EXECUTIVE SUMMARY …………………………………………………………………………. ES-1
i. Hospital-Based POC Diagnostics Market ………………………………… ES-3
ii. Methodology ……………………………………………………………………….. ES-6

Exhibit ES-1: Global POC in-vitro diagnostic products market, 2015-20 ………….. ES-2
Exhibit ES-2: Global POC diagnostics market, by place of service ($m), 2015-20 ……………………………………………………….. ES-4
Exhibit ES-3: Global hospital POC testing products market, share by product type, 2015 ……………………………………………………………….. ES-5

1. MARKET OVERVIEW ……………………………………………………………………… 1-1
1.1 Trends in the Global Clinical Diagnostics Market ………………………… 1-3
1.2 Trends in Laboratory Restructuring and the Organization of Testing ………………………………………………………………………………… 1-20
1.3 Factors Driving the Adoption of POC Testing ……………………………. 1-22
1.4 Regulatory Trends Impacting the Use of POC Testing ……………….. 1-27
1.5 Cost and Reimbursement Issues in POC Testing ……………………… 1-29
1.6 Quality Control and Quality Assurance Issues in POC Testing ……. 1-32
1.7 Trends in Self-Monitoring, Disease Screening, Wellness Testing, Risk Assessment, and Preventative Testing …………………………….. 1-35
1.8 Changes in the Site of Healthcare Delivery ………………………………. 1-36

Bibliography ………………………………………………………………………………….. 1-40

Exhibit 1-1: Global clinical diagnostics market, by segment ($000s), 2015-20 ….. 1-4
Exhibit 1-2: Clinical diagnostics market, by region ($000s), 2015-20 ………………. 1-5
Exhibit 1-3: Clinical chemistry market, by segment ($000s), 2015-20 ……………… 1-6
Exhibit 1-4: Hematology/coagulation testing market, by segment, 2015-20 ……. 1-11
Exhibit 1-5: Diagnostic microbiology products market, by segment, 2015-20 …. 1-13
Exhibit 1-6: Trends in population aged 65 and older and health expenditures, selected countries…………………………………………………………………. 1-17
Exhibit 1-7: Changes to the clinical laboratory fee schedule in the US, 2000-15 …………………………………………………………………… 1-19
Exhibit 1-8: Number of CLIA-registered clinical laboratories by type, 2000-16 … 1-21
Exhibit 1-9: Estimated surgical and non-surgical procedure volume in the US, by site, 2015 ………………………………………………………………….. 1-24
Exhibit 1-10: Trends in CLIA-waived labs versus total labs in the US ……………… 1-26
Exhibit 1-11: Segmentation of healthcare costs in the US ……………………………… 1-31
Exhibit 1-12: Historical trends in the number of hospitals, hospital beds, hospital admissions, and average hospital stay in the US, 1992-2014 ……… 1-37
Exhibit 1-13: Trend in the number of retail medical clinics in the US ……………….. 1-39

2. HOSPITAL-BASED POINT-OF-CARE TESTING PRODUCTS ……………… 2-1
2.1 Hospital Diagnostic Testing Environment …………………………………… 2-1
Bibliography ………………………………………………………………………………….. 2-11

Exhibit 2-1: Hospital sites for clinical diagnostic testing in the US …………………… 2-3
Exhibit 2-2: Number of clinical labs, hospital beds, and POC critical care testing adoption rates for key countries ……………………………………… 2-4
Exhibit 2-3: Trends in hospital-based POC in-vitro diagnostic test volume ………. 2-6
Exhibit 2-4: Trends in hospital-based POC test volume, by analyte segment, 2015-20 ……………………………………………………….. 2-7
Exhibit 2-5: Trends in emergency room visits and number of emergency rooms in community hospitals in the US, 1996-2014 …………………………….. 2-9
Exhibit 2-6: Distribution of hospital-based POC test volume by site ………………. 2-10

3. HOSPITAL BEDSIDE CRITICAL CARE TESTING PRODUCTS MARKET 3-1
3.1 Trends in POC Critical Care Testing …………………………………………. 3-1
3.2 Existing POC Critical Care Testing Products ………………………………. 3-2
3.3 New Technologies Under Development for POC Critical Care Testing ………………………………………………………………………….. 3-7
3.4 Bedside Critical Care Testing Market Analysis and Forecast ………… 3-8
3.5 Bedside Critical Care Testing Product Suppliers’ Sales and Market Shares ………………………………………………………………………………….. 3-8
3.6 Drivers and Limiters of the Hospital POC Critical Care Testing Products Market …………………………………………………………………… 3-14

