Point-of-Care Glucose Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Point-of-Care Glucose Testing Market is projected to expand from USD 3.62 Billion in 2025 to USD 4.68 Billion by 2031, reflecting a compound annual growth rate of 4.37%. This market sector comprises diagnostic instruments and consumables designed to deliver immediate blood sugar analysis at the point of care, encompassing hospitals, clinics, and home healthcare settings. Growth is primarily underpinned by the escalating prevalence of lifestyle-induced metabolic disorders and a rapidly aging global population that requires frequent health monitoring. These foundational drivers are distinct from technological trends, representing structural demographic and epidemiological shifts that necessitate 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.

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, creating a sustained demand for personal diagnostic instruments and reinforcing the market's trajectory towards decentralized care.

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.

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.

Key Players Profiled in the Point-of-Care Glucose Testing Market

• 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

Report Scope

In this report, the Global Point-of-Care Glucose Testing Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Point-of-Care Glucose Testing Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.