IVD Quality Control Market to Grow at 3.7% CAGR Through 2030 | North America Leads with Largest Market Share | DataM Intelligence

Leander, Texas and Tokyo, Japan - Nov 27, 2025
According to DataM Intelligence, the global IVD quality control market is estimated to reach at a CAGR of 3.7% over the forecast period (2023-2030). This steady growth is propelled by increasing adoption of automated diagnostic systems, rising regulatory requirements for laboratory testing, growing prevalence of chronic diseases, expanding molecular diagnostics applications, and the critical need for accurate and reliable diagnostic results across healthcare settings.

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North America - Largest Market Share

Recent Developments (November 2025)
✅ Bio-Rad Laboratories, Inc. (US) launched advanced whole blood-based quality controls with extended stability, specifically designed for hematology analyzers in high-volume clinical laboratories.
✅ Thermo Fisher Scientific, Inc. (US) expanded their serum and plasma-based quality control portfolio, introducing multi-analyte controls for comprehensive immunochemistry testing panels.
✅ Siemens Healthineers AG (Germany) developed innovative data management solutions with cloud-based platforms, providing real-time quality assurance monitoring for hospital laboratory networks.
✅ Abbott Laboratories (US) introduced specialized urine-based quality controls for toxicology and therapeutic drug monitoring applications, featuring clinically relevant concentration ranges.
✅ Roche Diagnostics (Switzerland) launched integrated quality assurance services with customized QC protocols for molecular diagnostics laboratories implementing next-generation sequencing technologies.

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Competitive Landscape
The market features strong competition between global diagnostic companies, specialized quality control providers, and laboratory services organizations.

1. Bio-Rad Laboratories, Inc. maintained market leadership with 30% global market share, expanding their quality control products portfolio and reporting 25% revenue growth in 2024-2025 through laboratory partnerships.
2. Thermo Fisher Scientific, Inc. captured 26% market share in multi-analyte controls, securing contracts with large hospital networks and achieving 23% growth through comprehensive solutions.
3. Siemens Healthineers AG dominated the data management segment with 22% market share, reporting 27% growth through digital platform integration.
4. Abbott Laboratories led specialized application controls with 18% market share, achieving 21% growth through targeted product development.
5. Roche Diagnostics expanded their quality assurance services with 16% market share, focusing on molecular diagnostics with 24% revenue growth.

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Segmentation Analysis
By Product and Services
• Quality Control Products dominates the market with 65% revenue share in 2024, projected to grow at 3.5% CAGR, valued for essential daily laboratory operations, regulatory compliance requirements, and critical role in ensuring accurate diagnostic results across various testing platforms and methodologies.
• Data Management Solutions shows accelerated growth with 22% revenue share in 2024, expected to grow at 4.8% CAGR, preferred for automated quality monitoring, trend analysis, and regulatory documentation in modern laboratory environments.
• Quality Assurance Services demonstrates significant expansion with 13% revenue share in 2024, growing at 4.2% CAGR, valued for expert consultation and customized quality programs.

By Application
• Immunochemistry represents the largest segment with 35% revenue share in 2024, growing at 3.9% CAGR, driven by high test volumes, expanding test menus, automation adoption, and critical role in chronic disease management, therapeutic drug monitoring, and routine health assessments.
• Hematology shows robust growth with 28% revenue share in 2024, expanding at 3.6% CAGR, valued for complete blood count testing, coagulation monitoring, and blood disorder diagnostics.
• Molecular Diagnostics demonstrates the fastest growth with 20% revenue share in 2024, supported by expanding genetic testing and infectious disease applications.

By End-user
• Clinical Laboratories leads the market with 45% revenue share in 2024, projected to grow at 3.8% CAGR, driven by high testing volumes, diverse test menus, regulatory accreditation requirements, and central role in patient diagnosis and monitoring across healthcare systems.
• Hospitals shows strong presence with 38% revenue share in 2024, expected to grow at 3.4% CAGR, preferred for integrated patient care, emergency testing needs, and comprehensive laboratory services.
• Research and Academic Institutes demonstrates consistent demand with 17% revenue share in 2024 for method development and validation.

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Regional Analysis:
North America holds the largest market share with 42% revenue share in 2024, driven by stringent regulatory framework, advanced healthcare infrastructure, high adoption of automated diagnostic systems, strong quality assurance culture, and significant investments in laboratory accreditation and standardization across the United States and Canada.

Asia-Pacific emerges as the fastest-growing region, projected to expand at 5.2% CAGR through 2030, fueled by improving healthcare infrastructure, rising laboratory accreditation, growing diagnostic test volumes, increasing quality awareness, and expanding medical tourism across China, India, Japan, and Southeast Asian countries.

Market Trends & Drivers
The IVD Quality Control Market is experiencing steady growth driven by quality assurance imperatives, regulatory compliance requirements, diagnostic technology advancement, and patient safety focus. Key trends include the development of multi-analyte controls, integration of digital quality management, growth of personalized medicine QC needs, advancement in third-party controls, and increasing focus on risk-based quality management. The regulatory evolution, technological complexity, and quality consciousness are significantly contributing to market expansion.

Related Reports:
1. In Vitro Diagnostics Market - https://www.datamintelligence.com/research-report/in-vitro-diagnostics-market?jd
2. Clinical Laboratory Services Market - https://www.datamintelligence.com/research-report/clinical-laboratory-services-market?jd
3. Molecular Diagnostics Market - https://www.datamintelligence.com/research-report/molecular-diagnostics-market?jd

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Sai Kiran
DataM Intelligence 4market Research LLP
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Email: Sai.k@datamintelligence.com

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