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市場調查報告書
針對HIV試驗之CDC最新指導方針
Updated CDC HIV Testing Guidelines to Shape Evolving Diagnostics Market
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本報告已在2011年12月21日停止出版。
對於診斷藥製造業者而言，HIV/AIDS已成為收益性很高的市場。用於HIV疾病管理之診斷藥更是扮演了相當重要的角色。
專門於醫療業界領域進行廣泛調查的美國專業調查公司Decision Resources Inc. (總公司：Massachusetts)，調查分析了針對HIV試驗之CDC最新指導方針，並有系統地出版了報告書"Updated CDC HIV Testing Guidelines to Shape Evolving Diagnostics Market" 。
此報告書除了調查現在的HIV診斷動向、新興診斷法、 主要活躍企業，也分析CDC指導方針在診斷或藥劑治療方面所扮演的角色。另外也包括戰略的考察與同市場今後的展望等。報告書之內容摘要如下所示。
摘要
說明
HIV指導方針的背景與新指導方針的影響
- 影響CDC對於定期篩檢所提出的建議之要因
- 醫療HIV篩檢
- 即時篩檢測試的好處
- 已感染HIV的成人及年輕人之監察
- 各式各樣專業族群的反應
對於HIV診斷藥之規定
定期HIV試驗給予病患族群的影響
- 沒有意識到自己有HIV血清的人們
- 發病後方才接受診斷的人們
- 懷孕中的女性
現在診斷法
新興診斷法
- OTC HIV家庭測試配套元件
- 病毒適性測試
- CCR5及CXCR4的趨性測試
關於HIV診斷藥的主要企業
- OraSure Technologies
- BioMerieux
今後的展望
- CDC指導方針給予定期HIV篩檢的影響
- 對於定期HIV測試的規定
- 戰略的考察
- 改良型及新製品的開發
- 醫師決定者
- 與藥劑的協同作用
附錄A：參考情報
附錄B：報告書之用語解說
圖表
Abstract
Introduction
HIV/AIDS stands out as a highly lucrative and expanding market for diagnostics
companies because of the close integration of diagnostics in initial diagnosis
and subsequent day-to-day disease management. With the newly released CDC
screening recommendations advocating increased testing for the infection,
diagnostics will play an increasingly critical role in HIV disease management.
Get the Answers You Need to Shape Your Strategy
- The revised CDC guidelines for HIV testing are set to dramatically benefi
t the HIV diagnostics market in the
- United States. Which sectors of the diagnostics market will benefi t most?
What will be the long-term
- impact of the CDC recommendations?
- The new recommendations have changed HIV testing from an
“opt-in” diagnostic to an “opt-out” test that is
- a routine part of medical practice. How will this new process affect the
diagnosis rates for HIV? Will it
- dramatically increase treatment rates?
- HIV diagnosis is currently a multistep process that involves
time-consuming confi rmatory tests. In its new
- recommendations, the CDC advocates the use of rapid testing. How will the
CDC recommendations impact
- the rapid testing arena? Which companies are the key players in this
sector?
- With the increase in drug resistance among HIV/AIDS patients, resistance
testing is playing a growing role in
- HIV disease management. Will the new CDC recommendations increase use of
monitoring tests as well?
- What unmet needs remain in the resistance testing sector? Which companies
are active in this area?
Scope
- Discussion of new CDC recommendations: revisions, rationale, target
populations, and response to changes.
- Current HIV diagnostics: screening, confi rmatory, and monitoring tests.
- Emerging HIV diagnostics: home test kits, replication capacity tests, and
CCR5 and CXCR4 tests.
- Key players: profi les of select leaders in HIV diagnostics.
- Outlook for HIV diagnostics: impact of CDC guidelines on diagnostics and
on drug treatment,
- constraints on routine testing, and strategic considerations.
Mentioned in This Spectrum Report
Companies:
- Abbott Laboratories
- Beckman Coulter
- Becton Dickinson
- BioMerieux
- Bio-Rad Laboratories
- Bristol-Myers Squibb
- Calypte Biomedical
- Celera Diagnostics
- Chembio Diagnostic Systems
- Gen-Probe
- Gilead Sciences
- GlaxoSmithKline
- Guava Technologies
- Home Access Health
- LabCorp
- MedMira Laboratories
- Monogram Biosciences
- Murex Diagnostics
- OraSure Technologies
- Partec
- pfizer
- Roche Molecular Diagnostics
- Siemens Medical Solutions
- Diagnostics
- Specialty Laboratories
- Trinity Biotech
- Virco
- ViroLogic
- Visible Genetics
- Waldheim Pharmazeutika
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Revised Guidelines and Target Populations
- HIV Testing and Prevention Trends
- Background on HIV Guidelines and Impact of New Guidelines
- Factors Infl uencing the CDC Recommendations for Routine Screening
- Screening for HIV in the Health Care Setting
- Advantages of Rapid Screening Tests
- Monitoring of HIV-Infected Adults and Adolescents
- Baseline Measurement
- Timing of Treatment Initiation
- Timing of Therapy Switch
- Response of Various Professional Groups
- Regulation of HIV Diagnostics
- Impact of Routine HIV Testing on Patient Groups
- People Unaware of Their HIV Serostatus
- People Diagnosed at an Advanced Stage of Disease
- Pregnant Women
- Current Diagnostics
- Screening Tests
- Confi rmatory Tests
- Monitoring Tests
- CD4 T-Cell Count
- Viral Load Test
- Resistance Tests
- Emerging Diagnostics
- Over-the-Counter HIV Home Test Kits
- Viral Fitness (Replication Capacity) Tests
- CCR5 and CXCR4 Tropism Tests
- Select Key Players in HIV Diagnostics
- OraSure Technologies
- BioMerieux
- Outlook
- Impact of CDC Guidelines on Routine HIV Screening
- Impact on Diagnostics Sectors
- Impact on Drug Treatment
- Constraints on Routine HIV Testing
- Strategic Considerations
- Development of Improved and New Products
- Infl uencing Decision Makers
- Synergy with Drugs
- Appendix A. Bibliography
- Appendix B. Explanation of Terms Used in This Report
Tables
- 1. High-Risk Categories for HIV Infection
- 2. Synopsis of the CDC HIV Testing Guidelines for Adults, Adolescents, and
Pregnant Women in Health Care Settings
- 3. Summary of Recommendations for Administration of HIV Diagnostics in the
Major Pharmaceutical Markets
- 4. Select FDA-Approved HIV Screening and Confi rmatory Tests
- 5. Select HIV Monitoring Tests
- 6. Select HIV Resistance Tests Available in the Major Markets
Figures
- 1. Segmentation of Newly Diagnosed HIV Cases by Transmission Category in
the Major Markets
- 2. Proportion of People Aged 18-64 in the United States Who Reported Being
Tested for HIV
- 3. Timeline of Key Advances in HIV Diagnostics and Testing Guidelines in
the United States
- 4. Interplay of HIV Diagnostics in the Treatment Cycle
- 5. HIV: Diagnosed and Undiagnosed Population Proportions, 2005
- 6. Estimated Sexual Transmission of HIV in People Aware and Unaware of
Their Serostatus in the United States
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