EXECUTIVE SUMMARY …………………………………………………………………………. ES-1

i. Report overview…………………………………………………………………… ES-1

ii. Diabetes prevalence …………………………………………………………….. ES-1

iii. Global diabetes management devices market ………………………….. ES-2

a. Selected market drivers and limiters ……………………………………….. ES-6

b. Blood glucose monitoring devices segment …………………………….. ES-7

c. Insulin pump systems segment ……………………………………………… ES-7

d. Technology trends ……………………………………………………………….. ES-7

e. Market leaders …………………………………………………………………….. ES-8

f. Competitive strategies ………………………………………………………….. ES-8

g. Emerging competition/startups …………………………………………….. ES-10

iv. Methodology ……………………………………………………………………… ES-11

Exhibit ES-1: Diabetes management devices market forecast, by segment, 2015-20 ……………………………………………………………. ES-3

Exhibit ES-2: Diabetes management devices market forecast, by region, 2015-20 ……………………………………………………………………………… ES-4

Exhibit ES-3: Diabetes management devices market, estimated share by region, 2015 ………………………………………………………………………………….. ES-5

1. OVERVIEW OF DIABETES ………………………………………………………………. 1-1

1.1 Overview of Diabetes ……………………………………………………………… 1-1

1.1.1 Symptoms ………………………………………………………………. 1-2

1.1.2 Complications ………………………………………………………….. 1-3

1.1.3 Diagnosis and treatment/prevention ……………………………. 1-4

1.1.3.1 The importance of maintaining glucose control . 1-4

1.1.3.2 Limitations of self-monitoring blood glucose …… 1-5

1.1.3.3 Insulin and usage of insulin pumps ………………. 1-6

1.2 Cost of Diabetes …………………………………………………………………….. 1-7

1.3 Diabetes Prevalence ………………………………………………………………. 1-7

1.3.1 Diabetes forecast for the US, 5EU, and Japan ……………… 1-7

1.3.1.1 Type 1 diabetes forecast …………………………….. 1-9

1.3.1.2 Type 2 diabetes forecast …………………………….. 1-9

1.3.2 Prediabetes in the US……………………………………………… 1-12

1.4 New Diabetes Device Technologies, Brief Overview ………………….. 1-12

1.4.1 Continuous blood glucose monitoring and patch-based systems………………………………………………. 1-12

1.4.2 The world’s first external artificial pancreas device system ………………………………………………………… 1-13

1.5 Bibliography …………………………………………………………………………. 1-15

Exhibit 1-1: Estimated diabetes prevalence, worldwide and by region, 2015 and 2040……………………………………………………………………….. 1-8

Exhibit 1-2: Type 1 diabetes prevalence across the US, Japan, and five major EU markets, by country, 2015-20 …………………………………… 1-10

Exhibit 1-3: Type 2 diabetes prevalence across the US, Japan, and five major EU markets, by country, 2015-20 …………………………………… 1-11

Exhibit 1-4: Diagram of an artificial pancreas system (an autonomous system for glycemic control) by the FDA…………………………………………….. 1-14

2. GLUCOSE MONITORING DEVICES………………………………………………….. 2-1

2.1 Selected Blood Glucose Meters ……………………………………………….. 2-1

2.1.1 Abbott Laboratories ………………………………………………… 2-12

2.1.2 Ascensia Diabetes Care/Panasonic

Healthcare Holdings ……………………………………………….. 2-12

2.1.3 LifeScan/Johnson & Johnson …………………………………… 2-19

2.1.4 Roche …………………………………………………………………… 2-11

2.2 Selected Continuous Glucose Monitoring Systems ……………………. 2-14

2.2.1 Abbott Laboratories ………………………………………………… 2-15

2.2.2 Dexcom ………………………………………………………………… 2-22

2.2.2.1 Dexcom and Google/Verily Life Sciences ……. 2-25

2.2.3 Medtronic ………………………………………………………………. 2-26

2.2.3.1 Medtronic/Qualcomm ……………………………….. 2-28

2.2.3.2 Medtronic/IBM Watson Health ……………………. 2-30

2.2.4 Nemaura Medical …………………………………………………… 2-31

2.2.5 Senseonics/Roche …………………………………………………. 2-32

2.3 Bibliography …………………………………………………………………………. 2-35

Exhibit 2-1: Blood glucose monitoring brands and portfolios offered by leading competitors, 2016 ……………………………………………………….. 2-3

