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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. Sector Overview
2.1 Global Diagnostic Products Industry
2.2 Global OTC Diagnostic Products Industry
2.2.1 General Global Market
2.2.2 German OTC and Home Self-Testing Diagnostic Markets
2.2.3 U.K. OTC and Home Self-Test Diagnostic Markets
2.2.3.1 U.K. Market Statistics
2.2.3.2 U.K. Competitive Analysis
2.2.3.3 U.K. Market Access
2.2.4 French OTC Diagnostic Market
2.2.5 Italian OTC Diagnostic Market
2.2.6 Spanish OTC Diagnostic Market
2.2.7 Japanese OTC Diagnostic Market
2.2.8 Chinese OTC Diagnostic Market
2.3 Description of the U.S. OTC Diagnostics Industry Segment
2.3.1 Market Overview
2.3.2 Diagnostic Test Categories
2.4 Market Drivers in the OTC Diagnostics Sector
2.4.1 Overview
2.4.2 Market Segments
2.5 Key Players in the OTC Diagnostics Segment
2.6 Sector Analysis

3. Market Analysis: Size, Growth, Share and Competitors
3.1 Glucose Monitoring
3.1.1 Glucose Control in Diabetic Patients
3.1.2 Tight Glucose Control in Treating Diabetes
3.1.3 Glucose-Monitoring Devices
3.1.4 Key Issues for Glucose Monitoring
3.1.5 Glucose Device Description
3.1.6 Precision in Glucose Meters
3.1.7 Limitations of Existing Glucose Monitoring Products
3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market
3.1.9 Worldwide Glucose Testing Market
3.1.9.1 U.S. Market
3.1.9.2 European Market
3.1.9.3 Asian Market
3.1.9.3.1 Japanese Market
3.1.9.3.2 Chinese Market
3.1.9.3.3 Indian Market
3.1.9.4 ROW Markets
3.1.10 Reagents and Equipment
3.1.10.1 Blood Glucose Monitoring
3.1.10.2 Lancets
3.1.10.3 Blood Glucose Monitor and Insulin Doser
3.1.10.4 Blood Glucose Reagent Test Strips
3.1.10.5 Control Solutions and Calibrators
3.1.10.6 Sharps Devices
3.1.10.7 Needle Destruction Devices
3.1.11 Glucose Meters
3.1.12 Voice-Operated Glucose Meters
3.2 Pregnancy and Fertility Testing
3.2.1 Major Players
3.2.1.1 U.S. Market
3.2.1.2 European Market
3.2.2 Diagnostic Kit Information
3.3 Hepatitis Testing
3.4 Drugs of Abuse Screening Testing
3.5 Infectious Disease Testing
3.5.1 HIV
3.5.2 Tuberculosis Testing
3.5.3 Infectious Disease Testing in Non-Medical Settings
3.5.4 West Nile Virus
3.5.5 Urinary Tract Infections
3.6 Cholesterol Testing
3.7 Coagulation Testing
3.8 Urine Dipstick Testing
3.9 Fertility Testing
3.9.1 Players
3.9.2 Diagnostic Test Kits
3.10 At-Home DNA Analysis
3.11 Biowarfare Detection
3.12 Home Patient Monitoring Devices
3.13 Home Patient Alert Systems
3.14 Home Genetic Testing Kits
3.15 Home Paternity Testing
3.16 Health Hazards Detection
3.16.1 Lead
3.16.2 Radon
3.16.3 Asbestos
3.16.4 Pesticides
3.16.5 Mold
3.16.6 Carbon Monoxide
3.16.7 Water Quality
3.16.8 Bacteria in Water
3.17 Thyroid Disease
3.18 Carpal Tunnel
3.19 Allergies
3.20 Nutrition and Wellness
3.20.1 Testosterone and Male Hormones
3.20.2 Female Hormones
. 3.20.3 Antioxidants
3.20.4 Sleep Apnea
3.20.5 Mineral Check
3.20.6 Stress Check
3.21 Colorectal Cancer (Occult Blood) Testing
3.22 Alzheimer's Disease Home Screening Test
3.23 Tobacco Testing

4. Business Trends in the Industry
4.1 Wholesale Distribution Overview
4.2 Factors Affecting OTC Medical Product Distribution
4.3 Government Regulation of Medical Devices
4.3.1 U.SRegulations
4.3.2 U.KRegulations
4.4 Clinical Laboratory Improvement Act (CLIA)
4.5 Legal, M&A and Corporate Partnerships

5. Patient Management Trends
5.1 Trends in OTC Testing and Reimbursement
5.1.1 American OTC Testing and Home Self-testing Reimbursement
5.1.2 European Reimbursement
5.2 Drivers of OTC and Home Self-Testing
5.3 Cost Elements of OTC Testing
5.4 Important Elements of OTC Testing
5.5 Growth of Home Care Testing
5.6 Non-Traditional Methods for Sample Collection

