The in vitro diagnostics (ivd) quality control market has seen considerable growth due to a variety of factors.
• The size of the in vitro diagnostics (IVD) quality control market has seen a stable progression in the past years. It is projected to surge from $1.4 billion in 2024 to $1.49 billion in 2025, experiencing a compound annual growth rate (CAGR) of 6.5%.
The historical growth is influenced by factors such as adherence to regulations, the growing incidence of diseases, an increasing elderly population, the expansion of diagnostic labs, and heightened awareness and need for precision medicine.
The in vitro diagnostics (ivd) quality control market is expected to maintain its strong growth trajectory in upcoming years.
• Over the next few years, the in vitro diagnostics (IVD) quality control market is projected to experience a significant surge, reaching $2.09 billion by 2029, growing at a compound annual growth rate (CAGR) of 8.7%.
Several contributing factors include the progression of personalized medicine, expansion of point-of-care testing, integration of digital health, adoption of next-generation sequencing (NGS), and global health security issues, combined with the incorporation of electronic health records (EHR). Furthermore, major trends predicted to dominate this growth period range from multi-analyte quality control materials, the application of artificial intelligence and machine learning, on-demand quality control solutions to continuous monitoring with real-time feedback, and the rise of portable and user-friendly quality control devices.
The escalating occurrence of infectious diseases like HIV and cancer is making a notable impact on the expansion of the in vitro diagnostics quality control market. Infectious diseases are prevalent and result from the transfer of pathogens like viruses, bacteria, fungi, or parasites. The increase in infectious diseases, inclusive of HIV and cancer conditions, calls for innovative diagnostic testing products and services for efficient treatment, thereby boosting the need for in vitro diagnostics quality control which guarantees the precision, functioning, and quality of testing equipment and results. For example, the Office for National Statistics, a renowned national statistics institute in the UK, noted that at the end of the week concluding December 9, 2022, the infection rate escalated for individuals aged 35 to 69 years and amplified for those in school years 12 to 24 years. Hence, the escalating frequency of infectious diseases like HIV and cancer is anticipated to propel the expansion of the in-vitro diagnostics quality control market in the coming years.
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
The expansion of research and development is moulding the future of the in vitro diagnostics quality control market. Leading companies in this market are creating innovative products to gain a superior competitive edge. For example, Newland EMEA, a Dutch-based Digital Technology company, announced in November 2023 the launch of a new line of in vitro diagnostics (IVD) products at the MEDICA trade fair. This product line includes five advanced barcode scanners specially designed for healthcare applications. Models such as the high-speed FM510 and FM530, and the multifunctional FM550 and intelligent FM600 camera are devised to amplify automation in IVD procedures, enhancing diagnostic speed and accuracy. This product launch highlights the dedication of Newland EMEA to pushing forward advances in automatic identification and data collection technology, with the end goal of improving patient care through more efficient healthcare solutions.
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