The In Vitro Diagnostic (IVD) Quality Controls Market continues to expand steadily, projected to grow from USD 1.65 billion in 2025 to USD 2.15 billion by 2030, at a CAGR of 5.5%, according to a recent MarketsandMarkets™ report.
This growth is driven by the increasing number of accredited clinical laboratories, the rising shift toward third-party quality controls, and the expanding demand for standardized and compliant diagnostic testing across the globe.
Understanding IVD Quality Controls
IVD quality controls are essential components in diagnostic testing workflows, ensuring accuracy, reliability, and consistency across various laboratory assays.
These controls help laboratories validate test results, maintain compliance with international regulatory standards, and support clinical decision-making with confidence.
As healthcare systems increasingly depend on diagnostics for patient management, the need for robust quality control systems has become indispensable.
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Market Growth Drivers
1. Expansion of Accredited Clinical Laboratories
The number of laboratories pursuing accreditation from organizations such as CLIA, CAP, and ISO is increasing globally. Accreditation drives laboratories to adopt stringent quality control measures, fueling the need for comprehensive IVD quality control products.
2. Shift Toward Third-Party Quality Controls
Clinical labs are progressively moving from manufacturer-provided controls to independent third-party controls. These solutions offer unbiased performance monitoring, reduce risk of data bias, and ensure regulatory compliance across multi-instrument setups.
3. Rising Participation in External Quality Assessment (EQA) Programs
To benchmark their performance and maintain global testing standards, more laboratories are engaging in EQA programs, increasing the demand for reliable external quality materials.
4. Increase in Chronic and Infectious Diseases
The global surge in chronic illnesses (such as diabetes, cardiovascular disorders, and cancer) and infectious diseases (including COVID-19 and emerging viral infections) has led to a significant rise in diagnostic test volumes—further fueling the adoption of IVD quality control systems.
5. Growing Point-of-Care (POC) Diagnostics
The increasing use of POC instruments in hospitals, clinics, and decentralized healthcare settings demands versatile quality control solutions that ensure accuracy across portable and automated diagnostic devices.
Key Market Developments
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December 2024 – LGC Limited (UK) acquired DiaMex GmbH (Germany), a global manufacturer of third-party serology and molecular quality controls. This acquisition expanded LGC’s clinical diagnostics and genomics portfolio, strengthening its Optitrol product line and positioning it as a comprehensive supplier for laboratories and blood banks worldwide.
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November 2024 – Bio-Techne Corporation (US) obtained IVDR certification for its R&D Systems Hematology Controls and Calibrators, meeting the European Union’s stringent in vitro diagnostic regulations, enhancing compliance and credibility in the European market.
Competitive Landscape: Market Leaders Shaping Quality Control Standards
The IVD quality controls market is highly competitive, with several key players focusing on innovation, product diversification, and global expansion.
1. Bio-Rad Laboratories, Inc. (US)
Bio-Rad is a market leader, offering one of the broadest portfolios of independent and instrument-specific quality controls across clinical chemistry, immunoassay, hematology, molecular diagnostics, and microbiology.
The company’s commitment to laboratory standardization, data accuracy, and multi-instrument compatibility has made it a trusted partner for diagnostic labs worldwide.
2. Thermo Fisher Scientific Inc. (US)
Thermo Fisher provides ready-to-use and barcode-enabled quality control materials that enhance traceability and streamline laboratory workflows.
With its global reach, advanced manufacturing, and compliance-driven product line, the company supports clinical chemistry and molecular diagnostics with precision and scalability.
3. Abbott (US)
Abbott integrates system-specific quality controls across its diagnostic platforms, ensuring optimal instrument performance and regulatory compliance.
Its global R&D capabilities and commitment to innovation allow it to deliver standardized, reliable, and scalable quality control solutions across diverse clinical testing environments.
4. LGC Limited (UK)
Known for its independent third-party controls, LGC combines scientific excellence with targeted acquisitions, expanding its presence in clinical diagnostics and genomics. Its DiaMex acquisition enhances its footprint in molecular quality controls and serology testing.
5. F. Hoffmann-La Roche Ltd. (Switzerland)
Roche leverages its expertise in clinical chemistry and immunoassays to deliver robust, integrated quality controls aligned with its instrument portfolio. Its strong innovation pipeline and R&D investments position it among the top five global players.
Market Ranking (Top 5 Players)
| Rank | Company | Strengths |
|---|---|---|
| 1 | Bio-Rad Laboratories, Inc. (US) | Broad third-party control portfolio, multi-instrument compatibility |
| 2 | Thermo Fisher Scientific Inc. (US) | Advanced QC materials, barcode integration, scalability |
| 3 | Abbott (US) | Integrated QC within diagnostic systems, global scalability |
| 4 | LGC Limited (UK) | Independent QC leadership, targeted acquisitions |
| 5 | F. Hoffmann-La Roche Ltd. (Switzerland) | Strong clinical chemistry expertise, innovation-driven |
Future Outlook
The future of the IVD Quality Controls Market lies in:
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Automation and Digital QC Platforms for real-time data analysis
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AI-integrated QC analytics for predictive performance monitoring
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Regulatory evolution under the EU IVDR and similar frameworks
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Sustainability and eco-efficient manufacturing in diagnostic consumables
With laboratories prioritizing accuracy, reliability, and compliance, IVD quality controls will remain critical to ensuring patient safety and diagnostic confidence worldwide.
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