The market for point-of-care (POC) diagnostic products comprises 28% of the total in-vitro diagnostics market. The market is projected to grow at a considerably slower rate than the overall IVD market over the 2014-2019 interval, primarily due to stagnant sales in the whole blood glucose self-testing segment, which accounts for more than half (53%) of the total market. However, most other segments of the POC diagnostics market are growing at rates well in excess of the overall POC market, and in excess of the rate for the total IVD market. Point of care testing encompasses a wide range of diagnostic applications and a wide range of product types. Examples are blood gas tests performed using handheld analyzers at the hospital bedside, whole blood glucose and pregnancy self-testing, rapid infectious disease tests performed in the physician's office or emergency department, and cardiac marker tests performed in the chest pain clinic. In this report, the POC market is segmented into three primary categories, including hospital bedside testing products, home and self-testing products, and physician's office lab products.
COVERAGE INCLUDES:
EXECUTIVE SUMMARY Exhibit ES-1: Worldwide POC In-Vitro Diagnostics Market, 2013-2019 Exhibit ES-2: Worldwide POC Test Volume Distribution by Site, 2013-2019 Exhibit ES-3: Worldwide POC Diagnostics Market Trend by Test Site, 2013-2019 Exhibit ES-4: Worldwide Hospital POC Testing Products Market by Segment, 2013-2019 Exhibit ES-5: Worldwide Home/Self-Testing Products Market, 2013-2019 Exhibit ES-6: Global Physician's Office Laboratory Market by Test Segment Exhibit ES-7: Comparison of POC Market Segment Growth Rates, 2014-2019 Exhibit ES-8: 2014 POC IVD Suppliers' Sales and Market Share 1. MARKET OVERVIEW 1.1 Trends in the Global Clinical Diagnostics Market 1.2 Clinical Diagnostics Market and Technology Trends by Segment 1.2.1 Clinical Chemistry 1.2.2 Immunodiagnostics 1.2.3 Hematology and Coagulation 1.2.4 Microbiology 1.2.5 Molecular Diagnostics 1.3 Trends in Laboratory Restructuring and the Organization of Testing 1.4 Factors Driving the Adoption of Point-of-Care Testing Regulatory Trends Impacting the Use of Point-of-Care Testing 1.6 Cost and Reimbursement Issues in Point-of-Care Testing 1.7 Quality Control and Quality Assurance Issues in Point-of-Care Testing 1.8 Trends in Self-Monitoring, Disease Screening, Wellness Testing, Risk Assessment and Preventative Testing 1.9 Changes in the Site of Health Care Delivery Exhibit 1.1: Global Medical Device and Diagnostics Market, 2013-2019 Exhibit 1.2: Trends in Population 65 and Older and Health Expenditures, Selected Countries Exhibit 1.3: U.S. Surgical Procedure Volume by Site, 2013 Exhibit 1.4: Expansion of Clinical Lab Automation in the U.S. Exhibit 1.5: Changes to the Clinical Laboratory Fee Schedule in the U.S., 2000-2014 Exhibit 1.6: Trends in the Site of Laboratory-Based Testing in the U.S., 2002-2014 Exhibit 1.7: Worldwide Clinical Diagnostics Market by Segment, 2013-2019 Exhibit 1.8: Worldwide Clinical Diagnostic Products Market by Region Exhibit 1.9: Worldwide Clinical Chemistry Market, 2013-2019 Exhibit 1.10: 2014 Worldwide Immunoassay Reagent and Supply Market by Segment Exhibit 1.11: Worldwide Hematology/Coagulation Testing Products Market, 2013-2019 Exhibit 1.12: Worldwide Microbiology Market by Segment Exhibit 1.13: Worldwide Molecular Diagnostics Market by Application Segment, 2013-2019 Exhibit 1.14: Number of CLIA-Registered U.S. Clinical Laboratories by Type, 2000-2014 Exhibit 1.15: Key Factors Driving Adoption of POC Testing Exhibit 1.16: Trends in CLIA-Waived Labs vs. Total Labs in the