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PUBLISHER: DataM Intelligence | PRODUCT CODE: 1629886

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PUBLISHER: DataM Intelligence | PRODUCT CODE: 1629886

Global Point-of-Care Testing Devices Market - 2025-2033

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The global point-of-care testing devices market reached US$ 49.73 billion in 2024 and is expected to reach US$ 101.51 billion by 2033, growing at a CAGR of 8.6% during the forecast period 2025-2033.

Point-of-Care Testing (POCT) is medical diagnostic testing that is performed at or near the patient's point of care, providing for quick outcomes that may assist in treatment decisions. This strategy differs from standard laboratory testing, which frequently involves transporting samples to central labs and waiting hours or days for findings. The fundamental purpose of POCT is to improve patient management by giving immediate information, which can lead to faster diagnosis and treatment. POCT covers a wide range of testing methods and technologies, such as handheld electronics, test kits, and portable analyzers. Common examples are blood glucose monitoring, quick strep testing, and pregnancy tests. These devices can be used in a variety of venues, including hospitals, clinics, pharmacies, and even the home, making healthcare more accessible and efficient. POCT technology has grown tremendously, with downsizing and enhanced instrumentation increasing accuracy and ease of use.

The technological advancements is the driving factor that drives the market over the forecast period. For instance, Masimo announced that MightySat Medical has received FDA clearance, making it the first and only FDA-cleared medical fingertip pulse oximeter offered over-the-counter (OTC) to consumers without a prescription. This approval provides customers a pulse oximeter medical gadget powered by Masimo SET pulse oximetry, the same technology used by hospitals and clinics around the world to monitor over 200 million patients every year.

Market Dynamics: Drivers & Restraints

Technological advancements

The technological advancements is expected to be a significant factor in the growth of the global point-of-care testing devices market. Technological advances are expected to play a significant influence in the expansion of the global point-of-care testing (POCT) devices market. As healthcare evolves, there is an increasing need for quick, accurate, and accessible diagnostic solutions. Innovations in numerous technologies, including as biosensors, microfluidics, and lab-on-a-chip systems, have altered diagnostics, making them more efficient and reliable. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Moreover in August 2024, DEXIS Launched DEXIS Connect Pro, a New Proactive Service Platform for DEXIS CBCT and Intraoral Sensor Devices, Focused on Increasing Device Uptime. This unique platform uses Internet of Things (IoT) technology to continuously check the health of these devices, ensuring they run at peak performance. DEXIS Connect Pro seeks to significantly improve device uptime by automatically recognizing potential difficulties and arranging for support or equipment replacements as needed, which is crucial for dental offices that rely on consistent operation to provide patient care.

Moreover in April 2024, Bio-Rad Laboratories has launched its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The assay adds to the company's Droplet Digital PCR (ddPC) portfolio in the cancer industry, where extremely sensitive and multiplexed mutation detection assays enhance translational research, medication selection, and disease monitoring. These recent launches and FDA approvals along with latest technological advancements in them makes the diagnostic results efficient and quick which drives the market.

High initial investment costs

Factors such as high initial investment costs are expected to hamper the global point-of-care testing devices market. Although POCT provides various benefits, such as rapid results and the ability to test outside of traditional laboratory settings, the financial costs associated with procuring these devices may dissuade healthcare organizations from using them. The initial investment for POCT equipment might be significant, especially for advanced technologies that promise improved diagnostic capabilities. This financial burden is particularly acute in resource-constrained environments where healthcare funds are tight, making it difficult for facilities to prioritize investment in novel diagnostic methods.

Segment Analysis

The global point-of-care testing devices market is segmented based on product , application, testing type, distribution channel and region.

Glucose monitoring products segment is expected to dominate the global point-of-care testing devices market share

The glucose monitoring products segment is predicted to dominate the global point-of-care testing (POCT) devices market due to a number of compelling factors, including increased diabetes prevalence, technological improvements, and an increase in demand for rapid diagnostic solutions. Diabetes remains a huge public health challenge around the world, thus effective management strategies are more important than ever. The increasing prevalence is one of the major reasons for the dominance of this segment. For instance, according to the National Institute of Health, approximately 462 million individuals were affected by type 2 diabetes corresponding to 6.28% of the world's population.

In the recent times, there are launches and FDA approvals of glucose monitoring devices. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Moreover, in June 2024, Prevounce Health, a leading provider of remote care management software, devices, and services, announced the launch of its first remote blood glucose monitoring device, Pylo GL1-LTE. The blood glucose meter has been scientifically tested and linked to numerous cellular networks to guarantee more dependable data transmission across the United States. The GL1-LTE is compatible with the Prevounce remote care management platform and may be integrated with other health software using the Pylo cloud API. Prevounce's Pylo cellular-connected gadgets include blood pressure monitors and weight scales.

Geographical Analysis

North America is expected to hold a significant position in the global point-of-care testing devices market share

North America is expected to hold a significant portion of the global point-of-care testing devices market. North America is projected to account for a significant portion of the global point-of-care testing (POCT) device market, owing to a mix of factors such as a strong healthcare infrastructure, rising chronic illness incidence, and technological improvements. The increased prevalence of chronic diseases, such as diabetes, cardiovascular problems, and infectious diseases, is a major driver of market expansion in North America. For instance, according to the Centers for Disease Control and Prevention, in 2024 more than 38 million Americans have diabetes (about 1 in 10), and about 90% to 95% of them have type 2 diabetes. Type 2 diabetes most often develops in people 45 or older, but more and more children, teens, and young adults are also developing it.

