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市場調查報告書

HIV (人類免疫缺乏病毒):歐洲主要5國(5EU)的醫藥品市場預測與分析

Human Immunodeficiency Virus (HIV) - 5EU Drug Forecast and Market Analysis to 2023

出版商 GlobalData 商品編碼 370556
出版日期 內容資訊 英文 305 Pages
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HIV (人類免疫缺乏病毒):歐洲主要5國(5EU)的醫藥品市場預測與分析 Human Immunodeficiency Virus (HIV) - 5EU Drug Forecast and Market Analysis to 2023
出版日期: 2015年09月09日 內容資訊: 英文 305 Pages
簡介

本報告提供歐洲的主要國家 (法國·德國·義大利·西班牙·英國) 的HIV (人類免疫缺乏病毒)治療藥臨床實驗趨勢與上市預測相關分析,提供您HIV概要 (病因·病理·症狀·診斷方法等) ,及目前的主要治療方法,現在臨床實驗中/已上市的開發中產品概要 (功效,SWOT分析及其它),市場規模預測 (總計11年份),主要推動市場要素等調查評估。

第1章 目錄

第2章 簡介

  • 分析的背景情況
  • 相關報告
  • 近日出版的相關報告

第3章 疾病概要

  • 病因
    • 病毒的生命週期
  • 病理生理學
  • 分期·症狀
    • 一次感染/急性感染疾病
    • 慢性感染疾病
  • 預後
  • 生活品質 (QoL)

第4章 疾病管理

  • 診斷·治療方法概要
    • 篩檢·診斷
    • 治療指南有代表性的處方藥
    • 臨床診療
  • (5EU)歐洲主要5個國家
    • 篩檢·診斷
    • 臨床診療

第5章 競爭力的評估

  • 概要
  • 產品簡介 - 領導品牌,STR (單一藥錠·治療方案)
  • 產品簡介 - 領導品牌,固定劑量複方藥物 (FDC)
  • 產品簡介 - 領導品牌,蛋白分解酵素抑制劑 (PI)
  • 產品簡介 - 領導品牌,Integrase抑制劑
  • 產品簡介 - 領導品牌,藥理加強劑
  • 其他的治療藥物級

第6章 未滿足需求·市場機會分析

第7章 開發中產品的評估

  • 概要
  • 臨床實驗的製圖
  • 臨床實驗的後期階段產品潛力醫藥品
  • 臨床實驗的初期階段有潛力的醫藥品
  • 其他臨床實驗階段的醫藥品

第8章 市場未來展望

  • (5EU)歐洲主要5個國家
    • 預測
    • 近幾年主要的事件
    • 市場促進·阻礙因素

第9章 附錄

目錄
Product Code: GDHC314CFR

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). This rapid progress has been headlined by the emergence of once-daily, single-tablet regimens (STRs) such as Gilead Science's Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate [TDF]), which offer patients an unparalleled level of convenience.

Gilead's first-in-class, NNRTI-based STR, Atripla, performed well, with its 2013 sales in the 5EU topping $830m (26% market share), despite competing in a highly fragmented market that featured over 18 different drugs spanning all classes of antiretrovirals, many of which, particularly NRTIs and NNRTIs, had already lost patent protection. Since Atripla's successful 5EU launch in 2007, companies have strived to develop STRs for this market, and these novel products are anticipated to heavily influence the future market dynamics.

Scope

  • Overview of Human Immunodeficiency Virus (HIV) including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on the key drugs in the 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in the 5EU from 2013-2023.
  • Analysis of the impact of key events as well the drivers and restraints affecting the 5EU Human Immunodeficiency Virus (HIV) market.

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 Human Immunodeficiency Virus (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 drug performance
  • Obtain sales forecast for drugs from 2013-2023 in the 5EU

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology
    • 3.1.1. Viral Lifecycle
  • 3.2. Pathophysiology
  • 3.3. Staging and Symptoms
    • 3.3.1. Primary or Acute Infection
    • 3.3.2. Chronic Infection
    • 3.3.3. Advanced Infection/AIDS
  • 3.4. Prognosis
  • 3.5. Quality of Life

