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In Vitro Diagnostics (IVD) Quality Control Market Forecast: What Value Will The Market Reach By 2030?
The in vitro diagnostics (ivd) quality control market size has demonstrated significant growth in recent years. It is forecast to increase from $1.48 billion in 2025 to $1.61 billion in 2026, achieving a compound annual growth rate (CAGR) of 8.5%. This market’s historical expansion is attributable to the escalating burden of infectious diseases, the growing adoption of in vitro diagnostic devices, regulatory concentration on diagnostic accuracy, the widening of clinical laboratory networks, and a heightened awareness of testing quality standards.
The in vitro diagnostics (ivd) quality control market is projected to experience robust expansion over the coming years, with its size expected to reach $2.24 billion by 2030, growing at a compound annual growth rate (CAGR) of 8.6%. This anticipated growth is driven by factors such as an escalating demand for precision in molecular diagnostics, the accelerating digitalization of healthcare, the increasing integration of automated laboratory systems, expanding investments in healthcare infrastructure, and more stringent regulatory compliance requirements. Prominent trends throughout this forecast period include a heightened emphasis on diagnostic accuracy and reliability, an increasing focus on quality compliance and standardization, the broader adoption of external quality assessment programs, the expansion of validation for multiplex and molecular diagnostic testing, and the growing utilization of automated quality monitoring systems.
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In Vitro Diagnostics (IVD) Quality Control Market Expansion Drivers: What’s Shaping Future Growth?
The increasing occurrence of infectious diseases is anticipated to boost the expansion of the in vitro diagnostics (IVD) quality control market in the future. These diseases are illnesses resulting from pathogenic microorganisms like bacteria, viruses, fungi, or parasites, capable of transmission directly or indirectly among people. The rise in infectious diseases stems from increasing antimicrobial resistance, which renders common infections more challenging to cure and simpler to transmit. In vitro diagnostics (IVD) quality control plays a crucial role in guaranteeing precise and dependable detection of infectious pathogens, thus facilitating prompt diagnosis and successful patient care. As an illustration, the World Health Organization, a Switzerland-based international public health organization, reported in October 2024 that around 8.2 million individuals received a new tuberculosis diagnosis in 2023, an increase from approximately 7.5 million in 2022, thereby identifying tuberculosis as the primary infectious disease cause of death. Consequently, the growing prevalence of infectious diseases is fueling the expansion of the in vitro diagnostics (IVD) quality control market.
In Vitro Diagnostics (IVD) Quality Control Market Segment Landscape: Which Areas Lead Development?
The in vitro diagnostics (ivd) quality control market covered in this report is segmented –
1) By Product type: Quality Control Products, Data Management Solutions, Quality Assurance Services
2) By Manufacturer Type: IVD Instrument Manufacturers, Third Party Quality Control Manufacturers
3) By Application: Clinical Chemistry, Hematology, Immunoassay, Molecular Diagnostics, Microbiology, Coagulation Or Hemostasis, Other Applications
4) By End-Users: Hospitals, Clinical Laboratories, Research And Academic Institutes, Other End Users
Subsegments:
1) By Quality Control Products: Control Materials, Quality Control Kits, Proficiency Testing Samples
2) By Data Management Solutions: Software For Quality Control Management, Data Analysis Tools, Cloud-Based Solutions
3) By Quality Assurance Services: Consulting Services, Training And Education Services, Audit And Compliance Services
In Vitro Diagnostics (IVD) Quality Control Market Strategic Trends: What Defines The Next Growth Phase?
Leading firms within the in vitro diagnostics (IVD) quality control sector are concentrating on incorporating sophisticated technologies like embedded barcode-scanning systems to boost efficiency, optimize diagnostic procedures, and minimize processing mistakes. These embedded barcode-scanning systems are miniature fixed-position units and intelligent vision modules designed to automatically interpret barcodes and record data instantaneously, facilitating accurate specimen recognition, automated data input, and enhanced traceability. As an illustration, in November 2023, Newland EMEA, a Digital Technology company based in the Netherlands, unveiled a new range of in vitro diagnostics (IVD) offerings at the MEDICA trade fair, which included five cutting-edge barcode scanners specifically developed for the healthcare industry. Comprising high-speed models like the FM510 and FM530, along with the adaptable FM550 and the intelligent FM600 camera, these scanners aim to increase automation in IVD operations, thereby accelerating diagnostic speed and precision. This introduction highlights Newland EMEA’s dedication to advancing technology in automated identification and data acquisition, with the ultimate goal of improving patient care via more streamlined healthcare solutions.
In Vitro Diagnostics (IVD) Quality Control Market Industry Leaders And Competitive Landscape
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.
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In Vitro Diagnostics (IVD) Quality Control Market Geographic Analysis: Where Is Demand Rising Fastest?
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.
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Wasay has over a decade of experience in market research, data modelling, and analytics, with prior experience at GlobalData and Decision Tree Consulting Services. At The Business Research Company , he leads research operations across syndicated studies, customized consulting engagements, and the Global Market Model platform. His professional experience includes supporting organizations such as Boston Consulting Group, KPMG, and Ernst & Young. Wasay holds a degree in Electronics and Communications Engineering, postgraduate management qualifications from International Management Institute Belgium and Indian School of Business and Entrepreneurship, and completed the Integrated Program in Business Analytics from Indian Institute of Management Indore.