U.S. In Vitro Diagnostics Market to Reach $31.8 Billion by 2032, Led by Cepheid & Driven by Automation – iData Research

The U.S. in vitro diagnostics market is projected to grow from $23.9B in 2025 to $31.8B by 2032, driven by automation, and AI-enabled testing.

As diagnostic platforms become more accessible, providers are able to deliver faster, more accurate results, ultimately improving patient outcomes and supporting more efficient care delivery.”

— Dr. Kamran Zamanian, CEO of iData Research

VANCOUVER, BRITISH COLUMBIA, CANADA, April 9, 2026 /EINPresswire.com/ -- The U.S. in vitro diagnostics (IVD) market is projected to grow from $23.9 billion in 2025 to approximately $31.8 billion by 2032, according to a new report by iData Research. Growth is being driven by continued advancements in diagnostic technologies, increasing demand for rapid and decentralized testing, and the expansion of automated laboratory systems.

The U.S. IVD market has undergone significant transformation in the post-pandemic environment, with healthcare systems prioritizing efficiency, scalability, and faster turnaround times. One of the most notable trends has been the expansion of core laboratory automation, where hospitals have invested heavily in high-throughput integrated systems that combine chemistry and immunochemistry testing on unified platforms. These systems enable laboratories to process larger volumes of tests with reduced manual intervention, improving operational efficiency and consistency of results.

“The increasing shift toward automation and decentralized diagnostics is redefining how testing is delivered across the U.S. healthcare system,” said Dr. Kamran Zamanian, CEO of iData Research.

From a segment perspective, molecular diagnostics remains one of the largest and fastest-growing areas of the IVD market. This segment continues to expand due to rising demand for testing in infectious diseases, women’s health, sexually transmitted infections, and oncology. The development of advanced analyzers tailored to these applications is supporting sustained growth and innovation within the segment.

Technological innovation is playing a critical role in shaping the future of the U.S. IVD market. The integration of artificial intelligence (AI) and digital connectivity into diagnostic platforms is becoming increasingly common. Modern systems are now capable of performing automated data analysis and seamlessly uploading results to hospital information systems, enabling faster clinical workflows. These capabilities are supporting the growing expectation for near-immediate diagnostic results across a wider patient population.

From a competitive standpoint, Cepheid held the leading position in the U.S. IVD market in 2025. Its GeneXpert^® platform is widely adopted due to its ability to consolidate multiple diagnostic tests onto a single system while offering high walk-away time and flexibility across both point-of-care and near-patient settings.

bioMérieux ranked as the second-largest competitor, supported by a strong presence in molecular diagnostics. The company’s FilmArray system and SpotFire analyzer are key platforms driving adoption in near-patient and rapid testing environments.

Abbott was the third-largest player in 2025, with a broad portfolio spanning both core laboratory and immunochemistry diagnostics. Its Alinity ci-series and ARCHITECT platforms continue to play a significant role in high-throughput laboratory settings, reinforcing its position across multiple diagnostic segments.

The 2026 U.S. In Vitro Diagnostics Market Report provides comprehensive analysis of market size, test volumes, unit sales, pricing trends, competitive dynamics, and long-term forecasts.

For deeper analysis, visit our Diagnostic Device Insights page at https://idataresearch.com/diagnostic-devices-anesthesiology-device-markets/ and explore market reports that highlight the key trends, competitive moves, and technology innovations shaping the future of diagnostic devices.

Maksym Brylkov
iData Research
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