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PharmaPoint: Human Immunodeficiency Virus (HIV)-Global Drug Forecast and Market Analysis to 2025

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PharmaPoint: Human Immunodeficiency Virus (HIV)-Global Drug Forecast and Market Analysis to 2025

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.

GlobalData projects the global HIV marketplace-which, for the purposes of this report, comprises nine major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China)-to experience modest growth during the forecast period. This growth will be driven primarily by the highly anticipated arrivals of novel integrase inhibitor (INI-) and protease inhibitor (PI-) based STRs, which include ViiV Healthcare's dolutegravir/lamivudine, ViiV's and Janssen's dolutegravir/rilpivirine, Gilead's bictegravir/emtricitabine/tenofovir alafenamide fumarate (TAF), Gilead's and Janssen's darunavir/cobicistat/emtricitabine/TAF, and ViiV's long-acting injectable formulation composed of cabotegravir/rilpivirine. Nevertheless, looming patent expiries of high-grossing branded drugs in the US, 5EU (France, Germany, Italy, Spain, UK), and Japan, along with compulsory licensing and generic erosion in Brazil and China, are expected to curtail market growth.

Key Questions Answered

How will the HIV market landscape in the 9MM (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China) change from 2015-2025?

What are the most promising late-stage pipeline drugs in HIV?

How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

What are the remaining unmet needs in HIV treatment management?

What drivers and barriers will affect HIV therapeutics sales in the 9MM over the forecast period?

Scope

Overview of HIV, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline HIV market revenue from 2015-2025. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting HIV therapeutics sales in the 9MM.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

Analysis of the current and future market competition in the global HIV therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global HIV therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HIV therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 10

2 Human Immunodeficiency Virus (HIV): Executive Summary 12

2.1 HIV Market Will Experience Modest Growth During the Forecast Period 13

2.2 Companies Leverage Partnerships to Develop New STRs and Fixed-Dose Combinations to Capture HIV Market Share 14

2.3 While HIV Therapies Continue to Raise the Bar on Efficacy, Safety, and Convenience, Unmet Needs Persist 15

2.4 Even in the Face of Strong Marketed and Pipeline Products, Opportunities Still Exist for Current and Future Players to Impact the HIV Marketplace 16

2.5 Novel STRs and FDCs With Improved Efficacy and Safety, and a Decreased Pill Burden, Are Expected to Dominate the Future HIV Treatment Landscape 17

2.6 What Do Physicians Think? 20

3 Introduction 23

3.1 Catalyst 23

3.2 Related Reports 24

3.3 Upcoming Related Reports 24

4 Disease Overview 25

4.1 Etiology 25

4.1.1 The Viral Lifecycle 26

4.2 Pathophysiology 29

4.3 Staging and Symptoms 30

4.3.1 Acute Infection 30

4.3.2 Chronic Infection 31

4.3.3 Advanced Infection (AIDS) 31

4.4 Prognosis 33

4.5 Quality of Life 34

5 Epidemiology 35

5.1 Disease Background 35

5.2 Risk Factors and Comorbidities 36

5.3 Global Trends 37

5.3.1 US 39

5.3.2 5EU 39

5.3.3 Japan, Brazil, and China 40

5.4 Forecast Methodology 41

5.4.1 Sources Used 43

5.4.2 Forecast Assumptions and Methods 47

5.4.3 Sources Not Used 65

5.5 Epidemiological Forecast for HIV in the 8MM (2015-2025) 66

5.5.1 Total Prevalent Cases of HIV 66

5.5.2 Diagnosed Prevalent Cases of HIV 67

5.5.3 Age-Specific Diagnosed Prevalent Cases of HIV 69

5.5.4 Sex-Specific Diagnosed Prevalent Cases of HIV 71

5.5.5 Age-Standardized Diagnosed Prevalence of HIV 73

5.5.6 Diagnosed Prevalent Cases of HIV Treated with Antiretroviral Therapy 74

5.5.7 Diagnosed Prevalent Cases of HIV with Hepatitis B Virus Co-infection 75

5.5.8 Diagnosed Prevalent Cases of HIV with Hepatitis C Virus Co-infection 76

5.6 Epidemiological Forecast for HIV in Japan (2015-2025) 78

5.6.1 20-Year Diagnosed Prevalent Cases of HIV 78

5.6.2 Age-Specific 20-Year Diagnosed Prevalent Cases of HIV 78

5.6.3 Sex-Specific 20-Year Diagnosed Prevalent Cases of HIV 79

5.6.4 Age-Standardized 20-Year Diagnosed Prevalence of HIV 80

5.6.5 20-Year Diagnosed Prevalent Cases of HIV Treated with Antiretroviral Therapy 80

5.6.6 20-Year Diagnosed Prevalent Cases of HIV with Hepatitis B Virus Co-infection 81

5.6.7 20-Year Diagnosed Prevalent Cases of HIV with Hepatitis C Virus Co-infection 81

