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市場調查報告書

全球執業醫師各種檢查裝置(POL)市場

Physician Office Laboratory Markets, 3rd Edition

出版商 Kalorama Information 商品編碼 312138
出版日期 內容資訊 英文 150 Pages
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全球執業醫師各種檢查裝置(POL)市場 Physician Office Laboratory Markets, 3rd Edition
出版日期: 2014年08月15日 內容資訊: 英文 150 Pages
簡介

在執業醫師的診療所、診所的診斷、檢驗內容,及使用的檢查裝置的種類,依照各醫生的診療領域而不同,使情況多樣。雖然任何檢驗內容、設備內容普遍單純,不過也有實施更複雜檢驗的情況。

本報告提供執業醫師的體外診斷(IDV)用各種設備(以下POL)的全球市場相關分析、整體市場結構和背景情況、市場規模趨勢和未來預測(今後5年份)、各國、各設備(各檢查項目)的詳細趨勢、各國家的醫療費用給付、法規環境、主要企業簡介等等。

第1章 摘要整理

第2章 簡介

  • 背景情況
  • 執業醫師檢驗(POL: Physician Office Laboratory)定義
  • 對POL檢驗的贊成、反對意見
  • 分析的觀點與手法

第3章 執業醫師檢驗(POL)的市場、技術趨勢

  • 背景情況
  • 非侵入性診斷技術的登場
    • 唾液與擦拭棒
    • 呼吸
    • 光學技術
  • 定點照護(POC)之生物感應器、微小液體技術
  • POC設備的連接性的必要條件
  • 美國臨床實驗室改進法案(CLIA)的檢驗表單擴大的觀望伴隨的,美國的POL市場成長預測
  • 醫療費給付相關課題
  • 結論

第4章 全球各國的POL檢驗市場

  • 背景情況
  • 全球POL市場概況
  • 全球各國的POL市場
    • 美國
    • 加拿大(各州的POL/POCT的範圍差異)
    • 歐洲:依據不同國家的未來展望
      • 英國
      • 德國
      • 義大利
      • 法國
      • 瑞士
    • 日本
    • 澳洲
    • 中國
    • 印度
  • 全球POL市場概況
  • 各檢查項目的市場分析與議論
    • 糖尿病:血糖值
    • 糖尿病:HbA1c
    • 糖尿病:微白蛋白
    • 心臟標記
    • 二次心臟標記:C反應蛋白(CRP)、同半胱胺酸、D-二聚體
    • 脂質操作面板、檢驗
    • 癌症標記:FOBT、PSA等
    • 臨床化學
    • 驗尿
    • 血液凝固檢驗
    • 血液檢驗
    • 組織診斷
    • 感染疾病
    • 免疫檢測:概要
    • 免疫檢測:TSH
    • 免疫檢測:Anemia
    • 免疫檢測:過敏
    • 免疫檢測:自體免疫不全
    • 免疫檢測:藥物濫用(DAU)
    • 免疫檢測:診斷藥監測(TDM)
    • 微生物檢驗
    • 分子診斷
  • 結論

第5章 體外診斷檢驗(IVD)的主要企業

  • Abbott Diagnostics
    • POC分析設備
    • 血液檢查裝置
    • 糖尿病檢查裝置
  • Alere
    • POC分析設備
    • 糖尿病檢查裝置
    • 血液凝固檢查設備
    • 感染疾病
    • 心臟標記
  • Arkray
  • Beckman Coulter
  • Becton, Dickinson and Company (BD)
    • 急性流感
  • bioMerieux
  • Bio-Rad Laboratories
  • 堀場製作所
  • Instrumentation Laboratory
  • Ortho-Clinical Diagnostics
  • QIAGEN
  • Radiometer
  • Roche Diagnostics
    • 專家用血糖值檢查裝置
    • POC用臨床化學設備
  • Siemens Healthcare Diagnostics
    • HbA1c
    • 驗尿用設備
  • Sysmex
    • 血液檢查裝置
    • 血液凝固檢查設備
  • Thermo Fisher Scientific
    • 傳染病檢查設備
    • 急性流感檢查裝置