Bibliography ………………………………………………………………………………….. 3-16

Exhibit 3-1: POC critical care testing products …………………………………………….. 3-3
Exhibit 3-2: Worldwide POC critical care testing market, 2015-20 ………………….. 3-9
Exhibit 3-3: POC critical care testing products market, by region ($m), 2015-20 ………………………………………………………… 3-10
Exhibit 3-4: Sales and market share for leading suppliers of POC critical care testing products, by region, 2015 ……………………………………………. 3-11

4. HOSPITAL BEDSIDE HEMOSTASIS TESTING PRODUCTS MARKET …. 4-1
4.1 Trends in POC Hemostasis Testing ………………………………………….. 4-4
4.2 Existing POC Hemostasis Testing Products ……………………………….. 4-8
4.3 New Products and Technologies Under Development for POC Hemostasis Testing ………………………………………………………………. 4-10
4.4 Hospital-Based POC Hemostasis Testing Market Analysis and Forecast ……………………………………………………………………………… 4-12
4.5 Hospital-Based POC Hemostasis Testing Product Suppliers’ Sales and Market Shares ………………………………………………………. 4-15
4.6 Drivers and Limiters of the Hospital POC Hemostasis Testing Products Market …………………………………………………………………… 4-17

Bibliography ………………………………………………………………………………….. 4-18

Exhibit 4-1: Diseases and procedures with potential requirements for anticoagulation therapy …………………………………………………………… 4-2
Exhibit 4-2: Trends in diagnosis of atrial fibrillation and atrial flutter in US hospital patients, 2003-13 ……………………………………………………….. 4-3
Exhibit 4-3: Trend in prothrombin time test volume in the US Medicare population, 2002-14 ………………………………………………………………… 4-5
Exhibit 4-5: Point-of-care hemostasis testing products ………………………………….. 4-9
Exhibit 4-6: Worldwide hospital POC hemostasis testing market, 2015-20 …….. 4-13
Exhibit 4-7: Hospital POC hemostasis testing products market, by region ($m), 2015-20 ………………………………………………………… 4-14
Exhibit 4-8: Sales and market share for leading suppliers of hospital POC hemostasis testing products, by region, 2015 …………………………… 4-16

5. HOSPITAL BEDSIDE POINT-OF-CARE DRUGS-OF-ABUSE TESTING PRODUCTS MARKET ……………………………………………………………………… 5-1
5.1 Trends in Bedside/POC Drugs-of-Abuse Testing ………………………… 5-1
5.2 Existing Bedside/POC Drugs-of-Abuse Testing Products …………….. 5-3
5.3 POC Drugs-of-Abuse Testing Market Analysis and Forecast ………… 5-7
5.4 POC Drugs-of-Abuse Testing Product Suppliers’ Sales and Market Shares ………………………………………………………………………………….. 5-7
5.5 Drivers and Limiters of the Hospital POC Drugs-of-Abuse Testing Products Market …………………………………………………………………… 5-11

Bibliography ………………………………………………………………………………….. 5-12

Exhibit 5-1: Number and percentage of US ED visits involving illicit drug use, 2006 and 2011 ………………………………………………………………… 5-2
Exhibit 5-2 Point-of-care drugs-of-abuse testing products …………………………….. 5-4
Exhibit 5-3: Hospital POC drugs-of-abuse testing products market, by region ($m), 2015-20 ………………………………………………………….. 5-8
Exhibit 5-4: Worldwide market for central laboratory versus hospital POC drugs-of-abuse testing products ($m), 2015-20 …………………………… 5-9
Exhibit 5-5: Sales and market share for leading suppliers of hospital POC drugs-of-abuse testing products, by region ($m), 2015 ………………. 5-10

6. HOSPITAL BEDSIDE POINT-OF-CARE CARDIAC MARKER TESTING PRODUCTS MARKET ……………………………………………………………………… 6-1
6.1 Trends in POC Cardiac Marker Testing ……………………………………… 6-1
6.2 POC Cardiac Marker Products …………………………………………………. 6-2
6.3 POC Cardiac Marker Products in Development ………………………….. 6-9
6.4 POC Cardiac Marker Market Analysis and Forecast ………………….. 6-10
6.5 POC Cardiac Marker Product Suppliers’ Sales and Market Shares ……………………………………………………………………… 6-13
6.6 Drivers and Limiters of the POC Cardiac Marker Testing Products Market ………………………………………………………………………………… 6-13

Bibliography ………………………………………………………………………………….. 6-15

Exhibit 6-1: Troponin test volume trend in the US, 2000-14 …………………………… 6-3
Exhibit 6-2: Hospital point-of-care cardiac marker products …………………………… 6-4
Exhibit 6-3: Hospital POC cardiac marker testing products market, by region ($m), 2015-20 ………………………………………………………… 6-11
Exhibit 6-4: Worldwide market for central laboratory versus hospital POC cardiac marker products ($m), 2015-20 ……………………………………. 6-12
Exhibit 6-5: Sales and market share for leading suppliers of hospital POC cardiac marker testing products, by region, 2015 ………………………. 6-14

