$4,750.00
In 2015, the global point-of-care (POC) clinical diagnostic products market was valued at $14.7bn, comprising 28% of the total in-vitro diagnostics (IVD) market. The market is projected to grow at a somewhat slower rate than the overall IVD market, due mainly to a decline in the overall blood glucose self-testing segment, which comprises more than half of the POC diagnostics market.
In 2015, the global point-of-care (POC) clinical diagnostic products market was valued at $14.7bn, comprising 28% of the total in-vitro diagnostics (IVD) market. The market is projected to grow at a somewhat slower rate than the overall IVD market, due mainly to a decline in the overall blood glucose self-testing segment, which comprises more than half of the POC diagnostics market. That trend is expected to gradually reverse, resulting in more rapid growth in the POC diagnostics market in the latter part of the forecast period. The market is forecast to increase at a 2.4% compound annual growth rate (CAGR) during 2015-20, with year-over-year growth increasing to 3.7% by 2020. A number of segments of the POC diagnostics market are forecast to grow at rates well in excess of the total market, including segments such as critical care testing, rapid POC tests, POC cardiac markers, POC coagulation tests, and certain other segments such as POC glycated hemoglobin testing and POC molecular infectious disease testing.
Topics covered by this report include:
· POC diagnostic products used in the hospital environment
· global market forecasts for 2015-20
· emerging POC diagnostic products in development
· global trends in the utilization of POC diagnostic products
· key market drivers and limiters
· estimated revenues and market shares for major competitors in the POC diagnostic products market.
EXECUTIVE SUMMARY …………………………………………………………………………. ES-1
i. Hospital-Based POC Diagnostics Market ………………………………… ES-3
ii. Methodology ……………………………………………………………………….. ES-6
Exhibit ES-1: Global POC in-vitro diagnostic products market, 2015-20 ………….. ES-2
Exhibit ES-2: Global POC diagnostics market, by place of service ($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
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