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Point-of-Care Diagnostics Market Assessment, By Product, By Prescription, By End-user, By Region, Opportunities and Forecast, 2017-2031F

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    • Abbott Laboratories
    • F. Hoffmann-La Roche Ltd
    • Cepheid Inc.
    • Becton Dickinson and Company
    • BioMerieux SA
    • Sekisui Diagnostics, LLC
    • Qiagen NV
    • Cipla Limited
    • QuidelOrtho Corporation
    • Nova Biomedical Corporation

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JHS 24.11.29

Global point-of-care diagnostics market is projected to witness a CAGR of 7.90% during the forecast period 2024-2031, growing from USD 47.21 billion in 2023 to USD 86.74 billion in 2031.

Factors driving the point-of-care diagnostics market include the rising prevalence of infectious diseases, increased investment in technology that includes artificial intelligence, growing demand for decentralized healthcare solutions, and increased corporate investments. Apart from this, improvement in the trend towards home care improves the patient's experience and lowers the costs of healthcare as well.

Global point-of-care (POC) diagnostics consists of rapid, on-site tests that enable immediate clinical decision-making. These tests are significant as they allow accurate and timely reporting, improving patient care results and reducing the need for centralized lab facilities. Its high ability to deliver fast, reliable diagnostics at the point of patient care positions it in a valuable category in every healthcare setting, initiating a more efficient, accessible healthcare delivery worldwide.

Companies are strengthening their diagnostics segment through R&D investment to gain a solid stand in the advanced point-of-care diagnostics market. Moreover, they obtain funds to develop their capabilities and speed up innovation in diagnostic solutions. Overall, these strategic initiatives enhance the quality and efficiency of POC diagnostics, fueling market growth and steadily increasing demand for faster, more accurate testing. For instance, in July 2024, NOWDiagnostics, Inc. (NOWDx) closed a USD 22.5 million Series B funding aimed at fast-tracking rapid at-home diagnostic tests. NOWDxwill utilize the funding for the launch of innovative diagnostics, and home-based tests and expand the portfolio of tests. NOWDx has a promising clinical research pipeline of around 30 diagnostic tests, and the company is willing to utilize the funding for the approval and commercialization of these tests.

Similarly, in August 2024, Lumos Diagnostics Holdings Limited (Lumos), a rapid POC diagnostic solutions manufacturer, extended its partnership with the Burnet Institute to conduct a clinical trial of a new POC test for monitoring liver health. This kind of development suggests that the market is expanding and increasing demand to innovate liver function monitoring and pave the way for future home-based tests.

Technological Advancements of Point-of-Care Diagnostics

Technological advancement is driving the growth of point-of-care diagnostics as a viable means to ease healthcare burdens. These devices are user-friendly and inexpensive, with rapid turnaround times; thus, they suit patients with financial constraints, social stigma, and mobility issues. Miniaturized biochip devices can detect diseases rapidly using simple samples such as blood or saliva. Integrating AI and microfluidic technologies improves diagnostic precision and efficiency, making it possible for POC devices to detect biomarkers in a wide range of conditions, from infectious diseases to oncology and many more. For instance, in June 2023, Sysmex Corporation launched its first point-of-care testing system for Europe, designed to diagnose antimicrobial susceptibility in 30 minutes rapidly. Using microfluidic technology, the system rapidly detects bacteria, analyzes the effectiveness of antimicrobial drugs using urine samples, and is likely to alter conventional approaches toward the diagnosis of infectious diseases and deal with the imperative urgency of speeding up the detection of UTI infections.

Growing Preference for Home Care Driving Market Growth

The growing preference for healthcare services at home is a key driver for growth in the point-of-care diagnostics segment. Patients are now looking for convenient, cost-effective, and more customized care delivery. There has been a rising demand for diagnostic tests that can be performed outside traditional clinical settings. POC diagnostics allow people to track their health conditions from the comfort of their homes. This reduces the number of hospital visits and decreases healthcare costs. The availability, accessibility, and usability of home-based diagnosis solutions are attractive factors contributing to increased usage and driving the market in the health sector. For instance, in March 2023, Cue Health Inc. launched a portfolio of home-based diagnostic test kits that offer company test-to-treat services to help people with easy health management from their homes. The marketed kits include heart health test kits, sexual health test kits, women's health test kits, metabolic health test kits, and wellness test kits. These kits are enabled with Cue Care, allowing a simple and private collection of samples for the CLIA-certified independent laboratory analysis. The results are efficiently provided in the Cue Health App, coupled with relevant health information.

Favorable Funding Scenario to Fuel Market Growth

The COVID-19 pandemic has significantly transformed the funding landscape of point-of-care diagnostics. Health disparities caused during the pandemic highlight the need for fast, accurate, and accessible testing. In response, funding for R&D has surged to develop advanced and more point-of-care diagnostic tests. That additional funding helped drive faster the development of new POC diagnostics solutions that could rapidly and effectively diagnose and treat health conditions. The capital inflow has also expanded testing capabilities beyond COVID-19 to a broader set of conditions and applications. For this reason, the market is likely to experience tremendous growth, with ongoing investment remaining in a core position to drive diagnostic innovations in terms of improved access to healthcare for populations.

For instance, in March 2024, BioMerieux SA invested USD 10.76 million (NOK 115 million) to develop a small-scale immunoassay POC analyzer with SpinChip Diagnostics ASA. This advanced platform delivers diagnostic performance from a single blood droplet within minutes and has scalability across the POC market. The first product is a high-sensitivity cardiac troponin I test, which will be a monumental step in the method of emergency triaging and treatment of acute heart attacks.

Infectious Disease Testing Products Dominating Point-of-Care Diagnostics Market

Infectious disease testing products hold the largest share of the POC diagnostics market. They create an utmost need to provide rapid, on-site diagnosis for conditions such as COVID-19, HIV, influenza, and tuberculosis. These tests can be done immediately; thus, results can speed up the decisions about treatment, and infectious diseases will not spread faster as they are being diagnosed promptly. The portability and ease with which they may be used in even clinical settings, as well as remote or resource-limited areas, ensure their effectiveness. The growing epidemics of infectious diseases coupled with the technological advancements in POC testing devices further gave strength to these tools for controlling outbreaks and managing public health challenges effectively.

In August 2023, QuidelOrtho Corporation received De Novo FDA approval for its Sofia 2 SARS Antigen+ FIA. The prescription test is well-suited to point-of-care settings, supporting companies' efforts to expand their product offerings for infectious disease testing. This approval reflects the ongoing trend of companies looking at upgrading diagnostic offerings by securing regulatory approvals and launching more advanced tests to respond to growing demand.

North America Dominates Point-of-Care Diagnostics Market Share

North America holds the largest share in the point-of-care diagnostics market due to robust healthcare infrastructure and is largely supported by the government, which leads to the encouragement of innovation and significant adoption of more advanced diagnostic technologies. The presence of prominent market players creates competition, and this, in turn, leads to a continued development in product offerings. For instance, in July 2023, Vital Biosciences Inc., a Canada-based company, launched its first point-of-care testing platform, VitalOne, a compact device roughly the size of a desktop computer, at the Annual Meeting of the American Association of Clinical Chemistry. It will revolutionize diagnostics, as the system can provide more than 50 lab-grade results within 20 minutes. Moreover, regional companies are streamlining efforts, helping drive its leadership. In July 2024, Babson Diagnostics, Inc. introduced its new BetterWay blood testing service at Austin retail pharmacies. This BetterWay enables patients to be tested at retail pharmacies. This makes access easier for consumers. This will encourage more people to seek such diagnostic services, further fueling the demand in the market.

Future Market Scenario (2024-2031F)

This market is expected to hold several growth opportunities in the coming years due to an increasing prevalence of infectious disease, advancement in point-of-care diagnostic technologies, growing advancements in home care diagnostics, and an increase in investments toward research and development activities. In addition, AI-integrated testing holds great promise in the future toward both accuracy and usability, and researchers are working to make the innovation even better. For example, in August 2024, a team at the University of California, Los Angeles (UCLA) managed to design an AI-based test similar to home-based COVID-19 tests that would detect Lyme disease accurately in under 20 minutes.

Key Players Landscape and Outlook

The global point-of-care diagnostics market is relatively competitive. Companies are enforcing their position through strategic collaborations, inventions of new and accurate testing methods, acquisition of necessary regulatory clearances, and diversification of their product portfolios to improve accessibility and fulfill rising healthcare demands.

