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市場調査レポート

HIV・エイズ検査市場

HIV-AIDS Testing Markets

発行 TriMark Publications 商品コード 231764
出版日 ページ情報 英文 151 Pages
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HIV・エイズ検査市場 HIV-AIDS Testing Markets
出版日: 2012年10月01日 ページ情報: 英文 151 Pages
概要

当レポートでは、世界のHIV・エイズ検査市場の現状と見通しについて調査分析し、HIVウイルスの概要と感染の状況、HIV検査の種類と概要、HIV検査の各種技術、HIV検査の選定・利用への影響因子、上市済み製品の概要、検査タイプ別の市場規模実績・予測、競合環境の分析などをまとめ、概略下記の内容でお届けいたします。

第1章 イントロダクション

第2章 HIVおよびエイズ:概要

  • HIVウイルス
  • ウイルスの作用機序(HIVライフサイクル)
  • HIV感染
  • HIVおよびエイズの症状
  • HIVおよびエイズの診断
  • 現在の治療法:サマリー

第3章 HIV/エイズのプロファイル:統計・疫学

  • 世界のHIV/エイズ発症率
  • 米国のHIV/エイズ
  • HIV/エイズの経済的影響

第4章 HIV検査の概要

  • HIV検査の主な目標
  • HIVスクリーニング検査
  • HIV確認試験
  • HIVモニタリング試験
  • HIV検査アルゴリズムに提案されている変更点
  • HIV検査の米国の提言
  • 米国のHIV検査に関する統計

第5章 HIV検査の技術プラットフォーム

  • ELISA(Enzyme-Linked Immunosorbent Assay)
  • 抗体/p24抗原検査(第4世代検査)
  • ウェスタンブロットアッセイ
  • ラインイムノアッセイ
  • 間接蛍光抗体(IFA)アッセイ
  • 核酸検査
  • 新しい技術

第6章 HIV検査への影響課題

  • HIV検査で利用される検体:概要
  • 既存のHIV検査製品の制約
  • 品質管理基準
  • HIV検査に関連する課題
  • HIV検査・アッセイ性能の潜在的な改善領域
  • HIV検査の選定・利用への影響因子
  • 定期的なHIV検査の障壁・推進因子
  • CLIA法

第7章 上市済みHIV検査

  • 上市済みHIV検査の各種タイプ:概要
  • 抗HIV抗体スクリーニング検査
  • HIV抗体/p24抗原検査(第4世代検査)
  • 抗HIV抗体確認検査
  • 核酸検査
  • 家庭用HIV検査
  • 新しい技術・製品

第8章 市場分析:市場規模・成長率・市場シェア・競合企業

  • 世界のHIV/エイズ検査市場
  • 市場成長推進因子・阻害因子
  • 市場・技術動向
  • 競合環境
  • HIV市場における課題・戦略的提言
  • 保険のカバー範囲と償還
  • HIV検査に影響を及ぼす各種政策
  • 近年の産業の取り組み

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目次
Product Code: TMRHIV12-1001

Abstract

There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population (with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing market. This TriMark Publications report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being utilized by the HIV testing field, defines the dollar volume of sales - both in the U.S. and worldwide - and analyzes the factors that influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and expanding markets, such as employee screening, emergency medicine and satellite clinic testing. Additionally, this analysis covers the following areas in details: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test), Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering HIV testing markets around the globe.

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. About This Report
  • 1.3. Scope of the Report
  • 1.4. Objectives
  • 1.5. Methodology
  • 1.6. Executive Summary

2. Overview of HIV and AIDS

  • 2.1. HIV Virus
    • 2.1.1. Structure
    • 2.1.2. Genetic Code
    • 2.1.3. Subtypes
      • 2.1.3.1. HIV-1
      • 2.1.3.2. HIV-2
  • 2.2. Viral Mechanism of Action (HIV Life Cycle)
    • 2.2.1. Entry into the Cell
    • 2.2.2. Replication and Transcription
    • 2.2.3. Assembly and Release
  • 2.3. HIV Transmission
  • 2.4. Symptoms of HIV and AIDS
    • 2.4.1. Acute (Primary) Infection
    • 2.4.2. Clinically Asymptomatic Infection
    • 2.4.3. Symptomatic HIV Infection
    • 2.4.4. AIDS
  • 2.5. Diagnosis of HIV and AIDS
  • 2.6. Brief Summary of Current Therapies