第6章 其他的企業

  • 77 Elektronika
  • Abaxis
  • Accriva Diagnostics
  • ACON Laboratories
  • Akers Biosciences
  • Alfa Wassermann Diagnostic Technologies
  • Axis-Shield
    • Afinion
    • NycoCard
    • 血液凝固檢查設備
  • Biomerica
  • Boule Diagnostics
  • Carolina Liquid Chemistries Corp.
  • Cepheid
  • Chembio Diagnostic Systems
  • CoaguSense
  • Diazyme Laboratories
  • DxNA
  • 榮研化學
  • EKF Diagnostics
  • Enigma Diagnostics
  • Enterix
  • GlycoMark
  • Helena Laboratories
  • 日立轉化
  • Labysystems Diagnostics
  • LifeAssays
  • LifeSign (Princeton BioMeditech)
  • Macherey-Nagel
  • Magellan Diagnostics
  • Meridian Bioscience
  • Micronics
  • Mindray
  • Nanosphere
  • OPKO Health
  • OraSure Technologies
  • Philips Handheld Diagnostics
  • Polymedco
  • Polymer Technology Systems (CHEK Diagnostics)
  • QBC Diagnostics
  • Quidel
  • Trinity Biotech
  • Vital Diagnostics

圖表一覽

目錄
Product Code: KLI5314670

This report, Physician Office Laboratory Markets is Kalorama's complete review of an important segment of the IVD industry. Physician office laboratories are diverse in their capabilities and setting. Individual practitioners may simply perform reimbursable, in-office pregnancy and glucose tests. Some specialty practices and clinics run CBCs and chemistry panels using small lab and benchtop automated analyzers requiring moderate complexity CLIA compliance. Medicare physician filings also indicate POLs perform moderate complexity infectious disease tests using plate immunoassays and molecular assays as well as in-situ hybridization tests using tissue samples.

While many tests run at POLs are simple in nature, more complex tests are being run

This report contains

  • Market Size Estimates for IVD Tests in POL Settings
  • Forecasts to 2018
  • POL Data
  • Important Trends
  • Most Common POL Tests
  • Reimbursement and Regulation
  • International POL Overview and Country Analysis
  • Corporate Profiles

The POL market encompasses a variety of institutions beyond physician practices, including specialty and multispecialty clinics; other primary care and urgent care clinics; and outpatient clinics not located or associated with a hospital (or hospital lab) or outpatient surgical services.

In general, the POL market includes tests which are: physically performed in a physician office setting or lab located on the premises of the clinic or practice (not an associated hospital) performed at the time of a consultation with a physician or other healthcare professional (nurse practitioner, pharmacist) reportable to the patient are provide results to be used during the medical visit or same day as the visit used for screening, diagnosis or monitoring purposes not performed by anatomic pathologists or similar pathology practices that operate as physician practices or offices but provide histology, microscopy, and high complexity testing services as outreach (outside patients and samples) and with results not available during the visit or in conjunction with one visit

What competitors are succeeding in this market What are the most profitable tests, and what growth levels can diagnostic companies expect in the future How will regulations affect this industry This report answers these questions. 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. Among the type of physician conducted tests covered in this market research report:

  • 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
  • Strep A
  • Autoimmune
  • Sed Rate
  • H. pylori
  • Cancer Markers
  • CRP
  • Hgb
  • Respiratory Viruses
  • STDs
  • Allergy
  • DAU
  • Infectious diseases
  • Microalbumin
  • TDM
  • Other

A truly global report, the 3rd edition this report discusses the POL market in the following countries

  • The United States
  • Canada - Provinces Determine POL and POCT Coverage
  • United Kingdom
  • Germany
  • Italy
  • France
  • Switzerland
  • Japan
  • Australia
  • China
  • India

Table of Contents

ONE: EXECUTIVE SUMMARY

  • Introduction
  • Technological Dynamics in the POL
  • POL Markets Worldwide
  • The United States of America
  • Germany
  • Switzerland
  • Japan
  • Global POL Market Overview
  • Conclusions

TWO: INTRODUCTION

  • Background
  • POL Definition
  • The Pros and Cons of POL Testing
  • Report Point of View and Methodology

THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING

  • Background
  • The Emergence of Non-invasive Technologies
  • Saliva and Swab
  • Breath
  • Optical Techniques
  • Biosensors and Microfluidics Support POC
  • Connectivity Imperative for POC Devices
  • CLIA Waived Test Menu Expansion Instills Points of Growth in U.S. POL Market
  • Reimbursement Challenges
  • Conclusions

FOUR: POL TESTING IN WORLD MARKETS

  • Background
  • Overview of the Global POL Market
  • Physician Office Labs by Country
  • The United States of America
  • Canada - Provinces Determine POL and POCT Coverage
  • Europe-Many Countries, Varied Prospects
  • United Kingdom
  • Germany
  • Italy
  • France
  • Switzerland
  • Japan
  • Australia
  • China
  • India
  • Global POL Market Overview
  • Test Segment Market Analyses and Discussion
  • Diabetes - Glucose
  • Diabetes - HbA1c
  • Diabetes - Microalbumin
  • Cardiac Markers
  • Secondary Cardiac Markers - CRP, Homocysteine, D-dimer
  • Lipid Panels and Tests
  • Cancer Markers - FOBT, PSA, Others
  • Clinical Chemistry
  • Urinalysis
  • Coagulation
  • Hematology
  • Histology
  • Infectious Diseases
  • Immunoassay Overview
  • Immunoassays - TSH
  • Immunoassays - Anemia
  • Immunoassays - Allergy
  • Immunoassays - Autoimmune
  • Immunoassays - Drugs of Abuse (DAU)
  • Immunoassays - Therapeutic Drug Monitoring (TDM)
  • Microbiology
  • Molecular
  • Conclusions

FIVE: TOP TIER IVD PLAYERS

  • Abbott Diagnostics
  • Point-of-Care Analyzers
  • Hematology
  • Diabetes
  • Alere
  • Point-of-Care Analyzers
  • Diabetes
  • Coagulation
  • Infectious Disease
  • Cardiac Markers
  • Arkray
  • Beckman Coulter
  • Becton, Dickinson and Company (BD)
  • Rapid Flu
  • bioMérieux
  • Bio-Rad Laboratories
  • Horiba Medical
  • Instrumentation Laboratory
  • Ortho-Clinical Diagnostics
  • QIAGEN
  • Radiometer
  • Roche Diagnostics
  • Professional Glucose Testing
  • Point-of-Care Clinical Chemistry
  • Siemens Healthcare Diagnostics
  • HbA1c
  • Urinalysis
  • Sysmex Corporation
  • Hematology
  • Coagulation
  • Thermo Fisher Scientific
  • Infectious Disease
  • Rapid Flu

SIX: OTHER POL COMPANIES

  • 77 Elektronika
  • Abaxis
  • Accriva Diagnostics
  • ACON Laboratories
  • Akers Biosciences
  • Alfa Wassermann Diagnostic Technologies
  • Axis-Shield
  • Afinion
  • NycoCard
  • Coagulation
  • Biomerica
  • Boule Diagnostics
  • Carolina Liquid Chemistries Corp.
  • Cepheid
  • Chembio Diagnostic Systems
  • CoaguSense
  • Diazyme Laboratories
  • DxNA
  • Eiken Chemical
  • EKF Diagnostics
  • Enigma Diagnostics
  • Enterix
  • GlycoMark
  • Helena Laboratories
  • Hitachi Chemical
  • Labysystems Diagnostics
  • LifeAssays
  • LifeSign (Princeton BioMeditech)
  • Macherey-Nagel
  • Magellan Diagnostics
  • Meridian Bioscience
  • Micronics
  • Mindray
  • Nanosphere
  • OPKO Health
  • OraSure Technologies
  • Philips Handheld Diagnostics
  • Polymedco
  • Polymer Technology Systems (CHEK Diagnostics)
  • QBC Diagnostics
  • Quidel
  • Trinity Biotech
  • Vital Diagnostics

