The U.S. in vitro diagnostics market was estimated at USD 27.5 billion in 2021 and it is projected to surpass around USD 45.7 billion by 2030, growing at a CAGR of 5.81% from 2022 to 2030.
The prevalence of various diseases such as cancer, autoimmune diseases, and inflammatory conditions is increasing, which is expected to drive the market. For instance, according to the American Cancer Society, about 1.8 million are estimated to be new cancer cases and around 606,520 individuals are projected to die in 2020. Breast, prostate, colorectal, lung, stomach, and liver cancers are the most common types.
In addition, cell counts are performed manually; however, companies are introducing automated instruments to reduce manual work and provide quick and accurate results. For instance, in July 2018, Sysmex America, Inc. entered into a partnership with Advanced Instruments to introduce a novel GloCyte Automated Cell Counter System that is used to detect cerebrospinal fluid cell count. As per this agreement, Sysmex America, Inc. would be the exclusive distributor of the system in the U.S.
Increasing use of approved blood-gas analyzers to monitor respiratory conditions is expected to fuel market growth. For instance, in March 2020, Siemens Healthineers AG received the U.S. FDA approval for the RapidPoint 500e blood gas analyzer. This blood gas analyzer can be used for critically ill patients under acute care. Furthermore, it is anticipated to support COVID-19 response efforts due to its ability to test blood gas, which, in turn, is expected to help manage infected patients by aiding the monitoring of their respiratory conditions.
An increase in the initiatives by organizations to improve patient outcomes using cost-effective and rapid diagnostic techniques to help fight antibiotic resistance is expected to fuel market growth. For instance, in April 2019, The University of Antwerp, Wellcome Trust, and bioMérieux, together launched Value-Dx-an Innovative Medicines Initiative (IMI) project-that was initiated by six IVD companies to fight against antimicrobial resistance. The aim of this project was to transform clinical practice and achieve better patient outcomes by implementing new diagnostic technologies.
Scope of the Report
|Market Size in 2021||USD 27.5 Billion|
|Revenue Forecast by 2030||USD 45.7 Billion|
|Growth Rate from 2022 to 2030||CAGR of 5.81%|
|Market Segmentation||Product, Technology, Application, End User|
|Forecast Period||20222 to 2030|
The reagents segment accounted for the largest revenue share of 67% in 2021. One of the key factors responsible for the dominance of this segment is the increasing volume of tests and the rise in the number of R&D initiatives pertaining to reagents. Furthermore, market players are undertaking strategic initiatives to increase their product capabilities and promote the outreach of their product offerings, thereby fueling the growth of the segment. For instance, in October 2019, QIAGEN N.V. and Illumina, Inc. partnered for 15 years to expand the availability and use of NGS-based IVD kits.
In addition, the reagents segment is estimated to be the fastest-growing segment, followed by instruments, during the forecast period owing to increasing approval of COVID-19 tests for emergency use by the regulatory authorities. For instance, in April 2020, Ortho Clinical Diagnostics received EUA from the U.S. FDA for VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. This approved test is used on the VITROS 3600 Immunodiagnostic system, VITROS 5600 Integrated system, and VITROS XT 7600 Integrated system.
The immunoassays segment accounted for the largest revenue share of 31% in 2021 owing to the presence of key players, such as Siemens Healthineers, Abbott, F. Hoffmann-La Roche Ltd., Quidel Corporation, and DiaSorin S.p.A., which are developing and distributing immunoassay analyzers in the U.S. These companies have a significant share in the U.S. IVD market due to a large number of the installed base.
In addition, the rising partnership between key players to strengthen their position and increase in the number of installed systems and the volume of immunoassay tests are anticipated to fuel the market growth. For instance, in February 2020, Quest Diagnostics chose Siemens Healthineers to supply their immunoassay tests, along with Atellica Solutions in the U.S. Under the agreement, it is estimated that Quest Diagnostics will deploy approximately 120 Atellica Solutions analyzers in 19 esoteric and core laboratories across the country. This is expected to boost the adoption of Siemens’s immunoassay analyzer and increase Quest’s testing volume.
The infectious diseases application segment accounted for the largest revenue share of 28% in 2021 and is anticipated to maintain its lead over the forecast period. This is attributed to the introduction of new products and the rising prevalence of infectious diseases. Furthermore, key market players are entering into a collaboration to improve access to high-quality and innovative laboratory services for patients and healthcare providers.
For instance, in January 2020, Quest Diagnostics collaborated with Memorial Hermann Health System to provide improved, cost-efficient, high quality, and innovative diagnostic services for 21 hospital laboratories in Houston. Such initiatives by market players to strengthen their presence are expected to drive the market.
The hospitals segment dominated the segment in 2021 with a revenue share of 47% owing to large space, developed infrastructure, and an increase in hospitalization. Furthermore, an increasing number of MRSA cases in hospitalized patients is expected to boost market growth. According to the CDC, around 5% of hospitalized patients suffer from MRSA infections and carry the bacteria. Therefore, in December 2019, the FDA authorized the marketing of the Cobas vivoDx MRSA diagnostic test, which can evaluate patients for bacterial colonization faster than conventional culture-based techniques. Such initiatives by the FDA to provide marketing authorization of diagnostic tests with new technologies and higher accuracy are anticipated to drive the market.
The home-care segment is projected to be the fastest-growing segment over the forecast period due to the rise in demand for affordable services, technological advancements, and increasing development of at-home tests. For instance, in April 2020, Laboratory Corporation of America Holdings received EUA for COVID-19 At-Home Test Kit. The nasal swabs are collected easily and safely using Pixel by LabCorp COVID-19 test home collection kit.
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