U.S., 2004-2014 Exhibit 1.17: Waived Analyte Tests Performed in Clinical Labs Exhibit 1.18: Waived Analyte Tests Performed by Type of Lab Exhibit 1.19: Segmentation of Healthcare Costs in the U.S. Exhibit 1.20: Historical Trends in the Number of Hospitals, Hospital Beds, Hospital Admissions, and Average Hospital Stay Exhibit 1.21: Trend in the Number of Retail Medical Clinics in the U.S. 2. HOSPITAL-BASED POINT-OF-CARE TESTING PRODUCTS 2.1 Hospital Diagnostic Testing Environment 2.2 Bedside Critical Care Testing Products Market 2.2.1 Trends in POC Critical Care Test Volume and Equipment Installed Base 2.2.2 Existing POC Critical Care Testing Products 2.2.3 New Technologies Under Development for POC Bedside Critical Care Testing 2.2.4 Bedside Critical Care Testing Market Analysis and Forecast 2.2.5 Bedside Critical Care Testing Product Suppliers' Sales and Market Shares 2.2.6 Drivers and Limiters of the Hospital POC Critical Care Testing Products Market 2.3 Hospital Bedside Hemostasis Testing Products Market 2.3.1 Trends in POC Hemostasis Test Volume and Equipment Installed Base 2.3.2 Existing POC Hemostasis Testing Products 2.3.3 New Products and Technologies Under Development for POC Hemostasis Testing 2.3.4 Hospital-Based POC Hemostasis Testing Market Analysis and Forecast 2.3.5 Hospital-Based POC Hemostasis Testing Product Suppliers' Sales and Market Shares 2.3.6 Drivers and Limiters of the Hospital POC Hemostasis Testing Products Market 2.4 Bedside/POC Drugs of Abuse Testing Products Market 2.4.1 Trends in Bedside/POC Drugs of Abuse Testing 2.4.2 Existing Bedside/POC Drugs of Abuse Testing Products 2.4.3 POC Drugs of Abuse Testing Market Analysis and Forecast 2.4.4 POC Drugs of Abuse Testing Product Suppliers' Sales and Market Shares 2.4.5 Drivers and Limiters of the Hospital POC Drugs of Abuse Testing Products Market 2.5 POC Cardiac Marker Testing Products Market Analysis 2.5.1 Trends in POC Cardiac Marker Testing 2.5.2 POC Cardiac Marker Products Under Development 2.5.3 POC Cardiac Marker Market Analysis and Forecast 2.5.4 POC Cardiac Marker Product Suppliers' Sales and Market Shares 2.5.5 Drivers and Limiters of the POC Cardiac Marker Testing Products Market 2.6 Other Bedside/POC Testing Products Markets 2.6.1 POC Infectious Disease Testing Products, Market Analysis and Suppliers 2.6.2 POC Products and Markets for Hemoglobin and Hematocrit Testing 2.6.3 Hospital and Institutional Bedside Whole Blood Glucose Monitoring Market 2.6.3.1 Products for Hospital/Institutional Bedside Whole Blood Glucose Monitoring 2.6.3.2 Hospital/Institutional Bedside Whole Blood Glucose Monitoring Market Analysis 2.6.3.3 Drivers and Limiters of the Hospital/Institutional Bedside Whole Blood Glucose Monitoring Products Market 2.6.3.4 Other Hospital Bedside POC Testing Products Exhibit 2.1: Hospital Sites for Clinical Diagnostic Testing in the U.S. Exhibit 2.2: Clinical Testing Site Distribution for Selected Countries Exhibit 2.3: Trends in Global Hospital-Based POC In-Vitro Diagnostic Test Volume Exhibit 2.4: Trends in Worldwide Hospital POC Test Volume by Analyte Segment Exhibit 2.5: Trends in Emergency Room Visits and Number of Emergency Rooms in Community Hospitals in the U.S. Exhibit 2.6: Distribution of Hospital-Based POC Test Volume by Site Exhibit 2.7: Clinical Factors Driving Usage of Point-of-Care Testing Exhibit 2.8: Trends in Worldwide POC Blood Gas/Electrolyte/Metabolite Test Volume and Instrument Installed Base Exhibit 2.9: Existing POC Critical Care Testing Products Exhibit 2.10: Development-Stage POC Critical Care Testing Products Exhibit 2.11: Worldwide Market for Hospital POC