6. Technology Trends
6.1 Sensor Systems for Diagnostic Applications
6.2 Glucose Measurements
6.3 Cholesterol Testing
6.4 Immunoassay Technology
6.5 Biosensor Technology
6.6 Fructosamine Test
6.7 Home Telemedicine Devices

7. OTC Testing: Critical Issues
7.1 Moderators of Growth for OTC Testing
7.2 Attitudes of Critical Care Nurses and Physicians
7.3 Personnel Impact for OTC Testing
7.4 Data Management Issues
7.5 POC Decentralization Issues
7.6 POC Testing and Clinical Outcomes
7.7 Focused Testing
7.8 Satellite Facilities
7.9 POC Testing Comparison and Cost Analysis

8. Competitive Assessments of the High-Growth Markets
8.1 Glucose Monitoring
8.1.1 Overview of Market Segment
8.1.2 Competitive Strategies
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix
8.1.4 Adjacent Markets
8.1.5 Market Drivers and Restraints
8.1.6 Market and Product Trends
8.2 Coagulation Testing
8.2.1 Overview of Market Segment
8.2.2 Competitive Strategies
8.2.3 Analyses of Current Market Conditions
8.2.4 Product Mix in Coagulation Testing
8.2.5 Adjacent Markets
8.2.6 Market Drivers and Restraints
8.2.7 Market and Product Trends
8.3 Cholesterol Testing
8.3.1 Overview of Market Segment
8.3.2 Competitive Strategies
8.3.3 Adjacent Markets
8.4 Infectious Disease Testing
8.4.1 Overview of Market Segment
8.4.2 Competitive Strategies
8.5 Drugs of Abuse
8.5.1 Overview of Market Segment
8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix
8.5.3 Adjacent Markets
8.6 Home Pregnancy Testing
8.6.1 Overview of Market Segment
8.6.2 Competitive Strategies
8.6.3 Analysis of Current Market Conditions
8.6.4 Product Mix
8.6.5 Adjacent Markets
8.6.6 Market Drivers and Restraints
8.6.7 Market and Product Trends

9. Current Issues for OTC and Home Diagnostic Testing
9.1 New Markets for OTC and Home Diagnostic Testing
9.2 Utility of OTC and Home Self-Testing
9.3 Corporate Screening
9.4 Generational Drivers of Home Testing
9.5 Move Away from Central Laboratories
9.6 Healthcare Cost Controls
9.7 Mergers of Diagnostic Companies
9.8 Home Healthcare Trends
9.9 Home Healthcare Providers versus Mass Market Retailers
9.10 Demographic Merchandising
9.11 Marketing Strategies
9.12 Third-Party Pharmacy Networks
9.13 Which Customer Segments Purchase Home Healthcare? Which Products Fit Their Needs?
9.14 Future of Patient Self-Testing

10. Corporate Profiles
10.1 Abbott Diagnostics
10.2 AmeriSourceBergen
10.3 Bayer Diagnostics
10.4 Becton Dickinson
10.5 Bindley Western Industries, Inc
10.6 Biosite, Inc
10.7 Cardinal Health, Inc
10.8 Cholestech
10.9 HemoCue
10.10 Home Access Health Corp
10.11 Inverness Medical Innovations, Inc
10.12 Johnson & Johnson
10.13 LifeScan
10.14 Princeton BioMeditech
10.15 Quidel Corp
10.16 Roche Diagnostics
10.17 Saliva Diagnostics

11. Corporate Directory
Appendix 1: Over-the-Counter In Vitro Diagnostic Devices
Appendix 2: OTC Waived Tests for Drugs of Abuse
Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing
Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare
Appendix 5: Frequently-Asked Questions About Drug Screening Kits

INDEX OF FIGURES
Figure 2.1: European OTC Diagnostic Products Market by Country
Figure 3.1: Single-Day Continuous Blood Glucose Data
Figure 3.2: Share of the U.SSelf-Testing Diagnostic Market, 2008
Figure 3.3: The Glucose Market U.SSales, 2000-2012