Exhibit 2-2: Selected new blood glucose monitoring devices, 2016 ………………… 2-5

Exhibit 2-3: Ascensia’s new Contour Next One and Contour Diabetes app ……… 2-8

Exhibit 2-4: LifeScan’s new OneTouch Verio Flex ………………………………………. 2-10

Exhibit 2-5: Roche’s Accu-Chek Mobile all-in-one system allowing “strip–free” testing …………………………………………………………………. 2-13

Exhibit 2-6: Selected new continuous glucose monitoring devices/sensors, 2016 …………………………………………………………… 2-16

Exhibit 2-7: Abbott’s FreeStyle Libre Pro reader device and sensor ……………… 2-20

Exhibit 2-8: The Dexcom G5 Mobile CGM system ……………………………………… 2-23

Exhibit 2-9: Medtronic’s Guardian Connect mobile CGM system ………………….. 2-27

Exhibit 2-10: Medtronic’s Enlite Sensor used with the MiniMed 530G insulin pump ………………………………………………………………………… 2-29

Exhibit 2-11: Senseonics/Roche’s new Eversense implantable CGM system …… 2-34

3. INSULIN PUMPS AND EMERGING INSULIN DELIVERY DEVICES ……… 3-1

3.1 Selected Insulin Pumps …………………………………………………………… 3-2

3.1.1 Animas/Johnson & Johnson ………………………………………. 3-2

3.1.2 Insulet Corporation …………………………………………………… 3-5

3.1.3 Medtronic ………………………………………………………………… 3-9

3.1.4 Roche …………………………………………………………………… 3-11

3.1.5 Tandem Diabetes Care …………………………………………… 3-13

3.2 Other Insulin Delivery Devices ……………………………………………….. 3-15

3.2.1 Cellnovo ……………………………………………………………….. 3-15

3.2.2 Calibra Medical/Johnson & Johnson …………………………. 3-16

3.2.3 Valeritas ……………………………………………………………….. 3-18

3.3 Bibliography …………………………………………………………………………. 3-21

Exhibit 3-1: Selected new or emerging insulin pump/delivery systems, 2016 …… 3-3

Exhibit 3-2: OneTouch Ping and Animas Vibe insulin pump systems ……………… 3-6

Exhibit 3-3: Omnipod and three-step insulin delivery ……………………………………. 3-8

Exhibit 3-4: Medtronic’s New MiniMed 630G and 530G insulin pump systems .. 3-12

Exhibit 3-5: Tandem Diabetes Care’s t:slim G4 insulin pump ……………………….. 3-14

Exhibit 3-6: The Cellnovo Diabetes Management System …………………………… 3-17

Exhibit 3-7: The V-Go Disposable and Wearable Insulin Delivery Device ………. 3-20

4. ARTIFICIAL PANCREAS AND EMERGING/COMPETING TECHNOLOGIES …………………………………………. 4-1

4.1 Medtronic’s Artificial Pancreas – the MiniMed 670G …………………….. 4-2

4.2 Artificial Pancreas Technology – Under Development ………………….. 4-5

4.2.1 Beta Bionics ……………………………………………………………. 4-5

4.2.2 Bigfoot Biomedical ………………………………………………….. 4-10

4.2.3 Cellnovo ……………………………………………………………….. 4-10

4.2.4 Insulet Corporation …………………………………………………. 4-11

4.2.5 Tandem Diabetes Care/Dexcom/TypeZero ………………… 4-12

4.2.6 TypeZero Technologies …………………………………………… 4-13

4.3 Bibliography …………………………………………………………………………. 4-17

Exhibit 4-1: Medtronic’s MiniMed 670G, the first FDA-approved artificial pancreas ……………………………………………………………………. 4-4

Exhibit 4-2: Selected emerging artificial pancreas systems and expected launch, 2018-19 ……………………………………………………………………… 4-6

Exhibit 4-3: TypeZero’s inControl proprietary smartphone-driven hybrid closed-loop AP algorithm and partnership collaboration ……………… 4-14

Exhibit 4-4: TypeZero’s inControl smartphone-driven artificial pancreas featuring inControl Advice ……………………………………………………… 4-16

