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 primarily driven by the following factors:

• Increasing prevalence of infectious diseases: The rising incidence of infectious diseases, both domestically and globally, has created a pressing need for rapid and accurate diagnostics to control the spread and improve patient outcomes.
• Technological advancements: Technological innovations in POC diagnostics have made them more sensitive, specific, and easy to use, broadening their applications and facilitating their implementation in a variety of settings.
• Government initiatives: Government agencies and healthcare organizations are promoting the adoption of POC diagnostics by providing funding, developing guidelines, and raising awareness about their benefits.
• Rising demand for rapid diagnostics: The urgent need for rapid and accurate diagnostics during outbreaks and pandemics further accelerates market growth. POC diagnostics provide fast and reliable results, enabling healthcare providers to implement effective measures promptly.

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

Despite the significant growth potential, the U.S. Infectious Disease POC Diagnostics Market faces certain challenges and restraints:

• Cost and reimbursement: POC diagnostics can be more expensive than traditional laboratory testing methods, which may limit their widespread adoption. Additionally, reimbursement policies may vary, affecting the accessibility and affordability of these tests.
• Regulatory hurdles: Stringent regulatory requirements for the development, approval, and distribution of POC diagnostics can delay market entry and increase development costs.
• Operator dependency: The accuracy and reliability of POC diagnostics rely heavily on the training and skills of the operator, which can introduce potential variances in results.
• Limited disease coverage: While POC diagnostics are rapidly expanding, they may not cover the full spectrum of infectious diseases, potentially limiting their utility in certain cases.

Key Region or Country & Segment to Dominate the Market

Dominant Region: The United States is the largest market for Infectious Disease POC Diagnostics, accounting for a significant share of the global market. This dominance is attributed to the high prevalence of infectious diseases, advanced healthcare infrastructure, and supportive regulatory policies.

Dominant Segment: Lateral Flow Immunoassay (LFI) is the most widely used technique in the Infectious Disease POC Diagnostics market. LFI tests are simple, cost-effective, and provide rapid results, making them suitable for use in various settings, including hospitals, clinics, and at-home use.

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

The U.S. Infectious Disease POC Diagnostics Industry is poised for continued growth driven by several key catalysts:

• Expanding application areas: POC diagnostics are finding increasing applications in disease screening, outbreak management, and real-time surveillance, boosting market growth.
• Advancements in AI and IoT: The integration of artificial intelligence (AI) and the Internet of Things (IoT) is enhancing the performance and connectivity of POC devices, leading to more accurate and efficient diagnostics.
• Focus on point-of-need testing: The growing emphasis on patient-centric care and the need for decentralized diagnostics is driving the development and deployment of POC diagnostics that can be used at the point of care.
• Increased awareness and education: Ongoing efforts to increase awareness about the benefits and capabilities of POC diagnostics among healthcare providers and the public are fueling market growth.

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.