4. Disease Management

  • 4.1. Diagnosis and Treatment Overview
    • 4.1.1. Screening and Diagnosis
    • 4.1.2. Treatment Guidelines and Leading Prescribed Drugs
    • 4.1.3. Clinical Practice
  • 4.2. 5EU
    • 4.2.1. Screening and Diagnosis
    • 4.2.2. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Product Profiles - Major Brands, Single-Tablet Regimens (STRs)
    • 5.2.1. Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
    • 5.2.2. Complera (emtricitabine/TDF/rilpivirine)
    • 5.2.3. Stribild (elvitegravir/cobicistat/TDF/emtricitabine)
    • 5.2.4. Triumeq (dolutegravir/abacavir/lamivudine)
  • 5.3. Product Profiles - Major Brands, Fixed-Dose Combinations
    • 5.3.1. Truvada (TDF/emtricitabine)
    • 5.3.2. Epzicom (abacavir/lamivudine)
    • 5.3.3. Kaletra (lopinavir/ritonavir)
    • 5.3.4. Prezcobix (darunavir/cobicistat)
    • 5.3.5. Evotaz (atazanavir sulfate/cobicistat)
  • 5.4. Product Profiles - Major Brands, Protease Inhibitors
    • 5.4.1. Reyataz (atazanavir)
    • 5.4.2. Prezista (darunavir)
  • 5.5. Product Profiles - Major Brands, Integrase Inhibitors
    • 5.5.1. Isentress (raltegravir)
    • 5.5.2. Tivicay (dolutegravir)
    • 5.5.3. Vitekta (elvitegravir)
  • 5.6. Product Profiles - Major Brands, Pharmacokinetic Enhancers
    • 5.6.1. Norvir (ritonavir)
    • 5.6.2. Tybost (cobicistat)
  • 5.7. Other Therapeutic Classes
    • 5.7.1. Entry Inhibitors

6. Unmet Need and Opportunity

  • 6.1. Overview
  • 6.2. Therapies with Improved Safety and Tolerability Profiles
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Simplified PI-Based ART Regimens with a Reduced Pill Burden
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Enhanced Public Awareness Initiatives Focused on Minimizing the Stigma Associated with HIV
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Improved Physician Education Tools That Emphasize the Importance of Early Testing and Diagnosis
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Safe and Efficacious Therapies for Patients with Drug-Resistant HIV Strains
    • 6.6.1. Unmet Need
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity
  • 6.7. Long-Acting Regimens That Require Less Frequent Administration
    • 6.7.1. Unmet Need
    • 6.7.2. Gap Analysis
    • 6.7.3. Opportunity
  • 6.8. Improved Access to Treatment
    • 6.8.1. Unmet Need
    • 6.8.2. Gap Analysis
    • 6.8.3. Opportunity
  • 6.9. Progress Towards a Functional Cure
    • 6.9.1. Unmet Need
    • 6.9.2. Gap Analysis
    • 6.9.3. Opportunity

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Clinical Trial Mapping
    • 7.2.1. Clinical Trials by Country
  • 7.3. Promising Drugs in Late-Stage Clinical Development
    • 7.3.1. Quad 2(elvitegravir/cobicistat/emtricitabine/TAF)
    • 7.3.2. Darunavir/Cobicistat/Emtricitabine/TAF
    • 7.3.3. Emtricitabine/TAF
    • 7.3.4. Dutrebis (raltegravir/lamivudine)
    • 7.3.5. Doravirine (MK-1439)
  • 7.4. Promising Drugs in Early-Stage Clinical Development
  • 7.5. Other Drugs in Clinical Development

8. Market Outlook

  • 8.1. 5EU
    • 8.1.1. Forecast
    • 8.1.2. Key Events
    • 8.1.3. Drivers and Barriers

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Total Prevalent Cases of HIV
    • 9.4.2. 20-Year Diagnosed Prevalent Cases of HIV
    • 9.4.3. HIV Cases Treated with ART
    • 9.4.4. Drugs Included in Each Therapeutic Class
    • 9.4.5. Launch and Patent Expiry Dates
    • 9.4.6. General Pricing Assumptions
    • 9.4.7. Individual Drug Assumptions
    • 9.4.8. Generic Erosion
    • 9.4.9. Pricing of Pipeline Agents
  • 9.5. Primary Research - KOLs Interviewed for This Report
  • 9.6. Primary Research - Prescriber Survey
  • 9.7. About the Authors
    • 9.7.1. Analyst
    • 9.7.2. Epidemiologists
    • 9.7.3. Therapy Area Director
    • 9.7.4. Global Director of Therapy Analysis and Epidemiology
    • 9.7.5. Global Head of Healthcare
  • 9.8. About GlobalData
  • 9.9. Disclaimer

