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U.S. Point-of-care Testing Markets
Table of Contents
C h a p t e r 1
Executive Summary
Market Overview 1-1
Introduction 1-1
C h a p t e r 2
Total Point-of-care Testing Market
Market Overview 2-1
Introduction 2-1
Research Methodology 2-2
Market Engineering Analysis 2-3
Market Segmentation and Revenue Forecasts 2-4
Scope and Segmentation 2-4
Revenue Forecasts 2-4
Market Share Analysis 2-8
Market Challenges and Strategic Recommendations 2-10
Industry Challenges 2-10
Increased Competition Continues to Wither Profit Margins 2-10
Medicare and Medicaid Increasingly Dictate Reimbursements for POCT Manufacturers 2-11
Accuracy of POCT Devices Questioned by Many in the Medical Community 2-11
Clinical Laboratories Dictate Adoption of POCT Devices in Hospitals 2-12
Higher Cost per Test at the Point-of-care Discourages Utilization 2-12
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Strategic Recommendations 2-12
Demonstrate Value of Immediate Diagnosis and Treatment in POCT 2-13
Support Reliability of POCT Through Clinical Studies and Professional Endorsements 2-14
Build Strong Relationships with Distributors and End-users 2-14
Expand Testing Menu in POCT Instruments 2-14
Innovate and Protect Intellectual Property 2-15
Market Drivers and Restraints 2-15
Market Drivers 2-15
Convenience and Speed of Diagnostic Tests Performed Near Patients Drive POCT Market 2-15
Glucose Testing 2-16
A1C Testing 2-16
Blood Gas and Electrolyte Testing 2-16
Cholesterol Testing 2-16
Drugs of Abuse Testing 2-17
Infectious Disease Testing 2-17
Pregnancy Testing 2-17
Hematology Testing 2-18
Coagulation Testing 2-18
Cardiac Biomarkers Testing 2-19
Fecal Occult Blood Testing 2-19
Ease of Use in Testing Devices Supports Adoption of POCT Market 2-19
Glucose Testing 2-20
A1C Testing 2-20
Blood Gas and Electrolyte Testing 2-21
Cholesterol Testing 2-21
Drugs of Abuse Testing 2-21
Infectious Disease Testing 2-21
Pregnancy Testing 2-22
Hematology Testing 2-22
Coagulation Testing 2-22
Cardiac Biomarkers Testing 2-22
Fecal Occult Blood Testing 2-23
Growing Sick Population Requiring Rapid Diagnosis Stimulates POCT Market 2-23
Glucose Testing 2-23
A1C Testing 2-23
Blood Gas and Electrolyte Testing 2-24
Cholesterol Testing 2-24
Drugs of Abuse Testing 2-24
Infectious Disease Testing 2-24
Pregnancy Testing 2-24
Hematology Testing 2-24
Coagulation Testing 2-25
Cardiac Biomarkers Testing 2-25
Fecal Occult Blood Testing 2-25
Market Restraints 2-25
Tests Categorized as Moderate or High Complexity are Restrained to Usage by Certain Markets 2-26
Glucose Testing 2-26
A1C Testing 2-26
Blood Gas and Electrolyte Testing 2-26
Cholesterol Testing 2-27
Drugs of Abuse Testing 2-27
Infectious Disease Testing 2-27
Pregnancy Testing 2-27
Hematology Testing 2-27
Coagulation Testing 2-28
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Cardiac Biomarkers Testing 2-28
Fecal Occult Blood Testing 2-28
Non-critical Diagnostic Tests Have Lower Clinical Utility at the Point-of-Care and Deter Adoption 2-28
Glucose Testing 2-29
A1C Testing 2-29
Blood Gas and Electrolyte Testing 2-29
Cholesterol Testing 2-29
Drugs of Abuse Testing 2-29
Infectious Disease Testing 2-30
Pregnancy Testing 2-30
Hematology Testing 2-30
Coagulation Testing 2-30
Cardiac Biomarkers Testing 2-30
Fecal Occult Blood Testing 2-31
C h a p t e r 3
Glucose Point-of-care Testing Market
Market Overview 3-1
Introduction 3-1
Market Engineering Measurements 3-2
Technology and Market Trends 3-3
Technology Trends 3-3
Minimally Invasive and Non-invasive Glucose Testing 3-3
