REDDING, Calif., May 21, 2024 /PRNewswire/ -- According to a
new market 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,' published by 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.
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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 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
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Related Blogs:
Top 10 Companies in IVD Quality Control Market
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