United States In-Vitro Diagnostics Market Research Report - Analysis on Size, Share, Growth, Trends & Forecast (2024 to 2029)

Updated On: January, 2024
ID: 10201
Pages: 100

U.S. In-Vitro Diagnostics Market Size (2023 to 2028)

The In-Vitro Diagnostics Market size in the United States is estimated to be worth USD 39.91 by 2028 from USD 29.54 billion in 2023 and is expected to grow at a CAGR of 6.2% from 2023 to 2028.

The samples of blood or tissues taken from the human body have undergone some in vitro diagnostic tests. These tests help the detection of underlying diseases and other health conditions. 

The contributing factors for in vitro diagnostic market growth are as mentioned below. The current technological developments in the United States and across this region lead to fully developed infrastructure like various laboratory equipment. This laboratory equipment is microscopes, testing devices, glassware, testing monitors, disposable materials, etc. Increased demand for courses like pathology and sciences made more pathologists and lab technicians count in the market. It helps and increases the number of tests being performed daily. Enhanced technology leads to the automation of labs and services. Hence the testing process and other tests related concepts are made more accessible after this, and the development of genetic markers and various biomarkers are helpful across multiple laboratory assessments. The increase and majority in key players and investors for this in vitro diagnostics market is a significant growth contributor. 

A few market restraints are listed below, along with market growth contributing factors. There is a lot of need for human resources and skilled staff to set up a fully equipped laboratory. The stringent regulations for the approval of devices, such as FDA regulations and other bodies, have been a growth-hampering factor for this market. Unfavorable reimbursement plans from health care, service, and the government to the in vitro diagnostic market are major market restraints. The other market restraints include high costs associated with laboratory tests. The equipment set-up price is also high, which hampers the market growth. The other major restraint is contamination issues in diagnostic centers. The maintenance and quality check for devices and equipment has to be done daily. As well, the maintenance of the environment has to be adequately sanitized.

Since the outbreak of the novel COVID-19, we all have learned social distancing is the only key to preventing the spread of infection. Hence the government has come up with lockdown regulations and norms with no or less contact between people. And the travel ban is stringent regulation announced during the pandemic. Due to travel ban issues, the awareness of early testing of diseases and early diagnosis of health conditions is not achieved. The imports and exports of materials and equipment related to maintenance are also on halt. The production and manufacturing loss has negatively impacted the in-vitro diagnostics market. Hence along with end-users, manufacturers are also at a loss.

This research report on the U.S. IVD market has been segmented and sub-segmented into the following categories:

By Product:

  • Instruments

  • Reagents and Kits

  • Software

By Technology:

  • Clinical Chemistry

  • Hematology

  • Immunoassays

  • Coagulation and Hemostasis

  • Molecular Diagnostics

  • Microbiology

  • Other IVD technologies

By Application:

  • Diabetes

  • Infectious Diseases

  • Oncology/Cancer

  • Cardiology

  • Nephrology

  • Autoimmune Diseases

  • Drug Testing

  • HIV

By Country:

  • The United States

Geographically, the North American market is the biggest market for the In-vitro diagnostics market across the globe. The United States holds the most significant shares and revenues among North American regions due to its well-developed healthcare and facilities, increased population, chronic diseases, research, and developmental activities. As a result, this region witnessed positive trends toward market growth in recent times and will continue to grow in the forecast period. 


Companies such as Abbott Laboratories, Johnson and Johnson, Siemens Healthcare, Becton Dickinson, Roche Diagnostics, Beckman Coulter Inc., Biomérieux, Ortho Clinical Diagnostics, Inc., Bio-Rad Laboratories, Inc., Danaher Corporation, Sysmex Corporation, Thermo Fisher Scientific, Inc. are playing a leading role in the U.S. In-Vitro Diagnostics Market.

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