Point Of Care Diagnostics Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Point of Care Diagnostics Market Report Segments the Industry Into by Product (Glucose Monitoring Kit, Cardio-Metabolic Monitoring Kit, and More), by Platform (Lateral Flow Assays and More), by Sample Type (Blood, Urine and More), by Mode of Purhcase (Over-The-Counter and Prescription-Based), by End User (Hospital and Critical Care Setting, and More), and Geography. The Market Forecasts are Provided in Terms of Value (USD)

Global Point Of Care Diagnostics Market Size and Share

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Global Point Of Care Diagnostics Market Analysis by Mordor Intelligence

The Global Point Of Care Diagnostics Market size is estimated at USD 53.63 billion in 2025, and is expected to reach USD 84.93 billion by 2030, at a CAGR of 9.63% during the forecast period (2025-2030).

The steady growth reflects an industry shift toward immediate, near-patient testing that trims time-to-treatment and lowers overall care costs. Decentralized testing, miniaturized electronics, and smartphone connectivity are converging to drive adoption across both clinical and home settings. Market leaders continue to invest in four-in-one molecular respiratory panels, Bluetooth-enabled glucose sensors, and handheld cardiac biomarker readers—all technologies that improve decision speed and broaden access. Regional performance varies: North America leverages mature reimbursement and robust R&D, whereas Asia-Pacific benefits from expanding health coverage and a rising chronic disease burden. Competitive intensity is accelerating as approvals for multiplex molecular cartridges shorten development cycles, while phased Laboratory Developed Test (LDT) rules favor firms with strong quality systems.

Key Report Takeaways

  • By product category, Blood Glucose Monitoring Kits held 39.9% of point-of-care diagnostics market share in 2024; Infectious Disease Testing Kits are projected to advance at a 10.1% CAGR to 2030.
  • By platform, Lateral Flow Assays led with 32.4% revenue share in 2024, while Molecular Diagnostics platforms are forecast to post the highest 11.8% CAGR through 2030.
  • By sample type, blood specimens accounted for 68.15% of the point-of-care diagnostics market size in 2024; nasal/throat swab specimens are poised to grow at a 10.7% CAGR between 2025-2030.
  • By mode of purchase, OTC products commanded 60.98% share of the point-of-care diagnostics market in 2024; prescription-based kits record a projected 11.09% CAGR to 2030.
  • By end user, hospitals & clinics represented 47.7% market share in 2024, while home-care settings expand at a 10.3% CAGR to 2030.
  • By geography, North America retained 43.6% revenue share in 2024; Asia-Pacific is forecast to exhibit the fastest 10.67% CAGR through 2030.

Segment Analysis

By Product: Glucose Monitoring Leads, Infectious Disease Kits Accelerate

Blood Glucose Monitoring Kits retained 39.87% of point-of-care diagnostics market share in 2024, buoyed by the worldwide diabetes epidemic. Continuous sensors and connected meters keep sales resilient, with the point-of-care diagnostics market size for glucose monitoring expected to expand steadily alongside type 2 diabetes incidence. Infectious Disease Testing Kits posted the fastest 10.1% CAGR outlook for 2025-2030, propelled by four-pathogen respiratory panels and at-home syphilis antibody tests. The FDA authorization of the First to Know Syphilis Test underscores regulatory support for consumer infectious-disease self-screening, accelerating segment momentum.

Demand is also diversifying: multiplex molecular strips now blend bacterial, viral, and fungal targets, letting primary-care clinics manage differential diagnoses on-site. Product pipelines show convergence, with companies integrating cardiac troponin, HbA1c, and CRP into comprehensive metabolic and sepsis panels that fit the same palm-sized reader, extending lifetime value per instrument.

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

By Platform: Molecular Diagnostics Upsets Lateral Flow Dominance

Lateral Flow Assays captured 32.4% revenue in 2024 thanks to low unit cost and easy distribution, yet their market weight is gradually ceding ground. Molecular platforms—projected at 11.8% CAGR—extend sensitivity, vital for variant-prone viruses and low-copy pathogens. The point-of-care diagnostics market size for molecular cartridges is forecast to double this decade as pharmacies adopt CLIA-waived analyzers.

Manufacturers focus on higher multiplex density without compromising run-time. QuidelOrtho’s Savanna console delivers PCR-grade accuracy from a single swab in 25 minutes, matching clinic cycle times. Meanwhile, cloud-linked analyzers push auto-result posting into electronic medical records, creating fertile ground for population-level antimicrobial stewardship dashboards.