7. OTHER HOSPITAL BEDSIDE POINT-OF-CARE TESTING PRODUCTS MARKETS ……………………………………………………………………………………… 7-1
7.1 POC Infectious Disease Testing Products, Market Analysis and Suppliers ………………………………………………………………………… 7-1
7.1.1 POC products and markets for hemoglobin and hematocrit testing …………………………………………………… 7-14
7.1.2 Hospital and institutional bedside whole-blood glucose monitoring market …………………………………………………… 7-21
7.1.2.1 Products for hospital/institutional bedside whole-blood glucose monitoring …………………. 7-22
7.1.2.2 Hospital/institutional bedside whole-blood glucose monitoring market analysis ……………. 7-25
7.1.2.3 Drivers and limiters of the hospital/institutional bedside whole-blood glucose monitoring products market ……………………………………….. 7-28
7.1.3 Other hospital bedside POC testing products ……………… 7-29
Bibliography ………………………………………………………………………………….. 7-29

Exhibit 7-1: Hospital point-of-care infectious disease testing products …………….. 7-3
Exhibit 7-2: Hospital POC infectious disease testing products market, by region ($m), 2015-20 …………………………………………………………….. 7-10
Exhibit 7-3: Worldwide market for central laboratory versus hospital POC infectious disease testing products ($m), 2015-20 …………………….. 7-11
Exhibit 7-4: Sales and market share for leading suppliers of hospital POC infectious disease testing products, by region, 2015 ………………….. 7-12
Exhibit 7-5: Worldwide market for hospital POC hemoglobin/hematocrit testing products ($m), 2015-20 ……………………………………………….. 7-17
Exhibit 7-6: Hospital POC hemoglobin/hematocrit testing products market, by region ($m), 2015-20 …………………………………………………………….. 7-18
Exhibit 7-7: Sales and market share for leading suppliers of hospital POC hemoglobin/hematocrit testing products, by region, 2015 …………… 7-20
Exhibit 7-8: Hospital point-of-care whole-blood glucose monitoring products …. 7-23
Exhibit 7-9: Hospital bedside whole-blood glucose testing products market, by region ($m), 2015-20 …………………………………………………………….. 7-26
Exhibit 7-10: Sales and market share for leading suppliers of hospital bedside whole-blood glucose monitoring products, by region, 2015 …………. 7-27

8. COMPETITOR ASSESSMENT ………………………………………………………….. 8-1
8.1 Overview of Companies in the Global POC Diagnostics Market ……. 8-1
8.2 Mergers and Partnerships to Improve Competitive Position ………….. 8-5
Exhibit 8-1: Overview of leading companies in the POC diagnostics market ……. 8-2
Exhibit 8-2: Recent mergers, acquisitions, and partnerships in the global POC diagnostics market………………………………………………………………….. 8-6

9. COMPANY PROFILES …………………………………………………………………….. 9-1
9.1 Abaxis …………………………………………………………………………………… 9-1
9.2 Abbott Laboratories ………………………………………………………………… 9-2
9.3 Accriva Diagnostics ………………………………………………………………… 9-4
9.4 Alere …………………………………………………………………………………….. 9-5
9.5 Alfa Wassermann …………………………………………………………………… 9-6
9.6 Arkray …………………………………………………………………………………… 9-7
9.7 Danaher ………………………………………………………………………………… 9-8
9.7.1 Beckman Coulter ……………………………………………………… 9-9
9.7.2 HemoCue ……………………………………………………………… 9-10
9.7.3 Radiometer ……………………………………………………………. 9-11
9.8 ELITech Group …………………………………………………………………….. 9-12
9.9 Helena Laboratories ……………………………………………………………… 9-12
9.10 Instrumentation Laboratory …………………………………………………….. 9-13
9.11 Menarini Diagnostics …………………………………………………………….. 9-15
9.12 Nova Biomedical ………………………………………………………………….. 9-15
9.13 OraSure Technologies …………………………………………………………… 9-17
9.14 Ortho Clinical Diagnostics ……………………………………………………… 9-18
9.15 Panasonic Healthcare …………………………………………………………… 9-18
9.16 Phamatech ………………………………………………………………………….. 9-19
9.17 Princeton BioMeditech …………………………………………………………… 9-20
9.18 Quidel …………………………………………………………………………………. 9-20
9.19 Response Biomedical ……………………………………………………………. 9-22
9.20 Roche Diagnostics………………………………………………………………… 9-22
9.21 Siemens Diagnostics …………………………………………………………….. 9-23
9.22 Trinity Biotech ………………………………………………………………………. 9-25
9.23 Trividia Health ……………………………………………………………………… 9-25

APPENDIX: COMPANY LISTING ……………………………………………………………… A-1