Point of Care Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Glucose Monitoring Products, Cardiometabolic Monitoring Products, Infectious Disease Testing Products, Coagulation Monitoring products, Covid-19 Test Products, Others), By Platform (Lateral Flow Assays, Dipsticks, Microfluidics, Molecular Diagnostics, Immunoassays), By Mode Of Purchase (Prescription Based Products, OTC Products), By End User (Hospitals & Clinics, Ambulatory Surgical Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 49.89 Billion
CAGR (2026-2031)	9.25%
Fastest Growing Segment	Lateral Flow Assays
Largest Market	North America
Market Size (2031)	USD 84.83 Billion

Market Overview

The Global Point of Care Diagnostics Market will grow from USD 49.89 Billion in 2025 to USD 84.83 Billion by 2031 at a 9.25% CAGR. Point of Care diagnostics are defined as medical testing activities performed in close proximity to the patient to provide rapid results outside of a central laboratory infrastructure. The primary drivers supporting the growth of this market include the rising global prevalence of chronic and infectious diseases which necessitate immediate clinical decision making to improve patient outcomes. Additionally, the increasing demand for decentralized healthcare services facilitates the widespread adoption of these testing solutions in non-hospital settings such as home care and remote clinics.

However, the market faces a significant challenge regarding stringent regulatory frameworks that impose substantial compliance costs and delay product commercialization. These complex approval processes create high financial barriers to entry for manufacturers seeking to introduce new technologies. According to MedTech Europe, in 2024, the average Notified Body fee for Quality Management System certification under the In Vitro Diagnostic Regulation was 108,307 euros. Such elevated operational expenses can impede innovation and restrict the expansion of the market by limiting the participation of smaller diagnostic developers.

Key Market Drivers

Technological innovations in microfluidics and biosensors are fundamentally reshaping the Global Point of Care Diagnostics Market by enabling laboratory-quality molecular testing at the patient's bedside. These advancements allow for the rapid detection of complex pathogens with high sensitivity, reducing the reliance on centralized infrastructure and accelerating treatment initiation. The integration of automated platforms has particularly surged, driven by the need for precise respiratory diagnostics that can be deployed outside of traditional hospital labs. According to Danaher Corporation, October 2024, in the 'Third Quarter 2024 Earnings Release', the company's Cepheid division reported that diagnostics revenue for respiratory products reached $425 million during the quarter. This robust performance highlights the critical role of advanced molecular technologies in sustaining market momentum and meeting the demand for decentralized testing solutions.

The rising global prevalence of chronic and infectious diseases further serves as a primary catalyst for market expansion, necessitating immediate clinical decision-making to mitigate severe health outcomes. As chronic conditions such as diabetes escalate, there is a growing dependency on continuous monitoring solutions that empower patient self-management and reduce the burden on emergency care facilities. According to Abbott, October 2024, in the 'Abbott Reports Third-Quarter 2024 Results' press release, sales in its Diabetes Care division grew by 19.1 percent on an organic basis, driven by the widespread adoption of continuous glucose monitoring systems. This demand for effective disease management tools underpins the broader resilience of the sector; according to Roche, in 2024, sales in the Diagnostics Division increased by 4 percent at constant exchange rates, reflecting sustained global demand for immunodiagnostic and clinical chemistry testing solutions.

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Key Market Challenges

Stringent regulatory frameworks impose substantial compliance costs and delay product commercialization, acting as a formidable obstruction to the growth of the Global Point of Care Diagnostics Market. These rigorous approval processes compel manufacturers to allocate extensive resources toward comprehensive clinical trials and detailed technical documentation, effectively diverting capital from research and development. This extensive compliance burden significantly prolongs the time-to-market for new testing solutions, creating a bottleneck that defers revenue generation. Consequently, the high financial and operational barriers discourage investment in novel technologies, particularly affecting smaller developers who lack the liquidity to sustain operations during extended non-revenue periods.

The impact of these regulatory hurdles is quantifiable in the reduced pace of innovation and market entry. When manufacturers face unpredictable certification timelines, they often delay or cancel product launches in key regions, directly stalling market expansion. According to MedTech Europe, in 2024, the preference for the European Union as the first launch geography dropped by 40% among large in vitro diagnostic manufacturers due to these implementation challenges. This statistic demonstrates a clear contraction in the deployment of new diagnostics, confirming that excessive regulatory demands are actively restricting the availability of essential medical testing and dampening overall market growth.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning for Automated Result Interpretation is fundamentally advancing the efficacy of the Global Point of Care Diagnostics Market by enhancing diagnostic accuracy and streamlining clinical workflows. These technologies are increasingly embedded into diagnostic platforms to automate the analysis of complex biological data, thereby minimizing human error and enabling non-specialized personnel to perform sophisticated testing in decentralized settings. This technological surge is substantiated by significant regulatory momentum; according to MedTech Dive, October 2024, in the 'The number of AI medical devices has spiked in the past decade' article, the U.S. Food and Drug Administration had authorized a cumulative total of 950 AI or machine learning-enabled medical devices as of August 2024. Such clearances allow manufacturers to deploy smart diagnostic tools that provide real-time clinical decision support, directly improving patient management at the point of care.

