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Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023

Published by Global Data: 09 Sep 2015 | 27237 | In Stock

Introduction

Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023

Summary

Human immunodeficiency virus (HIV) is a retrovirus that infects the cells of the immune system, destroying or impairing their function. As the infection progresses, the immune system becomes increasingly weaker, making the infected person more susceptible to other infections. Since the first anti-HIV drug, GlaxoSmithKline’s (GSK’s) Retrovir (azidothymidine), was approved in 1987, major improvements have been made in the field of antiretroviral therapy (ART). This rapid progress has been headlined by the emergence of once-daily, single-tablet regimens (STRs) such as Gilead Science's Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate [TDF]), which offer patients an unparalleled level of convenience.

The HIV therapeutics market in Brazil was valued at approximately 7m in 2013. In contrast to the 7MM, where branded therapies dominate the treatment landscape, HIV drug sales in Brazil are primarily attributable to generics. The branded STRs and FDCs that dominated the 7MM in 2013, such as ViiV’s Epzicom and Gilead’s HIV franchise (Atripla, Stribild, Complera, and Truvada), are still unavailable in Brazil due to their high price tags, with the government instead opting for the use of cheaper generics to address the growing demand for ART.

Scope

- Overview of Human Immunodeficiency Virus (HIV) 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 Brazil including product description, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in the Brazil from 2013-2023.

- Analysis of the impact of key events as well the drivers and restraints affecting the Brazil Human Immunodeficiency Virus (HIV) 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 Human Immunodeficiency Virus (HIV).

- 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 2013-2023 in the Brazil.

