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

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

Summary

GlobalData has released its new Country report, "PharmaPoint: Hepatitis C Virus - United Kingdom Drug Forecast and Market Analysis". 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

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 11
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 12
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 19
3.1.3 Prognosis 20
3.2 Symptoms 20
4 Disease Management 21
4.1 Diagnosis and Referral Overview 21
4.2 Treatment Overview 22
4.3 UK 25
4.3.1 Diagnosis 25
4.3.2 Clinical Practice 26
5 Competitive Assessment 27
5.1 Overview 27
5.2 Strategic Competitor Assessment 27
5.3 Product Profiles – Major Brands 29
5.3.1 Incivek (telaprevir) 29
5.3.2 Victrelis (boceprevir) 34
5.3.3 Pegasys (peginterferon alfa-2a) 38
5.3.4 PegIntron (peginterferon alfa-2b) 42
5.3.5 Copegus, Rebetol, and Generic Ribavirin 46
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 53
6.4 Opportunities 54
6.4.1 Opportunity: Pan-genotypic HCV Regimen 54
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 54
6.4.3 Opportunity: Involvement of Immune System 55
7 Pipeline Assessment 56
7.1 Overview 56
7.2 Promising Drugs in Clinical Development 57
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 58
7.2.2 Simeprevir 68
7.2.3 ABT-450 plus ABT-267 and ABT-333 75
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 82
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 89
7.2.6 Other Drug Classes 97
8 Market Outlook 101
8.1 UK 101
8.1.1 Forecast 101
8.1.2 Key Events 106
8.1.3 Drivers and Barriers 106
9 Appendix 109
9.1 Bibliography 109
9.2 Abbreviations 118
9.3 Methodology 119
9.4 Forecasting Methodology 119
9.4.1 Percent Drug-Treated Patients 119
9.4.2 Patient Warehousing 121
9.4.3 Drugs Included in Each Therapeutic Class 121
9.4.4 Launch and Patent Expiry Dates 122
9.4.5 General Pricing Assumptions 123
9.4.6 Individual Drug Assumptions 123
9.4.7 Generic Erosion 125
9.4.8 Selection of Pipeline Agents 125
9.4.9 Pricing of Pipeline Agents 126
9.5 Physicians and Specialists Included in this Study 128
9.6 Survey of Prescribing Physicians 131
9.7 About the Authors 132
9.7.1 Author 132
9.7.2 Global Head of Healthcare 132
9.8 About GlobalData 133
9.9 Contact Us 133
9.10 Disclaimer 133

List of Tables

Table 1: Modes of HCV Transmission 19
Table 2: Symptoms of Acute and Chronic HCV Infection 20
Table 3: HCV Genotypes Present in the 9MM 22
Table 4: General Standard of Care by HCV Genotype 22
Table 5: Treatment Guidelines for HCV by Country 23
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 24
Table 7: Leading Treatments for HCV, 2012 28
Table 8: Product Profile – Incivek 30
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 30
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 31
Table 11: Common Incivek Adverse Drug Reactions 32
Table 12: Incivek SWOT Analysis, 2012 33
Table 13: Product Profile – Victrelis 35
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 35
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 36
Table 16: Victrelis SWOT Analysis, 2012 38
Table 17: Product Profile – Pegasys 39
Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 40
Table 19: Pegasys SWOT Analysis, 2012 42
Table 20: Product Profile – PegIntron 43
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 44
Table 22: PegIntron SWOT Analysis, 2012 45
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 47
Table 24: Ribavirin SWOT Analysis, 2012 48
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 53
Table 28: HCV – Pipeline, 2012 57
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 58
Table 30: Gilead's Sofosbuvir Ongoing Clinical Trials of Interest 60
Table 31: Product Profile – Sofosbuvir 61
Table 32: Sofosbuvir's Most Common Adverse Effects 64
Table 33: Sofosbuvir SWOT Analysis, 2012 68
Table 34: Janssen's Simeprevir Ongoing Clinical Trials of Interest 69
Table 35: Product Profile – Simeprevir 70
Table 36: PILLAR Clinical Trial Results 71
Table 37: Adverse Events Observed in PILLAR Clinical Trial 72
Table 38: Simeprevir SWOT Analysis, 2012 75
Table 39: AbbVie's Combination Therapy Ongoing Clinical Trials of Interest 76
Table 40: Product Profile – AbbVie Combination Therapy 77
Table 41: AVIATOR Clinical Trial Results 77
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 81
Table 43: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 83
Table 44: Product Profile – Faldaprevir 84
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 85
Table 46: Faldaprevir SWOT Analysis, 2012 89
Table 47: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 91
Table 48: Product Profile – Daclatasvir 92
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 92
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 93
Table 51: Daclatasvir Triple Therapy Adverse Events 94
Table 52: Daclatasvir SWOT Analysis, 2012 97
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 97
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 99
Table 55: Sales Forecasts ($m) for HCV in the UK, 2012–2022 104
Table 56: Key Events Impacting Sales for HCV in the UK, 2012 106
Table 57: UK HCV Market – Drivers and Barriers, 2012 106
Table 58: Key Launch Dates 122
Table 59: Key Patent Expiries 122
Table 60: Physicians Surveyed, By Country 131

List of Figures

Figure 1: HCV Genome and Polyprotein Composition 16
Figure 2: HCV Lifecycle Overview 17
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012–2022 57
Figure 4: Sales for HCV Therapeutics in the UK by Drug Class, 2012–2022 105

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Drug_and_Medication Industry: PharmaPoint: Hepatitis C Virus - United Kingdom Drug Forecast and Market Analysis

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