5.7 Discussion 82

5.7.1 Epidemiological Forecast Insight 82

5.7.2 Limitations of Analysis 83

5.7.3 Strengths of Analysis 84

6 Disease Management 85

6.1 Diagnosis and Treatment Overview 85

6.1.1 Screening and Diagnosis 85

6.1.2 Treatment Guidelines and Leading Prescribed Drugs 86

6.1.3 Clinical Practice 87

6.2 US 94

6.2.1 Screening and Diagnosis 95

6.2.2 Clinical Practice 97

6.3 5EU 99

6.3.1 Screening and Diagnosis 100

6.3.2 Clinical Practice 101

6.4 Japan 105

6.4.1 Screening and Diagnosis 105

6.4.2 Clinical Practice 106

6.5 Brazil 109

6.5.1 Screening and Diagnosis 109

6.5.2 Clinical Practice 110

6.6 China 113

6.6.1 Screening and Diagnosis 113

6.6.2 Clinical Practice 114

7 Competitive Assessment 117

7.1 Overview 117

7.2 Product Profiles-Major Brands, Single-Tablet Regimens 120

7.2.1 Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 120

7.2.2 Stribild (cobicistat/elvitegravir/emtricitabine/TDF) 126

7.2.3 Genvoya (cobicistat/elvitegravir/emtricitabine/TAF) 132

7.2.4 Triumeq (abacavir/dolutegravir/lamivudine) 137

7.2.5 Complera (emtricitabine/rilpivirine/TDF) 143

7.2.6 Odefsey (emtricitabine/rilpivirine/TAF) 149

7.3 Product Profiles-Major Brands, Fixed-Dose NRTI Backbones 154

7.3.1 Truvada (emtricitabine/TDF) 154

7.3.2 Descovy (emtricitabine/TAF) 159

7.4 Product Profiles-Major Brands, Integrase Inhibitors 163

7.4.1 Tivicay (dolutegravir) 163

7.4.2 Isentress (raltegravir) 171

7.5 Product Profiles-Major Brands, Protease Inhibitors 175

7.5.1 Prezcobix (darunavir/cobicistat) 175

7.5.2 Evotaz (atazanavir/cobicistat) 179

7.6 Other Approved Drugs 183

7.6.1 Overview 183

8 Unmet Needs Assessment and Opportunity Analysis 187

8.1 Overview 187

8.2 Long-Acting Regimens that Require Less-Frequent Administration 189

8.2.1 Unmet Need 189

8.2.2 Gap Analysis 190

8.2.3 Opportunity 191

8.3 Enhanced Public Awareness Initiatives Focused on Minimizing the Stigma Associated with HIV Infection 191

8.3.1 Unmet Need 191

8.3.2 Gap Analysis 192

8.3.3 Opportunity 193

8.4 Improved Physician Education Tools That Emphasize the Importance of Early Testing and Diagnosis 193

8.4.1 Unmet Need 193

8.4.2 Gap Analysis 194

8.4.3 Opportunity 194

8.5 Safe and Efficacious Therapies for Patients with Drug-Resistant HIV Strains 195

8.5.1 Unmet Need 195

8.5.2 Gap Analysis 196

8.5.3 Opportunity 197

8.6 Therapies with Improved Safety and Tolerability Profiles 197

8.6.1 Unmet Need 197

8.6.2 Gap Analysis 198

8.6.3 Opportunity 199

8.7 Progress Towards a Functional Cure 200

8.7.1 Unmet Need 200

8.7.2 Gap Analysis 201

8.7.3 Opportunity 202

9 Pipeline Assessment 203

9.1 Overview 203

9.2 Promising Drugs in Clinical Development 204

9.2.1 Bictegravir/Emtricitabine/TAF 208

9.2.2 Dolutegravir/Lamivudine 213

9.2.3 Cobicistat/Darunavir/Emtricitabine/TAF 217

9.2.4 Doravirine/Lamivudine/TDF 221

9.2.5 Dolutegravir/Rilpivirine 226

9.2.6 Cabotegravir/Rilpivirine 230

9.2.7 Fostemsavir 235

9.2.8 Ibalizumab 239

9.2.9 PRO-140 243

9.3 Other Drugs in Clinical Development 247

10 Current and Future Players 248

10.1 Overview 248

10.2 Trends in Corporate Strategy 250

10.3 Company Profiles 253

10.3.1 Gilead Sciences 253

10.3.2 ViiV Healthcare 256

10.3.3 Janssen 259

10.3.4 Merck & Co. 261

10.3.5 Bristol-Myers Squibb 264

10.3.6 Minor and Emerging Players 266

11 Market Outlook 269

11.1 Global Markets 269

11.1.1 Forecast 269

11.1.2 Drivers and Barriers-Global Issues 275

11.2 US 275

11.2.1 Forecast 275

11.2.2 Key Events 281

11.2.3 Drivers and Barriers 282

11.3 5EU 282

11.3.1 Forecast 282

11.3.2 Key Events 289

11.3.3 Drivers and Barriers 290

11.4 Japan 290

11.4.1 Forecast 290

11.4.2 Key Events 295

11.4.3 Drivers and Barriers 296

11.5 Brazil 296

11.5.1 Forecast 296

11.5.2 Key Events 300

11.5.3 Drivers and Barriers 300

11.6 China 301

11.6.1 Forecast 301

11.6.2 Key Events 305

11.6.3 Drivers and Barriers 305

12 Appendix 306

12.1 Bibliography 306

12.2 Abbreviations 338

12.3 Methodology 343

12.4 Forecasting Methodology 343

12.4.1 Total and Diagnosed Prevalent Cases of HIV (8MM) 343

12.4.2 20-Year Diagnosed Prevalent Cases of HIV (Japan) 344

12.4.3 Diagnosed Prevalent Cases of HIV Treated with ART 344

12.4.4 Drugs Included in Each Therapeutic Class 344

12.4.5 Launch and Patent Expiry Dates 346

12.4.6 General Pricing Assumptions 347

12.4.7 Individual Drug Assumptions 349

12.4.8 Generic Erosion 355

12.4.9 Pricing of Pipeline Agents 355

12.5 Primary Research-KOLs and Payers Interviewed for this Report 357

12.5.1 KOLs 357

12.5.2 Payers 360

12.6 Primary Research-Prescriber Survey 361

12.7 About the Authors 362

12.7.1 Analyst 362

12.7.2 Therapy Area Director 362

12.7.3 Epidemiologists 362

12.7.4 Global Director of Therapy Analysis and Epidemiology 364

12.7.5 Global Head and EVP of Healthcare Operations and Strategy 364

12.8 About GlobalData 365

12.9 Contact Us 365

12.10 Disclaimer 365


List Of Figure

1.2 List of Figures

Figure 1: Global Sales for HIV by Country/Region, 2015 and 2025 14

Figure 2: Company Portfolio Gap Analysis in HIV, 2015-2025 15

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2015-2025 20

Figure 4: Cartoon Depicting the HIV Lifecycle 26

Figure 5: Global Overview of HIV, Men and Women, All Ages, 1990-2015 38

Figure 6: 8MM, Total Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 67

Figure 7: 8MM, Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 69

Figure 8: 8MM, Age-Specific Diagnosed Prevalent Cases of HIV, Both Sexes, N, Select Years, 2015-2025 71

Figure 9: 8MM, Sex-Specific Diagnosed Prevalent Cases of HIV, All Ages, N, Select Years, 2015-2025 73

Figure 10: 8MM, Age-Standardized Diagnosed Prevalence of HIV (%), All Ages, by Sex, 2015 74

Figure 11: Japan, 20-Year Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 78

Figure 12: Japan, Age-Standardized 20-Year Diagnosed Prevalence of HIV (%), All Ages, by Sex, 2015 80

Figure 13: HIV Disease Management Flowchart 88

Figure 14: HIV-Phase III Pipeline, 2016 205

Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2015-2025 206

Figure 16: Company Portfolio Gap Analysis in HIV, 2015-2025 250

Figure 17: Global Sales for HIV by Country/Region, 2015 and 2025 273

Figure 18: Global Sales for HIV by Drug Class, 2015 and 2025 274

Figure 19: Sales for HIV by Drug Class in the US, 2015 and 2025 280

Figure 20: Sales for HIV by Drug Class in the 5EU, 2015 and 2025 288

Figure 21: Sales for HIV by Drug Class in Japan, 2015 and 2025 294

Figure 22: Sales for HIV by Drug Class in Brazil, 2015 and 2025 299

Figure 23: Sales for HIV by Drug Class in China, 2015 and 2025 304


List Of Table

1.1 List of Tables

Table 1: HIV: Key Metrics in the Nine Major Pharmaceutical Markets 12

Table 2: CDC and WHO Staging Classification of HIV-1 Infection in Patients ?6 Years 30

Table 3: Symptoms of Acute, Chronic, and Advanced Stages of HIV Infection 32

Table 4: Risk Factors and Comorbidities for HIV 36

Table 5: 5EU, Total Prevalence of HIV in Men and Women (%), All Ages, Selected Years, 2001-2015 40

Table 6: 8MM, Sources of HIV Total Prevalence Data 43

Table 7: 8MM, Sources of HIV Diagnosed Prevalence Data 44

Table 8: Japan, Sources Used to Forecast the 20-Year Diagnosed Prevalent Cases of HIV in Japan 45

Table 9: 9MM, Sources Used to Forecast Diagnosed Prevalent Cases of HIV on ART 46

Table 10: 9MM, Sources Used to Forecast Diagnosed Prevalent Cases of HIV with HBV Co-infection 46

Table 11: 9MM, Sources Used to Forecast Diagnosed Prevalent Cases of HIV with HCV Co-infection 47

Table 12: 8MM, Total Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 67

Table 13: 8MM, Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 68

Table 14: 8MM, Age-Specific Diagnosed Prevalent Cases of HIV, Both Sexes, 2015, Cases (N) and Proportions (Row %) 70

Table 15: 8MM, Sex-Specific Diagnosed Prevalent Cases of HIV, Both Sexes, 2015 (Row %) 72

Table 16: 8MM, Diagnosed Prevalent HIV Cases Treated with ART, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 75

Table 17: 8MM, Diagnosed Prevalent HIV Cases with HBV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 76

Table 18: 8MM, Diagnosed Prevalent HIV Cases with HCV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 77

Table 19: Japan, 20-Year Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 78

Table 20: Japan, Age-Specific 20-Year Diagnosed Prevalent Cases of HIV, Both Sexes, N, 2015 (Row %) 79

Table 21: Japan, Sex-Specific 20-Year Diagnosed Prevalent Cases of HIV, All Ages, N, 2015 (Row %) 79

Table 22: Japan, 20-Year Diagnosed Prevalent HIV Cases Treated with ART, All Ages, Both Sexes 2015-2025, Cases (N) and Proportions (%) 81

Table 23: Japan, 20-Year Diagnosed Prevalent HIV Cases with HBV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 81

Table 24: Japan, 20-Year Diagnosed Prevalent HIV Cases with HCV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 82

Table 25: Treatment Guidelines for HIV-1 Used in the 9MM 86

Table 26: Most Commonly Prescribed Drugs for HIV-1 by Class in the 9MM, 2015 87

Table 27: Most Commonly Prescribed Drugs for HIV-1 by Class in the 9MM, 2016 87

Table 28: Diagnosis and Treatment of HIV Infection, Country Profile-US 95

Table 29: Switching of ART Regimens in the US, 2015 98

Table 30: Diagnosis and Treatment of HIV Infection, Country Profile-5EU 99

Table 31: CD4+ Thresholds and Corresponding Recommendations for the Initiation of ART in Asymptomatic Patients in the 5EU 102

Table 32: Switching of ART Regimens in the 5EU, 2015 104

Table 33: Diagnosis and Treatment of HIV Infection, Country Profile-Japan 105

Table 34: Switching of ART Regimens in Japan, 2015 108

Table 35: Diagnosis and Treatment of HIV Infection, Country Profile-Brazil 109

Table 36: Switching of ART Regimens in Brazil, 2015 112

Table 37: Diagnosis and Treatment of HIV Infection, Country Profile-China 113

Table 38: Switching of ART Regimens in China, 2015 116

Table 39: Leading Branded Treatments for HIV, 2016 119

Table 40: Product Profile-Atripla 122

Table 41: Efficacy of Atripla Compared with Combivir + Sustiva 123

Table 42: Safety of Atripla-Frequency of AEs Compared with Combivir + Sustiva 124

Table 43: Atripla SWOT Analysis, 2016 125

Table 44: Product Profile-Stribild 128

Table 45: Pivotal Phase III Trials of Stribild in Treatment-Naive Patients 129

Table 46: Stribild's Adverse Reactions-Pooled Results From Two Phase III Clinical Trials 130

Table 47: Stribild SWOT Analysis, 2016 131

Table 48: Product Profile-Genvoya 134

Table 49: Efficacy of Genvoya and Stribild in Studies 104 and 111 135

Table 50: Adverse Events Associated with Genvoya vs. Stribild Therapy in Two Phase III Clinical Studies 136

Table 51: Genvoya SWOT Analysis, 2016 137

Table 52: Product Profile-Triumeq 139

Table 53: Virologic Efficacy of Triumeq in the Phase III SINGLE Study 140

Table 54: Triumeq's Safety-Adverse Reactions Reported at 96 Weeks in the SINGLE Study 142

Table 55: Triumeq SWOT Analysis, 2016 142

Table 56: Product Profile-Complera 145

Table 57: ECHO and THRIVE Studies of the Complera and Atripla Multi-tablet Regimens 147

