USA Point of Care Infectious Disease Testing Market Size, Share, Trends and Forecasts 2031

Key Findings

• The USA Point of Care Infectious Disease Testing Market is witnessing strong growth due to the rising demand for rapid and decentralized diagnostic solutions.

• Increasing prevalence of infectious diseases and outbreaks is accelerating the adoption of point-of-care testing across healthcare settings in USA.

• Technological advancements in molecular diagnostics and immunoassays are improving test accuracy and turnaround time.

• Hospitals, clinics, and emergency care centers in USA are increasingly relying on point-of-care tests for faster clinical decision-making.

• The expansion of home-based and remote testing solutions is broadening the market scope.

• Government initiatives supporting early diagnosis and disease surveillance are strengthening market growth.

• Growing awareness of preventive healthcare is boosting demand for rapid infectious disease testing.

• Strategic collaborations between diagnostic companies and healthcare providers are driving innovation in USA.

USA Point of Care Infectious Disease Testing Market Size and Forecast

The USA Point of Care Infectious Disease Testing Market is projected to grow from USD 3.9 billion in 2025 to USD 8.7 billion by 2031, at a CAGR of 14.3% during the forecast period. This growth is driven by the increasing need for immediate diagnostic results to control disease spread and improve patient outcomes. The shift toward decentralized healthcare delivery and outpatient care is further supporting market expansion.

Technological innovations are making point-of-care tests more reliable and easier to use. With sustained investments in healthcare infrastructure, USA is expected to remain a high-growth market for point-of-care infectious disease diagnostics.

Introduction

Point of care infectious disease testing refers to diagnostic tests conducted near or at the site of patient care, delivering rapid results without the need for centralized laboratories. In USA, these tests play a critical role in early detection, treatment initiation, and disease containment. The growing burden of infectious diseases and rising healthcare demands have increased reliance on portable and easy-to-use diagnostic devices.

Point-of-care testing reduces diagnostic delays and supports faster clinical decisions. As healthcare systems prioritize efficiency and accessibility, point-of-care infectious disease testing is becoming an integral component of diagnostic strategies in USA.

Future Outlook

By 2031, point-of-care infectious disease testing in USA will be deeply integrated into routine healthcare workflows. The adoption of molecular-based point-of-care diagnostics will continue to rise, offering higher sensitivity and specificity. Home-based testing and telemedicine-supported diagnostics will further expand access to testing services.

Public health agencies will increasingly rely on point-of-care testing for disease surveillance and outbreak control. Continuous innovation and supportive regulatory frameworks will ensure sustained market growth in USA.

USA Point of Care Infectious Disease Testing Market Trends

• Rising Adoption of Rapid Diagnostic Tests
  Rapid diagnostic tests are gaining widespread acceptance across healthcare settings in USA due to their ability to deliver results within minutes. These tests enable clinicians to make immediate treatment decisions, reducing hospital stays and unnecessary antibiotic use. Their simplicity and portability make them suitable for emergency departments, clinics, and rural healthcare facilities. Manufacturers are improving test sensitivity and specificity to match laboratory standards. This trend underscores the growing reliance on speed and efficiency in infectious disease management.

• Growth of Molecular Point-of-Care Testing
  Molecular diagnostics at the point of care are transforming infectious disease testing in USA. These tests offer high accuracy and can detect pathogens at early stages of infection. Advances in microfluidics and nucleic acid amplification technologies are making molecular tests more compact and user-friendly. Healthcare providers are increasingly adopting these solutions for diseases requiring precise diagnosis. This trend reflects the shift toward advanced diagnostics outside traditional laboratories.

• Expansion of Home-Based Testing Solutions
  Home-based point-of-care infectious disease tests are becoming more prevalent in USA. Consumers value the convenience, privacy, and rapid results offered by these solutions. The integration of digital reporting and telehealth platforms is enhancing test usability and follow-up care. Regulatory approvals for at-home infectious disease tests are increasing market confidence. This trend is reshaping patient engagement and diagnostic accessibility.

• Increased Use in Emergency and Critical Care Settings
  Emergency departments in USA are increasingly relying on point-of-care infectious disease testing to manage patient flow efficiently. Rapid diagnosis helps in isolating infectious patients and initiating timely treatment. This reduces overcrowding and improves infection control within healthcare facilities. The ability to perform tests at bedside is particularly valuable in high-pressure clinical environments. This trend highlights the importance of speed and reliability in acute care settings.

• Integration with Digital Health Platforms
  Point-of-care testing devices in USA are being integrated with digital health systems for data management and reporting. Connectivity features allow test results to be transmitted directly to electronic health records. This improves clinical workflow efficiency and supports real-time disease monitoring. Digital integration also aids public health surveillance and outbreak response. This trend reflects the convergence of diagnostics and digital healthcare technologies.

Market Growth Drivers

• Rising Burden of Infectious Diseases
  The increasing prevalence of infectious diseases in USA is a major driver for point-of-care testing adoption. Early diagnosis is critical for effective treatment and prevention of disease transmission. Point-of-care tests enable healthcare providers to deliver timely care, particularly during outbreaks. Growing awareness of infectious disease risks is encouraging routine testing. This driver remains fundamental to sustained market growth.