By Sample Type: Blood Remains Cornerstone, Respiratory Specimens Surge

Blood-based assays comprised 68.15% of 2024 revenue, covering glucose, lipids, cardiac markers, and hemoglobin variants. Innovation now centers on capillary micro-volume handling and room-temperature whole-blood chemistry, minimizing preprocessing. Yet respiratory specimens are the growth story: nasal/throat swabs carry a 10.7% CAGR through 2030 as syndromic panels expand.

Self-collection kits broaden sampling beyond clinics—BD’s HPV solution lets women obtain vaginal samples in pharmacies, powering high-throughput molecular screening programs. Simultaneously, spin-disk microfluidics from SpinChip produce quantitative results out of fingerprick blood in 10 minutes, tightening links between sampling, analysis, and treatment.

By Mode of Purchase: OTC Channels Reshape Access

OTC products held 60.98% revenue share in 2024, reflecting stronger patient agency and retail clinic expansion. Chain pharmacies stock pregnancy, glucose, cholesterol, and rapid infection tests on adjacent shelves, making the point-of-care diagnostics market an everyday consumer category. Prescription kits, however, are set to outpace with 11.09% CAGR as molecular test complexity warrants professional interpretation and insurer coverage.

Regulatory shifts encourage OTC migration of once-clinical assays. Abbott’s Lingo CGM and Roche’s forthcoming at-home HPV test highlight the blurred boundary between consumer health and clinical diagnostics. Meanwhile, digital companion apps guide lay users in specimen collection, reducing invalid tests and building real-time epidemiological datasets.

Global Point Of Care Diagnostics Market: Market Share by Mode of Purchase
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Note: Segment shares of all individual segments available upon report purchase

By End User: Hospitals & Clinics Lead, Home-Care Gains Speed

Hospitals and clinics managed 47.7% of 2024 revenues, where immediate triage value justifies premium cartridges. Emergency departments rely on eight-minute troponin readers to rule out myocardial infarction and release low-risk patients sooner, cutting bed occupancy. In parallel, home-care settings grow at 10.3% CAGR as payers incentivize remote supervision. The point-of-care diagnostics market size for home testing devices climbs with broadband telehealth adoption.

Integration with smartphones and cloud dashboards enables virtual coaching. Libre Rio transmits CGM data straight into provider portals, while electrical-sensing blood analyzers schedule refill prompts when chronic-care labs exceed thresholds—mechanisms that align with value-based reimbursement

Geography Analysis

North America commands 43.6% of 2024 revenue, underpinned by policy initiatives, robust venture backing, and early-adopter health systems. The final LDT rule reshapes investment calculus; firms that already handle Medical Device Reporting glide through phase-in stages, consolidating competitive advantage. Strategic M&A—BD’s USD 4.2 billion Critical Care acquisition—adds AI-enabled monitors that feed real-time alerts to intensivists, marrying analytics with bedside diagnostics.

Asia-Pacific is the fastest climber, forecast at a 10.67% CAGR. Health ministries in India, China, and Southeast Asia are scaling remote vital-sign hubs to offset clinician shortages. Investment projections of USD 138 billion by 2027 in regional life-sciences infrastructure spur local cartridge manufacturing, reducing import dependency. Public-private collaborations—such as BD’s cervical cancer partnership with Kenya’s Ministry of Health—show how multinationals tailor solutions for resource-limited environments, often leapfrogging legacy lab models.

Europe balances stringent regulation with technological depth. CE-marked cobas 6800/8800 2.0 systems boost throughput by optimizing walk-away times, letting central labs handle surges without staff increases. Additionally, CE approvals for Bluetooth-enabled cardiac monitors extend arrhythmia surveillance for six years, aligning with EU digital-health reimbursement frameworks. In the Middle East and Africa, infection diagnostics dominate donor funding, while South America sees rising awareness of early cancer screening. Supply-chain cold-chain gaps persist, but rooftop solar refrigeration pilots in Nigeria indicate pathways to stabilize PCR reagent logistics.

Point of Care Diagnostics Market
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Competitive Landscape

The point-of-care diagnostics market shows moderate concentration. Abbott, Roche, Siemens Healthineers, and Danaher’s Cepheid division together hold an estimated upper-medium share, while dozens of specialists compete in niche assays. Larger firms leverage scale and regulatory muscle; Roche’s USD 350 million purchase of LumiraDx’s platform expands its decentralized menu from coagulation to COVID-19.

