In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029

    Published: November 25, 2024 | Price: $5,000.00 – $10,500.00

    The U.S. IVD market is a cornerstone of global healthcare innovation—but it is also a market in transition In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029, the fifth edition in Kalorama’s ongoing series, offers unparalleled access to insights on the trends and technologies that will define the industry's future. This report is essential for: Identifying market gaps and opportunities for product innovation. Gaining a competitive edge with strategic insights into the U.S. diagnostic landscape. Making informed...
    The Worldwide Market for Mass Spectrometry in Clinical Labs, 2024

    Published: September 11, 2024 | Price: $5,000.00 – $10,500.00

    Mass spectrometry (MS) is increasingly being integrated into clinical laboratories, revolutionizing diagnostics with its advanced sensitivity and specificity. This technology, once primarily utilized in research settings, is now making significant strides in clinical applications, particularly in areas like therapeutic drug monitoring, metabolite testing, steroid hormone analysis, and vitamin D testing. The growing demand for MS in clinical settings is driven by its ability to outperform traditional immunoassays in terms of accuracy and precision. Kalorama Information’s The Worldwide Market for Mass...
    The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028

    Published: July 26, 2024 | Price: $5,000.00 – $10,500.00

    Kalorama Information’s latest report, The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028, is now available for purchase. This comprehensive study delves into the dynamic landscape of LDTs, exploring both the services market and the market for test products sold to clinical laboratories. The Worldwide Market for Laboratory-Developed Tests includes comprehensive analysis of the effects of the FDA's new "Medical Devices: Laboratory Developed Tests" rule, passed in April 2024, which subjects LDTs to significantly greater regulatory oversight. Inclusion Criteria for LDTs: 2023-2024: LDTs...
    The Worldwide Market for Laboratory-Developed Tests (LDTs)

    Published: September 24, 2020 | Price: $5,500.00 – $11,000.00

    Laboratory developed tests (LDTs) are not a new or recent phenomenon but due to the incredible need for testing of SARS-CoV-2, there has been a flood of new tests and the regulatory guidance has changed dramatically.  Historically, these tests were called “home-brew tests” or “in-house tests.”  Also, historically, these tests were low-volume, simple and well characterized tests for low-risk diagnostic applications.  Today, high-risk, complex tests have been developed as LDTs, and are being used to provide clinical results to physicians...