In-vitro diagnostic is an advanced method that provides new tools to find disease diagnosis and treatment. In the United States, the growing prevalence of chronic and infectious diseases has spurred the development of the in-vitro diagnostics (IVD) market. In-vitro diagnostics (IVDs) in the US is considerably more than simple assays conducted in test tubes and examining glass dishes under microscopes. These instruments used to analyze body fluids and tissue samples collected from a patient. The United States In-vitro Diagnostics Market Size was worth US$ 26.9 Billion in 2020.


Besides, the United States In-Vitro Diagnostic market is broad and has various types of diagnostics instruments to perform different techniques. Clinical Chemistry, Microbiology–Molecular, POC–Professional, OTC Diabetes, Immunoassay–Infectious, Histology, Hematology, and Blood Testing are popular IVD techniques in the U.S.A. The growth of POC diagnostic market in the States is phenomenal. These POC diagnostics products have been developed to use at a patient’s bedside in hospitals to get instant results without sending the samples to the lab. Innovations in Microbiology and Immunochemistry diagnostic fields have made these tests economically viable and provide quicker and more precise results.


Further In-Vitro diagnostics are used in large-scale population screenings such as for cervical cancer. As well as predicting, whether a particular medicine or therapy would work on a patient. Patients with diabetes use IVDs to test their blood glucose levels regularly. At the same time it is also used to make or confirm a medical diagnosis, such as confirming a pregnancy or testing infectious diseases like HIV or hepatitis. According to Renub Research, United States In Vitro Diagnostics Market will be US$ 35.3 Billion opportunities by 2026.


The United States In-Vitro Diagnostics have vast product ranges. The reagents segment fastest-growing product in the In-Vitro Diagnostics market as the increasing volume of tests and the rise in R&D initiatives pertaining to reagents. Instrument product is also seen to dominate the market in the forecast period because of rising approval of COVID-19 tests for emergency use by the regulatory authorities. In the United States, the In-vitro diagnostics market is currently in the South of the country, followed by the West being second. As per our research findings, United States IVD Industry will further grow with a CAGR of 4.63% during 2020-2026.


Factors Driving the United States IVD Market

The growth factors like the increasing prevalence of chronic diseases such as heart disease, cancer, asthma, and diabetes are driving the In Vitro Diagnostics market in the United States. Thereon diseases, as mentioned earlier, were responsible for the majority of deaths in the United States, killing over 1.7 million people each year. IVD products used to diagnose and monitor these disorders. As a result, IVDs have proven to be effective in treating and diagnosing several chronic illnesses. However, a lack of effective reimbursement regulations and a shortage of experienced lab technicians are the challenges that are hindering the market’s growth.


Coronavirus Impact on IVD Industry of United States

The in-vitro diagnostics industry has seen a huge spurt in demand due to the Covid-19 Pandemic. Primary assays used for COVID-19 detection employ the RT-PCR technique. Although the traditional test takes 5 to 6 hours to produce a result, POC assays (Rapid Antigen Test) have drastically decreased the time. Thus, COVID-19 presents a significant opportunity for the IVD industry’s leading stakeholders. As a result, the overall impact of the COVID-19 pandemic on substantial companies in the in vitro diagnostics sector remained positive. Few organizations experiencing a setback due to the lockdown have decreased the amount of regular IVD tests completed across the United States. However, the rapid demand for newly available emergency use permitted IVD tests for COVID-19 detection offsets this negative impact.


Renub Research report titled “United States In Vitro Diagnostics Market, IVD Segments (Clinical Chemistry, Microbiology – Molecular, Microbiology -ID/AST, POC - OTC Diabetes, POC – Professional, POC – Others, Immunoassay – Infectious, Immunoassay – Others, Urinalysis, Histology, Hematology, Molecular - Non Infectious, Coagulation, Blood Testing and Typing, Flow Cytometry), Products (Services, Reagents, Software, Instruments) Regions (Midwest, South, North East West), Companies (Roche Diagnostics, Thermo Fisher Scientific, Siemens Healthineers, Danaher Corporation, Abbott Diagnostics, Sysmex Corporation)” provides a complete analysis of United States In Vitro Diagnostics (IVD) Market.


Segments - United States In-Vitro Diagnostics (IVD) Market

1. Clinical chemistry
2. Microbiology -ID/AST
3. Microbiology – Molecular
4. POC – Professional
5. POC - OTC Diabetes
6. POC – Others
7. Immunoassay – Infectious
8. Immunoassay – Others
9. Urinalysis
10. Molecular - Non Infectious
11. Coagulation
12. Histology
13. Hematology
14. Blood Testing and Typing
15. Flow Cytometry


Products - United States In-Vitro Diagnostics (IVD) Market

1. Services
2. Software
3. Reagents
4. Instruments


Regions - United States In-Vitro Diagnostics (IVD) Market

1. South
2. West
3. Midwest
4. North East


All the companies have been studied from three points

  • Overview
  • Recent Developments
  • Sales Analysis




Company covered in this report

1. Roche Diagnostics
2. Abbott Diagnostics
3. Siemens Healthineers
4. Danaher Corporation
5. Thermo Fisher Scientific
6. Sysmex Corporation