Global Point-of-Care Testing (POCT) Market – Industry Trends and Forecast to 2031

Point-of-Care Testing (POCT) Market Analysis and Size

In hematology, point-of-care testing (POCT) plays a crucial role in rapidly assessing various blood parameters at or near the patient's location. POCT devices for hematology enable healthcare professionals to measure key parameters such as hemoglobin levels, hematocrit, and white blood cell count without the need for samples to be sent to a centralized laboratory. This capability is particularly valuable in emergency situations, critical care settings, and remote or resource-limited areas where access to laboratory facilities may be limited. Rapid hematology testing aids in diagnosing conditions such as anemia, infections, and bleeding disorders, allowing for prompt initiation of appropriate treatment and management strategies.

Global point-of-care testing (POCT) market size was valued at USD 36.39 billion in 2023 and is projected to reach USD 80.88 billion by 2031, with a CAGR of 10.50% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation       

Market Definition

Point-of-care testing (POCT) is a medical diagnostic testing performed near or at the location of patient care, such as a doctor's office, clinic, or bedside. It provides rapid results, allowing for immediate clinical decision-making without the need for samples to be sent to a centralized laboratory. POCT devices are often portable and user-friendly, enabling healthcare professionals to conduct tests efficiently and conveniently. Common point of care testing examples include blood glucose monitoring, pregnancy tests, and rapid strep tests.

Point-of-Care Testing (POCT) Market Dynamics

Drivers

• Growing Technological Advancements Improving the Usability of Diagnostic Devices

Miniaturization of sensors, development of novel detection methods such as biosensors and microfluidics, and integration of wireless connectivity enhance the efficiency and accuracy of POCT devices. Furthermore, innovations in materials science and manufacturing techniques enable the production of cost-effective and robust point-of-care diagnostic solutions. These technological advancements empower healthcare providers with faster and more reliable diagnostic capabilities, leading to improved patient outcomes, reduced healthcare costs, and greater accessibility to testing in diverse clinical settings.

• Demand for Convenient Testing leads to the Rising Point of Care Technology in Various Medical Specialties

Patients and healthcare providers increasingly seek testing methods that offer quick results, allowing for immediate clinical decision-making and timely interventions. POCT devices fulfil this need by providing rapid diagnostics at or near the point of care, eliminating the time-consuming process of sending samples to centralized laboratories. This demand is particularly significant in emergency situations, critical care settings, and remote or resource-limited areas where access to laboratory facilities is limited. The convenience and efficiency offered by POCT devices enhance patient satisfaction, improve healthcare outcomes, and drive the adoption of these technologies in various medical specialties and settings.

Opportunities

• Increasing Prevalence of Chronic Diseases promotes the Adoption of POCT

As chronic conditions such as diabetes, cardiovascular diseases, and chronic respiratory disorders become more prevalent globally, there is a growing need for frequent monitoring and early detection of these conditions. POCT devices offer the advantage of providing rapid and convenient testing for various biomarkers associated with chronic diseases, enabling timely intervention and personalized treatment plans. It facilitates proactive disease management and reducing the burden on centralized healthcare facilities, POCT devices address the evolving healthcare needs of individuals with chronic conditions, thus driving market growth and adoption.

• Increasing Regulatory Support Providing Clear Standards for the Commercialization of POCT Devices

Well-defined regulatory frameworks ensure the safety, efficacy, and quality of POCT products, instilling confidence among healthcare providers and patients. Regulatory bodies such as the FDA in the United States and the European Medicines Agency (EMA) in Europe play crucial roles in streamlining the approval process for POCT devices, fostering innovation and market growth. Furthermore, regulatory support often includes expedited pathways for the approval of novel POCT technologies, encouraging manufacturers to invest in research and development efforts to bring innovative products to market more swiftly.

In response to the global burden of malaria highlighted by the WHO, well-defined regulatory frameworks, overseen by bodies such as the FDA and EMA, play a crucial role in expediting the approval of innovative point-of-care testing (POCT) devices for rapid and accurate diagnosis. This regulatory support not only ensures the safety and efficacy of POCT products but also fosters timely access to diagnostics, aiding in the effective management and control of malaria outbreaks worldwide.

Restraints/Challenges

• High Initial Investment Costs Pose Limitation for Point-of-Care Diagnostics Companies

Healthcare facilities also face substantial upfront expenses when purchasing POCT devices from these companies, along with additional costs for training staff, maintenance, and ongoing quality control. These costs may deter some healthcare providers, especially those in resource-constrained settings, from adopting POCT technologies developed by these companies. Furthermore, reimbursement policies and funding limitations may not adequately cover these initial investments, further limiting adoption and impacting the revenue potential of Point-of-Care diagnostics companies.

• Time Consuming Professional Training Limits the Growth of POCT

Extensive training necessary for healthcare professionals to proficiently operate POCT devices imposes significant time and resource constraints. This impediment slows down the adoption and expansion of POCT services within healthcare facilities. Moreover, the intricate nature of some POCT technologies demands specialized skills, exacerbating the training burden. Consequently, the market's potential for rapid growth is curtailed due to the limitations posed by the need for comprehensive and time-intensive training programs.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In May 2023, Siemens Healthcare GmbH formed a collabortaion with Unilabs worth over USD 200 million. Under this agreement, Unilabs will acquire 400 laboratory analyzers, aimed at enhancing the infrastructure for patient care
• In July 2022, BioGX launched a CE-marked three-gene multiplex POC COVID-19 test, utilizing their highly effective Xfree direct sample testing chemistry. This test, incorporated in their Xfree COVID-19 Direct RT-PCR assay, received emergency clearance from the USFDA, offering efficient and accurate COVID-19 diagnosis
• In January 2022, Roche launched its Cobas Pulse System in selected countries with the CE Mark approval. This system represents Roche Diagnostics' latest advancement in linked point-of-care solutions for professional blood glucose management, offering enhanced convenience and efficiency in monitoring blood glucose levels
• In October 2021, Thermo Fisher Scientific obtained FDA Emergency Use Authorization (EUA) to conduct COVID-19 tests utilizing the Spectrum Solutions SpectrumDNA SDNA-1000 collection device. This high-throughput, automated testing system, integrated with the Amplitude Solution, introduces a novel saliva sample collection method, streamlining COVID-19 testing processes

Point-of-Care Testing (POCT) Market Scope

The market is segmented on the basis of product, technology, prescription, application, end-user and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Product

• Glucose Monitoring Products
• Cardiometabolic Testing Products
• Infectious Disease Testing Products
• Pregnancy and Fertility Testing Products
• Tumor/Cancer Marker Testing Products
• Urinalysis Testing Products
• Cholesterol Testing Products
• Hematology Testing Products
• Drugs-of-Abuse Testing Products
• Fecal Occult Testing Products
• Rapid Coagulation Testing
• Other POC Products

Application

• Blood Transfusion
• Cardiac Monitoring
• Coagulation
• Blood Glucose
• Haematology
• Non- Invasive SPO2 Monitoring
• Non- Invasive PCO2 Monitoring
• Whole Blood Analysis
• Vital Sign Monitoring
• Others

Platform

• Lateral Flow Assays/Immunochromatography Tests
• Dipsticks, Microfluidics
• Molecular Diagnostics
• Immunoassays

Prescription Mode

• Prescription-Based Testing
• OTC Testing

Testing Type

• Immunoassays
• Cell-Based Assays
• Nucleic Acid Amplification Testing
• Clinical Chemistry Assays
• and Hematology

 End-User

• Hospitals
• Clinics
• Laboratories
• Home Care
• Ambulatory Surgery Centers
• Others

Distribution Channel

• Direct Tender
• Retail Pharmacies

 Point-of-Care Testing (POCT) Market Regional Analysis/Insights

The market is analyzed and market size insights and trends are provided by country, product, technology, prescription, application, end-user and distribution channel as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and rest of South America as part of South America.

North America is expected to dominate the market primarily because of its widespread adoption of advanced technologies in healthcare. Additionally, the region benefits from favorable reimbursement policies that encourage the utilization of POCT devices. Moreover, North America enjoys a higher standard of living, which increases the affordability and accessibility of such advanced medical technologies for the population. These factors collectively contribute to North America's dominance in the POCT market. For instance, In April 2023, Abbott announced clearance from the U.S. FDA for the reader component of the FreeStyle Libre 3 integrated continuous glucose monitoring system, marking a significant advancement in diabetes management technology.

The Asia-Pacific is expected for significant growth, driven by escalating demand for advanced diagnostic solutions and a concurrent rise in per capita income across the region. As individuals in Asia-Pacific gain greater purchasing power, they are increasingly investing in cutting-edge healthcare technologies, including diagnostic options. This trend is anticipated to fuel robust expansion, positioning the region as a key player in the global healthcare market during the forecast period.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and Point-of-Care Testing (POCT) Market Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• Abbott (U.S.)
• F. Hoffmann-La Roche Ltd (Switzerland)
• BD (U.S.)
• Siemens Healthcare Private Limited (Germany)
• Bio-Rad Laboratories, Inc. (U.S.)
• Danaher Corporation(U.S.)
• SEKISUI Diagnostics (U.S.)
• Trinity Biotech (Ireland)
• BIOMÉRIEUX (France)
• EKF Diagnostics (Germany)
• AccuBioTech Co., Ltd. (China)
• Beckman Coulter, Inc. (U.S.)
• PTS Diagnostics (U.S.)
• Nova Biomedical (U.S.)
• Chembio Diagnostics, Inc. (U.S.)
• QuidelOrtho Corporation (U.S.)
• Sienco, Inc (U.S.)

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