PharmaPoint: Hepatitis C Virus - United Kingdom Drug Forecast and Market Analysis to 2022



Summary



GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus - United Kingdom Drug Forecast and Market Analysis to 2022”. Hepatitis C is a liver infection caused by the hepatitis C virus (HCV) that results in acute or chronic presentation. The disease is often asymptomatic, but infected patients may experience fatigue, joint pain, itchy skin or jaundice. There is no effective vaccine against HCV, so the market is driven by therapeutics. Currently, drug combinations containing pegylated interferon (e.g., Roche’s Pegasys and Merck’s PegIntron) and ribavirin (e.g., Roche’s Copegus and Merck’s Rebetol) are used to treat HCV infection. Patients infected with HCV genotype 1 can also have a protease inhibitor added to their combination therapy, such as Merck’s Victrelis (boceprevir) or Vertex’s Incivek (telaprevir). The entrance of next-generation HCV therapies is expected to fundamentally change the HCV treatment algorithm. GlobalData expects a dramatic shift favoring the uptake of interferon-free regimens due to their more tolerable side-effect profiles and decreased duration of therapy compared with the current standard of care.

The anticipated drivers of growth in the UK market included increased awareness of HCV, the launch of improved HCV regimens, and advocacy for access to next-generation therapies.

Janssen’s Incivo is the current market leader in the UK. Incivo was among the first DAA HCV therapies launched in the UK. The regimen had an improved efficacy compared with the previous standard of care for HCV GT1, a combination of peginterferon and ribavirin. GlobalData assumes that Incivo’s shorter duration of triple-therapy (i.e., DAA, peginterferon, and ribavirin) compared with Merck’s Victrelis enabled it to outcompete Victrelis for market share. Incivo and Victrelis are both associated with adverse events, which has resulted in HCV-infected patients in the UK deciding to forego therapy in order to await the launch of more-tolerable HCV therapies.



Scope


- Overview of the HCV including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the UK including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the UK from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the UK HCV market.



Reasons to buy


- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for HCV
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2012-2022 in the UK

Table Of Contents

Table of Contents

1 Table of CContents 4
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 16
3.1.3 Prognosis 17
3.2 Symptoms 17
4 Disease Management 18
4.1 Diagnosis and Referral Overview 18
4.2 Treatment Overview 19
4.3 UK 22
4.3.1 Diagnosis 22
4.3.2 Clinical Practice 23
5 Competitive Assessment 24
5.1 Overview 24
5.2 Strategic Competitor Assessment 24
5.3 Product Profiles - Major Brands 26
5.3.1 Incivek (telaprevir) 26
5.3.2 Victrelis (boceprevir) 31
5.3.3 Pegasys (peginterferon alfa-2a) 36
5.3.4 PegIntron (peginterferon alfa-2b) 41
5.3.5 Copegus, Rebetol, and Generic Ribavirin 45
5.3.6 Therapeutic Class: Interferon 48
6 Opportunity and Unmet Need 49
6.1 Overview 49
6.2 Unmet Needs 50
6.2.1 Unmet Need: Treatment Tolerability 50
6.2.2 Unmet Need: Efficacy 50
6.2.3 Unmet Need: Disease Awareness 51
6.2.4 Unmet Need: Treatment Cost 52
6.2.5 Unmet Need: Shorter Treatment Duration 52
6.2.6 Unmet Need: Simplified Treatment Regimens 53
6.3 Unmet Needs Gap Analysis 54
6.4 Opportunities 55
6.4.1 Opportunity: Pan-genotypic HCV Regimen 55
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 55
6.4.3 Opportunity: Involvement of Immune System 56
7 Pipeline Assessment 57
7.1 Overview 57
7.2 Promising Drugs in Clinical Development 58
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 60
7.2.2 Simeprevir 70
7.2.3 ABT-450 plus ABT-267 and ABT-333 78
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 85
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 93
7.2.6 Other Drug Classes 101
8 Market Outlook 104
8.1 UK 104
8.1.1 Forecast 104
8.1.2 Key Events 109
8.1.3 Drivers and Barriers 109
9 Appendix 112
9.1 Bibliography 112
9.2 Abbreviations 120
9.3 Methodology 121
9.4 Forecasting Methodology 121
9.4.1 Percent Drug-Treated Patients 121
9.4.2 Patient Warehousing 122
9.4.3 Drugs Included in Each Therapeutic Class 122
9.4.4 Launch and Patent Expiry Dates 123
9.4.5 General Pricing Assumptions 124
9.4.6 Individual Drug Assumptions 124
9.4.7 Generic Erosion 126
9.4.8 Selection of Pipeline Agents 126
9.4.9 Pricing of Pipeline Agents 127
9.5 Physicians and Specialists Included in this Study 130
9.6 Survey of Prescribing Physicians 132
9.7 About the Authors 133
9.7.1 Author 133
9.7.2 Global Head of Healthcare 133
9.8 About GlobalData 134
9.9 Contact Us 134
9.10 Disclaimer 134



