U.S. Blood Glucose Monitoring System Market Size, Share & Share & COVID-19 Impact Analysis, By Device Type (Continuous Glucose Monitoring System and Self-monitoring Blood Glucose System), By Type (Non-invasive and Invasive), By Modality (Wearable and Non-wearable), By Patient Type (Type 1 Diabetes and Type 2 Diabetes), By Distribution Channel (Institutional Sales and Retail Sales), and Forecast, 2023-2030

The U.S. blood glucose monitoring system market size was valued at USD 6.26 billion in 2022 and is projected to grow from USD 6.82 billion in 2023 to USD 12.94 billion by 2030, exhibiting a CAGR of 9.6% during the forecast period.

Blood glucose monitoring systems are medical devices used to monitor the blood glucose levels in individuals, especially type 1 and type 2 diabetic patients. These devices can provide accurate, quick glucose levels in the blood that can be used to make therapeutic decisions on the basis of the sugar level.

The rising prevalence of diabetes among the general population globally and rising awareness regarding the complications associated with higher blood glucose levels are significant factors contributing to the increasing adoption of these devices in the market.

• According to a 2021 report published by the Centers for Disease Control and Prevention (CDC), around 37.3 million people in the U.S. have diabetes, which is about 11.3% of the U.S. population, among which 28.7 million people are diagnosed.

Along with this, the rising focus of the market players to develop and introduce novel products to cater for the demand from the population is another important factor supporting the growth of the market.

However, the higher cost of the blood glucose monitoring system and delays in product approvals and launches in the U.S. market compared to other markets are a few major reasons limiting the market growth.

COVID-19 IMPACT

Rise in Demand for Remote Monitoring Devices Amid the Pandemic Fueled the Market Growth

The COVID-19 pandemic had an overall positive impact on the U.S. blood glucose monitoring system market. The increased demand for home monitoring devices among the population was one of the major factors that contributed to the market's growth during the COVID-19 pandemic.

• For instance, Abbott reported that the FreeStyle Libre users globally increased to 3.5 million in 2020 from 2.1 million in 2019, witnessing a growth of around 66.7%.

The increased focus and efforts of several healthcare organizations and market players toward strong initiatives to cater to the rising demand for these devices through strategic partnerships and mergers was another major factor that supported the growth of the market during the period.

The major market players witnessed growth in 2020 compared to the previous year, owing to higher demand for these devices among the patient population.

• Dexcom, Inc. generated a revenue of USD 1,509.5 million in 2020, witnessing a growth of 30.0% as compared to the previous year.

The increasing prevalence of diabetes among the general population, along with the rising number of product approvals and launches in the U.S. market by key players, is expected to fuel the U.S. blood glucose monitoring system market growth.

LATEST TRENDS

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Shifting Preference toward CGM Systems Among the Population 

Increasing awareness among the population regarding the benefits of the Continuous Glucose Monitoring (CGM) system, such as minimally invasive, speedy and accurate results, and pain-free, among others, is a factor resulting in shifting preference toward these devices for users’ blood glucose monitoring.

Along with this, the rising number of potential products receiving CE mark approvals and being launched in European countries is shifting the focus of the U.S. manufacturers toward the development and introduction of these devices to cater to the rising demand for these devices among the patient population in the country.

• In July 2020, Nemaura Medical Inc. filed a PMA application with the U.S. FDA for its product, SugarBeat, a disposable adhesive skin patch for continuous monitoring system, which generated USD 74,027 in the third quarter of 2022 in Europe.

Thus, the rising penetration of these devices among the patient population owing to the shifting preference of patients to use continuous glucose monitoring systems is an upcoming trend observed in the market.

DRIVING FACTORS

Growing Prevalence of Diabetes and Awareness Among the U.S. Population to Surge Demand

The growing prevalence of diabetes (type 1 and type 2) among the U.S. population is a major factor resulting in rising patient population. This, along with growing awareness initiatives by market players and government authorities, is surging the demand for blood glucose monitoring devices among the patient population.

