Point-of-care Biosensors Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Glucose Monitoring, HIV, Hepatitis C, Pregnancy), By Platforms (Microfluidics, Dipsticks, Immunoassays), By End User (Hospitals & Clinics, Pharmacy, Others) Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 81.56 Billion
CAGR (2026-2031)	8.11%
Fastest Growing Segment	Glucose Monitoring
Largest Market	North America
Market Size (2031)	USD 130.22 Billion

Market Overview

The Global Point-of-care Biosensors Market will grow from USD 81.56 Billion in 2025 to USD 130.22 Billion by 2031 at a 8.11% CAGR. Point-of-care biosensors are analytical devices designed to convert a biological response into a measurable signal, enabling immediate diagnostic testing near the patient rather than in centralized laboratories. The market expansion is fundamentally supported by the rising incidence of chronic conditions which necessitates frequent monitoring and rapid clinical decision making. According to the International Diabetes Federation, in 2024, approximately 589 million adults were living with diabetes globally, creating a substantial demand for portable glucose testing solutions. Furthermore, the ongoing decentralization of medical services from hospitals to home care settings continues to drive the adoption of these convenient diagnostic tools.

However, a significant barrier to market expansion involves the stringent and complex regulatory approval processes required by health authorities. Manufacturers often encounter prolonged product development cycles and increased compliance costs when navigating these rigorous standards, which can delay the commercialization of new diagnostic devices and impede their availability to the broader healthcare sector.

Key Market Drivers

The integration of biosensors with smartphones and wearable devices is fundamentally reshaping the market by facilitating continuous physiological monitoring and seamless data transmission. This technological convergence allows patients to track critical biomarkers in real-time, thereby reducing the necessity for frequent hospital visits and enabling proactive health management. The commercial viability of this trend is evident in the strong performance of leading continuous monitoring platforms. According to Abbott, October 2024, in the 'Third Quarter 2024 Financial Results', worldwide sales for the FreeStyle Libre continuous glucose monitoring system reached 1.6 billion USD. Such widespread adoption underscores how connectivity and user-friendly interfaces are accelerating the shift from episodic testing to longitudinal health tracking, securing a pivotal role for these devices in modern medical infrastructure.

Simultaneously, the rising prevalence of infectious diseases compels global healthcare systems to prioritize rapid point-of-care testing for immediate detection and containment. Efficient diagnostic tools are essential for managing outbreaks and initiating timely treatment protocols, particularly in resource-limited settings where laboratory access is restricted. According to the World Health Organization, October 2024, in the 'Global Tuberculosis Report 2024', an estimated 10.8 million people fell ill with tuberculosis worldwide in 2023, highlighting the critical need for accessible screening mechanisms. To support the infrastructure required for such extensive testing capabilities, significant industry consolidation and investment are occurring. For instance, according to Roche, in 2023, the company entered an agreement to acquire LumiraDx's point-of-care technology platform for a purchase price of 295 million USD, aiming to expand decentralized diagnostic offerings.

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Key Market Challenges

The stringent and complex regulatory approval processes imposed by health authorities significantly hamper the growth of the Global Point-of-care Biosensors Market. These rigorous standards create extended product development cycles, forcing manufacturers to navigate intricate compliance pathways that delay the introduction of innovative diagnostic tools. Consequently, companies face substantial financial burdens and must divert critical resources toward administrative compliance rather than research and development. This diversion slows the commercialization of new devices and limits their immediate availability to healthcare providers who require rapid testing solutions, thereby stalling the overall momentum of the sector.

This regulatory unpredictability directly impacts strategic decision-making and discourages manufacturers from prioritizing certain markets for new product launches. The high cost and uncertainty associated with obtaining certifications reduce the speed at which essential technologies reach patients. According to MedTech Europe, in 2024, the selection of the European Union as the first launch geography for new medical devices dropped by 40% for large manufacturers compared to previous regulatory frameworks. This decline illustrates how regulatory barriers actively impede market expansion and restrict the global accessibility of advanced point-of-care biosensors.

Key Market Trends

The development of multiplexing capabilities for simultaneous multi-analyte detection is significantly impacting the sector by enabling the diagnosis of overlapping conditions in a single test run. This trend is vital in respiratory diagnostics, where syndromic panels distinguishing between COVID-19, influenza, and RSV replace single-target assays to streamline patient management. The demand for such comprehensive solutions is substantial as providers seek efficiency in differentiating pathogens with similar symptoms. According to Danaher Corporation, October 2024, in the 'Third Quarter 2024 Results', revenue for Cepheid’s respiratory diagnostics, which include these multiplexed assays, reached 425 million USD. This adoption highlights how simultaneous detection is becoming a standard of care for infectious disease management.

