United States In-Vitro Diagnostics Market is expected to be valued at around US$ 56.52 Billion by 2030, according to Renub Research. Globally, in vitro diagnostics (IVD) is experiencing an excellent increase. Technological advancements, more robust accuracy, and speedy results propel expanded adoption. IVD encompasses tests performed on samples like blood or tissues outside the body, which is pivotal in disorder prognosis, monitoring, and treatment. As personalized remedies and early ailment detection benefit significantly, the demand for IVD solutions is growing in various healthcare settings. This evolution in diagnostic practices is drastically improving patient effects.


United States In-Vitro Diagnostics Market is anticipated to expand at a CAGR of 4.62% during the projection time (2024 to 2030)

The market is poised for growth with the development of automatic IVD structures that provide improved efficiency, accuracy, and throughput. This reflects a commitment to enhancing patient care through innovative technology and positioning the United States at the forefront of the in-vitro diagnostics market. Moreover, the growing occurrence of infectious and persistent illnesses is projected to boost the adoption of in vitro diagnostic testing strategies. For example, according to the American Cancer Society, in 2023, approximately 1.96 million new cancer instances were estimated, and around 609,820 people died due to cancer.

The senior population in the United States is developing, which is expected to drive growth in the market. With aged individuals requiring everyday fitness tracking and disease management, there is an extended want for diagnostic tests for age-related situations along with cardiovascular disease, cancer, and diabetes. According to America’s Health Rankings senior report, over 54 million senior citizens aged 65 and above live in the U.S., accounting for 16.5% of the United States’ population. By 2050, this range is projected to exceed 85.7 million. This demographic shift highlights the significance of superior diagnostic technology, which can guide early detection, remedy optimization, and advanced lifestyles for older adults, thereby increasing the in-vitro diagnostics market in the United States. Hence, the United States In-Vitro Diagnostics Market was US$ 41.19 Billion in 2023.

Technological advancements are set to propel the United States in the in vitro diagnostics (IVD) market. Innovations, next-technology sequencing, virtual PCR, and advanced imaging strategies promise superior diagnostic testing accuracy, sensitivity, and specificity. These breakthroughs allow earlier sickness detection, customized remedy techniques, and more efficient laboratory workflows. Integrating modern technology into in-vitro diagnostics practices is expected to drive the boom in the United States market, improve patient outcomes, and reduce healthcare costs while revolutionizing diagnostic talents and shaping the future of healthcare.


PCR technology is preferred in the United States in vitro diagnostics market

By test types, the United States In-Vitro Diagnostics Market is fragmented into ELISA & CLIA, PCR, Rapid Test, Fluorescence Immunoassays (FIA), In Situ Hybridization, Transcription Mediated Amplification, Sequencing, Colorimetric Immunoassay, Isothermal Nucleic Acid Amplification Technology, Radioimmunoassay (RIA), and Others.

PCR technology is anticipated to experience an increase in the in vitro diagnostics market. This is due to its versatility, sensitivity, and vast applicability. PCR assays are vital in diagnosing infectious illnesses, genetic problems, and cancer, providing speedy and correct outcomes. With ongoing improvements in real-time PCR and digital PCR, PCR-based tests continue to extend their utility in medical laboratories and healthcare settings, driving their adoption and contributing to the overall increase of the in-vitro diagnostics market.


Instruments are anticipated to be one of the foremost products in the United States In-Vitro diagnostics market

By products, the United States In-Vitro Diagnostics Market is segmented into Reagents, Instruments, and Services. Instruments are predicted to be among the leading products in the United States in vitro diagnostics (IVD) market. This is owed to their pivotal role in conducting diagnostic exams efficiently and accurately. Advanced automated units provide expanded throughput, progressed workflow, and enhanced reliability, catering to the developing need for high-performance diagnostic solutions in medical laboratories and healthcare centers. With a focus on optimizing diagnostic methods and improving patient care outcomes, instruments continue to be a critical element in the increase and evolution of the IVD market in the United States.


Hematology is poised to be one of the fastest-growing segments in the United States In Vitro diagnostics (IVD) market

By application, the United States In-Vitro Diagnostics Market is categorized into Immunochemistry, Clinical Chemistry, Hematology, Coagulation, Molecular Diagnostics, Microbiology, and Others. Hematology is expected to be one of the fastest-growing segments over the marketplace’s forecast duration. This is because blood problems like anemia, leukemia, and hemophilia are becoming more common. There is a developing desire for correct and timely tests to diagnose, display, and deal with these sicknesses. Further, technological advancements in hematology analyzers, which include better automation and integration of superior parameters, also power the adoption of hematology testing, positioning it as a critical growth section in the United States IVD market.


Key Players

Roche Diagnostics, Danaher Corporation, Thermofisher Scientific Inc., Bio–Rad Laboratories, Inc., Biomerieux, Abbott Laboratories, and Sysmex Corporation are the major enterprises in the United States In-Vitro Diagnostics (IVD) Market.

In March 2023 - Atila Biosystems and Stilla Technologies decided to sell co-labeled digital PCR equipment. Atila manufactures the kits and assays, which would be used on Naica systems, Stilla’s lead PCR instrument.
In January 2023, QIAGEN launched the EZ2 Connect MDx platform to improve its automation capabilities in sample processing. The advancement would be compatible with PCR, qPCR, and other downstream applications.


Renub Research report titled “United States In-Vitro Diagnostics (IVD) Market By Test Types (ELISA & CLIA, PCR, Rapid Test, Fluorescence Immunoassays (FIA), In Situ Hybridization, Transcription Mediated Amplification, Sequencing, Colorimetric Immunoassay, Radioimmunoassay (RIA), Isothermal Nucleic Acid Amplification Technology, and Others), Products (Reagents, Instruments, and Services), Application (Immunochemistry, Clinical Chemistry, Hematology, Coagulation, Molecular Diagnostics, Microbiology, and Others), Company Analysis (Roche Diagnostics, Danaher Corporation, Thermofisher Scientific Inc., Bio–Rad Laboratories, Inc., Biomerieux, Abbott Laboratories, and Sysmex Corporation)” provides a complete study of the United States In-Vitro Diagnostics (IVD) Industry.


Test Types – Market breakup in 11 viewpoints:

1. ELISA & CLIA
2. PCR
3. Rapid Test
4. Fluorescence Immunoassays (FIA)
5. In Situ Hybridization
6. Transcription Mediated Amplification
7. Sequencing
8. Colorimetric Immunoassay
9. Radioimmunoassay (RIA)
10. Isothermal Nucleic Acid Amplification Technology
11. Others


Product – Market breakup in 3 viewpoints:

1. Reagents
2. Instruments
3. Services


Application – Market breakup in 7 viewpoints:

1. Immunochemistry
2. Clinical Chemistry
3. Hematology
4. Coagulation
5. Molecular Diagnostics
6. Microbiology
7. Others


All the Key players have been covered from 3 Viewpoints:

  • Overview
  • Recent Development
  • Revenue Analysis




Company Analysis:

1. Roche Diagnostics
2. Danaher Corporation
3. Thermofisher Scientific Inc.
4. Bio–Rad Laboratories, Inc.
5. Biomerieux
6. Abbott Laboratories
7. Sysmex Corporation