Continuous glucose monitoring (CGM) allows for a more accurate reading of how blood glucose levels fluctuate throughout the day by measuring interstitial glucose levels on a continuous basis and estimating blood glucose levels based on these readings. A CGM system is typically made up of three components: a glucose sensor, transmitter and receiver. The sensor is inserted under the skin into the interstitial fluid and held with an adhesive. Sensors are typically sold in groups of four and are labeled for six to seven days of use, depending on the manufacturer. A transmitter takes the glucose reading from the sensor and wirelessly sends it to a small, hand-held receiver. If glucose levels are too low or high, the receiver warns the patient. Some manufacturers have even built-in a threshold audible alarm as a fixed safety feature when the patient approaches levels below 55 mg/dL, at which point the patient is still interactive but severely hypoglycemic.
The U.S. continuous glucose monitoring (CGM) market can be segmented by setting, yielding two segments: professional CGM and personal CGM. In 2016, the largest segment in the total CGM market was the personal CGM segment. Growth is expected to continue over the forecast period and will be driven by favorable reimbursement, technological innovation and increased uptake of personal CGM among type 1 diabetics and insulin-dependent type 2 diabetics. Professional CGM is typically used in retrospective sessions initiated by physicians, during which a patient wears a CGM sensor for several days to a week, but is ‘blinded’ to the real-time CGM data and must adhere to frequent self-monitoring of blood glucose (SMBG) using traditional blood glucose meters. Additionally, the patient must maintain a record of their daily dietary intake and activity during the time that the sensor is worn. At the end of the session, the patient returns to their physician to remove the sensor and retrospectively analyze the glucose data that was collected. The ‘blinded’ aspect of professional CGM allows physicians to more easily assess their patient’s behavior because their actions are not influenced by ‘real-time’ glucose data, as is the case with personal CGM products.
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TABLE OF CONTENTS I
LIST OF FIGURES III
LIST OF CHARTS V
EXECUTIVE SUMMARY 1
U.S. DIABETES MONITORING, TREATMENT AND DRUG DELIVERY MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 7
MARKET DEVELOPMENTS 9
PROCEDURE NUMBERS 10
PROCEDURE CODES INVESTIGATED 10
MARKETS INCLUDED 11
KEY REPORT UPDATES 13
VERSION HISTORY 13
RESEARCH METHODOLOGY 14
1.1 RESEARCH SCOPE 14
1.2 IDATA’S 9-STEP METHODOLOGY 14
Step 1: Project Initiation & Team Selection 14
Step 2: Prepare Data Systems and Perform Secondary Research 16
Step 3: Preparation for Interviews & Questionnaire Design 17
Step 4: Performing Primary Research 18
Step 5: Research Analysis: Establishing Baseline Estimates 20
Step 6: Market Forecast and Analysis 21
Step 7: Identify Strategic Opportunities 23
Step 8: Final Review and Market Release 24
Step 9: Customer Feedback and Market Monitoring 25
DISEASE OVERVIEW 26
2.1 INTRODUCTION 26
2.1.1 Types of Diabetes 26
2.1.2 Diabetes Complications 28
2.1.3 Risk Factors Associated with Type 1 and Type 2 Diabetes 30
2.1.4 Signs and Symptoms 31
2.1.5 Diabetes Monitoring 33
2.1.6 Treatment 35
2.1.7 Drug Delivery Systems 36
CONTINUOUS GLUCOSE MONITORING MARKET 38
3.1 INTRODUCTION 38
3.2 MARKET OVERVIEW 40
3.3 MARKET ANALYSIS AND FORECAST 44
3.3.1 Total Personal Continuous Glucose Monitoring Market 44
3.3.1.1 Personal Continuous Glucose Monitoring Receiver Market 48
3.3.1.2 Personal Continuous Glucose Monitoring Transmitter Market 50
3.3.1.3 Personal Continuous Glucose Monitoring Sensor Market 53
3.3.2 Total Professional Continuous Glucose Monitoring Market 55
3.3.2.1 Professional Continuous Glucose Monitoring System Market 59
3.3.2.2 Professional Continuous Glucose Monitoring Transmitter Market 61
3.3.2.3 Professional Continuous Glucose Monitoring Sensor Market 63
3.3.3 Emerging Markets: Non-Invasive CGM 65
3.4 DRIVERS AND LIMITERS 66
3.4.1 Market Drivers 66
