IVDMarket worth $2.15 billion by 2030

The global In Vitro Diagnostics (IVD) Quality Control Market, valued at USD 1.58 billion in 2024, grew to USD 1.65 billion in 2025 and is projected to reach USD 2.15 billion by 2030, expanding at a CAGR of 5.5% during the forecast period.

Market Overview

The expansion of the IVD quality controls market is being fueled by several key drivers:

Rising number of accredited clinical laboratories worldwide, increasing the demand for reliable and standardized quality control solutions.
Growing shift toward third-party quality controls for unbiased performance monitoring and enhanced regulatory compliance.
Increasing participation in external quality assessment (EQA) programs, allowing laboratories to validate test performance against independent benchmarks.
Higher prevalence of chronic and infectious diseases, leading to a surge in diagnostic testing volumes.
Widespread adoption of point-of-care (POC) instruments, particularly in developed markets, generating demand for versatile, high-quality control systems.

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Market Segmentation

By Product & Service

The IVD quality control market is segmented into:

Quality Control Products
Data Management Solutions
Quality Assurance Services

Among these, quality control products are expected to register the highest growth rate through 2030.

This is largely attributed to:

Increasing global diagnostic test volumes.
Greater emphasis on accuracy, reproducibility, and reliability of test outcomes.
Growing use of advanced diagnostic technologies such as molecular assays.
Regulatory mandates requiring control materials for performance validation.
Rising preference for third-party controls over instrument-specific ones — offering broader platform compatibility and unbiased results.

These factors position the quality control products segment as the fastest-growing area within the IVD quality control market.

By Technology

The molecular diagnostics segment is forecasted to exhibit the fastest CAGR from 2025–2030.

Key Growth Drivers:

Rising global burden of infectious diseases, genetic disorders, and cancers.
Expanding use of molecular testing methods such as PCR, NGS, and isothermal amplification.
Growing focus on personalized medicine and companion diagnostics.
Increasing regulatory scrutiny and the push for standardized molecular testing.
Adoption of stringent quality control protocols to ensure accuracy and consistency in molecular results.

Regional Insights

North America: Market Leader in IVD Quality Control

North America remains the dominant region in the IVD quality controls market, underpinned by:

A highly developed healthcare ecosystem and advanced diagnostic infrastructure.
Strong regulatory frameworks emphasizing accuracy and reliability in diagnostic results.
High testing volumes linked to chronic and infectious disease prevalence.
Widespread adoption of early diagnostic and personalized medicine approaches.

The region’s leadership is further reinforced by:

Presence of leading global IVD quality control manufacturers such as Bio-Rad Laboratories, Thermo Fisher Scientific, and Abbott.
Ongoing investment in automation, data management, and digital QC platforms, which enhance workflow efficiency and reduce human error.
Stringent accreditation and compliance standards driving demand for premium quality control materials.
Substantial R&D investment and healthcare spending, enabling rapid adoption of new QC technologies.

Emerging Opportunities

The IVD quality control market is evolving with the rise of advanced diagnostics and the decentralization of testing toward point-of-care (POC) environments.

Key opportunity areas include:

Development of multianalyte controls to consolidate multiple assays, improve efficiency, and lower operational costs.
Integration of digital tools for real-time quality control data monitoring and automated error detection.
Expansion into emerging regions with increasing diagnostic infrastructure.
Strategic partnerships and collaborations to enhance distribution and innovation capabilities.

Recent Developments

December 2024 – LGC Limited (UK) acquired DiaMex GmbH (Germany), strengthening its diagnostics and genomics portfolio with the Optitrol product range.
November 2024 – Bio-Techne Corporation (US) obtained IVDR certification for its hematology controls and calibrators, ensuring compliance with EU in vitro diagnostic regulations.

Leading Companies in the IVD Quality Control Market

Company Highlights

Bio-Rad Laboratories (US): Market leader with a comprehensive range of independent and instrument-specific controls. Its strong R&D investments, multi-instrument compatibility, and regulatory compliance make it a preferred partner for clinical labs worldwide.
Thermo Fisher Scientific (US): Offers precision-engineered QC materials for clinical chemistry and molecular diagnostics. Its focus on automation, scalability, and customer-centric innovation reinforces its market position.
Abbott (US): Known for integrating QC solutions across its instrument portfolio, ensuring consistent, high-quality performance in clinical chemistry, immunoassay, and molecular testing applications.

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Conclusion

The In Vitro Diagnostics (IVD) Quality Control Market is on a steady growth trajectory through 2030, driven by technological innovation, rising disease burden, and stricter quality standards. As laboratories worldwide adopt third-party and multianalyte controls and embrace digital QC integration, market leaders focusing on automation, interoperability, and data-driven quality assurance are poised for sustained success.

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