• According to a 2021 report published by the Centers for Disease Control and Prevention (CDC), around 37.3 million people in the U.S. have diabetes which is about 11.3% of the U.S. population, among which 28.7 million people are diagnosed.

The increasing collaborations among public and private players and government bodies in the country to raise awareness among the general population regarding diabetes, diagnosis, and management of the condition is another important factor leading to a growing patient population with the rising demand for monitoring devices.

• For instance, in August 2022, Abbott partnered with WW International Inc. to integrate WW International Inc.’s diabetes-tailored weight management program with Abbott’s FreeStyle Libre product portfolio. The partnership is aimed toward helping people with diabetes understand and manage the condition in a better way.

Along with this, there is rising R&D activities of the market players to receive approvals for their new products in the country to improve the accessibility among patients.

Rising Technological Advancements to Accelerate the Demand for Blood Glucose Monitoring Systems

The growing diabetic patient population, along with rising awareness regarding the devices and their benefits, is resulting in the rising focus of market players on technological advancements of blood glucose monitoring devices.

Recent advancements in Blood Glucose Monitoring (BGM) devices, such as remote monitoring of the blood glucose level via smartphones and apps, small and discreet sensors with wireless monitors for real-time monitoring of the levels, and digital patches, among others, enable personalized fits to the rising demand of diabetic patients and improving the accessibility and management of the condition in the U.S.

• For instance, recent advancement in Abbott’s FreeStyle Libre 2 system, a 14-day wearable device with optional alarms, allows the user to scan for a real-time reading on high, low, and urgent low level alarms for blood glucose. The product also has a feature that automatically delivers continuous real-time glucose readings to the smartphone via the mobile application.

Similarly, long-term versions of continuous glucose monitoring systems that can monitor blood sugar for more days once implanted is another major factor driving the adoption of these devices as it increases usability and reduces the high cost associated with the management among patients.

Thus, robust efforts of the market players and research institutes, along with constant support of the regulatory bodies, government, and other national organizations, are expected to spur the demand for these devices among the population in the country during the forecast period.

RESTRAINING FACTORS

Delay in Product Launches in the U.S. to Hinder the Market Growth

The U.S. FDA and other regulatory bodies collectively approve medical devices after strict adherence to the policies and guidelines established by these bodies.

This is a crucial factor limiting the easy approvals and introduction of medical devices in the U.S. market compared to other countries. Before their introduction in the U.S. market, blood glucose monitoring devices must present data on safety and accuracy through clinical trials.

On the other hand, the number of products receiving CE mark approval is rising, leading to blood glucose monitoring systems being launched in the European market compared to the U.S. market. This is resulting in the growing penetration of these devices in European countries.

• For instance, in December 2021, Nemaura Medical Inc. launched its non-invasive product, SugarBeat, in the U.K. with CE mark approval. However, the company filed a PMA with the U.S. FDA in 2020, which is under review by the regulatory authority,

Therefore, these factors leading to delayed approvals and launches of the products in the U.S. market are anticipated to hamper the market growth.

SEGMENTATION

By Device Type Analysis

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Continuous Glucose Monitoring Segment to Dominate Due to Rising Penetration

Based on device type, the market is segmented into continuous glucose monitoring system and self-monitoring blood glucose system.

The continuous glucose monitoring system segment dominated the market in 2022. The rising penetration of the devices among the diabetic population is one of the major factors supporting the segment's growth.

Also, rising initiatives by governments and market players to expand coverage for this system in the country to increase the adoption of the devices is another major factor contributing to the segment's growth.

• According to CMS, Medicare covered CGM devices under the Durable Medical Equipment (DME) benefit, which covered only non-adjunctive devices since 2017. In February 2022, CMS determined that both non-adjunctive and adjunctive devices may be classified as DME, thus expanding the coverage of these devices to improve their accessibility and adoption in the country.

The Self-monitoring Blood Glucose (SMBG) system segment is expected to lose market share during the forecast period. A few limitations associated with the devices, such as discomfort due to pain and the need for finger pricks several times a day, are some factors hindering the adoption of these devices among the population.

By Type Analysis

Invasive Segment Dominated the Market Owing to Rising Number of Product Approvals & Launches

On the basis of type, the market is segmented into invasive and non-invasive.

The invasive segment dominated the market in 2022. Increasing efforts of regulatory authorities to expand reimbursement policies are expected to lead to higher penetration and adoption of this invasive blood glucose monitoring system in the market. Moreover, the rising number of product approvals and launches in the market by key players operating is another crucial factor to fuel the adoption.

• In December 2022, Dexcom, Inc. received the U.S. FDA clearance for Dexcom G7, a continuous glucose monitoring system, which aids in lowering A1C (glycated hemoglobin) and also manages hyper and hypoglycemic conditions.

The non-invasive segment is expected to grow at a higher CAGR during the forecast period. The growth is majorly due to increasing R&D activities of the market players to develop and introduce products using novel technologies such as Raman spectroscopy, ultrasonic, radiofrequency, and others.

• In January 2023, Know Labs, Inc., an emerging developer of non-invasive medical diagnostic technology, received a new foundational patent titled “High-Performance Glucose Sensor”. This unique patented technology is aimed at expanding the company’s product portfolio in the non-invasive segment.

By Modality Analysis

Wearable Segment Dominated the Market Owing to Rising Penetration of CGM Systems in the U.S.

On the basis of modality, the market is segmented into wearable and non-wearable.

The wearable segment is expected to grow at a higher CAGR during the forecast period. The CGM systems currently available in the market are wearable in nature. Thus, the rising penetration of these devices among the diabetic population is a contributing factor to the growth of the segment.

The non-wearable segment is expected to lose market share during the forecast period. However, several market players, including DiaMonTech AG (DMT Base), RSP Systems (GlucoBeam), and others are focusing on developing novel technologies to introduce products in the segment.

• In February 2022, DiaMonTech AG, a medtech start-up focused on non-invasive blood glucose monitors, announced a USD 5 million investment from Samsung ventures. The company plans to use this funding to accelerate its product development and expand its product “D-Pocket” to the U.S.

By Patient Type Analysis

Type 2 Diabetes Segment Dominated the Market Owing to Rising Penetration of Devices Among the Patient Population

On the basis of patient type, the market is segmented into type 1 diabetes and type 2 diabetes.

The type 2 diabetes segment dominated the market in 2022. The rising prevalence of the condition in the country is leading to an increasing patient pool requiring blood glucose level monitoring on a regular basis.

Along with this, the increasing focus on diagnosis and management of diabetes and improving reimbursement structure for these devices among type 2 diabetes patients are contributing factors to the growth of the segment in the market during the forecast period.

• According to a 2022 article published by the National Institute of Diabetes and Digestive and Kidney Diseases, the American Diabetes Association published the updated clinical practice standards for diagnosing and managing diabetes, which stated that adults should be screened for prediabetes and type 2 diabetes at the age of 35, instead of age 45, also focus on improving hypoglycemia awareness, and emphasize on training patients and caregivers in technologies.

On the other hand, the type 1 diabetes segment is expected to grow at a higher CAGR during the forecast period. The rising prevalence of the condition among the general population and increasing adoption of these devices to monitor blood glucose level to improve diabetic management are some of the major factors supporting the segment's growth.

By Distribution Channel Analysis

Retail Sales Segment Held the Largest Market Share due to Increasing Penetration in Homecare Settings

On the basis of distribution channel, the market is segmented into retail sales and institutional sales.

The retail sales segment dominated the market in 2022 and is expected to grow at a higher CAGR during the forecast period. The rising penetration of private-label brands in retail outlets at discounted prices is one of the factors likely to propel the growth of the retail sales segment.

This, along with increasing penetration of these devices among the patient population in the U.S. has led to increasing demand for these systems in home care settings. This has subsequently driven the sales of these devices through retail channels.

• For instance, in August 2022, Intuity Medical, Inc., a commercial-stage MedTech and digital health company, announced the availability of POGO Automatic, a BGM system, at more than 2,200 U.S. pharmacies of Kroger Health.

On the other hand, the institutional sales segment is expected to grow due to increasing collaborations of market players with hospitals to expand the availability of remote monitoring.

• According to a 2021 article published by American Diabetes Association (ADA), ADA partnered with Abbott to deliver 25,000 CGM sensors to hospitals nationwide to expand the availability and capability of non-invasive remote monitoring devices, including blood glucose monitors in inpatient hospital settings.

KEY INDUSTRY PLAYERS

Dexcom, Inc. Dominated the CGM System Market Owing to New Product Approvals & Launches

This market is consolidated with three major players operating in the market. DexCom Inc., Abbott, and Medtronic are the major and currently the only players offering CGMs in the market.

Dexcom, Inc. dominated the U.S. blood glucose monitoring system market share in 2022. The rising focus of the company to introduce newer versions of the products to strengthen its product portfolio and its presence in the country are some of the major factors contributing to the company's rising share.

• In December 2022, Dexcom Inc. received the U.S. FDA approval for its next-generation Dexcom G7 Continuous Glucose Monitoring System for all types of diabetic patients.

Abbott and Medtronic are other major players operating in the market with a robust product portfolio in diabetes care, including blood glucose meters and monitoring systems. Abbott’s FreeStyle Libre 3 received the U.S. FDA approval for use by people aged four and above living with diabetes.

The U.S. self-monitoring blood glucose system is a consolidated market with a few major players, such as LifeScan IP Holdings, LLC, Abbott, F. Hoffmann-La Roche Ltd., and Ascensia Diabetes Care Holdings AG, dominating the market.

• In January 2022, F. Hoffmann-La Roche Ltd launched the Cobas pulse system in countries accepting the CE mark. This handheld blood glucose management device led to the expansion of the company’s product portfolio in the region.

Additionally, several other market players are focused on developing and introducing novel technologies with non-invasive CGM devices such as NEMAURA MEDICAL INC., Eker Design AS, and GlucoRx Limited., among others. Few players, such as DiamonTech AG, GlucoActive, KnowLabs, Inc., and others, are focusing on the introduction of newer SMBG devices with their products either under investigation or in the approval process, thereby contributing to the growing market in the U.S

Thus, rising effort of key players, such as Dexcom, Inc., Abbott, F. Hoffmann-La Roche Ltd., Medtronic, and others, to increase their penetration and market share in the U.S. is expected to boost the growth of the market.

LIST OF KEY COMPANIES PROFILED:

• Dexcom, Inc. (U.S.)


• Abbott (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Medtronic (Ireland)


• Senseonics (U.S.)


• Ascensia Diabetes Care Holdings AG (Switzerland)


• LifeScan IP Holdings, LLC (U.S.)


• Prodigy Diabetes Care, LLC (U.S.)


• GlucoTrack, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• November 2022 - Ascensia Diabetes Care Holdings AG launched GLUCOCONTRO, an online diabetes management and analytics platform in the U.S. This platform aids the user in analyzing diabetes data online and sharing it with their healthcare provider.


• October 2022 - Abbott launched the FreeStyle Libre 3 system in the U.S. This system automatically delivers minute glucose readings and provides accuracy in a wearable sensor.


• March 2022 - Dexcom, Inc. received breakthrough device designation from the FDA for using Dexcom CGM in hospital settings for continuously measuring glucose levels. Approval as a device designation demonstrated that the medical device holds the potential for effective treatment.   


• December 2021 - Medtronic announced that the U.S. CMS would expand Medicare coverage for all continuous glucose monitors, including adjunctive and non-adjunctive systems that integrate with Medtronic insulin pumps.


• September 2021 - LifeScan IP Holdings, LLC collaborated with Welldoc, a digital health company, in transforming chronic care. The collaboration aimed to integrate Welldoc’s chronic condition platform into the new OneTouch Solutions portal.

REPORT COVERAGE

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The research report provides a detailed market analysis. It focuses on key aspects such as market overview, market segmentation and analysis by device type, type, modality, patient type, and distribution channel, competitive landscape of the key players, and comparative analysis of the average prices of products. Besides this, it offers insights into market trends and highlights key industry developments. The report further includes a COVID-19 impact analysis of the market.

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