Table of Contents

Executive Summary …………………………………………………………………………………………………………….ES-1
i. Introduction………………………………………………………………………………………………………………ES-1
ii. Point of Care diagnostics products market …………………………………………………………………..ES-1
a. Blood gas/electrolyte/metabolite testing……………………………………………………ES-4
b. Cardiac marker testing……………………………………………………………………………..ES-4
c. Hemostasis testing …………………………………………………………………………………..ES-4
d. Infectious disease testing …………………………………………………………………………ES-4
e. Cancer screening……………………………………………………………………………………..ES-5
f. Pregnancy and fertility testing……………………………………………………………………ES-5
g. Drugs of abuse testing ……………………………………………………………………………..ES-5
h. Whole blood glucose testing in diabetics……………………………………………………ES-5
i. Other POC testing applications…………………………………………………………………..ES-5
iii. Market drivers and limiters……………………………………………………………………………………….ES-6
iv. Technology trends ……………………………………………………………………………………………………ES-6
v. Market leaders………………………………………………………………………………………………………….ES-7
vi. Competitive strategies………………………………………………………………………………………………ES-7
vii. Emerging competition ……………………………………………………………………………………………..ES-8
viii. Methodology………………………………………………………………………………………………………….ES-8

Exhibit ES-1: Point of care diagnostics, combined market forecast ($millions), by product segment, 2020–25 …………………………………………………………………………….ES-2
Exhibit ES-2: Point of care diagnostics, combined market forecast ($millions), by region, 2020–25……………………………………………………………………………………………………………ES-3

1. Clinical Overview …………………………………………………………………………………………………………….. 1-1
1.1 Infectious disease testing…………………………………………………………………………………………. 1-1
1.1.1 Human immunodeficiency virus……………………………………………………………. 1-5
1.1.2 Tuberculosis……………………………………………………………………………………….. 1-5
1.1.3 Chlamydia trachomatis/Neisseria gonorrhoea………………………………………… 1-6
1.1.4 Human papilloma virus………………………………………………………………………… 1-6
1.1.5 Methicillin-resistant Staphylococcus aureus…………………………………………… 1-7
1.1.6 Novel coronavirus (COVID-19)………………………………………………………………. 1-7
1.1.7 Other infectious diseases……………………………………………………………………… 1-8
1.2 Cardiorespiratory and cardiovascular disease testing………………………………………………….. 1-9
1.3 Diabetes testing ……………………………………………………………………………………………………. 1-10
1.4 Cancer screening…………………………………………………………………………………………………… 1-11
1.4.1 Colorectal cancer………………………………………………………………………………. 1-15
1.4.2 Other cancers……………………………………………………………………………………. 1-15
1.5 Hemostasis testing………………………………………………………………………………………………… 1-17
1.6 Drugs of abuse testing …………………………………………………………………………………………… 1-17
1.7 Pregnancy and fertility testing………………………………………………………………………………… 1-19
1.8 Other applications…………………………………………………………………………………………………. 1-21
1.9 Bibliography …………………………………………………………………………………………………………. 1-23

Exhibit 1-1: Incidence and prevalence of selected infectious diseases, by region………………………… 1-2
Exhibit 1-2: Cardiovascular disease mortality (‘000), by region, 2011–2016……………………………….. 1-9
Exhibit 1-3: Prevalence of diabetes (‘000), by region, 2010–2045……………………………………………. 1-11
Exhibit 1-4: Incidence of selected cancer types, by region, 2020 & 2040………………………………….. 1-13
Exhibit 1-5: Proportion of emergency department visits with reports of illicit drug use, US, 2006–2011 and 2020………………………………………………………………………………………… 1-18
Exhibit 1-6: Number of births (in millions), by country/region, 2020–2040 ………………………………. 1-20