Table of Contents
for Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023

  • 1 Table of Contents

    1 Table of Contents 2

    1.1 List of Tables 7

    1.2 List of Figures 12

    2 Introduction 13

    2.1 Catalyst 13

    2.2 Related Reports 14

    2.3 Upcoming Related Reports 14

    3 Disease Overview 15

    3.1 Etiology 15

    3.1.1 Viral Lifecycle 15

    3.2 Pathophysiology 18

    3.3 Staging and Symptoms 19

    3.3.1 Primary or Acute Infection 19

    3.3.2 Chronic Infection 20

    3.3.3 Advanced Infection/AIDS 20

    3.4 Prognosis 22

    3.5 Quality of Life 22

    4 Disease Management 24

    4.1 Diagnosis and Treatment Overview 24

    4.1.1 Screening and Diagnosis 24

    4.1.2 Treatment Guidelines and Leading Prescribed Drugs 25

    4.1.3 Clinical Practice 27

    4.2 Brazil 38

    4.2.1 Screening and Diagnosis 38

    4.2.2 Clinical Practice 39

    5 Competitive Assessment 42

    5.1 Overview 42

    5.2 Product Profiles - Major Brands, Single-Tablet Regimens (STRs) 45

    5.2.1 Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 45

    5.2.2 Complera (emtricitabine/TDF/rilpivirine) 51

    5.2.3 Stribild (elvitegravir/cobicistat/TDF/emtricitabine) 58

    5.2.4 Triumeq (dolutegravir/abacavir/lamivudine) 66

    5.3 Product Profiles - Major Brands, Fixed-Dose Combinations 74

    5.3.1 Truvada (TDF/emtricitabine) 74

    5.3.2 Epzicom (abacavir/lamivudine) 80

    5.3.3 Kaletra (lopinavir/ritonavir) 85

    5.3.4 Prezcobix (darunavir/cobicistat) 91

    5.3.5 Evotaz (atazanavir sulfate/cobicistat) 96

    5.4 Product Profiles - Major Brands, Protease Inhibitors 102

    5.4.1 Reyataz (atazanavir) 102

    5.4.2 Prezista (darunavir) 107

    5.5 Product Profiles - Major Brands, Integrase Inhibitors 112

    5.5.1 Isentress (raltegravir) 112

    5.5.2 Tivicay (dolutegravir) 118

    5.5.3 Vitekta (elvitegravir) 126

    5.6 Product Profiles - Major Brands, Pharmacokinetic Enhancers 132

    5.6.1 Norvir (ritonavir) 132

    5.6.2 Tybost (cobicistat) 136

    5.7 Other Therapeutic Classes 142

    5.7.1 Entry Inhibitors 142

    6 Unmet Need and Opportunity 143

    6.1 Overview 143

    6.2 Therapies with Improved Safety and Tolerability Profiles 145

    6.2.1 Unmet Need 145

    6.2.2 Gap Analysis 146

    6.2.3 Opportunity 147

    6.3 Simplified PI-Based ART Regimens with a Reduced Pill Burden 148

    6.3.1 Unmet Need 148

    6.3.2 Gap Analysis 149

    6.3.3 Opportunity 150

    6.4 Enhanced Public Awareness Initiatives Focused on Minimizing the Stigma Associated with HIV 151

    6.4.1 Unmet Need 151

    6.4.2 Gap Analysis 152

    6.4.3 Opportunity 153

    6.5 Improved Physician Education Tools That Emphasize the Importance of Early Testing and Diagnosis 153

    6.5.1 Unmet Need 153

    6.5.2 Gap Analysis 155

    6.5.3 Opportunity 155

    6.6 Safe and Efficacious Therapies for Patients with Drug-Resistant HIV Strains 155

    6.6.1 Unmet Need 155

    6.6.2 Gap Analysis 156

    6.6.3 Opportunity 157

    6.7 Long-Acting Regimens That Require Less Frequent Administration 157

    6.7.1 Unmet Need 157

    6.7.2 Gap Analysis 158

    6.7.3 Opportunity 159

    6.8 Improved Access to Treatment 159

    6.8.1 Unmet Need 159

    6.8.2 Gap Analysis 160

    6.8.3 Opportunity 160

    6.9 Progress Towards a Functional Cure 161

    6.9.1 Unmet Need 161

    6.9.2 Gap Analysis 161

    6.9.3 Opportunity 162

    7 Pipeline Assessment 163

    7.1 Overview 163

    7.2 Clinical Trial Mapping 164

    7.2.1 Clinical Trials by Country 164

    7.3 Promising Drugs in Late-Stage Clinical Development 165

    7.3.1 Quad 2 (elvitegravir/cobicistat/emtricitabine/TAF) 168

    7.3.2 Darunavir/Cobicistat/Emtricitabine/TAF 179

    7.3.3 Emtricitabine/TAF 188

    7.3.4 Dutrebis (raltegravir/lamivudine) 196

    7.3.5 Doravirine (MK-1439) 203

    7.4 Promising Drugs in Early-Stage Clinical Development 211

    7.5 Other Drugs in Clinical Development 214

    8 Market Outlook 216

    8.1 Brazil 216

    8.1.1 Forecast 216

    8.1.2 Key Events 221

    8.1.3 Drivers and Barriers 222

    9 Appendix 224

    9.1 Bibliography 224

    9.2 Abbreviations 258

    9.3 Methodology 265

    9.4 Forecasting Methodology 265

    9.4.1 Total Prevalent Cases of HIV 265

    9.4.2 20-Year Diagnosed Prevalent Cases of HIV 265

    9.4.3 HIV Cases Treated with ART 266

    9.4.4 Drugs Included in Each Therapeutic Class 267

    9.4.5 Launch and Patent Expiry Dates 268

    9.4.6 General Pricing Assumptions 269

    9.4.7 Individual Drug Assumptions 271

    9.4.8 Generic Erosion 289

    9.4.9 Pricing of Pipeline Agents 289

    9.5 Primary Research - KOLs Interviewed for This Report 291

    9.6 Primary Research - Prescriber Survey 293

    9.7 About the Authors 294

    9.7.1 Analyst 294

    9.7.2 Epidemiologists 294

    9.7.3 Therapy Area Director 294

    9.7.4 Global Director of Therapy Analysis and Epidemiology 295

    9.7.5 Global Head of Healthcare 295

    9.8 About GlobalData 296

    9.9 Disclaimer 296

List Of Tables
in Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023

1.1 List of Tables

Table 1: Symptoms of HIV-1 Infection and AIDS 21

Table 2: Treatment Guidelines for HIV-1 Used in the 9MM 26

Table 3: Most Commonly Prescribed Drugs for HIV-1 by Class in the 9MM, 2013 27

Table 4: Diagnosis and Treatment of HIV Infection, Country Profile - Brazil 38

Table 5: Switching of ART Regimens in Brazil. 2013 41

Table 6: Leading Branded Treatments for HIV, 2013 44

Table 7: Product Profile - Atripla 47

Table 8: Antiviral Efficacy of Atripla Compared with Combivir-Efavirenz Combination Therapy 48

Table 9: Atripla’s Safety - Adverse Reactions Reported in a 144-Week Clinical Study 49

