North America Point-Of-Care Diagnostics Market – Industry Trends and Forecast to 2031

North America Point-Of-Care Diagnostics Market Analysis and Size

The point-of-care diagnostics market is expected to experience significant growth due to the rising importance of such diagnostics in environmental monitoring and public health. Increased funding from sources such as NIH, private foundations such as the Bill & Melinda Gates Foundation, and the U.S. Department of Defense has empowered manufacturers to enhance their capabilities in producing point-of-care diagnostics equipment.

Data Bridge Market Research analyses the North America point-of-care diagnostics market, which was USD 18.62 billion in 2023, is expected to reach USD 30.12 billion by 2031, at a CAGR of 6.20% during the forecast period 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 diagnostics are rapid and sensitive methods employed for early infection detection. They offer cost-effective solutions for outpatients, physicians, clinical labs, and home health settings. This approach enables swift medical decisions by facilitating early disease diagnosis, leading to improved health outcomes through prompt initiation of treatment.

North America Point-Of-Care Diagnostics Market Dynamics

Drivers

• Technological Advancements Provide Enhanced Diagnostic Capabilities

Continuous innovations, such as miniaturized devices, advanced sensors, and cutting-edge biosensors, contribute to quicker and more accurate disease detection. These technological strides empower healthcare professionals with efficient tools, enabling rapid on-the-spot diagnostics. As the point-of-care landscape evolves, the integration of state-of-the-art technologies improves testing accuracy and supports the market's growth by addressing the increasing demand for quick and precise diagnostic solutions.

• Rising Incidence of Infectious Diseases Increases the Need for Rapid Diagnostic Solutions

The rising incidence of infections necessitates quick and accurate diagnostic solutions to enable prompt initiation of treatment. Point-of-care diagnostics offer a timely and efficient means of disease detection, particularly in regions with a high burden of infectious diseases. This growing demand for rapid and on-the-spot diagnostic tools propels the market forward, as healthcare systems seek effective strategies for early detection and containment of infectious threats.

Opportunities

• Growing Emphasis on Non-Communicable Diseases Increases the Growth of the Diagnostic Market

As the prevalence of chronic conditions such as diabetes, cardiovascular diseases, and cancer rises, there is a growing need for rapid and accessible diagnostic tools. Point-of-care diagnostics offer quick and efficient means of detecting and monitoring NCDs, enabling timely intervention and personalized treatment strategies. This heightened focus on NCDs propels the demand for point-of-care solutions, contributing to the expansion of the diagnostic market in addressing the challenges posed by chronic illnesses.

• Remote Patient Monitoring Provides Certain Tests at Home 

Enabling individuals to conduct specific tests in the comfort of their homes, this approach enhances accessibility to healthcare. Remote monitoring devices, coupled with diagnostic capabilities, empower patients to conveniently perform tests, promoting early detection and proactive management of health conditions. This trend fosters patient engagement and contributes to the overall growth of the point-of-care diagnostics market by expanding its reach beyond traditional healthcare settings.

Restraints/Challenges

• Regulatory Challenges Effecting Seamless Operations

Stringent regulatory requirements and approval processes can lead to delays in product launches and market entry. Compliance complexities and evolving regulatory landscapes may pose hurdles for companies in achieving swift and efficient commercialization of point-of-care diagnostic technologies. These challenges may impact the market's growth by creating barriers to the timely introduction of innovative solutions and hindering the operational fluidity in the industry.

• Economic Constraints Limits the Affordability of Point-of-care Diagnostic Devices

The high initial costs and ongoing expenses associated with these advanced technologies may hinder their widespread adoption, particularly in resource-constrained settings. Limited financial resources within healthcare systems and among end-users could impede the accessibility of point-of-care diagnostic solutions, potentially slowing down market growth.