2. Point of Care Diagnostics Products…………………………………………………………………………………….. 2-1
2.1 Technology Insights ………………………………………………………………………………………………… 2-1
2.1.1 Dipsticks …………………………………………………………………………………… 2-1
2.1.2 Immunoassays…………………………………………………………………………… 2-1
2.1.3 Lateral flow assays …………………………………………………………………….. 2-2
2.1.4 Microfluidic sensors…………………………………………………………………… 2-2
2.1.5 Molecular technologies………………………………………………………………. 2-2
2.2 Point of care diagnostic products for infectious disease testing……………………………………. 2-3
2.3 Point of care diagnostic products for blood gas/electrolyte/metabolite testing……………… 2-7
2.4 Point of care diagnostic products for cardiac marker testing ……………………………………… 2-10
2.5 Point of care diagnostic products for hemostasis testing …………………………………………… 2-12
2.6 Point of care diagnostic products for cancer screening ……………………………………………… 2-15
2.7 Point of care diagnostic products for pregnancy and fertility testing…………………………… 2-17
2.8 Point of care diagnostic products for drugs of abuse testing………………………………………. 2-19
2.9 Point of care diagnostic products for blood glucose testing ……………………………………….. 2-22
2.10 Point of care diagnostic products for other applications…………………………………………… 2-25
2.11 Bibliography………………………………………………………………………………………………………… 2-27

Exhibit 2-1: Selected POC diagnostics products for infectious disease testing, 2021……………………. 2-5
Exhibit 2-2: Selected POC diagnostic products for blood gas/electrolyte/metabolite testing, 2021 . 2-8
Exhibit 2-3: Selected point of care diagnostic products for cardiac marker testing, 2021 …………… 2-11
Exhibit 2-4: Selected point of care diagnostic products for hemostasis testing, 2021 ………………… 2-13
Exhibit 2-5: Selected point of care diagnostic products for cancer screening, 2021 …………………… 2-16
Exhibit 2-6: Selected point of care diagnostic products for pregnancy and fertility testing, 2021… 2-18
Exhibit 2-7: Selected point of care diagnostic products for drugs of abuse testing, 2021……………. 2-20
Exhibit 2-8: Selected point of care diagnostic products for blood glucose testing, 2021…………….. 2-23
Exhibit 2-9: Selected point of care diagnostic products for other applications, 2021 …………………. 2-26

3. Point of Care Diagnostics Market Analysis …………………………………………………………………. 3-1
3.1 Regional insights…………………………………………………………………………………………………….. 3-1
3.1.1 United States…………………………………………………………………………….. 3-1
3.1.2 Five major European markets……………………………………………………… 3-1
3.1.3 Japan………………………………………………………………………………………… 3-3
3.1.4 Rest of world …………………………………………………………………………….. 3-3
3.2 Point of care diagnostics, market forecast by product segment……………………………………. 3-3
3.2.1 Competitive analysis ………………………………………………………………….. 3-4
3.3 Trends in the point of care diagnostics products market……………………………………………… 3-3
3.4 Laboratory developed tests……………………………………………………………………………………… 3-3
3.5 Market drivers and limiters ……………………………………………………………………………………… 3-4
3.6 Products for blood gas/electrolyte/metabolite testing, market analysis………………………… 3-5
3.6.1 Competitive analysis ………………………………………………………………….. 3-7
3.7 Point of care diagnostics for cardiac marker testing, market analysis……………………………. 3-8
3.7.1 Competitive analysis ………………………………………………………………… 3-10
3.8 Point of care diagnostics for hemostasis testing, market analysis……………………………….. 3-11
3.8.1 Competitive analysis ………………………………………………………………… 3-11
3.9 Point of care diagnostics for infectious disease testing, market analysis ……………………… 3-14
3.9.1 Competitive analysis ………………………………………………………………… 3-16
3.10 Point of care diagnostics for cancer screening, market analysis………………………. 3-18
3.10.1 Competitive analysis ………………………………………………………………… 3-18
3.11 Point of care diagnostics for pregnancy and fertility testing, market analysis…… 3-20
3.11.1 Competitive analysis ………………………………………………………………… 3-21
3.12 Point of care diagnostics for drugs of abuse testing, market forecast………………. 3-22
3.12.1 Competitive analysis ………………………………………………………………… 3-23
3.13 Point of care diagnostics for blood glucose testing, market forecast……………….. 3-24
3.13.1 Competitive analysis ………………………………………………………………… 3-28
3.14 Point of care diagnostics for other applications, market forecast……………………. 3-30
3.14.1 Competitive analysis ………………………………………………………………… 3-33
3.15 Bibliography……………………………………………………………………………………………… 3-36

