U.S. In Vitro Diagnostics Market By Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Haematology, Others), By Product (Instruments, Reagents, Others), By Usability (Disposable IVD, Reusable IVD), By Application (Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, Drug Testing, Others), By End User (Diagnostic Laboratories, Hospitals & Clinics, Others), By Geography - Global Opportunity Analysis & Industry Forecast, 2021-2026
U.S. In Vitro Diagnostics Market Overview
The U.S. In Vitro Diagnostics Market size is estimated to reach $27.1 billion by 2026, growing at a CAGR of 4.5% during the forecast period 2021-2026. As per U.S. Food and Drug Administration (FDA), “ In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae and such products are intended for use in the collection, preparation, and examination of specimens taken from the human body”. The U.S. Invitrio Diagnostics (IVD) Market is characterized by the advantageous handling of incessant conditions like heart ailments in conjunction with Novel Coronavirus (COVID-19) in 2020. Clinical Chemistry and Molecular Diagnostics are segments of the U.S. Invitrio Diagnostics (IVD) Market based on Test Type. Rapid diagnostics have been fuelled by rapid tests during the Novel Coronavirus (COVID-19) Pandemic in the U.S. Invitrio Diagnostics (IVD) Market. Drug Testing may be considered to be a segment of the U.S. Invitrio Diagnostics (IVD) Market on the basis of application.
Report Coverage
Key Takeaways
- U.S. In Vitro Diagnostics Market growth is being driven by the great predominance of incessant ailments, boost in the utilization of POC (Point-of-care) diagnostics, progressive technologies for rapid tests, heightening awareness, and adoption of personalized medications. However, the dearth of efficient reimbursement regulations and a lack of experienced laboratory technicians are some of the major factors hampering the growth of U.S. In Vitro Diagnostics Market.
- U.S. In Vitro Diagnostics Market Detailed Analysis on the Strength, Weakness, and Opportunities of the prominent players operating in the market will be provided in the U.S. In Vitro Diagnostics Market report.
U.S. In Vitro Diagnostics Market Segment Analysis – By Application:
The U.S. In Vitro Diagnostics Market based on the application can be further segmented into Infectious Diseases, Diabetes, Cancer/Oncology, Cardiology, Autoimmune Disease, Nephrology, Drug Testing, and Others. The Infectious Diseases Segment held the largest market share in 2020. This growth is owing to the great predominance of ailments like pneumonia and tuberculosis, resulting in increased utilization of in vitrio diagnostic tools. Rapid tests for tuberculosis have been developed. The Xpert MTB/RIF assay is a novel test that is transforming tuberculosis (TB) regulation by contributing to the accelerated diagnosis of Tuberculosis (TB) ailment and drug resistance. The test concurrently identifies Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) in fewer than 2 hours. These kinds of advancements are driving the growth of the Infectious Diseases segment.
U.S. In Vitro Diagnostics Market Segment Analysis – By End Use:
The U.S. In Vitro Diagnostics Market based on End Use can be further segmented into Diagnostic Laboratories, Hospitals and Clinics and Others. The Hospitals and Clinics Segment held the largest market share in 2020. This growth is owing to the enormous volume of diagnostic tests and rapid tests performed in hospitals and clinics and the increasing volumes of Class II and Class III IVD medical devices that are accessible for diagnostic testing. The healthcare professionals in hospitals use in vitro diagnostics for discovery of ailments and to obtain the best outcomes for every patient. These determinants are fuelling the growth of the Hospitals and Clinics segment.
U.S. In Vitro Diagnostics Market Drivers
Global Prevalence Of Incessant Ailments Is Projected To Drive The Growth Of U.S. In Vitro Diagnostics Market:
Technological Innovations Are Expected To Boost The Demand Of U.S. In Vitro Diagnostics:
U.S. In Vitro Diagnostics Market Challenges
Premarket Approval (PMA) and IVD labelling Requirements As Specified Under The Specific Sections of the U.S. Food And Drug Administration (FDA) Are Challenging:
U.S. In Vitro Diagnostics Market Landscape:
- Abbott Laboratories
- Becton, Dickinson and Company
- F.Hoffmann-La Roche Ltd
- BioMerieux SA
- Thermo Fischer Scientific Inc
- Danaher Corporation
- Bio-Rad Laboratories, Inc.
- Sysmex Corporation
- Quest Diagnostics Incorporated
- Siemens Healthineers
Acquisitions/Product Launches:
- In March 2020, Abbott introduced Novel Coronavirus Test which will be utilized on m2000 RealTime system accessible in hospitals and molecular labs in the U.S. Abbott has acquired emergency use authorization (EUA) from the Food And Drug Administration (FDA) for its molecular test for the recognition of SARS-CoV-2, the virus that brings about COVID-19.
- In July 2020, BD (Becton, Dickinson and Company), a chief global medical technology firm, declared the accessibility of BD PurPrep™ patient preoperative skin preparation with sterile solution, the earliest and only completely sterile povidone-iodine plus isopropyl alcohol single-use antiseptic skin preparation (PVP-I; 0.83% accessible iodine and 72.5% isopropyl alcohol) commercially accessible in the U.S.