3.4.2 Market Limiters 68
3.5 COMPETITIVE MARKET SHARE ANALYSIS 70
ABBREVIATIONS 74
Chart 1 1: Diabetes Monitoring, Treatment and Drug Delivery Market by Segment, U.S., 2013 – 2023 3
Chart 1 2: Diabetes Monitoring, Treatment and Drug Delivery Market Overview, U.S., 2013 &2023 3
Chart 3 1: Continuous Glucose Monitoring Market by Segment, U.S., 2013 – 2023 42
Chart 3 2: Continuous Glucose Monitoring Market Breakdown, U.S., 2016 43
Chart 3 3: Continuous Glucose Monitoring Market Breakdown, U.S.,2023 43
Chart 3 4: Total Personal Continuous Glucose Monitoring Market by Segment, U.S., 2013 – 2023 46
Chart 3 5: Total Personal Continuous Glucose Monitoring Market Breakdown, U.S., 2016 47
Chart 3 6: Total Personal Continuous Glucose Monitoring Market Breakdown, U.S.,2023 47
Chart 3 7: Personal Continuous Glucose Monitoring Receiver Market, U.S., 2013 – 2023 49
Chart 3 8: Personal Continuous Glucose Monitoring Transmitter Market, U.S., 2013 – 2023 52
Chart 3 9: Personal Continuous Glucose Monitoring Sensor Market, U.S., 2013 – 2023 54
Chart 3 10: Total Professional Continuous Glucose Monitoring Market by Segment, U.S., 2013 – 2023 57
Chart 3 11: Total Professional Continuous Glucose Monitoring Market Breakdown, U.S., 2016 58
Chart 3 12: Total Professional Continuous Glucose Monitoring Market Breakdown, U.S.,2023 58
Chart 3 13: Professional Continuous Glucose Monitoring System Market, U.S., 2013 – 2023 60
Chart 3 14: Professional Continuous Glucose Monitoring Transmitter Market, U.S., 2013 – 2023 62
Chart 3 15: Professional Continuous Glucose Monitoring Sensor Market, U.S., 2013 – 2023 64
Chart 3 16: Leading Competitors, Continuous Glucose Monitoring Market, U.S., 2016 73
Figure 1 1: Diabetes Monitoring, Treatment and Drug Delivery Market Share Ranking by Segment, U.S., 2016 (1 of 2) 4
Figure 1 2: Diabetes Monitoring, Treatment and Drug Delivery Market Share Ranking by Segment, U.S., 2016 (2 of 2) 5
Figure 1 3: Companies Researched in this Report, U.S., 2016 6
Figure 1 4: Factors Impacting the Diabetes Monitoring, Treatment and Drug Delivery Market by Segment, U.S. (1 of 2) 7
Figure 1 5: Factors Impacting the Diabetes Monitoring, Treatment and Drug Delivery Market by Segment, U.S. (2 of 2) 8
Figure 1 6: Recent Events in the Diabetes Monitoring, Treatment and Drug Delivery Market, U.S., 2013 – 2016 9
Figure 1 7: Diabetes Monitoring, Treatment and Drug Delivery Markets Covered, U.S., 2016 10
Figure 1 8: Procedure Codes Investigated, U.S., 2016 10
Figure 1 9: Diabetes Monitoring, Treatment and Drug Delivery Markets Covered, U.S., 2016 (1 of 2) 11
Figure 1 10: Diabetes Monitoring, Treatment and Drug Delivery Markets Covered, U.S., 2016 (2 of 2) 12
Figure 1 11: Key Report Updates 13
Figure 1 12: Version History 13
Figure 2 1: Major Types of Diabetes and Related Pathologies, U.S., 2016 27
Figure 2 2: Risk Factors Associated with Type 1 and Type 2 Diabetes, U.S., 2016 31
Figure 2 3: Signs and Symptoms Associated with Type 1 and Type 2 Diabetes, U.S., 2016 32
Figure 3 1: Continuous Glucose Monitoring Market by Segment, U.S., 2013 – 2023 (US$M) 41
Figure 3 2: Total Personal Continuous Glucose Monitoring Market by Segment, U.S., 2013 – 2023 (US$M) 45
Figure 3 3: Personal Continuous Glucose Monitoring Receiver Market, U.S., 2013 – 2023 48
Figure 3 4: Personal Continuous Glucose Monitoring Transmitter Market, U.S., 2013 – 2023 51
Figure 3 5: Personal Continuous Glucose Monitoring Sensor Market, U.S., 2013 – 2023 53
Figure 3 6: Total Professional Continuous Glucose Monitoring Market by Segment, U.S., 2013 – 2023 (US$M) 56
Figure 3 7: Professional Continuous Glucose Monitoring System Market, U.S., 2013 – 2023 59
Figure 3 8: Professional Continuous Glucose Monitoring Transmitter Market, U.S., 2013 – 2023 61
Figure 3 9: Professional Continuous Glucose Monitoring Sensor Market, U.S., 2013 – 2023 63
Figure 3 10: Drivers and Limiters, Continuous Glucose Monitoring Market, U.S., 2016 69
Figure 3 11: Leading Competitors, Continuous Glucose Monitoring Market, U.S., 2016 72
Sanofi
Novo Nordisk
Eli Lilly
Medtronic
Johnson & Johnson
Becton Dickinson
Abbott
Roche
DexCom
Ascensia
Insulet
Trividia Health
Tandem
Nova Biomedical
Valeritas
