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

  • ID: 2814131
  • Report
  • Region: Global
  • 170 Pages
  • GBI Research
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Patent Protection Losses Will Hinder HIV Treatment Market Growth Within Seven Years
'HIV Therapeutics in Major Developed Markets to 2019 - Limited Pipeline Efficacy Improvement, Patent Expirations and Stringent Healthcare Spending to Suppress Market Growth' 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 a team of industry experts. The authors 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.
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1 Table of Contents
1.1 List of Tables
1.2 List of Figures

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

3 Marketed Products
3.1 Therapeutic Landscape
3.1.1 Multi-class Combinations
3.1.2 Nucleotide Reverse Transcriptase Inhibitors
3.1.3 Non-Nucleoside Reverse Transcriptase Inhibitor
3.1.4 HIV Protease Inhibitor
3.1.5 Integrase Inhibitor
3.1.6 Entry Inhibitor
3.2 Comparative Efficacy and Safety
3.2.1 Multi-class Combination
3.2.2 Nucleotide Reverse Transcriptase Inhibitor
3.2.3 Non-Nucleotide Reverse Transcriptase Inhibitor
3.2.4 HIV Protease Inhibitor
3.2.5 Integrase Inhibitor
3.2.6 Entry Inhibitor
3.3 Unmet Need

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

5 Market Forecast to 2019
5.1 Geographical Markets
5.1.1 Global Market
5.1.2 North America
5.1.3 Top Five Countries in Europe
5.1.4 Japan
5.2 Drivers and Barriers
5.2.1 Drivers
5.2.2 Barriers

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

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

1.1 List of Tables

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

1.2 List of Figures

Figure 1: HIV Therapeutics Market, Treatment Algorithm for HIV-infected Adults and Adolescents under World Health Organization Guidelines, 2013
Figure 2: HIV Therapeutics Market, Treatment Algorithm for Infants and Children with HIV under World Health Organization Guidelines, 2013
Figure 3: HIV Therapeutics Market, Global, Annual Sales of Key Marketed Products ($bn), 2013
Figure 4: HIV Therapeutics Market, Global, Annual Sales of Atripla ($bn), 2006–2013
Figure 5: HIV Therapeutics Market, Global, Annual Sales of Complera ($m), 2011–2013
Figure 6: HIV Therapeutics Market, Global, Annual Sales of Truvada ($bn), 2004–2013
Figure 7: HIV Therapeutics Market, Global, Annual Sales of Epzicom ($m), 2004–2013
Figure 8: HIV Therapeutics Market, Global, Annual Sales of Viread ($m), 2001–2013
Figure 9: HIV Therapeutics Market, Global, Annual Sales of Combivir ($m), 2000–2013
Figure 10: HIV Therapeutics Market, Global, Annual Sales of Trizivir ($m), 2000–2013
Figure 11: HIV Therapeutics Market, Global, Annual Sales of Epivir ($m), 1996–2013
Figure 12: HIV Therapeutics Market, Global, Annual Sales of Sustiva ($m), 2001–2013
Figure 13: HIV Therapeutics Market, Global, Annual Sales of Intelence ($m), 2010–2013
Figure 14: HIV Therapeutics Market, Global, Annual Sales of Reyataz ($m), 2003–2013
Figure 15: HIV Therapeutics Market, Global, Annual Sales of Prezista ($m), 2006–2013
Figure 16: HIV Therapeutics Market, Global, Annual Sales of Kaletra ($bn), 2009–2012
Figure 17: HIV Therapeutics Market, Global, Annual Sales of Norvir ($m), 2010–2012
Figure 18: HIV Therapeutics Market, Global, Annual Sales of Isentress ($m), 2007–2013
Figure 19: HIV Therapeutics Market, Global, Annual Sales of Selzentry ($m), 2010–2013
Figure 20: HIV Therapeutics Market, Global, Heat Map of Marketed Products, 2013
Figure 21: HIV Therapeutics Market, Global, Overall Pipeline, 2014
Figure 22: HIV Therapeutics Market, Global, Breakdown of Biologics and Vaccine, 2014
Figure 23: HIV Therapeutics Market, Global, Mechanism of Action in the Pipeline, 2014
Figure 24: HIV Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006–2013
Figure 25: HIV Therapeutics Market, Global, Clinical Trial Failure Rate by Mechanism of Action, 2006–2013
Figure 26: HIV Therapeutics Market, Global, Clinical Trial Failure Reasons, 2006–2013
Figure 27: HIV Therapeutics Market, Global, Mean Recruitment Size of Clinical Trial by Molecule Type (Participants), 2006–2013
Figure 28: HIV Therapeutics Market, Global, Mean Recruitment Size of Clinical Trial by Mechanism of Action (Participants), 2006–2013
Figure 29: HIV Therapeutics Market, Global, Mean Duration of Clinical Trial by Molecule Type (Months), 2006–2013*
Figure 30: HIV Therapeutics Market, Global, Mean Duration of clinical Trial by Mechanism of Action (Months), 2006–2013
Figure 31: HIV Therapeutics Market, Global, Failure Rate, Duration and Recruitment Size by Mechanism of Action, 2006–2013
Figure 32: HIV Therapeutics Market, Global, Sales Forecast for 572-Trii ($bn), 2014–2019
Figure 33: HIV Therapeutics Market, Global, Sales Forecast for Atazanavir Sulfate + Cobicistat ($m), 2014–2019
Figure 34: HIV Therapeutics Market, Global, Sales Forecast for Elvitegravir + Cobicistat + Emtricitabine + Tenofovir Alafenamide ($m), 2015–2019
Figure 35: HIV Therapeutics Market, Global, Sales Forecast for Apricitabine ($m), 2016–2019
Figure 36: HIV Therapeutics Market, Global, Sales Forecast for Censavudine ($m), 2016–2019
Figure 37: HIV Therapeutics Market, Global, Sales Forecast for Elvucitabine ($m), 2016–2019
Figure 38: HIV Therapeutics Market, Global, Sales Forecast for Cenicriviroc ($m), 2016–2019
Figure 39: HIV Therapeutics Market, Global, Heat Map of Pipeline Products, 2013
Figure 40: HIV Therapeutics Market, Global, Competitor Matrix, 2013
Figure 41: HIV Therapeutics Market, Global, Treatment Patterns and Market Size, 2012–2019
Figure 42: HIV Therapeutics Market, North America, Treatment Patterns, 2012–2019
Figure 43: HIV Therapeutics Market, North America, Annual Cost of Therapy ($), 2012–2019
Figure 44: HIV Therapeutics Market, North America, Market Size, 2012–2019
Figure 45: HIV Therapeutics Market, Top Five European Countries, Treatment Patterns (‘000), 2012–2019
Figure 46: HIV Therapeutics Market, Top Five European Countries, Annual Cost of Therapy ($), 2012–2019
Figure 47: HIV Therapeutics Market, Top Five European Countries, Market Size ($m), 2012–2019
Figure 48: HIV Therapeutics Market, Japan, Treatment Patterns and Annual Cost of Therapy, 2012–2019
Figure 49: HIV Therapeutics Market, Japan, Market Size ($m), 2012–2019
Figure 50: HIV Therapeutics Market, Global, Co-development Deals, 2006–2014*
Figure 51: HIV Therapeutics Market, Global, Co-development Deals, 2006–2014
Figure 52: HIV Therapeutics Market, Global, Licensing Deals, 2006–2014*
Figure 53: HIV Therapeutics Market, Global, Licensing Deals, 2006–2014
Figure 54: HIV Therapeutics Market, Global, Licensing Deals by Mechanism of Action, 2006–2014
Figure 55: Authors Market Forecasting Model
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Patent Protection Losses Will Hinder HIV Treatment Market Growth Within Seven Years, says GBI Research

Thanks to patent expirations of several key therapies, the Human Immunodeficiency Virus (HIV) treatment market value will increase at a slow pace in the coming years, from $14.3 billion in 2012 to $16.3 billion by 2019, at a Compound Annual Growth Rate (CAGR) of 1.9%

According to the company's latest report, the first-line antiretroviral therapies Atripla and Truvada will lose patent protection during the forecast period, which will hurt their markets in Europe and Canada.

Angel Wong, report analyst, says: “Despite such patent losses, a number of drugs will enter the HIV market by 2019. Among these new entrants, 572-Trii is expected to perform the strongest commercially and will compete with Atripla following its approval. However, these drugs will not offset the impact of generic erosion.”

Currently, the HIV pipeline is strong and displays a high degree of novelty and diversity, according to the authors. The pipeline also consists of therapies that address the unmet needs of drug resistance and toxicity. These drugs are Nucleoside Reverse Transcriptase Inhibitor (NRTI) apricitabine, censavudine and elvucitabine, which deal with the issue of NRTI resistance.

Another candidate in the HIV pipeline, which is a new pro-drug of tenofovir, called tenofovir alafenamide, has also demonstrated a more favorable toxicity profile than its predecessor Viread.

Wong says: “Despite the promising outlook, the HIV pipeline has suffered from high attrition rates in recent years, particularly with vaccines. None of these have been approved for the treatment of HIV. These failures reflect an urgent need for a more thorough understanding of immune response against HIV and more streamlined clinical trial designs,” the analyst concludes.

This report analyzes treatment usage patterns, drug types available and pipeline and market forecasts across indications for HIV. Countries covered in this report include the US, France, Germany, Italy, Spain, the UK, Japan and Canada.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by a team of industry experts.
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