In Vitro Diagnostics Quality Control Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Quality Controls, Data Management Solutions, Quality Assurance Services), By Application (Immunoassay, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation, Microbiology, Others), By End-use (Hospitals & Clinics, Ambulatory Surgical Centers, Others) Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.16 Billion
CAGR (2026-2031)	1.52%
Fastest Growing Segment	Quality Controls
Largest Market	North America
Market Size (2031)	USD 1.27 Billion

Market Overview

The Global In Vitro Diagnostics Quality Control Market will grow from USD 1.16 Billion in 2025 to USD 1.27 Billion by 2031 at a 1.52% CAGR. In vitro diagnostics quality controls are stabilized materials utilized to verify the accuracy of diagnostic testing systems and ensure reliable patient results. The market is primarily driven by the stringent enforcement of laboratory accreditation standards and the increasing burden of chronic diseases requiring frequent monitoring. Furthermore, the rising adoption of independent third-party controls to eliminate instrument bias supports growth distinct from general technological trends.

A significant challenge impeding expansion is the high cost of compliance and complex regulatory frameworks that strain smaller diagnostic facility budgets. However, the push for certified operational excellence continues to expand the customer base. According to the College of American Pathologists, in 2024, the organization accredited a record 657 new laboratories, bringing the global total to 8,350 facilities. This data underscores the critical necessity of quality assurance products despite financial hurdles.

Key Market Drivers

The rising prevalence of chronic and infectious diseases serves as a primary catalyst for the Global In Vitro Diagnostics Quality Control Market, fundamentally increasing the volume of patient testing required. As the burden of conditions such as cancer and diabetes escalates, diagnostic facilities must process higher sample throughputs, which necessitates the frequent utilization of quality control materials to validate instrument precision and mitigate error rates. This direct correlation between disease incidence and diagnostic consumption is evident in oncology, where accurate biomarker testing is critical for treatment planning. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, projections indicated that 2,001,140 new cancer cases would be diagnosed in the United States, underscoring the massive scale of critical diagnostics requiring continuous quality assurance.

The implementation of stringent regulatory standards and the increasing number of accredited clinical laboratories further compel market expansion by mandating rigorous compliance protocols. Accreditation bodies enforce strict guidelines that require laboratories to run third-party controls at fixed intervals, transforming quality control from an optional best practice into an operational requirement. This regulatory pressure expands the addressable customer base as more facilities seek certification to ensure reimbursement and reputation. According to the Centers for Medicare & Medicaid Services, March 2024, in the 'CLIA Laboratory Statistical Update', there were 15,894 laboratories in the United States holding a Certificate of Accreditation, representing a substantial segment of highly regulated end-users. Reflecting the commercial impact of these compliance and volume drivers, according to Bio-Rad Laboratories, February 2024, in the 'Fourth-Quarter and Full-Year 2023 Financial Results', the company’s Clinical Diagnostics segment reported net sales of $1,489.3 million, driven specifically by demand for quality control and diabetes-related products.

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Key Market Challenges

The high cost of compliance and complex regulatory frameworks serves as a substantial impediment to the growth of the global in vitro diagnostics quality control market. As authorities implement more rigorous accreditation standards to ensure patient safety, diagnostic manufacturers and laboratories face soaring operational expenses related to validation, documentation, and personnel training. This financial pressure is particularly acute for smaller facilities with limited budgets, forcing them to prioritize basic regulatory adherence over the acquisition of advanced quality control systems. Consequently, the diversion of capital toward meeting mandatory requirements reduces the funds available for innovation and market expansion, thereby slowing the overall industry development.

The magnitude of this economic burden is evident in recent industry findings regarding the expenses tied to evolving regulatory landscapes. According to MedTech Europe, in 2024, certification and maintenance costs for diagnostic manufacturers under new regulations have escalated by up to 100 percent compared to previous directives. This significant increase in non-revenue generating expenditure limits the ability of companies to invest in new product development or enter new geographical regions, directly constraining the potential revenue growth of the global market.

Key Market Trends

The Development of Specialized Controls for Next-Generation Sequencing (NGS) is reshaping the market as clinical laboratories increasingly integrate genomic profiling into routine diagnostic workflows. Unlike traditional single-analyte testing, modern molecular diagnostics require highly multiplexed reference materials capable of validating hundreds of variant targets simultaneously to ensure the accuracy of precision medicine assays. This shift is driving manufacturers to innovate beyond standard infectious disease controls into complex genomic segments such as reproductive health. According to LGC Clinical Diagnostics, August 2024, in the 'LGC Clinical Diagnostics Launches Seraseq Carrier Screening DNA Mix Reference Materials' press release, the company introduced a new reference material containing 54 clinically significant variants across 48 genes to support the validation of high-throughput genetic assays.