INDEX OF TABLES
Table 2.1: Market Share of Top Three In Vitro Diagnostic Companies
Table 2.2: Worldwide Clinical Laboratory Market Size, 2003-2012
Table 2.3: U.SClinical Laboratory Testing Market, 2003-2012
Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2003-2013
Table 2.5: Worldwide OTC Diagnostic Products Market, 2003-2013
Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2008
Table 2.7: Major European OTC Diagnostics Markets, 2008
Table 2.8: German OTC Diagnostic Products Market Sales, 2003-2013
Table 2.9: U.KOTC Diagnostic Products Market Sales, 2003-2013
Table 2.10: Major U.KIVD Manufacturers
Table 2.11: U.SIVD Manufacturers Doing Business in the U.K.
Table 2.12: Other European Companies that Manufacture IVD Products in the U.K.
Table 2.13: French OTC Diagnostic Products Market Sales, 2003-2013
Table 2.14: Italian OTC Diagnostic Products Market Sales, 2003-2013
Table 2.15: Spanish OTC Diagnostic Products Market Sales, 2003-2013
Table 2.16: Japanese OTC Diagnostic Products Market Sales, 2003-2013
Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2003-2013
Table 2.18: U.SOTC Diagnostic Products Market Sales 2003-2013
Table 2.19: U.SClinical Diagnostic Home Test Market Segments
Table 2.20: Top Drugstore Retailers in the U.S
Table 2.21: Top Drugstore Wholesalers in the U.S
Table 3.1: Market for OTC Glucose Self-Testing in the U.S., 2004-2012
Table 3.2: Glucose Market for OTC Testing Worldwide, 2003-2013
Table 3.3: Top Ten Countries in Number of Persons with Diabetes (Aged 20 to 79 Years), in 2007 and 2025
Table 3.4: Share of the U.SSelf-Testing Diagnostic Market, 2008
Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail
Table 3.6: World Market Share of POC Glucose Monitoring Marketers
Table 3.7: Key Features Considered for Glucose Meter Devices
Table 3.8: Demographic Characteristics Home-Testing Kit Buyers
Table 3.9: Top Brand Preferences for Home Glucose Testing Kits
Table 3.10: Instances When Patients Prefer Professional's Glucose Testing
Table 3.11: Advantages of a Home-Testing Kit
Table 3.12: Disadvantages of Using a Home-Testing Kit
Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits
Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2013
Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2003-2013
Table 3.16: U.SBlood Glucose Reagent Strip Market, 2004-2013
Table 3.17: OTC Glucose Meter U.SMarket Share for Blood Glucose Measurements
Table 3.18: U.SDiabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages
Table 3.19: Top Four Players in the U.SBlood Glucose Strips Market-Ranked by Percentage Sales, 2008
Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 2008
Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2013
Table 3.22: European Glucose Self-Testing Market by Country Market
Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2012
Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2002-2012
Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2012
Table 3.26: Chinese Blood Glucose Reagent Strip Market, 2000-2012
Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012
Table 3.28: Indian Blood Glucose Reagent Strip Market, 2000-2012
Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2013
Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2003-2013
Table 3.31: Unit Sales of Lancets in the E.U., 2003-2013
Table 3.32: Dollar Sales of Lancets in the U.S., 2003-2013
Table 3.33: Dollar Sales of Lancets in the E.U., 2003-2013
Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2003-2013
Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2003-2013
Table 3.36: Competition in the Lancet Market Segment
Table 3.37: Key Features of Reagent Test Strips
Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2012
Table 3.39: Accu-Chek Blood Glucose Monitoring Systems
Table 3.40: Pregnancy Test Market for OTC Testing in the U.S., 2000-2012
Table 3.41: Pregnancy Test Market for OTC Testing in Europe, 2003-2013
Table 3.42: U.SMarket Share for Home Pregnancy Tests
Table 3.43: European Market Share for OTC Pregnancy Tests
Table 3.44: Home Pregnancy Tests Available in the U.SMarket
Table 3.45: Hepatitis C Statistics
Table 3.46: Hepatitis Market for OTC Testing in the U.S., 2003-2013
Table 3.47: U.SPOC Drugs of Abuse Testing Market in the U.S., 2006-2012
Table 3.48: Illicit Drugs that are Important for Detection
Table 3.49: Analytical Detection Levels for Drugs of Abuse
Table 3.50: Princeton BioMeditech's Drugs of Abuse Tests
Table 3.51: Abbott Drugs of Abuse Tests on the ARCHITECT System
Table 3.52: Infectious Disease Market for OTC Testing in the U.S., 2003-2013
Table 3.53: HIV Testing Market for OTC Testing in the U.S., 2003-2013
Table 3.54: Home Testing for Urinary Tract Infections
Table 3.55: Cholesterol Market for OTC and Home Self-Testing in the U.S., 2003-2013
Table 3.56: Coagulation Market for OTC Testing in the U.S., 2003-2013
Table 3.57: Glucose Market for OTC Testing in the U.S., 2003-2013
Table 3.58: Fertility Testing Market for OTC Testing in the U.S., 2003-2013
Table 3.59: Fertility Testing Market for OTC Testing in Europe, 2003-2013
Table 3.60: Rite Aid and Other OEM Ovulation Predictors
Table 3.61: At-Home DNA Tests
Table 3.62: At-Home DNA Market for OTC Testing Worldwide, 2003-2013
Table 3.63: Home Genetic Testing Market in the U.S., 2003-2013
Table 3.64: Genovations Profiles
Table 3.65: Featured Tests by DNA Direct
Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies
Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs
Table 5.1: U.SHome Testing Market Size, 2003-2013
Table 6.1: Normal Glucose Values, Fasting State
Table 6.2: Leading Home Patient Monitoring Products in the U.SMarket
Table 7.1: POC Testing: Cost Analysis
Table 7.2: POC Testing: Cost Analysis with Labor Included
Table 8.1: Total World Cholesterol Testing Market, 2006-2012
Table A.1: Over-the-Counter In Vitro Diagnostic Devices