Sheridan, Wyo. – October 05, 2026 -- The global in vitro diagnostics (IVD) quality control market is set to climb from $1.7 billion in 2026 to $2.2 billion by 2031, a 5.3% compound annual growth rate, according to a new study by Wissen Research.
Rising testing volumes and regulatory pressure push labs toward automated QC
Growth is driven by expanding testing complexity across clinical chemistry, immunoassay, hematology, and molecular diagnostics, combined with tightening regulatory requirements such as CLIA in the United States. Laboratories are increasingly adopting internal quality controls, third-party control materials, and external quality assessment programs as standard practice.
QC shifts from manual checks to continuous, connected monitoring
Commercial platforms including Roche's navify Lab Operations now embed configurable QC rules, Levey-Jennings charting, and automated suspension of result transmission when issues arise, turning QC into a continuously monitored process rather than a periodic check. Patient-based real-time quality monitoring is emerging alongside this shift, using normal patient population results to flag analyzer drift between scheduled QC events. In the US, the CDC's Individualized Quality Control Plan (IQCP) lets labs design QC procedures around their specific testing environment rather than fixed frequencies, while Roche's navify POC Operations extends centralized oversight to point-of-care testing sites.
Automated QC cuts processing time by two-thirds in Chinese hospital study
A multicenter study across 13 hospitals in China found automated QC reduced processing time from 30 minutes to 10 minutes while producing a lower out-of-control rate than manual QC. Hospitals dominated the market by end user in 2025, reflecting the volume and diversity of testing performed across clinical chemistry, immunoassay, hematology, microbiology, and molecular platforms.
Immunoassay leads technology segment on hormone and infectious disease testing volumes
Immunoassay/immunochemistry dominated the market by technology in 2025, supported by widespread automated immunochemistry systems used for hormones, tumor markers, cardiac markers, and infectious disease panels. A survey of 21 large academic medical centers found widespread use of third-party QC materials specifically for immunochemistry testing.
North America leads on CLIA standards; Asia-Pacific grows fastest
North America held the largest regional share in 2025, backed by established clinical laboratory infrastructure and CLIA's federal quality standards; the CDC notes more than 14 billion laboratory tests are performed annually in the US alone. Bio-Rad's Unity QC platform, offering interlaboratory comparison and QC data management across major US diagnostic platforms, reinforces the region's position. Asia-Pacific is the fastest-growing region, driven by expanding diagnostic infrastructure and laboratory automation across China, India, Japan, and South Korea.
Thermo Fisher and RealBio pair global standards with local regulatory expertise
In May 2026, China's RealBio signed a strategic agreement with Thermo Fisher Scientific to collaborate on comprehensive IVD quality control solutions, combining Thermo Fisher's global standards with RealBio's local regulatory support and raw material development. In July 2025, Siemens Healthineers became the first IVD manufacturer to earn the My Green Lab ACT Ecolabel for its Atellica analyzers and more than 150 reagents, providing transparent environmental impact data on factors such as energy use and waste.
Cross-platform standardization and implementation costs remain barriers
Laboratories running multiple analyzers and control materials face difficulty standardizing QC acceptance criteria and calibration procedures across platforms. Implementation costs, including digital QC systems, staff training, and data management, pose a further constraint for smaller labs and decentralized testing sites. The World Health Organization notes that QC materials alone cannot guarantee accurate patient results, forming only part of a broader quality-management system that includes staff training and proficiency testing.