3. Profile of HIV/AIDS: Statistics and Epidemiology

  • 3.1. Worldwide HIV/AIDS Incidence
    • 3.1.1. Sub-Saharan Africa
    • 3.1.2. Asia
    • 3.1.3. Eastern Europe and Central Asia
    • 3.1.4. Caribbean
    • 3.1.5. Central and South America
    • 3.1.6. Middle East and North Africa
    • 3.1.7. North America and Western and Central Europe
    • 3.1.8. Oceania
  • 3.2. HIV/AIDS in the U.S.
  • 3.3. Economic Impact of HIV/AIDS

4. Overview of HIV Testing

  • 4.1. Main Objectives of HIV Testing
  • 4.2. HIV Screening Tests
  • 4.3. HIV Confirmation Tests
  • 4.4. HIV Monitoring Tests
    • 4.4.1. Measuring Viral Loads
    • 4.4.2. Genotyping Assays
    • 4.4.3. Phenotyping Assays
  • 4.5. Proposed Changes to the HIV Testing Algorithm
  • 4.6. U.S. Recommendations for HIV Testing
  • 4.7. U.S. HIV Testing Statistics

5. Technological Platforms Used in HIV Testing

  • 5.1. Enzyme-Linked Immunosorbent Assay (ELISA)
    • 5.1.1. Rapid HIV Tests
      • 5.1.1.1. Immunoconcentration (Flow Through Assay)
      • 5.1.1.2. Immunochromatography (Lateral Flow Assay)
      • 5.1.1.3. Particle Agglutination
      • 5.1.1.4. Solid Phase (Dipstick Assay)
  • 5.2. Antibody/p24 Antigen Test (Fourth-Generation Test)
  • 5.3. Western Blot Assay
  • 5.4. Line Immunoassays
  • 5.5. Indirect Fluorescent Antibody (IFA) Assay
  • 5.6. Nucleic Acid Tests
  • 5.7. Emerging Technologies

6. Issues Affecting HIV Testing

  • 6.1. Overview of Specimens Used in HIV Testing
    • 6.1.1. Blood Samples
      • 6.1.1.1. Dried Blood Spot Samples
    • 6.1.2. Oral Fluid Samples
    • 6.1.3. Urine Samples
  • 6.2. Limitations of Existing HIV Testing Products
    • 6.2.1. Sensitivity and Specificity
      • 6.2.1.1. False Negative Rates
      • 6.2.1.2. False Positive Rates
      • 6.2.1.3. Positive Predictive Values
    • 6.2.2. Indeterminate Results
    • 6.2.3. Window Period (Delayed Detection of HIV Infection)
  • 6.3. Quality Control Criteria
  • 6.4. Challenges Associated with HIV Testing
  • 6.5. Potential Areas of Improvement in HIV Testing and Assay Performance
  • 6.6. Factors Influencing Selection and Use of HIV Tests
  • 6.7. Barriers and Facilitators to Routine HIV Testing
    • 6.7.1. Routine HIV Testing in Emergency Departments
    • 6.7.2. Compatibility of State Laws with CDC HIV Testing Recommendations
  • 6.8. Clinical Laboratory Improvement Amendments (CLIA)

