The IVD Quality Control Market is projected to reach $2.19 billion by 2030, at a CAGR of 4.3% from 2023 to 2030. IVD Quality Control (QC) involves the detection of analytical errors to guarantee the precision and dependability of test results. QC testing is an essential prerequisite for every laboratory, yet the reliability of QC systems may differ across laboratories due to the variability in control materials being utilized.
The IVD quality control market covers quality control products, external quality assessment services, and data management solutions offered by companies for infectious diseases, cardiology, hematology, oncology, and other applications for use in hospitals & clinics, diagnostic laboratories, academic & research institutes, and blood banks.
The rising prevalence of chronic diseases, coupled with the increasing geriatric population, growing demand for third-party quality controls, need for internal and external quality assessment reports, increasing number of clinical laboratories, and growing demand for Point-of-Care (POC) and rapid diagnostics drive the market growth. However, stringent technical requirements and regulatory processes for quality controls restrain this market's growth.
Growing demand for multi-analyte and multi-instrument controls offers opportunities for market growth. However, the evolving regulatory landscape and lack of access to quality control/quality assurance materials are the major challenges to market growth.
Growing Demand for Multi-analyte and Multi-instrument Controls to Drive the Demand for IVD Quality Control Market
Among the IVD quality controls commercially available, there is an increasing demand for multi-analyte and multi-instrument controls. Multi-analyte controls are designed to contain multiple analytes of interest, representing a range of concentrations typically found in patient samples. On the other hand, multi-instrument controls are designed to be compatible with different types of laboratory instruments and testing platforms.
There is an increasing demand for multi-analyte controls as they eliminate the need to use separate controls for each analyte, streamlining the quality control process and saving time and resources. They are also cost-effective, as consolidating multiple analytes into a single control can be more cost-effective than purchasing separate controls for each analyte. Overall, the demand for multi-analyte and multi-instrument controls is driven by the need for efficient, cost-effective, and standardized quality control processes in diagnostic testing.
Need for Internal and External Quality Assessment Reports to Propel the Demand for IVD Quality Controls
Both the internal and external quality assessment reports are required due to several reasons. Quality Assessment (QA) reports provide a systematic evaluation of the laboratory's performance by monitoring the accuracy and precision of test results. These reports ensure that the laboratory consistently produces reliable results. Internal QA reports contribute to meeting regulatory standards and accreditation requirements. These reports demonstrate the laboratory's commitment to quality and compliance with established guidelines. By analyzing internal QA data, laboratories can identify trends, patterns, and potential sources of error. This information facilitates targeted process improvements, leading to enhanced testing procedures and reduced chances of errors. Whereas external QA reports enable laboratories to compare their results with those of other facilities. Discrepancies can identify areas for improvement and prompt corrective actions. Moreover, participation in external QA programs is often a requirement for laboratory accreditation. Proficiency testing through external QA helps laboratories maintain their accreditation status. External QA reports validate the accuracy of a laboratory's testing methods and verify its ability to generate reliable results. These assessment data are analyzed using quality controls, hence driving the market growth.
Key Findings in the IVD Quality Control Market Study:
In 2023, the Quality Control Products Segment is Expected to Account for the Largest Share of the IVD Quality Control Market
Among the offering, in 2023, the quality control products segment is expected to account for the largest share of the IVD quality control market. The large market share of this segment is attributed to the wide availability of controls for various applications. Also, advancements in these controls have expanded their utilization. For instance, in February 2020, Bio-Rad Laboratories, Inc. (U.S.) launched EDX RP Positive Run Control for clinical respiratory assays. It contains 22 respiratory analytes.
