Quality controls for in vitro diagnostics consist of liquid or lyophilized samples containing a predetermined amount of the target analyte. These controls are utilized in laboratory settings to confirm the reliability and accuracy of test results in an in vitro environment. Adhering to quality control and external quality assurance principles is crucial for effectively managing clinical laboratories. By implementing these processes proficiently, the potential risks to patients are minimized, and overall quality is enhanced.
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, the evolving regulatory landscape and lack of access to quality control/quality assurance materials are the major challenges to market growth.
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.), Microbiologics, Inc. (U.S.), and Bio-Techne Corporation (U.S.)
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The Rising Prevalence of Chronic Diseases Coupled with the Increasing Geriatric Population, Drives the IVD Quality Control Market’s Growth
The prevalence of chronic diseases and conditions such as cancer, diabetes, arthritis, and heart disease is rising globally. According to the International Diabetes Federation, the global prevalence of diabetes is estimated to increase from 10.5% of the global population in 2021 to 11.3% in 2030. Also, as per WHO estimates, the global prevalence of cancer is expected to increase from 19.2 million new cases in 2020 to 24.5 million new cases in 2030.
Growth in the geriatric population and social behaviors such as tobacco and alcohol use, physical inactivity, and unhealthy diets are major factors driving a steady increase in the number of people suffering from chronic diseases. Chronic diseases are often associated with the elderly population due to the declining bodily functions and immunity among people in this population segment. As per United Nations data, in 2020, nearly 727 million people (9.3% of the global population) were over the age of 65 years. This number is projected to cross 1.5 billion (16% of the global population) by 2050. These factors are increasing the utilization of IVD tests, driving the demand for IVD quality control.
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.
Based on offering, the IVD quality control market is segmented into quality control products, quality assessment services, and data management solutions. In 2024, the quality control products segment is expected to account for the largest share of 77.4% of the IVD quality control market. Quality control products ensure the reliability of test results and identify any inconsistencies or errors in laboratory testing processes. The need for careful validation, ongoing monitoring, and dedicated resources for preparation and maintenance of the in-vitro diagnostics in the laboratories contributed to the largest share of the segment.
Based on technology, the IVD quality control market is segmented into immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular diagnostics, hematology, coagulation/hemostasis, microbiology, and other technologies. In 2024, the immunoassay/immunochemistry segment is expected to account for the largest share of 32.8% of the IVD quality control market. The large market share of this segment is attributed to the high adoption of immunoassays due to the rapid, convenient, and accurate results; continuous development of new biomarkers; cost-benefit of immunoassays compared to other techniques; and growing adoption of automated platforms for ELISA resulting in increased usage of quality controls.
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Based on application, the IVD quality control market is segmented into infectious diseases, oncology, cardiology, autoimmune disorders, neurology, and other applications. In 2024, the infectious diseases 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 rising prevalence of infectious diseases, government initiatives to promote awareness and testing, and emerging outbreaks of infectious diseases around the world, which resulted in increased usage of IVD products for infectious diseases, including IVD quality controls.
Based on end user, the IVD quality controls market is segmented into hospitals & clinics, diagnostic laboratories, academic institutes & research laboratories, and other end users. In 2024, the hospitals & clinics segment is expected to account for the largest share of the IVD quality controls market. A hospital lab consists of various sections for testing, focusing on particular methods or techniques for investigating the sample specimens. As there are increasing hospital admissions, there is a rise in the usage of IVD tests and IVD quality controls, which further supports the segment’s largest share.
Based on geography, the IVD quality controls market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In 2024, North America is expected to account for the largest share of 38.2% of the IVD quality controls market owing to the rising number of accredited laboratories, stringent rules and regulations on quality assurance in the region, higher adoption of innovative multi-analyte third-party controls and related products & services, and well-established healthcare system in North America. The North America IVD quality controls market is estimated to be worth USD 650 million in 2024.
However, the Asia-Pacific IVD quality controls market is to register the highest growth rate during the forecast period.
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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 Control Products, by Type
- 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
- U.S.
- Canada
- 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
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