The IVD contract research organization market in North America is expected to grow from US$ 1,882.10 million in 2021 to US$ 3,213.78 million by 2028. It is estimated to grow at a CAGR of 7.9% from 2021 to 2028.
The increasing prevalence of disorders, such as cancer, cardiovascular disorders, autoimmune disorders, and health problems, has created the need for advanced and efficient in-vitro diagnostics and monitoring of disorders which helps in the treatment. As per the National Stem Cell Foundation (NSCF) 2022 report, ~4% of the world’s population was affected by 1 among over 80 different autoimmune diseases. It affects 5–8% of the total population in the US alone. This is driving the growth of the IVD contract research organization market. Clinical trials play a critical role in evaluating the safety and effectiveness of drugs or devices for commercial usage. These studies help understand the best possible approaches for diagnostics and therapeutic areas. The increased prevalence of disorders has created the demand for advanced IVD diagnostics, which fueled the clinical trial promoting the growth of the IVD contract research organization market.
Furthermore, increased research & development activities and the rising investment in the development of IVD diagnostics have increased the adoption of outsourcing activities. The rising adoption of outsourcing in drug or device development services is time-saving and cost-effective. This has led to an increase in contract research organizations to support manufacturers in developing advanced IVD diagnostics. For instance, it is expected that by 2022, there will be 4,250 contract research organizations businesses in the US. Thus, an increasing prevalence of disorders and clinical trials and a surge in R&D investments and contract research organizations are driving the growth of the IVD contract research organization market.
North America IVD Contract Research Organization Market Revenue and Forecast to 2028 (US$ Million)

North America IVD Contract Research Organization Market Segmentation
The North America IVD contract research organization market is analyzed on the basis of type, services, and country. By type, the market is segmented into clinical chemistry, molecular diagnostics, immunochemistry, companion diagnostics, hematology, histology and cytology, microbiology, and others. The clinical chemistry segment held the largest share of the market in 2020. By services, the market is segmented into clinical research, biostatistics and data management services, therapeutic expertise, regulatory services, reimbursement services, assay development services, and others. The biostatistics and data management services segment held the largest share of the market in 2020.
Based on country, the North America IVD contract research organization market is segmented into the US, Canada, and Mexico. The US contributed a substantial share in 2020.
CMIC HOLDINGS CO., LTD; DCN Dx; ICON PLC; NAMSA; Nexelis, a Q² Solutions Company; Proxima Clinical Research, Inc.; ResearchDx; and Toolbox Medical Innovations are the leading companies in the North America IVD contract research organization market.
North America IVD Contract Research Organization Market Strategic Insights
North America IVD Contract Research OrganizationMarket Report Highlights
| Report Attribute | Details |
| Market size in 2021 | US$ 1,882.10 Million |
| Market Size by 2028 | US$ 3,213.78 Million |
| CAGR (2021 - 2028) | 7.9% |
| Historical Data | 2019-2020 |
| Forecast period | 2022-2028 |
| Segments Covered |
By Type
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Regions and Countries Covered
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| North America | US, Canada, Mexico |
| Market leaders and key company profiles |
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North America IVD Contract Research Organization Market Country and Regional Insights