In Vitro Diagnostics (IVD) Quality Control Global Market Report 2024

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 in vitro diagnostics (ivd) quality control market size has grown strongly in recent years. It will grow from $1.33 billion in 2023 to $1.42 billion in 2024 at a compound annual growth rate (CAGR) of 6.8%. The growth during the historical period can be attributed to several factors, including regulatory compliance, the increasing prevalence of diseases, a growing aging population, the expansion of diagnostic laboratories, and 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 $1.91 billion in 2028 at a compound annual growth rate (CAGR) of 7.8%. The anticipated growth in the forecast period can be attributed to several factors, including advancements in personalized medicine, the expansion of point-of-care testing, integration with digital health technologies, the adoption of next-generation sequencing (NGS), global health security concerns, and integration with electronic health records (EHR). Significant trends expected in the forecast period encompass the development of multi-analyte quality control materials, applications of artificial intelligence (AI) and machine learning, on-demand quality control solutions, continuous monitoring with real-time feedback, and the emergence of 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.

The in vitro diagnostics quality control market is being shaped by increasing research and development initiatives. Companies in the market are actively involved in research and development to introduce and optimize products and processes. For instance, in August 2021, Microbiologics, a US-based biotechnology company, introduced a new SARS-CoV-2 quality control (QC) tool designed for antigen point-of-care (POC) testing. This SARS-CoV-2 Whole Virus Antigen Control, highly concentrated and containing fully intact genomic and viral proteins, is suitable for both antigen testing and nucleic acid amplification studies (NAATs). It is part of Microbiologics' broad line of In Vitro Diagnostic (IVD) quality controls and Research Use Only (RUO) products aimed at supporting the ongoing COVID-19 pandemic response.

In January 2021, Cole-Parmer, a US-based analytical products manufacturing company, acquired Zeptometrix for an undisclosed amount. This strategic acquisition positions Cole-Parmer to expand its portfolio of quality controls and reference standards, establishing itself as a leading manufacturer for life sciences research and diagnostic testing. Zeptometrix, a US-based company, specializes in manufacturing a range of quality controls and verification panels for in-vitro diagnostics tests.

Major companies operating in the 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, SeraCare Life Sciences Inc., 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., Maine Standards Company LLC

North America was the largest region in the in vitro diagnostics (IVD) quality control market in 2023. 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.

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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