepatitis C Therapeutics Market, Global, Revenue Forecasts by Geography ($m), 2011-2018 20
  • Table 12: Hepatitis C Therapeutics Market, Global, Annual Cost of Therapy ($), 2004-2011 22
  • Table 13: Hepatitis C Therapeutics Market, Global, Annual Cost of Therapy ($), 2011-2018 22
  • Table 14: Hepatitis C Therapeutics Market, Global, Treatment Usage Pattern, Population ('000), 2004-2011 24
  • Table 15: Hepatitis C Therapeutics Market, Global, Treatment Usage Pattern, Population ('000), 2011-2018 24
  • Table 16: Hepatitis C Therapeutics Market, The US, Revenues ($m), 2004-2011 27
  • Table 17: Hepatitis C Therapeutics Market, The US, Revenue Forecasts ($m), 2011-2018 27
  • Table 18: Hepatitis C Therapeutics Market, The US, Annual Cost of Therapy ($), 2004-2011 28
  • Table 19: Hepatitis C Therapeutics Market, The US, Annual Cost of Therapy ($), 2011-2018 28
  • Table 20: Hepatitis C Therapeutics Market, The US, Treatment Usage Pattern, Population ('000), 2004-2011 30
  • Table 21: Hepatitis C Therapeutics Market, The US, Treatment Usage Pattern, Population ('000), 2011-2018 30
  • Table 22: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Revenue ($m), 2004-2011 32
  • Table 23: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Revenue Forecasts ($m), 2011-2018 32
  • Table 24: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Revenues by Country ($m), 2004-2011 33
  • Table 25: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Revenue Forecasts by Country ($m), 2011-2018 34
  • Table 26: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2004-2011 35
  • Table 27: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2011-2018 35
  • Table 28: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Treatment Usage Pattern, Population ('000), 2004-2011 36
  • Table 29: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Treatment Usage Pattern, Population ('000), 2011-2018 37
  • Table 30: Hepatitis C Therapeutics Market, Japan, Revenue ($m), 2004-2011 38
  • Table 31: Hepatitis C Therapeutics Market, Japan, Revenue Forecasts ($m), 2011-2018 38
  • Table 32: Hepatitis C Therapeutics Market, Japan, Annual Cost of Therapy ($), 2004-2011 39
  • Table 33: Hepatitis C Therapeutics Market, Japan, Annual Cost of Therapy ($), 2011-2018 39
  • Table 34: Hepatitis C Therapeutics Market, Japan, Treatment Usage Pattern, Population ('000), 2004-2011 40
  • Table 35: Hepatitis C Therapeutics Market, Japan, Treatment Usage Pattern, Population ('000), 2011-2018 41
  • Table 36: Hepatitis C Therapeutics Market, Australia, Pipeline Analysis, 2012 43
  • Table 37: Hepatitis C Therapeutics Market, China, Factors Associated with HCV Infection 47
  • Table 38: Hepatitis C Therapeutics Market, China, Pipeline Analysis, 2012 49
  • Table 39: Hepatitis C Therapeutics Market, India, Pipeline Analysis, 2012 51
  • Table 40: Hepatitis C Therapeutics Market, Global, Notable Interferon-free Therapy Regimens Presented at EASL 2012 53
  • Table 41: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Recently Launched Products, 2012 55
  • Table 42: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Incivek, ADVANCE Phase III Study Results 56
  • Table 43: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Incivek, ILLUMINATE Phase III Study Results 56
  • Table 44: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Incivek, REALIZE Phase III Study Results 57
  • Table 45: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Most Promising Molecules in Phase III, 2012 61
  • Table 46: Hepatitis C Therapeutics Market, Global, GS-7977, Phase III Program 61
  • Table 47: Hepatitis C Therapeutics Market, Global, GS-7977, The QUANTUM Study Results 62
  • Table 48: Hepatitis C Therapeutics Market, Global, GS-7977, The ELECTRON Study Results 63
  • Table 49: Hepatitis C Therapeutics Market, Global, GS-7977, Partnership with BMS-790052, Study Results 66
  • Table 50: Hepatitis C Therapeutics Market, Global, TMC-435, The Phase III Program 68
  • Table 51: Hepatitis C Therapeutics Market, Global, TMC-435, ASPIRE Study, Efficacy Results 69
  • Table 52: Hepatitis C Therapeutics Market, Global, BI-201335, The SILEN-C1 Study Results 71
  • Table 53: Hepatitis C Therapeutics Market, Global, BI-201335, The SILEN-C2 Study Efficacy Results 72
  • Table 54: Hepatitis C Therapeutics Market, Global, BI-201335, The SILEN-C2 Study Safety Results 72
  • Table 55: Hepatitis C Therapeutics Market, Global, BI-201335, The SOUND-C2 Study Results 72
  • Table 56: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Most Promising Molecules in Phase II, 2012 73
  • Table 57: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Combination Therapies with PEG-IFN and RBV, 2012 76
  • Table 58: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Combination Therapies with RBV, 2012 77
  • Table 59: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Combination Therapies without PEG-IFN and RBV, 2012 78
  • Table 60: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Mergers and Acquisitions, 2010-2012 100
  • Table 61: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Licensing Agreements, 2010-2012 102
  • Table 62: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Partnerships, 2010-2012 104