7. HIV Tests on the Market

  • 7.1. Overview of the Types of HIV Tests on the Market
  • 7.2. Anti-HIV Antibody Screening Tests
    • 7.2.1. Whole Blood, Serum, or Plasma-based HIV Tests
      • 7.2.1.1. Abbott Diagnostics
      • 7.2.1.2. Ani Labsystems
      • 7.2.1.3. Avioq, Inc.
      • 7.2.1.4. Bio-Rad Laboratories
      • 7.2.1.5. Green Cross
      • 7.2.1.6. Maxim Biomedical
      • 7.2.1.7. Ortho-Clinical Diagnostics
      • 7.2.1.8. Shanghai Kehua
      • 7.2.1.9. Siemens Healthcare Diagnostics
      • 7.2.1.10. Span Diagnostics
      • 7.2.1.11. Biomedical, Inc.
    • 7.2.2. Oral HIV Tests
      • 7.2.2.1. Avioq, Inc.
      • 7.2.2.2. Chembio Diagnostic Systems
      • 7.2.2.3. Immunoscience, Inc.
      • 7.2.2.4. Maxim Biomedical
      • 7.2.2.5. OraSure Technologies
      • 7.2.2.6. Oral Collection Devices
    • 7.2.3. Urine-based HIV Tests
      • 7.2.3.1. Maxim Biomedical
    • 7.2.4. Rapid HIV Tests
      • 7.2.4.1. Alere
      • 7.2.4.2. bioLytical Laboratories, Inc.
      • 7.2.4.3. Bio-Rad Laboratories
      • 7.2.4.4. MedMira Laboratories, Inc.
      • 7.2.4.5. OraSure Technologies
      • 7.2.4.6. Trinity Biotech
      • 7.2.4.7. Alere
      • 7.2.4.8. bioMerieux
      • 7.2.4.9. Bioner
      • 7.2.4.10. Chembio Diagnostics
      • 7.2.4.11. Core Diagnostics
      • 7.2.4.12. EY Laboratories
      • 7.2.4.13. Green Cross
      • 7.2.4.14. InTec Products
      • 7.2.4.15. J Mitra & Co.
      • 7.2.4.16. Orgenics, Ltd.
      • 7.2.4.17. Premier Medical Corporation
      • 7.2.4.18. Qualpro Diagnostics
      • 7.2.4.19. Savyon Diagnostics
      • 7.2.4.20. Shanghai Kehua
      • 7.2.4.21. Span Diagnostics
      • 7.2.4.22. Standard Diagnostics, Inc.
      • 7.2.4.23. Additional Companies Selling Non-FDA-Approved Rapid HIV Assays Outside of the U.S.
  • 7.3. HIV Antibody/p24 Antigen Tests (Fourth-Generation Tests)
    • 7.3.1. FDA-Approved Fourth-Generation HIV Assays
      • 7.3.1.1. ARCHITECT HIV Ag/Ab Combo Assay (Abbott Laboratories)
      • 7.3.1.2. GS HIV Ag/Ab Combo EIA (Bio-Rad Laboratories)
    • 7.3.2. Fourth-Generation HIV Assays Commercially Available Outside of the U.S.
      • 7.3.2.1. ABBOTT AxSYM HIV Ab/Ag Combo (Abbott Laboratories)
      • 7.3.2.2. Determine-HIV 1/2 Ag/Ab Combo (Alere)
      • 7.3.2.3. VironostikaR HIV Uni-Form II Ag/Ab (bioMerieux)
      • 7.3.2.4. GENEDIAR HIV Ag-Ab ELISA (Green Cross)
      • 7.3.2.5. HIV TRI-DOT + Ag (J Mitra & Co.)
      • 7.3.2.6. Fourth-Generation Microlisa HIV Ag and Ab (J Mitra & Co.)
      • 7.3.2.7. ImmunocombR II HIV 1&2 TriSpot Ag-Ab (Orgenics)
      • 7.3.2.8. Enzygnost HIV Integral II (Siemens Healthcare Diagnostics)
      • 7.3.2.9. Enzaids Duet (Span Diagnostics)
  • 7.4. Anti-HIV Antibody Confirmation Tests
    • 7.4.1. Western Blot
      • 7.4.1.1. Cambridge Biotech HIV-1 Western Blot Kit (Maxim Biomedical)
      • 7.4.1.2. GS HIV-1 Western Blot (Bio-Rad Laboratories)
      • 7.4.1.3. OraSure HIV-1 Western Blot Kit (OraSure Technologies)
      • 7.4.1.4. HIV Blot 2.2 (MP Diagnostics)
    • 7.4.2. Line Immunoassays
    • 7.4.3. Indirect Fluorescent Antibody
  • 7.5. Nucleic Acid Tests
    • 7.5.1. Measuring Viral Loads and Resistance Testing
    • 7.5.2. Instruments and Reagents
      • 7.5.2.1. Abbott Molecular
      • 7.5.2.2. Gen-Probe, Inc.
      • 7.5.2.3. Roche Molecular Systems
      • 7.5.2.4. Siemens Healthcare Diagnostics
      • 7.5.2.5. bioMerieux
      • 7.5.2.6. Qiagen
    • 7.5.3. Diagnostic Testing Services
    • 7.5.4. Comparisons of HIV Nucleic Acid Testing Platforms
    • 7.5.5. HIV Molecular Diagnostic and NAT HIV Monitoring Market History
  • 7.6. Home HIV Testing
    • 7.6.1. Home HIV Testing Kits
      • 7.6.1.1. Direct Access Diagnostics
      • 7.6.1.2. Home Access Health Corp.
    • 7.6.2. Competitive Situation for Home HIV Testing Kits
    • 7.6.3. Advantages and Disadvantages of Home HIV Testing
  • 7.7. Emerging Technologies and Products

