$6995 | Single User
$13990 | Site License
$20985 | Enterprise License

Human Immunodeficiency Virus (HIV) - 5EU Drug Forecast and Market Analysis to 2023

Published by Global Data: 09 Sep 2015 | 27236 | In Stock

Introduction

Human Immunodeficiency Virus (HIV) - 5EU 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.

Gilead’s first-in-class, NNRTI-based STR, Atripla, performed well, with its 2013 sales in the 5EU topping 0m (26% market share), despite competing in a highly fragmented market that featured over 18 different drugs spanning all classes of antiretrovirals, many of which, particularly NRTIs and NNRTIs, had already lost patent protection. Since Atripla’s successful 5EU launch in 2007, companies have strived to develop STRs for this market, and these novel products are anticipated to heavily influence the future market dynamics.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in the 5EU from 2013-2023.

- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU

Table of Contents
for Human Immunodeficiency Virus (HIV) - 5EU 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 5EU 38

    4.2.1 Screening and Diagnosis 39

    4.2.2 Clinical Practice 40

    5 Competitive Assessment 44

    5.1 Overview 44

    5.2 Product Profiles - Major Brands, Single-Tablet Regimens (STRs) 47

    5.2.1 Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 47

    5.2.2 Complera (emtricitabine/TDF/rilpivirine) 53

    5.2.3 Stribild (elvitegravir/cobicistat/TDF/emtricitabine) 60

    5.2.4 Triumeq (dolutegravir/abacavir/lamivudine) 68

    5.3 Product Profiles - Major Brands, Fixed-Dose Combinations 76

    5.3.1 Truvada (TDF/emtricitabine) 76

    5.3.2 Epzicom (abacavir/lamivudine) 82

    5.3.3 Kaletra (lopinavir/ritonavir) 87

    5.3.4 Prezcobix (darunavir/cobicistat) 93

    5.3.5 Evotaz (atazanavir sulfate/cobicistat) 98

    5.4 Product Profiles - Major Brands, Protease Inhibitors 104

    5.4.1 Reyataz (atazanavir) 104

    5.4.2 Prezista (darunavir) 109

    5.5 Product Profiles - Major Brands, Integrase Inhibitors 114

    5.5.1 Isentress (raltegravir) 114

    5.5.2 Tivicay (dolutegravir) 120

    5.5.3 Vitekta (elvitegravir) 128

    5.6 Product Profiles - Major Brands, Pharmacokinetic Enhancers 134

    5.6.1 Norvir (ritonavir) 134

    5.6.2 Tybost (cobicistat) 138

    5.7 Other Therapeutic Classes 144

    5.7.1 Entry Inhibitors 144

    6 Unmet Need and Opportunity 145

    6.1 Overview 145

    6.2 Therapies with Improved Safety and Tolerability Profiles 147

    6.2.1 Unmet Need 147

    6.2.2 Gap Analysis 148

    6.2.3 Opportunity 149

    6.3 Simplified PI-Based ART Regimens with a Reduced Pill Burden 150

    6.3.1 Unmet Need 150

    6.3.2 Gap Analysis 151

    6.3.3 Opportunity 152

    6.4 Enhanced Public Awareness Initiatives Focused on Minimizing the Stigma Associated with HIV 153

    6.4.1 Unmet Need 153

    6.4.2 Gap Analysis 154

    6.4.3 Opportunity 155

    6.5 Improved Physician Education Tools That Emphasize the Importance of Early Testing and Diagnosis 155

    6.5.1 Unmet Need 155

    6.5.2 Gap Analysis 157

    6.5.3 Opportunity 157

    6.6 Safe and Efficacious Therapies for Patients with Drug-Resistant HIV Strains 157

    6.6.1 Unmet Need 157

    6.6.2 Gap Analysis 158

    6.6.3 Opportunity 159

    6.7 Long-Acting Regimens That Require Less Frequent Administration 159