Glucose Meters Offering Connectivity to Hospital LIS for Data Management 3-3
Market Trends 3-4
Tight Glycemic Control Programs in Hospitals Being Implemented 3-4
Market Forecasts 3-4
Revenue Forecasts 3-4
Competitive Analysis 3-6
Competitive Structure 3-6
Market Share Analysis 3-7
Product Analysis 3-9
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C h a p t e r 4
A1C Point-of-care Testing Market
Market Overview 4-1
Introduction 4-1
Market Engineering Measurements 4-2
Technology and Market Trends 4-3
Technology Trends 4-3
Combining A1C Tests with Other Supplementary Tests for Diabetes Care 4-3
Market Trends 4-3
Investments in A1C POCT Market Increasing Awareness of A1C Testing 4-3
Market Forecasts 4-4
Revenue Forecasts 4-4
Competitive Analysis 4-5
Competitive Structure 4-5
Market Share Analysis 4-7
Product Analysis 4-9
C h a p t e r 5
Cholesterol Point-of-care Testing Market
Market Overview 5-1
Introduction 5-1
Market Engineering Measurements 5-2
Technology and Market Trends 5-3
Technology Trends 5-3
Larger Testing Menu to Include Full Lipid Profile Normally Available Only to Central Labs 5-3
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Market Trends 5-3
Growing Health-conscious Population Interested in Cholesterol Testing 5-3
Market Forecasts 5-4
Revenue Forecasts 5-4
Competitive Analysis 5-5
Competitive Structure 5-5
Market Share Analysis 5-7
Product Analysis 5-8
C h a p t e r 6
Blood Gas and Electrolyte Point-of-care Testing Market
Market Overview 6-1
Introduction 6-1
Market Engineering Measurements 6-2
Technology and Market Trends 6-3
Technology Trends 6-3
Miniaturization of Testing Instruments for Increased Portability and Use at the Point of Care 6-3
Market Trends 6-3
Analyzing the Testing Process of Hospitals to Market the Appropriate Product 6-3
Market Forecasts 6-4
Revenue Forecasts 6-4
Competitive Analysis 6-5
Competitive Structure 6-5
Market Share Analysis 6-8
Product Analysis 6-10
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C h a p t e r 7
Drugs of Abuse Point-of-care Testing Market
Market Overview 7-1
Introduction 7-1
Market Engineering Measurements 7-2
Technology and Market Trends 7-3
Technology Trends 7-3
Testing Different Types of Sample Specimens for Drugs of Abuse at the Point-of-Care 7-3
Market Trends 7-3
Increased Competition Continues to Commoditize Products 7-3
Market Forecasts 7-3
Revenue Forecasts 7-3
Competitive Analysis 7-5
Competitive Structure 7-5
Market Share Analysis 7-7
Product Analysis 7-8
C h a p t e r 8
Infectious Disease Point-of-care Testing Market
Market Overview 8-1
Introduction 8-1
Market Engineering Measurements 8-2
Technology and Market Trends 8-3
Technology Trends 8-3
Development of Molecular Diagnostics for the Point of Care 8-3
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Market Trends 8-3
Decreasing Number of Brands for Improved Visibility and Recognition 8-3
Market Forecasts 8-4
Revenue Forecasts 8-4
Competitive Analysis 8-7
Competitive Structure 8-7
Market Share Analysis 8-10
Product Analysis 8-11
C h a p t e r 9
Pregnancy Point-of-care Testing Market
Market Overview 9-1
Introduction 9-1
Market Engineering Measurements 9-2
Technology and Market Trends 9-3
Technology Trends 9-3
Continuous Refining of Pregnancy POCT Products for Clearer Results 9-3
Market Trends 9-3
Strengthening Sales and Distribution Capabilities to Push Product Lines 9-3
Market Forecasts 9-3
Revenue Forecasts 9-3
Competitive Analysis 9-5
Competitive Structure 9-5
Market Share Analysis 9-7
Product Analysis 9-8
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C h a p t e r 1 0
