HIV Therapeutics in Major Developed Markets to 2019 – Limited Pipeline Efficacy Improvement, Patent Expirations and Stringent Healthcare Spending to Suppress Market Growth

Publisher Name :
Date: 14-Apr-2014
No. of pages: 170

Summary

The leading business intelligence provider GBI Research has released its latest research report, entitled,’HIV Therapeutics in Major Developed Markets to 2019 Limited Pipeline Efficacy Improvement, Patent Expirations and Stringent Healthcare Spending to Suppress Market Growth’. The report provides insights into the HIV (Human Immunodeficiency Virus) therapeutics market including market forecasts up to 2019. It provides an in-depth analysis of the major marketed products, as well as insights into the HIV therapeutics R&D pipeline. The report provides in-depth analysis of the unmet needs, drivers and barriers that affect the global HIV therapeutics market. The report analyzes the market for HIV therapeutics in eight major markets of the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain), Japan and Canada. The report discusses the global pipeline for all the HIV molecules across various stages of development. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts. GBI Research found that the HIV therapeutics market in the top seven markets was valued at $14.3 billion in 2012 and is projected to witness growth of 1.9% during the 2012–2019 forecast period to reach $16.3 billion.

Scope

The report analyzes treatment usage patterns, drug types available and pipeline and market forecasts across indications for HIV.The report covers and includes -

  • A brief introduction to HIV, including the symptoms, pathogenesis, risk factors and diagnosis
  • In-depth analysis of major glucose-lowering drugs for HIV, including analyses of their safety, efficacy, treatment patterns, strengths/weaknesses and overall commercial prospects. Includes a heat map comparing major drugs in terms of safety, efficacy and dosing parameters.
  • Comprehensive review of the pipeline for HIV therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets.
  • Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action
  • Multi-scenario forecast data for the market up to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and changes in disease epidemiology across key developed markets including the US, Japan, Germany, the UK, France, Italy, Spain and Canada
  • Discussion of the drivers and barriers for market growth

Reasons to buy

The report will enhance your decision-making capability. It will allow you to -

  • Align your product portfolio to the markets with high growth potential.
  • Develop market-entry and market expansion strategies by identifying the potential region and HIV/AIDS therapeutics market segments poised for strong growth.
  • Create a more tailored country strategy through the understanding of key drivers and barriers of the global HIV/AIDS therapeutics market.
  • Develop key strategic initiatives by understanding the key focus areas and top selling products of leading companies.
  • Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.

HIV Therapeutics in Major Developed Markets to 2019 – Limited Pipeline Efficacy Improvement, Patent Expirations and Stringent Healthcare Spending to Suppress Market Growth

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 9
2.1 Disease Introduction 9
2.2 Route of HIV Transmission 10
2.3 Etiology 10
2.4 Classification of HIV-1 Subtypes 11
2.5 Pathophysiology 11
2.5.1 HIV-1 Replication Cycle 12
2.5.2 Mechanism of CD4 T-Cell Death 13
2.5.3 Latent Infection and Viral Persistence 14
2.6 Symptoms 14
2.7 Diagnosis 15
2.7.1 HIV Antibody Assay 15
2.7.2 Rapid HIV Antibody Test 16
2.7.3 Western Blot 16
2.7.4 HIV p24 Antigen Test 16
2.7.5 Antigen-Antibody Immunoassay 16
2.7.6 Polymerase Chain Reaction Test 16
2.7.7 HIV Home-Testing Kit 17
2.8 Disease Staging 17
2.8.1 WHO Clinical Staging 17
2.8.2 Centers for Disease Control and Prevention Classification System 19
2.8.3 Immunological Classification 19
2.9 Co-morbidities and Complications 20
2.10 Epidemiology 21
2.11 Treatment Options 22
2.11.1 Nucleoside/Nucleotide Reverse Transcriptase Inhibitor 23
2.11.2 Non-Nucleoside Reverse Transcriptase Inhibitor 23
2.11.3 Entry Inhibitor 23
2.11.4 Integrase Inhibitor 23
2.11.5 HIV-1 Protease Inhibitor 24
2.11.6 Pharmacokinetic Enhancer 24
2.12 Treatment Algorithm 24

3 Marketed Products 29
3.1 Therapeutic Landscape 31
3.1.1 Multi-class Combinations 31
3.1.2 Nucleotide Reverse Transcriptase Inhibitors 35
3.1.3 Non-Nucleoside Reverse Transcriptase Inhibitor 44
3.1.4 HIV Protease Inhibitor 48
3.1.5 Integrase Inhibitor 55
3.1.6 Entry Inhibitor 57
3.2 Comparative Efficacy and Safety 60
3.2.1 Multi-class Combination 62
3.2.2 Nucleotide Reverse Transcriptase Inhibitor 62
3.2.3 Non-Nucleotide Reverse Transcriptase Inhibitor 63
3.2.4 HIV Protease Inhibitor 63
3.2.5 Integrase Inhibitor 64
3.2.6 Entry Inhibitor 64
3.3 Unmet Need 65

4 Pipeline for HIV 67
4.1 Overall Pipeline 67
4.2 Mechanism of Action in HIV Pipeline 70
4.3 Clinical Trials 72
4.3.1 Failure Rate of Developmental Pipeline 72
4.3.2 Clinical Trial Sizes 76
4.3.3 Clinical Trial Duration 80
4.3.4 Summary of Clinical Trial and Risk Analysis 84
4.4 Promising Candidates in Pipeline 85
4.4.1 572-Trii (dolutegravir + abacavir sulfate + lamivudine) – Shionogi-ViiV Healthcare 85
4.4.2 Atazanavir sulfate + cobicistat – Bristol-Myers Squibb, Gilead 86
4.4.3 Elvitegravir + cobicistat + emtricitabine + tenofovir alafenamide – Gilead 88
4.4.4 Apricitabine – Avexa 90
4.4.5 Remune (IR-103) – Immune Response BioPharma 91
4.4.6 Censavudine – Bristol-Myers Squibb 93
4.4.7 Elvucitabine – Achillion 94
4.4.8 Cenicriviroc – Tobira Therapeutics 95
4.5 Heat Map and Competitor Matrix for HIV Pipeline Products 97

5 Market Forecast to 2019 103
5.1 Geographical Markets 103
5.1.1 Global Market 106
5.1.2 North America 107
5.1.3 Top Five Countries in Europe 112
5.1.4 Japan 117
5.2 Drivers and Barriers 119
5.2.1 Drivers 119
5.2.2 Barriers 120

6 Deals and Strategic Consolidations 122
6.1 Major Co-development Deals 122
6.1.1 DFH Pharma Enters Agreement with Hetero Drugs 124
6.1.2 GlaxoSmithKline Enters Agreement with Concert Pharmaceuticals 125
6.1.3 GenVec Enters Agreement with SAIC-Frederick 125
6.2 Major Licensing Deals 125
6.2.1 Merck Enters Agreement with Chimerix 128
6.2.2 Bristol-Myers Squibb Enters Agreement with Gilead 128
6.2.3 Japan Tobacco Enters Agreement with Gilead 129
6.2.4 Gilead Enters Agreement with Tibotec 129
6.2.5 Benitec Enters Agreement with Calimmune 129
6.2.6 Bristol-Myers Squibb Enters Agreement with Oncolys BioPharma 129

7 Appendix 130
7.1 All Pipeline Products, by Phase 130
7.1.1 Discovery 130
7.1.2 Preclinical 137
7.1.3 Phase I 142
7.1.4 Phase II 145
7.1.5 Phase III and Pre-registration 148
7.2 Tabular Forecast Data 149
7.2.1 Global 149
7.2.2 US 149
7.2.3 Canada 150
7.2.4 UK 150
7.2.5 France 150
7.2.6 Germany 151
7.2.7 Italy 151
7.2.8 Spain 152
7.2.9 Japan 152
7.3 Sources 153
7.4 Market Definition 164
7.5 Abbreviations 164
7.6 Research Methodology 167
7.6.1 Coverage 167
7.6.2 Secondary Research 167
7.7 Therapeutic Landscape 167
7.8 Epidemiology-Based Forecasting 168
7.9 Market Size by Geography 169
7.10 Geographical Landscape 169
7.11 Pipeline Analysis 170
7.12 Competitive Landscape 170
7.12.1 Expert Panel Validation 170
7.13 Contact Us 170
7.14 Disclaimer 170

