In Vitro Diagnostics Quality Controls Market Size in 2026

The global in vitro diagnostics (IVD) quality controls market is expected to reach USD 1.45 billion in 2026, rising from USD 1.41 billion in 2025. The market is projected to grow steadily and reach approximately USD 1.94 billion by 2035, expanding at a compound annual growth rate (CAGR) of 3.24% from 2026 to 2035. Growth of the market is largely driven by the increasing adoption of advanced diagnostic technologies, the expansion of microbiology laboratories, and the growing need to ensure accuracy, reliability, and regulatory compliance in diagnostic testing.

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Market Overview

The in vitro diagnostics quality controls market focuses on the production and distribution of reference materials, reagents, and analytical tools that help ensure the reliability and consistency of laboratory diagnostic tests.

Quality control (QC) solutions play a critical role in monitoring the performance of diagnostic assays across multiple laboratory disciplines, including:

• Hematology

• Microbiology

• Clinical chemistry

• Immunoassays

• Molecular diagnostics

• Genetic testing

These solutions are essential for maintaining laboratory accreditation, meeting regulatory requirements, and ensuring patient safety. As diagnostic testing becomes more complex and automated, laboratories are increasingly relying on advanced QC solutions and data management systems.

Role of Artificial Intelligence in IVD Quality Controls

Artificial intelligence is transforming the in vitro diagnostics quality controls market by enhancing diagnostic accuracy and improving laboratory efficiency.

AI-driven systems help laboratories by:

• Monitoring diagnostic instruments in real time

• Detecting performance patterns and predicting component failures

• Reducing human errors in testing workflows

• Optimizing reagent production and usage

AI technologies are also being used across the pre-analytical, analytical, and post-analytical phases of laboratory testing to reduce errors and improve diagnostic reliability.

For example, in May 2025, Diagnostics.ai launched a CE-IVDR-certified transparent AI platform designed to improve the performance and efficiency of molecular diagnostic systems.

Additionally, AI-based data analytics tools allow laboratories to perform automated trend analysis, predictive maintenance, and regulatory compliance monitoring, ensuring consistent diagnostic performance.

Role of Artificial Intelligence in IVD Quality Controls

Artificial intelligence is transforming the in vitro diagnostics quality controls market by enhancing diagnostic accuracy and improving laboratory efficiency.

AI-driven systems help laboratories by:

• Monitoring diagnostic instruments in real time

• Detecting performance patterns and predicting component failures

• Reducing human errors in testing workflows

• Optimizing reagent production and usage

AI technologies are also being used across the pre-analytical, analytical, and post-analytical phases of laboratory testing to reduce errors and improve diagnostic reliability.

For example, in May 2025, Diagnostics.ai launched a CE-IVDR-certified transparent AI platform designed to improve the performance and efficiency of molecular diagnostic systems.

Additionally, AI-based data analytics tools allow laboratories to perform automated trend analysis, predictive maintenance, and regulatory compliance monitoring, ensuring consistent diagnostic performance.

Key Market Trends

Strategic Partnerships in Diagnostic Development

Pharmaceutical companies are increasingly partnering with diagnostic solution providers to develop advanced in vitro diagnostic technologies and QC solutions.

Expansion of Research Laboratories

Governments worldwide are investing heavily in new research laboratories to evaluate novel therapeutics and improve diagnostic capabilities, thereby increasing the demand for QC solutions.

Rising Prevalence of Genetic Disorders

The growing incidence of genetic and rare diseases in countries such as Japan, the United Kingdom, and Canada is driving demand for advanced diagnostic testing and quality control systems.

Adoption of Cloud-Based Data Management

Hospitals are increasingly implementing cloud-based QC data management platforms that enable:

• Real-time monitoring

• Peer benchmarking

• Advanced analytics

• Centralized laboratory management

Growing Use of Third-Party Quality Controls

Clinical laboratories are increasingly adopting third-party QC products because they provide greater flexibility, unbiased performance validation, and compatibility with multiple diagnostic platforms.

Segment Analysis

Product & Service Insights

Quality Control Products

The quality control products segment dominated the market in 2025, accounting for 56% of total revenue.

These products are widely used in clinical laboratories to:

• Validate diagnostic equipment performance

• Ensure reagent reliability

• Maintain regulatory compliance

Increasing regulatory requirements and the rapid adoption of advanced diagnostic technologies have further strengthened the demand for third-party and OEM quality control products.

Data Management Solutions

The data management solutions segment is expected to grow at the highest CAGR during the forecast period.

Laboratories are increasingly adopting automated informatics platforms to manage large volumes of QC data. These systems enable:

• Automated trend analysis

• Real-time monitoring

• Error detection and reporting

Such capabilities significantly improve laboratory efficiency and reduce human errors in diagnostic processes.