The Adoption of Multi-Analyte Consolidated Control Materials is accelerating as laboratories strive to streamline daily workflows and reduce the volume of reagents required for instrument validation. By utilizing single formulations that contain multiple analytes, diagnostic facilities can significantly lower handling time and storage costs, a crucial advantage given the current global shortage of laboratory technicians. This operational shift toward efficiency-enhancing solutions is generating substantial revenue for established market leaders. According to Bio-Rad Laboratories, October 2024, in the 'Q3 2024 Financial Results' report, the company’s Clinical Diagnostics segment generated net sales of $389 million, a performance primarily attributed to the sustained robust demand for its quality control products.

Segmental Insights

The Quality Controls segment constitutes the fastest-growing component of the Global In Vitro Diagnostics Quality Control Market. This growth is primarily fueled by the increasing requirement for clinical laboratories to achieve accreditation from regulatory bodies, including the International Organization for Standardization (ISO) and the College of American Pathologists (CAP). To meet these rigorous compliance standards, laboratories are rapidly adopting independent third-party quality controls that offer unbiased performance verification. Furthermore, the rising preference for multi-analyte controls, which allow facilities to consolidate testing procedures and enhance operational efficiency, continues to drive the substantial demand for this segment.

Regional Insights

North America holds the leading position in the Global In Vitro Diagnostics Quality Control Market, supported by a highly developed healthcare sector and stringent regulatory frameworks. This dominance is primarily driven by rigorous compliance standards established by the U.S. Food and Drug Administration and the Clinical Laboratory Improvement Amendments. These measures compel clinical laboratories to implement consistent quality assurance protocols, creating a sustained demand for control products to ensure testing accuracy. Furthermore, the strong presence of key industry manufacturers within the United States ensures the widespread availability of approved diagnostic solutions, further solidifying the region's market superiority.

Recent Developments

• In November 2024, Randox Laboratories collaborated with Data Innovations to launch a new automated driver that facilitates seamless quality control data connectivity. This development enables the direct upload of QC data from laboratory instruments into the Acusera 24.7 data management software, eliminating the need for manual data entry. By streamlining the data transfer process, the solution aims to reduce transcription errors and improve overall operational efficiency within clinical laboratories. The integration supports a wide range of diagnostic instruments, allowing laboratory managers to access real-time peer group data and performance analytics more effectively, thereby ensuring regulatory compliance and high testing standards.
• In September 2024, LGC Clinical Diagnostics announced a strategic partnership with AccuGenomics to develop advanced quality control materials for next-generation sequencing (NGS) applications. This collaboration aims to combine LGC's extensive expertise in clinical genomics reference materials with AccuGenomics' proprietary technology for monitoring molecular diagnostic assay performance. The partnership focuses on creating highly accurate and reliable controls that support the growing demand for precision medicine and personalized cancer treatments. These new solutions are designed to help clinical laboratories validate their NGS workflows and ensure the delivery of consistent, actionable patient data in oncology and other critical therapeutic areas.
• In August 2024, Bio-Rad Laboratories launched Specialty Immunoassay Plus, a comprehensive quality control product designed to monitor the precision of laboratory specialty immunoassay testing procedures. This independent control, available in an automation-compatible liquid format, covers clinically relevant analytes such as Procalcitonin, Interleukin-6, and Active Vitamin B12. The product is intended to streamline laboratory workflows by reducing manual preparation time and minimizing waste through improved stability. By integrating with the company's data management software, laboratories can compare their performance against a global peer group, enhancing confidence in instrument accuracy and patient results.
• In April 2024, Streck launched the Protein Plus BCT, a direct-draw whole blood collection tube developed to maintain the integrity of plasma proteins during storage and transport. This new product utilizes a specialized preservative reagent that minimizes ex vivo hemolysis and platelet activation, ensuring that sample quality is preserved for downstream analysis. Designed to support the rapidly expanding field of proteomics, the tube allows laboratories to maintain draw-time protein concentrations at ambient temperatures. This innovation addresses critical pre-analytical variables, providing researchers and clinical developers with a reliable tool to enhance the accuracy and reproducibility of mass spectrometry and immunoassay-based protein assays.

Key Market Players

• F. Hoffmann-La Roche Ltd
• Alere, Inc.
• Abbott Laboratories Inc.
• Hologic, Inc.
• Qiagen N.V.
• Bio-Rad Laboratories, Inc.
• Quidel Corporation
• bioMerieux, Inc.
• Sysmex Corporation
• Thermo Fisher Scientific, Inc.

By Type	By Application	By End-use	By Region
Quality Controls Data Management Solutions Quality Assurance Services	Immunoassay Hematology Clinical Chemistry Molecular Diagnostics Coagulation Microbiology Others	Hospitals & Clinics Ambulatory Surgical Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global In Vitro Diagnostics Quality Control Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• In Vitro Diagnostics Quality Control Market, By Type:

• Quality Controls
• Data Management Solutions
• Quality Assurance Services

• In Vitro Diagnostics Quality Control Market, By Application:

• Immunoassay
• Hematology
• Clinical Chemistry
• Molecular Diagnostics
• Coagulation
• Microbiology
• Others

• In Vitro Diagnostics Quality Control Market, By End-use:

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Others

• In Vitro Diagnostics Quality Control Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE