Point Of Care Diagnostics Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Point Of Care Diagnostics Market Trends and Insights

Rising Prevalence of Chronic and Infectious Diseases

Globally, 537 million adults lived with diabetes in 2024, and the International Diabetes Federation projects 643 million by 2030, underscoring sustained demand for glucose monitoring kits ^{[1]International Diabetes Federation, “IDF Diabetes Atlas 10th Edition,” idf.org} .Parallel outbreaks such as dengue in Southeast Asia and mpox in Central Africa have moved governments to stockpile rapid diagnostic tests. WHO prequalified 12 new malaria rapid tests in 2025, allowing procurement agencies to source assays that meet stringent sensitivity thresholds for low-parasitemia detection. Abbott supplied 15 million malaria tests to India’s National Health Mission the same year, covering districts where laboratory microscopy remains unavailable in 40% of primary health centers. Cepheid’s GeneXpert MTB/RIF Ultra assay shortened tuberculosis time-to-treatment in South African clinics from 14 days to under 2 hours, demonstrating the clinical advantage of rapid molecular testing. This dual burden of chronic management and outbreak response creates a structural tailwind that lifts the point-of-care diagnostics market across income settings. 

Technological Advances and Home-Based POC Uptake

Medicare introduced CPT 99454 in the 2025 Physician Fee Schedule, reimbursing USD 64 per patient per month for devices transmitting physiological data at least 16 days a month. Roche’s CoaguChek systems now qualify for virtual INR consultations under this code, while Abbott’s Bluetooth-enabled FreeStyle Libre 3 Plus streams glucose readings every minute for remote insulin titration. Dexcom’s over-the-counter Stelo sensor, approved in June 2024, opened continuous glucose monitoring to 30 million U.S. Type 2 diabetics previously outside insurance coverage. Smartphone penetration above 70% in many emerging markets further lowers barriers for cloud-linked diagnostic devices. As sensor miniaturization converges with reimbursement reform, the hospital-centric testing model is giving way to decentralized, patient-directed workflows that expand the point-of-care diagnostics market.  

Surge in CLIA-Waived Molecular Respiratory Tests

FDA granted CLIA-waived status to eight molecular respiratory panels between 2024 and 2025, including Cepheid’s Xpert Xpress Flu/RSV and Roche’s cobas Liat Influenza A/B & RSV, permitting deployment in physician offices without high-complexity lab certification ^{[2]U.S. Food and Drug Administration, “Medical Device Databases,” fda.gov}. Molecular POC assays reach sensitivities above 95% while delivering results in 15-20 minutes, compared with 50-70% for antigen-based lateral flow tests. CMS reimburses CLIA-waived molecular assays at USD 45-75 per panel, creating an economic incentive for practices to upgrade. Cartridge demand responded sharply, with Cepheid shipping 2.3 million Xpert Xpress units in Q3 2024, a 35% year-on-year surge. The waived designation effectively shifts highly sensitive PCR testing from reference labs to frontline clinicians, reinforcing the growth trajectory of the point-of-care diagnostics market.  

Increasing Regulatory Approvals for Novel Assays

FDA cleared 47 new POC devices in 2024, 22% more than the prior year, under an expedited 510(k) pathway for products demonstrating substantial equivalence to predicate systems. Notable examples include Sonic Incytes’ Velacur ONE urinalysis analyzer and NOWDiagnostics’ finger-stick ADEXUSDx Syphilis Test. China’s NMPA authorized Roche’s cobas Liat platform in 2024, unlocking access to 36,000 township health centers that serve 600 million rural residents. The European Medicines Agency granted CE-IVD marks to 12 new POC cardiac biomarker assays during 2024-2025, enabling one-hour myocardial infarction rule-outs in emergency departments. Faster approvals compress time-to-market, allowing manufacturers to ride outbreak-driven demand spikes and broaden the global footprint of the point-of-care diagnostics market.   

Stringent Regulations and Reimbursement Gaps

FDA guidance issued in 2024 raised analytical validation thresholds for POC molecular tests to at least 95% positive and 98% negative percent agreement across three diverse clinical sites. CMS then cut payment for several CLIA-waived codes by 8-12% in the 2025 fee schedule, squeezing the economics for smaller practices ^{[3]Centers for Medicare & Medicaid Services, “2025 Physician Fee Schedule Final Rule,” cms.gov} . Private insurers such as Anthem introduced prior authorization rules that limit respiratory pathogen panels to high-risk patients. In Europe, the In Vitro Diagnostic Regulation deadline of May 2025 forced roughly 30% of legacy POC devices off the market because manufacturers could not secure notified-body audits. These policy shifts raise compliance costs and curb near-term adoption, tempering growth in the point-of-care diagnostics market.

Product Recalls and Accuracy Concerns

The FDA issued Class I recalls for 3.7 million TRUEresult and TRUEtrack glucose meters in May 2024 after software errors produced falsely elevated readings in hypoglycemic patients. Abbott followed with a voluntary recall of 3.6 million FreeStyle Libre 2 readers in October 2024 due to battery overheating risks. Such events erode clinician confidence, prompting hospital procurement committees to demand third-party accuracy audits before adopting new platforms. A 2024 College of American Pathologists survey found 18% of POC glucose meters in physician offices reported out-of-range results, compared with 4% for central laboratory analyzers. Ongoing safety alerts create scrutiny that can delay purchasing decisions, softening short-term demand within the point-of-care diagnostics market.

Segment Analysis

By Product: Glucose Monitoring Anchors Revenue, Infectious Disease Accelerates

Glucose monitoring kits maintained 37.9% of the point-of-care diagnostics market share in 2025, supported by the ubiquity of capillary blood glucose meters and the rapid uptake of CGM sensors. Infectious disease kits, however, are forecast to grow at a 10.2% CAGR through 2031 as global health agencies prequalify new rapid assays for malaria, tuberculosis, and sexually transmitted infections. Cardiometabolic panels built around high-sensitivity troponin and BNP markers are standard in 85% of U.S. emergency departments for rapid myocardial infarction rule-outs. Coagulation kits, led by Roche’s CoaguChek, benefit from Medicare reimbursement for patient self-testing of INR. Pregnancy and fertility kits retain high volume in retail channels, while digital ovulation monitors are carving premium subsegments. Blood gas and electrolyte cartridges remain mission-critical in critical care units, and AI-enabled hematology analyzers such as Sight Diagnostics’ OLO are lowering the entry threshold for urgent care clinics. 

The product mix is likely to rebalance as closed-loop insulin delivery systems pair CGMs with automated pumps, yet novel infectious disease panels promise faster relative growth. Manufacturers that integrate wireless connectivity and cloud analytics into commodity product lines stand to extend lifetime revenue per user, fortifying their positions within the point of care diagnostics market.   

Note: Segment shares of all individual segments available upon report purchase

By Platform: Molecular Diagnostics Outpace Lateral Flow

Lateral flow assays captured 34.1% revenue share in 2025, due to entrenched pregnancy and antigen test volumes. Molecular diagnostics platforms, however, are scaling at a 10.5% CAGR, supported by PCR cartridges that deliver sample-to-answer results in under 30 minutes without high-complexity lab certification. Dipsticks and test strips remain the highest-volume consumables but face commoditization as smartphone cameras replace dedicated optical readers. 

Microfluidic cartridges such as Abbott’s i-STAT house multiple chemistries, electrolytes, blood gases, and cardiac markers inside a palm-sized single-use chip that returns results in under 10 minutes. Immunoassay analyzers serve mid-throughput hospital labs that bridge the gap between bedside testing and central automation. As PCR becomes simpler and cheaper, molecular systems are expected to erode lateral flow share in physician offices, home-care, and retail clinics, further enlarging the point-of-care diagnostics market size for high-sensitivity diagnostics.

By Sample Type: Blood Dominates, Respiratory Swabs Surge

Blood draws contributed 68.2% of overall test volume in 2025, anchored by glucose, cardiac biomarker, and coagulation assays. Respiratory swabs are projected to rise at a 10.4% CAGR through 2031 as national surveillance programs institutionalize same-visit PCR testing for influenza, RSV, and SARS-CoV-2. Urine remains routine in pregnancy and urinalysis testing, while saliva is gaining acceptance in HIV self-testing and nascent oral glucose monitoring. Sweat and tear specimens stay niche but underscore continued innovation in non-invasive sampling. The pivot toward nasal and throat swabs reflects a public-health imperative to triage respiratory infections quickly, reinforcing the versatility of the point-of-care diagnostics market.

Respiratory-focused sampling also shortens antiviral prescribing windows, while capillary blood retains unmatched breadth across analytes. Vendors that support both specimen types protect revenue diversity, positioning for sustained participation in the broader point-of-care diagnostics industry.  

Note: Segment shares of all individual segments available upon report purchase

By Mode of Purchase: OTC Channels Lead, Prescription Segment Accelerates

Over-the-counter test kits held 61.4% of 2025 revenue, propelled by pregnancy tests, glucose meters, and emerging consumer-friendly molecular assays. Prescription-based diagnostics are forecast to advance at a 10.0% CAGR to 2031 as payers cover complex panels requiring clinical oversight, such as CLIA-waived PCR respiratory assays and cardiac biomarkers. FDA guidance issued in 2024 set analytical benchmarks for OTC molecular tests, spurring device makers to improve sensitivity and specificity. Dexcom’s Stelo sensor illustrates boundary blurring by selling CGM technology directly to consumers yet integrating data with physician dashboards. Reimbursement for self-testing of coagulation parameters under CPT 99454 further narrows the gap between retail convenience and clinician-supervised care. The coexistence of OTC and prescription channels broadens consumer access and sustains the multi-tiered growth path of the point-of-care diagnostics market.  

By End User: Home-Care Settings Disrupt Hospital-Centric Model

Hospitals and clinics commanded 46.9% share of 2025 demand, driven by emergency departments that rely on rapid cardiac and coagulation panels to triage acute cases. Home-care settings, however, are pacing the field with an 11.2% CAGR through 2031 thanks to Medicare reimbursement for remote physiologic monitoring and advancements in cellular-connected CGM and INR devices. Roche’s CoaguChek and Abbott’s Libre 3 Plus enable patients to self-test and push data to physicians who can adjust therapy without in-person visits. Ambulances, retail clinics, and workplace wellness programs are also deploying compact analyzers to expedite diagnosis and reduce downstream healthcare costs. As chronic disease prevalence mounts, the ability to monitor patients continually rather than episodically will remain a pivotal growth vector for the point-of-care diagnostics market size.  

Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America retained 45.6% revenue share in 2025, supported by a dense network of CLIA-certified physician office laboratories and generous Medicare coverage for both molecular and remote monitoring devices cleared 47 POC devices in 2024 under its accelerated 510(k) process, fostering rapid commercialization cycles. Cepheid maintains an installed base of 12,000 GeneXpert units across urgent care centers and emergency departments, driving cartridge growth of 35% year-over-year in Q3 2024. However, reimbursement cuts for certain waived tests and private-payer prior authorization hurdles may temper future expansion.

Asia-Pacific is the fastest-growing region, projected to log a 10.7% CAGR through 2031 as China and India roll out rural health initiatives. China’s NMPA cleared Roche’s cobas Liat system in 2024, unlocking a network of 36,000 township clinics that serve 600 million residents. India’s National Health Mission distributed 15 million Abbott malaria rapid tests in 2025 to areas where microscopy is unavailable in 40% of primary centers. Japan, South Korea, and Australia are also extending coverage to CGM and AI-enabled diagnostics, enlarging the point-of-care diagnostics market in developed Asia.

Europe is navigating the stringent IVDR regime that removed roughly 30% of legacy POC devices from the market by May 2025. Germany expanded reimbursement for patient-managed INR testing, while the UK’s National Health Service deployed Roche cobas Liat units in 200 general practices to curb inappropriate antibiotic prescribing. Southern European nations procured rapid respiratory assays ahead of the 2025 flu season, acknowledging laboratory staffing gaps in rural areas. Cold-chain limitations continue to constrain molecular cartridge deployment in parts of Africa and remote Pacific islands, yet donor-funded programs are bridging those gaps. Overall, regional policies and infrastructure investments shape a mosaic of opportunities that together reinforce the growth trajectory of the point of care diagnostics market.