1 Table of Contents
1 Table of Contents 11
1.1 List of Tables 19
1.2 List of Figures 26
2 Introduction 28
2.1 Catalyst 28
2.2 Related Reports 29
2.3 Upcoming Related Reports 29
3 Disease Overview 30
3.1 Etiology 30
3.1.1 Viral Lifecycle 30
3.2 Pathophysiology 33
3.3 Staging and Symptoms 34
3.3.1 Primary or Acute Infection 34
3.3.2 Chronic Infection 35
3.3.3 Advanced Infection/AIDS 35
3.4 Prognosis 37
3.5 Quality of Life 37
4 Epidemiology 39
4.1 Disease Background 39
4.2 Risk Factors and Comorbidities 39
4.3 Global Trends 41
4.3.1 US 42
4.3.2 5EU 42
4.3.3 Brazil, China, and Japan 43
4.4 Forecast Methodology 44
4.4.1 Sources Used 45
4.4.2 Sources Not Used 55
4.4.3 Forecast Assumptions and Methods 56
4.5 Epidemiological Forecast for HIV in the 8MM (2013-2023) 62
4.5.1 Total Prevalent Cases of HIV 62
4.5.2 Age-Specific Total Prevalent Cases of HIV 64
4.5.3 Sex-Specific Total Prevalent Cases of HIV 66
4.5.4 Age-Standardized Total Prevalence of HIV 68
4.5.5 HIV Cases Treated with ART 69
4.5.6 Cases of HIV in Pregnant Women 70
4.6 Epidemiological Forecast for HIV in Japan (2013-2023) 71
4.6.1 20-Year Diagnosed Prevalent Cases of HIV 71
4.6.2 Age-Specific 20-Year Diagnosed Prevalent Cases of HIV 72
4.6.3 Sex-Specific 20-Year Diagnosed Prevalent Cases of HIV 73
4.6.4 Age-Standardized 20-Year Diagnosed Prevalence of HIV 74
4.6.5 HIV Cases Treated with ART 75
4.6.6 Cases of HIV in Pregnant Women 76
4.7 Discussion 76
4.7.1 Epidemiological Forecast Insight 76
4.7.2 Limitations of the Analysis 77
4.7.3 Strengths of the Analysis 78
5 Disease Management 79
5.1 Diagnosis and Treatment Overview 79
5.1.1 Screening and Diagnosis 79
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 80
5.1.3 Clinical Practice 82
5.2 US 92
5.2.1 Screening and Diagnosis 94
5.2.2 Clinical Practice 95
5.3 5EU 97
5.3.1 Screening and Diagnosis 98
5.3.2 Clinical Practice 99
5.4 Japan 103
5.4.1 Screening and Diagnosis 104
5.4.2 Clinical Practice 104
5.5 Brazil 107
5.5.1 Screening and Diagnosis 107
5.5.2 Clinical Practice 108
5.6 China 111
5.6.1 Screening and Diagnosis 111
5.6.2 Clinical Practice 112
6 Competitive Assessment 115
6.1 Overview 115
6.2 Product Profiles - Major Brands, Single-Tablet Regimens (STRs) 118
6.2.1 Atripla (efavirenz/emtricitabine/tenofovirdisoproxil fumarate) 118
6.2.2 Complera (emtricitabine/TDF/rilpivirine) 124
6.2.3 Stribild (elvitegravir/cobicistat/TDF/emtricitabine) 131
6.2.4 Triumeq (dolutegravir/abacavir/lamivudine) 139
6.3 Product Profiles - Major Brands, Fixed-Dose Combinations 147
6.3.1 Truvada (TDF/emtricitabine) 147
6.3.2 Epzicom (abacavir/lamivudine) 153
6.3.3 Kaletra (lopinavir/ritonavir) 158
6.3.4 Prezcobix (darunavir/cobicistat) 164
6.3.5 Evotaz (atazanavirsulfate/cobicistat) 169
6.4 Product Profiles - Major Brands, Protease Inhibitors 175
6.4.1 Reyataz (atazanavir) 175
6.4.2 Prezista (darunavir) 180
6.5 Product Profiles - Major Brands, Integrase Inhibitors 185
6.5.1 Isentress (raltegravir) 185
6.5.2 Tivicay (dolutegravir) 191
6.5.3 Vitekta (elvitegravir) 199
6.6 Product Profiles - Major Brands, Pharmacokinetic Enhancers 205
6.6.1 Norvir (ritonavir) 205
6.6.2 Tybost (cobicistat) 209
6.7 Other Therapeutic Classes 215
6.7.1 Entry Inhibitors 215
7 Unmet Need and Opportunity 216
7.1 Overview 216
7.2 Therapies with Improved Safety and Tolerability Profiles 218