Exhibit 3-1: Point of care diagnostics products, combined market forecast ($m), by region, 2020–25……………………………………………………………………………………………………………. 3-2
Exhibit 3-2: Point of care diagnostics products, combined market forecast ($m), by segment, 2020–25……………………………………………………………………………………………………………. 3-1
Exhibit 3-3: Point of care diagnostics products, combined market ($m), global share by supplier, 2020…………………………………………………………………………………………………………………. 3-2
Exhibit 3-4: Exact Sciences’ home colorectal cancer screening service revenue ($m), 2015–20 ……. 3-4
Exhibit 3-5: Point of care diagnostics for blood gas/electrolyte/metabolite testing, market forecast ($m) by region, 2020–25……………………………………………………………… 3-6
Exhibit 3-6: Market for point of care diagnostics products for blood gas/electrolyte/metabolite testing ($m), global share by supplier, 2020………………………………………………………….. 3-7
Exhibit 3-7: Point of care diagnostics products for cardiac marker testing, market forecast ($m), by region, 2020–25…………………………………………………………………………………………….. 3-9
Exhibit 3-8: Market for point of care diagnostics products for cardiac marker testing, global share by supplier, 2020 …………………………………………………………………………… 3-10
Exhibit 3-9: Point of care diagnostics products for hemostasis testing, market forecast ($m), by region, 2020–25…………………………………………………………………………………………… 3-12
Exhibit 3-10: Point of care diagnostics products market for hemostasis testing, global share by supplier, 2020 …………………………………………………………………………… 3-13
Exhibit 3-11: Point of care diagnostics products for infectious disease testing, market forecast ($m), by region, 2020–25…………………………………………………………… 3-15
Exhibit 3-12: Point of care diagnostics products for infectious disease testing, global share by supplier, 2020 …………………………………………………………………………… 3-17
Exhibit 3-13: Point of care diagnostics products for cancer screening, market forecast ($m), by region, 2020–25…………………………………………………………………………………………… 3-19
Exhibit 3-14: Point of care diagnostics products for pregnancy and fertility testing, market forecast ($m), by region, 2020–25…………………………………………………………… 3-20
Exhibit 3-15: Point of care diagnostics products for pregnancy and fertility testing, global share by supplier, 2020 …………………………………………………………………………… 3-21
Exhibit 3-16: Point of care diagnostics products for drugs of abuse testing, market forecast ($m), by region, 2020–25…………………………………………………………………………………………… 3-22
Exhibit 3-17: Point of care diagnostics products for drugs of abuse testing, global share by supplier, 2020 …………………………………………………………………………… 3-23
Exhibit 3-18: Point of care diagnostics products for blood glucose testing, market forecast ($m), by region, 2020–25…………………………………………………………………………………………… 3-25
Exhibit 3-19: Point of care diagnostics products for professional-use blood glucose testing, market forecast ($m), by region, 2020–25…………………………………………………………… 3-26
Exhibit 3-20: Point of care diagnostics products for blood glucose self-testing, market forecast ($m), by region, 2020–25…………………………………………………………………………………………… 3-27
Exhibit 3-21: Point of care diagnostics products for blood glucose testing, global share by supplier, 2020……………………………………………………………………………………………………………….. 3-29
Exhibit 3-22: Point of care diagnostics products for other applications, market forecast ($m), by product segment, 2020–25 …………………………………………………………………………… 3-31
Exhibit 3-23: Point of care diagnostics products for other applications, market forecast ($m) by region, 2020–25…………………………………………………………………………………………… 3-32
Exhibit 3-24: Point of care diagnostics market for other applications, share by supplier, 2020 …… 3-33
Exhibit 3-25: Point of care diagnostics market for hemoglobin and hematocrit testing, share by supplier, 2020 …………………………………………………………………………………….. 3-34
Exhibit 3-26: Point of care diagnostics market for urinalysis products, share by supplier, 2020 ….. 3-34
Exhibit 3-27: Point of care diagnostics market for glycated hemoglobin testing products, share by supplier, 2020 …………………………………………………………………………………….. 3-35
Exhibit 3-28: Point of care diagnostics market for allergy testing products, share by supplier, 2020 …………………………………………………………………………………….. 3-35

APPENDIX A: COMPANY REVENUES………………………………………………………………………………………A-1

APPENDIX B: COMPANY LISTING………………………………………………………………………………………….. B-1