The U.S. in-vitro diagnostics market was valued at USD 32.94 billion in 2022 and is projected to grow from USD 33.78 billion in 2023 to USD 56.81 billion by 2030, reflecting a CAGR of 7.7% during the forecast period.
The growth of the U.S. in-vitro diagnostics market is driven by the strong presence of major industry players, increasing demand for rapid diagnostic testing and point-of-care devices, a rising prevalence of chronic diseases, and heightened awareness of early disease detection. Organizations such as the Pan American Health Organization (PAHO), Childhood Cancer International, and St. Jude Children’s Hospital have launched initiatives to promote early cancer detection in children and adolescents. According to PAHO, timely diagnosis and treatment of pediatric cancer significantly enhance survival rates. Additionally, the expanding geriatric population is a key driver of demand for diagnostic products. A demographic study by the University of Washington, published in July 2021, projected that half of all individuals born in the U.S. since the start of the 21st century will live to 100 years. This rising life expectancy is expected to increase the adoption of diagnostic devices, further propelling market growth. Moreover, data from the U.S. Census Bureau estimates that by 2060, the number of individuals with diabetes will surge by 25.1%, reaching 162 million. Government-led initiatives promoting early disease detection are anticipated to further drive demand for diagnostic products, contributing to the continued expansion of the U.S. in-vitro diagnostics market during the forecast period.
Market Segmentation:
The U.S. in-vitro diagnostics market is segmented into instruments and reagents & consumables, with the latter holding a dominant share. The surge in COVID-19 testing significantly increased the demand for reagents & consumables, further driven by the growing need for cancer and disease diagnostics. For example, the Illumina NovaSeq 6000Dx S2 Reagent Kit supplies essential consumables for sequencing sample libraries. Meanwhile, the instruments segment is poised for notable growth, driven by advancements in diagnostic technology. Abbott, for instance, introduced serology blood tests on its ARCHITECT and Alinity platforms in 2020–2021 to detect COVID-19 antibodies, which were launched under EUAs in the U.S. and CE marks in Europe.
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Major Players Profiled in the U.S. In-vitro Diagnostics Market Report:
· Abbott (U.S.)
· F. Hoffmann-La Roche AG (Switzerland)
· Thermo Fisher Scientific Inc. (U.S.)
· Quest Diagnostics Incorporated (U.S.)
· Bio Rad Laboratories, Inc. (U.S.)
· BD (Becton, Dickinson, and Company) (U.S.)
· Agilent Technologies, Inc. (U.S.)
· Quidel Corporation (U.S.)
· Siemens Healthcare GmbH (Germany)
Driving Factors:
Point-of-care diagnostics enables decentralized testing for conditions such as diabetes, infectious diseases, and cardiovascular health, providing rapid and reliable results crucial for diagnosing and managing chronic diseases. With expanding applications, innovators in this field are advancing bio-sensing technologies to detect proteins, biomarkers, and DNA. In-vitro diagnostics manufacturers are also developing multifunctional technologies capable of identifying multiple diseases with a single device. For instance, in March 2022, Visby Medical secured $25.5 million in funding from the U.S. Biomedical Advanced Research and Development Authority to develop a rapid flu-COVID-19 PCR test. This test can simultaneously detect COVID-19, influenza A, and influenza B from a single sample. Additionally, the rising prevalence of diabetes in the U.S. has heightened the demand for regular blood sugar monitoring, driving growth in glucose monitoring products. According to the National Diabetes Statistics report published in June 2022, approximately 37.3 million people in the U.S.—or 11.3% of the population—had diabetes, while 96 million adults, about 38% of the adult population, were reported to have prediabetes. This increasing diabetic population is expected to fuel demand for glucose monitoring devices, further accelerating the growth of the U.S. in-vitro diagnostics market.
Restraining Factors:
The ongoing debate over whether in-vitro diagnostics (IVDs) should be classified as medical devices or biological products has led to several regulatory updates. However, frequent changes in regulations can pose operational challenges for IVD manufacturers, resulting in unnecessary time and resource expenditures. According to the U.S. Food and Drug Administration (USFDA), IVDs are currently categorized as medical devices. However, in some cases, they may also be classified as biological products under Section 351 of the Public Health Service Act. Furthermore, advancements in laboratory testing have led to increased regulatory scrutiny of diagnostic tests that do not fall strictly under the IVD category. The FDA has issued draft guidance and discussion papers outlining enforcement discretion for certain regulatory requirements and laboratory-developed tests (LDTs). These evolving regulations create uncertainty for IVD manufacturers regarding compliance, potentially hindering market growth.
Key Industry Developments:
· February 2023 – BD received Emergency Use Authorization (EUA) from the USFDA for its molecular diagnostic test detecting SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV).
· October 2022 – Thermo Fisher Scientific Inc. announced the acquisition of the Binding Site Group, a provider of specialty diagnostic assays and instruments, to strengthen its specialty diagnostics portfolio.