With the Point of Care (POC) diagnostics market forecasted to grow by USD 16.42 billion at a CAGR of 10.87% between 2023 and 2028, the industry is on a trajectory that will redefine decentralized healthcare delivery. In this 2025 Outlook and Comprehensive Guide, we dissect the evolving POC diagnostics landscape — from AI-driven technologies to emerging global health applications — offering expert-level insight and strategic foresight for stakeholders across the healthcare continuum.
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Point of Care diagnostics refers to medical testing conducted at or near the site of patient care, enabling faster clinical decisions and improved outcomes. These solutions range from glucose meters and pregnancy tests to advanced molecular diagnostics and AI-integrated analyzers. From infectious disease detection in remote villages to at-home chronic disease monitoring in urban centers, POC devices are revolutionizing how care is delivered and who gets access to it.
The movement toward precision medicine demands rapid and accurate diagnostics, pushing the integration of AI and machine learning in POC platforms. Tools powered by smart algorithms now provide real-time insights, especially in oncology and cardiology.
Chronic illnesses such as type 2 diabetes, cardiometabolic disorders, and obesity have made continuous monitoring essential. POC solutions like glucose monitoring kits and cardiometabolic analyzers allow patients and providers to track and manage conditions in real time.
Fact Check:
According to the CDC, over 34 million Americans had diabetes in 2020 — and the demand for home-based glucose testing devices has surged since then.
In a post-COVID world, readiness for outbreaks is non-negotiable. From tuberculosis to HIV and malaria, POC diagnostics ensure faster containment and targeted treatment.
The rise of wearables, smartphone diagnostics, and lab-on-a-chip platforms enables non-invasive, portable, and user-friendly diagnostics, bringing lab-quality results to resource-limited environments.
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Hematology diagnostics leads the pack, having been valued at USD 4.12 billion in 2018 and expected to expand substantially. Innovations in portable blood analyzers and real-time coagulation monitoring are fueling this momentum.
Other key segments include:
Infectious Disease Diagnostics
Cardiovascular & Coagulation Rapid Tests
Others
Hospitals & Clinics dominate usage, but homecare settings are the fastest-growing segment, thanks to the self-testing trend and decentralization of health services.
Clinical Diagnostic Laboratories are adopting POC systems to offload lower-complexity testing, improving workflow efficiency.
North America contributes 38% to market growth, driven by chronic disease prevalence, advanced healthcare infrastructure, and tech innovation. Europe and Asia are close followers, with China emerging as a powerhouse for affordable manufacturing and innovation.
In 2024, a public-private initiative in India piloted an AI-integrated microfluidic POC device capable of detecting tuberculosis in under 10 minutes. Within six months, diagnosis rates in remote clinics rose by 48%, with treatment adherence also improving.
Rapid results enabling timely treatment
Improved access in remote and underserved regions
Integration with telehealth platforms
Reduced burden on centralized laboratories
Regulatory and reimbursement complexities
Risk of inaccurate results with low-quality devices
Product recalls can erode consumer trust
Driven by cost pressures and patient demand, diagnostic services are moving away from hospitals into homes, clinics, and community settings.
Empowered patients are using at-home cholesterol tests, fertility kits, and COVID-19 rapid tests to manage health proactively — a trend that shows no sign of slowing.
Continuous vital sign tracking through wearables is creating a feedback loop between diagnostics, treatment, and lifestyle changes.
Product Recalls: Safety and efficacy concerns can derail consumer confidence. Ensuring robust QA and post-market surveillance is crucial.
Regulatory Bottlenecks: Lengthy approval processes slow innovation. Agile policy reform is needed to keep up with technological pace.
Reimbursement Cuts: Reduced coverage may limit adoption among low-income users unless offset by value-based pricing models.
The Point of Care (POC) Diagnostics Market is experiencing a surge in adoption due to the rising demand for rapid, on-site testing. Key technologies such as rapid test, molecular diagnostics, and real-time PCR are central to enabling timely results across various health conditions. Devices like glucose meter, pulse oximeter, and ECG monitor exemplify the use of portable device solutions, while innovations like biosensor technology, microfluidics chip, and digital reader continue to shape the evolution of smartphone diagnostics. Consumer demand is driving the growth of home testing and self-testing device segments, particularly for conditions like pregnancy test, cholesterol test, and hemoglobin test. The widespread use of test strip, diagnostic cartridge, and point-of-care analyzer has enhanced usability and accessibility in non-laboratory settings. Meanwhile, respiratory screening is expanding through nasal swab, saliva test, and breath analyzer formats, supported by telehealth integration and growing acceptance of clia-waived test technologies.
AI-diagnostics with predictive analytics will become standard for chronic disease management.
Smartphone-based molecular testing will disrupt how we test for STIs and other common infections.
Microfluidic lab-on-a-chip devices will expand into oncology and rare disease diagnostics.
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Invest in AI Integration
Stakeholders should focus on diagnostic platforms that integrate artificial intelligence for predictive analysis and efficiency.
Expand Home-Based Testing Solutions
Companies should capitalize on the homecare trend by designing intuitive, app-integrated diagnostic kits.
Target Underserved Markets
With global health organizations like UNITAID pushing for access equity, there's opportunity in emerging markets.
Strengthen Regulatory Navigation Capabilities
Partnering with compliance experts or lobbying for policy streamlining could be a game-changer.
Analytical insights into the POC diagnostics market highlight its clinical impact across a wide spectrum of conditions. Testing for infectious disease has gained urgency, with increasing use of HIV test, COVID test, flu test, and strep test in both clinical and at-home settings. Antigen test and antibody test options are proving vital in infectious disease control, offering faster results with improved diagnostic accuracy. Meanwhile, blood glucose and blood gas monitoring remain critical for chronic care, alongside coagulation test, tumor marker, and cardiac marker diagnostics. Tools designed for drug abuse detection and urine chemistry analysis are enhancing public health interventions. Diagnostic workflows increasingly utilize blood sample collection optimized for use with lateral flow assays and AI-enhanced platforms. The integration of AI diagnostics helps clinicians interpret results in real time, while antibody test innovations and policy-compliant tools solidify the market's position as a cornerstone in modern decentralized healthcare.
As healthcare evolves toward precision, decentralization, and real-time intelligence, the Point of Care (POC) diagnostics market is at the heart of that transformation. With a projected market size growth of USD 16.42 billion by 2028, stakeholders can’t afford to ignore the strategic imperatives of innovation, regulation, and global accessibility.
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