NEW YORK, April 16, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Elvitegravir (HIV) - Forecast and Market Analysis to 2022
Elvitegravir (HIV) - Forecast and Market Analysis to 2022
Summary
GlobalData has released its new PharmaPoint Drug Evaluation report, "Elvitegravir (HIV) - Forecast and Market Analysis to 2022". Human Immunodeficiency Virus (HIV), the causative agent of AIDS, has claimed millions of lives since its emergence. However, the advent of antiretroviral therapy (ART) has transformed the face of HIV/AIDS from a deadly disease to a manageable chronic condition for most infected individuals. Antiretroviral treatment not only reduces the viral load and reconstitutes immune function, but also decreases infection incidence rates by limiting viral transmission. The treatment algorithm in HIV has characteristically involved multiple drug regimens designed to tackle the virus on different levels. In the recent past, simplified dosing regimens through the emergence of single tablet regimens (STRs) or fixed dose combination (FDC) therapies have become increasingly popular amongst physicians and patients alike by increasing clinical efficacy thresholds and enabling patient compliance.
Gilead obtained the exclusive global marketing rights (excluding Japan) for elvitegravir from Japan Tobacco in 2005. Elvitegravir would be the second INI after Merck's Isentress (raltegravir), which was launched in the US and Europe in 2007, in Japan and Brazil in 2008, and in China 2009 (Merck, 2012a). INI's mechanism of action involves inhibiting the catalytic activity of HIV integrase, an enzyme that is required for viral replication, which blocks HIV from integrating its DNA into the host cell genome. This prevents HIV from replicating (Isentress Highlights of Prescribing Information, 2012). INIs are an attractive antiretroviral class due to their favorable side effect profile compared with NNRTIs and PIs. Unlike Isentress, which requires two doses a day, elvitegravir is administered once daily, but requires boosting by a PK enhancer, such as AbbVie's ritonavir or Gilead's cobicistat, in order to delay the metabolism of elvitegravir by cytochrome P450 enzymes (Mathias et al., 2009). Elvitegravir has been approved as a component of Gilead's single-pill regimen, Stribild (elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine), which was approved by the FDA in 2012 and currently under review in the EU and Japan. Elvitegravir is also being developed as a standalone compound, for which an NDA was submitted to the FDA in June 2012 (Gilead Sciences, press release, June 27, 2012). GlobalData estimates that elvitegravir will be launched as a standalone drug in 2013.
Scope
- Overview of HIV, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Elvitegravir including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Elvitegravir for the top nine countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Brazil and China
Reasons to buy
- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for HIV
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of Elvitegravir performance
- Obtain sales forecast for Elvitegravir from 2012-2022 in top nine countries (the US, France, Germany, Italy, Spain, the UK, Japan, Brazil and China)
Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 8
3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 13
3.1.3 Prognosis 13
3.1.4 Quality of Life 14
3.2 Symptoms 14
3.2.1 Primary or Acute Infection 14
3.2.2 Chronic Infection 14
3.2.3 Advanced Infection/AIDS 15
4 Disease Management 16
4.1 Treatment Overview 16
5 Competitive Assessment 20
5.1 Overview 20
5.2 Strategic Competitor Assessment 20
6 Opportunity and Unmet Need 23
6.1 Overview 23
6.1.1 Simplified regimens and dosing frequency 23
6.1.2 Side effects and toxicities 24
6.1.3 Drug resistance 24
6.1.4 Prophylaxis 25
6.1.5 Lack of functional cure 25
6.1.6 Patient awareness 26
6.1.7 Treatment availability 26
6.1.8 Treatment affordability 27
6.2 Unmet Needs Gap Analysis 27
6.3 Opportunities 29
6.3.1 Development of treatments to counter drug resistance 29
6.3.2 Collaborations to develop newer STRs 29
6.3.3 Development of new injectable formulations 29
6.3.4 Development of new prophylactics 30
6.3.5 Development of drugs that use a novel mechanism of action 30
6.3.6 Public-Private Partnerships 30
7 Pipeline Assessment 31
7.1 Overview 31
7.2 Promising Drugs in Clinical Development 33
8 Elvitegravir 35
8.1 Overview 35
8.2 Efficacy 36
8.3 Safety 37
8.4 Dosing and Formulation 37
8.5 Potential Clinical Positioning 37
8.6 Potential Commercial Positioning 37
8.7 Pricing and Reimbursement 38
8.8 SWOT Analysis 38
8.9 Forecast 40
9 Appendix 41
9.1 Bibliography 41
9.2 Abbreviations 45
9.3 Methodology 47
9.4 Forecasting Methodology 47
9.4.1 HIV Prevalence 47
9.4.2 Percent Drug-Treated Patients 47
9.4.3 General Pricing Assumptions 48
9.4.4 Generic Erosion 49
9.4.5 Pricing of Pipeline agents 49
9.5 Physicians and Specialists Included in this Study 50
9.5.1 Survery of Prescribing Physicians 51
9.6 About the Authors 52
9.6.1 Authors 52
9.6.2 Global Head of Healthcare 53
9.7 About GlobalData 54
9.8 Contact Us 54
9.9 Disclaimer 54
List of Tables
Table 1: Symptoms HIV 15
Table 2: Treatment Guidelines for HIV 17
Table 3: Most Prescribed Drugs for HIV by Class in the Global Markets, 2012 18
Table 4: Leading Treatments for HIV, 2012 22
Table 5: Overall Unmet Needs – Current Level of Attainment 23
Table 6: Clinical Unmet Needs – Gap Analysis, 2012 28
Table 7: HIV – Promising Drugs in Clinical Development, 2012 33
Table 8: Comparison of Therapeutic Classes in Development for HIV, 2012 34
Table 9: Product Profile – Elvitegravir 36
Table 10: Elvitegravir SWOT Analysis, 2012 39
Table 11: Global Sales Forecasts ($m) for elvitegravir, 2012–2022 40
Table 12: Physicians Surveyed, By Country 51
List of Figures
Figure 1: HIV Lifecycle 11
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2012–2022 33
To order this report:
Drug_and_Medication Industry: Elvitegravir (HIV) - Forecast and Market Analysis to 2022
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