U.S. IVD Market to Garner $46.41 Billion by 2032: The Brainy Insights
The Brainy Insights
Updated 5 min read
The Brainy Insights
Technological advancements are driving the expansion of the U.S. IVD market. Growing product launches due to Emergency Use Authorization for several COVID-19 diagnostic procedures have also contributed to the rise. Also, the market is anticipated to witness new opportunities due to ongoing R&D efforts connected to IVD.
Newark, June 28, 2023 (GLOBE NEWSWIRE) -- The Brainy Insights estimates that the U.S. IVD market will grow from USD 28.63 Billion in 2022 to USD 46.41 Billion by 2032. The demand for in vitro diagnostics (IVD) to diagnose SARS-CoV-2 infection is predicted to decrease exponentially throughout the projection period. Nevertheless, IVD is a cutting-edge technique that offers novel illness recognition and therapy methods. The growing prevalence of chronic and infectious diseases in the United States is expected to increase the adoption of IVD methods for diagnosis.
The coagulation segment is expected to grow at the highest CAGR of 6.26% during the forecast period.
The technology segment is divided into hematology, molecular diagnostics, microbiology, immunoassays, coagulation, clinical chemistry, and others. During the projection period, the coagulation segment is projected to expand at the highest CAGR of 6.26%. The usage of IVD assays is expanding, and there is a growing need for point-of-care diagnostics. The demand for coagulation testing is anticipated to increase as cardiovascular diseases, blood-related disorders, and autoimmune diseases become more common.
The oncology segment is expected to grow at the highest CAGR of 5.83% during the forecast period.
The application segment is divided into diabetes, cardiology, autoimmune diseases, hematologic diseases, infectious diseases, nephrology, oncology, drug testing, and others. During the projection period, the oncology segment is projected to expand at the highest CAGR of 5.83%. Over the forecast period, the segment is predicted to develop more rapidly due to rising cancer prevalence, awareness of early cancer diagnosis, and government initiatives.
• For example, the U.S. government launched the Cancer Moonshot initiative in February 2022 to increase cancer screening rates and find cases of cancer that were overlooked because of the COVID-19 pandemic. The government intends to use early detection and treatment to cut the death rate from cancer by 50% during the next 25 years.
Driver: Worldwide occurrence of chronic diseases and technological advances
Approximately 70% of cancer-related deaths occur in low- and middle-income countries. Rapid tests have seen a rise in demand due to the Coronavirus (COVID-19) Pandemic. Point of Care (POC) diagnostics are experiencing an increase due to the rising incidence of cancer cases and other chronic illnesses in the United States. Consequently, the need for oncology-based diagnostic tests will increase during the forecast period. Technical developments fuel the growth of the IVD market in the United States. Molecular diagnostics is a collection of techniques used to look for biomarkers in the genome and proteome. These tests examine specific nucleic acid sequences as well as how genes are converted into proteins by cells. Rapid molecular tests are a novel type of molecular influenza diagnostic test that detect influenza virus RNA or nucleic acids in upper respiratory tract specimens in about 15 to 30 minutes.
Challenge: Premarket approval and IVD labelling requirements as specified under the sections of the United States FDA
The FDA uses premarket approval (PMA) to assess the efficacy and safety of Class III medical devices through regulatory and scientific analysis. IVDs have a special relationship between security and efficiency because the security of the instrument is rarely connected to an interaction between the instrument and the patient. In the case of IVD products, the instrument's security is impacted by how the device works and, more precisely, by how false positive and false negative results affect patient health. Securing Premarket Approval is crucial. Additional labelling requirements for in vitro diagnostic products are outlined in 21 CFR 809, Subpart B, In Vitro Diagnostic products for Human Use. Before obtaining marketing authorization, manufacturers of IVD products must label their items in compliance with the labelling rules. These issues affect Invitrio Diagnostics' ability to grow its U.S. market.
The market is analyzed based on value (USD Billion). All the segments have been analyzed on a country basis. The report analyzes driving factors, opportunities, restraints, and challenges to gain critical market insight. The study includes Porter's five forces model, attractiveness analysis, product analysis, supply, and demand analysis, competitor position grid analysis, distribution, and marketing channels analysis.
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