7.2.1 Unmet Need 218
7.2.2 Gap Analysis 219
7.2.3 Opportunity 220
7.3 Simplified PI-Based ART Regimens with a Reduced Pill Burden 221
7.3.1 Unmet Need 221
7.3.2 Gap Analysis 222
7.3.3 Opportunity 223
7.4 Enhanced Public Awareness Initiatives Focused on Minimizing the Stigma Associated with HIV 224
7.4.1 Unmet Need 224
7.4.2 Gap Analysis 225
7.4.3 Opportunity 226
7.5 Improved Physician Education Tools That Emphasize the Importance of Early Testing and Diagnosis 226
7.5.1 Unmet Need 226
7.5.2 Gap Analysis 228
7.5.3 Opportunity 228
7.6 Safe and Efficacious Therapies for Patients with Drug-Resistant HIV Strains 228
7.6.1 Unmet Need 228
7.6.2 Gap Analysis 229
7.6.3 Opportunity 230
7.7 Long-Acting Regimens That Require Less Frequent Administration 230
7.7.1 Unmet Need 230
7.7.2 Gap Analysis 231
7.7.3 Opportunity 232
7.8 Improved Access to Treatment 232
7.8.1 Unmet Need 232
7.8.2 Gap Analysis 233
7.8.3 Opportunity 233
7.9 Progress Towards a Functional Cure 234
7.9.1 Unmet Need 234
7.9.2 Gap Analysis 234
7.9.3 Opportunity 235
8 Pipeline Assessment 236
8.1 Overview 236
8.2 Clinical Trial Mapping 237
8.2.1 Clinical Trials by Country 237
8.3 Promising Drugs in Late-Stage Clinical Development 238
8.3.1 Quad 2 (elvitegravir/cobicistat/emtricitabine/TAF) 241
8.3.2 Darunavir/Cobicistat/Emtricitabine/TAF 252
8.3.3 Emtricitabine/TAF 261
8.3.4 Dutrebis (raltegravir/lamivudine) 269
8.3.5 Doravirine (MK-1439) 276
8.4 Promising Drugs in Early-Stage Clinical Development 284
8.5 Other Drugs in Clinical Development 287
9 Current and Future Players 289
9.1 Overview 289
9.2 Trends in Corporate Strategy 291
9.3 Company Profiles 293
9.3.1 Gilead Sciences 293
9.3.2 ViiV Healthcare 298
9.3.3 AbbVie 303
9.3.4 Merck & Co. 306
9.3.5 Janssen 310
9.3.6 Bristol-Myers Squibb 314
9.3.7 Japan Tobacco 319
9.3.8 Avexa 322
9.3.9 TaiMed Biologics 325
9.3.10 Tobira Therapeutics 327
10 Market Outlook 331
10.1 Global Markets 331
10.1.1 Forecast 331
10.1.2 Drivers and Barriers - Global Issues 337
10.2 United States 339
10.2.1 Forecast 339
10.2.2 Key Events 345
10.2.3 Drivers and Barriers 346
10.3 5EU 348
10.3.1 Forecast 348
10.3.2 Key Events 356
10.3.3 Drivers and Barriers 357
10.4 Japan 363
10.4.1 Forecast 363
10.4.2 Key Events 368
10.4.3 Drivers and Barriers 370
10.5 Brazil 372
10.5.1 Forecast 372
10.5.2 Key Events 377
10.5.3 Drivers and Barriers 378
10.6 China 380
10.6.1 Forecast 380
10.6.2 Key Events 384
10.6.3 Drivers and Barriers 385
11 Appendix 388
11.1 Bibliography 388
11.2 Abbreviations 422
11.3 Methodology 429
11.4 Forecasting Methodology 429
11.4.1 Total Prevalent Cases of HIV 429
11.4.2 20-Year Diagnosed Prevalent Cases of HIV 429
11.4.3 HIV Cases Treated with ART 430
11.4.4 Drugs Included in Each Therapeutic Class 431
11.4.5 Launch and Patent Expiry Dates 432
11.4.6 General Pricing Assumptions 433
11.4.7 Individual Drug Assumptions 435
11.4.8 Generic Erosion 453
11.4.9 Pricing of Pipeline Agents 453
11.5 Primary Research - KOLs Interviewed for This Report 455
11.6 Primary Research - Prescriber Survey 457
11.7 About the Authors 458
11.7.1 Analyst 458
11.7.2 Epidemiologists 458
11.7.3 Therapy Area Director 458
11.7.4 Global Director of Therapy Analysis and Epidemiology 459
11.7.5 Global Head of Healthcare 459
11.8 About GlobalData 460
11.9 Disclaimer 460