Manufacturer Type Insights

Third-Party Controls

The third-party controls segment held the largest market share of 58% in 2025.

These controls provide independent verification of assay performance, ensuring higher accuracy compared with in-house or kit-based controls.

Benefits include:

• Greater compatibility across multiple analyzer platforms

• Improved reliability in diagnostic testing

• Compliance with stringent regulatory standards

Because of these advantages, laboratories widely prefer third-party QC solutions for multi-platform diagnostic environments.

OEM Controls

The original equipment manufacturer (OEM) controls segment is expected to grow at a significant rate during the forecast period.

OEM controls are specifically designed for particular diagnostic analyzers, ensuring seamless integration and optimal performance.

Growing collaborations between diagnostic equipment manufacturers and laboratories are driving the adoption of OEM QC solutions.

Technology Insights

Immunoassay Diagnostics

The immunoassay diagnostics segment dominated the market with a 29% share in 2025.

Immunoassay technologies are widely used to detect:

• Hormone levels

• Tumor markers

• Autoimmune diseases

• Chronic disease biomarkers

Due to the high sensitivity of immunoassay testing, laboratories require frequent calibration and validation, increasing demand for quality control systems.

Molecular Diagnostics

The molecular diagnostics segment is expected to grow at the fastest CAGR during the forecast period.

This growth is driven by the increasing use of real-time PCR and next-generation sequencing (NGS) technologies for diagnosing:

• Infectious diseases

• Cancer

• Genetic disorders

Leading companies in molecular diagnostics include:

• Thermo Fisher Scientific

• F. Hoffmann-La Roche Ltd

These technologies require strict quality control processes due to their high sensitivity and complexity.

Application Insights

Infectious Disease Testing

The infectious disease testing segment dominated the market in 2025, accounting for around 27% of total revenue.

Laboratories conduct large volumes of tests for diseases such as:

• HIV

• Hepatitis

• Respiratory infections

• Viral outbreaks

Accurate diagnosis requires strict QC protocols to ensure reliable results and prevent diagnostic errors.

Genetic and Rare Disease Testing

The genetic and rare disease testing segment is expected to grow at the fastest rate during the forecast period.

Hospitals are increasingly using next-generation sequencing and exome sequencing technologies to diagnose inherited disorders.

These complex tests require stringent quality control validation, driving demand for advanced QC products and third-party controls.

End User Insights

Hospitals

The hospitals segment dominated the market in 2025 with around 38% market share.

Hospitals operate large diagnostic laboratories that conduct testing across:

• Hematology

• Clinical chemistry

• Molecular diagnostics

• Immunoassays

The high volume of diagnostic testing increases the demand for advanced quality control systems to ensure accurate results.

Clinical Diagnostic Laboratories

The clinical diagnostic laboratories segment is expected to grow at the fastest CAGR during the forecast period.

Growth is driven by:

• An increasing number of independent diagnostic laboratories

• Rising prevalence of infectious diseases

• Adoption of advanced automated diagnostic systems

These laboratories rely heavily on QC services to maintain testing accuracy and operational efficiency.

Regional Insights

North America

North America dominated the in vitro diagnostics quality controls market in 2025, accounting for around 41% of the global market share.

The region benefits from:

• Advanced healthcare infrastructure

• High adoption of laboratory information management systems

• Strong presence of diagnostic technology companies

Major industry players contributing to regional growth include:

• Revvity

• Bio-Rad Laboratories

In June 2025, Revvity launched three Mimix reference standards designed to monitor NGS and droplet digital PCR assays in diagnostic laboratories across the United States.

Asia Pacific

Asia Pacific is expected to grow at the fastest CAGR during the forecast period.

Market growth is driven by:

• Rising demand for diagnostic testing

• Expansion of healthcare infrastructure

• Rapid adoption of AI-based QC technologies

Key companies operating in the region include:

• Sysmex Corporation

• Seegene Inc.

• Eiken Chemical Co., Ltd.

In November 2025, the government of Western Australia announced an investment of USD 1.5 billion to construct three new public hospitals, further strengthening diagnostic infrastructure in the region.

China

China plays a major role in the Asia Pacific market due to:

• Rapid healthcare digitalization

• Growing prevalence of viral diseases

• Increasing adoption of AI-based quality control systems in laboratories

Competitive Landscape

Key companies operating in the in vitro diagnostics quality controls market include:

• Siemens Healthineers AG

• Abbott

• Bio-Rad Laboratories

• Danaher Corporation

• Randox Laboratories Ltd

• Helena Laboratories Corporation

• Thermo Fisher Scientific

• BD (Becton, Dickinson and Company)

• Merck KGaA

• QIAGEN

• Hologic, Inc.

• Bio-Techne

• Fortress Diagnostics

• Microbiologics

• QuidelOrtho Corporation