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Redding, California - January 24, 2024

IVD Quality Control Market to be Worth $2.28 Billion by 2031

IVD Quality Control Market Size, Share, Forecast & Trends Analysis by Offering (Product [Serum, Blood], Data Management, Service) Technology (Biochemistry, Molecular, Immunoassay) Application (cardiology, Oncology) End User – Global Forecast to 2031


Meticulous Research®—a leading market research company, published a research report titled, ‘IVD Quality Control Market Size, Share, Forecast & Trends Analysis by Offering (Product [Serum, Blood], Data Management, Service) Technology (Biochemistry, Molecular, Immunoassay) Application (cardiology, Oncology) End User – Global Forecast to 2031’

According to this latest publication from Meticulous Research®, the IVD quality control market is projected to reach $2.28 billion by 2031, at a CAGR of 4.3% from 2024 to 2031. The growth of the IVD quality control market is driven by 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, growing demand for Point-of-Care (POC) and rapid diagnostics. 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, evolving regulatory landscape and lack of access to quality control/quality assurance materials are the major challenges to market growth.

Key Players

Key companies operating in the IVD quality control market 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.), and Bio-Techne Corporation (U.S.)

The IVD quality control market is segmented 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); Technology (Immunoassay/Immunochemistry, Biochemistry/Clinical Chemistry, Molecular Diagnostics, Hematology, Coagulation/Hemostasis, Microbiology, Other Technologies); Application (Infectious Diseases, Oncology, Cardiology, Autoimmune Disorders, Neurology, Other Applications); End User (Hospitals & Clinics, Diagnostic Laboratories, Academic Institutes & Research Laboratories, Other End Users), and Geography. The study also evaluates industry competitors and analyzes the regional and country-level markets.

Among the offerings, in 2024, the quality control products segment is expected to account for the largest share of the IVD quality control market. Among the quality control products segment by type, serum/plasma-based controls are expected to account for the largest share as various diagnostic tests, such as those for glucose, cholesterol, electrolytes, liver enzymes, and cardiac markers, are performed using serum or plasma samples. Serum/plasma-based controls offer a direct and accurate way to monitor the accuracy and precision of these tests, thus supporting the largest share.

Among the technology, in 2024, the immunoassay/immunochemistry segment is expected to account for the largest share of the IVD quality control market. Immunoassay/immunochemistry advantages, such as inherent specificity, high-throughput, high sensitivity, and low cost, are driving the growth of this technology segment. Further, 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 support the increased demand for IVD quality controls for immunoassays.

Among the applications, in 2024, the infectious diseases segment is expected to account for the largest share of the IVD quality control market. The high prevalence of infectious diseases such as HIV, dengue, influenza, and pneumonia, the emergence of pandemics such as COVID-19, and supportive initiatives by public organizations to increase diagnostic testing are the factors supporting the large market share of this segment. For instance, According to UNAIDS estimates, in 2021, 38.4 million people were living with HIV globally (36.7 million adults and 1.7 million children aged 0–14 years). Additionally, in 2021, 1.5 million new cases of HIV were reported globally. This increased the usage of quality controls for infectious diseases.

Based on end user, in 2024, the hospitals & clinics segment is expected to account for the largest share of the IVD quality control market. The large market segment share is majorly attributed to the increasing prevalence of healthcare-associated infections (HAIs), the high volume of diagnostic tests conducted in hospitals, the growth in healthcare expenditure, and the expansion of hospitals and clinics in emerging markets. Additionally, during the COVID-19 pandemic, hospital admissions increased with the number of hospitals, leading to the high adoption of COVID-19 test quality controls in hospitals & clinics.

Based on geography, Asia-Pacific is expected to register the highest growth rate over the forecast period. The significantly growing IVD industry in the region with rising demand for early diagnosis from the large patient population in Asia, rising number of accredited laboratories, increasing number of hospitals and clinical pathologies, increasing healthcare spending, and improving healthcare infrastructure in the region are some of the major drivers for the growth of the Asia-Pacific market.

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Key questions answered in the report:

  • What are the high-growth market segments in terms of the offering, technology, application, end user, and country/region?
  • What was the historical market for IVD quality control across the globe?
  • What are the market forecasts and estimates for 2024–2031?
  • What are the major drivers, restraints, opportunities, and challenges in the global IVD quality control market?
  • Who are the major players in the global IVD quality control market?
  • How is the competitive landscape, and who are the market leaders in the global IVD quality control market?
  • What are the recent developments in the IVD quality control market?
  • What are the different strategies adopted by the major players in the IVD quality control market?
  • What are the geographic trends and high-growth regions/countries?

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