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

Publisher Name :
Date: 31-May-2013
No. of pages: 127

Summary

GlobalData has released its new Country report, “PharmaPoint: Hepatitis C Virus – Spain 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 in the HCV market in Spain are expected to include an increase in HCV awareness and the launch of next-generation HCV regimens.

Incivo and Merck’s Victrelis were the first DAA HCV therapies launched in Spain. Both therapies had significantly improved efficacy compared with the front-line therapy for HCV GT1 in Spain at the time, which was a combination of peginterferon and ribavirin. Incivo quickly became the standard of care for HCV GT1 in Spain.

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

PharmaPoint: Hepatitis C Virus – Spain 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 12
3.1.1 Etiology 12
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 Spain 21
4.3.1 Diagnosis 21
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) 38
5.3.5 Copegus, Rebetol, and Generic Ribavirin 42
5.3.6 Therapeutic Class: Interferon 44

6 Opportunity and Unmet Need 45
6.1 Overview 45
6.2 Unmet Needs 46
6.2.1 Unmet Need: Treatment Tolerability 46
6.2.2 Unmet Need: Efficacy 46
6.2.3 Unmet Need: Disease Awareness 47
6.2.4 Unmet Need: Treatment Cost 48
6.2.5 Unmet Need: Shorter Treatment Duration 48
6.2.6 Unmet Need: Simplified Treatment Regimens 49
6.3 Unmet Needs Gap Analysis 49
6.4 Opportunities 50
6.4.1 Opportunity: Pan-genotypic HCV Regimen 50
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 50
6.4.3 Opportunity: Involvement of Immune System 51

7 Pipeline Assessment 52
7.1 Overview 52
7.2 Promising Drugs in Clinical Development 53
7.2.1 Sofosbuvir and Sofosbuvir/Ledipasvir 54
7.2.2 Simeprevir 64
7.2.3 ABT-450 plus ABT-267 and ABT-333 71
7.2.4 Faldaprevir and Faldaprevir plus BI 207127 78
7.2.5 Daclatasvir and Daclatasvir plus Asunaprevir 86
7.2.6 Other Drug Classes 94

8 Market Outlook 97
8.1 Spain 97
8.1.1 Forecast 97
8.1.2 Key Events 101
8.1.3 Drivers and Barriers 101

9 Appendix 104
9.1 Bibliography 104
9.2 Abbreviations 112
9.3 Methodology 114
9.4 Forecasting Methodology 114
9.4.1 Percent Drug-Treated Patients 114
9.4.2 Patient Warehousing 115
9.4.3 Drugs Included in Each Therapeutic Class 115
9.4.4 Launch and Patent Expiry Dates 116
9.4.5 General Pricing Assumptions 117
9.4.6 Individual Drug Assumptions 117
9.4.7 Generic Erosion 119
9.4.8 Selection of Pipeline Agents 119
9.4.9 Pricing of Pipeline Agents 120
9.5 Physicians and Specialists Included in this Study 123
9.6 Survey of Prescribing Physicians 125
9.7 About the Authors 126
9.7.1 Author 126
9.7.2 Global Head of Healthcare 126
9.8 About GlobalData 127
9.9 Contact Us 127
9.10 Disclaimer 127

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 20
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 34
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 39
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 40
Table 22: PegIntron SWOT Analysis, 2012 41
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 43
Table 24: Ribavirin SWOT Analysis, 2012 44
Table 25: Summary of Minor Therapeutic Classes, 2012 44
Table 26: Overall Unmet Needs - Current Level of Attainment 45
Table 27: Clinical Unmet Needs - Gap Analysis, 2012 49
Table 28: HCV - Pipeline, 2012 53
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 54
Table 30: Gilead's Sofosbuvir Ongoing Clinical Trials of Interest 56
Table 31: Product Profile - Sofosbuvir 57
Table 32: Sofosbuvir's Most Common Adverse Effects 60
Table 33: Sofosbuvir SWOT Analysis, 2012 64
Table 34: Janssen's Simeprevir Ongoing Clinical Trials of Interest 65
Table 35: Product Profile - Simeprevir 66
Table 36: PILLAR Clinical Trial Results 66
Table 37: Adverse Events Observed in PILLAR Clinical Trial 67
Table 38: Simeprevir SWOT Analysis, 2012 70
Table 39: AbbVie's Combination Therapy Ongoing Clinical Trials of Interest 72
Table 40: Product Profile - AbbVie Combination Therapy 73
Table 41: AVIATOR Clinical Trial Results 73
Table 42: AbbVie Combination Therapy SWOT Analysis, 2012 77
Table 43: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 79
Table 44: Product Profile - Faldaprevir 80
Table 45: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 81
Table 46: Faldaprevir SWOT Analysis, 2012 85
Table 47: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 87
Table 48: Product Profile - Daclatasvir 88
Table 49: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 88
Table 50: Daclatasvir and Asunaprevir Quad Therapy Efficacy 89
Table 51: Daclatasvir Triple Therapy Adverse Events 90
Table 52: Daclatasvir SWOT Analysis, 2012 93
Table 53: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 94
Table 54: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 95
Table 55: Sales Forecasts ($m) for HCV in Spain, 2012-2022 99
Table 56: Key Events Impacting Sales for HCV in Spain, 2012 101
Table 57: Spanish HCV Market - Drivers and Barriers, 2012 101
Table 58: Key Launch Dates 116
Table 59: Key Patent Expiries 116
Table 60: Physicians Surveyed, By Country 125

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 53
Figure 4: Sales for HCV Therapeutics in Spain by Drug Class, 2012-2022 100

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