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市場調查報告書

HIV (人類免疫缺乏病毒):日本的醫藥品市場預測與分析

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

出版商 GlobalData 商品編碼 370555
出版日期 內容資訊 英文 299 Pages
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HIV (人類免疫缺乏病毒):日本的醫藥品市場預測與分析 Human Immunodeficiency Virus (HIV) - Japan Drug Forecast and Market Analysis to 2023
出版日期: 2015年09月09日 內容資訊: 英文 299 Pages
簡介

本報告提供日本的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
  • 日本
    • 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

  • 日本
    • 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: GDHC313CFR

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.

The Japanese HIV market also differs from that of the US and the 5EU in that the uptake of STRs has been less pronounced. For example, Atripla, which has become a leading HIV drug across the 6MM, is not currently licensed in Japan. Gilead's Stribild, an INI-based STR that was approved by the FDA in August 2012, became the first STR to be licensed in Japan, in early 2013 (Japan Tobacco, press release, March 25, 2013).

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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in the Japan from 2013-2023.
  • Analysis of the impact of key events as well the drivers and restraints affecting the Japan 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 Japan.

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

US Key Opinion Leader 27

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