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

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

Summary

GlobalData has released its new Country report, "PharmaPoint: Hepatitis C Virus - Brazil 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 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

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 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 Brazil 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) 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 Simeprevir 55
7.2.2 Faldaprevir and Faldaprevir plus BI 207127 62
7.2.3 Daclatasvir and Daclatasvir plus Asunaprevir 70
7.2.4 Other Drug Classes 77
8 Market Outlook 81
8.1 Brazil 81
8.1.1 Forecast 81
8.1.2 Key Events 85
8.1.3 Drivers and Barriers 85
9 Appendix 88
9.1 Bibliography 88
9.2 Abbreviations 96
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 99
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 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 55
Table 30: Janssen's Simeprevir Ongoing Clinical Trials of Interest 56
Table 31: Product Profile – Simeprevir 57
Table 32: PILLAR Clinical Trial Results 57
Table 33: Adverse Events Observed in PILLAR Clinical Trial 58
Table 34: Simeprevir SWOT Analysis, 2012 61
Table 35: Boehringer Ingelheim's Faldaprevir Ongoing Clinical Trials of Interest 63
Table 36: Product Profile – Faldaprevir 64
Table 37: Efficacy of Interferon-Free Faldaprevir Regimen (SOUND-C2 Trial) 65
Table 38: Faldaprevir SWOT Analysis, 2012 69
Table 39: Bristol-Myers Squibb's Daclatasvir Ongoing Clinical Trials of Interest 71
Table 40: Product Profile – Daclatasvir 72
Table 41: Efficacy of Daclatasvir in Treatment-Naïve Patients (COMMAND-1 Trial) 72
Table 42: Daclatasvir and Asunaprevir Quad Therapy Efficacy 73
Table 43: Daclatasvir Triple Therapy Adverse Events 74
Table 44: Daclatasvir SWOT Analysis, 2012 77
Table 45: Comparison of Peginterferon lambda with Peginterferon alfa (EMERGE Trial) 78
Table 46: Efficacy of Alisporivir in Treatment-Naïve HCV GT2/3 Patients (VITAL-1 Trial) 79
Table 47: Sales Forecasts ($m) for HCV in Brazil, 2012–2022 83
Table 48: Key Events Impacting Sales for HCV in Brazil, 2012 85
Table 49: Brazilian HCV Market – Drivers and Barriers, 2012 85
Table 50: Physicians Surveyed, By Country 107

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 54
Figure 4: Sales for HCV Therapeutics in Brazil by Drug Class, 2012–2022 84

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Drug_and_Medication Industry: PharmaPoint: Hepatitis C Virus - Brazil Drug Forecast and Market Analysis to 2022

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