Hematology Point-of-care Testing Market
Market Overview 10-1
Introduction 10-1
Market Engineering Measurements 10-2
Technology and Market Trends 10-3
Technology Trends 10-3
Increasing Number of Hematology Panels for POCT 10-3
Market Trends 10-3
More Hematology POCT Devices Encourage Adoption by Healthcare Practitioners 10-3
Market Forecasts 10-3
Revenue Forecasts 10-3
Competitive Analysis 10-5
Competitive Structure 10-5
Market Share Analysis 10-6
Product Analysis 10-7
C h a p t e r 1 1
Coagulation Point-of-care Testing Market
Market Overview 11-1
Introduction 11-1
Market Engineering Measurements 11-2
Technology and Market Trends 11-4
Technology Trends 11-4
Increasing Development of User-friendly Hand-held Monitors for PT Tests 11-4
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Market Trends 11-4
Increasing Competition in the Coagulation PT POCT Market Leads to Commoditization of Pricing 11-4
Market Forecasts 11-4
Revenue Forecasts: Coagulation ACT POCT Market 11-4
Revenue Forecasts: Coagulation PT POCT Market 11-6
Competitive Analysis 11-7
Competitive Structure: Coagulation ACT POCT Market 11-7
Competitive Structure: Coagulation PT POCT Market 11-9
Market Share Analysis: Coagulation ACT POCT Market 11-10
Market Share Analysis: Coagulation PT POCT Market 11-12
Product Analysis: Coagulation ACT POCT Market 11-13
Product Analysis: Coagulation PT POCT Market 11-14
C h a p t e r 1 2
Cardiac Biomarkers Point-of-care Testing Market
Market Overview 12-1
Introduction 12-1
Market Engineering Measurements 12-2
Technology and Market Trends 12-3
Technology Trends 12-3
Combining Multiple Tests for Cardiac Biomarkers 12-3
Market Trends 12-3
Developing Cardiac Biomarkers Tests for Physician Office Laboratories 12-3
Market Forecasts 12-4
Revenue Forecasts 12-4
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Competitive Analysis 12-5
Competitive Structure 12-5
Market Share Analysis 12-7
Product Analysis 12-9
C h a p t e r 1 3
Fecal Occult Blood Testing Market
Market Overview 13-1
Introduction 13-1
Market Engineering Measurements 13-2
Technology and Market Trends 13-3
Technology Trends 13-3
Increased Development of More Immunoassays for FOBT 13-3
Market Trends 13-3
The iFOBT is Expected to Phase Out the Usage of the Guaiac Smear Method 13-3
Market Forecasts 13-3
Revenue Forecasts 13-3
Competitive Analysis 13-5
Competitive Structure 13-5
Market Share Analysis 13-6
Product Analysis 13-8
C h a p t e r 1 4
Multi-testing Platform Trends
Market Overview 14-1
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Introduction 14-1
Technology and Market Trends 14-2
Technology Trends 14-2
Developing Test Panels to Address Particular Needs 14-2
Market Trends 14-2
Multi-testing Platforms are Still Challenged by Traditional Single-test Products 14-2
Competitive Analysis 14-3
Product Analysis 14-3
C h a p t e r 1 5
Decision Support Databases
Decision Support Databases 15-1
Number of Physicians 15-1
Number of Hospitals 15-3
Number of Hospital Beds 15-5
Number of People Aged 65 Years and Older 15-8
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List of Figures
Ch a p t e r 2
Total Point-of-care Testing Market
2-1 Total POCT Market:
Revenue Forecasts (U.S.), 2002-2012 2-5
2-2 Total POCT Market:
Percent of Revenues by Segment (U.S.), 2005 2-6
2-3 Total POCT Market:
Percent of Revenues by Segment (U.S.), 2012 2-7
2-4 Total POCT Market:
Company Market Share by Revenues (U.S.), 2005 2-9
2-5 Total POCT Market:
Impact of Top Five Industry Challenges (U.S.), 2006-2012 2-10
2-6 Total POCT Market:
Challenges and Corresponding Strategic Recommendations (U.S.), 2006-2012 2-13