    6.7.1 Unmet Need 159

    6.7.2 Gap Analysis 160

    6.7.3 Opportunity 161

    6.8 Improved Access to Treatment 161

    6.8.1 Unmet Need 161

    6.8.2 Gap Analysis 162

    6.8.3 Opportunity 162

    6.9 Progress Towards a Functional Cure 163

    6.9.1 Unmet Need 163

    6.9.2 Gap Analysis 163

    6.9.3 Opportunity 164

    7 Pipeline Assessment 165

    7.1 Overview 165

    7.2 Clinical Trial Mapping 166

    7.2.1 Clinical Trials by Country 166

    7.3 Promising Drugs in Late-Stage Clinical Development 167

    7.3.1 Quad 2 (elvitegravir/cobicistat/emtricitabine/TAF) 170

    7.3.2 Darunavir/Cobicistat/Emtricitabine/TAF 181

    7.3.3 Emtricitabine/TAF 190

    7.3.4 Dutrebis (raltegravir/lamivudine) 198

    7.3.5 Doravirine (MK-1439) 205

    7.4 Promising Drugs in Early-Stage Clinical Development 213

    7.5 Other Drugs in Clinical Development 216

    8 Market Outlook 218

    8.1 5EU 218

    8.1.1 Forecast 218

    8.1.2 Key Events 225

    8.1.3 Drivers and Barriers 226

    9 Appendix 232

    9.1 Bibliography 232

    9.2 Abbreviations 266

    9.3 Methodology 273

    9.4 Forecasting Methodology 273

    9.4.1 Total Prevalent Cases of HIV 273

    9.4.2 20-Year Diagnosed Prevalent Cases of HIV 273

    9.4.3 HIV Cases Treated with ART 274

    9.4.4 Drugs Included in Each Therapeutic Class 275

    9.4.5 Launch and Patent Expiry Dates 276

    9.4.6 General Pricing Assumptions 277

    9.4.7 Individual Drug Assumptions 279

    9.4.8 Generic Erosion 297

    9.4.9 Pricing of Pipeline Agents 297

    9.5 Primary Research - KOLs Interviewed for This Report 299

    9.6 Primary Research - Prescriber Survey 301

    9.7 About the Authors 302

    9.7.1 Analyst 302

    9.7.2 Epidemiologists 302

    9.7.3 Therapy Area Director 302

    9.7.4 Global Director of Therapy Analysis and Epidemiology 303

    9.7.5 Global Head of Healthcare 303

    9.8 About GlobalData 304

    9.9 Disclaimer 304

List Of Tables
in Human Immunodeficiency Virus (HIV) - 5EU 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 - 5EU 38

Table 5: CD4+ Thresholds and Corresponding Recommendations for the Initiation of ART in Asymptomatic Patients in the 5EU 41

Table 6: Switching of ART Regimens in the 5EU, 2013 43

Table 7: Leading Branded Treatments for HIV, 2013 46

Table 8: Product Profile - Atripla 49

Table 9: Antiviral Efficacy of Atripla Compared with Combivir-Efavirenz Combination Therapy 50

Table 10: Atripla’s Safety - Adverse Reactions Reported in a 144-Week Clinical Study 51

Table 11: Atripla SWOT Analysis, 2014 52

Table 12: Sales Forecasts ($m) for Atripla, 2013-2023 53

Table 13: Product Profile - Complera 56

Table 14: ECHO and THRIVE Studies of the Complera and Atripla Multi-Tablet Regimens 58

Table 15: Complera SWOT Analysis, 2014 59

Table 16: Sales Forecasts ($m) for Complera, 2013-2023 60

Table 17: Product Profile - Stribild 63

Table 18: Pivotal Phase III Trials of Stribild in Treatment-Naϊve Patients 65

Table 19: Stribild’s Adverse Reactions - Pooled Results From the Two Phase III Clinical Trials 66

Table 20: Stribild SWOT Analysis, 2014 67

Table 21: Sales Forecasts ($m) for Stribild, 2013-2023 68

Table 22: Product Profile - Triumeq 72

Table 23: Virologic Efficacy of Triumeq in the Phase III SINGLE Study 73

Table 24: Triumeq’s Safety - Adverse Reactions Reported at 96 Weeks in the SINGLE Study 74

Table 25: Triumeq SWOT Analysis, 2014 75

Table 26: Sales Forecasts ($m) for Triumeq, 2013-2023 76

Table 27: Product Profile - Truvada 78

Table 28: Truvada’s Efficacy - Results of the SWIFT Trial at 48 Weeks 80

Table 29: Truvada SWOT Analysis, 2014 81

Table 30: Sales Forecasts ($m) for Truvada, 2013-2023 82

Table 31: Product Profile - Epzicom 84

Table 32: Epzicom SWOT Analysis, 2014 86

Table 33: Sales Forecasts ($m) for Epzicom, 2013-2023 87

Table 34: Product Profile - Kaletra 90

Table 35: Kaletra SWOT Analysis, 2014 91

Table 36: Sales Forecasts ($m) for Kaletra, 2013-2023 92

Table 37: Product Profile - Prezcobix 95

Table 38: Efficacy of Prezcobix in the Phase III Trial 96

Table 39: Prezcobix SWOT Analysis, 2014 97

Table 40: Sales Forecasts ($m) for Prezcobix, 2013-2023 98

Table 41: Product Profile - Evotaz 100

Table 42: Efficacy of BMS’ Evotaz in the Phase III Study 101

Table 43: Evotaz SWOT Analysis, 2014 103

Table 44: Sales Forecasts ($m) for Evotaz, 2013-2023 104

Table 45: Product Profile - Reyataz 105

Table 46: Reyataz SWOT Analysis, 2014 108

Table 47: Sales Forecasts ($m) for Reyataz, 2013-2023 109

Table 48: Product Profile - Prezista 111

Table 49: Prezista SWOT Analysis, 2014 113

Table 50: Sales Forecasts ($m) for Prezista, 2013-2023 114

Table 51: Product Profile - Isentress 116

Table 52: Percentage of Patients with HIV-1 RNA Levels <50 Copies/mL from the SMARTMRK Study 117

Table 53: Isentress’ Safety - Adverse Reactions Reported in the SMARTMRK Study 118

Table 54: Isentress SWOT Analysis, 2014 118

Table 55: Sales Forecasts ($m) for Isentress, 2013-2023 119

Table 56: Product Profile - Tivicay 121

Table 57: Pivotal Phase III Trials of Tivicay 125

Table 58: Tivicay’s Safety - Adverse Reactions Reported in the 48-Week SINGLE Study 126

Table 59: Tivicay SWOT Analysis, 2014 127

Table 60: Sales Forecasts ($m) for Tivicay, 2013-2023 128

Table 61: Product Profile - Vitekta 130

Table 62: Efficacy of Vitekta in the Pivotal Phase III Clinical Study 131

Table 63: Vitekta’s Safety - Adverse Reactions Reported in the 96-Week Clinical Study 132

Table 64: Vitekta SWOT Analysis, 2014 133

Table 65: Sales Forecasts ($m) for Vitekta, 2013-2023 134

Table 66: Product Profile - Norvir (ritonavir) 136

Table 67: Norvir SWOT Analysis, 2014 137

Table 68: Sales Forecasts ($m) for Norvir, 2013-2023 138

Table 69: Product Profile - Tybost 140

Table 70: Efficacy of Tybost Versus Ritonavir as a Pharmacoenhancer of Atazanavir in the Phase III Trial 141

Table 71: Tybost SWOT Analysis, 2014 142

Table 72: Sales Forecasts ($m) for Tybost, 2013-2023 143

Table 73: Summary of the Minor Therapeutic Classes of EIs, 2014 144

Table 74: Unmet Need and Opportunity in HIV 146

Table 75: Promising Drugs in Clinical Development for HIV, 2014 167

Table 76: Comparison of Therapeutic Classes in Development for HIV, 2013-2023 170

Table 77: Gilead’s Quad 2 - Phase III Clinical Trials 172

Table 78: Product Profile - Quad 2 174

Table 79: Efficacy of Quad 2 and Stribild in Studies 104 and 111 176

Table 80: Adverse Events Associated with Quad 2 vs. Stribild Therapy in two Phase III Clinical Studies 177

Table 81: Renal and Bone Safety of Quad 2 Versus Stribild Treatment in the Two Pivotal Phase III Studies 178

Table 82: Quad 2 SWOT Analysis, 2014 180

Table 83: Sales Forecasts ($m) for Quad 2, 2013-2023 181

Table 84: Product Profile - Darunavir/cobicistat/emtricitabine/TAF 184

Table 85: Efficacy of Darunavir/Cobicistat/Emtricitabine/TAF in the Phase II Study 185

Table 86: Safety of Darunavir/Cobicistat/Emtricitabine/TAF - Adverse Reactions Reported at 48 Weeks in the Phase II Study 186

Table 87: Renal and Bone Safety of Darunavir/Cobicistat/Emtricitabine/TAF in the Phase II Study 187

Table 88: Darunavir/Cobicistat/Emtricitabine/TAF SWOT Analysis, 2014 189

Table 89: Sales Forecasts ($m) for Darunavir/Cobicistat/Emtricitabine/TAF, 2013-2023 190

Table 90: Product Profile - Emtricitabine/TAF 192

Table 91: Two Pivotal Clinical Trials of Emtricitabine/TAF 194

Table 92: Phase III Clinical Trials Assessing the Safety of Emtricitabine/TAF 195

Table 93: Emtricitabine/TAF SWOT Analysis, 2014 197

Table 94: Sales Forecasts ($m) for Emtricitabine/TAF, 2013-2023 198

Table 95: Product Profile - Dutrebis 200

Table 96: Percentage of Patients with HIV-1 RNA Levels of <50 Copies/mL in the SMARTMRK Study 201

Table 97: Dutrebis SWOT Analysis, 2014 204

Table 98: Sales Forecasts ($m) for Dutrebis, 2013-2023 205

Table 99: Product Profile - Doravirine 207

Table 100: Efficacy Results of a Phase II Dose-Ranging Study of Doravirine Compared with a Standard Dose of Efavirenz 208

Table 101: Doravirine SWOT Analysis, 2014 211

Table 102: Sales Forecasts ($m) for Doravirine, 2013-2023 212

Table 103: Promising Drugs in Early-Stage Clinical Development for HIV, 2014 213

Table 104: Other Earlier-Stage Drugs in Active Clinical Development for HIV, 2014 217

Table 105: Number of People Living with HIV Who Received ART in the 5EU, and Sales of HIV Therapeutics, 2013 218

Table 106: Sales Forecasts ($m) for HIV Therapeutics in the 5EU, 2013-2023 221

Table 107: Key Events Impacting Sales of HIV Therapeutics in the 5EU, 2013-2023 225

Table 108: HIV Therapeutics Market in the 5EU - Drivers and Barriers, 2013-2023 226

Table 109: Financing of ART in the 5EU Countries by the National Healthcare Authorities 227

Table 110: Electronic Healthcare Systems Introduced in the 5EU Nations 228

Table 111: ART Initiation Criteria in the 5EU 229

Table 112: Systems Used to Control Drug Prices in the 55EU 230

Table 113: Key Historical and Projected Launch Dates for HIV Therapeutics Across the 9MM 276

Table 114: Key Historical and Projected Patent Expiry Dates for HIV Therapeutics Across the 9MM 277

Table 115: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 301

List Of Figures, Charts and Diagrams
in Human Immunodeficiency Virus (HIV) - 5EU 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 166

Figure 4: HIV Phase II/Phase III Pipeline, 2014 168

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2013-2023 169

Figure 6: Potential Clinical and Commercial Positioning of Quad 2 179

Figure 7: Potential Clinical and Commercial Positioning of Darunavir/Cobicistat/Emtricitabine/TAF 188

Figure 8: Potential Clinical and Commercial Positioning of Emtricitabine/TAF 196

Figure 9: Potential Clinical and Commercial Positioning of Dutrebis 203

Figure 10: Potential Clinical and Commercial Positioning of Doravirine 210

Figure 11: Sales for HIV Therapeutics in the 5EU by Drug Class, 2013-2023 223

Figure 12: Sales for HIV Therapeutics in the 5EU by Country, 2013-2023 224

Additional Details

Publisher

Global Data

Publisher Information

Reference

27236 | GDHC314CFR

Number of Pages

305

Report Format

PDF

Global Data Reports

Related Reports

TitleDate PublishedPrice fromMore Details
Global Human Papilloma Virus Partnering 2010 to 2016
The Global Therapy Partnering Terms and Agreements since 2010 report provides understanding and acce...
01 Oct 2016 by Current Partnering USD $1,495 More Info
Human Drugs For Veterinary Use - Current Trends and Future Commercial Prospects for Crossover Drugs
Human Drugs For Veterinary Use - Current Trends and Future Commercial Prospects for Crossover DrugsS...
01 May 2016 by CBR Pharma Insights USD $2,995 More Info
National Human Genome Research Institute - Pharmaceuticals & Healthcare - Deals and Alliances Profile
SummaryNational Human Genome Research Institute (NHGRI) a subsidiary of National Institutes of Healt...
27 Apr 2016 by Global Data USD $250 More Info
National Human Genome Research Institute - Pharmaceuticals & Healthcare - Deals and Alliances Profile
SummaryNational Human Genome Research Institute (NHGRI) a subsidiary of National Institutes of Healt...
14 Mar 2016 by Global Data USD $250 More Info
Human Immunodeficiency Virus (HIV) - US Drug Forecast and Market Analysis to 2023
Human Immunodeficiency Virus (HIV) - US Drug Forecast and Market Analysis to 2023SummaryHuman immuno...
09 Sep 2015 by Global Data USD $4,995 More Info
Human Immunodeficiency Virus (HIV) - Japan Drug Forecast and Market Analysis to 2023
Human Immunodeficiency Virus (HIV) - Japan Drug Forecast and Market Analysis to 2023SummaryHuman imm...
09 Sep 2015 by Global Data USD $4,995 More Info
Human Immunodeficiency Virus (HIV) - 5EU Drug Forecast and Market Analysis to 2023
Human Immunodeficiency Virus (HIV) - 5EU Drug Forecast and Market Analysis to 2023SummaryHuman immun...
09 Sep 2015 by Global Data USD $6,995 More Info
Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023
Human Immunodeficiency Virus (HIV) - Brazil Drug Forecast and Market Analysis to 2023SummaryHuman im...
09 Sep 2015 by Global Data USD $4,995 More Info
Human Immunodeficiency Virus (HIV) - China Drug Forecast and Market Analysis to 2023
Human Immunodeficiency Virus (HIV) - China Drug Forecast and Market Analysis to 2023SummaryHuman imm...
09 Sep 2015 by Global Data USD $4,995 More Info
Human Immunodeficiency Virus (HIV) - Current and Future Players
Human Immunodeficiency Virus (HIV) - Current and Future PlayersSummaryGlobalData has released its ph...
09 Sep 2015 by Global Data USD $2,995 More Info

This report is published by Global Data

Download Free Report Summary PDF

Human Immunodeficiency Virus (HIV) - 5EU Drug Forecast and Market Analysis to 2023 | Download PDF Summary

Download our FREE report summary PDF. It contains all the information on these web pages, plus a Proforma Invoice request form, should you need it to satisfy your company's internal order procedures.

Ordering Information

Orders are processed immediately and you will be notified of the despatch date on confirmation of your order.

Accepted Card Types

Payment

Buy now using our secure payment system.

We Stock...

  • Allied Market Research
  • CBR Pharma
  • Current Partnering
  • Firstword
  • Global Data
  • Global Markets Direct
  • ICD Research
  • Infinti Research Technavio
  • Marketline
  • Markets and Markets
  • Micro Markets Monitor
  • MP Advisors
  • Venture Planning Group
  • GMR Data