In Vitro Diagnostics (IVD) Quality Control Market Report 2026

The in vitro diagnostics (ivd) quality control market size has grown strongly in recent years. It will grow from $1.48 billion in 2025 to $1.61 billion in 2026 at a compound annual growth rate (CAGR) of 8.5%. The growth in the historic period can be attributed to growing burden of infectious diseases, rising adoption of in vitro diagnostic devices, regulatory focus on diagnostic accuracy, expansion of clinical laboratory networks, increasing awareness of testing quality standards.

The in vitro diagnostics (ivd) quality control market size is expected to see strong growth in the next few years. It will grow to $2.24 billion in 2030 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to rising demand for molecular diagnostics precision, increasing healthcare digitalization, growing adoption of automated lab systems, expanding healthcare infrastructure investments, stricter regulatory compliance requirements. Major trends in the forecast period include increasing emphasis on diagnostic accuracy and reliability, rising focus on quality compliance and standardization, growing adoption of external quality assessment programs, expansion of multiplex and molecular diagnostic testing validation, increasing use of automated quality monitoring systems.

The rising prevalence of infectious diseases is expected to propel the growth of the in vitro diagnostics (IVD) quality control market going forward. Infectious diseases are illnesses caused by pathogenic microorganisms such as bacteria, viruses, fungi, or parasites that can spread directly or indirectly between individuals. The prevalence of infectious diseases is increasing due to factors such as growing antimicrobial resistance, which makes common infections more difficult to treat and control, thereby facilitating wider transmission. IVD quality control plays a critical role in ensuring the accuracy, reliability, and consistency of diagnostic test results, enabling timely detection of infectious pathogens and supporting effective clinical decision-making and patient management. For instance, in October 2024, according to the World Health Organization (WHO), a Switzerland-based international public health organization, approximately 8.2 million people were newly diagnosed with tuberculosis in 2023, an increase from about 7.5 million in 2022, making tuberculosis the leading infectious disease killer globally. Therefore, the rising prevalence of infectious diseases is driving the growth of the in vitro diagnostics (IVD) quality control market.

Major companies operating in the in vitro diagnostics (IVD) quality control market are focusing on integrating advanced technologies such as embedded barcode-scanning systems to improve efficiency, streamline diagnostic workflows, and reduce processing errors. Embedded barcode-scanning systems are compact fixed-mount devices and smart vision modules that automatically read barcodes and capture data in real time, enabling accurate specimen identification, automated data entry, and enhanced traceability throughout the diagnostic process. For instance, in November 2023, Newland EMEA, a Netherlands-based digital technology company, launched a new line of IVD-focused barcode-scanning products at the MEDICA trade fair. The portfolio includes high-speed scanners such as the FM510 and FM530, the versatile FM550, and the smart FM600 camera, all designed to enhance automation, improve diagnostic speed, and increase accuracy in IVD laboratories. This launch highlights the growing emphasis on automation and data integrity in diagnostic quality control.

In May 2024, Bruker, a US-based analytical instrumentation company, acquired ELITechGroup for €870 ($948) million. This acquisition aims to strengthen Bruker's position in the molecular diagnostics market by integrating ELITech's innovative sample-to-answer platforms along with its diverse portfolio of assays for infectious diseases. ELITech, also a US-based in-vitro diagnostics company, develops, manufactures, and markets a wide range of advanced diagnostic products and solutions, which include instruments, reagents, and software.

Major companies operating in the in vitro diagnostics (ivd) quality control market report are Bio-Rad Laboratories Inc., Thermo Fisher Scientific Inc., LGC Limited., Abbott Laboratories, Roche Diagnostics AG, Siemens AG, Ortho Clinical Diagnostics Inc., Helena Laboratories Corporation, Quidel Corporation, Microbiologics Inc., Sun Diagnostics LLC, Fortress Diagnostics Ltd., Seegene Inc., Bio-Techne Corp., Randox Laboratories, Danaher Corporation, Sysmex Corporation, Beckman Coulter Inc., Grifols India Healthcare Private Limited., Hologic Inc., Qiagen NV, Becton Dickinson and Company, Luminex Corporation, BioMerieux SA, Meridian Bioscience Inc., Sekisui Diagnostics LLC, ZeptoMetrix Corporation, Maine Molecular Quality Controls Inc.

North America was the largest region in the in vitro diagnostics (IVD) quality control market in 2025.Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the in vitro diagnostics (ivd) quality control market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the in vitro diagnostics (ivd) quality control market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The in-vitro diagnostics (IVD) quality control market consists of revenues earned by entities that evaluate and validate the reliability of in-vitro diagnostics testing systems. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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