The global IVD contract research organization market is expected to grow from US$ 4,738.79 million in 2021 to US$ 8,019.53 million by 2028; it is estimated to grow at a CAGR of 7.8% from 2021 to 2028.

The rising prevalence of infectious diseases increases the demand for IVD and clinical trials along with new product launches, which fuels the growth of the IVD contract research organization market. However, the stringent regulatory policies and lack of skilled workforce hamper the market growth.

IVD contract research organizations provide support services to the biotechnology companies throughout the development and commercialization of the product. Diagnostic instruments/equipment companies require various regulatory and testing services to implement product lifecycle. CROs are specifically designed to perform these services to reduce the in-house cost and time of the companies. The continuous development in healthcare facilities and IVD products and new products launches propel the growth of the market. Also, rising demand for technological advancements and biomarker-based IVD owing to several advantages offered by them promotes the growth of the market.

As per the National Stem Cell Foundation (NSCF) 2022 report, ~4% of the world’s population was affected by one of more than 80 different autoimmune diseases; in the US, it affects 5–8% of the total population. 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. 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 devices development services is time-saving and cost-effective. This has led to the increase in contract research organizations to support manufacturers in developing advanced IVD diagnostics. For instance, it is expected that by 2022, there will be 4250 contract research organizations businesses in the US.

Based on type, the IVD contract research organization 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 2021. However, the hematology segment is anticipated to register the highest CAGR during the forecast period.

A few of the key primary and secondary sources referred to while preparing the report on the IVD contract research organization market are the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Stem Cell Foundation (NSCF), CMIC Group and Scientific Institute for Research, Hospitalization and Healthcare (IRCCS).