• Demand for Rapid and Decentralized Diagnostics
  Healthcare systems in USA are shifting toward decentralized diagnostic models to improve efficiency. Point-of-care testing reduces dependence on centralized laboratories and shortens diagnostic timelines. This is especially important in remote and resource-limited settings. Faster results lead to improved patient outcomes and optimized healthcare resources. This driver aligns with broader healthcare transformation goals.

• Technological Advancements in Testing Platforms
  Continuous innovation in diagnostic technologies is expanding the capabilities of point-of-care tests in USA. Advances in biosensors, microfluidics, and assay design are improving test accuracy and reliability. These improvements are increasing clinician confidence in point-of-care results. Manufacturers are also focusing on ease of use to reduce training requirements. This technological progress is fueling market expansion.

• Government Support and Public Health Initiatives
  Governments in USA are promoting early disease detection through funding and policy support. Public health programs emphasize rapid testing to control infectious disease spread. Point-of-care testing is being incorporated into national disease surveillance strategies. Regulatory agencies are streamlining approvals to accelerate market entry. This supportive environment is driving adoption across healthcare settings.

• Growing Awareness of Preventive Healthcare
  Preventive healthcare initiatives in USA are encouraging routine screening and early diagnosis. Point-of-care infectious disease tests support these initiatives by offering quick and accessible testing. Increased health literacy among populations is boosting demand for diagnostic services. Employers and institutions are also adopting testing programs to ensure safety. This driver strengthens long-term market demand.

Challenges in the Market

• Limited Test Accuracy Compared to Laboratory Diagnostics
  Despite advancements, some point-of-care tests in USA still offer lower accuracy than laboratory-based methods. False positives or negatives can impact clinical decision-making. Healthcare providers may hesitate to rely solely on point-of-care results for critical diagnoses. Continuous validation and quality improvements are required to address this concern. This challenge affects trust and adoption in certain clinical scenarios.

• Regulatory and Compliance Complexity
  Regulatory requirements for diagnostic devices vary across regions in USA, creating challenges for manufacturers. Ensuring compliance with quality and safety standards can delay product launches. Smaller companies may struggle with regulatory costs and documentation. Harmonization of regulatory frameworks is still evolving. This challenge can slow innovation and market entry.

• High Cost of Advanced Point-of-Care Technologies
  Advanced molecular point-of-care tests can be expensive to manufacture and deploy. In USA, cost constraints limit adoption in low-resource healthcare settings. Budget limitations may restrict widespread implementation in public healthcare systems. Manufacturers are working to reduce costs through innovation and scale. Affordability remains a critical challenge for market expansion.

• Limited Skilled Workforce for Test Administration
  Proper administration and interpretation of point-of-care tests require trained personnel. In some regions of USA, there is a shortage of skilled healthcare workers. Inadequate training can lead to errors and reduced test reliability. Continuous education programs are needed to address this gap. Workforce limitations can hinder effective adoption.

• Supply Chain and Distribution Challenges
  The distribution of point-of-care testing kits in USA faces logistical challenges, especially in remote areas. Supply chain disruptions can affect product availability during peak demand periods. Maintaining cold chain and storage conditions adds complexity. Manufacturers are investing in resilient supply chains to mitigate these risks. Distribution challenges remain a barrier to consistent market growth.

USA Point of Care Infectious Disease Testing Market Segmentation

By Test Type

• Molecular Tests

• Immunoassays

• Rapid Antigen Tests

• Others

By Disease Type

• Respiratory Infections

• HIV

• Hepatitis

• Sexually Transmitted Infections

• Tropical Infectious Diseases

• Others

By End-User

• Hospitals

• Clinics

• Diagnostic Centers

• Home Care Settings

• Others

Leading Key Players

• Abbott Laboratories

• Roche Diagnostics

• Siemens Healthineers

• Becton, Dickinson and Company (BD)

• bioMérieux SA

• Danaher Corporation

• QuidelOrtho Corporation

• Cepheid (Danaher)

• Hologic, Inc.

• Thermo Fisher Scientific Inc.

Recent Developments

• Abbott Laboratories launched a next-generation rapid infectious disease test in USA.

• Roche Diagnostics expanded its molecular point-of-care portfolio for decentralized testing in USA.

• Siemens Healthineers partnered with healthcare providers in USA to enhance diagnostic accessibility.

• bioMérieux SA introduced automated point-of-care solutions for hospital settings in USA.

• QuidelOrtho Corporation expanded distribution of rapid antigen tests across USA.

This Market Report Will Answer the Following Questions

1. What is the projected size and CAGR of the USA Point of Care Infectious Disease Testing Market by 2031?

2. Which technologies are driving innovation in point-of-care infectious disease diagnostics?

3. How are government initiatives influencing market adoption in USA?

4. What challenges are limiting the accuracy and accessibility of point-of-care tests?

5. Who are the leading companies shaping the future of the USA Point of Care Infectious Disease Testing Market?