Critical Care Testing Products Exhibit 2.12: Worldwide Market for POC Single-Test Cartridge Critical Care Testing Products Exhibit 2.13: Worldwide Market for POC Multi-Test Cartridge Critical Care Testing Products Exhibit 2.14: Laboratory Versus POC Critical Care Testing Products Market Exhibit 2.15: 2014 Worldwide Sales and Market Share for Leading Suppliers of POC Critical Care Testing Products Exhibit 2.16: 2014 Worldwide Sales and Market Share for Leading Suppliers of POC Critical Care Testing Products by Region Exhibit 2.17: Diseases and Procedures with Indications for Anti-coagulation Therapy Exhibit 2.18: Trends in Diagnosis of Atrial Fibrillation in U.S. Hospital Patients, 1996-2006 Exhibit 2.19: Platelet Aggregation/Platelet Function Test Volume Trend in the U.S. Medicare Population, 2002-2013 Exhibit 2.20: Trends in Worldwide POC Hemostasis Test Volume and Instrument Installed Base Exhibit 2.21: Existing POC Hemostasis Testing Products Exhibit 2.22: Worldwide Market for Hospital POC Hemostasis Testing Products Exhibit 2.23: Worldwide Market for Hospital POC Hemostasis Testing Products by Segment Exhibit 2.24: Laboratory Versus Hospital-Based POC and Self-Test Hemostasis Products Market, 2013-2019 Exhibit 2.25: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Hemostasis Testing Products Exhibit 2.26: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Hemostasis Testing Products by Region Exhibit 2.27: CMS Decision Memorandum Observations Exhibit 2.28: Number and Percentage of U.S. ED Visits Involving Illicit Drug Use, 2006 and 2011 Exhibit 2.29: Existing Hospital POC Drugs of Abuse Testing Products Exhibit 2.30: Worldwide Market for POC Drugs-of-Abuse Testing Products (Hospital Segment) Exhibit 2.31: Worldwide Market for Laboratory Versus POC Drugs-of-Abuse Testing Products (Hospital Segment) Exhibit 2.32: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Drugs-of-Abuse Testing Products by Region Exhibit 2.33: Analytical Characteristics of Cardiac Troponin I and T Assays for POC and Laboratory Use Exhibit 2.34: Existing Hospital POC Cardiac Marker Testing Products Exhibit 2.35: New POC Cardiac Marker Testing Products Under Development Exhibit 2.36: Worldwide Market for POC Cardiac Marker Products Exhibit 2.37: Worldwide Market for Laboratory Versus POC Cardiac Marker Products Exhibit 2.38: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Cardiac Marker Products by Region Exhibit 2.39: Existing Hospital POC Infectious Disease Testing Products Exhibit 2.40: Worldwide Market for Hospital POC Infectious Disease Testing Products Exhibit 2.41: Worldwide Market for Laboratory Versus Hospital POC Infectious Disease Testing Products Exhibit 2.42: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Infectious Disease Testing Products by Region Exhibit 2.43: Worldwide Market for Hospital POC Hemoglobin and Hematocrit Testing Products Exhibit 2.44: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Hemoglobin and Hematocrit Testing Products by Region Exhibit 2.45: Existing Hospital POC Whole Blood Glucose Monitoring Products Exhibit 2.46: Worldwide Market for Hospital POC Whole Blood Glucose Products by Segment Exhibit 2.47: Total Worldwide Market for Hospital POC Whole Blood Glucose Testing Products Exhibit 2.48: 2014 Worldwide Sales and Market Share for Leading Suppliers of Hospital POC Whole Blood Glucose Testing Products by Region CHAPTER 3: HOME AND SELF-TESTING PRODUCTS 3.1 Whole Blood Glucose Self-Testing Products Market 3.1.1 Existing Whole Blood Glucose Self-Testing Products 3.1.2 Development-Stage Whole Blood Glucose Self-Testing Products 3.1.2.1 Integrated Glucose