List of Figures

1.2 List of Figures

  • Figure 1: Hepatitis C, Global, Prevalence (million) and Genotype Distribution, 2011 11
  • Figure 2: Hepatitis C Therapeutics Market, Global, Revenue Forecasts ($m), 2004-2018 18
  • Figure 3: Hepatitis C Therapeutics Market, Global, Revenue Forecasts by Geography ($m), 2004-2018 19
  • Figure 4: Hepatitis C Therapeutics Market, Global, Branded and Generic Product Share (%), 2011 and 2018 21
  • Figure 5: Hepatitis C Therapeutics Market, Global, Annual Cost of Therapy ($), 2004-2018 22
  • Figure 6: Hepatitis C Therapeutics Market, Global, Treatment Usage Pattern, Population ('000), 2004-2018 23
  • Figure 7: Hepatitis C Therapeutics Market to 2018, Global, Market Trends, Drivers and Barriers 26
  • Figure 8: Hepatitis C Therapeutics Market, The US, Revenue Forecasts ($m), 2004-2018 27
  • Figure 9: Hepatitis C Therapeutics Market, The US, Annual Cost of Therapy ($), 2004-2018 28
  • Figure 10: Hepatitis C Therapeutics Market, The US, Treatment Usage Pattern, Population ('000), 2004-2018 29
  • Figure 11: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Revenue Forecasts ($m), 2004-2018 31
  • Figure 12: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Revenue Forecasts by Country ($m), 2004-2018 33
  • Figure 13: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2004-2018 35
  • Figure 14: Hepatitis C Therapeutics Market, Top Five Countries of Europe, Treatment Usage Pattern, Population ('000), 2004-2018 36
  • Figure 15: Hepatitis C Therapeutics Market, Japan, Revenue Forecasts ($m), 2004-2018 38
  • Figure 16: Hepatitis C Therapeutics Market, Japan, Annual Cost of Therapy ($), 2004-2018 39
  • Figure 17: Hepatitis C Therapeutics Market, Japan, Treatment Usage Pattern, Population ('000), 2004-2018 40
  • Figure 18: Hepatitis C Therapeutics Market, China, Revenue ($m), 2007-2011 48
  • Figure 19: Hepatitis C Therapeutics Market, India, Revenue ($m), 2007-2011 50
  • Figure 20: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Molecules in Development by Phase, May 2012 52
  • Figure 21: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Incivek, ADVANCE Phase III Study Design 55
  • Figure 22: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Incivek, ILLUMINATE Phase III Study Design 56
  • Figure 23: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Incivek, REALIZE Phase III Study Design 57
  • Figure 24: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Victrelis, SPRINT-2 Phase III Study Design 58
  • Figure 25: Hepatitis C Therapeutics Market, Global, Pipeline Analysis, Victrelis, RESPOND-2 Phase III Study Design 59
  • Figure 26: Hepatitis C Therapeutics Market, Global, GS-7977, The QUANTUM Study Design 62
  • Figure 27: Hepatitis C Therapeutics Market, Global, GS-7977, The ELECTRON Study Design 63
  • Figure 28: Hepatitis C Therapeutics Market, Global, GS-7977, The PROTON Study Design 64
  • Figure 29: Hepatitis C Therapeutics Market, Global, GS-7977, The ATOMIC Study Design 65
  • Figure 30: Hepatitis C Therapeutics Market, Global, BI-201335, The SILEN-C1 Study Design 70
  • Figure 31: Hepatitis C Therapeutics Market, Global, BI-201335, The SILEN-C2 Study Results 71
  • Figure 32: Hepatitis C Therapeutics Market, Global, Mericitabine, The PROPEL Study Design 74
  • Figure 33: Hepatitis C Therapeutics Market, Global, Mericitabine, The INFORM-SVR Study Design 75
  • Figure 34: Hepatitis C Therapeutics Market, Global, Competitive Landscape, Market Share (%), 2011 80
  • Figure 35: Hepatitis C Therapeutics Market, Global, Vertex Pharmaceuticals, SWOT Analysis 82
  • Figure 36: Hepatitis C Therapeutics Market, Global, Merck and Co., SWOT Analysis 83
  • Figure 37: Hepatitis C Therapeutics Market, Global, Gilead Sciences, SWOT Analysis 85
  • Figure 38: Hepatitis C Therapeutics Market, Global, Bristol-Myers Squibb Company, SWOT Analysis 86
  • Figure 39: Hepatitis C Therapeutics Market, Global, Abbott Laboratories, SWOT Analysis 88
  • Figure 40: Hepatitis C Therapeutics Market, Global, F. Hoffmann-La Roche, SWOT Analysis 89
  • Figure 41: Hepatitis C Therapeutics Market, Global, Johnson & Johnson/Tibotec, SWOT Analysis 90
  • Figure 42: Hepatitis C Therapeutics Market, Global, Boehringer Ingelheim, SWOT Analysis 91
  • Figure 43: Hepatitis C Therapeutics Market, Global, Novartis, SWOT Analysis 92
  • Figure 44: Hepatitis C Therapeutics Market, Global, Achillion Pharmaceuticals, SWOT Analysis 93
  • Figure 45: Hepatitis C Therapeutics Market, Global, Idenix Pharmaceuticals, SWOT Analysis 94
  • Figure 46: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Deals by Year, 2010-2012 96
  • Figure 47: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Deals by Type, 2010-2012 97
  • Figure 48: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Deals by Value, 2010-2012 98
  • Figure 49: Hepatitis C Therapeutics Market, Global, Strategic Consolidations, Deals by Region, 2010-2012 99
  • Figure 50: GBI Research Market Forecasting Model 112
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