There are recent launches in this region due to the presence of major players. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases.

Asia Pacific is growing at the fastest pace in the global point-of-care testing devices market

The Asia Pacific region is experiencing rapid growth in the global point-of-care testing (POCT) device market. Several significant factors contribute to this expansion, including rising healthcare costs, increased awareness of early disease diagnosis, and the demand for quick and precise diagnostic results. The need for POCT has increased as these devices have proven invaluable for the early diagnosis and monitoring of a variety of health disorders, thereby improving disease management results throughout the region.

There are recent launches of devices in this region making it the fastest growing region. For instance, in November 2023, UK-based LumiraDx Healthcare has launched its highly sensitive C-Reactive Protein (CRP) point of care (POC) antigen test across India. The point of care CRP test can be used in multiple clinical settings to help reduce unnecessary antibiotic prescribing that leads to antimicrobial resistance (AMR). From a tiny sample of finger-prick blood, the CRP test gives results within four minutes on the portable LumiraDx platform which weighs just over a kilogram.

Competitive Landscape

The major global players in the global point-of-care testing devices market include Abbott, F. Hoffmann-La Roche, BD, Siemens Healthcare Private Limited, Bio-Rad Laboratories, Inc., Danaher Corporation, SEKISUI Diagnostics, Trinity Biotech, Beckman Coulter, Inc., Nova Biomedical among others.

Emerging Players

PocDoc, Biocode, Sense4Med among others

Key Developments

  • In January 2023, Cipla has announced the launch of Cippoint, a point-of-care testing device. This state-of-the-art device offers a wide range of testing parameters including cardiac markers, diabetes, infectious diseases, fertility, thyroid function, inflammation, metabolic markers, and coagulation markers. The device is CE IVD approved, indicating the device is approved by the European In-Vitro Diagnostic Device Directive, thus ensuring reliable testing solutions.
  • In November 2024, Caris Life Sciences announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global point-of-care testing devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.
Product Code: MD8922

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Product
  • 3.2. Snippet by Application
  • 3.3. Snippet by Testing Type
  • 3.4. Snippet by Distribution Channel
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
    • 4.1.2. Technological Advancements
    • 4.1.3. Restraints
    • 4.1.4. High Initial Investment Costs
    • 4.1.5. Opportunity
    • 4.1.6. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Reimbursement Analysis
  • 5.6. Patent Analysis
  • 5.7. SWOT Analysis
  • 5.8. DMI Opinion

6. By Product

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 6.1.2. Market Attractiveness Index, By Product
  • 6.2. Glucose Monitoring Products*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Infectious Disease Testing Products
  • 6.4. Pregnancy and Fertility Testing Products
  • 6.5. Tumor/Cancer Marker Testing Products
  • 6.6. Hematology Testing Products
  • 6.7. Others

7. By Application

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.1.2. Market Attractiveness Index, By Application
  • 7.2. Blood Transfusion*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Cardiac Monitoring
  • 7.4. Blood Glucose
  • 7.5. Haematology
  • 7.6. Non-Invasive SPO2 and CO2 Monitoring
  • 7.7. Others

8. By Testing Type

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
    • 8.1.2. Market Attractiveness Index, By Testing Type
  • 8.2. Immunoassays*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Cell-Based Assays
  • 8.4. Nucleic Acid Amplification Testing
  • 8.5. Clinical Chemistry Assays
  • 8.6. Hematology
  • 8.7. Others

9. By Distribution Channel

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.1.2. Market Attractiveness Index, By Distribution Channel
  • 9.2. Hospital Pharmacies*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Retail Pharmacies
  • 9.4. Online Pharmacies

10. By Region

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.8. The U.S.
    • 10.2.9. Canada
    • 10.2.10. Mexico
  • 10.3. Europe
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.8. Germany
    • 10.3.9. UK
    • 10.3.10. France
    • 10.3.11. Italy
    • 10.3.12. Spain
    • 10.3.13. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.8. Brazil
    • 10.4.9. Argentina
    • 10.4.10. Rest of South America
  • 10.5. Asia-Pacific
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.8. China
    • 10.5.9. India
    • 10.5.10. Japan
    • 10.5.11. South Korea
    • 10.5.12. Rest of Asia-Pacific
  • 10.6. Middle East and Africa
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Product
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Testing Type
    • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

11. Competitive Landscape

  • 11.1. Competitive Scenario
  • 11.2. Market Positioning/Share Analysis
  • 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

  • 12.1. Abbott*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. F. Hoffmann-La Roche
  • 12.3. BD
  • 12.4. Siemens Healthcare Private Limited
  • 12.5. Bio-Rad Laboratories, Inc.
  • 12.6. Danaher Corporation
  • 12.7. SEKISUI Diagnostics
  • 12.8. Trinity Biotech
  • 12.9. Beckman Coulter, Inc.
  • 12.10. Nova Biomedical

LIST NOT EXHAUSTIVE

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us
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