PharmaPoint: Hepatitis C Virus - Brazil Drug Forecast and Market Analysis

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PharmaPoint: Hepatitis C Virus - Brazil Drug Forecast and Market Analysis
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PharmaPoint: Hepatitis C Virus - Brazil Drug Forecast and Market Analysis

Summary

GlobalData has released its new Country report, "PharmaPoint: Hepatitis C Virus - Brazil 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 of the HCV market in Brazil include increasing awareness of the disease, the adoption of non-invasive liver diagnostic tests, and the launch of next-generation HCV therapies.

Roche's Pegasys (peginterferon alfa-2a) is the current market leader in Brazil. Pegasys was launched in Brazil after Merck's PegIntron (peginterferon alfa-2b), but GlobalData believes that Pegasys was able to quickly dominate the market due to a perceived better side effect profile and efficacy. Sales of both Pegasys and PegIntron are projected to increase in Brazil as a result an increase in the country's HCV treatment rate. Sales of both drugs are also expected to be boosted by their drug's inclusion in triple therapies (i.e., DAA, peginterferon, and ribavirin).

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

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 10
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 11
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 18
3.1.3 Prognosis 19
3.2 Symptoms 19
4 Disease Management 20
4.1 Diagnosis and Referral Overview 20
4.2 Treatment Overview 21
4.3 Brazil 24
4.3.1 Diagnosis 24
4.3.2 Clinical Practice 24
5 Competitive Assessment 25
5.1 Overview 25
5.2 Strategic Competitor Assessment 25
5.3 Product Profiles – Major Brands 27
5.3.1 Incivek (telaprevir) 27
5.3.2 Victrelis (boceprevir) 32
5.3.3 Pegasys (peginterferon alfa-2a) 36
5.3.4 PegIntron (peginterferon alfa-2b) 40
5.3.5 Copegus, Rebetol, and Generic Ribavirin 44
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 51
6.4 Opportunities 52
6.4.1 Opportunity: Pan-genotypic HCV Regimen 52
6.4.2 Opportunity: Treatment of Underrepresented Patient Populations 52
6.4.3 Opportunity: Involvement of Immune System 53
7 Pipeline Assessment 54
7.1 Overview 54
7.2 Promising Drugs in Clinical Development 55
7.2.1 Simeprevir 56
7.2.2 Faldaprevir and Faldaprevir plus BI 207127 63
7.2.3 Daclatasvir and Daclatasvir plus Asunaprevir 70
7.2.4 Other Drug Classes 78
8 Market Outlook 82
8.1 Brazil 82
8.1.1 Forecast 82
8.1.2 Key Events 86
8.1.3 Drivers and Barriers 86
9 Appendix 89
9.1 Bibliography 89
9.2 Abbreviations 97
9.3 Methodology 98
9.4 Forecasting Methodology 98
9.4.1 Percent Drug-Treated Patients 98
9.4.2 Patient Warehousing 99
9.4.3 Drugs Included in Each Therapeutic Class 99
9.4.4 General Pricing Assumptions 100
9.4.5 Individual Drug Assumptions 100
9.4.6 Generic Erosion 102
9.4.7 Selection of Pipeline Agents 102
9.4.8 Pricing of Pipeline Agents 103
9.5 Physicians and Specialists Included in this Study 105
9.6 Survey of Prescribing Physicians 107
9.7 About the Authors 108
9.7.1 Author 108
9.7.2 Global Head of Healthcare 108
9.8 About GlobalData 109
9.9 Contact Us 109
9.10 Disclaimer 109

List of Tables

Table 1: Modes of HCV Transmission 18
Table 2: Symptoms of Acute and Chronic HCV Infection 19
Table 3: HCV Genotypes Present in the 9MM 21
Table 4: General Standard of Care by HCV Genotype 21
Table 5: Treatment Guidelines for HCV by Country 22
Table 6: Most-Prescribed Drugs for HCV by Class in the Global Markets, 2013 23
Table 7: Leading Treatments for HCV, 2012 26
Table 8: Product Profile – Incivek 28
Table 9: Efficacy of Incivek in Treatment-Naïve Patients (ADVANCE Trial) 28
Table 10: Efficacy of Incivek in Treatment-Experienced Patients (REALIZE Trial) 29
Table 11: Common Incivek Adverse Drug Reactions 30
Table 12: Incivek SWOT Analysis, 2012 31
Table 13: Product Profile – Victrelis 33
Table 14: Victrelis Efficacy in Treatment-Naïve Patients (SPRINT-2 Trial) 33
Table 15: Victrelis Efficacy in Treatment-Experienced Patients (RESPOND-2 Trial) 34
Table 16: Victrelis SWOT Analysis, 2012 36
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 41
Table 21: Antiviral Efficacy of Peginterferon alfa-2b Compared with Interferon alfa-2b 42
Table 22: PegIntron SWOT Analysis, 2012 43
Table 23: Effect of Addition of Ribavirin to Peginterferon HCV Therapy 45
Table 24: Ribavirin SWOT Analysis, 2012 46
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 51
Table 28: HCV – Pipeline, 2012 55
Table 29: Comparison of Therapeutic Classes in Development for HCV, 2012 56
Table 30: Janssen's Simeprevir Ongoing Clinical Trials of Interest 57
Table 31: Product Profile – Simeprevir 58
Table 32: PILLAR Clinical Trial Results 59
Table 33: Adverse Events Observed in PILLAR Clinical Trial 60
Table 34: Simeprevir SWOT Analysis, 2012 63
Table 35: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 64
Table 36: Product Profile – Faldaprevir 65
Table 37: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 66
Table 38: Faldaprevir SWOT Analysis, 2012 70
Table 39: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 72
Table 40: Product Profile – Daclatasvir 73
Table 41: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 73
Table 42: Daclatasvir and Asunaprevir Quad Therapy Efficacy 74
Table 43: Daclatasvir Triple Therapy Adverse Events 75
Table 44: Daclatasvir SWOT Analysis, 2012 78
Table 45: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 79
Table 46: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 80
Table 47: Sales Forecasts ($m) for HCV in Brazil, 2012–2022 84
Table 48: Key Events Impacting Sales for HCV in Brazil, 2012 86
Table 49: Brazilian HCV Market – Drivers and Barriers, 2012 86
Table 50: Physicians Surveyed, By Country 107

List of Figures

Figure 1: HCV Genome and Polyprotein Composition 15
Figure 2: HCV Lifecycle Overview 16
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HCV, 2012–2022 55
Figure 4: Sales for HCV Therapeutics in Brazil by Drug Class, 2012–2022 85

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

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