Technology remains the key differentiator. Siemens Healthineers’ handheld high-sensitivity troponin device shrinks diagnosis time to eight minutes using magnetic nanoparticles while keeping lab-grade precision. bioMérieux’s acquisition of SpinChip brings centrifugal microfluidics that return immunoassay results from fingerstick blood within 10 minutes, broadening the firm’s sepsis and antimicrobial stewardship offerings 

Partnerships with digital-health players multiply value. Chronus Health integrates machine-learning edge analytics, enabling electrical-sensing chips to classify analytes without optics or reagents. QuidelOrtho’s revamped R&D leadership signals a push toward broader multiplex menus across both immunoassay and molecular domains, a move expected to intensify competition among mid-tier innovators.

Global Point Of Care Diagnostics Industry Leaders

  1. F. Hoffmann-La Roche Ltd

  2. Abbott Laboratories

  3. Siemens Healthineers AG

  4. Becton, Dickinson and Company

  5. Qiagen Inc.

  6. *Disclaimer: Major Players sorted in no particular order
Point of Care Diagnostics Market Concentration
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Recent Industry Developments

  • January 2025: bioMérieux acquired SpinChip Diagnostics for EUR 138 million to strengthen its 10-minute whole-blood immunoassay platform.
  • January 2025: Beckman Coulter Diagnostics introduced new RUO blood-based biomarker immunoassays for neurodegenerative disease research.
  • May 2025: Roche received FDA Breakthrough Device Designation for its Elecsys pTau217 plasma biomarker test to aid early Alzheimer’s diagnosis.
  • December 2024: Roche secured CE Mark for updated cobas 6800/8800 systems 2.0 that increase laboratory throughput.

Table of Contents for Global Point Of Care Diagnostics Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Glucose Self-Management Becoming a Standard of Care in diabetes
    • 4.2.2 Surge in CLIA-Waived Molecular POC Platforms for Respiratory Pathogens
    • 4.2.3 Rising Prevalence of Chronic and Infectious Diseases
    • 4.2.4 Increasing Number of Regulatory Approvals for Novel Immunoassay Techniques
    • 4.2.5 Technological Advancements and Rising Usage of Home-based POC Devices
    • 4.2.6 National Newborn Screening Mandates Accelerating Bedside Bilirubin Testing in Europe
  • 4.3 Market Restraints
    • 4.3.1 Product Recalls
    • 4.3.2 Stringent Regulatory Policies and Reimbursement Issues
    • 4.3.3 Quality-Control Non-Compliance Penalties in US Physician-Office Labs
    • 4.3.4 Supply-Chain Cold-Chain Gaps for Molecular Cartridges in Africa
  • 4.4 Supply-Chain Analysis
  • 4.5 Regulatory & Technological Outlook
  • 4.6 Porter’s Five Forces
    • 4.6.1 Threat of New Entrants
    • 4.6.2 Bargaining Power of Suppliers
    • 4.6.3 Bargaining Power of Buyers
    • 4.6.4 Threat of Substitutes
    • 4.6.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Product
    • 5.1.1 Glucose Monitoring Kits
    • 5.1.2 Infectious Disease Testing Kits
    • 5.1.3 Cardiometabolic (Cardiac Marker) Testing Kits
    • 5.1.4 Coagulation Monitoring Kits
    • 5.1.5 Pregnancy & Fertility Testing Kits
    • 5.1.6 Blood Gas / Electrolyte & Metabolite Testing Kits
    • 5.1.7 Hematology Testing Kits
    • 5.1.8 Tumor / Cancer Marker Testing Kits
    • 5.1.9 Urinalysis Testing Kits
    • 5.1.10 Cholesterol Test Strips
  • 5.2 By Platform
    • 5.2.1 Lateral Flow Assays
    • 5.2.2 Dipsticks & Test Strips
    • 5.2.3 Microfluidics-Based Platforms
    • 5.2.4 Immunoassays (CLIA & FIA)
    • 5.2.5 Molecular Diagnostics (PCR, INAAT)
  • 5.3 By Sample Type
    • 5.3.1 Blood
    • 5.3.2 Urine
    • 5.3.3 Saliva
    • 5.3.4 Nasal / Throat Swab
    • 5.3.5 Other Specimens (Sweat, Tear, CSF)
  • 5.4 By Mode of Purchase
    • 5.4.1 Over-the-Counter (OTC)
    • 5.4.2 Prescription-Based
  • 5.5 By End User
    • 5.5.1 Hospitals & Clinics
    • 5.5.2 Home-Care Settings
    • 5.5.3 Others
  • 5.6 By Geography
    • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
    • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
    • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
    • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East
    • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Competitive Benchmarking
  • 6.3 Market Share Analysis
  • 6.4 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
    • 6.4.1 Abbott Laboratories
    • 6.4.2 F. Hoffmann-La Roche Ltd.
    • 6.4.3 Siemens Healthineers AG
    • 6.4.4 Danaher Corporation (Cepheid & Beckman Coulter)
    • 6.4.5 QuidelOrtho Corporation
    • 6.4.6 Becton, Dickinson and Company
    • 6.4.7 Johnson & Johnson (LifeScan)
    • 6.4.8 bioMérieux SA
    • 6.4.9 Bio-Rad Laboratories Inc.
    • 6.4.10 Chembio Diagnostics Inc.
    • 6.4.11 Trinity Biotech plc
    • 6.4.12 Nova Biomedical Corporation
    • 6.4.13 Werfen (Instrumentation Laboratory)
    • 6.4.14 PTS Diagnostics
    • 6.4.15 Sekisui Diagnostics
    • 6.4.16 OraSure Technologies Inc.
    • 6.4.17 Accubiotech Co. Ltd.
    • 6.4.18 HemoCue AB
    • 6.4.19 Radiometer Medical ApS
    • 6.4.20 EKF Diagnostics

