North America Point-of-Care Molecular Testing for Infectious Diseases Market is expected to reach US$ 2.62 billion by 2031


PRESS RELEASE BY The Insight Partners 22 May 2024

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Respiratory Infection Testing Segment to Contribute Significantly to North America Point-of-Care Molecular Testing for Infectious Diseases Market Growth During 2023–2031 

According to our latest study on "North America Point-of-Care Molecular Testing for Infectious Diseases Market Forecast to 2031 – Market Analysis – Disease, Technology, Sample, Prescription Testing, and End User," the market was valued at US$ 1.09 billion in 2023 and is projected to reach US$ 2.62 billion by 2031. The surging prevalence of infectious diseases and preference for rapid diagnostic solutions are the key factors propelling the market development. However, inadequate reimbursement scenarios impede the North America point-of-care molecular testing for infectious diseases market growth.

Small and big companies operating in the North America point-of-care testing for infectious disease market adopt strategies such as regional expansion, new product launches, and technological advancements to increase their revenue. Infectious disease diagnostic products are made safer and more effective with continued developments and technological advancements.

North America Point-of-Care Molecular Testing for Infectious Diseases Market

North America Point-of-Care Molecular Testing for Infectious Diseases Market


North America Point-of-Care Molecular Testing for Infectious Diseases Market 2031

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North America Point-of-Care Molecular Testing for Infectious Diseases Market Size and Forecast (2021-2031), Regional Share, Trend, and Growth Opportunity Analysis Report Coverage By: Diseases (HIV Testing, Influenza Testing, Sexually Transmitted Diseases Testing, Hepatitis C Virus Testing, Tropical Diseases Testing, Respiratory Infection Testing, Hospital Acquired Infections, Strep, Others), Technology (Lateral Flow Assay, Dipsticks, Microfluidics, Molecular Diagnostics, Immunoassays, Solid Phase, Others), Prescription Testing (Prescription Based Testing, OTC Testing), Sample (Blood Sample, Urine Sample, Nasal and Oropharyngeal Swabs Sample, Others), End User (Hospitals and Clinics, Home Care Settings, Ambulatory and Urgent Care Facilities, Nursing Home and Assisted Living Facilities, Research Laboratories, Diagnostics Centers), Distribution Channel (E-Com Platforms, Retail Channel and Pharmacies, Others), and Country

  • In February 2023, Thermo Fisher Scientific collaborated with Mylab to source RT-PCR kits for the detection of multidrug-resistant Mycobacterium tuberculosis (MDR MTB), hepatitis B and C viruses, and HIV; genetic analysis of HLA B27; and so on.
  • In August 2023, QuidelOrtho Corporation—a global supplier of cutting-edge in-vitro diagnostic technologies intended for clinical labs, point-of-care settings, and transfusion medicine—won FDA approval for its De Novo request, enabling the business to commercialize its new Sofia 2 SARS Antigen+ FIA. The Sofia 2 SARS Antigen+ FIA became the first fast antigen test to receive FDA market clearance for COVID-19 detection. The test can be utilized in point-of-care settings and is only meant to be used with a prescription.
  • In March 2022, Quest Diagnostics launched two post-COVID-19 panels to provide information on health problems that may persist after prior COVID-19 virus infections. According to Quest, the Post-COVID-19 Basic Panel and Post-COVID-19 Expanded Test Panel offers customers a more thorough examination of their health and aid in getting them ready for conversations with their healthcare providers.
  • In February 2021, Thermo Fisher Scientific Inc. acquired Mesa Biotech, Inc., a privately held point-of-care molecular diagnostic company. With this acquisition, Mesa Biotech joined the Life Sciences Solution segment of Thermo Fisher Scientific. The Accula System is a point-of-care PCR-based testing technology designed by Mesa Biotech for infectious illness diagnosis. This inexpensive and user-friendly product makes findings available in 30 minutes, and the platform facilitates quick, extremely accurate testing at doctor's offices, pharmacies, and other locations. In addition to COVID-19 testing, Mesa Biotech's current platform also offers tests for Strep A, influenza, and RSV. With Mesa’s acquisition, Thermo Fisher Scientific added its point-of-care PCR-based testing technologies to its portfolio.

The active participation of market players in product innovation and development, and product approvals by regulatory authorities are likely to bring new North America point-of-care testing for infectious diseases market trends in the coming years.

Market Segmentation:

The North America point-of-care molecular testing for infectious diseases market analysis has been carried out by considering the following segments: disease, technology, prescription testing, sample, and end user. Based on disease, the market is segmented into HIV testing, influenza testing, sexually transmitted diseases testing, hepatitis C virus testing, tropical diseases testing, respiratory infection testing, hospital-acquired infections, strep, and others. Based on molecular diagnostics, the market point-of-care molecular testing for infectious diseases into polymerase chain reactions (PCR), isothermal nucleic acid amplification technology (INAAT), and others. Respiratory infection testing typically involves collecting samples from the respiratory tract, such as nasal swabs, throat swabs, or sputum samples, to detect the presence of viruses, bacteria, and other pathogens. Rapid diagnostic tests such as antigen tests or molecular tests (PCR) are commonly used to identify the causes of respiratory infections.

By technology, the market is segmented into lateral flow assays, dipsticks, microfluidics, molecular diagnostics, immunoassays, solid phase, and others. The lateral flow assay segment held the largest North America point-of-care molecular testing for infectious diseases market share in 2023. Lateral flow assays (LFAs) represent a crucial technology in point-of-care testing for infectious diseases. These assays offer rapid and user-friendly detection methods, making them invaluable in various healthcare settings, from clinics to remote areas. 

The North America point-of-care molecular testing for infectious diseases market, based on end user, is categorized into hospitals and clinics, home care settings, ambulatory and urgent care facilities, nursing home and assisted living facilities, research laboratories, and diagnostics centers. The market is further divided on the basis of hospitals and clinics into clinical laboratories, professional physician offices, and others. Hospitals receive more footfall of patients than any other healthcare facility. These facilities offer various services and good-quality treatments. The fees charged for these services are reimbursed as part of various policies. Moreover, a high and quick availability of medicines helps care providers and patients avoid delays in treatments. Therefore, the number of patients visiting hospitals for disease diagnosis is increasing rapidly. The cost of medical facilities has risen in recent decades. Further, the increasing number of hospitals, adoption of advanced therapeutic platforms, and growing accessibility of hospitals in emerging nations are estimated to offer lucrative opportunities for the hospital segment growth during the forecast period.

North America Point-Of-Care Molecular Testing for Infectious Diseases Market, by Country:

The scope of the North America point-of-care molecular testing for infectious diseases market report entails the US, Canada, and Mexico. In terms of revenue, the US dominated the North America point-of-care molecular testing for infectious diseases market share in 2023. The increasing prevalence of infectious diseases, the rising geriatric population, and a surging number of product launches by key players are the primary contributors to the growth of the North America point-of-care molecular testing for infectious diseases market size in the US. Regulatory agencies in the US rigorously monitor the development of point-of-care (POC) testing products. For instance, in May 2022, Becton Dickinson and Company (BD), one of the leading global medical technology companies, announced the launch of its new, fully automated, high-throughput molecular diagnostics platform for infectious diseases in the US. The new BD COR MX instrument was launched as an analytical option for the BD COR platform, with 510(k) clearance from the FDA. As of May 2022, the BD CTGCTV2 molecular assay, the first test available on the new system, was the single test that detected the three most prevalent non-viral sexually transmitted infections (STIs)—Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV).

Apart from factors driving the market, the North America point-of-care molecular testing for infectious diseases market report emphasizes prominent players operating in the market; these include Abbott Laboratories, Agilent Technologies Inc, Becton Dickinson and Co, Bio-Rad Laboratories Inc, Cardinal Health Inc, Danaher Corp, Cue Health Inc, QuidelOrtho Corp, Thermo Fisher Scientific Inc, and F. Hoffmann-La Roche Ltd.

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