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In 2023, the Immunoassay/Immunochemistry Segment Expected to Account for the Largest Share of the IVD Quality Control Market
Among the technologies, in 2023, the immunoassay/immunochemistry segment is expected to account for the largest share of the IVD quality control market. The increasing use of immunoassays in POC & infectious disease testing, development of novel tests, increasing usage of miniaturized devices, and rising demand for immunoassay-based tests are expected to support the segment’s largest share. For instance, in February 2021, Agilent Technologies Inc. (U.S.) launched Agilent Dako SARS-CoV-2 IgG, an immunoassay kit to detect SARS-CoV-2 IgG antibodies.
In 2023, the Infectious Diseases Segment Expected to Account for the Largest Share of the IVD Quality Control Market
Among the applications, in 2023, the infectious diseases segment is expected to account for the largest share of the IVD quality control market. There has been an increasing prevalence of infectious diseases globally. According to a 2022 article published by Families Fighting Flu, Inc. (U.S.), an estimated 1 billion people worldwide are infected by seasonal influenza every year, of which 3-5 million people have a severe case of flu. Moreover, according to the WHO, a total of 1.6 million people died from TB in 2021 globally (out of which 187,000 were HIV patients). Hence, the higher adoption of sensitive and cost-effective tests to diagnose increasing infectious diseases resulted in an increased demand for IVD quality controls for infectious diseases.
In 2023, the Hospitals & Clinics Segment Expected to Account for the Largest Share of the IVD Quality Control Market
Among the end users, in 2023, the hospitals & clinics segment is expected to account for the largest share of the IVD quality control market. The largest share of this segment is mainly attributed to the large share of diagnostics tests performed in the hospital-attached laboratories and the relatively higher demand for quality controls in these healthcare settings to ensure the accuracy and reliability of IVD test results of the patients. Additionally, during COVID-19, hospital admissions increased, which further led to the adoption of COVID-19 test quality controls in hospitals & clinics.
North America to Dominate the Market in 2023
In 2023, North America is expected to account for the largest share of the global IVD quality control market. The large market share of this region is attributed to the rising prevalence of chronic and infectious diseases, increasing awareness regarding early disease diagnosis, advanced diagnostics infrastructure, a large number of laboratory tests performed annually, the mandatory quality assessments of laboratories, and the participation of laboratories in external quality assessment programs.
Key Players
This report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market participants in the last few years. The key players profiled in the IVD quality control market report are Seimens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), LGC Group (U.K.), Thermo Fisher Scientific Inc. (U.S.), SERO AS (Norway), Randox Laboratories Ltd. (U.K.), QuidelOrtho Corporation (U.S.), Streck LLC (U.S.), and Microbiologics, Inc. (U.S.).
Scope of the Report:
IVD Quality Control Market Assessment, by Offering
- Quality Control Products
- Quality Control Products, by Type
- Serum/Plasma-based Controls
- Whole Blood-based Controls
- Urine-based Controls
- Other Controls
- Quality Control Products, by Function
- Independent Controls
- Instrument-Specific Controls
- Quality Assessment Services
- Data Management Solutions
(Notes: Other controls include saliva-based controls, cerebrospinal fluid-based, and protein controls.)
IVD Quality Control Market Assessment, by Technology
- Immunoassay/Immunochemistry
- Biochemistry/Clinical Chemistry
- Molecular Diagnostics
- Hematology
- Coagulation/Hemostasis
- Microbiology
- Other Technologies
(Notes: Other technologies include histochemistry, urinalysis, and whole-blood glucose monitoring)
IVD Quality Control Market Assessment, by Application
- Infectious Diseases
- Oncology
- Cardiology
- Autoimmune Disorders
- Neurology
- Other Applications
(Notes: Other applications include pregnancy and fertility testing, drug abuse testing, diabetes, genetic disorders, and trace elements testing)
IVD Quality Control Market Assessment, by End User
- Hospitals & Clinics
- Diagnostic Laboratories
- Academic Institutes & Research Laboratories
- Other End Users
(Notes: Other end users include home care, nursing homes, ambulatory care centers, and transfusion laboratories.)
IVD Quality Control Market Assessment, by Geography
- North America
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Rest of Asia-Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
Key questions answered in the report: