Point-of-Care Glucose Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Accu Check Aviva Meter, Onetouch Verio Flex, i-STAT, Bayer CONTOUR Blood Glucose Monitoring System, Freestyle Lite, True Metrix, Accu-Chek Inform II, StatStrip, Others), By Region, and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.62 Billion
CAGR (2026-2031)	4.37%
Fastest Growing Segment	Accu-Chek Inform II
Largest Market	North America
Market Size (2031)	USD 4.68 Billion

Market Overview

The Global Point-of-Care Glucose Testing Market will grow from USD 3.62 Billion in 2025 to USD 4.68 Billion by 2031 at a 4.37% CAGR. The Global Point-of-Care Glucose Testing Market comprises diagnostic instruments and consumables designed to provide immediate blood sugar analysis at the site of patient care, encompassing hospital, clinic, and home healthcare settings. The market is primarily supported by the escalating prevalence of lifestyle-induced metabolic disorders and a rapidly aging global population that requires frequent health monitoring. These fundamental drivers are distinct from technological trends as they represent the structural demographic and epidemiological shifts necessitating decentralized and rapid diagnostic solutions to alleviate the burden on central laboratory infrastructure.

However, a significant challenge impeding broader market expansion is the stringent regulatory framework governing device accuracy and performance standards which creates high barriers to entry for manufacturers. These rigorous compliance requirements can delay product approvals and increase development costs, thereby limiting the speed at which new solutions reach the consumer. According to the 'International Diabetes Federation', in '2024', approximately 589 million adults worldwide were estimated to be living with diabetes. This substantial disease burden underscores the critical necessity for accessible and compliant testing modalities despite the operational difficulties imposed by regulatory pressures.

Key Market Drivers

Technological Advancements in Continuous Glucose Monitoring Systems are fundamentally reshaping the Global Point-of-Care Glucose Testing Market by replacing episodic capillary blood checks with real-time, sensor-based tracking. These innovations significantly enhance patient compliance and clinical outcomes through features like predictive alerts, extended sensor wear-time, and seamless smartphone integration, which collectively reduce the invasiveness of daily management. The commercial impact of this technological shift is evident in the rapid growth of sensor-based platforms. According to Abbott, October 2024, in the 'Third Quarter 2024 Financial Results', sales of the FreeStyle Libre continuous glucose monitoring system reached $1.6 billion, demonstrating the substantial market appetite for these advanced diagnostic technologies. This surge underscores the critical role of user-friendly innovation in driving the expansion of the point-of-care landscape.

Concurrently, the Rising Adoption of Home-Based Self-Monitoring Solutions is broadening market access as healthcare systems decentralize chronic disease management to alleviate hospital burdens. This structural shift is heavily accelerated by the economic necessity of managing the condition's escalating financial impact, incentivizing the widespread deployment of cost-effective, patient-operated testing devices. The viability of this patient-centric model is reflected in the performance of major home-care device providers; according to Dexcom, October 2024, in the 'Third Quarter 2024 Financial Results', quarterly revenue reached $994.2 million, driven largely by the uptake of self-monitoring biosensors. This transition is further supported by the expanding patient pool requiring frequent monitoring; according to the World Health Organization, in November 2024, the number of adults living with diabetes worldwide surpassed 800 million. This vast demographic creates a sustained demand for personal diagnostic instruments, reinforcing the market's trajectory towards decentralized care.

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Key Market Challenges

The stringent regulatory framework governing device accuracy and performance standards stands as a primary obstacle hampering the growth of the Global Point-of-Care Glucose Testing Market. Manufacturers must navigate complex compliance protocols and conduct extensive clinical trials to meet rigorous safety benchmarks. This demanding process creates substantial barriers to entry, inflating development costs and extending the timeline required to bring new products to commercial realization. These operational hurdles discourage smaller innovators from entering the sector and slow the pace at which testing solutions become available to consumers.

Consequently, the market struggles to scale rapidly enough to address the escalating global demand for decentralized monitoring. The disconnect between the urgent need for accessible diagnostic tools and the slow rate of regulatory approval restricts the availability of cost-effective options. According to the 'World Health Organization', in '2024', the number of adults living with diabetes worldwide surpassed 800 million. This magnitude of disease burden highlights the critical gap where regulatory delays prevent the market from fully capitalizing on the expanding patient base that requires immediate glucose analysis.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning for Predictive Analytics is moving glucose monitoring from reactive to proactive. Algorithms now analyze historical patterns to forecast fluctuations, enabling preventative interventions critical for decision support systems. This capability enhances clinical utility by identifying adverse events before they occur, a feature increasingly demanded in precision medicine. According to JMIR Medical Informatics, May 2024, in the study 'Generalization of a Deep Learning Model for Continuous Glucose Monitoring–Based Hypoglycemia Prediction', a deep learning model based on long short-term memory networks achieved an Area Under the Curve of 96.40% for predicting severe hypoglycemia. This predictive accuracy allows manufacturers to deploy reliable automated alerts, increasing user trust in next-generation platforms.