This North America point-of-care diagnostics 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 North America point-of-care diagnostics 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 2023, QIAGEN achieved CE certification for its IVD kit and NeuMoDx automated testing platform. This certification significantly bolstered the company's market share and revenue, marking a positive stride in the adoption of their advanced diagnostic technologies
• In 2023, Danaher Corporation introduced the Dxl 9000 Access Immunoassay Analyzer, capable of running up to 215 tests per hour. This strategic initiative expanded Danaher's portfolio in the point-of-care diagnostics sector, emphasizing increased testing efficiency and contributing to the company's market presence
• In 2022, Genes2Me Pvt. Ltd launched the Rapi-Q Point of Care RT PCR solution, targeting human papillomavirus (HPV) and tuberculosis. The device, with CE-IVD marking, offers rapid results in less than 45 minutes, displaying superior performance, high sensitivity, and user-friendly features
• In 2022, LumiraDx Healthcare launched its highly sensitive C-Reactive Protein (CRP) point-of-care antigen test in India. This innovative diagnostic tool addresses clinical settings' needs, aiding in the reduction of unnecessary antibiotic prescribing to combat antimicrobial resistance (AMR)
• In 2022, Genes2Me Pvt. Ltd, also launched the Rapi-Q Point of Care RT PCR solution for HPV and tuberculosis. Featuring CE-IVD marking, this device stands out for its simplicity, delivering rapid results in under 45 minutes, coupled with superior sensitivity and stable detection capabilities

North America Point-Of-Care Diagnostics Market Scope

The North America point-of-care diagnostics market is segmented on the basis of product, platform, prescription and end user. 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
• Strips
• Meters
• Lancets
• Lancing Device
• Cardio metabolic
• Cardiac marker
• Blood Gas
• Electrolytes
• HBA1C
• Infectious Disease
• Influenza
• HIV
• Hepatitis C
• Sexually Transmitted Disease (STD)
• Healthcare-Associated Infection (HAI)
• Respiratory Infection
• Tropical Disease
• Other Infectious Disease
• Coagulation
• PT or INR
• Activated clotting time (ACT or APTT)
• Pregnancy and Fertility
• Pregnancy Test
• Fertility Test
• Tumour or Cancer Marker
• Urinalysis
• Cholesterol
• Haematology
• Drugs-of-Abuse
• Fecal Occult
• Others

Platform

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

Prescription

• Prescription-Based Testing
• OTC Testing

End User

• Clinical Laboratories
• Outpatient Healthcare and Ambulatory Care Settings
• Hospitals or Critical Care Centres
• Home Care
•  Research Laboratories
• Others

North America Point-Of-Care Diagnostics Market Regional Analysis/Insights

The North America point-of-care diagnostics market is analyzed and market size insights and trends are provided by product, platform, prescription and end user as referenced above.

The major countries covered in the North America point-of-care diagnostics market report are U.S., Canada and Mexico

The U.S. is expected to grow with the CAGR in the forecast period, primarily attributed to a surge in COVID-19 cases. The heightened demand for point-of-care diagnostics is driven by the pandemic's impact. Furthermore, a growing awareness of self-testing and home care products is poised to contribute significantly to the expansion of the North America point-of-care diagnostics market, reflecting a broader trend toward decentralized and accessible healthcare solutions.

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 North America point-of-care diagnostics 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 North America point-of-care diagnostics market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the North America point-of-care diagnostics market. The data is available for historic period 2016-2021.

Competitive Landscape and North America Point-Of-Care Diagnostics Market Share Analysis

The North America point-of-care diagnostics 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, North America 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 North America point-of-care diagnostics market.

Key players operating in the North America point-of-care diagnostics market include:

• Abbott. (U.S.)
• Danaher Corporation (U.S.)
• B.D. (U.S.)
• QIAGEN (Germany)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Johnson & Johnson Private Limited (U.S.
• BIOMÉRIEUX (France)
•  Trividia Health, Inc (U.S.)
• Siemens Healthcare GmbH (Germany)
• QuidelOrtho Corporation (U.S.)
• Spectral Medical Inc (Canada)
• Abaxis (U.S.)
• Nova Biomedical (U.S.)
• Trinity Biotech (Ireland)
• Alfa Scientific Designs, Inc (U.S.)
• Bio-Rad Laboratories, Inc (U.S.) 

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