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

The Global Point of Care Diagnostics Market is projected to expand from USD 49.89 Billion in 2025 to USD 84.83 Billion by 2031, registering a compound annual growth rate of 9.25%. Defined as medical testing conducted near the patient to deliver rapid results independent of central laboratory infrastructure, this market is primarily driven by the increasing global prevalence of chronic and infectious diseases that require immediate clinical decision-making to improve patient outcomes. Furthermore, the rising demand for decentralized healthcare services supports the widespread adoption of these diagnostic solutions in non-hospital environments, such as home care settings and remote clinics.

However, the market confronts significant challenges due to stringent regulatory frameworks that mandate high compliance costs and prolong product commercialization. These complex approval processes establish substantial financial barriers for manufacturers attempting to introduce new technologies. For instance, MedTech Europe reported that in 2024, the average fee for Quality Management System certification under the In Vitro Diagnostic Regulation was 108,307 euros. Such elevated operational expenses can stifle innovation and hinder market expansion by restricting the participation of smaller diagnostic developers.

Market Drivers

Technological advancements in microfluidics and biosensors are fundamentally transforming the Global Point of Care Diagnostics Market by facilitating laboratory-quality molecular testing directly at the patient's bedside. These innovations enable the rapid detection of complex pathogens with high sensitivity, reducing dependence on centralized infrastructure and accelerating treatment initiation. The integration of automated platforms has seen a particular surge, driven by the need for precise respiratory diagnostics deployable outside traditional hospital labs; for example, Danaher Corporation’s Cepheid division reported in its 'Third Quarter 2024 Earnings Release' that respiratory product diagnostics generated $425 million in revenue, highlighting the critical role of advanced molecular technologies in maintaining market momentum.

Additionally, the rising global incidence of chronic and infectious diseases acts as a primary catalyst for market expansion, necessitating immediate clinical insights to mitigate severe health outcomes. As chronic conditions like diabetes escalate, there is a growing reliance on continuous monitoring solutions that empower patient self-management and relieve pressure on emergency facilities. Notably, Abbott’s 'Abbott Reports Third-Quarter 2024 Results' press release indicated that sales in its Diabetes Care division grew by 19.1 percent on an organic basis due to the widespread adoption of continuous glucose monitoring systems. This demand for effective disease management tools is further evidenced by Roche, where Diagnostics Division sales increased by 4 percent at constant exchange rates in 2024, reflecting sustained global demand for immunodiagnostic and clinical chemistry testing.

Market Challenges

Stringent regulatory frameworks impose substantial compliance costs and delay product commercialization, presenting a formidable obstacle to the growth of the Global Point of Care Diagnostics Market. These rigorous approval processes require manufacturers to allocate extensive resources to comprehensive clinical trials and detailed technical documentation, diverting capital away from research and development. This heavy compliance burden significantly extends the time-to-market for new testing solutions, creating a bottleneck that postpones revenue generation and discourages investment in novel technologies, particularly affecting smaller developers who lack the liquidity to endure prolonged non-revenue periods.

The impact of these regulatory hurdles is evident in the reduced pace of innovation and market entry. Faced with unpredictable certification timelines, manufacturers often delay or cancel product launches in key regions, which directly stalls market expansion. According to MedTech Europe, the preference for the European Union as a primary launch geography dropped by 40% among large in vitro diagnostic manufacturers in 2024 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.

Market Trends

The integration of Artificial Intelligence and Machine Learning for Automated Result Interpretation is significantly advancing the Global Point of Care Diagnostics Market by improving diagnostic accuracy and streamlining clinical workflows. These technologies are increasingly embedded in diagnostic platforms to automate the analysis of complex biological data, minimizing human error and enabling non-specialized personnel to perform sophisticated testing in decentralized settings. This technological shift is supported by regulatory momentum; as noted by MedTech Dive in October 2024, the U.S. Food and Drug Administration had authorized a cumulative total of 950 AI or machine learning-enabled medical devices by August 2024, allowing manufacturers to deploy smart tools that provide real-time clinical decision support.

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 service portfolios, integrating primary care clinics and diagnostic hubs directly into their retail footprints to capture the demand for convenient, walk-in medical services. This strategic pivot is yielding financial growth; according to the Walgreens Boots Alliance 'Fiscal Year 2024 Earnings' report, the company's U.S. Healthcare segment generated fourth-quarter sales of $2.1 billion, a 7.1 percent increase over the prior year, underscoring consumer preference for decentralized testing locations that offer immediate results and seamless connections to treatment.

Key Players Profiled in the Point of Care Diagnostics Market

• 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.
• Biomerieux S.A.
• Chembio Diagnostics, Inc.

Report Scope

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

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
• 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 Diagnostics 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.