U.S. Infectious Disease Point-of-care (POC) Diagnostics Market Size, Share & Industry Analysis, By Technique (Lateral Flow Immunoassay, Agglutination Test, Flow-through Test, Molecular Diagnostics, and Others), By Disease (Human Immunodeficiency Virus (HIV), Hepatitis B Virus, Pneumonia/Streptococcus Associated Infections, Respiratory Syncytial Virus (RSV), Influenza, Clostridium Difficile Infections (CDI), Hepatitis C Virus, Tuberculosis, COVID-19, and Others), By End-user (Hospitals, Physician’s Offices, Urgent Care & Retail Clinics, and Others), and Country Forecast, 2024-2032

The U.S. infectious disease point-of-care (POC) diagnostics market size was worth USD 227.0 million in 2023 and exhibited a CAGR of 6.0% during the forecast period. 

Infectious disease point-of-care (POC) diagnostics are rapid test used to diagnose HIV, hepatitis B and C, pneumonia/streptococcus-associated infections, respiratory syncytial virus (RSV), influenza, clostridium difficile infections (CDI), and tuberculosis. The growing demand for innovative diagnostic technologies, rising prevalence of infectious disease, growing awareness about early disease detection, increasing product approvals, rising technological advancements, and growing funding for new product development are the major driving factors contributing to the market’s growth.

• For instance, in June 2024, the U.S. FDA allowed the marketing of the first point-of-care hepatitis C RNA test, which enables the single visit diagnosis and treatment for the hepatitis C. This test called the, Xpert HCV test and GeneXpert Xpress System was developed by Cepheid (Danaher).
• For instance, in November 2021, Inflammatix, Inc., a U.S.-based molecular diagnostics company, announced that the company received additional funding of USD 12.1 million from the Biomedical Advanced Research and Development Authority (BARDA). The company aimed to utilize the funding for the development and clinical studies of the ViraBac EZ POC test for acute infections.

In addition, the impact of the COVID-19 pandemic on the U.S. infectious disease point-of-care (POC) diagnostics market was moderately positive in 2020 due to the launch of COVID-19 POC testing kits and increased focus on the development of new POC methods to test the disease.

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

Rising Patient Preference for At-Home Diagnostic Tests for Infectious Diseases

The growing interest of the patient pool toward at-home diagnostics tests is gaining the attention of key market players. The advantages associated with at-home diagnostics tests, such as convenience, accessibility, and rapid diagnosis, enable early disease detection at low cost. The rising use of at-home tests for infectious diseases such as HIV, COVID-19, urinary tract infections, and sexually transmitted diseases is encouraging market players to develop new products. Moreover, increasing at-home testing reduced the healthcare burden and chances of infection transmission. Hence, this are identified as a prominent infectious disease point-of-care (POC) diagnostics market trends.

• For instance, a study published in March 2021 by the National Center for Biotechnology Information (NCBI) revealed that the use of home-based SARS-CoV-2 antigen testing reduced in-patient outlays and testing expenditures by USD 12.5 million. The study, conducted on the U.S. population for 60 days, was funded by the National Institutes of Health (NIH). Such positive data is expected to contribute to the growth of the point of care diagnostic in the U.S.

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

Increasing Number of Product Approval and Launches to Drive Market Growth

The rising prevalence of Infectious diseases is one of the growing concerns for the U.S. healthcare system. The country spends around USD 120 billion annually to manage the burden of infectious diseases, which accounts for around 15% of U.S. healthcare expenditure. The rising prevalence of infectious diseases, coupled with the emergence of new variants of SARS-CoV-2, is driving a rising demand for infectious disease point-of-care (POC) diagnostics in the country. This heightened demand for infectious disease point-of-care (POC) diagnostics is encouraging key players to develop and launch new products in the market, which is anticipated to contribute to the U.S. infectious disease point-of-care (POC) diagnostics market growth during the forecast period.

• For instance, in February 2022, Trinity Biotech received approval for its TrinScreen HIV, an HIV screening product, from the World Health Organization (WHO). It is a rapid test providing results in less than 12 minutes from a finger stick drop of blood.

Download Free sample to learn more about this report.

The incidence of TB in the U.S. was 2.9 cases per 100,000 population in 2023, which was slightly above as compared to 2022. Among all states of the U.S., Alaska reported the highest TB incidence, and California reported the highest number of TB cases, which was around 2,113 in 2023.

RESTRAINING FACTORS

High Potential for False Results to Limit Market Growth

Lack of accuracy is one of the major drawbacks associated with infectious disease point-of-care (POC) diagnostics. The treatment protocol for infectious diseases includes many antibiotics and antiviral drugs. The rising occurrence of false positive test results is leading to inappropriate antibiotic prescriptions leading to less efficient patient care and contributing to increasing antimicrobial resistance (AMR). In addition, the false negative test is increasing, leading to disease severity, high healthcare expenditure, and out-of-pocket expenses to manage the disease.

• For instance, according to an article published by the American Association for Clinical Chemistry in April 2022, the two major challenges associated with POCT testing are test errors and quality control.
• According to an article published by the U.S. FDA in November 2022, at-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests. It further advises against relying solely on a negative POC COVID-19 antigen test result, recommending repeat testing for accurate and reliable results.

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

By Technique Analysis

Based on technique, the market is categorized into agglutination test, lateral flow immunoassay, molecular diagnostics, flow-through test, and others.