7. Market Opportunities & Future Outlook

  • 7.1 White-Space & Unmet-Need Assessment
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Global Point Of Care Diagnostics Market Report Scope

As per the scope of the report, point of care (POC) diagnostics have many advantages over traditional methods as it allows patient diagnosis at different places other than only hospitals and clinics, including remote areas, such as in the physician's office, an ambulance, the home, the field, or in the hospital.

The Point of care Diagnostics Market is segmented by Product (Glucose Monitoring Kit, Cardio-metabolic Monitoring Kit, Pregnancy and Fertility Testing Kit, Infectious Disease Testing Kit, Cholesterol Test Strip, Hematology Testing Kit, and Other Products), End-User (Hospital and Critical Care Setting, Ambulatory Care Setting, Research Laboratory, and Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Product Glucose Monitoring Kits
Infectious Disease Testing Kits
Cardiometabolic (Cardiac Marker) Testing Kits
Coagulation Monitoring Kits
Pregnancy & Fertility Testing Kits
Blood Gas / Electrolyte & Metabolite Testing Kits
Hematology Testing Kits
Tumor / Cancer Marker Testing Kits
Urinalysis Testing Kits
Cholesterol Test Strips
By Platform Lateral Flow Assays
Dipsticks & Test Strips
Microfluidics-Based Platforms
Immunoassays (CLIA & FIA)
Molecular Diagnostics (PCR, INAAT)
By Sample Type Blood
Urine
Saliva
Nasal / Throat Swab
Other Specimens (Sweat, Tear, CSF)
By Mode of Purchase Over-the-Counter (OTC)
Prescription-Based
By End User Hospitals & Clinics
Home-Care Settings
Others
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
India
Japan
South Korea
Australia
Rest of Asia-Pacific
Middle East and Africa GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
By Product
Glucose Monitoring Kits
Infectious Disease Testing Kits
Cardiometabolic (Cardiac Marker) Testing Kits
Coagulation Monitoring Kits
Pregnancy & Fertility Testing Kits
Blood Gas / Electrolyte & Metabolite Testing Kits
Hematology Testing Kits
Tumor / Cancer Marker Testing Kits
Urinalysis Testing Kits
Cholesterol Test Strips
By Platform
Lateral Flow Assays
Dipsticks & Test Strips
Microfluidics-Based Platforms
Immunoassays (CLIA & FIA)
Molecular Diagnostics (PCR, INAAT)
By Sample Type
Blood
Urine
Saliva
Nasal / Throat Swab
Other Specimens (Sweat, Tear, CSF)
By Mode of Purchase
Over-the-Counter (OTC)
Prescription-Based
By End User
Hospitals & Clinics
Home-Care Settings
Others
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
India
Japan
South Korea
Australia
Rest of Asia-Pacific
Middle East and Africa GCC
South Africa
Rest of Middle East
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the current value of the point-of-care diagnostics market?

The market is valued at USD 53.63 billion in 2025 and is projected to reach USD 84.93 billion by 2030.

Which product segment leads the point-of-care diagnostics market?

Blood Glucose Monitoring Kits lead, holding 39% market share in 2024 as continuous sensors anchor diabetes management.

Which region shows the fastest growth?

Asia-Pacific is the fastest-growing region, forecast at a 10.67% CAGR for 2025-2030.

What is driving the shift toward home-based testing?

Healthcare decentralization, patient preference, and connected devices like Abbott’s new CGMs support a 10.3% CAGR for home-care settings.

How are new regulations affecting the market?

The FDA’s phased LDT rule increases compliance demands but clarifies approval pathways, favoring companies with established quality systems and accelerating innovation.

Page last updated on: July 11, 2025

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