In August 2024, F. Hoffmann-La Roche Ltd expanded its partnership with Glytec, LLC, to enhance hospital diabetes management. Through this collaboration, Glytec's software will be integrated with Roche's Cobas pulse point-of-care blood glucose system, which is looking to enhance safety and quality of care along with cost-effectiveness for patients. Its lab-quality results minimize the retesting rate, and Cobas pulse is suitable for a wide range of patient groups, including neonates and intensive care patients.

In March 2024, QuidelOrtho Corporation received Health Canada approval for its Triage PLGF test for laboratory use nationwide. The fluorescence immunoassay measuring placental growth factor (PLGF) in maternal plasma is used with the Triage MeterPro Instrument to detect angiogenic imbalance caused by poor placental blood flow, which may lead to pregnancy complications, including pre-eclampsia. Such testing can diagnose preterm pre-eclampsia and predict short-term risks for delivery.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Impact of COVID-19 on Global Point-of-Care Diagnostics Market

5. Voice of Customer

  • 5.1. Product and Market Intelligence
  • 5.2. Mode of Brand Awareness
  • 5.3. Factors Considered in Purchase Decisions
    • 5.3.1. Features and Other Value-Added Service
    • 5.3.2. Infrastructure Compatibility
    • 5.3.3. Efficiency of Solutions
    • 5.3.4. After-Sales Support
  • 5.4. Consideration of Privacy and Regulations

6. Global Point-of-Care Diagnostics Market Outlook, 2017-2031F

  • 6.1. Market Size Analysis & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share Analysis & Forecast
    • 6.2.1. By Product
      • 6.2.1.1. Glucose Monitoring
        • 6.2.1.1.1. Strips
        • 6.2.1.1.2. Meters
        • 6.2.1.1.3. Lancets
      • 6.2.1.2. Cardiometabolic Testing Products
        • 6.2.1.2.1. Cardiac Marker Testing Products
          • 6.2.1.2.1.1. High Sensitive Troponin-I (hsTnl)
          • 6.2.1.2.1.2. Brain natriuretic peptide (BNP)
          • 6.2.1.2.1.3. D-dimer
          • 6.2.1.2.1.4. Creatine Kinase-MB (CK-MB)
          • 6.2.1.2.1.5. Myoglobin
          • 6.2.1.2.1.6. Others
        • 6.2.1.2.2. Blood Gas/Electrolytes Testing Products
        • 6.2.1.2.3. HbA1C Testing Products
      • 6.2.1.3. Infectious Disease Testing Products
        • 6.2.1.3.1. Sexually Transmitted Disease (STD) Testing Products
        • 6.2.1.3.2. Healthcare-associated Infection (HAI) Testing Products
        • 6.2.1.3.3. Respiratory Infection Testing Products
        • 6.2.1.3.4. Tropical Disease Testing Products
        • 6.2.1.3.5. Others
      • 6.2.1.4. Coagulation Testing Products
        • 6.2.1.4.1. Prothrombin Time Testing Products
        • 6.2.1.4.2. Activated Clotting Time/Activated Partial Thromboplastin Clotting Time (ACT/APTT) Testing Products
      • 6.2.1.5. Pregnancy and Fertility Testing Products
        • 6.2.1.5.1. Pregnancy Testing Products
        • 6.2.1.5.2. Fertility Testing Products
      • 6.2.1.6. Tumor/cancer Marker Testing Products
      • 6.2.1.7. Cholesterol Testing Products
      • 6.2.1.8. Hematology Testing Products
      • 6.2.1.9. Drug-of-abuse (DoA) Testing Products
      • 6.2.1.10. Fecal Occult Testing Products
      • 6.2.1.11. Urinalysis Testing Products
      • 6.2.1.12. Others
    • 6.2.2. By Prescription
      • 6.2.2.1. OTC Testing
      • 6.2.2.2. Prescription-based Testing
    • 6.2.3. By End-user
      • 6.2.3.1. Hospitals
      • 6.2.3.2. Diagnostic Centers
      • 6.2.3.3. Research Laboratories
      • 6.2.3.4. Home-care Settings
      • 6.2.3.5. Others
    • 6.2.4. By Region
      • 6.2.4.1. North America
      • 6.2.4.2. Europe
      • 6.2.4.3. Asia-Pacific
      • 6.2.4.4. South America
      • 6.2.4.5. Middle East and Africa
    • 6.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
  • 6.3. Market Map Analysis, 2023
    • 6.3.1. By Product
    • 6.3.2. By Prescription
    • 6.3.3. By End-user
    • 6.3.4. By Region

