The United States in vitro diagnostics market was valued at USD 19.84 Billion in 2024, driven by the increasing adoption of advanced molecular diagnostics and the growing prevalence of chronic diseases across the region. The market is anticipated to grow at a CAGR of 6.30% during the forecast period of 2025-2034, with the values likely to reach USD 36.55 Billion by 2034. The market is growing due to a robust healthcare infrastructure and continuous technological innovation. Additionally, growing demand for rapid, accurate testing fuels market expansion during the forecast period.
Base Year
Historical Period
Forecast Period
According to the Centers for Disease Control and Prevention, approximately 129 million people in the United States have at least one major chronic disease, significantly driving the demand for advanced in vitro diagnostic solutions.
In June 2024, MP Biomedicals, a United States-based company, launched advanced gastrointestinal diagnostic kits, enhancing the rapid detection of H. pylori, Salmonella typhi, and Vibrio cholerae, boosting precision and efficiency in IVD testing.
One of the major market trends driving demand is the development of sensitive blood-based neurodegenerative diagnostics. For instance, in March 2024, Beckman Coulter and Fujirebio expanded their partnership to improve Alzheimer’s disease detection and patient access.
Compound Annual Growth Rate
6.3%
Value in USD Billion
2025-2034
United States In Vitro Diagnostics Market Outlook
*this image is indicative*
In vitro diagnostics (IVD) encompass tests performed on biological samples, such as blood or tissue, outside the human body to detect diseases, infections, or medical conditions. These tests play a crucial role in clinical decision-making by delivering accurate and timely results. The in vitro diagnostics market in the United States was valued at USD 19.84 Billion in 2024 and is driven by rapid technological advancements, growing prevalence of chronic diseases, and increasing healthcare awareness. The market is growing due to robust demand for innovative diagnostic solutions and ongoing product development across the healthcare industry.
Rapid Diagnostic Launches to Strengthen the In Vitro Diagnostics Market Growth in the United States
The introduction of innovative diagnostic products is driving the market growth. For instance, in August 2024, InBios International launched the Strongy Detect IgG ELISA. It is a rapid serological test for the diagnosis of strongyloidiasis, delivering results in under 75 minutes. As a CLIA-classified test for high-complexity labs, this launch addresses critical diagnostic gaps and supports market expansion through improved infectious disease detection.
The market is experiencing key trends such as the approval of advanced genomic diagnostics and the expansion of diagnostic access through decentralized molecular testing collaborations.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Product & Services
Market Breakup by Technology
Market Breakup by Application
Market Breakup by End User
Immunodiagnostics to Dominate the Market by Technology
In the evolving landscape of diagnostic technologies, immunodiagnostics is emerging as the frontrunner in the market. Apart from immunodiagnostics, the market is segmented into clinical chemistry, molecular diagnostics, hematology, microbiology, coagulation and haemostasias, urinalysis, and others. Immunodiagnostics stands out due to its precision, adaptability, and expanding role in detecting complex conditions. A notable example is Quest Diagnostics' AAVrh74 ELISA assay, which received FDA Breakthrough Device Designation in August 2023, reinforcing the segment’s pivotal role in advancing personalized medicine.
The key features of the market report comprise patent analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
bioMérieux SA, established in 1963 and headquartered in Marcy l’Étoile, France, is a global leader in in vitro diagnostics. In January 2025, it expanded its presence in the IVD market by acquiring SpinChip Diagnostics, a company specializing in rapid, high-sensitivity immunoassay platforms for point-of-care testing. This acquisition enhances bioMérieux’s offerings with fast, precise cardiac biomarker tests, advancing acute care diagnostics.
Founded in 1968 and headquartered in Kobe, Japan, Sysmex Corporation is a key player in the in vitro diagnostics market. In August 2024, the company broadened its partnership with QIAGEN to advance genetic testing, emphasizing precision medicine and liquid biopsy technologies. Sysmex leverages its state-of-the-art laboratories in both Japan and the United States to support clinical trials and drive innovation in diagnostic testing.
Thermo Fisher Scientific Inc. is a global leader in scientific services, headquartered in Waltham, Massachusetts. In October 2023, the company gained prominence through its partnership with Boehringer Ingelheim to develop companion diagnostics (CDx) for non-small cell lung cancer. This includes the Oncomine Dx Express Test and Genexus Dx System, offering rapid and precise genomic testing to support targeted therapies. Thermo Fisher’s continued innovation strengthens its critical role in advancing precision oncology diagnostics across U.S. healthcare settings.
QIAGEN is headquartered in Venlo, Netherlands, was founded in 1984. In August 2023, the company gained FDA approval for its therascreen PDGFRA RGQ PCR kit, a companion diagnostic to identify PDGFRA D842V mutations in gastrointestinal stromal tumors. This approval strengthens QIAGEN’s presence in the market and highlights its leadership in precision medicine.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories, Inc., Abbott, Quidel Corporation, and Danaher Corporation.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2024 |
| Historical Period | 2018-2024 |
| Forecast Period | 2025-2034 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product & Services |
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| Breakup by Technology |
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| Breakup by Application |
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| Breakup by End User |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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