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PharmaPoint:ヒト免疫不全ウイルス (HIV) - 世界の医薬品市場の予測と市場分析

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

発行 GlobalData 商品コード 346487
出版日 ページ情報 英文 365 Pages
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PharmaPoint:ヒト免疫不全ウイルス (HIV) - 世界の医薬品市場の予測と市場分析 PharmaPoint: Human Immunodeficiency Virus (HIV) - Global Drug Forecast and Market Analysis to 2025
出版日: 2017年04月12日 ページ情報: 英文 365 Pages
概要

当レポートでは、世界のHIV治療薬市場について調査分析し、疾患の概要とガイドライン、競合情勢、主要薬剤の詳細情報 (製品説明、安全性、有効性) 、SWOT分析、売上高予測、影響分析 (動向、促進要因・抑制要因) などについて、体系的な情報を提供しています。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因
  • 病態生理
  • 病期と症状
  • 予後
  • QOL

第4章 疫学

  • 疾患の背景
  • 危険因子と併存疾患
  • 世界の動向
    • 米国
    • EU5ヶ国
    • ブラジル、中国、日本
  • 予測手法
    • 利用した情報源
    • 利用しなかった情報源
    • 予測の前提条件と手法
  • 主要8か国のHIVの疫学予測
    • 有病者総数
    • 有病者総数:年齢別
    • 有病者総数:性別
    • 有病者総数:年齢調整
    • 抗レトロウイルス療法 (ART)
    • 妊婦
  • 日本のHIVの疫学予測
    • HIVと診断された有病者数
    • HIVと診断された有病者数:年齢別
    • HIVと診断された有病者数:性別
    • HIVと診断された有病者数:年齢調整
    • 抗レトロウイルス療法 (ART)
    • 妊婦
  • 議論
    • 疫学予測に関する考察
    • 分析の限界
    • 分析の強み

第5章 疾患の管理

  • 診断と治療の概要
  • 米国
  • EU5ヶ国
  • 日本
  • ブラジル
  • 中国

第6章 競合評価

第7章 アンメットニーズと機会

第8章 パイプライン評価

  • 概要
  • 臨床試験マッピング
  • 後期開発中の有望な薬剤
  • 初期開発中の有望な薬剤
  • その他

第9章 現在・将来の主要企業

  • 概要
  • 企業戦略の動向
  • 企業プロファイル

第10章 市場の見通し

  • 世界市場
  • 米国
  • EU5ヶ国
  • 日本
  • ブラジル
  • 中国

第11章 付録

図表

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目次
Product Code: GDHC135PIDR

Global HIV therapeutics market was worth approximately US$16.3 billion in 2015, and GlobalData projects this market to reach a total of US$22.5 billion in sales by 2025, at a Compound Annual Growth Rate (CAGR) of 3.3%.

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).

Some of the main drivers of the growth of the HIV market during the forecast period are expected to be -

  • The introduction of novel drugs-most notably, single-tablet regimens (STRs) and nucleotide reverse transcriptase inhibitor (NRTI)-free regimens with improved tolerability, a reduced pill burden, or increased efficacy.
  • An increasing number of people living with HIV who are treated with antiretroviral therapy (ART).
  • Increased efforts to identify new HIV infections through more aggressive screening and diagnostic policies, along with new and more sensitive diagnostic testing tools and methods.
  • Adoption of the test-and-treat approach to increase the number of patients on ART and reduce viral loads.

HIV market is dominated by the Big Pharma players, such as Gilead, ViiV Healthcare (a collaboration between GlaxoSmithKline [GSK], Pfizer, and Shionogi), Janssen, and Merck, and other companies that have carved out a niche in the existing marketplace. While some of the companies involved in the HIV marketplace have invested in their R&D to build exhaustive pipelines spanning all phases of clinical development, others, such as Bristol-Myers Squibb (BMS), moved out of the HIV market in favor of other disease markets, such as oncology.

Two of the most important persistent unmet needs with regard to the current HIV therapies are concerns about drug adverse effects and the need for drugs that are active against drug-resistant strains of HIV. Currently, it is relatively common for drug-resistant viral strains to force physicians to move patients from one therapy to the next, which can result in in the emergence of untreatable strains and restrict the use of the available drugs. This is especially a concern among patients who are treated with a multi-pill regimen, which negatively affects compliance rates.

The report "PharmaPoint: Human Immunodeficiency Virus (HIV) - Global Drug Forecast and Market Analysis to 2025" provides an overview of HIV, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

In particular, this report provides the following -

  • 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.

Companies mentioned in this report: Gilead Sciences, ViiV Healthcare,Merck & Co. , Janssen (Johnson & Johnson), Bristol-Myers Squibb, TaiMed Biologics, Cytodyn.

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.

Table of Contents

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 Tables

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

List of Figures

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
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