7. North America Point-of-Care Diagnostics Market Outlook, 2017-2031F*

  • 7.1. Market Size Analysis & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share Analysis & Forecast
    • 7.2.1. By Product
      • 7.2.1.1. Glucose Monitoring
        • 7.2.1.1.1. Strips
        • 7.2.1.1.2. Meters
        • 7.2.1.1.3. Lancets
      • 7.2.1.2. Cardiometabolic Testing Products
        • 7.2.1.2.1. Cardiac Marker Testing Products
          • 7.2.1.2.1.1. High Sensitive Troponin-I (hsTnl)
          • 7.2.1.2.1.2. Brain natriuretic peptide (BNP)
          • 7.2.1.2.1.3. D-dimer
          • 7.2.1.2.1.4. Creatine Kinase-MB (CK-MB)
          • 7.2.1.2.1.5. Myoglobin
          • 7.2.1.2.1.6. Others
        • 7.2.1.2.2. Blood Gas/Electrolytes Testing Products
        • 7.2.1.2.3. HbA1C Testing Products
      • 7.2.1.3. Infectious Disease Testing Products
        • 7.2.1.3.1. Sexually Transmitted Disease (STD) Testing Products
        • 7.2.1.3.2. Healthcare-associated Infection (HAI) Testing Products
        • 7.2.1.3.3. Respiratory Infection Testing Products
        • 7.2.1.3.4. Tropical Disease Testing Products
        • 7.2.1.3.5. Others
      • 7.2.1.4. Coagulation Testing Products
        • 7.2.1.4.1. Prothrombin Time Testing Products
        • 7.2.1.4.2. Activated Clotting Time/Activated Partial Thromboplastin Clotting Time (ACT/APTT) Testing Products
      • 7.2.1.5. Pregnancy and Fertility Testing Products
        • 7.2.1.5.1. Pregnancy Testing Products
        • 7.2.1.5.2. Fertility Testing Products
      • 7.2.1.6. Tumor/cancer Marker Testing Products
      • 7.2.1.7. Cholesterol Testing Products
      • 7.2.1.8. Hematology Testing Products
      • 7.2.1.9. Drug-of-abuse (DoA) Testing Products
      • 7.2.1.10. Fecal Occult Testing Products
      • 7.2.1.11. Urinalysis Testing Products
      • 7.2.1.12. Others
    • 7.2.2. By Prescription
      • 7.2.2.1. OTC Testing
      • 7.2.2.2. Prescription-based Testing
    • 7.2.3. By End-user
      • 7.2.3.1. Hospitals
      • 7.2.3.2. Diagnostic Centers
      • 7.2.3.3. Research Laboratories
      • 7.2.3.4. Home-care Settings
      • 7.2.3.5. Others
    • 7.2.4. By Country Share
      • 7.2.4.1. United States
      • 7.2.4.2. Canada
      • 7.2.4.3. Mexico
  • 7.3. Country Market Assessment
    • 7.3.1. United States Point-of-Care Diagnostics Market Outlook, 2017-2031F*
      • 7.3.1.1. Market Size Analysis & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share Analysis & Forecast
        • 7.3.1.2.1. By Product
          • 7.3.1.2.1.1. Glucose Monitoring
          • 7.3.1.2.1.1.1. Strips
          • 7.3.1.2.1.1.2. Meters
          • 7.3.1.2.1.1.3. Lancets
          • 7.3.1.2.1.2. Cardiometabolic Testing Products
          • 7.3.1.2.1.2.1. Cardiac Marker Testing Products
          • 7.3.1.2.1.2.1.1. High Sensitive Troponin-I (hsTnl)
          • 7.3.1.2.1.2.1.2. Brain natriuretic peptide (BNP)
          • 7.3.1.2.1.2.1.3. D-dimer
          • 7.3.1.2.1.2.1.4. Creatine Kinase-MB (CK-MB)
          • 7.3.1.2.1.2.1.5. Myoglobin
          • 7.3.1.2.1.2.1.6. Others
          • 7.3.1.2.1.2.2. Blood Gas/Electrolytes Testing Products
          • 7.3.1.2.1.2.3. HbA1C Testing Products
          • 7.3.1.2.1.3. Infectious Disease Testing Products
          • 7.3.1.2.1.3.1. Sexually Transmitted Disease (STD) Testing Products
          • 7.3.1.2.1.3.2. Healthcare-associated Infection (HAI) Testing Products
          • 7.3.1.2.1.3.3. Respiratory Infection Testing Products
          • 7.3.1.2.1.3.4. Tropical Disease Testing Products
          • 7.3.1.2.1.3.5. Others
          • 7.3.1.2.1.4. Coagulation Testing Products
          • 7.3.1.2.1.4.1. Prothrombin Time Testing Products
          • 7.3.1.2.1.4.2. Activated Clotting Time/Activated Partial Thromboplastin Clotting Time (ACT/APTT) Testing Products
          • 7.3.1.2.1.5. Pregnancy and Fertility Testing Products
          • 7.3.1.2.1.5.1. Pregnancy Testing Products
          • 7.3.1.2.1.5.2. Fertility Testing Products
          • 7.3.1.2.1.6. Tumor/cancer Marker Testing Products
          • 7.3.1.2.1.7. Cholesterol Testing Products
          • 7.3.1.2.1.8. Hematology Testing Products
          • 7.3.1.2.1.9. Drug-of-abuse (DoA) Testing Products
          • 7.3.1.2.1.10. Fecal Occult Testing Products
          • 7.3.1.2.1.11. Urinalysis Testing Products
          • 7.3.1.2.1.12. Others
        • 7.3.1.2.2. By Prescription
          • 7.3.1.2.2.1. OTC Testing
          • 7.3.1.2.2.2. Prescription-based Testing
        • 7.3.1.2.3. By End-user
          • 7.3.1.2.3.1. Hospitals
          • 7.3.1.2.3.2. Diagnostic Centers
          • 7.3.1.2.3.3. Research Laboratories
          • 7.3.1.2.3.4. Home-care Settings
          • 7.3.1.2.3.5. Others
    • 7.3.2. Canada
    • 7.3.3. Mexico