The adoption of microfluidic and lab-on-a-chip technologies for miniaturization is driving market expansion by condensing complex workflows into portable cartridges. These systems manipulate minute fluid volumes to perform intricate molecular processes like PCR at the point of care, offering speed and accuracy comparable to central laboratories. This miniaturization allows for the deployment of highly sensitive tools in decentralized settings like urgent care clinics and physician offices. The commercial uptake of such platforms demonstrates this technological shift. According to bioMérieux, September 2024, in the 'First-Half 2024 Results', sales for the SPOTFIRE system, a microfluidic-based point-of-care solution, reached 33 million EUR. This underscores the role of lab-on-a-chip innovations in expanding diagnostic access.

Segmental Insights

The Glucose Monitoring segment is currently recognized as the fastest-growing category within the Global Point-of-care Biosensors Market. This rapid expansion is primarily driven by the escalating global prevalence of diabetes and a definitive shift towards personalized, home-based disease management. The widespread adoption of Continuous Glucose Monitoring (CGM) systems has revolutionized the sector by providing patients with real-time, actionable health data, significantly enhancing user convenience. Additionally, regulatory institutions such as the U.S. Food and Drug Administration continue to facilitate this momentum by granting approvals for innovative, user-friendly monitoring devices, thereby fostering greater market penetration and patient compliance.

Regional Insights

North America holds a dominant position in the Global Point-of-care Biosensors Market, driven by its highly developed healthcare infrastructure and the rising prevalence of chronic conditions such as diabetes and cardiovascular diseases. The region exhibits strong demand for rapid, self-testing diagnostic tools that enable effective patient monitoring outside of traditional hospital settings. This growth is substantially supported by the U.S. Food and Drug Administration (FDA), which provides a structured regulatory framework that ensures device safety while facilitating market access for new technologies. These factors collectively create a favorable environment for sustained industry expansion and investment.

Recent Developments

• In August 2025, Siemens Healthineers entered into a strategic agreement with Carna Health to enhance the detection and management of chronic kidney disease using point-of-care diagnostics. The collaboration involved integrating a proprietary artificial intelligence-enabled platform with the Siemens Healthineers epoc Blood Analysis System to facilitate rapid testing in decentralized settings. This partnership aimed to improve patient outcomes in underserved populations by streamlining clinical workflows and enabling earlier disease identification through portable biosensor technologies. The initiative highlighted the increasing focus on deploying advanced diagnostic tools outside traditional laboratory environments to address critical global health challenges effectively.
• In November 2024, Dexcom announced a strategic partnership with Oura, a prominent smart ring manufacturer, which included a $75 million investment in the partner company. The collaboration focused on integrating data from Dexcom’s continuous glucose biosensors with the vital sign metrics collected by the Oura Ring, such as sleep patterns and physical activity levels. This joint effort aimed to provide users with a comprehensive view of their metabolic health by correlating glucose fluctuations with daily lifestyle factors. The partnership underscored the growing industry trend of combining different wearable biosensor platforms to deliver personalized health insights to consumers.
• In July 2024, Roche completed the acquisition of the point-of-care technology platform from LumiraDx, following the receipt of all necessary regulatory approvals. This strategic transaction allowed Roche to integrate an innovative multi-assay biosensor system into its global diagnostics portfolio, which supports testing for various clinical conditions on a single portable instrument. The acquisition was designed to expand the company's presence in decentralized healthcare settings and improve patient access to timely diagnostic results worldwide. The move consolidated Roche's position in the rapidly evolving market for rapid diagnostic solutions and distributed testing capabilities.
• In June 2024, Abbott received clearance from the U.S. Food and Drug Administration for two new over-the-counter continuous glucose monitoring systems, expanding its portfolio in the consumer biowearable market. The newly approved devices included a system designed for general health and wellness tracking and another specifically tailored for adults with Type 2 diabetes who do not use insulin. These launches utilized the company's established biosensor technology to provide real-time glucose data directly to consumer smartphones. This regulatory milestone marked a significant shift towards making biosensor-based metabolic monitoring accessible to a broader population without the need for a prescription.

Key Market Players

• Abbott Laboratories Inc.
• Koninklijke Philips N.V.
• Accubiotech Co, Ltd.
• ACON Laboratories, Inc
• Becton, Dickinson and Company
• Biolytical Laboratories Inc.
• Danaher Corporation
• Siemens Healthineers AG
• Meridian Bioscience, Inc
• GE HealthCare Technologies Inc.

By Product	By Platforms	By End User	By Region
Glucose Monitoring HIV Hepatitis C Pregnancy	Microfluidics Dipsticks Immunoassays	Hospitals & Clinics Pharmacy Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Point-of-care Biosensors Market, By Product:

• Glucose Monitoring
• HIV
• Hepatitis C
• Pregnancy

• Point-of-care Biosensors Market, By Platforms:

• Microfluidics
• Dipsticks
• Immunoassays

• Point-of-care Biosensors Market, By End User:

• Hospitals & Clinics
• Pharmacy
• Others

• Point-of-care Biosensors 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