List of Tables

Table 1: HIV Therapeutics Market, Subtypes of HIV-1 and Geographical Patterns, 2013 11
Table 2: HIV Therapeutics Market, World Health Organization’s Clinical Staging of HIV/AIDS for Adults and Adolescents with Confirmed HIV Infection, 2014 18
Table 3: HIV Therapeutics Market, US Centers for Disease Control and Prevention’s Classification System for Adults and Adolescents with HIV, 1993–2014 19
Table 4: HIV Therapeutics Market, World Health Organization’s Immunological Classification for Adults and Children with Established HIV, 2014 20
Table 5: HIV Therapeutics Market, Global, Expected Patent Expirations in the HIV Market, 2013–2019 104
Table 6: All Pipeline Products, by Phase, Discovery 130
Table 7: All Pipeline Products, by Phase, Preclinical 137
Table 8: All Pipeline Products, by Phase, Phase I 142
Table 9: All Pipeline Products, by Phase, Phase II 145
Table 10: All Pipeline Products, by Phase, Phase III and Pre-registration 148
Table 11: HIV Theraputic Market, Global, Market Forecast, 2012-2019 149
Table 12: HIV Therapeutic Market, US, Market Forecast, 2012-2019 149
Table 13: HIV Therapeutic Market, Canada, Market Forecast, 2012-2019 150
Table 14: HIV Therapeutic Market, UK, Market Forecast, 2012-2019 150
Table 15: HIV Therapeutic Market, France, Market Forecast, 2012-2019 150
Table 16: HIV Therapeutic Market, Germany, Market Forecast, 2012-2019 151
Table 17: HIV Therapeutic Market, Italy, Market Forecast, 2012-2019 151
Table 18: HIV Therapeutic Market, Spain, Market Forecast, 2012-2019 152
Table 19: HIV Therapeutic Market, Japan, Market Forecast, 2012-2019 152