8. Market Analysis: Size, Growth, Share and Competitors

  • 8.1. Worldwide HIV/AIDS Testing Market
    • 8.1.1. U.S. Market
    • 8.1.2. European Market
    • 8.1.3. Asian Market
    • 8.1.4. ROW Market
  • 8.2. Market Drivers and Restraints
    • 8.2.1. Market Drivers
    • 8.2.2. Market Restraints
  • 8.3. Market and Technology Trends
    • 8.3.1. Market Trends
    • 8.3.2. Technology Trends
  • 8.4. Competitive Situation
  • 8.5. HIV Market Challenges and Strategic Recommendations
  • 8.6. Insurance Coverage and Reimbursement
  • 8.7. Policies Affecting HIV Testing
  • 8.8. Recent Industry Activity

INDEX OF FIGURES

  • Figure 2.1: Diagram of HIV
  • Figure 2.2: HIV Replication Cycle
  • Figure 2.3: Ten Best-Selling AIDS Drugs in the U.S., 2009
  • Figure 3.1: Global Trend of HIV Infection, 1990-2009
  • Figure 3.2: Number of People Newly Infected with HIV, 1990-2009
  • Figure 3.3: Number of Deaths Due to AIDS, 1990-2009
  • Figure 3.4: Top Ten Countries with the Highest Adult HIV Prevalence Rate, 2009
  • Figure 3.5: Global View of Adult (Ages 15-49) HIV Infection, 2009
  • Figure 3.6: Ethnic Distribution of AIDS Patients in the U.S., 2009
  • Figure 3.7: U.S. Rates for New HIV Cases, 2008
  • Figure 3.8: New HIV Infections by Transmission Category, 2009
  • Figure 4.1: Proposed HIV Testing Algorithm
  • Figure 4.2: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in the U.S., 2011
  • Figure 4.3: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in the U.S. by Race/Ethnicity, 2011
  • Figure 5.1: Schematic of ELISA Tests
  • Figure 5.2: Concentration of Different HIV Markers in Plasma Following Initial Infection
  • Figure 5.3: Schematic of a Flow Through Assay
  • Figure 5.4: Schematic of a Lateral Flow Assay
  • Figure 5.5: Basic Components of a Lateral Flow Device
  • Figure 5.6: Schematic of a Dipstick Assay
  • Figure 5.7: Schematic of an Antibody/p24 Antigen (Fourth-Generation) Test
  • Figure 5.8: Western Blot Assay Preparation
  • Figure 5.9: Western Blot Banding Pattern
  • Figure 6.1: Understanding Positive Predictive Values
  • Figure 6.2: Window Period for Antibody-based HIV Tests
  • Figure 6.3: Concentration of Different HIV Markers in Plasma Following Initial Infection
  • Figure 6.4: Percentage of Emergency Departments Performing HIV Testing, 2011
  • Figure 6.5: Legislative Changes in State Laws to Increase Compatibility with CDC Recommendations, 2011
  • Figure 8.1: Global POCT Share of HIV Testing Market, 2010
  • Figure 8.2: HIV Test Kits Procured by WHO in 2009, by Region
  • Figure 8.3: Distribution of HIV Molecular Diagnostic Testing by Purpose
  • Figure 8.4: Market Share Viral Load HIV NAT Diagnostic Testing