Table 10: Atripla SWOT Analysis, 2014 50

Table 11: Sales Forecasts ($m) for Atripla, 2013-2023 51

Table 12: Product Profile - Complera 54

Table 13: ECHO and THRIVE Studies of the Complera and Atripla Multi-Tablet Regimens 56

Table 14: Complera SWOT Analysis, 2014 57

Table 15: Sales Forecasts ($m) for Complera, 2013-2023 58

Table 16: Product Profile - Stribild 61

Table 17: Pivotal Phase III Trials of Stribild in Treatment-Naϊve Patients 63

Table 18: Stribild’s Adverse Reactions - Pooled Results From the Two Phase III Clinical Trials 64

Table 19: Stribild SWOT Analysis, 2014 65

Table 20: Sales Forecasts ($m) for Stribild, 2013-2023 66

Table 21: Product Profile - Triumeq 70

Table 22: Virologic Efficacy of Triumeq in the Phase III SINGLE Study 71

Table 23: Triumeq’s Safety - Adverse Reactions Reported at 96 Weeks in the SINGLE Study 72

Table 24: Triumeq SWOT Analysis, 2014 73

Table 25: Sales Forecasts ($m) for Triumeq, 2013-2023 74

Table 26: Product Profile - Truvada 76

Table 27: Truvada’s Efficacy - Results of the SWIFT Trial at 48 Weeks 78

Table 28: Truvada SWOT Analysis, 2014 79

Table 29: Sales Forecasts ($m) for Truvada, 2013-2023 80

Table 30: Product Profile - Epzicom 82

Table 31: Epzicom SWOT Analysis, 2014 84

Table 32: Sales Forecasts ($m) for Epzicom, 2013-2023 85

Table 33: Product Profile - Kaletra 88

Table 34: Kaletra SWOT Analysis, 2014 89

Table 35: Sales Forecasts ($m) for Kaletra, 2013-2023 90

Table 36: Product Profile - Prezcobix 93

Table 37: Efficacy of Prezcobix in the Phase III Trial 94

Table 38: Prezcobix SWOT Analysis, 2014 95

Table 39: Sales Forecasts ($m) for Prezcobix, 2013-2023 96

Table 40: Product Profile - Evotaz 98

Table 41: Efficacy of BMS’ Evotaz in the Phase III Study 99

Table 42: Evotaz SWOT Analysis, 2014 101

Table 43: Sales Forecasts ($m) for Evotaz, 2013-2023 102

Table 44: Product Profile - Reyataz 103

Table 45: Reyataz SWOT Analysis, 2014 106

Table 46: Sales Forecasts ($m) for Reyataz, 2013-2023 107

Table 47: Product Profile - Prezista 109

Table 48: Prezista SWOT Analysis, 2014 111

Table 49: Sales Forecasts ($m) for Prezista, 2013-2023 112

Table 50: Product Profile - Isentress 114

Table 51: Percentage of Patients with HIV-1 RNA Levels <50 Copies/mL from the SMARTMRK Study 115

Table 52: Isentress’ Safety - Adverse Reactions Reported in the SMARTMRK Study 116

Table 53: Isentress SWOT Analysis, 2014 116

Table 54: Sales Forecasts ($m) for Isentress, 2013-2023 117

Table 55: Product Profile - Tivicay 119

Table 56: Pivotal Phase III Trials of Tivicay 123

Table 57: Tivicay’s Safety - Adverse Reactions Reported in the 48-Week SINGLE Study 124

Table 58: Tivicay SWOT Analysis, 2014 125

Table 59: Sales Forecasts ($m) for Tivicay, 2013-2023 126

Table 60: Product Profile - Vitekta 128

Table 61: Efficacy of Vitekta in the Pivotal Phase III Clinical Study 129

Table 62: Vitekta’s Safety - Adverse Reactions Reported in the 96-Week Clinical Study 130

Table 63: Vitekta SWOT Analysis, 2014 131

Table 64: Sales Forecasts ($m) for Vitekta, 2013-2023 132

Table 65: Product Profile - Norvir (ritonavir) 134

Table 66: Norvir SWOT Analysis, 2014 135

Table 67: Sales Forecasts ($m) for Norvir, 2013-2023 136

Table 68: Product Profile - Tybost 138

Table 69: Efficacy of Tybost Versus Ritonavir as a Pharmacoenhancer of Atazanavir in the Phase III Trial 139

Table 70: Tybost SWOT Analysis, 2014 140

Table 71: Sales Forecasts ($m) for Tybost, 2013-2023 141

Table 72: Summary of the Minor Therapeutic Classes of EIs, 2014 142

Table 73: Unmet Need and Opportunity in HIV 144

Table 74: Promising Drugs in Clinical Development for HIV, 2014 165

Table 75: Comparison of Therapeutic Classes in Development for HIV, 2013-2023 168