Table 58: Complera SWOT Analysis, 2016 148

Table 59: Product Profile-Odefsey 150

Table 60: Safety of Odefsey-Frequency of AEs 152

Table 61: Odefsey SWOT Analysis, 2016 153

Table 62: Product Profile-Truvada 155

Table 63: Truvada's Efficacy-Results of the SWIFT Trial at 48 Weeks 157

Table 64: Truvada SWOT Analysis, 2016 158

Table 65: Product Profile-Descovy 161

Table 66: Safety of Descovy-Frequency of AEs 162

Table 67: Descovy SWOT Analysis, 2016 163

Table 68: Product Profile-Tivicay 165

Table 69: Pivotal Phase III Trials of Tivicay 168

Table 70: Tivicay's Safety-Adverse Reactions Reported in the 48-Week SINGLE Study 169

Table 71: Tivicay SWOT Analysis, 2016 170

Table 72: Product Profile-Isentress 172

Table 73: Percentage of Patients with HIV-1 RNA Levels <50 Copies/mL from the SMARTMRK Study 173

Table 74: Isentress' Safety-Adverse Reactions Reported in the SMARTMRK Study 173

Table 75: Isentress SWOT Analysis, 2016 174

Table 76: Product Profile-Prezcobix 177

Table 77: Efficacy of Prezcobix in the Phase III Trial 178

Table 78: Prezcobix SWOT Analysis, 2016 179

Table 79: Product Profile-Evotaz 180

Table 80: Efficacy of BMS' Evotaz in the Phase III Study 182

Table 81: Evotaz SWOT Analysis, 2016 183

Table 82: Other Approved HIV Drugs 184

Table 83: Unmet Need and Opportunity in HIV 189

Table 84: Key Late-Stage Pipeline Agents for HIV Therapeutics, 2016 207

Table 85: Comparison of Therapeutic Classes in Development for HIV, 2015-2025 207

Table 86: Product Profile-Bictegravir/Emtricitabine/TAF 210

Table 87: Gilead's Bictegravir/Emtricitabine/TAF-Phase III Clinical Trials 210

Table 88: Bictegravir/Emtricitabine/TAF SWOT Analysis, 2016 212

Table 89: Product Profile-Dolutegravir/Lamivudine 214

Table 90: ViiV's Dolutegravir/Lamivudine-Phase III Clinical Trials 215

Table 91: Dolutegravir/Lamivudine Safety-Adverse Reactions Reported at 24 Weeks-PADDLE Study 215

Table 92: Dolutegravir/Lamivudine SWOT Analysis, 2016 216

Table 93: Product Profile-Cobicistat/Darunavir/Emtricitabine/TAF 218

Table 94: Janssen's Cobicistat/Darunavir/Emtricitabine/TAF-Phase III Clinical Trials 219

Table 95: Cobicistat/Darunavir/Emtricitabine/TAF SWOT Analysis, 2016 221

Table 96: Product Profile-Doravirine/Lamivudine/TDF 223

Table 97: Efficacy Results of a Phase II Dose-Ranging Study of Doravirine Compared with a Standard Dose of Efavirenz 224

Table 98: Doravirine/Lamivudine/TDF SWOT Analysis, 2016 226

Table 99: Product Profile-Dolutegravir/Rilpivirine 228

Table 100: Tivicay's Safety-Adverse Reactions Reported in the 48-Week SINGLE Study 229

Table 101: Dolutegravir/Rilpivirine SWOT Analysis, 2016 230

Table 102: Product Profile-Cabotegravir/Rilpivirine 232

Table 103: Cabotegravir/Rilpivirine SWOT Analysis, 2016 235

Table 104: Product Profile-Fostemsavir 236

Table 105: Fostemsavir SWOT Analysis, 2016 238

Table 106: Product Profile-Ibalizumab 240

Table 107: TaiMed's and Theratechnologies' Ibalizumab-Phase IIb Clinical Trial Outcomes 241

Table 108: Ibalizumab SWOT Analysis, 2016 242

Table 109: Product Profile-PRO-140 244

Table 110: PRO-140 SWOT Analysis, 2016 246

Table 111: Other Drugs in Phase II of Clinical Development for HIV, 2016 247

Table 112: Key Companies in the HIV Market in the 9MM, 2016 249

Table 113: Gilead Sciences' HIV Portfolio Assessment, 2016 255

Table 114: ViiV Healthcare's HIV Portfolio Assessment, 2016 258

Table 115: Janssen's HIV Portfolio Assessment, 2016 261

Table 116: Merck & Co.'s HIV Portfolio Assessment, 2016 264

Table 117: BMS' HIV Portfolio Assessment, 2016 266

Table 118: Global Sales Forecasts ($m) for HIV, 2015-2025 271

Table 119: HIV Therapeutics Market-Global Drivers and Barriers, 2015-2025 275

Table 120: Sales Forecasts ($m) for HIV in the US, 2015-2025 278

Table 121: Key Events Impacting Sales for HIV Therapeutics in the US, 2015-2025 281

Table 122: HIV Therapeutics Market-Drivers and Barriers in the US, 2015?2025 282

Table 123: Number of People Living with HIV Who Received ART in the 5EU, and Sales of HIV Therapeutics, 2015 283

Table 124: Sales Forecasts ($m) for HIV in the 5EU, 2015-2025 286

Table 125: Key Events Impacting Sales for HIV in the 5EU, 2015-2025 289

Table 126: HIV Therapeutics Market-Drivers and Barriers in the 5EU, 2015?2025 290

Table 127: Sales Forecasts ($m) for HIV in Japan, 2015-2025 292

Table 128: Key Events Impacting Sales for HIV Therapeutics in Japan, 2015-2025 295

Table 129: Sales Forecasts ($m) for HIV in Brazil, 2015-2025 298

Table 130: Key Events Impacting Sales for HIV Therapeutics in Brazil, 2015-2025 300

Table 131: HIV Therapeutics Market-Drivers and Barriers in Brazil, 2015?2025 300

Table 132: Sales Forecasts ($m) for HIV in China, 2015-2025 303

Table 133: Key Events Impacting Sales of HIV Therapeutics in China, 2015-2025 305

Table 134: HIV Therapeutics Market-Drivers and Barriers in China, 2015?2025 305

Table 135: Key Historical and Projected Launch Dates for HIV Therapeutics Across the 9MM 346

Table 136: Patent Expiry Dates for HIV Therapeutics Across the 9MM 347

Table 137: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 361

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Products and Companies


Companies

Gilead Sciences

ViiV Healthcare

Janssen

Merck & Co.

Bristol-Myers Squibb

TaiMed Biologics

CytoDyn

PharmaPoint: Human Immunodeficiency Virus (HIV)-Global Drug Forecast and Market Analysis to 2025

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.

