The United States in vitro diagnostics (IVD) market was valued at USD 32.84 billion in 2022 and is projected to grow to USD 56.43 billion by 2030, with a compound annual growth rate (CAGR) of 7% from 2023 to 2030. This market plays a crucial role in the healthcare system, facilitating disease diagnosis, treatment monitoring, and patient health management. IVD encompasses medical devices, reagents, and systems used to analyze biological samples such as blood, urine, and tissue outside the human body, helping improve healthcare outcomes and cost efficiency.
The market has witnessed significant expansion due to rising cases of chronic diseases such as diabetes, cardiovascular conditions, and cancer. Additionally, the growing elderly population has increased demand for IVD products, given the need for frequent medical testing. Technological advancements, including automation and digitalization, have further propelled market growth by enhancing diagnostic accuracy and efficiency.
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Rising Incidence of Infectious Diseases
The increasing prevalence of infectious diseases has fueled demand for rapid and accurate diagnostic tests in the U.S. Factors such as globalization, high population density, and changing disease patterns have contributed to this trend. The IVD industry has responded by developing advanced diagnostic tools that swiftly identify pathogens like viruses, bacteria, and fungi. These innovations help healthcare providers diagnose infections quickly, enabling prompt treatment and effective outbreak control.
Growing awareness of early detection and disease surveillance has further stimulated market expansion, with increased investment in research and development. This has led to the introduction of highly sensitive and user-friendly diagnostic solutions. For example, in July 2022, the U.S. Food and Drug Administration (FDA) approved Fujirebio Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) test, the first laboratory diagnostic test cleared for aiding in the diagnosis of Alzheimer’s disease.
Technological Advancements in IVD Instruments
Innovation in diagnostic instruments has transformed the IVD market in the U.S., enhancing efficiency, accuracy, and accessibility. Miniaturization and automation have enabled the development of portable, point-of-care devices, allowing rapid diagnostics at patients’ bedsides. The integration of artificial intelligence (AI) and telemedicine has further improved data analysis and remote monitoring, optimizing disease management.
The market has seen the increased adoption of portable diagnostic instruments, such as Roche Diagnostics’ cobas 4800 and Cepheid’s GeneXpert. In December 2022, Abbott introduced the NavitorTM transcatheter aortic valve implantation (TAVI) system, designed for patients at high surgical risk. Similarly, in November 2021, Roche launched the cobas 5800 System, a molecular testing platform for diagnosing infectious diseases, including respiratory and sexually transmitted infections.
Advancements in Oncology Diagnostics
Oncology is expected to be the fastest-growing segment in the U.S. IVD market, driven by rising cancer cases and increasing demand for early-stage diagnosis. The most common cancers include breast, prostate, colorectal, lung, stomach, and liver cancer. Additionally, viruses such as human papillomavirus (HPV) and hepatitis B and C contribute to a significant proportion of cancer-related deaths. With cancer cases projected to rise by 70% over the next two decades, the demand for clinical testing and in vitro diagnostics is expected to surge.
Regulatory agencies have supported this growth by approving innovative diagnostic solutions. In August 2022, the FDA approved the Divitum TKa blood-based biomarker assay for monitoring metastatic breast cancer. Additionally, in November 2020, the FDA cleared FoundationOne Liquid CDx, a liquid biopsy test for detecting multiple cancer biomarkers.
Impact of COVID-19
The COVID-19 pandemic significantly boosted the demand for IVD kits and reagents, as testing became essential for controlling the outbreak. The crisis underscored the importance of in vitro diagnostics in detecting infectious diseases, leading to increased investments in research and home-based testing solutions.
Regulatory agencies prioritized the approval of molecular diagnostic self-tests. For example, in 2021, BATM Advanced Communications Ltd. launched a molecular diagnostics self-test kit for COVID-19 detection. Retail chains also played a role in expanding access to testing. In May 2021, Kroger announced the availability of Abbott’s BinaxNOW COVID-19 Ag Card for self-testing. Similarly, in April 2021, Abbott partnered with major retailers like Walgreens, Walmart, and CVS to distribute the BinaxNOW self-test, broadening market reach.
Additionally, strategic collaborations strengthened diagnostic services. In January 2020, Quest Diagnostics partnered with Memorial Hermann Health System to enhance testing capabilities in Houston, improving efficiency and cost-effectiveness.
Report Scope
The report “United States In Vitro Diagnostics Market Assessment, Opportunities, and Forecast, 2016-2030F” by Markets and Data offers a detailed analysis of market trends, industry dynamics, and growth opportunities. It covers market size, segmental shares, the impact of COVID-19, and future forecasts (2023-2030). The report also provides insights into leading market players, competitive strategies, and business models.
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