Table 76: Gilead’s Quad 2 - Phase III Clinical Trials 170

Table 77: Product Profile - Quad 2 172

Table 78: Efficacy of Quad 2 and Stribild in Studies 104 and 111 174

Table 79: Adverse Events Associated with Quad 2 vs. Stribild Therapy in two Phase III Clinical Studies 175

Table 80: Renal and Bone Safety of Quad 2 Versus Stribild Treatment in the Two Pivotal Phase III Studies 176

Table 81: Quad 2 SWOT Analysis, 2014 178

Table 82: Sales Forecasts ($m) for Quad 2, 2013-2023 179

Table 83: Product Profile - Darunavir/cobicistat/emtricitabine/TAF 182

Table 84: Efficacy of Darunavir/Cobicistat/Emtricitabine/TAF in the Phase II Study 183

Table 85: Safety of Darunavir/Cobicistat/Emtricitabine/TAF - Adverse Reactions Reported at 48 Weeks in the Phase II Study 184

Table 86: Renal and Bone Safety of Darunavir/Cobicistat/Emtricitabine/TAF in the Phase II Study 185

Table 87: Darunavir/Cobicistat/Emtricitabine/TAF SWOT Analysis, 2014 187

Table 88: Sales Forecasts ($m) for Darunavir/Cobicistat/Emtricitabine/TAF, 2013-2023 188

Table 89: Product Profile - Emtricitabine/TAF 190

Table 90: Two Pivotal Clinical Trials of Emtricitabine/TAF 192

Table 91: Phase III Clinical Trials Assessing the Safety of Emtricitabine/TAF 193

Table 92: Emtricitabine/TAF SWOT Analysis, 2014 195

Table 93: Sales Forecasts ($m) for Emtricitabine/TAF, 2013-2023 196

Table 94: Product Profile - Dutrebis 198

Table 95: Percentage of Patients with HIV-1 RNA Levels of <50 Copies/mL in the SMARTMRK Study 199

Table 96: Dutrebis SWOT Analysis, 2014 202

Table 97: Sales Forecasts ($m) for Dutrebis, 2013-2023 203

Table 98: Product Profile - Doravirine 205

Table 99: Efficacy Results of a Phase II Dose-Ranging Study of Doravirine Compared with a Standard Dose of Efavirenz 206

Table 100: Doravirine SWOT Analysis, 2014 209

Table 101: Sales Forecasts ($m) for Doravirine, 2013-2023 210

Table 102: Promising Drugs in Early-Stage Clinical Development for HIV, 2014 211

Table 103: Other Earlier-Stage Drugs in Active Clinical Development for HIV, 2014 215

Table 104: Sales Forecasts ($m) for HIV Therapeutics in Brazil, 2013-2023 218

Table 105: Key Events Impacting Sales of HIV Therapeutics in Brazil, 2013-2023 221

Table 106: HIV Therapeutics Market in Brazil - Drivers and Barriers, 2013-2023 222

Table 107: Key Historical and Projected Launch Dates for HIV Therapeutics Across the 9MM 268

Table 108: Key Historical and Projected Patent Expiry Dates for HIV Therapeutics Across the 9MM 269

Table 109: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 293

List Of Figures, Charts and Diagrams
in Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023

1.2 List of Figures

Figure 1: HIV Lifecycle 16

Figure 2: HIV-1 Disease Management Flowchart 37

Figure 3: HIV Therapeutics - Phase II and III Clinical Trials by Country, 2014 164

Figure 4: HIV Phase II/Phase III Pipeline, 2014 166

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2013-2023 167

Figure 6: Potential Clinical and Commercial Positioning of Quad 2 177

Figure 7: Potential Clinical and Commercial Positioning of Darunavir/Cobicistat/Emtricitabine/TAF 186

Figure 8: Potential Clinical and Commercial Positioning of Emtricitabine/TAF 194

Figure 9: Potential Clinical and Commercial Positioning of Dutrebis 201

Figure 10: Potential Clinical and Commercial Positioning of Doravirine 208

Figure 11: Sales for HIV Therapeutics in Brazil by Drug Class, 2013-2023 220

Additional Details

Publisher

Global Data

Publisher Information

Reference

27237 | GDHC315CFR

Number of Pages

297

Report Format

PDF

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