全球執業醫師（POL）檢查市場：現況及未來趨勢 是由出版商Kalorama Information在2010年11月所出版的。
這份英文市場調查報告書包含250 pages 價格從美金3995起跳。
執業醫師檢査是診療所等的醫師與醫療團隊的檢査與診斷、觀察等目的而對外來患者所實施的動作，在對預防醫療與糖尿病患者的積極方法之普及、世界規模的傳染病擴大、帶有慢性病的患者急增這樣的趨勢的背景下在近年急速擴張著。
本報告書以舊版所出版的2007年以降之市場動向為焦點，對於對應各種疾病的檢査市場進行定量的分析，包含檢査内容與技術現狀、今後的前景等，更有主要企業與新進入市場的企業簡介，概述如下。
第1章 總綱
第2章 導論
- 背景
- 執業醫師檢査的定義
- 執業醫師檢査的長處與短處
- 基本的思考方法
第3章 市場與技術的動向
- 背景
- 非侵襲製技術的登場
- 微細化與微流體技術
- 隨著美國臨床檢査室改善法(CLIA)的檢査清單之擴大，執業醫師檢査的市場也擴大
- 臨床檢査機器的接續機能相關的要件
第4章 執業醫師檢査的經濟之側面
- 背景
- 關於補償的課題與展開
- 執業醫師檢査與臨床結果的管理
- 執業醫師檢査的經營面的檢討課題
- 執業醫師檢査的法規環境
第5章 世界市場之執業醫師檢査
- 背景
- 全球執業醫師檢査市場
- 各國的情報
- 美國
- 歐洲－多樣化的系統
- 日本
- 中國
- 印度
- 澳洲
第6章 市場分析
- 市場概要
- 主要企業
- 疾病的負擔與執業醫師檢査的需求
- 檢査市場的分析
- 糖尿病－葡萄糖
- 糖尿病－HbA1c
- 糖尿病－微量白蛋白
- 心臟疾病
- 脂質面板與混合型心臟疾病
- 癌
- 臨床化學
- 凝固物
- 血液學
- 組織學
- 感染症
- 發展中國家的公衆衛生
- 免疫學的檢定
- 甲狀腺機能
- 貧血
- 過敏
- 自體免疫
- 藥物依存(DAU)
- 藥物治療管理(TDM)
- 細菌學
- 分子
- 婦科/懷孕/不孕
- 商業面的展望
第7章 主要企業
- Abbott Diagnostics
- Alere Inc.
- ARKRAY
- Bayer Diabetes Care
- Becton, Dickinson and Company(BD)
- Beckman Coulter Inc.
- bioMerieux Inc.
- Bio-Rad Laboratories Inc.
- Horiba Medical
- Instrumentation Laboratory(IL)
- Lifescan Inc.
- Ortho Clinical Diagnostics(OCD)
- Phadia AB
- QIAGEN N.V.
- Radiometer A/S
- Roche Diagnostics
- Siemens Healthcare Diagnostics
- Sysmex Corporation
第8章 開拓「新市場」的企業
- 3M Medical Diagnostics
- 77 Elektronika Kft.
- Abaxis, Inc.
- A/C Diagnostics
- Accumetrics
- Acon Laboratories, Inc.
- Acrongenomics Inc.
- Akers Biosciences, Inc.
- Alfa Wassermann Diagnostic Technologies, LLC
- Ani Biotech Oy
- Axis-Shield plc
- Biomerica Inc.
- BioVei Incorporated
- Carolina Liquid Chemistries Corp.
- Celerus Diagnostics
- Cepheid
- Chembio Diagnostic Systems, Inc.
- Chempaq A/S
- Claros Diagnostics, Inc.
- CoaguSense, Inc.
- diaDexus, Inc.
- Diaglobal GmbH
- Diazyme Laboratories
- DxNA
- Eiken Chemical Co., Ltd
- Enigma Diagnostics Limited
- Enterix Inc.
- ESA Biosciences Inc.
- HandyLab, Inc.
- Helena Laboratories
- HemoCue AB
- Idaho Technology
- Innovative Biosensors
- International Technidyne Corp (ITC)
- LifeAssays AB
- LifeSign LLC
- MACHEREY-NAGEL GmbH & Co.
- Meridian Bioscience, Inc.
- Micronics Inc.
- Nanosphere, Inc.