All segments will be provided for all regions and countries covered

8. Europe Point-of-Care Diagnostics Market Outlook, 2017-2031F

  • 8.1. Germany
  • 8.2. France
  • 8.3. Italy
  • 8.4. United Kingdom
  • 8.5. Russia
  • 8.6. Netherlands
  • 8.7. Spain
  • 8.8. Turkey
  • 8.9. Poland

9. Asia-Pacific Point-of-Care Diagnostics Market Outlook, 2017-2031F

  • 9.1. India
  • 9.2. China
  • 9.3. Japan
  • 9.4. Australia
  • 9.5. Vietnam
  • 9.6. South Korea
  • 9.7. Indonesia
  • 9.8. Philippines

10. South America Point-of-Care Diagnostics Market Outlook, 2017-2031F

  • 10.1. Brazil
  • 10.2. Argentina

11. Middle East and Africa Point-of-Care Diagnostics Market Outlook, 2017-2031F

  • 11.1. Saudi Arabia
  • 11.2. UAE
  • 11.3. South Africa

12. Demand Supply Analysis

13. Value Chain Analysis

14. Porter's Five Forces Analysis

15. PESTLE Analysis

16. Pricing Analysis

17. Market Dynamics

  • 17.1. Market Drivers
  • 17.2. Market Challenges

18. Market Trends and Developments

19. Regulatory Framework and Innovation

  • 19.1. Regulatory Approvals

20. Case Studies

21. Competitive Landscape

  • 21.1. Competition Matrix of Top 5 Market Leaders
  • 21.2. SWOT Analysis for Top 5 Players
  • 21.3. Key Players Landscape for Top 10 Market Players
    • 21.3.1. Abbott Laboratories
      • 21.3.1.1. Company Details
      • 21.3.1.2. Key Management Personnel
      • 21.3.1.3. Products and Services
      • 21.3.1.4. Financials (As Reported)
      • 21.3.1.5. Key Market Focus and Geographical Presence
      • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
    • 21.3.2. F. Hoffmann-La Roche Ltd
    • 21.3.3. Cepheid Inc.
    • 21.3.4. Becton Dickinson and Company
    • 21.3.5. BioMerieux SA
    • 21.3.6. Sekisui Diagnostics, LLC
    • 21.3.7. Qiagen N.V.
    • 21.3.8. Cipla Limited
    • 21.3.9. QuidelOrtho Corporation
    • 21.3.10. Nova Biomedical Corporation

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

22. Strategic Recommendations

23. About Us and Disclaimer

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