List of Tables

  • Table 1: Symptoms of HIV-1 Infection and AIDS
  • Table 2: Treatment Guidelines for HIV-1 Used in the 9MM
  • Table 3: Most Commonly Prescribed Drugs for HIV-1 by Class in the 9MM, 2013
  • Table 4: Diagnosis and Treatment of HIV Infection, Country Profile - 5EU
  • Table 5: CD4+ Thresholds and Corresponding Recommendations for the Initiation of ART in Asymptomatic Patients in the 5EU
  • Table 6: Switching of ART Regimens in the 5EU, 2013
  • Table 7: Leading Branded Treatments for HIV, 2013
  • Table 8: Product Profile - Atripla
  • Table 9: Antiviral Efficacy of Atripla Compared with Combivir-Efavirenz Combination Therapy
  • Table 10: Atripla's Safety - Adverse Reactions Reported in a 144-Week Clinical Study
  • Table 11: Atripla SWOT Analysis, 2014
  • Table 12: Sales Forecasts ($m) for Atripla, 2013-2023
  • Table 13: Product Profile - Complera
  • Table 14: ECHO and THRIVE Studies of the Complera and Atripla Multi-Tablet Regimens
  • Table 15: Complera SWOT Analysis, 2014
  • Table 16: Sales Forecasts ($m) for Complera, 2013-2023
  • Table 17: Product Profile - Stribild
  • Table 18: Pivotal Phase III Trials of Stribild in Treatment-NaIve Patients
  • Table 19: Stribild's Adverse Reactions - Pooled Results From the Two Phase III Clinical Trials
  • Table 20: Stribild SWOT Analysis, 2014
  • Table 21: Sales Forecasts ($m) for Stribild, 2013-2023
  • Table 22: Product Profile - Triumeq
  • Table 23: Virologic Efficacy of Triumeq in the Phase III SINGLE Study
  • Table 24: Triumeq's Safety - Adverse Reactions Reported at 96 Weeks in the SINGLE Study
  • Table 25: Triumeq SWOT Analysis, 2014
  • Table 26: Sales Forecasts ($m) for Triumeq, 2013-2023
  • Table 27: Product Profile - Truvada
  • Table 28: Truvada's Efficacy - Results of the SWIFT Trial at 48 Weeks
  • Table 29: Truvada SWOT Analysis, 2014
  • Table 30: Sales Forecasts ($m) for Truvada, 2013-2023
  • Table 31: Product Profile - Epzicom
  • Table 32: Epzicom SWOT Analysis, 2014
  • Table 33: Sales Forecasts ($m) for Epzicom, 2013-2023
  • Table 34: Product Profile - Kaletra
  • Table 35: Kaletra SWOT Analysis, 2014
  • Table 36: Sales Forecasts ($m) for Kaletra, 2013-2023
  • Table 37: Product Profile - Prezcobix
  • Table 38: Efficacy of Prezcobix in the Phase III Trial
  • Table 39: Prezcobix SWOT Analysis, 2014
  • Table 40: Sales Forecasts ($m) for Prezcobix, 2013-2023
  • Table 41: Product Profile - Evotaz
  • Table 42: Efficacy of BMS' Evotaz in the Phase III Study
  • Table 43: Evotaz SWOT Analysis, 2014
  • Table 44: Sales Forecasts ($m) for Evotaz, 2013-2023
  • Table 45: Product Profile - Reyataz
  • Table 46: Reyataz SWOT Analysis, 2014
  • Table 47: Sales Forecasts ($m) for Reyataz, 2013-2023
  • Table 48: Product Profile - Prezista
  • Table 49: Prezista SWOT Analysis, 2014
  • Table 50: Sales Forecasts ($m) for Prezista, 2013-2023
  • Table 51: Product Profile - Isentress
  • Table 52: Percentage of Patients with HIV-1 RNA Levels <50 Copies/mL from the SMARTMRK Study
  • Table 53: Isentress' Safety - Adverse Reactions Reported in the SMARTMRK Study
  • Table 54: Isentress SWOT Analysis, 2014
  • Table 55: Sales Forecasts ($m) for Isentress, 2013-2023
  • Table 56: Product Profile - Tivicay
  • Table 57: Pivotal Phase III Trials of Tivicay
  • Table 58: Tivicay's Safety - Adverse Reactions Reported in the 48-Week SINGLE Study
  • Table 59: Tivicay SWOT Analysis, 2014
  • Table 60: Sales Forecasts ($m) for Tivicay, 2013-2023
  • Table 61: Product Profile - Vitekta
  • Table 62: Efficacy of Vitekta in the Pivotal Phase III Clinical Study
  • Table 63: Vitekta's Safety - Adverse Reactions Reported in the 96-Week Clinical Study
  • Table 64: Vitekta SWOT Analysis, 2014
  • Table 65: Sales Forecasts ($m) for Vitekta, 2013-2023
  • Table 66: Product Profile - Norvir (ritonavir)
  • Table 67: Norvir SWOT Analysis, 2014
  • Table 68: Sales Forecasts ($m) for Norvir, 2013-2023
  • Table 69: Product Profile - Tybost
  • Table 70: Efficacy of Tybost Versus Ritonavir as a Pharmacoenhancer of Atazanavir in the Phase III Trial
  • Table 71: Tybost SWOT Analysis, 2014
  • Table 72: Sales Forecasts ($m) for Tybost, 2013-2023
  • Table 73: Summary of the Minor Therapeutic Classes of EIs, 2014
  • Table 74: Unmet Need and Opportunity in HIV
  • Table 75: Promising Drugs in Clinical Development for HIV, 2014
  • Table 76: Comparison of Therapeutic Classes in Development for HIV, 2013-2023
  • Table 77: Gilead's Quad 2 - Phase III Clinical Trials
  • Table 78: Product Profile - Quad 2
  • Table 79: Efficacy of Quad 2 and Stribild in Studies 104 and 111
  • Table 80: Adverse Events Associated with Quad 2 vs. Stribild Therapy in two Phase III Clinical Studies
  • Table 81: Renal and Bone Safety of Quad 2 Versus Stribild Treatment in the Two Pivotal Phase III Studies
  • Table 82: Quad 2 SWOT Analysis, 2014
  • Table 83: Sales Forecasts ($m) for Quad 2, 2013-2023
  • Table 84: Product Profile - Darunavir/cobicistat/emtricitabine/TAF
  • Table 85: Efficacy of Darunavir/Cobicistat/Emtricitabine/TAF in the Phase II Study
  • Table 86: Safety of Darunavir/Cobicistat/Emtricitabine/TAF - Adverse Reactions Reported at 48 Weeks in the Phase II Study
  • Table 87: Renal and Bone Safety of Darunavir/Cobicistat/Emtricitabine/TAF in the Phase II Study
  • Table 88: Darunavir/Cobicistat/Emtricitabine/TAF SWOT Analysis, 2014
  • Table 89: Sales Forecasts ($m) for Darunavir/Cobicistat/Emtricitabine/TAF, 2013-2023
  • Table 90: Product Profile - Emtricitabine/TAF
  • Table 91: Two Pivotal Clinical Trials of Emtricitabine/TAF
  • Table 92: Phase III Clinical Trials Assessing the Safety of Emtricitabine/TAF
  • Table 93: Emtricitabine/TAF SWOT Analysis, 2014
  • Table 94: Sales Forecasts ($m) for Emtricitabine/TAF, 2013-2023
  • Table 95: Product Profile - Dutrebis
  • Table 96: Percentage of Patients with HIV-1 RNA Levels of <50 Copies/mL in the SMARTMRK Study
  • Table 97: Dutrebis SWOT Analysis, 2014
  • Table 98: Sales Forecasts ($m) for Dutrebis, 2013-2023
  • Table 99: Product Profile - Doravirine
  • Table 100: Efficacy Results of a Phase II Dose-Ranging Study of Doravirine Compared with a Standard Dose of Efavirenz
  • Table 101: Doravirine SWOT Analysis, 2014
  • Table 102: Sales Forecasts ($m) for Doravirine, 2013-2023
  • Table 103: Promising Drugs in Early-Stage Clinical Development for HIV, 2014
  • Table 104: Other Earlier-Stage Drugs in Active Clinical Development for HIV, 2014
  • Table 105: Number of People Living with HIV Who Received ART in the 5EU, and Sales of HIV Therapeutics, 2013
  • Table 106: Sales Forecasts ($m) for HIV Therapeutics in the 5EU, 2013-2023
  • Table 107: Key Events Impacting Sales of HIV Therapeutics in the 5EU, 2013-2023
  • Table 108: HIV Therapeutics Market in the 5EU - Drivers and Barriers, 2013-2023
  • Table 109: Financing of ART in the 5EU Countries by the National Healthcare Authorities
  • Table 110: Electronic Healthcare Systems Introduced in the 5EU Nations
  • Table 111: ART Initiation Criteria in the 5EU
  • Table 112: Systems Used to Control Drug Prices in the 55EU
  • Table 113: Key Historical and Projected Launch Dates for HIV Therapeutics Across the 9MM
  • Table 114: Key Historical and Projected Patent Expiry Dates for HIV Therapeutics Across the 9MM
  • Table 115: High-Prescribing Physicians (non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: HIV Lifecycle
  • Figure 2: HIV-1 Disease Management Flowchart
  • Figure 3: HIV Therapeutics - Phase II and III Clinical Trials by Country, 2014
  • Figure 4: HIV Phase II/Phase III Pipeline, 2014
  • Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2013-2023
  • Figure 6: Potential Clinical and Commercial Positioning of Quad 2
  • Figure 7: Potential Clinical and Commercial Positioning of Darunavir/Cobicistat/Emtricitabine/TAF
  • Figure 8: Potential Clinical and Commercial Positioning of Emtricitabine/TAF
  • Figure 9: Potential Clinical and Commercial Positioning of Dutrebis
  • Figure 10: Potential Clinical and Commercial Positioning of Doravirine
  • Figure 11: Sales for HIV Therapeutics in the 5EU by Drug Class, 2013-2023
  • Figure 12: Sales for HIV Therapeutics in the 5EU by Country, 2013-2023
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