Published : Apr-2017
No. of Pages : 365
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
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-Naïve 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
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