Testing Devices 3.1.2.2 Implantable Glucose Monitors 3.1.2.3 Non-Invasive Glucose Monitoring 3.1.3 Whole Blood Glucose Self-Testing Products Market Analysis and Forecast 3.1.4 Whole Blood Glucose Self-Testing Product Suppliers' Sales and Market Shares 3.1.5 Drivers and Limiters of the Whole Blood Glucose Self-Testing Products Market 3.2 OTC Pregnancy and Fertility Testing Products Market 3.2.1 Trends in Home Pregnancy and Fertility Testing 3.2.2 Existing Products for Home Pregnancy and Fertility Testing 3.2.3 New Products Under Development for Home Pregnancy and Fertility Testing 3.2.4 OTC Pregnancy and Fertility Testing Products Market Analysis and Forecast 3.2.5 OTC Pregnancy and Fertility Testing Product Suppliers' Sales and Market Shares 3.2.6 Drivers and Limiters of the OTC Pregnancy and Fertility Testing Products Market 3.3 Markets for Other Home and Self-Testing Products 3.3.1 Cholesterol Self-Testing 3.3.2 Fecal Occult Blood Testing 3.3.3 Home Drugs of Abuse Testing 3.3.4 Coagulation Self-Testing 3.3.5 Infectious Disease Self-Testing 3.3.6 Home Heart Failure Monitoring Exhibit 3.1: Global Diabetes Prevalence Trends According to the World Health Organization and the International Diabetes Federation Exhibit 3.2: Frequency of Blood Glucose Testing by Diabetics in the U.S. Exhibit 3.3: Feature Comparison for Leading Brands and Models of Whole Blood Glucose Self-Testing Products Exhibit 3.4: Other Suppliers of Glucose Self-Testing Products Exhibit 3.5: Development-Stage Noninvasive/Minimally Invasive Glucose Monitoring Devices Exhibit 3.6: Worldwide Market for Whole Blood Glucose Self-Testing Products Exhibit 3.7: Worldwide Market for Whole Blood Glucose Test Strips, Self-Testing Segment Exhibit 3.8: Worldwide Market for Lancets Used in Whole Blood Glucose Self-Testing Exhibit 3.9: Worldwide Market for Whole Blood Glucose Self-Testing Products by Region, 2013-2019 Exhibit 3.10: 2014 Worldwide Sales and Market Shares for Leading Suppliers of Whole Blood Glucose Self-Testing Products Exhibit 3.11: Home Pregnancy and Fertility Tests Exhibit 3.12: Worldwide Market for OTC Pregnancy and Fertility Testing Products, 2013-2019 Exhibit 3.13: Worldwide Market for OTC Pregnancy Testing Products, 2013-2019 Exhibit 3.14: Worldwide Market for OTC Fertility Testing Products, 2013-2019 Exhibit 3.15: U.S. Market for OTC Pregnancy and Fertility Testing Products, 2013-2019 Exhibit 3.16: U.S. Market for OTC Pregnancy Testing Products, 2013-2019 Exhibit 3.17: U.S. Market for OTC Fertility Testing Products, 2014-2019 Exhibit 3.18: European Market for OTC Pregnancy and Fertility Testing Products, 2013-2019 Exhibit 3.19: European Market for OTC Pregnancy Testing Products, 2013-2019 Exhibit 3.20: European Market for OTC Fertility Testing Products, 2013-2019 Exhibit 3.21: Japan/ROW Market for OTC Pregnancy and Fertility Testing Products, 2013-2019 Exhibit 3.22: Japan/ROW Market for OTC Pregnancy Testing Products, 2013-2019 Exhibit 3.23: Japan/ROW Market for OTC Fertility Testing Products, 2013-2019 Exhibit 3.24: Worldwide Sales and Market Share for the Leading Suppliers of OTC Pregnancy and Fertility Testing Products, 2014 Exhibit 3.25: Worldwide Market for OTC Blood Lipid Testing Products, 2013-2019 Exhibit 3.26: Worldwide Sales and Market Share for the Leading Suppliers of OTC Blood Lipid Testing Products, 2014 Exhibit 3.27: Fecal Occult Blood Testing Products Available in the Global Market Exhibit 3.28: Worldwide Market for Home Drugs of Abuse Testing Products, 2013-2019 Exhibit 3.29: Worldwide Sales and Market Share for the Leading Suppliers of Home Drugs of Abuse Testing Products, 2014 Exhibit 3.30: INR Self-Testing Products Available in the Global Market Exhibit 3.31: Worldwide Market for PT/INR Self-Testing Products, 2013-2019 Exhibit 3.32: Worldwide Sales and Market Share for the Leading Suppliers of PT/INR Self-Testing Products, 2014 CHAPTER 4: PHYSICIAN'S OFFICE AND OTHER ALTERNATE SITE TESTING PRODUCTS 4.1 Types of Testing Performed in Physician Offices and Other Alternate Sites 4.2 Existing Physician's Office Laboratory Products 4.3 New POL Products Under Development 4.4 Physician's Office Laboratory Market Analysis 4.5 POL Product Suppliers' Sales and Market Shares 4.6 Drivers and Limiters of the Worldwide POL Products Market 4.7 Other Alternate Site Testing Products and Markets Exhibit 4.1: Trends in the Number of CLIA-Registered Physician's Office and Other Selected Alternate Site Labs in the U.S. Exhibit 4.2: Health Care Financing Administration, Center for Laboratories, CLIA Statistics for POLs as of November 2014 (POLs by Certificate Type) Exhibit 4.3: Tests Ordered by Office-Based Physicians in the U.S., 2000-2006 Exhibit 4.4: Physician's Office Laboratory Products Exhibit 4.5: New Products Under Development for the POL Market Exhibit 4.6: Worldwide Market for Physician's Office Laboratory Testing Products, 2013-2019 Exhibit 4.7: Worldwide Market for Physician's Office Laboratory Testing Products by Segment, 2013-2019 Exhibit 4.8: Worldwide Sales and Market Share for the Leading Suppliers of POL Chemistry Products, 2014 Exhibit 4.9: Worldwide Sales and Market Share for the Leading Suppliers of POL Immunodiagnostic Products, 2014 Exhibit 4.10: Worldwide Sales and Market Share for the Leading Suppliers of POL Hematology Products, 2014 Exhibit 4.11: Worldwide Sales and Market Share for the Leading Suppliers of POL Rapid Test Kits, 2014 Exhibit 4.12: Worldwide Sales and Market Share for the Leading Suppliers of POL Urinalysis Products, 2014 Exhibit 4.13: Worldwide Sales and Market Share for the Leading Suppliers of POL Allergy Testing Products, 2014 Exhibit 4.14: Worldwide Sales and Market Share for the Leading Suppliers of POL Whole Blood Glucose Testing Products, 2014 Exhibit 4.15: Worldwide Sales and Market Share for the Leading Suppliers of POL Whole Blood Hemoglobin Testing Products, 2014 Exhibit 4.16: Worldwide Sales and Market Share for the Leading Suppliers of POL Glycated Hemoglobin Testing Products, 2014 Exhibit 4.17: Worldwide Sales and Market Share for the Leading Suppliers of POL Coagulation Testing Products, 2014 Exhibit 4.18: Combined Worldwide Sales and Market Shares of Leading Suppliers of Physician's Office Laboratory Products, 2014 CHAPTER 5: COMPETITOR ASSESSMENT 5.1 Overview of Companies in the Global POC Diagnostics Market 5.2 Mergers and Partnerships to Improve Competitive Position 5.3 Marketing and Distribution Strategies for the Global POC Diagnostics Market Exhibit 5.1: Overview of Leading Competitors in the POC Diagnostics Market Exhibit 5.2: Mergers, Acquisitions, and Partnerships Impacting the POC Diagnostics Market CHAPTER 6: COMPANY PROFILES 6.1 Abaxis 6.2 Abbott Laboratories 6.3 Accriva Diagnostics 6.4 Alere 6.5 Alfa Wassermann 6.6 Arkray 6.7 Bayer Diabetes Care 6.8 Danaher 6.8.1 Beckman Coulter 6.8.2 Hemocue 6.8.3 Radiometer 6.9 Dexcom 6.10 ELITech Group 6.11 Helena Laboratories 6.12 Instrumentation Laboratory 6.13 Menarini Diagnostics 6.14 Nipro Diagnostics 6.15 NOVA Biomedical 6.16 OraSure Technologies 6.17 Ortho Clinical Diagnostics 6.18 Phamatech 6.19 Princeton BioMeditech 6.20 Quidel 6.21 Response Biomedical 6.22 Roche Diagnostics 6.23 Siemens Diagnostics 6.24 Trinity Biotech APPENDIX - COMPANY LISTING REFERENCES COMPANY DIRECTORY