In-Vitro Diagnostics (IVD) Quality Control Market Report 2025

This in Vitro Diagnostics (IVD) Quality Control market report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The in vitro diagnostics (IVD) quality control market size has grown strongly in recent years. It will grow from $1.4 billion in 2024 to $1.49 billion in 2025 at a compound annual growth rate (CAGR) of 6.5%. The growth in the historic period can be attributed to regulatory compliance, increasing prevalence of diseases, growing aging population, expansion of diagnostic laboratories, increased awareness and demand for precision medicine.

The in vitro diagnostics (IVD) quality control market size is expected to see strong growth in the next few years. It will grow to $2.09 billion in 2029 at a compound annual growth rate (CAGR) of 8.7%. The growth in the forecast period can be attributed to personalized medicine advancements, point-of-care testing expansion, digital health integration, adoption of next-generation sequencing (NGS), global health security concerns, integration with electronic health records (EHR). Major trends in the forecast period include multi-analyte quality control materials, ai and machine learning applications, on-demand quality control solutions, continuous monitoring and real-time feedback, portable and easy-to-use quality control devices.

The increase in the prevalence of infectious diseases, such as HIV and cancer, is a significant driver of the growth observed in the in vitro diagnostics quality control market. These infectious diseases, caused by various pathogens like viruses, bacteria, fungi, or parasites, necessitate advanced diagnostic testing products and services for effective treatment. This surge in infectious diseases, including HIV and cancer cases, underscores the growing demand for in vitro diagnostics quality control, ensuring the accuracy, performance, and quality of test equipment and results. As reported by the Office for National Statistics, the infection rate in England increased for individuals aged 35 to 69 years and those in school years 12 to 24 years by the end of the week ending December 9, 2022. Hence, the expected rise in infectious diseases, such as HIV and cancer, is poised to propel the growth of the in vitro diagnostics quality control market in the forecast years.

The increasing prevalence of chronic diseases is anticipated to drive the demand for the in-vitro diagnostics (IVD) quality control market in the foreseeable future. Chronic diseases, characterized by slow progression and long-term persistence, underscore the crucial role of in vitro diagnostics quality control in ensuring accurate and reliable diagnostic tests. This, in turn, facilitates precise and trustworthy clinical results. A report from the National Library of Medicine in January 2023 indicates that the number of people in the US aged 50 and older with at least one chronic condition is projected to reach 142. 66 million by 2050. Therefore, the surge in chronic diseases is a key factor propelling the growth of the in-vitro diagnostics (IVD) quality control market.

Increasing research and development is influencing the in vitro diagnostics quality control market. Major companies in the in vitro diagnostics (IVD) quality control sector are creating innovative products to gain a competitive edge. For example, in November 2023, Newland EMEA, a Netherlands-based digital technology company, unveiled a new line of in vitro diagnostics (IVD) products at the MEDICA trade fair. This lineup includes five advanced barcode scanners designed specifically for the healthcare sector, such as the high-speed FM510 and FM530, along with the versatile FM550 and the intelligent FM600 camera. These scanners aim to enhance automation in IVD processes, leading to improvements in diagnostic speed and accuracy. This launch highlights Newland EMEA's dedication to advancing technology in automatic identification and data collection, ultimately focusing on enhancing patient care through more efficient healthcare solutions.

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 include 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 2024. 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, 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, Russia, South Korea, UK, USA, Italy, Canada, 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.

In-vitro diagnostics (IVD) quality control encompasses a set of processes designed to ensure the accuracy, performance, and environmental conditions impacting in vitro diagnostic tests, including in vitro nucleic acid testing processes for pathogen detection and healthcare-associated infections (HAIs) like pneumonia and urinary tract infections.

The primary products in in-vitro diagnostics quality control include quality control products, data management solutions, and quality assurance services. Quality control products comprise serum/plasma-based control products, whole blood-based control products, urine-based control products, and other control products manufactured by IVD instrument manufacturers. These products aim to cure, mitigate, or treat conditions through in-vitro diagnostics quality control. Manufacturers can be categorized as IVD instrument manufacturers and third-party quality control manufacturers. These products find applications in various diagnostic areas, such as clinical chemistry, hematology, immunoassay, molecular diagnostics, microbiology, coagulation, or hemostasis, among others. The implementation of in-vitro diagnostics quality control occurs in various settings, including hospitals, clinical laboratories, research and academic institutes, and other healthcare facilities.

The in-vitro diagnostics (IVD) quality control market research report is one of a series of new reports that provides in-vitro diagnostics (IVD) quality control market statistics, including in-vitro diagnostics (IVD) quality control industry global market size, in-vitro diagnostics (IVD) quality control market regional shares, competitors with an in-vitro diagnostics (IVD) quality control market share, detailed in-vitro diagnostics (IVD) quality control market segments, in-vitro diagnostics (IVD) quality control market trends and opportunities, and any further data you may need to thrive in the in-vitro diagnostics (IVD) quality control industry. This in-vitro diagnostics (IVD) quality control market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

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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