GlobalData projects the global HIV marketplace-which, for the purposes of this report, comprises nine major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China)-to experience modest growth during the forecast period. This growth will be driven primarily by the highly anticipated arrivals of novel integrase inhibitor (INI-) and protease inhibitor (PI-) based STRs, which include ViiV Healthcare's dolutegravir/lamivudine, ViiV's and Janssen's dolutegravir/rilpivirine, Gilead's bictegravir/emtricitabine/tenofovir alafenamide fumarate (TAF), Gilead's and Janssen's darunavir/cobicistat/emtricitabine/TAF, and ViiV's long-acting injectable formulation composed of cabotegravir/rilpivirine. Nevertheless, looming patent expiries of high-grossing branded drugs in the US, 5EU (France, Germany, Italy, Spain, UK), and Japan, along with compulsory licensing and generic erosion in Brazil and China, are expected to curtail market growth.

Key Questions Answered

How will the HIV market landscape in the 9MM (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China) change from 2015-2025?

What are the most promising late-stage pipeline drugs in HIV?

How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

What are the remaining unmet needs in HIV treatment management?

What drivers and barriers will affect HIV therapeutics sales in the 9MM over the forecast period?

Scope

Overview of HIV, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline HIV market revenue from 2015-2025. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting HIV therapeutics sales in the 9MM.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

Analysis of the current and future market competition in the global HIV therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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The report will enable you to

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global HIV therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HIV therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

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Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 10

2 Human Immunodeficiency Virus (HIV): Executive Summary 12

2.1 HIV Market Will Experience Modest Growth During the Forecast Period 13

2.2 Companies Leverage Partnerships to Develop New STRs and Fixed-Dose Combinations to Capture HIV Market Share 14

2.3 While HIV Therapies Continue to Raise the Bar on Efficacy, Safety, and Convenience, Unmet Needs Persist 15

2.4 Even in the Face of Strong Marketed and Pipeline Products, Opportunities Still Exist for Current and Future Players to Impact the HIV Marketplace 16

2.5 Novel STRs and FDCs With Improved Efficacy and Safety, and a Decreased Pill Burden, Are Expected to Dominate the Future HIV Treatment Landscape 17

2.6 What Do Physicians Think? 20

3 Introduction 23

3.1 Catalyst 23

3.2 Related Reports 24

3.3 Upcoming Related Reports 24

4 Disease Overview 25

4.1 Etiology 25

4.1.1 The Viral Lifecycle 26

4.2 Pathophysiology 29

4.3 Staging and Symptoms 30

4.3.1 Acute Infection 30

4.3.2 Chronic Infection 31

4.3.3 Advanced Infection (AIDS) 31

4.4 Prognosis 33

4.5 Quality of Life 34

5 Epidemiology 35

5.1 Disease Background 35

5.2 Risk Factors and Comorbidities 36

5.3 Global Trends 37

5.3.1 US 39

5.3.2 5EU 39

5.3.3 Japan, Brazil, and China 40

5.4 Forecast Methodology 41

5.4.1 Sources Used 43

5.4.2 Forecast Assumptions and Methods 47

5.4.3 Sources Not Used 65

5.5 Epidemiological Forecast for HIV in the 8MM (2015-2025) 66

5.5.1 Total Prevalent Cases of HIV 66

5.5.2 Diagnosed Prevalent Cases of HIV 67

5.5.3 Age-Specific Diagnosed Prevalent Cases of HIV 69

5.5.4 Sex-Specific Diagnosed Prevalent Cases of HIV 71

5.5.5 Age-Standardized Diagnosed Prevalence of HIV 73

5.5.6 Diagnosed Prevalent Cases of HIV Treated with Antiretroviral Therapy 74

5.5.7 Diagnosed Prevalent Cases of HIV with Hepatitis B Virus Co-infection 75

5.5.8 Diagnosed Prevalent Cases of HIV with Hepatitis C Virus Co-infection 76

5.6 Epidemiological Forecast for HIV in Japan (2015-2025) 78

5.6.1 20-Year Diagnosed Prevalent Cases of HIV 78

5.6.2 Age-Specific 20-Year Diagnosed Prevalent Cases of HIV 78

5.6.3 Sex-Specific 20-Year Diagnosed Prevalent Cases of HIV 79

5.6.4 Age-Standardized 20-Year Diagnosed Prevalence of HIV 80

5.6.5 20-Year Diagnosed Prevalent Cases of HIV Treated with Antiretroviral Therapy 80

5.6.6 20-Year Diagnosed Prevalent Cases of HIV with Hepatitis B Virus Co-infection 81

5.6.7 20-Year Diagnosed Prevalent Cases of HIV with Hepatitis C Virus Co-infection 81

