In-Vitro Diagnostics Quality Control Market Size (2024 - 2029)

In-Vitro Diagnostics Quality Control Market Analysis

The in-vitro diagnostics (IVD) quality control market studied is expected to register a CAGR of 3.5% during the forecast period.

COVID-19 has significantly impacted the growth of the studied market. Due to the spread of the coronavirus infection among the population, the demand for in-vitro diagnostic kits and devices for rapid and accurate diagnosis of SARS-CoV-2 virus infection increased. Also, the strict regulatory guidelines for reducing the spread of COVID-19 and conducting effective testing increased the need and demand for stringent quality controls of testing kits and devices. This has impacted the market growth during the forecast period.

Certain factors attributing to the market growth are the increasing demand for advanced diagnostics for sensitive reports and accurate diagnosis of chronic and infectious diseases and genetic disorders, the growing volume of accredited clinical laboratories, and the adoption of third-party quality controls. 

The increasing incidences of chronic, infectious, and genetic diseases across the globe is the key factor driving the market growth. For instance, as per 2022 statistics published by IDF, it has been observed that 74.1 million people were suffering from diabetes in 2021 in India. This number is estimated to reach 92.9 million and 124.8 million by 2030 and 2045, respectively. Thus, the rising burden of diabetes among the population is expected to increase the demand for conducting in-vitro assays for detecting blood glucose. This is anticipated to propel the demand for effective in-vitro diagnostics, thus propelling the need for strict quality control. 

Also, according to the data from American Cancer Society in 2022, an estimated 1,908,030 new cancer cases are expected to be diagnosed in United States in 2022. Moreover, as per the same source, among all cancers, digestive system cancer is expected to account for 343,040 cases, breast cancer is expected to account for 290,560 new cancer cases, followed by respiratory system cancer with 254,850 new cases in 2022. Thus, the rising burden of cancer raises the need to detect cancer early for more effective and timely treatment, which increases the demand for in-vitro diagnostics devices and kits, which is anticipated to boost the need for strict quality control of in-vitro diagnostics devices to reduce the chances of false results, which is expected to augment the market growth over the forecast period.

Furthermore, according to an article published by Frontiers in Medicine in May 2022, it has been observed that automated blood culture systems have improved microbiological diagnostic performance, reduced turnaround times, and enhanced yield as compared to manual blood cultures. Thus, the increasing usage of quality-assured advanced blood culture devices and instruments for detecting bloodstream infections is expected to propel the market growth over the forecast period. 

Moreover, the rising company activities in developing technologically advanced diagnostic products and increasing product launches contribute to market growth. For instance, in June 2021, Thermo Fisher Scientific Inc. launched TaqPath, a new CE-IVD-marked fast PCR combo kit 2.0, to detect active SARS-CoV-2 infection. 

Therefore, due to the above mentioned factors such as the rising company activities in developing technologically advanced diagnostic products and increasing product launches, increasing usage of quality-assured advanced blood culture devices and instruments for detecting bloodstream infections, the studied market is expected to experience growth during the forecast period of the study. However, unfavorable reimbursement policies for the IVD industry and a lack of stringent regulations for clinical laboratory accreditation in several emerging economies are some of the factors impeding the market growth over the forecast period.

In-Vitro Diagnostics Quality Control Industry Segmentation

As per the scope of the report, in-vitro diagnostic quality controls are used to evaluate the performance of in-vitro diagnostic tests, such as in vitro nucleic acid testing procedures for pathogen detection, healthcare-associated infections (HAIs) like pneumonia, and urinary tract infections. These products majorly focus on the detection of defects, quality control, and validation panels, such as the Human Papillomavirus (HPV) Control Panel and Blood Culture (BCID) Control Panel, to support the implementation and monitoring of the performance of clinical and research laboratories, blood diagnostic centers, and IVD manufacturers. The In-Vitro Diagnostics Quality Control Market is segmented by Products and Services (Quality Control Products, Data Management Solutions, and Quality Assurance Services), Applications (Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, and Other Applications), End Users (Hospitals, Clinical Laboratories, IVD Manufacturers & CROs and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (USD million) for the above segments.