U.S. Infectious Disease Point-of-care (POC) Diagnostics Market Strategic Roadmap: Analysis and Forecasts 2025-2033

Key Insights

The size of the U.S. Infectious Disease Point-of-care (POC) Diagnostics Market was valued at USD 227.0 USD Million in 2023 and is projected to reach USD 341.32 USD Million by 2032, with an expected CAGR of 6.0% during the forecast period. Infectious disease point-of-care (POC) diagnostics in the U.S. refer to diagnostic tests and technologies designed to detect infections at or near the site of patient care, typically outside of traditional laboratory settings. These tests enable quick, on-site results, facilitating faster diagnosis and treatment, which is critical for controlling the spread of infectious diseases and improving patient outcomes. POC diagnostics are particularly important in urgent care settings, emergency departments, and for patients with limited access to healthcare facilities.

U.S. Infectious Disease Point-of-care (POC) Diagnostics Market Trends

Key market trends driving the growth of the U.S. Infectious Disease POC Diagnostics Market include:

• The rise in healthcare-associated infections (HAIs), which has led to an increased demand for rapid and accurate diagnostics to prevent and control the spread of infections in healthcare settings.
• The development of new and innovative POC diagnostic technologies, such as microfluidics and molecular diagnostics, which have improved the sensitivity, specificity, and speed of testing.
• The increasing adoption of POC diagnostics in various settings, including hospitals, physician's offices, urgent care clinics, and retail pharmacies, due to their convenience, portability, and user-friendliness.
• The growing awareness of the importance of early diagnosis and treatment of infectious diseases, which has fueled the demand for POC diagnostics that can provide timely and accurate results.

Driving Forces: What's Propelling the U.S. Infectious Disease Point-of-care (POC) Diagnostics Market

The U.S. Infectious Disease POC Diagnostics Market is experiencing robust expansion driven by a confluence of critical factors:

• Escalating Infectious Disease Burden: The persistent and, in some cases, increasing prevalence of both endemic and emerging infectious diseases within the U.S. necessitates rapid, accessible diagnostic solutions. This demand is fueled by the need for timely intervention, effective containment strategies, and improved patient management to mitigate the impact of outbreaks and individual infections.
• Transformative Technological Innovations: Continuous advancements in POC diagnostic technologies are revolutionizing the field. Innovations in areas such as microfluidics, biosensors, molecular diagnostics, and user-friendly interfaces are leading to POC devices that offer enhanced sensitivity, improved specificity, faster turnaround times, and broader multiplexing capabilities. These improvements expand the range of detectable pathogens and biomarkers, making POC testing more versatile and reliable.
• Proactive Government and Regulatory Support: Government initiatives, including funding for research and development, favorable regulatory pathways for emergency use authorizations (EUAs) and streamlined approvals, and public health campaigns promoting early detection, are significantly bolstering the market. Organizations like the CDC and FDA play a crucial role in setting standards, providing guidelines, and encouraging the adoption of effective POC diagnostic tools.
• Unmet Demand for Rapid and Decentralized Testing: The inherent need for immediate diagnostic results, particularly in critical care settings, during public health emergencies, and in remote or underserved areas, is a primary market driver. POC diagnostics empower healthcare professionals to make informed clinical decisions at the patient's bedside, reducing delays in treatment initiation and improving overall patient care efficiency.
• Shift Towards Value-Based Healthcare: The broader healthcare landscape's focus on value-based care, emphasizing cost-effectiveness and improved patient outcomes, favors the adoption of POC diagnostics. By enabling earlier diagnosis and treatment, POC tests can potentially reduce downstream healthcare costs associated with complications and prolonged hospital stays.

Challenges and Restraints in U.S. Infectious Disease Point-of-care (POC) Diagnostics Market

While the U.S. Infectious Disease POC Diagnostics Market demonstrates substantial growth potential, several hurdles and limitations need to be addressed for its full realization:

• Cost-Effectiveness and Reimbursement Landscape: The initial investment in some advanced POC devices and consumables can be higher compared to conventional laboratory testing. Furthermore, inconsistent or inadequate reimbursement policies from payers can hinder adoption, particularly for smaller clinics and healthcare facilities, impacting the accessibility and affordability of these crucial diagnostic tools.
• Navigating Complex Regulatory Pathways: Obtaining regulatory clearance from bodies like the FDA for new POC diagnostic tests and devices can be a lengthy and resource-intensive process. While expedited pathways exist, the stringent requirements for analytical and clinical validation can present significant challenges for manufacturers, potentially delaying market entry and innovation.
• Ensuring Operator Proficiency and Standardization: The performance and accuracy of many POC tests are highly dependent on the skill, training, and adherence to protocols by the healthcare professional administering the test. Variability in operator expertise can lead to discrepancies in results, underscoring the need for comprehensive training programs and robust quality control measures to ensure reliable outcomes.
• Scope of Disease Coverage and Diagnostic Certainty: While the range of infectious diseases detectable by POC diagnostics is constantly expanding, there remain specific pathogens or disease stages for which highly sensitive and specific POC tests are not yet available. This can necessitate confirmatory testing in centralized laboratories, limiting the complete decentralization of diagnostic capabilities for certain conditions.
• Data Integration and Interoperability: Seamless integration of POC device data into existing Electronic Health Record (EHR) systems and hospital information systems can be a technical challenge. Lack of interoperability can impede real-time data sharing, disease surveillance, and efficient clinical decision-making.

Key Region or Country & Segment to Dominate the Market

Dominant Region: The United States unequivocally holds the position as the leading market for Infectious Disease POC Diagnostics. This market supremacy is a direct consequence of its sophisticated healthcare infrastructure, substantial investment in medical research and development, high prevalence of various infectious diseases, and a robust ecosystem of technology developers and healthcare providers. The established reimbursement frameworks and a strong emphasis on rapid diagnostics in clinical settings further solidify its dominance.

Dominant Segment: Within the U.S. market, Lateral Flow Immunoassay (LFI)-based diagnostics continue to be the most dominant segment. Their enduring popularity stems from their inherent simplicity of use, portability, rapid result generation (often within minutes), and relatively low cost of manufacturing. These attributes make LFI tests ideal for a wide array of settings, from emergency rooms and physician offices to community health centers and point-of-care testing outside traditional healthcare facilities.

Growth Catalysts in U.S. Infectious Disease Point-of-care (POC) Diagnostics Industry

The U.S. Infectious Disease POC Diagnostics Industry is primed for sustained and accelerated growth, propelled by several potent catalysts:

• Expanding Applications in Public Health and Clinical Practice: POC diagnostics are increasingly being integrated into broader public health strategies, including robust outbreak preparedness and response, routine infectious disease screening in diverse settings (e.g., schools, workplaces), and chronic disease management where co-infections are a concern. Their utility in decentralized testing for conditions like influenza, strep throat, UTIs, and sexually transmitted infections (STIs) continues to grow.
• Synergistic Integration of AI and IoT Technologies: The convergence of Artificial Intelligence (AI) and the Internet of Things (IoT) is a significant growth enabler. AI algorithms can enhance the analytical capabilities of POC devices, enabling more accurate interpretation of results and predictive diagnostics. IoT connectivity allows for remote monitoring, real-time data transmission to healthcare providers and public health agencies, device calibration, and efficient inventory management, creating smarter and more interconnected diagnostic ecosystems.
• Heightened Emphasis on Point-of-Need and Patient-Centric Care: The paradigm shift towards patient-centric healthcare models strongly favors the deployment of POC diagnostics. By bringing testing closer to the patient, these solutions reduce patient anxiety, minimize the need for travel and follow-up appointments, and empower individuals with faster access to information about their health, thereby improving adherence to treatment plans.
• Increased Awareness, Education, and Training Initiatives: Growing recognition of the benefits of POC diagnostics among healthcare professionals, policymakers, and the general public is a key growth driver. Ongoing educational campaigns, professional training programs, and demonstration of successful POC implementations are fostering greater trust and encouraging wider adoption across the healthcare continuum.
• Development of Multiplexed and Next-Generation POC Platforms: The ongoing development of POC platforms capable of detecting multiple pathogens or biomarkers simultaneously (multiplexing) offers significant advantages in terms of efficiency and comprehensive diagnostic information. Furthermore, advancements in molecular POC technologies (e.g., isothermal amplification) are bringing laboratory-grade accuracy to the point of care, expanding the diagnostic capabilities for a wider range of infectious agents.