5. GLOBAL DIABETES MANAGEMENT DEVICES MARKET ………………….. 5-1

5.1 Global Market Analysis ……………………………………………………………. 5-1

5.1.1 Market drivers and limiters ………………………………………. 5-10

5.1.2 Market forecast: US ………………………………………………… 5-11

5.1.2.1 Reimbursement issues ……………………………… 5-16

5.1.2.1.1 Blood glucose monitors/testing supplies ……………………………….. 5-16

5.1.2.1.2 Continuous glucose monitoring devices ………………………………… 5-17

5.1.2.1.3 Insulin pumps ……………………….. 5-18

5.1.3 Market forecast: 5EU ………………………………………………. 5-18

5.1.4 Market forecast: Japan ……………………………………………. 5-20

5.1.5 Market forecast: rest of the world ……………………………… 5-20

5.1.6 Competitive analysis: global …………………………………….. 5-22

5.1.6.1 Global market share: diabetes management devices (total market) ……………………………….. 5-22

5.1.6.1.1 Estimated global market share: blood glucose monitoring devices ………………………………… 5-24

5.1.6.1.2 Estimated global market share: insulin pump systems …………….. 5-24

5.1.6.2 Competitive analysis: US ………………………….. 5-27

5.1.6.3 Competitive analysis: EU ………………………….. 5-29

5.1.6.4 Competitive analysis: Japan ………………………. 5-29

5.1.6.5 Competitive analysis: rest of the world ………… 5-29

5.1.7 Detailed analysis, by competitor ……………………………….. 5-33

5.1.7.1 Ascensia Diabetes Care (formerly Bayer Diabetes Care) ………………………………………… 5-33

5.1.7.1.1 Strategic growth initiatives ……… 5-33

5.1.7.2 Abbott Laboratories ………………………………….. 5-34

5.1.7.2.1 Strategic growth initiatives ……… 5-34

5.1.7.3 Johnson & Johnson ………………………………….. 5-35

5.1.7.3.1 Strategic growth initiatives ……… 5-35

5.1.7.4 Medtronic………………………………………………… 5-36

5.1.7.4.1 Strategic growth initiatives ……… 5-36

5.1.7.5 Roche …………………………………………………….. 5-37

5.1.7.5.1 FY2015 ……………………………….. 5-37

5.1.7.5.2 FY2016 ……………………………….. 5-38

5.1.7.5.3 Strategic growth initiatives ……… 5-38

5.1.7.6 Dexcom ………………………………………………….. 5-39

5.1.7.6.1 FY2015 ……………………………….. 5-39

5.1.7.6.2 FY2016 ……………………………….. 5-39

5.1.7.6.3 Strategic growth initiatives ……… 5-40

5.1.7.7 Insulet Corporation …………………………………… 5-41

5.1.7.7.1 FY2015 ……………………………….. 5-41

5.1.7.7.2 FY2016 ……………………………….. 5-41

5.1.7.7.3 Strategic growth initiatives ……… 5-42

5.1.7.8 Tandem Diabetes Care …………………………….. 5-42

5.2 Bibliography …………………………………………………………………………. 5-44

Exhibit 5-1: Diabetes management devices market forecast, by segment and region, 2015-20 ……………………………………………………………………… 5-3

Exhibit 5-2: Global diabetes management devices market, estimated share by region, 2015 ………………………………………………………………………. 5-6

Exhibit 5-3: Global diabetes management devices market, estimated share by region, 2020 ………………………………………………………………………. 5-7

Exhibit 5-4: Global diabetes management devices market, estimated share by device segment, 2015 …………………………………………………………. 5-8

Exhibit 5-5: Global diabetes management devices market, estimated share by device segment, 2020 …………………………………………………………. 5-9

Exhibit 5-6: Selected market drivers and limiters for diabetes management devices ……………………………………………………………………………….. 5-12

Exhibit 5-7: Diabetes management devices global market, share by supplier, 2015 ………………………………………………………………….. 5-23

Exhibit 5-8: Blood glucose monitoring devices global market, share by supplier, 2015 ………………………………………………………………….. 5-25

Exhibit 5-9: Insulin pumps global market, share by supplier, 2015 ………………… 5-26

Exhibit 5-10: Diabetes management devices US market, share by supplier, 2015 ………………………………………………………………….. 5-28

Exhibit 5-11: Diabetes management devices 5EU market, share by supplier, 2015 ………………………………………………………………….. 5-30

Exhibit 5-12: Diabetes management devices Japan market, share by supplier, 2015 ………………………………………………………………….. 5-31

Exhibit 5-13: Diabetes management devices RoW market, share by supplier, 2015 ………………………………………………………………….. 5-32

APPENDIX A: COMPANY LISTING