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

  • Table 1-1: Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse andTherapeutic Drugs, Urinalysis, Glucose Monitoring, General Chemistry,Infectious Diseases, Other) (2010-2014) Table 1-2: Global POL Market by Region/Country (United States, Europe, Japan,ROW) (2014-2019)
  • Table 1-3: Overview of POLs by Country (U.S., Canada, Australia, China, India,Japan, Philippines, Belgium, Britain, Czech Republic, France, Germany, Greece,Hungary, Italy, Spain, Sweden, Switzerland)
  • Table 1-4: Number of POLs in the United States (Compliance [Moderate and HighComplexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation[Moderate and High Complexity]) (2005-2013) Table 1-5: U.S. Physician Office Laboratory (POL) Tests - Ranked by EstimatedVolume (2014)
  • Table 1-6: Global POL Market by Segment ($ millions) (2014-2019) (Allergy, Anemia,Autoimmune, Cardiac Markers, Hematology [CBC], Chemistry, Coagulation [PT],CRP, Drugs of Abuse, D-dimer, ESR, FOB, Glucose, H. pylori, HbA1c, Hepatitis,Hemoglobin/Hematocrit, Histology, HIV, Homocysteine, Lipids, Microalbumin,Microbiology, Pregnancy/Ovulation, PSA, Rapid Flu, Respiratory Viruses, STDs,Strep A, Therapeutic Drugs, TSH, Urinalysis, Other Cancer Markers, OtherInfectious Diseases)

THREE: MARKET AND TECHNOLOGICAL DYNAMICS IN POL TESTING

  • Table 3-1: Selected Disease Markers in Exhaled Breath (Asthma, Breast cancer,Diabetes, Liver function, Lung cancer, Organ rejection, Renal function,Schizophrenia, Gastrointestinal malabsorption / Irritable Bowel Syndrome (IBS) /Celiac disease and food intolerances / Bacterial overgrowth, Bacterial infection) Table 3-2: Selected Biochip and Biosensor Players, 2014
  • Table 3-3: Traditional CLIA-Waived Tests
  • Table 3-4: Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse andTherapeutic Drugs, Urinalysis, Glucose Monitoring, General Chemistry, InfectiousDiseases, Other) (2010-2014) Table 3-5: CLIA-Waived Tests and Analytes
  • Table 3-6: 2014 CLIA Waivers (Manufacturer and Instrument / Assay)
  • Table 3-7: Number of POLs in the United States (Compliance [Moderate and HighComplexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation[Moderate and High Complexity]) (2005-2013) Table 3-8: U.S. Physician Office Laboratory (POL) Tests - Ranked by EstimatedVolume (2014)

FOUR: POL TESTING IN WORLD MARKETS

  • Table 4-1: Global POL Market by Region/Country (United States, Europe, Japan,ROW) (2014-2019)
  • Table 4-2: Overview of POLs by Country (U.S., Canada, Australia, China, India,Japan, Philippines, Belgium, Britain, Czech Republic, France, Germany, Greece,Hungary, Italy, Spain, Sweden, Switzerland)
  • Table 4-3: Non-Practice U.S. POL Sites (Community Clinic, Home Health Agency,Pharmacy, Other Practitioner, Rural Health Clinic, Total) (# of Locations, Est.Test Volume, CLIA-% of Test Volume)
  • Table 4-4: U.S. POL Test Volume Distribution (Physician Practices Only)
  • Table 4-5: U.S. Physician Practices and Physicians by Practice Type(Solo/2-PhysicianPractice, Group Practice (3-5), Group Practice (6-50), Group Practice (51+),Hospital-Based, Medical School/University, Group/Staff HMO, CommunityHealth Center)
  • Table 4-6: U.S. Physician Office Laboratory (POL) Tests - Ranked by EstimatedVolume (2014)
  • Table 4-7: Global POL Market by Segment ($ millions) (2014-2019) (Allergy, Anemia,Autoimmune, Cardiac Markers, Hematology [CBC], Chemistry, Coagulation [PT],CRP, Drugs of Abuse, D-dimer, ESR, FOB, Glucose, H. pylori, HbA1c, Hepatitis,Hemoglobin/Hematocrit, Histology, HIV, Homocysteine, Lipids, Microalbumin,Microbiology, Pregnancy/Ovulation, PSA, Rapid Flu, Respiratory Viruses, STDs,Strep A, Therapeutic Drugs, TSH, Urinalysis, Other Cancer Markers, OtherInfectious Diseases)
  • Table 4-8: Selected HbA1c Tests and Devices, 2014
  • Table 4-9: Selected Microalbumin Tests and Devices, 2014
  • Table 4-10: Selected Cardiac Marker Tests and Systems, 2014
  • Table 4-11: Selected CRP Tests and Systems, 2014
  • Table 4-12: Selected Lipid Tests and Systems, 2014
  • Table 4-13: Selected Clinical Chemistry Systems, 2014
  • Table 4-14: Selected Dipstick Urinalysis Systems, 2014
  • Table 4-15: Selected PT/INR Systems, 2014
  • Table 4-16: Selected POL Hematology Analyzer Systems, 2014
  • Table 4-17: Selected POL Hemoglobin and Hematocrit Systems, 2014
  • Table 4-18: Global POL Market for Rapid Infectious Disease Tests(Rapid Flu, HIV, Hepatitis, Strep A, Respiratory Viruses, STDs, Other, Total) (2014-2019)
  • Table 4-19: Global POL Market for Immunoassays by Segment (2014-2019) (Allergy,Anemia, Autoimune, Cancer Markers, Cardiac Markers, CRP, Drugs of Abuse,Pregnancy/Ovulation, PSA, Therapeutic Drugs, TSH)
  • Table 4-20: Selected POL Immunoanalyzers, 2014