Simultaneously, the Rising Utilization of Point of Care Testing in Retail Clinics and Pharmacies is transforming healthcare delivery by establishing accessible "test-to-treat" pathways outside of traditional hospital infrastructure. Major pharmacy chains are aggressively expanding their healthcare service portfolios, integrating primary care clinics and diagnostic hubs directly into their retail footprints to capture the growing demand for convenient, walk-in medical services. This strategic pivot towards retail-based care is yielding substantial financial growth; according to Walgreens Boots Alliance, October 2024, in the 'Fiscal Year 2024 Earnings' report, the company's U.S. Healthcare segment generated fourth-quarter sales of $2.1 billion, representing an increase of 7.1 percent compared to the prior year. This expansion underscores the increasing consumer preference for decentralized testing locations that offer immediate diagnostic results and seamless connection to treatment protocols.

Segmental Insights

Lateral Flow Assays are currently recognized as the fastest-growing segment in the Global Point of Care Diagnostics Market. This significant surge is primarily attributed to the rising global prevalence of infectious diseases and a paradigm shift toward decentralized, patient-centered healthcare. Regulatory authorities, including the U.S. Food and Drug Administration, have played a pivotal role by authorizing various over-the-counter diagnostic tests, thereby increasing market accessibility. Additionally, the segment’s growth is bolstered by the cost-efficiency and user-friendly nature of these devices, which allow for rapid decision-making in non-clinical environments.

Regional Insights

North America holds the leading position in the global point of care diagnostics market, driven by the rising prevalence of chronic conditions and an established healthcare infrastructure. The region benefits significantly from favorable reimbursement policies that support the widespread adoption of rapid testing solutions. Additionally, the U.S. Food and Drug Administration plays a critical role by streamlining product approvals, ensuring a steady introduction of compliant diagnostic tools. The concentration of key industry players and increased government initiatives focused on early disease detection further sustain North America’s dominance in this sector.

Recent Developments

• In January 2025, bioMérieux announced an agreement to acquire SpinChip Diagnostics, a Norwegian company specializing in point-of-care diagnostics. The collaboration focused on leveraging SpinChip’s innovative immunoassay platform, which was designed to deliver high-sensitivity results from whole blood samples in under 10 minutes. This technology combined the ease of use typical of near-patient testing with performance comparable to central laboratory instruments. The acquisition was intended to address critical needs in acute care settings, particularly for conditions such as myocardial infarction, by bringing precise diagnostic testing closer to the patient and significantly reducing turnaround times.
• In July 2024, Roche completed the acquisition of the Point of Care technology platform from LumiraDx. This strategic transaction integrated LumiraDx’s multi-assay technology into Roche’s diagnostics portfolio, enabling the consolidation of various immunoassay and clinical chemistry tests onto a single, user-friendly instrument. The acquisition aimed to enhance the company’s offerings in decentralized patient care and improve global access to timely diagnostic results in community-based healthcare settings. The integration included related research and development, commercial, and operational sites, positioning the company to further expand its capabilities into molecular testing in the future.
• In June 2024, Cepheid obtained De Novo marketing authorization from the U.S. Food and Drug Administration for its Xpert HCV test and GeneXpert Xpress System. This milestone marked the approval of the first point-of-care molecular test capable of detecting Hepatitis C virus RNA directly from a capillary whole blood fingerstick sample. The authorization enabled testing in decentralized settings such as substance use disorder treatment facilities and urgent care clinics, allowing for a diagnosis in about one hour. This development supported a test-and-treat approach, facilitating immediate linkage to care for patients during a single clinical visit.
• In April 2024, Abbott received clearance from the U.S. Food and Drug Administration for its i-STAT TBI cartridge to be used with whole blood. This regulatory approval allowed healthcare providers to assess patients with suspected concussions directly at the bedside and obtain lab-quality results in approximately 15 minutes. Previously, the test was restricted to plasma or serum samples, which necessitated time-consuming laboratory processing. The expansion to whole blood testing aimed to accelerate the evaluation of traumatic brain injuries and facilitate quicker clinical decision-making regarding the need for CT scans in healthcare settings lacking immediate laboratory access.

Key Market Players

• EKF Diagnostics
• Abbott Laboratories Inc.
• Siemens Healthineers Ag
• F. Hoffmann-La Roche Ltd
• Quidel Corporation
• Danaher Corporation
• Becton, Dickinson and Company
• Thermo Fisher Scientific Inc
• Biomérieux S.A.
• Chembio Diagnostics, Inc

By Product	By Platform	By Mode Of Purchase	By End User	By Region
Glucose Monitoring Products Cardiometabolic Monitoring Products Infectious Disease Testing Products Coagulation Monitoring products Covid-19 Test Products Others	Lateral Flow Assays Dipsticks Microfluidics Molecular Diagnostics Immunoassays	Prescription Based Products OTC Products	Hospitals & Clinics Ambulatory Surgical Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Point of Care Diagnostics Market, By Product:

• Glucose Monitoring Products
• Cardiometabolic Monitoring Products
• Infectious Disease Testing Products
• Coagulation Monitoring products
• Covid-19 Test Products
• Others

• Point of Care Diagnostics Market, By Platform:

• Lateral Flow Assays
• Dipsticks
• Microfluidics
• Molecular Diagnostics
• Immunoassays

• Point of Care Diagnostics Market, By Mode Of Purchase:

• Prescription Based Products
• OTC Products

• Point of Care Diagnostics Market, By End User:

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Others

• Point of Care Diagnostics 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