United states IVD Quality Control Market expected to grow at a CAGR of 3.7% during 2023-2030 | Top Companies - Bio-Rad Laboratories Inc., bioMerieux Inc., F. Hoffmann-La Roche AG

Leander, Texas and Tokyo, Japan - Dec.26.2025
As per DataM intelligence research report" The global IVD quality control market is estimated to reach at a CAGR of 3.7% over the forecast period (2023-2030)." Accuracy and regulatory compliance in diagnostic testing are boosting IVD quality control systems.

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United States: Recent Industry Developments

✅ In November 2025, Bio-Techne obtained IVDR certification for its new hematology controls. The certification ensures continued access to the European market for U.S.-manufactured controls. It demonstrates compliance with the strictest global regulatory standards.

✅ In October 2025, Abbott Laboratories launched a cloud-based QC data management system for point-of-care devices. The system allows remote monitoring of glucometers and rapid test kits across hospital networks. It improves compliance and reliability in decentralized U.S. healthcare settings.

✅ In September 2025, Streck introduced a new stabilization control for cell-free DNA blood tubes. The product ensures sample integrity for non-invasive prenatal testing (NIPT). It supports the high-growth liquid biopsy market in the U.S.

✅ In August 2025, Randox Laboratories established a new distribution hub in the Midwest to speed up QC delivery. The hub ensures cold-chain integrity for temperature-sensitive control materials. It improves service levels for clinical labs in the central United States.

Japan: Recent Industry Developments

✅ In December 2025, Roche Diagnostics Japan released a "Smart QC" module for its Cobas analyzers. The module uses AI to detect instrument drift before it affects patient results. It enhances the operational efficiency of high-volume Japanese labs.

✅ In November 2025, Sekisui Medical launched a liquid-stable control for coagulation testing. The ready-to-use format eliminates reconstitution errors and saves technician time. It addresses the staffing shortages in Japanese hospital laboratories.

✅ In October 2025, Denka Company introduced a specialized control for rapid influenza/COVID combo tests. The control validates the performance of antigen kits used in clinics. It supports accurate diagnosis during Japan's respiratory virus season.

✅ In September 2025, A Japanese external quality assessment (EQA) provider expanded its program to include genetic testing. The expansion covers new cancer panels reimbursed by national insurance. It ensures the accuracy of precision medicine diagnostics in Japan.

IVD quality control Market: Drivers
The in vitro diagnostics (IVD) quality control market is expanding due to increasing demand for reliable, accurate, and reproducible diagnostic testing. Rising prevalence of chronic diseases, infectious outbreaks, and personalized medicine drives adoption. Automated, high-sensitivity assays enhance workflow efficiency and reduce human error. Regulatory mandates enforce stringent quality standards, accelerating adoption of advanced QC solutions. Integration with digital monitoring and AI-driven analysis improves data reliability and compliance. Collaborative research between diagnostic manufacturers and academic institutions fosters innovation in QC methodologies. Increasing awareness among healthcare providers and patients further fuels market expansion.

Investments in next-generation diagnostic technologies are shaping the growth of IVD quality control. High-throughput, multi-target assays support complex disease detection and monitoring. Adoption of laboratory information management systems enhances operational efficiency. Technological advancements enable cost-effective and scalable QC solutions for diverse healthcare settings. Regulatory approvals for innovative diagnostic devices encourage clinical adoption. With rising healthcare expenditures and emphasis on patient safety, the IVD quality control market is poised for sustained growth and technological innovation.

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IVD quality control Market: Major Players
Bio-Rad Laboratories Inc ., bioMerieux Inc., F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc., ZeptoMetrix Corporation, Thermo Fisher Scientific, Inc., Quidel Corporation, Grifols, S.A., Bio-Techne Corporation and Streck, Inc.

Segment Covered in the IVD quality control Market:
By Product and Services
The market is segmented into Quality Control Products 60%, Data Management Solutions 25%, and Quality Assurance Services 15%, with quality control products dominating due to their routine use in ensuring accuracy, precision, and reliability of in vitro diagnostic tests. Within quality control products, Serum & Plasma-based quality controls lead adoption owing to broad applicability across chemistry and immunoassay tests, followed by Whole Blood-based quality controls, which are widely used in hematology and point-of-care testing. Urine-based quality controls are gaining traction in routine urinalysis and kidney function diagnostics. Increasing regulatory scrutiny and laboratory accreditation requirements drive sustained demand.

By Application
Applications include Immunochemistry 30%, Hematology 25%, Molecular Diagnostics 20%, Coagulation/Hemostasis 15%, and Others 10%, with immunochemistry dominating due to high test volumes in hormone, infectious disease, and tumor marker diagnostics. Hematology applications remain strong owing to routine blood testing across hospitals and laboratories. Molecular diagnostics are experiencing rapid growth driven by precision medicine and infectious disease testing. Coagulation and hemostasis applications are expanding with rising cardiovascular and bleeding disorder diagnostics.

By End-User
End-users include Clinical Laboratories 45%, Hospitals 35%, Research & Academic Institutes 10%, and Others 10%, with clinical laboratories leading due to centralized testing facilities and high throughput diagnostic workflows. Hospitals rely heavily on IVD quality controls for routine and emergency diagnostics. Research and academic institutes utilize quality controls during assay development and validation. Growing emphasis on quality assurance and compliance supports end-user adoption.

Regional Analysis
North America - 40% Share
North America leads with 40% share, driven by advanced diagnostic infrastructure, stringent regulatory requirements, and high adoption of automated IVD systems in the US and Canada. Immunochemistry and molecular diagnostics dominate applications. Clinical laboratories are the primary end-users. Continuous investments in laboratory automation and data management solutions support market growth.

Europe - 25% Share
Europe accounts for 25% share, supported by strong laboratory accreditation standards and widespread adoption of quality control programs across healthcare systems. Immunochemistry and hematology applications lead demand. Quality control products dominate the product mix. Regulatory compliance and patient safety initiatives drive steady market expansion.

Asia Pacific - 20% Share
Asia Pacific holds 20% share, driven by expanding healthcare infrastructure, rising diagnostic testing volumes, and growing awareness of laboratory quality standards in China, India, and Southeast Asia. Hematology and molecular diagnostics show strong growth. Increasing hospital and laboratory investments support market expansion.

Latin America - 10% Share
Latin America records 10% share, supported by improving clinical laboratory infrastructure and growing adoption of standardized diagnostic practices. Immunochemistry and hematology applications dominate. Clinical laboratories are the key end-users. Government healthcare initiatives support gradual market growth.

Middle East & Africa - 5% Share
Middle East & Africa account for 5% share, driven by expanding diagnostic capacity, hospital modernization, and growing focus on laboratory accreditation. Quality control products dominate due to essential diagnostic needs. Healthcare infrastructure development supports steady growth.

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