FIVE: TOP TIER IVD PLAYERS

  • Table 5-1: Top Tier IVD Player POL Market Shares (%) (Abbott, Alere, Arkray,Beckman Coulter, BD, bioMérieux, Bio-Rad, Horiba, Instrumentation Laboratory,Ortho Clinical, QIAGEN, Radiometer, Roche, Siemens, Sysmex)
  • Table 5-2: Abbott Diagnostics: Estimated Revenue by IVD Segment - (Core Lab[Chem/Immuno], Hematology, POC, Molecular, Diabetes) (2011-2013)
  • Table 5-3: Alere: Revenue by IVD Segment - (Professional POC - Cardiology,Infectious Disease, Toxicology, Diabetes, Other; Consumer [OTC] Diagnostics)(2011-2013)
  • Table 5-4: Beckman Coulter: Estimated Revenue by IVD Segment - (ClinicalChemistry, Immunoassays, Hematolgy, Flow Cytometry) (2011-2013)
  • Table 5-5: Becton Dickinson: Estimated Revenue by IVD Segment - (Histology,Molecular, Microbiology [ID/AST, Media, Rapid Tests, Blood Culture], FlowCytometry) (FY 2011-2013)
  • Table 5-6: bioMérieux: Estimated Revenue by IVD Segment - (Microbiology,Immunoassays, Molecular, Industrial [Applied], Other) (FY 2011-2013)
  • Table 5-7: Ortho-Clinical Diagnostics: Estimated Revenue by Product Group -(Immunoassays, Chemistry, Blood Banking) (2011-2013)
  • Table 5-8: QIAGEN: Estimated Revenue by Segment - (HPV, Other MolecularClinical, Applied Testing, Pharma, Academia) (2011-2013)
  • Table 5-9: Roche Diagnostics: Estimated Revenue by Segment - (ProfessionalDiagnostics, Diabetes Care, Molecular Diagnostics, Tissue Diagnostics)(2011-2013)
  • Table 5-10: Siemens Healthcare Diagnostics: Estimated Revenue by Segment -(Hematology, Coagulation, Chemistry/Immunoassays, Microbiology, Urinalysis,Blood Gases) (2011-2013)
  • Table 5-11: Sysmex Corporation: Estimated Revenue by Segment - (Hematology,Coagulation, Urinalysis, Chemistry/Immuno, Other IVD) (2011-2013)
  • Table 5-12: Thermo Fisher Scientific: Estimated Revenue by Segment - (ClinicalProducts, Immunoassays [Phadia], Microbiology, Histology, TransplantDiagnostics) (2011-2013)

SIX: OTHER POL COMPANIES

  • Table 6-1: Abaxis: Estimated Revenue by Business Segment Segment - (Piccolo /Clinical IVD, VetScan Chemistry, Veterinary Hematology, Other)(CY 2011-2013)
  • Table 6-2: Cepheid: Estimated Revenue by Business Segment Segment - (NorthAmerican Clinical, North American Non-Clinical, International Clinical,International Non-Clinical) (2011-2013)
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