5.7 Discussion 82

5.7.1 Epidemiological Forecast Insight 82

5.7.2 Limitations of Analysis 83

5.7.3 Strengths of Analysis 84

6 Disease Management 85

6.1 Diagnosis and Treatment Overview 85

6.1.1 Screening and Diagnosis 85

6.1.2 Treatment Guidelines and Leading Prescribed Drugs 86

6.1.3 Clinical Practice 87

6.2 US 94

6.2.1 Screening and Diagnosis 95

6.2.2 Clinical Practice 97

6.3 5EU 99

6.3.1 Screening and Diagnosis 100

6.3.2 Clinical Practice 101

6.4 Japan 105

6.4.1 Screening and Diagnosis 105

6.4.2 Clinical Practice 106

6.5 Brazil 109

6.5.1 Screening and Diagnosis 109

6.5.2 Clinical Practice 110

6.6 China 113

6.6.1 Screening and Diagnosis 113

6.6.2 Clinical Practice 114

7 Competitive Assessment 117

7.1 Overview 117

7.2 Product Profiles-Major Brands, Single-Tablet Regimens 120

7.2.1 Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 120

7.2.2 Stribild (cobicistat/elvitegravir/emtricitabine/TDF) 126

7.2.3 Genvoya (cobicistat/elvitegravir/emtricitabine/TAF) 132

7.2.4 Triumeq (abacavir/dolutegravir/lamivudine) 137

7.2.5 Complera (emtricitabine/rilpivirine/TDF) 143

7.2.6 Odefsey (emtricitabine/rilpivirine/TAF) 149

7.3 Product Profiles-Major Brands, Fixed-Dose NRTI Backbones 154

7.3.1 Truvada (emtricitabine/TDF) 154

7.3.2 Descovy (emtricitabine/TAF) 159

7.4 Product Profiles-Major Brands, Integrase Inhibitors 163

7.4.1 Tivicay (dolutegravir) 163

7.4.2 Isentress (raltegravir) 171

7.5 Product Profiles-Major Brands, Protease Inhibitors 175

7.5.1 Prezcobix (darunavir/cobicistat) 175

7.5.2 Evotaz (atazanavir/cobicistat) 179

7.6 Other Approved Drugs 183

7.6.1 Overview 183

8 Unmet Needs Assessment and Opportunity Analysis 187

8.1 Overview 187

8.2 Long-Acting Regimens that Require Less-Frequent Administration 189

8.2.1 Unmet Need 189

8.2.2 Gap Analysis 190

8.2.3 Opportunity 191

8.3 Enhanced Public Awareness Initiatives Focused on Minimizing the Stigma Associated with HIV Infection 191

8.3.1 Unmet Need 191

8.3.2 Gap Analysis 192

8.3.3 Opportunity 193

8.4 Improved Physician Education Tools That Emphasize the Importance of Early Testing and Diagnosis 193

8.4.1 Unmet Need 193

8.4.2 Gap Analysis 194

8.4.3 Opportunity 194

8.5 Safe and Efficacious Therapies for Patients with Drug-Resistant HIV Strains 195

8.5.1 Unmet Need 195

8.5.2 Gap Analysis 196

8.5.3 Opportunity 197

8.6 Therapies with Improved Safety and Tolerability Profiles 197

8.6.1 Unmet Need 197

8.6.2 Gap Analysis 198

8.6.3 Opportunity 199

8.7 Progress Towards a Functional Cure 200

8.7.1 Unmet Need 200

8.7.2 Gap Analysis 201

8.7.3 Opportunity 202

9 Pipeline Assessment 203

9.1 Overview 203

9.2 Promising Drugs in Clinical Development 204

9.2.1 Bictegravir/Emtricitabine/TAF 208

9.2.2 Dolutegravir/Lamivudine 213

9.2.3 Cobicistat/Darunavir/Emtricitabine/TAF 217

9.2.4 Doravirine/Lamivudine/TDF 221

9.2.5 Dolutegravir/Rilpivirine 226

9.2.6 Cabotegravir/Rilpivirine 230

9.2.7 Fostemsavir 235

9.2.8 Ibalizumab 239

9.2.9 PRO-140 243

9.3 Other Drugs in Clinical Development 247

10 Current and Future Players 248

10.1 Overview 248

10.2 Trends in Corporate Strategy 250

10.3 Company Profiles 253

10.3.1 Gilead Sciences 253

10.3.2 ViiV Healthcare 256

10.3.3 Janssen 259

10.3.4 Merck & Co. 261

10.3.5 Bristol-Myers Squibb 264

10.3.6 Minor and Emerging Players 266

11 Market Outlook 269

11.1 Global Markets 269

11.1.1 Forecast 269

11.1.2 Drivers and Barriers-Global Issues 275

11.2 US 275

11.2.1 Forecast 275

11.2.2 Key Events 281

11.2.3 Drivers and Barriers 282

11.3 5EU 282

11.3.1 Forecast 282

11.3.2 Key Events 289

11.3.3 Drivers and Barriers 290

11.4 Japan 290

11.4.1 Forecast 290

11.4.2 Key Events 295

11.4.3 Drivers and Barriers 296

11.5 Brazil 296

11.5.1 Forecast 296

11.5.2 Key Events 300

11.5.3 Drivers and Barriers 300

11.6 China 301

11.6.1 Forecast 301

11.6.2 Key Events 305

11.6.3 Drivers and Barriers 305

12 Appendix 306

12.1 Bibliography 306

12.2 Abbreviations 338

12.3 Methodology 343

12.4 Forecasting Methodology 343

12.4.1 Total and Diagnosed Prevalent Cases of HIV (8MM) 343

12.4.2 20-Year Diagnosed Prevalent Cases of HIV (Japan) 344

12.4.3 Diagnosed Prevalent Cases of HIV Treated with ART 344

12.4.4 Drugs Included in Each Therapeutic Class 344

12.4.5 Launch and Patent Expiry Dates 346

12.4.6 General Pricing Assumptions 347

12.4.7 Individual Drug Assumptions 349

12.4.8 Generic Erosion 355

12.4.9 Pricing of Pipeline Agents 355

12.5 Primary Research-KOLs and Payers Interviewed for this Report 357

12.5.1 KOLs 357

12.5.2 Payers 360

12.6 Primary Research-Prescriber Survey 361

12.7 About the Authors 362

12.7.1 Analyst 362

12.7.2 Therapy Area Director 362

12.7.3 Epidemiologists 362

12.7.4 Global Director of Therapy Analysis and Epidemiology 364

12.7.5 Global Head and EVP of Healthcare Operations and Strategy 364

12.8 About GlobalData 365

12.9 Contact Us 365

12.10 Disclaimer 365


List Of Figure

1.2 List of Figures

Figure 1: Global Sales for HIV by Country/Region, 2015 and 2025 14

Figure 2: Company Portfolio Gap Analysis in HIV, 2015-2025 15

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2015-2025 20

Figure 4: Cartoon Depicting the HIV Lifecycle 26

Figure 5: Global Overview of HIV, Men and Women, All Ages, 1990-2015 38

Figure 6: 8MM, Total Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 67

Figure 7: 8MM, Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 69

Figure 8: 8MM, Age-Specific Diagnosed Prevalent Cases of HIV, Both Sexes, N, Select Years, 2015-2025 71

Figure 9: 8MM, Sex-Specific Diagnosed Prevalent Cases of HIV, All Ages, N, Select Years, 2015-2025 73

Figure 10: 8MM, Age-Standardized Diagnosed Prevalence of HIV (%), All Ages, by Sex, 2015 74

Figure 11: Japan, 20-Year Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 78

Figure 12: Japan, Age-Standardized 20-Year Diagnosed Prevalence of HIV (%), All Ages, by Sex, 2015 80