List of Figures

Figure 1: HIV Therapeutics Market, Treatment Algorithm for HIV-infected Adults and Adolescents under World Health Organization Guidelines, 2013 26
Figure 2: HIV Therapeutics Market, Treatment Algorithm for Infants and Children with HIV under World Health Organization Guidelines, 2013 27
Figure 3: HIV Therapeutics Market, Global, Annual Sales of Key Marketed Products ($bn), 2013 30
Figure 4: HIV Therapeutics Market, Global, Annual Sales of Atripla ($bn), 2006–2013 31
Figure 5: HIV Therapeutics Market, Global, Annual Sales of Complera ($m), 2011–2013 34
Figure 6: HIV Therapeutics Market, Global, Annual Sales of Truvada ($bn), 2004–2013 36
Figure 7: HIV Therapeutics Market, Global, Annual Sales of Epzicom ($m), 2004–2013 37
Figure 8: HIV Therapeutics Market, Global, Annual Sales of Viread ($m), 2001–2013 39
Figure 9: HIV Therapeutics Market, Global, Annual Sales of Combivir ($m), 2000–2013 40
Figure 10: HIV Therapeutics Market, Global, Annual Sales of Trizivir ($m), 2000–2013 41
Figure 11: HIV Therapeutics Market, Global, Annual Sales of Epivir ($m), 1996–2013 43
Figure 12: HIV Therapeutics Market, Global, Annual Sales of Sustiva ($m), 2001–2013 45
Figure 13: HIV Therapeutics Market, Global, Annual Sales of Intelence ($m), 2010–2013 47
Figure 14: HIV Therapeutics Market, Global, Annual Sales of Reyataz ($m), 2003–2013 49
Figure 15: HIV Therapeutics Market, Global, Annual Sales of Prezista ($m), 2006–2013 51
Figure 16: HIV Therapeutics Market, Global, Annual Sales of Kaletra ($bn), 2009–2012 53
Figure 17: HIV Therapeutics Market, Global, Annual Sales of Norvir ($m), 2010–2012 54
Figure 18: HIV Therapeutics Market, Global, Annual Sales of Isentress ($m), 2007–2013 57
Figure 19: HIV Therapeutics Market, Global, Annual Sales of Selzentry ($m), 2010–2013 59
Figure 20: HIV Therapeutics Market, Global, Heat Map of Marketed Products, 2013 61
Figure 21: HIV Therapeutics Market, Global, Overall Pipeline, 2014 68
Figure 22: HIV Therapeutics Market, Global, Breakdown of Biologics and Vaccine, 2014 69
Figure 23: HIV Therapeutics Market, Global, Mechanism of Action in the Pipeline, 2014 70
Figure 24: HIV Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006–2013 73
Figure 25: HIV Therapeutics Market, Global, Clinical Trial Failure Rate by Mechanism of Action, 2006–2013 75
Figure 26: HIV Therapeutics Market, Global, Clinical Trial Failure Reasons, 2006–2013 76
Figure 27: HIV Therapeutics Market, Global, Mean Recruitment Size of Clinical Trial by Molecule Type (Participants), 2006–2013 77
Figure 28: HIV Therapeutics Market, Global, Mean Recruitment Size of Clinical Trial by Mechanism of Action (Participants), 2006–2013 79
Figure 29: HIV Therapeutics Market, Global, Mean Duration of Clinical Trial by Molecule Type (Months), 2006–2013* 81
Figure 30: HIV Therapeutics Market, Global, Mean Duration of clinical Trial by Mechanism of Action (Months), 2006–2013 83
Figure 31: HIV Therapeutics Market, Global, Failure Rate, Duration and Recruitment Size by Mechanism of Action, 2006–2013 84
Figure 32: HIV Therapeutics Market, Global, Sales Forecast for 572-Trii ($bn), 2014–2019 86
Figure 33: HIV Therapeutics Market, Global, Sales Forecast for Atazanavir Sulfate + Cobicistat ($m), 2014–2019 88
Figure 34: HIV Therapeutics Market, Global, Sales Forecast for Elvitegravir + Cobicistat + Emtricitabine + Tenofovir Alafenamide ($m), 2015–2019 89
Figure 35: HIV Therapeutics Market, Global, Sales Forecast for Apricitabine ($m), 2016–2019 91
Figure 36: HIV Therapeutics Market, Global, Sales Forecast for Censavudine ($m), 2016–2019 93
Figure 37: HIV Therapeutics Market, Global, Sales Forecast for Elvucitabine ($m), 2016–2019 95
Figure 38: HIV Therapeutics Market, Global, Sales Forecast for Cenicriviroc ($m), 2016–2019 96
Figure 39: HIV Therapeutics Market, Global, Heat Map of Pipeline Products, 2013 98
Figure 40: HIV Therapeutics Market, Global, Competitor Matrix, 2013 99
Figure 41: HIV Therapeutics Market, Global, Treatment Patterns and Market Size, 2012–2019 106
Figure 42: HIV Therapeutics Market, North America, Treatment Patterns, 2012–2019 108
Figure 43: HIV Therapeutics Market, North America, Annual Cost of Therapy ($), 2012–2019 110
Figure 44: HIV Therapeutics Market, North America, Market Size, 2012–2019 111
Figure 45: HIV Therapeutics Market, Top Five European Countries, Treatment Patterns (‘000), 2012–2019 112
Figure 46: HIV Therapeutics Market, Top Five European Countries, Annual Cost of Therapy ($), 2012–2019 114
Figure 47: HIV Therapeutics Market, Top Five European Countries, Market Size ($m), 2012–2019 116
Figure 48: HIV Therapeutics Market, Japan, Treatment Patterns and Annual Cost of Therapy, 2012–2019 117
Figure 49: HIV Therapeutics Market, Japan, Market Size ($m), 2012–2019 119
Figure 50: HIV Therapeutics Market, Global, Co-development Deals, 2006–2014* 123
Figure 51: HIV Therapeutics Market, Global, Co-development Deals, 2006–2014 124
Figure 52: HIV Therapeutics Market, Global, Licensing Deals, 2006–2014* 126
Figure 53: HIV Therapeutics Market, Global, Licensing Deals, 2006–2014 127
Figure 54: HIV Therapeutics Market, Global, Licensing Deals by Mechanism of Action, 2006–2014 128
Figure 55: GBI Research Market Forecasting Model 169

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