PharmaPoint: Hepatitis C Virus – Italy Drug Forecast and Market Analysis to 2022

Publisher Name :
Date:31-May-2013
No. of pages: 132

Summary

GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus – Italy 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 main drivers of growth of the Italian HCV market are expected to be an increase in HCV awareness and the launch of next-generation HCV therapies.

The current market leader in Italy is Roche’s Pegasys (peginterferon alfa-2a). The current standard of HCV therapy in Italy is a combination of interferon and ribavirin. The less-frequent dosing of peginterferon compared with standard interferon (i.e., once a week compared with three times a week) enabled peginterferon to quickly capture market share. In addition to standard interferon, Pegasys directly competes for market share with Merck’s ViraferonPeg (peginterferon alfa-2b).

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 Italy including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Italy from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Italy 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 Italy

PharmaPoint: Hepatitis C Virus – Italy Drug Forecast and Market Analysis to 2022

Table Of Contents

1 Table of Contents 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 Italy 22
4.3.1 Diagnosis 22
4.3.2 Clinical Practice 22

5 Competitive Assessment 23
5.1 Overview 23
5.2 Strategic Competitor Assessment 23
5.3 Product Profiles – Major Brands 25
5.3.1 Incivek (telaprevir) 25
5.3.2 Victrelis (boceprevir) 30
5.3.3 Pegasys (peginterferon alfa-2a) 34
5.3.4 PegIntron (peginterferon alfa-2b) 39
5.3.5 Copegus, Rebetol, and Generic Ribavirin 43
5.3.6 Therapeutic Class: Interferon 46

6 Opportunity and Unmet Need 47
6.1 Overview 47
6.2 Unmet Needs 48
6.2.1 Unmet Need: Treatment Tolerability 48
6.2.2 Unmet Need: Efficacy 48
6.2.3 Unmet Need: Disease Awareness 49
6.2.4 Unmet Need: Treatment Cost 50
6.2.5 Unmet Need: Shorter Treatment Duration 50
6.2.6 Unmet Need: Simplified Treatment Regimens 51
6.3 Unmet Needs Gap Analysis 52
6.4 Opportunities 53
6.4.1 Opportunity: Pan-genotypic HCV Regimen 53
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 53
6.4.3 Opportunity: Involvement of Immune System 54

7 Pipeline Assessment 55
7.1 Overview 55
7.2 Promising Drugs in Clinical Development 56
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 58
7.2.2 Simeprevir 68
7.2.3 ABT-450 plus ABT-267 and ABT-333 76
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 83
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 91
7.2.6 Other Drug Classes 99

8 Market Outlook 102
8.1 Italy 102
8.1.1 Forecast 102
8.1.2 Key Events 106
8.1.3 Drivers and Barriers 106

9 Appendix 109
9.1 Bibliography 109
9.2 Abbreviations 117
9.3 Methodology 119
9.4 Forecasting Methodology 119
9.4.1 Percent Drug-Treated Patients 119
9.4.2 Patient Warehousing 120
9.4.3 Drugs Included in Each Therapeutic Class 120
9.4.4 Launch and Patent Expiry Dates 121
9.4.5 General Pricing Assumptions 121
9.4.6 Individual Drug Assumptions 122
9.4.7 Generic Erosion 124
9.4.8 Selection of Pipeline Agents 124
9.4.9 Pricing of Pipeline Agents 125
9.5 Physicians and Specialists Included in this Study 128
9.6 Survey of Prescribing Physicians 130
9.7 About the Authors 131
9.7.1 Author 131
9.7.2 Global Head of Healthcare 131
9.8 About GlobalData 132
9.9 Contact Us 132
9.10 Disclaimer 132

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 24
Table 8: Product Profile – Incivek 26
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 26
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 27
Table 11: Common Incivek Adverse Drug Reactions 28
Table 12: Incivek SWOT Analysis, 2012 29
Table 13: Product Profile – Victrelis 30
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 31
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 32
Table 16: Victrelis SWOT Analysis, 2012 33
Table 17: Product Profile – Pegasys 35
Table 18: Antiviral Efficacy of Peginterferon alfa-2a Compared with Interferon alfa-2b 36
Table 19: Pegasys SWOT Analysis, 2012 38
Table 20: Product Profile – PegIntron 40
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 40
Table 22: PegIntron SWOT Analysis, 2012 42
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 44
Table 24: Ribavirin SWOT Analysis, 2012 45
Table 25: Summary of Minor Therapeutic Classes, 2012 46
Table 26: Overall Unmet Needs – Current Level of Attainment 47
Table 27: Clinical Unmet Needs – Gap Analysis, 2012 52
Table 28: HCV – Pipeline, 2012 56
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 57
Table 30: Gilead’s Sofosbuvir Ongoing Clinical Trials of Interest 59
Table 31: Product Profile – Sofosbuvir 60
Table 32: Sofosbuvir’s Most Common Adverse Effects 63
Table 33: Sofosbuvir SWOT Analysis, 2012 67
Table 34: Janssen’s Simeprevir Ongoing Clinical Trials of Interest 69
Table 35: Product Profile – Simeprevir 70
Table 36: PILLAR Clinical Trial Results 70
Table 37: Adverse Events Observed in PILLAR Clinical Trial 71
Table 38: Simeprevir SWOT Analysis, 2012 75
Table 39: AbbVie’s Combination Therapy Ongoing Clinical Trials of Interest 77
Table 40: Product Profile – AbbVie Combination Therapy 78
Table 41: AVIATOR Clinical Trial Results 78
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 82
Table 43: Boehringer Ingelheim’s Faldaprevir Ongoing Clinical Trials of Interest 84
Table 44: Product Profile – Faldaprevir 85
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 85
Table 46: Faldaprevir SWOT Analysis, 2012 90
Table 47: Bristol-Myers Squibb’s Daclatasvir Ongoing Clinical Trials of Interest 92
Table 48: Product Profile – Daclatasvir 93
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 93
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 94
Table 51: Daclatasvir Triple Therapy Adverse Events 95
Table 52: Daclatasvir SWOT Analysis, 2012 98
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 99
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 100
Table 55: Sales Forecasts ($m) for HCV in Italy, 2012–2022 104
Table 56: Key Events Impacting Sales for HCV in Italy, 2012 106
Table 57: Italian HCV Market – Drivers and Barriers, 2012 106
Table 58: Key Launch Dates 121
Table 59: Key Patent Expiries 121
Table 60: Physicians Surveyed, By Country 130

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 56
Figure 4: Sales for HCV Therapeutics in Italy by Drug Class, 2012–2022 105

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