EXECUTIVE SUMMARY …………………………………………………………………………. ES-1
i. Self-Testing POC Diagnostics Market …………………………………….. ES-3
ii. Physician Office-based POC Diagnostics Market ……………………… ES-6
iii. Methodology ……………………………………………………………………….. ES-7

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 home and self-testing POC products market, share by product type, 2015 ……………………………………………………………….. ES-5
Exhibit ES-4: Global POL and alternate laboratory sites POC diagnostic products market, share by product type, 2015 …………………………. ES-8

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 volumes 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. HOME AND SELF-TESTING PRODUCTS ………………………………………….. 2-1
2.1 Whole Blood Glucose Self-Testing Products Market ……………………. 2-2
2.1.1 Existing whole blood glucose self-testing products ……………………… 2-4
2.1.2 Development-stage whole blood glucose self-testing products ………………………………………………………………….. 2-4
2.1.2.1 Integrated glucose testing devices ……………… 2-17
2.1.2.2 Implantable glucose monitors …………………….. 2-18
2.1.3 Whole blood glucose self-testing products market analysis and forecast ………………………………………………. 2-20
2.1.4 Whole blood glucose self-testing product suppliers’ sales and market shares …………………………………………. 2-22
2.1.5 Drivers and limiters of the whole blood glucose self-testing products market …………………………………….. 2-24
2.2 OTC Pregnancy and Fertility Testing Products Market ……………….. 2-26
2.2.1 Trends in home pregnancy and fertility testing ……………. 2-26
2.2.2 Existing products for home pregnancy and fertility testing …………………………………………………………………… 2-26
2.2.3 New products under development for home pregnancy and fertility testing ………………………………………………….. 2-29
2.2.4 OTC pregnancy and fertility testing products market analysis and forecast ………………………………………………. 2-30
2.2.5 OTC pregnancy and fertility testing product suppliers’ sales and market shares …………………………………………. 2-34
2.2.6 Drivers and limiters of the OTC pregnancy and fertility testing products market …………………………………………… 2-34
2.3 Markets for Other Home and Self-Testing Products …………………… 2-36
2.3.1 Cholesterol self-testing ……………………………………………. 2-36
2.3.2 Fecal occult blood testing ………………………………………… 2-41
2.3.3 Home drugs of abuse testing ……………………………………. 2-44
2.3.4 Coagulation self-testing …………………………………………… 2-48
2.3.5 Infectious disease self-testing ………………………………….. 2-51
2.3.6 Cancer marker self-testing ………………………………………. 2-55

Bibliography ………………………………………………………………………………….. 2-56

Exhibit 2-1: Trends in diabetes prevalence, 2013-35 ……………………………………. 2-3
Exhibit 2-2: Leading whole blood glucose self-testing products available in the global market …………………………………………………………………………. 2-5
Exhibit 2-3: Other whole blood glucose self-testing products ……………………….. 2-14
Exhibit 2-4: Whole blood glucose self-testing products market, by region ($m), 2015-20 …………………………………………………………….. 2-21
Exhibit 2-5: Sales and market share for leading suppliers of whole blood glucose self-testing products, by region, 2015 ………………………….. 2-23
Exhibit 2-6: Home pregnancy and fertility testing products …………………………… 2-27
Exhibit 2-7: OTC pregnancy and fertility testing products market, by region ($m), 2015-20 …………………………………………………………….. 2-31
Exhibit 2-8: Number of births by region (million), 2015-20 ……………………………. 2-32
Exhibit 2-9: Home pregnancy and fertility testing market by product segment … 2-33
Exhibit 2-10: Sales and market share for leading suppliers of OTC pregnancy and fertility testing products, by region, 2015 ……………………………. 2-35
Exhibit 2-11: Cholesterol self-testing products market, by region ($m), 2015-20 …………………………………………………………….. 2-39
Exhibit 2-12: Sales and market share for leading suppliers of cholesterol self-testing products, by region, 2015 ………………………………………. 2-40
Exhibit 2-13: Fecal occult blood testing products available in the global market .. 2-42
Exhibit 2-14: Home drugs of abuse testing products market, by region ($m), 2015-20 …………………………………………………………….. 2-46
Exhibit 2-15: Sales and market share for leading suppliers of home drugs of abuse testing products, by region, 2015 ……………………………….. 2-47
Exhibit 2-16: PT/INR self-testing products available in the global market ………… 2-50
Exhibit 2-17: Coagulation self-testing products market, by region ($m), 2015-20 …………………………………………………………….. 2-52
Exhibit 2-18: Sales and market share for leading suppliers of coagulation self-testing products, by region, 2015 ………………………………………. 2-53

