Global IVD Quality Control Market Outlook 2024-2031: Trends, Drivers, and Growth Opportunities| Meticulous Research®

The IVD quality control market has become an essential part of modern diagnostics as healthcare systems increasingly depend on accurate laboratory results for timely and effective patient care. In 2023, the market stood at a value of USD 1.63 billion, and projections indicate it will reach USD 2.28 billion by 2031. With an expected CAGR of 4.3% between 2024 and 2031, the industry is evolving in response to rising global healthcare demands, growing disease burdens, and the need for both internal and external testing validation. The expansion of the clinical laboratory sector, the rising number of diagnostic tests worldwide, and the momentum toward reliable quality assurance practices have all played major roles in shaping this market.

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Market Landscape and Key Drivers

The overall growth of the IVD quality control market is tied closely to the increasing prevalence of chronic diseases such as cardiovascular disorders, autoimmune conditions, and various forms of cancer. At the same time, infectious diseases continue to remain a major global concern, with high annual rates of influenza and tuberculosis contributing significantly to testing volumes. As diseases become more complex and test menus expand, the demand for dependable quality controls becomes even more crucial.
One of the central forces behind market growth is the rising use of multi-analyte and multi-instrument controls. These controls bring together a broad range of analytes in a single formulation, reflecting concentrations typically observed in patient samples. For laboratories that previously relied on separate controls for each analyte, these expanded products save time, reduce operational costs, and simplify daily workflows. Multi-instrument controls add another layer of convenience by offering compatibility across different testing platforms, reducing the need for labs to maintain separate materials for each device.
Internal and external quality assessment requirements also contribute significantly to market expansion. Internal evaluations allow laboratories to monitor precision, stability, and long-term instrument performance, while external evaluations provide comparative insight by measuring lab results against those from other facilities. Participation in external programs is often mandatory for accreditation, making quality controls indispensable for maintaining regulatory compliance. As laboratories continue to adopt more rigorous assessment practices, the need for reliable quality control materials grows accordingly.

Market Opportunities

The growing emphasis on standardization and efficiency has created opportunities for more advanced control materials. Laboratories are increasingly searching for products that reduce manual work, shorten testing cycles, and provide broad applicability across diverse instruments and test menus. Multi-analyte and multi-instrument controls address many of these needs, and their rising adoption signals a shift toward simplified, integrated quality assurance systems. This trend is expected to remain influential in the coming years, especially as diagnostic technologies continue to advance.

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Segment Overview

Offering
Within the IVD quality control market, the largest share in 2024 is expected to come from quality control products. Their dominance stems from the wide range of applications they cover and the continuous innovation that has enhanced their performance characteristics. These products are used daily in laboratories across the world, supporting countless diagnostic tests. Alongside them, assessment services and data management solutions also form part of the market landscape, each serving essential roles in performance validation and laboratory workflow optimization.

Technology
Among the technological segments, immunoassay and immunochemistry controls hold the largest share. This leadership position reflects the widespread use of immunoassay-based testing for infectious diseases, chronic conditions, and point-of-care applications. Clinical chemistry, molecular diagnostics, hematology, coagulation testing, and microbiology also contribute significantly, each requiring tailored quality control materials to ensure consistent results. The diversity of these technologies highlights the broad reach of the quality control market across multiple diagnostic areas.

Application
Infectious diseases represent the largest application segment in 2024. This dominance is driven by the high global prevalence of respiratory infections, tuberculosis, and other communicable illnesses, all of which require accurate and sensitive diagnostic tests. Laboratories depend on reliable controls to validate these tests, especially in settings where early detection is critical. Beyond infectious diseases, oncology, cardiology, autoimmune conditions, and neurological disorders also contribute to the demand for quality control products.

End Users
Hospitals and clinics account for the largest user base in 2024. These healthcare settings conduct a significant number of diagnostic tests, making accurate results essential for clinical decision-making. With high-volume testing comes a greater need for dependable quality assurance practices, and this fuels demand for quality control materials. Diagnostic labs, academic institutions, and research facilities also play important roles in the market, relying on quality controls for routine procedures and investigative research.

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Regional Breakdown

North America is expected to lead the global market in 2024, supported by its advanced diagnostic infrastructure, strong emphasis on early disease detection, and regulatory requirements for quality assessment in laboratories. The large number of annual diagnostic tests conducted in this region contributes heavily to its market share. The Asia-Pacific region, on the other hand, is projected to experience the fastest growth during the forecast period. Increasing population sizes, rising chronic and infectious disease rates, expanding laboratory capacity, and enhanced attention to quality standards in diagnostics are key factors driving growth. As healthcare systems in this region continue to modernize, demand for quality control materials is expected to rise rapidly.

Conclusion

The IVD quality control market is on a trajectory of steady growth, driven by the rising global burden of disease, expanding diagnostic capabilities, and a strong emphasis on accuracy and compliance. As testing technologies evolve and laboratories look for more efficient ways to maintain reliability in results, the demand for advanced quality control products will continue to grow. While the market faces regulatory challenges, the need for precise and consistent diagnostics ensures a positive outlook through 2031.

Key questions answered in the IVD quality control market report:

What role do advancements in diagnostic testing technologies play in shaping future demand for quality control materials?

How is the increasing global burden of chronic and infectious diseases shaping the demand for IVD quality control materials?

In what ways do multi-analyte and multi-instrument controls simplify laboratory workflow and reduce operational challenges?

Why are internal and external quality assessments becoming essential requirements for modern diagnostic laboratories?

Which offering segment holds the largest share of the market in 2024, and what makes this segment so dominant?

How do immunoassay and immunochemistry technologies maintain their lead within the market's technology-based segmentation?

What are the reasons behind infectious diseases being the largest application area for IVD quality controls in 2024?

Why do hospitals and clinics account for the largest portion of end users in the IVD quality control market?

What specific conditions in North America allow it to maintain a leading share of the market?

Why is the Asia-Pacific region expected to experience the fastest growth during the forecast period?

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