- OraSure Technologies, Inc.
- Oxonica Diagnostics
- Philips Handheld Immunoassays
- Pocared Diagnostics Ltd
- Polymedco, Inc.
- Polymer Technology Systems, Inc.
- QBC Diagnostics, Inc.
- QuantRx Biomedical Corporation
- Quidel Corporation
- Quotient Diagnostics
- Randox
- Response Biomedical Corp.
- Rheonix Inc.
- Screening Devices Canada, Inc.
- SQI Diagnostics Inc.
- Trinity Biotech plc
- TwistDx, Ltd.
- Veredus Laboratories Pte
- Vital Diagnostics
第9章 執業醫師檢査市場的將來像：SWOT分析
圖表
Abstract
This report is the second edition of the report “Physician Office
Testing, Worldwide: Status Quo and Future Trends” that was first
published in 2007. The report concentrates on how the market for POL testing
has evolved from 2007 to 2010.
The report takes a bold look into the technologies and trends in physician
office testing and laboratories (POLs) with a special focus on the economics
of test use in on-site patient care. The report is conservative in its
predictions and offers a calculated look into the future, based on events
taking place in the present.
The term physician office lab (POL) is as wide and diverse as one can imagine.
It encompasses physician practices as small as 2 to 5 doctors that perform a
few rapid tests to large practices of some 200 physicians that operate labs
similar to small hospital laboratories. The definition used here is therefore
broad and refers to the market for tests which are: Performed in a physician
office setting, At the time of a consultation between a physician or other
healthcare professional (nurse practitioner, pharmacist, provides a result to
be used during the medical visit and, is used for screening, diagnosis or
monitoring purposes. Growth in physician office testing is fueled by trends in
preventative medicine and proactive approaches in treating the increasing
number of diagnosed diabetics; by the globalization of infectious diseases and
the associated public health issues; and by the need to monitor the explosion
of people with cardiovascular disease and other chronic conditions.
The report offers a quantitative assessment of specific markets, worldwide, in
U.S. dollars for 2009 to 2014. This data is provided in order to set the
status quo of tests and technologies. However the report concentrates on how
these will impact the economics of healthcare over the near term and longer
when possible.
This exhaustive report provides:
- Discussions of the Regulatory Environment for POLs in various
countries and regions.
- The Top POL-conducted Tests and average reimbursement level.
- POL Test Revenues by Type of Test, 2009-2014, for more than 35 test
segments.
- POL Test Revenues by Region (Europe, Asia, US) , 2009 to 2014.
- Breakout of the Number of POLS in the US by type (CLIA-waived,
non-waived)
- Complete discussions of the POL environments in top geographic
markets.
- Profiles of the POL Offerings of over 75 suppliers.
- Market Analyses for Key POL Testing Areas. including:
- Chemistry panels
- Coag PT
- Lipids
- Hemato - CBC
- Glucose
- HbA1c
- Rapid Flu
- Anemia ferritin, iron
- Preg/LH
- Urinalysis
- PSA
- TSH
- FOB
- Cardiac Markers
- Hepatitis
- HIV
- Histology
- Microbiology culture
- Atrep A
- Autoimmune
- Sed rate
- H. pylori
- Cancer Markers
- CRP
- Hgb
- Respiratory Viruses
- STDs
- Allergy
- DAU
- Infectious diseases
- Microalbumin
- TDM
- Other
The world market for the POL sector of point-of-care diagnostics is provided
in U.S. dollars for the years 2009 - 2014. No adjustments have been made to
the market data for the effects of currency exchange fluctuations or
inflation. This may seem problematic, given the drastic devaluation of the
U.S. dollar versus the Japanese Yen, euro and Swiss Franc. Kalorama has
decided to use a constant exchange rate because it is a more accurate
reflection of actual revenue growth in dollars rather than growth due to
exchange rate fluctuations.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Market Trends
CHAPTER TWO: INTRODUCTION
- Background
- POL definition
- The pros and cons of POL testing
- Point of View
CHAPTER THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING
- Background
- The Emergence of Non-invasive Technologies
- Saliva
- Breath
- Optical Techniques
- Miniaturization and Microfluidics Support POC
- CLIA Waived Test Menu Expansion Drives U.S. POLs
- Connectivity Imperative for POC devices
CHAPTER FOUR: THE ECONOMICS OF POL TESTING
- Background
- Reimbursement Challenges and Developments
- POLs and Clinical Outcomes Management
- POL Management Considerations
- The Regulatory Environment for POLs
CHAPTER FIVE: POL TESTING IN WORLD MARKETS
- Background
- Overview of the POL Market, Worldwide
- Specific Country Information
- The United States of America
- Europe - Many Countries and Systems
- Japan
- China
- India
- Australia
CHAPTER SIX: MARKET ANALYSIS
- Market Overview
- The Major Players
- Disease Burden and POL Testing Needs
- Test Segment Market Analysis
- Diabetes - Glucose
- Diabetes - HbA1c
- Diabetes - Microalbumin
- Cardiac Markers
- Lipid Panels and Miscellaneous Cardiac Markers
- Cancer Markers
- Clinical Chemistry
- Coagulation
- Hematology
- Histology
- Infectious Diseases
- Public Health in Developing Countries
- Immunoassays
- Thyroid Function
- Anemia
- Allergy
- Autoimmune
- Drugs of Abuse (DAU)
- Therapeutic Drug Monitoring (TDM)
- Microbiology
- Molecular
- Women' s Health / Pregnancy/Fertility
- Commercial Outlook
CHAPTER SEVEN: TOP COMPANIES
- Abbott Diagnostics
- Alere Inc.
- ARKRAY
- Bayer Diabetes Care
- Becton, Dickinson and Company (BD)
- Beckman Coulter Inc.
- bioMérieux Inc.
- Bio-Rad Laboratories Inc.
- Horiba Medical
- Instrumentation Laboratory (IL)
- Lifescan Inc.
- Ortho Clinical Diagnostics (OCD)
- Phadia AB
- QIAGEN N.V.
- Radiometer A/S
- Roche Diagnostics
- Siemens Healthcare Diagnostics
- Sysmex Corporation
CHAPTER EIGHT: “NEW FRONTIER” COMPANIES IN THE POL MARKET
- 3M Medical Diagnostics
- 77 Elektronika Kft.
- Abaxis, Inc.
- A/C Diagnostics
- Accumetrics
- Acon Laboratories, Inc.
- Acrongenomics Inc.
- Akers Biosciences, Inc.
- Alfa Wassermann Diagnostic Technologies, LLC
- Ani Biotech Oy
- Axis-Shield plc
- Biomerica Inc.
- BioVei Incorporated
- Carolina Liquid Chemistries Corp.
- Celerus Diagnostics
- Cepheid
- Chembio Diagnostic Systems, Inc.
- Chempaq A/S
- Claros Diagnostics, Inc.
- CoaguSense, Inc.
- diaDexus, Inc.
- Diaglobal GmbH
- Diazyme Laboratories
- DxNA
- Eiken Chemical Co., Ltd
- Enigma Diagnostics Limited
- Enterix Inc.
- ESA Biosciences Inc.
- HandyLab, Inc.
- Helena Laboratories
- HemoCue AB
- Idaho Technology
- Innovative Biosensors
- International Technidyne Corp (ITC)
- LifeAssays AB
- LifeSign LLC
- MACHEREY-NAGEL GmbH & Co.
- Meridian Bioscience, Inc.
- Micronics Inc.
- Nanosphere, Inc.
- OraSure Technologies, Inc.
- Oxonica Diagnostics
- Philips Handheld Immunoassays
- Pocared Diagnostics Ltd
- Polymedco, Inc.
- Polymer Technology Systems, Inc.
- QBC Diagnostics, Inc.
- QuantRx Biomedical Corporation
- Quidel Corporation
- Quotient Diagnostics
- Randox
- Response Biomedical Corp.
- Rheonix Inc.
- Screening Devices Canada, Inc.
- SQI Diagnostics Inc.
- Trinity Biotech plc
- TwistDx, Ltd.
