The global In Vitro Diagnostics (IVD) Quality Control Market, valued at US$1.58 billion in 2024, reached US$1.65 billion in 2025 and is projected to grow at a CAGR of 5.5% from 2025 to 2030, reaching approximately US$2.15 billion by 2030.
Market growth is driven by the increasing number of accredited clinical laboratories, the rising adoption of third-party quality controls, and the expansion of external quality assessment programs to ensure accuracy and compliance in diagnostic testing. The rising global burden of chronic and infectious diseases is further accelerating test volumes and the need for robust quality control (QC) solutions, while the widespread adoption of point-of-care instruments underscores the importance of standardized and flexible QC systems.
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Market Overview
As the diagnostics industry continues to evolve, quality control in IVD testing has become critical for ensuring accuracy, reliability, and regulatory compliance. Laboratories are under increasing pressure to deliver consistent and error-free results, driving demand for advanced QC products and data management solutions.
The shift from instrument-specific controls to third-party quality controls has been a defining trend in recent years. Third-party controls offer unbiased performance evaluation, cross-platform compatibility, and enhanced flexibility—features that are essential in an era of automation, digital transformation, and integrated testing workflows.
Market Dynamics
Key Growth Drivers
- Rising number of accredited laboratories: Global expansion of accredited diagnostic facilities increases the demand for standardized QC systems.
- Shift toward third-party quality controls: Laboratories prefer independent controls to meet compliance standards and ensure unbiased accuracy.
- Rising disease burden: Growth in chronic and infectious diseases elevates diagnostic testing volumes, boosting QC requirements.
- Adoption of point-of-care (POC) devices: Increased POC testing in hospitals and clinics drives demand for portable, multi-analyte QC materials.
- Regulatory stringency: Stronger global regulations from bodies such as the FDA and EMA mandate rigorous quality assurance practices.
Market Opportunities
- Development of multianalyte controls to streamline QC processes and reduce costs.
- Integration of digital data management systems for real-time QC monitoring and performance analytics.
- Expansion into emerging markets through partnerships and localized manufacturing.
- Rising focus on automation and AI-enabled QC platforms for next-generation diagnostic workflows.
Market Segmentation
By Product & Service
- Quality Control Products
- Data Management Solutions
- Quality Assurance Services
The Quality Control Products segment dominates the market and is expected to grow at the highest CAGR through 2030. This growth is driven by the increasing number of diagnostic tests performed worldwide and the growing adoption of molecular and immunoassay-based diagnostics.
Regulatory compliance requirements, coupled with laboratories’ preference for third-party QC products, are further boosting segment growth. These products enable laboratories to ensure test accuracy across multiple platforms while maintaining consistency and traceability.
By Technology
- Immunoassays
- Clinical Chemistry
- Molecular Diagnostics
- Microbiology
- Hematology
- Coagulation & Hemostasis
- Others
The Molecular Diagnostics segment is projected to witness the fastest growth during the forecast period. The surge in genetic testing, cancer diagnostics, and infectious disease screening—powered by technologies like PCR and Next-Generation Sequencing (NGS)—has heightened the need for high-quality molecular QC products.
Increased regulatory oversight and the push for standardized testing protocols further strengthen demand in this category.
Regional Insights
North America
North America remains the largest regional market for IVD quality control solutions. The region’s dominance is attributed to:
- A highly developed healthcare infrastructure and advanced diagnostic networks.
- The presence of leading market players such as Bio-Rad Laboratories, Thermo Fisher Scientific, and Abbott.
- Stringent regulatory standards emphasizing laboratory accuracy and accreditation.
- Rapid adoption of digital QC systems and automation technologies.
The U.S. market benefits from high healthcare expenditure and strong R&D investments that foster innovation in QC systems, including AI-driven data platforms and cloud-based performance analytics.
Europe
Europe holds a significant market share, driven by strict EU In Vitro Diagnostic Regulation (IVDR) compliance requirements and ongoing initiatives to enhance laboratory quality management. The presence of established manufacturers such as LGC Limited, Randox Laboratories, and Siemens Healthineers further supports market strength.
Asia-Pacific
The Asia-Pacific region is expected to record robust growth during the forecast period. The expansion of diagnostic infrastructure in China, India, and Japan, increasing adoption of automation, and growing awareness of laboratory quality standards are key contributors. Emerging economies in the region offer lucrative opportunities for global QC solution providers through localized distribution partnerships.
Competitive Landscape
The IVD quality control market is moderately consolidated, with global and regional players focusing on strategic acquisitions, technological innovation, and regulatory compliance to maintain competitive advantage.
Key Market Players:
- Bio-Rad Laboratories, Inc. (US)
- Thermo Fisher Scientific Inc. (US)
- Abbott (US)
- LGC Limited (UK)
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Randox Laboratories Ltd. (UK)
- Siemens Healthineers AG (Germany)
- Danaher Corporation (US)
- Sysmex Corporation (Japan)
- Bio-Techne Corporation (US)
Other notable participants include Microbiologics, ZeptoMetrix, Streck, Fortress Diagnostics, Eurotrol, and Grifols.
Recent Developments
- December 2024: LGC Limited (UK) acquired DiaMex GmbH (Germany), expanding its clinical diagnostics and genomics portfolio with the Optitrol product range.
- November 2024: Bio-Techne Corporation (US) obtained IVDR certification for its hematology controls and calibrators, demonstrating compliance with EU diagnostic regulations.
Leading Companies at a Glance
Bio-Rad Laboratories, Inc.
Bio-Rad is a market leader offering one of the industry’s most comprehensive portfolios of independent and instrument-specific controls. Its continuous innovation, R&D investment, and global reach reinforce its dominance in laboratory standardization and regulatory compliance.
Thermo Fisher Scientific Inc.
Thermo Fisher provides advanced QC materials for clinical chemistry and molecular diagnostics. The company’s integrated solutions focus on reliability, scalability, and precision, helping laboratories achieve consistent testing performance.
Abbott
Abbott integrates QC across its broad diagnostic instrument portfolio, emphasizing system-specific controls and automation-driven reliability. Its global presence and customer-centric innovation approach position it as a trusted player in the IVD QC ecosystem.
Future Outlook
The future of the IVD Quality Control Market lies in digitization, standardization, and automation. Laboratories are increasingly adopting software-based QC monitoring, multianalyte controls, and AI-integrated solutions to optimize workflows and ensure compliance.
With expanding test volumes, growing molecular diagnostics adoption, and continuous regulatory evolution, the market is set for sustained growth through 2030. Companies that invest in smart QC technologies and data-driven solutions will be best positioned to capture the next wave of opportunity in the global diagnostics landscape.
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