INDEX OF TABLES

  • Table 2.1: AIDS-Defining Conditions
  • Table 2.2: Different Types of HIV Screening and Diagnostic Tests
  • Table 2.3: Comparison of CDC and WHO Case Definitions
  • Table 2.4: CDC Case Definition for HIV Infection Among Adults and Adolescents (Aged ?13 years), 2008
  • Table 2.5: WHO Case Definition for HIV Infection, 2007
  • Table 2.6: WHO Case Definition for Advanced HIV (Including AIDS), 2007
  • Table 2.7: WHO Immunological Classification for Established HIV Infection, 2007
  • Table 2.8: Classes of Antiretroviral HIV Drugs
  • Table 2.9: New Antiretroviral Drugs
  • Table 3.1: Global Summary of the HIV/AIDS Epidemic, 2009
  • Table 3.2: Global HIV Statistics, 2009
  • Table 3.3: Countries with the Greatest Number of People Living with HIV, 2009
  • Table 3.4: Top Ten States by Cumulative AIDS Diagnosis, 2009
  • Table 3.5: Top Ten States by AIDS Diagnosis Rate, 2009
  • Table 4.1: Tests Used to Detect Acute HIV Infection
  • Table 4.2: HIV Antiviral Drug Resistance Testing Recommendations
  • Table 4.3: Common HIV Testing Sites
  • Table 4.4: Public Health HIV Testing Sites
  • Table 5.1: Advantages and Disadvantages of ELISA HIV Tests
  • Table 5.2: Rapid HIV Testing Outlets
  • Table 5.3: Desirable Characteristics of Rapid Tests
  • Table 5.4: Advantages of Rapid HIV Tests
  • Table 5.5: Disadvantages of Rapid HIV Tests
  • Table 5.6: Advantages and Disadvantages of Fourth-Generation Tests
  • Table 5.7: Advantages and Disadvantages of Nucleic Acid HIV Assays
  • Table 6.1: FDA-Approved Assays for Dried Blood Spot Samples
  • Table 6.2: Challenges Associated with HIV Testing
  • Table 6.3: Factors Influencing Assay Selection
  • Table 6.4: Compatibility of Consent and Counseling Laws with 2006 CDC Recommendations, 2011
  • Table 6.5: Financial Comparison for Moderate and Waived CLIA Labs
  • Table 7.1: ELISA Assays Detecting Anti-HIV Antibodies
  • Table 7.2: HIV Assays Using Oral Fluid Specimens
  • Table 7.3: Rapid HIV Immunoassay Tests
  • Table 7.4: FDA-Approved Rapid HIV Antibody Screening Tests
  • Table 7.5: USAID List of Approved HIV/AIDS Rapid Test Kits, June 2011
  • Table 7.6: HIV Antibody/p24 Antigen (Fourth-Generation) Tests
  • Table 7.7: FDA-Approved Confirmation Tests
  • Table 7.8: Nucleic Acid HIV Tests
  • Table 7.9: Summary of Assays for HIV Viral Load Testing
  • Table 7.10: Commercially Available Molecular Diagnostic Products for HIV Assay
  • Table 7.11: Comparison of HIV Home Sampling and Home Testing Services
  • Table 8.1: Worldwide HIV Testing Market, 2007-2016
  • Table 8.2: Worldwide HIV Screening and Confirmatory Testing Market, 2007-2016
  • Table 8.3: Worldwide POCT Market for HIV, 2007-2016
  • Table 8.4: Largest POCT Diagnostic Companies Worldwide, 2008
  • Table 8.5: Worldwide HIV Monitoring (NAT) Market, 2007-2016
  • Table 8.6: Number of Testing Facilities and Number of People Who Received HIV Testing Worldwide, 2010
  • Table 8.7: U.S. HIV Testing Market, 2007-2016
  • Table 8.8: U.S. HIV Screening and Confirmatory Testing Market, 2007-2016
  • Table 8.9: U.S. POCT Market for HIV, 2007-2016
  • Table 8.10: Estimated U.S. Market Share for CLIA-waived HIV POCT, 2011
  • Table 8.11: U.S. Market for NAT Testing to Monitor HIV, 2007-2016
  • Table 8.12: HIV Testing Market for OTC Testing in the U.S., 2007-2016
  • Table 8.13: Drivers of Demand for HIV Diagnostic Testing
  • Table 8.14: NAT HIV Monitoring Market: Market Drivers Ranked in Order of Impact
  • Table 8.15: Drivers of Demand for HIV Diagnostic Testing
  • Table 8.16: NAT HIV Monitoring Market: Market Restraints Ranked in Order of Impact
  • Table 8.17: Competitive Factors Related to HIV Tests
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