Point-of-care Biosensors Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Point-of-care Biosensors Market is projected to expand from USD 81.56 Billion in 2025 to USD 130.22 Billion by 2031, reflecting a CAGR of 8.11%. These biosensors serve as critical analytical tools that translate biological responses into measurable signals, facilitating immediate diagnostic testing near the patient instead of relying on centralized labs.

This growth is primarily underpinned by the increasing burden of chronic diseases, which require regular monitoring and swift clinical interventions. For instance, the International Diabetes Federation reported that around 589 million adults worldwide were living with diabetes in 2024, generating significant demand for portable glucose monitoring options. Additionally, the shift of healthcare services from hospital settings to home care environments further accelerates the adoption of these accessible diagnostic devices.

Despite these growth prospects, the market faces substantial obstacles due to the stringent and intricate regulatory approval procedures mandated by health authorities. Manufacturers frequently grapple with extended product development timelines and escalated compliance costs while adhering to these rigorous standards. Such challenges often postpone the commercialization of novel diagnostic devices and hinder their widespread availability within the healthcare sector.

Market Drivers

The convergence of biosensors with smartphones and wearable technology is transforming the market by enabling continuous physiological tracking and seamless data transfer. This integration empowers patients to monitor vital biomarkers in real-time, minimizing the need for frequent hospital visits and supporting proactive health management. The commercial success of this trend is highlighted by the robust performance of major monitoring platforms; for example, Abbott reported in its October 2024 financial results that worldwide sales for the FreeStyle Libre continuous glucose monitoring system hit USD 1.6 billion. This widespread usage demonstrates how connectivity and intuitive interfaces are driving the transition from sporadic testing to long-term health tracking, cementing these devices as essential components of modern medical infrastructure.

Concurrently, the increasing prevalence of infectious diseases is pushing global healthcare systems to emphasize rapid point-of-care testing for immediate detection and outbreak control. Effective diagnostic tools are crucial for managing infections and starting timely treatments, especially in resource-constrained areas with limited laboratory access. The World Health Organization's 'Global Tuberculosis Report 2024' estimated that 10.8 million people fell ill with tuberculosis globally in 2023, underscoring the urgent need for accessible screening methods. To build the necessary infrastructure for such extensive testing, the industry is seeing significant investment and consolidation, such as Roche's 2023 agreement to acquire LumiraDx's point-of-care platform for USD 295 million to broaden its decentralized diagnostic capabilities.

Market Challenges

The expansion of the Global Point-of-care Biosensors Market is significantly impeded by the rigorous and complicated regulatory approval processes enforced by health authorities. These strict standards result in prolonged product development cycles, compelling manufacturers to navigate complex compliance routes that delay the launch of innovative diagnostic tools. As a result, companies endure heavy financial costs and must allocate vital resources toward administrative requirements instead of research and development. This reallocation slows the commercialization of new devices and restricts their immediate availability to healthcare providers needing rapid testing solutions, thereby stalling the sector's overall progress.

Furthermore, this regulatory uncertainty influences strategic planning and deters manufacturers from prioritizing specific markets for new product introductions. The substantial costs and unpredictability linked to securing certifications decrease the pace at which critical technologies reach patients. According to MedTech Europe in 2024, the choice of the European Union as the primary launch region for new medical devices among large manufacturers fell by 40% compared to earlier regulatory frameworks. This statistic demonstrates how regulatory barriers actively hinder market growth and limit the global reach of advanced point-of-care biosensors.

Market Trends

The rise of multiplexing capabilities, which allow for the simultaneous detection of multiple analytes, is significantly influencing the sector by facilitating the diagnosis of co-existing conditions in a single test. This trend is particularly important in respiratory diagnostics, where syndromic panels that distinguish between COVID-19, influenza, and RSV are replacing single-target assays to improve patient management. There is substantial demand for these comprehensive solutions as healthcare providers look for efficiency in identifying pathogens with overlapping symptoms. Highlighting this shift, Danaher Corporation reported in October 2024 that revenue for Cepheid’s respiratory diagnostics, utilizing these multiplexed assays, reached USD 425 million, proving that simultaneous detection is becoming a standard practice in infectious disease management.

Additionally, the adoption of microfluidic and lab-on-a-chip technologies is driving market growth by shrinking complex laboratory workflows into portable cartridges. These systems handle minute fluid volumes to execute intricate molecular processes, such as PCR, at the point of care, delivering speed and accuracy similar to central laboratories. This miniaturization enables the deployment of highly sensitive diagnostic tools in decentralized locations like urgent care clinics and physician offices. The commercial success of these platforms reflects this technological evolution; for instance, bioMérieux reported in September 2024 that sales for its microfluidic-based SPOTFIRE system reached EUR 33 million, underscoring the importance of lab-on-a-chip innovations in widening diagnostic access.

Key Players Profiled in the Point-of-care Biosensors Market

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

Report Scope

In this report, the Global Point-of-care Biosensors Market has been segmented into the following categories:

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
• 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 Biosensors 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.