The lateral flow immunoassay segment captured the largest U.S. infectious disease point-of-care (POC) diagnostics market share. The segment is expected to grow with a notable CAGR during the forecast period. The rapid growth of the lateral flow immunoassay segment is attributed to its high ability to detect analytes, including antibodies and antigens. In addition, lateral flow immunoassay can be used for primary screening at the point of care testing due to advantages such as low cost, high sensitivity and selectivity, increasing demand for patient-centric care, and growing pressure to reduce healthcare costs. The advantages associated with lateral flow immunoassay and the increasing developments using the technology are anticipated to boost the segment’s growth during the forecast period.

• For instance, a study published in February 2023 assessed the specificity of the lateral flow immunoassay to detect SARS-CoV-2 spike protein. The assay exhibited a specificity of 98% and showed improved performance for early detection of SARS-CoV-2, specifically for at-home monitoring of COVID-19 tests.

By Disease Analysis

Based on disease segment, the market is categorized into human immunodeficiency virus (HIV), hepatitis B virus, pneumonia/streptococcus associated infections, respiratory syncytial virus (RSV), influenza, clostridium difficile infections (CDI), hepatitis C virus, methicillin-resistant staphylococcus aureus (MRSA), tuberculosis, COVID-19, and other.                 

The clostridium difficile infections (CDI) segment held the largest share of the infectious disease point-of-care (POC) diagnostics market in the U.S. in 2023. The high share of the segment is due to the increasing prevalence of infectious diseases such as malaria, including clostridium difficile infections (CDI), leading to the rising adoption of these tests. For instance, according to an article published in March 2023, the rising burden of CDI in the U.S. affects approximately 500,000 patients yearly, out of which 30,000 patients die annually. Recurrent CDI impacts a significant number of patients, with up to 35.0% experiencing annual recurrence.

The influenza segment is anticipated to register notable growth during the forecast period. Moreover, the rising incidence of influenza due to its rapid transmission and weakened immunity is anticipated to drive the growth of the market during the forecast period.

• For instance, according to the World Health Organization (WHO), four types of influenza cause seasonal epidemics. Moreover, according to the Centers for Disease Control and Prevention (CDC) report published in August 2021, influenza affects approximately 8.0% of the U.S. population annually.

By End-user Analysis

Based on end-user, the market is categorized into hospitals, physician’s offices, urgent care & retail clinics, homecare settings, nursing homes, and others.       

The hospitals segment held the largest share in infectious disease point-of-care (POC) diagnostics market in the U.S. in 2023. Increasing number of inpatient admissions due to the rising prevalence of chronic conditions, leading to rising demand for point-of-care tests in hospital settings.

However, the urgent care & retail clinics segment is anticipated to register notable growth during the forecast period. This growth is attributed to the effective implementation of POC diagnosis, leading to reduced preanalytical errors and faster therapeutic intervention. Moreover, the increasing number of hospitalizations due to infectious diseases is driving the demand for bedside POC diagnostics.

• For instance, according to the Centers for Disease Control and Prevention (CDC) report published in August 2021, in the U.S., around 7,000 - 26,000 children under the age of 5 years are hospitalized each year due to influenza.

KEY INDUSTRY PLAYERS

Companies operating in the U.S. infectious disease point-of-care (POC) diagnostics market are growing significantly, driven by portfolio expansion, new product launches, strategic alliances, and increased R&D expenditure. Companies including Abbott Laboratories, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., and Cepheid accounted for a significant share of the market.

• For instance, in December 2022, Thermo Fisher Scientific Inc. announced the launch of TrueMark Infectious Disease Research Panels. The use of these test panels enabled the rapid detection of infectious disease-causing microorganisms. The panel is predefined and can detect more than 90 different disease pathogens.

Moreover, companies such as BD, bioMérieux, and Quidel Corporation are also expanding owing to the growing network and product approvals for infectious disease point-of-care (POC) diagnostics in the U.S., contributing to market growth.

• For instance, in February 2022, Cardinal Health announced its collaboration with Cue Health Inc. to expand the distribution network by using the latter company’s professionals. The collaboration aimed to expand the distribution network to increase the availability of over-the-counter COVID-19 tests by Cue Health Inc.

LIST OF TOP INFECTIOUS DISEASE POINT-OF-CARE (POC) DIAGNOSTICS COMPANIES IN U.S./ LIST OF TOP INFECTIOUS DISEASE POINT-OF-CARE (POC) DIAGNOSTICS COMPANIES:

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

KEY INDUSTRY DEVELOPMENTS:

• May 2023: bioMérieux announced that the company received the U.S. FDA CLIA waiver for its BIOFIRE SPOTFIRE Respiratory (R) Panel Mini. The BIOFIRE SPOTFIRE is a point-of-care system that provides results within 20 minutes and can detect Influenza A, SARS-CoV-2, Influenza B, Rhinovirus and Respiratory Syncytial Virus (RSV).
• March 2023: bioMérieux announced a strategic investment in Proxim Diagnostics Corp., a U.S.-based point-of-care diagnostics company. The investment aimed to aid the development and commercialization of Proxim’s Profile System, which can run immunoassays for infectious disease, cardiology, and sepsis.
• March 2021: Cardinal Health announced its collaboration with eMed, LLC, a digital point-of-care solution provider. The collaboration aimed to distribute At-Home COVID-19 rapid tests to pharmacies across the U.S.

REPORT COVERAGE

The market research report provides a detailed U.S. infectious disease point-of-care (POC) diagnostics market analysis. It focuses on key aspects such as the prevalence of infectious diseases, new product launches, key market trends, and technological advancements. Additionally, it includes key industry developments such as mergers, partnerships, acquisitions, and the impact of COVID-19 on the. Besides this, the report also highlights key industry dynamics.

To gain extensive insights into the market, Download for Customization

Report Scope & Segmentation