Leading Players in the U.S. Infectious Disease Point-of-care (POC) Diagnostics Market

The U.S. Infectious Disease POC Diagnostics Market is highly competitive, with several leading players operating in the market, including:

• F. Hoffmann-La Roche Ltd
• Thermo Fisher Scientific Inc.
• Abbott Laboratories
• Quest Diagnostics Incorporated
• BD
• bioMérieux SA
• Cardinal Health, Inc.
• Cepheid
• Trinity Biotech
• Quidel Corporation
• Bio-Rad Laboratories Inc.

Significant Developments in U.S. Infectious Disease Point-of-care (POC) Diagnostics Sector

The U.S. Infectious Disease POC Diagnostics Sector has witnessed several significant developments in recent years:

• May 2023: bioMérieux announced the U.S. FDA CLIA waiver for its BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, a point-of-care system that provides rapid and accurate detection of respiratory pathogens, including Influenza A, SARS-CoV-2, and RSV.
• March 2023: bioMérieux made a strategic investment in Proxim Diagnostics Corp., a U.S.-based point-of-care diagnostics company, to support the development and commercialization of the Proxim Profile System for infectious disease, cardiology, and sepsis diagnostics.
• March 2021: Cardinal Health collaborated with eMed, LLC, a digital point-of-care solution provider, to distribute At-Home COVID-19 rapid tests to pharmacies across the U.S., expanding access to convenient and reliable testing options.

Comprehensive Coverage U.S. Infectious Disease Point-of-care (POC) Diagnostics Market Report

Our comprehensive U.S. Infectious Disease POC Diagnostics Market Report provides an in-depth analysis of the market, covering various aspects such as:

• Market Dynamics: Presents key market drivers, restraints, trends, and challenges shaping the market landscape.
• Market Size and Forecast: Provides historical, current, and projected market size, along with detailed segmentation.
• Market Segmentation: Classifies the market based on technique, disease, and end-user, offering insights into the performance of each segment.
• Competitive Landscape: Profiles the leading companies, their market share, product portfolios, financial performance, and recent developments.
• Growth Strategies: Explores the key growth strategies adopted by players, including product innovation, strategic partnerships, and market expansion.
• Future Outlook: Discusses the potential opportunities and challenges for the market, along with projections for the future.

DROCT

• Global DROCT (Diagnostic Related Group Outpatient Procedures): Provides data on outpatient procedures and their associated costs.
• Medicare DROCT: Focuses on the DROCT system used by Medicare, providing detailed information on payment rates and reimbursement policies.

Pricing Analysis

• Pricing Trends: Analyzes the historical and current pricing trends for Infectious Disease POC Diagnostics in the U.S. market.
• Pricing Strategies: Examines the pricing strategies employed by leading market players.
• Regional Price Variations: Compares pricing across different regions and states within the U.S.

Import And Export Analysis

• Import Trends: Examines the historical and current import trends for Infectious Disease POC Diagnostics in the U.S.
• Export Trends: Analyzes the historical and current export trends for Infectious Disease POC Diagnostics from the U.S.
• Trade Balance: Evaluates the trade balance between imports and exports, providing insights into the U.S.'s position in the global market.

Patent/Trademark Analysis

• Patent Landscape: Provides a

U.S. Infectious Disease Point-of-care (POC) Diagnostics Market Segmentation

• 1. Technique
  • 1.1. Lateral Flow Immunoassay
  • 1.2. Agglutination Test
  • 1.3. Flow-through Test
  • 1.4. Molecular Diagnostics
  • 1.5. Others
• 2. Disease
  • 2.1. Human Immunodeficiency Virus (HIV
• 3. End-user
  • 3.1. Hospitals
  • 3.2. Physician’s Offices
  • 3.3. Urgent Care & Retail Clinics
  • 3.4. Others

U.S. Infectious Disease Point-of-care (POC) Diagnostics Market Segmentation By Geography

• 1. U.S.