- Veredus Laboratories Pte
- Vital Diagnostics
CHAPTER NINE: THE FUTURE OF THE POL MARKET: SWOT ANALYSIS
- Strengths
- Weaknesses
- Opportunities
- Threats
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: Historic Exchange Rate Data
- Table 1-2: Worldwide POL Diagnostic Reagent Sales by country, 2009-2014 ($ million)
CHAPTER THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING
- Table 3-1: Selected Innovations in non-invasive testing, 2010
- Table 3-2: Selected disease markers in exhaled breath
- Table 3-3: Selected biochip and biosensor innovations, 2010
- Table 3-4: Traditional CLIA waived tests
- Table 3-5: Selected Waived Test Categories 2010
- Table 3-6: Selected Waived Instruments and Devices 2010
- Table 3-7: POLs in the U.S., 2000-2010
- Table 3-8: Tests performed in-office
- Table 3-9: Tests sent out to a laboratory
CHAPTER FOUR: THE ECONOMICS OF POL TESTING
- Table 4-1: Selected chemistry and hematology POL systems
CHAPTER FIVE: POL TESTING IN WORLD MARKETS
- Table 5-1: Worldwide POL Diagnostic Reagent Sales by Country, 2009-2014 ($
million)
- Table 5-2: Overview of POLs by Country
- Table 5-3: Distribution of lab tests in physician offices
- Table 5-4: Top 25 POL Tests, U.S., 2009
CHAPTER SIX: MARKET ANALYSIS
- Table 6-1: Worldwide POL Diagnostic Reagent Sales by test segment,
2009-2014 ($ million)
- Table 6-2: POC Test Revenues of Selected Companies, Global, Estimated
- Table 6-3: Selected Disease Statistics, Worldwide, 2008
- Table 6-4: Selected Blood Glucose Test Devices on the Market, 2010
- Table 6-5: Selected HbA1c Tests and Devices, 2010
- Table 6-6: Selected Microalbumin Tests, waived
- Table 6-7: Selected Cardiac Market Tests and Systems
- Table 6-8: Worldwide Sales, Selected Cardiac Marker IVDs, 2009
- Table 6-9: Selected Rapid CRP Diagnostics
- Table 6-10: Selected Lipid Panel Tests
- Table 6-11: Selected Small Footprint Chemistry Systems, 2009
- Table 6-12: Selected CLIA Waived PT Devices
- Table 6-13: Selected Platelet Function Tests
- Table 6-14: Selected Small Footprint Hematology Systems, 2010
- Table 6-15: Selected POC Hemoglobin Test Systems
- Table 6-16: Worldwide POL Infectious Disease Rapid Test Sales, 2009-2014
($ million)
- Table 6-17: Worldwide POL Immunoassay Test Sales, 2009-2014 ($ million)
- Table 6-18: Selected Compact Immunoassay Systems, 2010
2010年全球執業醫生檢查市場的銷售額達到20億美元
2010年11月24日
Global Information, Inc.已開始銷售美國調查公司Kalorama Information所發行的報告書「Physician Office Laboratory (POL) Testing Markets Worldwide: Status Quo and Future Trends (全球執業醫師（POL）檢查市場：現況及未來趨勢)」。
全球執業醫生檢查市場今年的銷售額預計達到20億美元。執業醫生檢查這個用語意義廣泛，其中包含從1∼5人的醫生實施立即會知道結果的檢查之小規模形態，到超過200人的醫生在各種檢驗室進行作業的大規模形態等。典型性的是妊娠檢查、血糖值、單檢體血紅素、驗尿、航班潛入血檢驗等，這些都是執業醫生日常作的檢查工作。
執業醫生大半的檢查，都不適用美國臨床檢查室改善法(CLIA)，故不須適用美國食品醫藥品管理局(FDA)制定的手續就能實施。檢查的大半都是單純使用一般的器具進行，故幾乎沒有發生錯誤的可能性。
Kalorama Information的主任分析師、診斷領域專業的Shara Rosen先生陳述：「因為要件不嚴苛，當然，即使是CLIA適用對象的設施，亦能實施這些檢查。然為獲得CLIA認定，每2年需要150美元的費用，該費用與檢查件數有關，接受CLIA認定的檢査設施之負擔額，有時2年需數千美元。」。
本報告主要的內容
- 執業醫生檢查室實施最多的檢查與一般補償的水準
- 2009∼2014年執業醫生檢查的各類型(35種類)銷售額
- 2009∼2014年執業醫生檢查各地區（亞洲、歐洲、美國等)的銷售額
- 全球各地及各國執業醫生檢查的法規環境
- 美國各類型(CLIA不適用、CLIA認定)執業醫生的檢查室數
- 針對主要地區市場執業醫生檢查環境的總括性考察
- 75家以上企業提供執業醫生檢查產品的概況
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