The Emergence of Over-the-Counter Continuous Glucose Biosensors is structurally shifting accessibility by decoupling technology from prescription requirements. This trend targets the massive demographic managing metabolic health through lifestyle modifications rather than insulin. By removing regulatory friction, manufacturers are expanding their addressable market beyond the core Type 1 diabetes population to include pre-diabetics and wellness users. According to Dexcom, March 2024, in the press release 'Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter', there are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from this technology. This non-prescription expansion facilitates earlier intervention, significantly broadening the sector's commercial scope.

Segmental Insights

The Accu-Chek Inform II segment is recognized as the fastest growing category in the Global Point-of-Care Glucose Testing Market, fueled by the rising necessity for connected hospital systems. Medical facilities are increasingly implementing this solution because its wireless capabilities facilitate immediate data transfer to electronic health records, significantly streamlining clinical workflows and reducing manual errors. Moreover, the device’s alignment with rigorous accuracy benchmarks, such as those established by the International Organization for Standardization, ensures patient safety and data reliability. These factors drive its accelerated uptake among healthcare providers seeking efficient, compliant, and integrated diagnostic tools.

Regional Insights

North America maintains the leading position in the Global Point-of-Care Glucose Testing Market due to the rising prevalence of diabetes and broad healthcare coverage. The dominance of this region is supported by favorable reimbursement policies that facilitate patient access to testing devices. Additionally, the U.S. Food and Drug Administration (FDA) ensures a structured approval process for medical devices, which encourages the introduction of compliant products. The presence of established healthcare systems and high awareness regarding diabetes management further reinforces North America as the primary market for these testing solutions.

Recent Developments

• In October 2024, a major diabetes care company launched the world’s first continuous glucose monitoring system approved by the FDA to operate for one full year with a single sensor. This breakthrough long-term device was designed to address the inconvenience of traditional sensors that require replacement every one to two weeks. The system utilized a tiny sensor implanted under the skin of the upper arm, paired with a removable transmitter that sent real-time glucose readings to a mobile application. This innovation provided adults with Type 1 and Type 2 diabetes a more consistent and durable monitoring solution, significantly reducing the frequency of sensor insertions and enhancing daily convenience.
• In June 2024, a global healthcare leader obtained U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems based on its proprietary sensing technology. One system was developed for adults with Type 2 diabetes who do not use insulin, offering a specific measurement range to detect high and low glucose events essential for managing the condition through lifestyle changes. The second device was introduced as a consumer biowearable intended for general wellness, providing users with personalized coaching and metabolic insights. These launches represented a strategic expansion of the company's portfolio, making continuous glucose monitoring accessible to a broader population beyond prescription-only models.
• In May 2024, a prominent manufacturer of diagnostic devices announced the commercial launch of its next-generation hospital glucose meter system in the United States. This advanced point-of-care testing platform was engineered to meet the rigorous demands of critical care settings, featuring a Linux-based operating system for enhanced cybersecurity and a ruggedized design resistant to harsh disinfectants. The system retained the use of test strips that were the only ones cleared by the FDA for testing critically ill patients, ensuring freedom from clinical interferences. New capabilities included wireless charging and RFID data entry, significantly improving workflow efficiency and security for healthcare professionals managing bedside glucose testing.
• In March 2024, a leading medical technology company received clearance from the U.S. Food and Drug Administration for the first glucose biosensor available for use without a prescription. This new over-the-counter device was designed specifically for individuals aged 18 and older who do not use insulin, such as those treating Type 2 diabetes with oral medications. The system featured a wearable sensor applied to the back of the upper arm that transmitted glucose data directly to a smartphone application. By eliminating the need for a physician's order, the company aimed to expand access to continuous monitoring technology for approximately 25 million people in the United States who manage diabetes without insulin.

Key Market Players

• F. Hoffmann-La Roche Ltd
• Abbott Laboratories Inc.
• Nipro Corporation
• Lifescan, Inc.
• Nova Biomedical Corporation
• ACON Laboratories Inc.
• Trividia Health, Inc.
• Prodigy Diabetes Care, LLC
• Ascensia Diabetes Care Holdings AG
• EKF Diagnostics Holdings PLC

By Product Type	By Region
Accu Check Aviva Meter Onetouch Verio Flex i-STAT Bayer CONTOUR Blood Glucose Monitoring System Freestyle Lite True Metrix Accu-Chek Inform II StatStrip Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Point-of-Care Glucose Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Point-of-Care Glucose Testing Market, By Product Type:

• Accu Check Aviva Meter
• Onetouch Verio Flex
• i-STAT
• Bayer CONTOUR Blood Glucose Monitoring System
• Freestyle Lite
• True Metrix
• Accu-Chek Inform II
• StatStrip
• Others

• Point-of-Care Glucose Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE