U.S. In-Vitro Diagnostics Market - Focused Insights 2024-2029

THE U.S. IN-VITRO DIAGNOSTICS MARKET OVERVIEW

The U.S. in-vitro diagnostics (IVDs) market was valued at USD 40.79 billion in 2023 and is expected to reach USD 44.95 billion by 2029, growing at a CAGR of 1.63% during the forecast period. The demand for the in-vitro diagnostics market is rising due to multiple factors, including the awareness of infection control and prevention, increased healthcare expenditure, and growing chronic disorders.

This report offers market size & forecast data for the in-vitro diagnostics market in the US. The revenue generated from self-test kits, rapid test kits, and advanced IVD solutions are included in the report. The revenue generated from the services is excluded from the report. This report provides a comprehensive and current market scenario of the U.S. in-vitro diagnostics market, including the U.S. in-vitro diagnostics market size, anticipated market forecast, relevant market segmentations, and industry trends.

MARKET DEFINITION

In vitro diagnostics (IVDs) detect diseases, conditions, and infections in human blood or tissue samples. IVD medical devices include reagents, kits, instruments, equipment, or systems used to diagnose various diseases and health conditions or determine a patient's state of health.

MARKET DRIVERS

Growing Importance of IVD In Healthcare: The technological innovation and its application in healthcare are leading to the practical implementation of new treatment methods. The expectations for personalized medicine are growing, wherein medication and treatment are tailored to each patient's unique characteristics and medical condition. Testing is likely to play an increasingly important role in healthcare, as the realization of personalized medicine will require testing to confirm individual characteristics. For instance, cancer genomic medicine, which has begun earnestly, requires analysis of genetic information within cancer cells through genetic testing. Sysmex is working to achieve this type of cancer genomic medicine and to make liquid biopsy a reality.

Increasing Adoption Of Automation in Laboratories: Integrating automation into the IVD manufacturing process has many benefits for IVD device designers and manufacturers. Automation allows for the inclusion of software-based calculation, calibration, and documentation, improving test efficiency, calibration schedules, regulatory compliance, and instrument/equipment traceability. These benefits reduce labor, lower error (standardization) risk, and fewer calibration tests. Furthermore, automated volumetric measurements simplify production fabrication processes by giving manufacturers better control over manufacturing equipment and steps in the production line.

U.S. IN-VITRO DIAGNOSTICS MARKET HIGHLIGHTS

• The reagents and consumables product segment occupies a major market share of over 67% in the U.S. in-vitro diagnostics (IVDs) market. Reagents and consumables are used in in-vitro diagnostics procedures as a medium and transporter of specimens. With the increasing adoption of in-vitro diagnostics solutions, the demand for reagents and consumables is increasing. Infectious diseases and pandemics such as COVID-19 significantly fuel the demand for reagents in diagnosis.
• By technology, the hematology segment is growing significantly, with the highest CAGR of 3.05% during the forecast period. The growth of the segment is attributed to the increasing incidences of blood disorders and other diseases, rapid technological advances in hematology, and the emergence of high-throughput hematology analyzers.
• The diabetes application segment is propelling, with the fastest-growing CAGR in the U.S. market during the forecast period. The rising health consciousness among the population and the demand for diabetes monitoring devices, coupled with the easy availability of advanced diabetes devices, are fostering market growth in this country.
• The standard reference labs segment dominated the market share of the U.S. in-vitro diagnostics market. The segmental growth is primarily due to impeccable quality control standards, delivering top-tier testing services to hospitals, clinics, and various public and private healthcare institutions. Standard reference laboratories majorly contribute to the in-vitro diagnostics (IVD) market. These facilities undertake multiple responsibilities and a broad network of labs across regions. They are adept at conducting intricate and high-risk tests for many purposes.

VENDOR LANDSCAPE

The U.S. in-vitro diagnostics (IVDs)  market report contains exclusive data on 83 vendors. The competition among market players in the IVD market is significantly high for products, solutions, reagents, consumables, and services in terms of pricing, product, and associated brand image, services, and associated quality, a new product launched and developed, customer services, and financing terms. The leading market players in the US IVD market are F Hoffmann-La Roche, Abbott, Thermo Fisher Scientific, Diasorin, Biomerieux, Danaher, Bio-Rad, and Siemens Healthineers, competing with rapidly emerging market players. Vendors in the market are increasing their market share through inorganic growth strategies.