2-7 Total POCT Market:
Market Drivers Ranked in Order of Impact (U.S.), 2006-2012 2-15
2-8 Total POCT Market:
Market Restraints Ranked in Order of Impact (U.S.), 2006-2012 2-25
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Ch a p t e r 3
Glucose Point-of-care Testing Market
3-1 Glucose POCT Market:
Revenue Forecasts (U.S.), 2002-2012 3-5
3-2 Glucose POCT Market:
Competitive Structure (U.S.), 2005 3-6
3-3 Glucose POCT Market:
Company Market Share by Revenues (U.S.), 2005 3-8
3-4 Glucose POCT Market:
Product Analysis (U.S.), 2005 3-9
Ch a p t e r 4
A1C Point-of-care Testing Market
4-1 A1C POCT Market:
Revenue Forecasts (U.S.), 2002-2012 4-4
4-2 A1C POCT Market:
Competitive Structure (U.S.), 2005 4-6
4-3 A1C POCT Market:
Company Market Share by Revenues (U.S.), 2005 4-7
4-4 A1C POCT Market:
Product Analysis (U.S.), 2005 4-9
Ch a p t e r 5
Cholesterol Point-of-care Testing Market
5-1 Cholesterol POCT Market:
Revenue Forecasts (U.S.), 2002-2012 5-4
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5-2 Cholesterol POCT Market:
Competitive Structure (U.S.), 2005 5-6
5-3 Cholesterol POCT Market:
Company Market Share by Revenues (U.S.), 2005 5-7
5-4 Cholesterol POCT Market:
Product Analysis (U.S.), 2005 5-8
Ch a p t e r 6
Blood Gas and Electrolyte Point-of-care Testing Market
6-1 Blood Gas and Electrolyte POCT Market:
Revenue Forecasts (U.S.), 2002-2012 6-4
6-2 Blood Gas and Electrolyte POCT Market:
Competitive Structure (U.S.), 2005 6-6
6-3 Blood Gas and Electrolyte POCT Market:
Company Market Share by Revenues (U.S.), 2005 6-8
6-4 Blood Gas and Electrolyte POCT Market:
Product Analysis (U.S.), 2005 6-10
Ch a p t e r 7
Drugs of Abuse Point-of-care Testing Market
7-1 Drugs of Abuse POCT Market:
Revenue Forecasts (U.S.), 2002-2012 7-4
7-2 Drugs of Abuse POCT Market:
Competitive Structure (U.S.), 2005 7-5
7-3 Drugs of Abuse POCT Market:
Company Market Share by Revenues (U.S.), 2005 7-7
7-4 Drugs of Abuse POCT Market:
Product Analysis (U.S.), 2005 7-9
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Ch a p t e r 8
Infectious Disease Point-of-care Testing Market
8-1 Infectious Disease POCT Market:
Revenue Forecasts (U.S.), 2002-2012 8-4
8-2 Infectious Disease POCT Market:
Percent of Revenues by Sub-segment (U.S.), 2005 8-6
8-3 Infectious Disease POCT Market:
Competitive Structure (U.S.), 2005 8-8
8-4 Infectious Disease POCT Market:
Company Market Share by Revenues (U.S.), 2005 8-10
8-5 Infectious Disease POCT Market:
Product Analysis (U.S.), 2005 8-12
Ch a p t e r 9
Pregnancy Point-of-care Testing Market
9-1 Pregnancy POCT Market:
Revenue Forecasts (U.S.), 2002-2012 9-4
9-2 Pregnancy POCT Market:
Competitive Structure (U.S.), 2005 9-5
9-3 Pregnancy POCT Market:
Company Market Share by Revenues (U.S.), 2005 9-7
9-4 Pregnancy POCT Market:
Product Analysis (U.S.), 2005 9-8
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Ch a p t e r 1 0
Hematology Point-of-care Testing Market
10-1 Hematology POCT Market:
Revenue Forecasts (U.S.), 2002-2012 10-4
10-2 Hematology POCT Market:
Competitive Structure (U.S.), 2005 10-5
10-3 Hematology POCT Market:
Company Market Share by Revenues (U.S.), 2005 10-6
10-4 Hematology POCT Market:
Product Analysis (U.S.), 2005 10-8
Ch a p t e r 1 1
Coagulation Point-of-care Testing Market
11-1 Coagulation ACT POCT Market:
Revenue Forecasts (U.S.), 2002-2012 11-5
11-2 Coagulation PT POCT Market:
Revenue Forecasts (U.S.), 2002-2012 11-6
11-3 Coagulation ACT POCT Market:
Competitive Structure (U.S.), 2005 11-8
11-4 Coagulation PT POCT Market:
Competitive Structure (U.S.), 2005 11-9
