According to The Insight Partners' research, the North America Point of Care Diagnostics Market was valued at US$ 15,289.0 Million in 2024 and is expected to reach US$ 34,026.8 Million by 2031, registering a CAGR of 12.2% from 2025 to 2031.
Integration of artificial intelligence (AI) and machine learning (ML) and increasing prevalence of infectious diseases are among the critical factors attributed to driving the North America point of care diagnostics market growth.
The integration of AI and machine learning ML into diagnostic devices is transforming healthcare by enabling faster, more accurate, and personalized diagnostics outside traditional clinical settings. AI-powered POC devices are enhancing diagnostic capabilities, improving decision-making, and reducing human error. These devices utilize machine learning algorithms to analyze complex data from diagnostic tests, such as blood glucose levels, infections, and genetic markers, providing accurate results with high precision. Companies such as Abbott Laboratories have developed AI-driven POC devices for continuous glucose monitoring (CGM), which help individuals with diabetes manage their condition effectively. The Freestyle Libre system, a leading product in this category, uses machine learning to offer personalized insights based on glucose trends and patterns, helping patients make informed decisions about their health. AI is also being incorporated into rapid COVID-19 testing kits, significantly reducing testing time and enabling quicker results at the point of care, thus enhancing the efficiency of managing infectious disease outbreaks.
The increasing partnerships among market players for the development of AI-based POC diagnostics are expected to contribute to their adoption. In June 2025, PathAI received FDA 510(k) clearance for its AISight® Dx platform, a cloud-based digital pathology system for primary diagnosis in clinical settings. The platform combines AI-driven image management and analysis tools to improve efficiency and accuracy in anatomic pathology workflows. With features like synchronized multi-slide navigation and strong annotation capabilities, AISight® Dx aims to speed up turnaround times and boost pathologist productivity. This development highlights the increasing role of AI in changing diagnostic practices in the U.S. healthcare system. The increasing demand for AI-enabled POC diagnostics is rising, especially in emerging markets where access to traditional healthcare infrastructure is limited. AI's ability to improve diagnostic speed and accuracy, reduce healthcare costs, and enable better management of chronic conditions is poised to continue driving its adoption.
On the contrary, the product recalls hamper the growth of the North America point of care diagnostics market.
North America Point of Care Diagnostics Market Segmentation Analysis:
- By Product, the North America Point of Care Diagnostics Market is segmented into Glucose Monitoring, Infectious Disease Testing, Cardio metabolic Testing, Pregnancy and Fertility Testing, Coagulation Testing, Tumor or Cancer Marker Testing, Cholesterol Testing, Urinalysis Testing, Hematology Testing, Thyroid Testing, and Others. The Glucose Monitoring segment is projected to expand at 14.7% CAGR during 2025 - 2031.
- By Glucose Monitoring, the North America Point of Care Diagnostics Market is segmented into Blood Glucose Meter, Lancet, and Strips. The Strips segment is projected to expand at 14.3% CAGR during 2025 - 2031.
- By Infectious Disease Testing, the North America Point of Care Diagnostics Market is segmented into HIV Testing, Influenza Testing, Sexually Transmitted Diseases Testing, Hepatitis C Virus Testing, Tropical Diseases Testing, Respiratory Infection Testing, Hospital Acquired Infections, and Others. The Respiratory Infection Testing segment is projected to expand at 15.5% CAGR during 2025 - 2031
- By Cardio Metabolic Testing, the North America Point of Care Diagnostics Market is segmented into Cardiac Troponin (cTn) Test, Myoglobin Test, and Others. The Cardiac Troponin (cTn) Test segment is projected to expand at 12.3% CAGR during 2025 - 2031.
- By Purchase Mode, the North America Point of Care Diagnostics Market is segmented into OTC and Prescription. The Prescription segment is projected to expand at 12.0% CAGR during 2025 - 2031.
- By Sample, the North America Point of Care Diagnostics Market is segmented into Blood, Urine, and Others. The Blood segment is projected to expand at 12.5% CAGR during 2025 - 2031.
- By End User, the North America Point of Care Diagnostics Market is segmented into Healthcare Facilities, Homecare, and Others. The Healthcare Facilities segment is projected to expand at 12.0% CAGR during 2025 - 2031.
- By Healthcare Facilities, the North America Point of Care Diagnostics Market is segmented into Hospitals and Clinics, Diagnostic Centers, and Others. The Diagnostic Centers segment is projected to expand at 12.5% CAGR during 2025 - 2031.
By country, the North America Point of Care Diagnostics Market is categorized into the United States, Canada, and Mexico. The United States is projected to expand at 12.3% CAGR during 2025 - 2031.
Key players operating in the Point of Care Diagnostics Market are Siemens AG, Abbott Laboratories, F. Hoffmann-La Roche Ltd, bioMerieux SA, Bio-Rad Laboratories Inc, QIAGEN NV, Nova Biomedical Corporation, Polymer Technology Systems, Inc. (PTS), and Danaher Corp, among others.
- In May 2023, PTS Diagnostics, a U.S. based manufacturer of point-of-care medical testing devices, announced today that they have signed a strategic distribution agreement with BIOSYNEX S.A.
- In April 2025, bioMérieux, a world leader in the field of in vitro diagnostics, today announces the launch of its WATCHFIRE molecular testing solution. The WATCHFIRE Respiratory (R) Panel, targeting 22 pathogens, will run on the BIOFIRE FILMARRAY TORCH instrument, integrated with FIREWORKS™ software, to deliver real-time trending of viruses and bacteria present in wastewater samples.
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