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市場調查報告書

HIV·愛滋病檢查市場

HIV-AIDS Testing Markets

出版商 TriMark Publications 商品編碼 231764
出版日期 內容資訊 英文 151 Pages
商品交期: 最快1-2個工作天內
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HIV·愛滋病檢查市場 HIV-AIDS Testing Markets
出版日期: 2012年10月01日 內容資訊: 英文 151 Pages
簡介

本報告提供全球HIV、愛滋檢查市場現況與預測相關調查分析,HIV病毒概要與染途徑、HIV檢查種類與概要、HIV檢查的各種技術、影響HIV檢查的選擇、使用的影響因素、已上市產品的概要、各檢查類型的市場規模實績與預測(∼2016年)、競爭環境分析等彙整,為您概述為以下內容。

第1章 簡介

第2章 HIV及愛滋病:概要

  • HIV病毒
  • 病毒的作用機制(HIV生命週期)
  • HIV感染
  • HIV及愛滋病的症狀
  • HIV及愛滋病的診斷
  • 目前治療方法:摘要

第3章 HIV/愛滋病簡介:統計·免疫學

  • 全球HIV/愛滋病發病率
  • 美國的HIV/愛滋病
  • HIV/愛滋病的經濟影響

第4章 HIV檢驗概要

  • HIV檢查主要的目標
  • HIV篩檢
  • HIV確認實驗
  • HIV監測實驗
  • HIV檢驗研究建議的變更點
  • 美國的HIV檢驗建議
  • 美國的HIV檢驗相關統計

第5章 HIV檢驗的技術平台

  • 酵素連結免疫吸附法ELISA(Enzyme-Linked Immunosorbent Assay)
  • 抗體/p24抗原檢驗(第4代檢驗)
  • 西方墨點法
  • 在線免疫分析法
  • 間接螢光抗體(IFA)化驗
  • 核酸檢驗
  • 新的技術

第6章 HIV檢驗的影響課題

  • HIV檢驗所使用的檢體:概要
  • 現有的HIV檢驗產品的法規
  • 品管標準
  • HIV檢驗相關的課題
  • HIV檢驗·化驗性能潛在的改善領域
  • HIV檢驗的選擇·利用的因素
  • 定期性的HIV檢驗的障礙·推進因素
  • CLIA法

第7章已上市HIV檢查

  • 已上市HIV檢查的各種類型:概要
  • 抗HIV抗體篩檢
  • HIV抗體/p24抗原檢查(第4代檢查)
  • 抗HIV抗體確認檢查
  • 核酸檢查
  • 家用HIV檢查
  • 新的技術•產品

第8章 市場分析:市場規模·成長率·市場佔有率·競爭企業

  • 全球HIV/愛滋病檢查市場
  • 市場促進因素·阻礙要素
  • 市場·技術趨勢
  • 競爭環境
  • HIV市場上課題·策略性建議
  • 保險的補助範圍與償還
  • 影響HIV檢查的各種政策
  • 近幾年的產業配合措施

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目錄
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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