Figure 13: HIV Disease Management Flowchart 88

Figure 14: HIV-Phase III Pipeline, 2016 205

Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2015-2025 206

Figure 16: Company Portfolio Gap Analysis in HIV, 2015-2025 250

Figure 17: Global Sales for HIV by Country/Region, 2015 and 2025 273

Figure 18: Global Sales for HIV by Drug Class, 2015 and 2025 274

Figure 19: Sales for HIV by Drug Class in the US, 2015 and 2025 280

Figure 20: Sales for HIV by Drug Class in the 5EU, 2015 and 2025 288

Figure 21: Sales for HIV by Drug Class in Japan, 2015 and 2025 294

Figure 22: Sales for HIV by Drug Class in Brazil, 2015 and 2025 299

Figure 23: Sales for HIV by Drug Class in China, 2015 and 2025 304


List Of Table

1.1 List of Tables

Table 1: HIV: Key Metrics in the Nine Major Pharmaceutical Markets 12

Table 2: CDC and WHO Staging Classification of HIV-1 Infection in Patients ?6 Years 30

Table 3: Symptoms of Acute, Chronic, and Advanced Stages of HIV Infection 32

Table 4: Risk Factors and Comorbidities for HIV 36

Table 5: 5EU, Total Prevalence of HIV in Men and Women (%), All Ages, Selected Years, 2001-2015 40

Table 6: 8MM, Sources of HIV Total Prevalence Data 43

Table 7: 8MM, Sources of HIV Diagnosed Prevalence Data 44

Table 8: Japan, Sources Used to Forecast the 20-Year Diagnosed Prevalent Cases of HIV in Japan 45

Table 9: 9MM, Sources Used to Forecast Diagnosed Prevalent Cases of HIV on ART 46

Table 10: 9MM, Sources Used to Forecast Diagnosed Prevalent Cases of HIV with HBV Co-infection 46

Table 11: 9MM, Sources Used to Forecast Diagnosed Prevalent Cases of HIV with HCV Co-infection 47

Table 12: 8MM, Total Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 67

Table 13: 8MM, Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 68

Table 14: 8MM, Age-Specific Diagnosed Prevalent Cases of HIV, Both Sexes, 2015, Cases (N) and Proportions (Row %) 70

Table 15: 8MM, Sex-Specific Diagnosed Prevalent Cases of HIV, Both Sexes, 2015 (Row %) 72

Table 16: 8MM, Diagnosed Prevalent HIV Cases Treated with ART, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 75

Table 17: 8MM, Diagnosed Prevalent HIV Cases with HBV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 76

Table 18: 8MM, Diagnosed Prevalent HIV Cases with HCV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 77

Table 19: Japan, 20-Year Diagnosed Prevalent Cases of HIV, All Ages, Both Sexes, N, Select Years, 2015-2025 78

Table 20: Japan, Age-Specific 20-Year Diagnosed Prevalent Cases of HIV, Both Sexes, N, 2015 (Row %) 79

Table 21: Japan, Sex-Specific 20-Year Diagnosed Prevalent Cases of HIV, All Ages, N, 2015 (Row %) 79

Table 22: Japan, 20-Year Diagnosed Prevalent HIV Cases Treated with ART, All Ages, Both Sexes 2015-2025, Cases (N) and Proportions (%) 81

Table 23: Japan, 20-Year Diagnosed Prevalent HIV Cases with HBV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 81

Table 24: Japan, 20-Year Diagnosed Prevalent HIV Cases with HCV Co-infection, All Ages, Both Sexes, 2015-2025, Cases (N) and Proportions (%) 82

Table 25: Treatment Guidelines for HIV-1 Used in the 9MM 86

Table 26: Most Commonly Prescribed Drugs for HIV-1 by Class in the 9MM, 2015 87

Table 27: Most Commonly Prescribed Drugs for HIV-1 by Class in the 9MM, 2016 87

Table 28: Diagnosis and Treatment of HIV Infection, Country Profile-US 95

Table 29: Switching of ART Regimens in the US, 2015 98

Table 30: Diagnosis and Treatment of HIV Infection, Country Profile-5EU 99

Table 31: CD4+ Thresholds and Corresponding Recommendations for the Initiation of ART in Asymptomatic Patients in the 5EU 102

Table 32: Switching of ART Regimens in the 5EU, 2015 104

Table 33: Diagnosis and Treatment of HIV Infection, Country Profile-Japan 105

Table 34: Switching of ART Regimens in Japan, 2015 108

Table 35: Diagnosis and Treatment of HIV Infection, Country Profile-Brazil 109

Table 36: Switching of ART Regimens in Brazil, 2015 112

Table 37: Diagnosis and Treatment of HIV Infection, Country Profile-China 113

Table 38: Switching of ART Regimens in China, 2015 116

Table 39: Leading Branded Treatments for HIV, 2016 119

Table 40: Product Profile-Atripla 122

Table 41: Efficacy of Atripla Compared with Combivir + Sustiva 123

Table 42: Safety of Atripla-Frequency of AEs Compared with Combivir + Sustiva 124

Table 43: Atripla SWOT Analysis, 2016 125

Table 44: Product Profile-Stribild 128

Table 45: Pivotal Phase III Trials of Stribild in Treatment-Naive Patients 129

Table 46: Stribild's Adverse Reactions-Pooled Results From Two Phase III Clinical Trials 130

Table 47: Stribild SWOT Analysis, 2016 131

Table 48: Product Profile-Genvoya 134

Table 49: Efficacy of Genvoya and Stribild in Studies 104 and 111 135

Table 50: Adverse Events Associated with Genvoya vs. Stribild Therapy in Two Phase III Clinical Studies 136

Table 51: Genvoya SWOT Analysis, 2016 137

Table 52: Product Profile-Triumeq 139

Table 53: Virologic Efficacy of Triumeq in the Phase III SINGLE Study 140

Table 54: Triumeq's Safety-Adverse Reactions Reported at 96 Weeks in the SINGLE Study 142

Table 55: Triumeq SWOT Analysis, 2016 142

Table 56: Product Profile-Complera 145

Table 57: ECHO and THRIVE Studies of the Complera and Atripla Multi-tablet Regimens 147

