U.S. In Vitro Diagnostics Market Size, Share & Trends Report

U.S. In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product (Reagents, Instruments, Services), By Technology (Immunoassay, Molecular Diagnostics), By Application, By End-use, And Segment Forecasts, 2024 - 2030

  • Report ID: GVR-4-68039-256-6
  • Number of Pages: 358
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2022
  • Industry: Healthcare

Market Segmentation

  • U.S. In Vitro Diagnostics Product Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2018 - 2030)
    • Instruments
    • Reagents
    • Services
  • U.S. In Vitro Diagnostics Technology Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2018 - 2030)
    • Immunoassays
      • Instruments
      • Reagents
      • Services
    • Hematology
      • Instruments
      • Reagents
      • Services
    • Clinical Chemistry
      • Instruments
      • Reagents
      • Services
    • Molecular Diagnostics
      • Instruments
      • Reagents
      • Services
    • Coagulation
      • Instruments
      • Reagents
      • Services
    • Microbiology
      • Instruments
      • Reagents
      • Services
    • Others
      • Instruments
      • Reagents
      • Services
  • U.S. In Vitro Diagnostics Application Outlook (Revenue, USD Million, 2018 - 2030)
    • Infectious Diseases
      • Upper respiratory
      • Gastrointestinal panel testing
      • Methicillin-resistant Staphylococcus Aureus (MRSA)
      • Clostridium difficile
      • Vancomycin-Resistant Enterococci (VRE)
      • Carbapenem-resistant bacteria
      • Flu
      • Respiratory Syncytial Virus (RSV)
      • Candida
      • Tuberculosis (TB) and drug-resistant TB
      • Meningitis
      • Chlamydia
      • Gonorrhoea
      • HIV
      • Hepatitis C
      • Hepatitis B
      • Other infectious disease
    • Diabetes
    • Oncology
    • Cardiology
    • Nephrology
    • Autoimmune Diseases
    • Drug Testing
    • Hematologic Diseases
    • Others
  • U.S. In Vitro Diagnostics End-use Outlook (Volume, Number of Tests and Instruments; Revenue, USD Million, 2018 - 2030)
    • Hospitals
      • Immunoassays
        • Instruments
        • Reagents
        • Services
      • Hematology
        • Instruments
        • Reagents
        • Services
      • Clinical Chemistry
        • Instruments
        • Reagents
        • Services
      • Molecular Diagnostics
        • Instruments
        • Reagents
        • Services
      • Coagulation
        • Instruments
        • Reagents
        • Services
      • Microbiology
        • Instruments
        • Reagents
        • Services
      • Others
    • Laboratories
      • Immunoassays
        • Instruments
        • Reagents
        • Services
      • Hematology
        • Instruments
        • Reagents
        • Services
      • Clinical Chemistry
        • Instruments
        • Reagents
        • Services
      • Molecular Diagnostics
        • Instruments
        • Reagents
        • Services
      • Coagulation
        • Instruments
        • Reagents
        • Services
      • Microbiology
        • Instruments
        • Reagents
        • Services
      • Others
    • Home-care
      • Immunoassays
        • Instruments
        • Reagents
        • Services
      • Hematology
        • Instruments
        • Reagents
        • Services
      • Clinical Chemistry
        • Instruments
        • Reagents
        • Services
      • Molecular Diagnostics
        • Instruments
        • Reagents
        • Services
      • Coagulation
        • Instruments
        • Reagents
        • Services
      • Microbiology
        • Instruments
        • Reagents
        • Services
      • Others
    • Others

U.S. In Vitro Diagnostics Market Dynamics

Driver: Growing Geriatric Population

The geriatric population in the U.S. is gradually increasing. According to America’s Health Rankings senior report, more than 54 million adults aged 65 & above are living in the U.S., accounting for 16.5% of the country’s population. By 2050, this number is expected to surpass 85.7 million. Moreover, with rising age, the immune system is affected, which increases susceptibility to various diseases. Hence, a large geriatric population requires better healthcare, especially for chronic diseases. It was observed that over 80% of adults who are 60 years and above have at least one chronic disease. Some of the diseases associated with aging are Alzheimer’s disease, Parkinson’s disease, arthritis, and heart attack. Therefore, increasing elderly population is expected to be one of the high impact rendering drivers for this market over the forecast period. In addition, geriatric population is more likely to suffer from COVID-19-related issues due to decreased immune function, multimorbidity, and physiological changes associated with aging. This group has to be tested continuously to avoid severe infections, which creates growth opportunities for IVDs in the U.S. In addition, government initiatives, such as distribution of USD 2.5 billion to nursing homes in the U.S. in August 2020 for encouraging testing and care of vulnerable older adults, are expected to boost the demand for molecular diagnostics for SARS-CoV-2 detection, thereby boosting the IVDs market.

Driver: Technological Advancements

Technological advancements in terms of accuracy, cost-effectiveness, and portability are expected to be among the high impact rendering drivers for this market. Leading market participants are updating their range of testing options for qPCR instruments by undertaking R&D initiatives for development of kits that target life-threatening conditions or by entering collaborations with other kit manufacturing players. For instance, introduction of BD Methicillin-resistant Staphylococcus aureus (MRSA) ACP assay by Becton, Dickinson, and Company, which runs on SmartCycler developed by Cepheid and, cobas HPV test assay in cobas 4800 by Roche Diagnostics. The introduction of Xpert assay for tuberculosis testing by Cepheid on its GeneXpert platform is another example of an advancement. Growing use of Fluorescence In Situ Hybridization (FISH) and Enzyme-Linked Immunosorbent Assay (ELISA) technologies is also anticipated to boost the market growth during the forecast period. Moreover, growing efforts from government and nongovernment organizations to promote development of rapid diagnostic solutions are expected to offer lucrative growth opportunities in the market. For instance, in October 2022, Day Zero Diagnostics, Inc., a leader in infectious disease diagnostics, announced that it has been awarded additional funding of USD 8.2 million from CARB-X for the development of precise and cutting-edge diagnostic solutions for infectious diseases.

Restraint: Higher Cost Of Devices

IVD renders accurate and effective results and has indispensable applications in disease diagnosis. However, high prices associated with molecular assays are among major factors impeding growth of this market. In addition, flow cytometry technique encompasses a large range of prices for instruments, reagents, software, and services. The reagents used for specific applications and flow cytometry setup are cost-intensive in nature. These factors are limiting the growth of in vitro diagnostics market during the forecast period. However, healthcare authorities have taken measures to reduce the burden of high costs on manufacturers. EUA approval from the U.S. FDA for COVID-19 tests is expected to reduce development costs and accelerate the process to increase availability at more testing sites. Hence, decrease in development costs is anticipated to reduce the cost of tests for healthcare providers and patients.

What Does This Report Include?

This section will provide insights into the contents included in this u.s. in vitro diagnostics market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

U.S. in vitro diagnostics market qualitative analysis

  • Industry overview

  • Industry trends

  • Market drivers and restraints

  • Market size

  • Growth prospects

  • Porter’s analysis

  • PESTEL analysis

  • Key market opportunities prioritized

  • Competitive landscape

    • Company overview

    • Financial performance

    • Product benchmarking

    • Latest strategic developments

U.S. in vitro diagnostics market quantitative analysis

  • Market size, estimates, and forecast from 2018 to 2030

  • Market estimates and forecast for product segments up to 2030

  • Regional market size and forecast for product segments up to 2030

  • Market estimates and forecast for application segments up to 2030

  • Regional market size and forecast for application segments up to 2030

  • Company financial performance

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