11-5 Coagulation ACT POCT Market:
Company Market Share by Revenues (U.S.), 2005 11-11
11-6 Coagulation PT POCT Market:
Company Market Share by Revenues (U.S.), 2005 11-12
11-7 Coagulation ACT POCT Market:
Product Analysis (U.S.), 2005 11-13
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11-8 Coagulation PT POCT Market:
Product Analysis (U.S.), 2005 11-14
Ch a p t e r 1 2
Cardiac Biomarkers Point-of-care Testing Market
12-1 Cardiac Biomarkers POCT Market:
Revenue Forecasts (U.S.), 2002-2012 12-4
12-2 Cardiac Biomarkers POCT Market:
Competitive Structure (U.S.), 2005 12-6
12-3 Cardiac Biomarkers POCT Market:
Company Market Share by Revenues (U.S.), 2005 12-8
12-4 Cardiac Biomarkers POCT Market:
Product Analysis (U.S.), 2005 12-9
Ch a p t e r 1 3
Fecal Occult Blood Testing Market
13-1 FOBT Market:
Revenue Forecasts (U.S.), 2002-2012 13-4
13-2 FOBT Market:
Competitive Structure (U.S.), 2005 13-5
13-3 FOBT Market:
Company Market Share by Revenues (U.S.), 2005 13-7
13-4 FOBT Market:
Product Analysis (U.S.), 2005 13-8
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Ch a p t e r 1 4
Multi-testing Platform Trends
14-1 Total POCT Market:
Multi-testing Platform Analysis (U.S.), 2005 14-3
Ch a p t e r 1 5
Decision Support Databases
15-1 Decision Support Database:
Number of Physicians in ’000 (World), 2002-2012 15-1
15-2 Decision Support Database:
Number of Hospitals (World), 2002-2012 15-3
15-3 Decision Support Database:
Number of Hospital Beds in ’000 (World), 2002-2012 15-6
15-4 Decision Support Database:
Population 65 Plus in Mn (World), 2002-2012 15-8
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List of Charts
Ch a p t e r 2
Total Point-of-care Testing Market
2.1 Total POCT Market:
Market Engineering Measurements (U.S.), 2005 2-3
2.2 Total POCT Market:
Revenue Forecasts (U.S.), 2002-2012 2-5
2.3 Total POCT Market:
Percent of Revenues by Segment (U.S.), 2005 2-7
2.4 Total POCT Market:
Percent of Revenues by Segment (U.S.), 2012 2-8
2.5 Total POCT Market:
Company Market Share by Revenues (U.S.), 2005 2-9
Ch a p t e r 3
Glucose Point-of-care Testing Market
3.1 Glucose POCT Market:
Market Engineering Measurements (U.S.), 2005 3-2
3.2 Glucose POCT Market:
Revenue Forecasts (U.S.), 2002-2012 3-5
3.3 Glucose POCT Market:
Company Market Share by Revenues (U.S.), 2005 3-8
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Ch a p t e r 4
A1C Point-of-care Testing Market
4.1 A1C POCT Market:
Market Engineering Measurements (U.S.), 2005 4-2
4.2 A1C POCT Market:
Revenue Forecasts (U.S.), 2002-2012 4-5
4.3 A1C POCT Market:
Company Market Share by Revenues (U.S.), 2005 4-8
Ch a p t e r 5
Cholesterol Point-of-care Testing Market
5.1 Cholesterol POCT Market:
Market Engineering Measurements (U.S.), 2005 5-2
5.2 Cholesterol POCT Market:
Revenue Forecasts (U.S.), 2002-2012 5-5
5.3 Cholesterol POCT Market:
Company Market Share by Revenues (U.S.), 2005 5-7
Ch a p t e r 6
Blood Gas and Electrolyte Point-of-care Testing Market
6.1 Blood Gas and Electrolye POCT Market:
Market Engineering Measurements (U.S.), 2005 6-2
6.2 Blood Gas and Electrolyte POCT Market:
Revenue Forecasts (U.S.), 2002-2012 6-5
6.3 Blood Gas and Electrolyte POCT Market:
Company Market Share by Revenues (U.S.), 2005 6-8
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Ch a p t e r 7
Drugs of Abuse Point-of-care Testing Market
7.1 Drugs of Abuse POCT Market:
Market Engineering Measurements (U.S.), 2005 7-2
7.2 Drugs of Abuse POCT Market:
Revenue Forecasts (U.S.), 2002-2012 7-4
7.3 Drugs of Abuse POCT Market:
Company Market Share by Revenues (U.S.), 2005