Table 58: Complera SWOT Analysis, 2016 148

Table 59: Product Profile-Odefsey 150

Table 60: Safety of Odefsey-Frequency of AEs 152

Table 61: Odefsey SWOT Analysis, 2016 153

Table 62: Product Profile-Truvada 155

Table 63: Truvada's Efficacy-Results of the SWIFT Trial at 48 Weeks 157

Table 64: Truvada SWOT Analysis, 2016 158

Table 65: Product Profile-Descovy 161

Table 66: Safety of Descovy-Frequency of AEs 162

Table 67: Descovy SWOT Analysis, 2016 163

Table 68: Product Profile-Tivicay 165

Table 69: Pivotal Phase III Trials of Tivicay 168

Table 70: Tivicay's Safety-Adverse Reactions Reported in the 48-Week SINGLE Study 169

Table 71: Tivicay SWOT Analysis, 2016 170

Table 72: Product Profile-Isentress 172

Table 73: Percentage of Patients with HIV-1 RNA Levels <50 Copies/mL from the SMARTMRK Study 173

Table 74: Isentress' Safety-Adverse Reactions Reported in the SMARTMRK Study 173

Table 75: Isentress SWOT Analysis, 2016 174

Table 76: Product Profile-Prezcobix 177

Table 77: Efficacy of Prezcobix in the Phase III Trial 178

Table 78: Prezcobix SWOT Analysis, 2016 179

Table 79: Product Profile-Evotaz 180

Table 80: Efficacy of BMS' Evotaz in the Phase III Study 182

Table 81: Evotaz SWOT Analysis, 2016 183

Table 82: Other Approved HIV Drugs 184

Table 83: Unmet Need and Opportunity in HIV 189

Table 84: Key Late-Stage Pipeline Agents for HIV Therapeutics, 2016 207

Table 85: Comparison of Therapeutic Classes in Development for HIV, 2015-2025 207

Table 86: Product Profile-Bictegravir/Emtricitabine/TAF 210

Table 87: Gilead's Bictegravir/Emtricitabine/TAF-Phase III Clinical Trials 210

Table 88: Bictegravir/Emtricitabine/TAF SWOT Analysis, 2016 212

Table 89: Product Profile-Dolutegravir/Lamivudine 214

Table 90: ViiV's Dolutegravir/Lamivudine-Phase III Clinical Trials 215

Table 91: Dolutegravir/Lamivudine Safety-Adverse Reactions Reported at 24 Weeks-PADDLE Study 215

Table 92: Dolutegravir/Lamivudine SWOT Analysis, 2016 216

Table 93: Product Profile-Cobicistat/Darunavir/Emtricitabine/TAF 218

Table 94: Janssen's Cobicistat/Darunavir/Emtricitabine/TAF-Phase III Clinical Trials 219

Table 95: Cobicistat/Darunavir/Emtricitabine/TAF SWOT Analysis, 2016 221

Table 96: Product Profile-Doravirine/Lamivudine/TDF 223

Table 97: Efficacy Results of a Phase II Dose-Ranging Study of Doravirine Compared with a Standard Dose of Efavirenz 224

Table 98: Doravirine/Lamivudine/TDF SWOT Analysis, 2016 226

Table 99: Product Profile-Dolutegravir/Rilpivirine 228

Table 100: Tivicay's Safety-Adverse Reactions Reported in the 48-Week SINGLE Study 229

Table 101: Dolutegravir/Rilpivirine SWOT Analysis, 2016 230

Table 102: Product Profile-Cabotegravir/Rilpivirine 232

Table 103: Cabotegravir/Rilpivirine SWOT Analysis, 2016 235

Table 104: Product Profile-Fostemsavir 236

Table 105: Fostemsavir SWOT Analysis, 2016 238

Table 106: Product Profile-Ibalizumab 240

Table 107: TaiMed's and Theratechnologies' Ibalizumab-Phase IIb Clinical Trial Outcomes 241

Table 108: Ibalizumab SWOT Analysis, 2016 242

Table 109: Product Profile-PRO-140 244

Table 110: PRO-140 SWOT Analysis, 2016 246

Table 111: Other Drugs in Phase II of Clinical Development for HIV, 2016 247

Table 112: Key Companies in the HIV Market in the 9MM, 2016 249

Table 113: Gilead Sciences' HIV Portfolio Assessment, 2016 255

Table 114: ViiV Healthcare's HIV Portfolio Assessment, 2016 258

Table 115: Janssen's HIV Portfolio Assessment, 2016 261

Table 116: Merck & Co.'s HIV Portfolio Assessment, 2016 264

Table 117: BMS' HIV Portfolio Assessment, 2016 266

Table 118: Global Sales Forecasts ($m) for HIV, 2015-2025 271

Table 119: HIV Therapeutics Market-Global Drivers and Barriers, 2015-2025 275

Table 120: Sales Forecasts ($m) for HIV in the US, 2015-2025 278

Table 121: Key Events Impacting Sales for HIV Therapeutics in the US, 2015-2025 281

Table 122: HIV Therapeutics Market-Drivers and Barriers in the US, 2015?2025 282

Table 123: Number of People Living with HIV Who Received ART in the 5EU, and Sales of HIV Therapeutics, 2015 283

Table 124: Sales Forecasts ($m) for HIV in the 5EU, 2015-2025 286

Table 125: Key Events Impacting Sales for HIV in the 5EU, 2015-2025 289

Table 126: HIV Therapeutics Market-Drivers and Barriers in the 5EU, 2015?2025 290

Table 127: Sales Forecasts ($m) for HIV in Japan, 2015-2025 292

Table 128: Key Events Impacting Sales for HIV Therapeutics in Japan, 2015-2025 295

Table 129: Sales Forecasts ($m) for HIV in Brazil, 2015-2025 298

Table 130: Key Events Impacting Sales for HIV Therapeutics in Brazil, 2015-2025 300

Table 131: HIV Therapeutics Market-Drivers and Barriers in Brazil, 2015?2025 300

Table 132: Sales Forecasts ($m) for HIV in China, 2015-2025 303

Table 133: Key Events Impacting Sales of HIV Therapeutics in China, 2015-2025 305

Table 134: HIV Therapeutics Market-Drivers and Barriers in China, 2015?2025 305

Table 135: Key Historical and Projected Launch Dates for HIV Therapeutics Across the 9MM 346

Table 136: Patent Expiry Dates for HIV Therapeutics Across the 9MM 347

Table 137: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 361

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Companies

Gilead Sciences

ViiV Healthcare

Janssen

Merck & Co.

Bristol-Myers Squibb

TaiMed Biologics

CytoDyn