3. PHYSICIAN’S OFFICE AND OTHER ALTERNATE SITE TESTING PRODUCTS ……………………………………………………………………………………. 3-1
3.1 Types of Testing Performed in Physician’s Offices and Other Alternate Sites ……………………………………………………………………….. 3-4
3.2 Existing Physician’s Office Laboratory Products …………………………. 3-6
3.3 New POL Products Under Development ………………………………….. 3-19
3.4 Physician’s Office Laboratory Market Analysis by Segment: General Chemistry, Hematology, Immunochemistry, Rapid Test Kits, Urinalysis, Whole Blood Glucose, Allergy, Other ………………… 3-22
3.5 POL Product Suppliers’ Sales and Market Shares …………………….. 3-26
3.6 Drivers and Limiters of the Worldwide POL Products Market ………. 3-38
3.7 Other Alternate Site Testing Products and Markets …………………… 3-40

Exhibit 3-1: Trends in CLIA-registered POLs and other selected alternate site labs in the US ………………………………………………………………………… 3-2
Exhibit 3-2: US POLs by certificate type and Certificate of Compliance POLs by Certificate Schedule …………………………………………………………… 3-3
Exhibit 3-3: Tests ordered by office-based physicians in the US, 2000-12 ……….. 3-5
Exhibit 3-4: Physician’s office laboratory products ……………………………………….. 3-7
Exhibit 3-5: Products in development for the POL and alternate site laboratory ………………………………………………………………………. 3-20
Exhibit 3-6: Worldwide POL market, by region ($m), 2015-20 …………………….. 3-23
Exhibit 3-7: Worldwide POL market, by product segment ($m), 2015-20 ……….. 3-25
Exhibit 3-8: Sales and market share for leading suppliers of POL chemistry products, by region, 2015 ………………………………………………………. 3-27
Exhibit 3-9: Sales and market share for leading suppliers of POL immunochemistry products, by region, 2015 …………………………….. 3-28
Exhibit 3-10: Sales and market share for leading suppliers of POL hematology products, 2015 ……………………………………………………………………… 3-29
Exhibit 3-11: Sales and market share for leading suppliers of POL rapid test kits, by region, 2015 ……………………………………………………………… 3-30
Exhibit 3-12: Sales and market share for leading suppliers of POL urinalysis products, by region, 2015 ………………………………………………………. 3-31
Exhibit 3-13: Sales and market share for leading suppliers of POL allergy testing products, by region, 2015 ……………………………………………. 3-32
Exhibit 3-14: Sales and market share for leading suppliers of POL whole blood glucose testing products, by region, 2015 ………………………………… 3-33
Exhibit 3-15: Sales and market share for leading suppliers of POL hemoglobin testing products, by region, 2015 ……………………………………………. 3-34
Exhibit 3-16: Sales and market share for leading suppliers of POL coagulation testing products, by region, 2015 ……………………………………………. 3-35
Exhibit 3-17: Sales and market share for leading suppliers of POL glycated hemoglobin testing products, by region, 2015 …………………………… 3-36
Exhibit 3-18: Combined worldwide sales and market share for leading suppliers of POL testing products, 2015 …………………………………… 3-39

4. COMPETITOR ASSESSMENT ………………………………………………………….. 4-1
4.1 Overview of Companies in the Global POC Diagnostics Market ……. 4-1
4.2 Mergers and Partnerships to Improve Competitive Position ………….. 4-5

Exhibit 4-1: Overview of leading companies in the POC diagnostics market ……. 4-2
Exhibit 4-2: Recent mergers, acquisitions, and partnerships in the global
POC diagnostics market ………………………………………………………….. 4-6

5. COMPANY PROFILES …………………………………………………………………….. 5-1
5.1 Abaxis …………………………………………………………………………………… 5-1
5.2 Abbott Laboratories ………………………………………………………………… 5-2
5.3 Accriva Diagnostics ………………………………………………………………… 5-4
5.4 Alere …………………………………………………………………………………….. 5-5
5.5 Alfa Wassermann …………………………………………………………………… 5-6
5.6 Arkray …………………………………………………………………………………… 5-7
5.7 Danaher ………………………………………………………………………………… 5-8
5.7.1 Beckman Coulter ……………………………………………………… 5-9
5.7.2 HemoCue ……………………………………………………………… 5-10
5.7.3 Radiometer ……………………………………………………………. 5-11
5.8 ELITech Group …………………………………………………………………….. 5-12
5.9 Helena Laboratories ……………………………………………………………… 5-12
5.10 Instrumentation Laboratory …………………………………………………….. 5-13
5.11 Menarini Diagnostics …………………………………………………………….. 5-15
5.12 Nova Biomedical ………………………………………………………………….. 5-15
5.13 OraSure Technologies …………………………………………………………… 5-17
5.14 Ortho Clinical Diagnostics ……………………………………………………… 5-18
5.15 Panasonic Healthcare …………………………………………………………… 5-18
5.16 Phamatech ………………………………………………………………………….. 5-19
5.17 Princeton BioMeditech …………………………………………………………… 5-20
5.18 Quidel …………………………………………………………………………………. 5-20
5.19 Response Biomedical ……………………………………………………………. 5-22
5.20 Roche Diagnostics………………………………………………………………… 5-22
5.21 Siemens Diagnostics …………………………………………………………….. 5-23
5.22 Trinity Biotech ………………………………………………………………………. 5-25
5.23 Trividia Health ……………………………………………………………………… 5-25

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