List of Tables

Table 1: Modes of HCV Transmission 16
Table 2: Symptoms of Acute and Chronic HCV Infection 17
Table 3: HCV Genotypes Present in the 9MM 19
Table 4: General Standard of Care by HCV Genotype 19
Table 5: Treatment Guidelines for HCV by Country 21
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 21
Table 7: Leading Treatments for HCV, 2012 25
Table 8: Product Profile - Incivek 27
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 27
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 28
Table 11: Common Incivek Adverse Drug Reactions 29
Table 12: Incivek SWOT Analysis, 2012 30
Table 13: Product Profile - Victrelis 31
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 32
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 33
Table 16: Victrelis SWOT Analysis, 2012 35
Table 17: Product Profile - Pegasys 37
Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 38
Table 19: Pegasys SWOT Analysis, 2012 40
Table 20: Product Profile - PegIntron 42
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 42
Table 22: PegIntron SWOT Analysis, 2012 44
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 46
Table 24: Ribavirin SWOT Analysis, 2012 47
Table 25: Summary of Minor Therapeutic Classes, 2012 48
Table 26: Overall Unmet Needs - Current Level of Attainment 49
Table 27: Clinical Unmet Needs - Gap Analysis, 2012 54
Table 28: HCV - Pipeline, 2012 58
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 59
Table 30: Gilead’s Sofosbuvir Ongoing Clinical Trials of Interest 61
Table 31: Product Profile - Sofosbuvir 62
Table 32: Sofosbuvir’s Most Common Adverse Effects 65
Table 33: Sofosbuvir SWOT Analysis, 2012 69
Table 34: Janssen’s Simeprevir Ongoing Clinical Trials of Interest 71
Table 35: Product Profile - Simeprevir 72
Table 36: PILLAR Clinical Trial Results 72
Table 37: Adverse Events Observed in PILLAR Clinical Trial 73
Table 38: Simeprevir SWOT Analysis, 2012 77
Table 39: AbbVie’s Combination Therapy Ongoing Clinical Trials of Interest 79
Table 40: Product Profile - AbbVie Combination Therapy 80
Table 41: AVIATOR Clinical Trial Results 80
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 84
Table 43: Boehringer Ingelheim’s Faldaprevir Ongoing Clinical Trials of Interest 86
Table 44: Product Profile - Faldaprevir 87
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 87
Table 46: Faldaprevir SWOT Analysis, 2012 92
Table 47: Bristol-Myers Squibb’s Daclatasvir Ongoing Clinical Trials of Interest 94
Table 48: Product Profile - Daclatasvir 95
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 95
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 96
Table 51: Daclatasvir Triple Therapy Adverse Events 97
Table 52: Daclatasvir SWOT Analysis, 2012 100
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 101
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 102
Table 55: Sales Forecasts ($m) for HCV in the UK, 2012-2022 107
Table 56: Key Events Impacting Sales for HCV in the UK, 2012 109
Table 57: UK HCV Market - Drivers and Barriers, 2012 109
Table 58: Key Launch Dates 123
Table 59: Key Patent Expiries 123
Table 60: Physicians Surveyed, By Country 132



List of Figures

Figure 1: HCV Genome and Polyprotein Composition 13
Figure 2: HCV Lifecycle Overview 14
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012-2022 58
Figure 4: Sales for HCV Therapeutics in the UK by Drug Class, 2012-2022 108

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