In Vitro Diagnostics Quality Control Market is growing rapidly as an industry due to rising number of accredited clinical laboratories, rising geriatric population, rising demand for external quality assessment programs, increasing adoption of and POC instruments in developed regions and increasing adoption of third-party quality controls.
Currently, In Vitro Diagnostics Quality Control Market is growing at a Compound Annual Growth Rate (CAGR) of 5.3 % to reach USD 1.4 billion by 2026. The rising focus on multi-analyte controls is also expected to offer significant growth opportunities for the market in the coming years. The use of quality control products is, however, not mandatory for all clinical laboratories in many countries. The lack of regulations for these products is expected to adversely affect the market growth.
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Growth Drivers
- Increasing number of accredited clinical laboratories
- Growing adoption of third-party quality controls
- Rising demand for external quality assessment support
- Rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases
Growth Opportunities
- Rising demand for multi-analyte controls
Challenges
- Stringent product approval process
- Lack of regulations for clinical laboratory accreditation in several emerging countries
Trends
- Lyophilized/freeze-dried Controls
- Trends On Analyte Source: Human Vs. Animal Origin
- Consolidation of Laboratories
The prominent players operating in the In Vitro Diagnostics Quality Control Market are
Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US).
Bio-Rad Laboratories, Inc. holds the leading position in the IVD quality control market. The company provides innovative quality control products and services. It also offers a range of third-party quality controls, data management solutions, and external quality assurance services for hospital laboratories, reference laboratories, transfusion laboratories, and physician office laboratories. Under its leading brands, such as Lyphochek and Liquichek, the company offers various IVD quality controls to customers globally. The company is expected to sustain its leading market position in the coming years owing to its strong product portfolio, geographic presence, and brand name in the global market. Its market leadership can also be attributed to its strong distribution and subsidiary network across the globe, enabling it to serve customers in North America, Europe, and the Asia Pacific. Bio-Rad Laboratories has direct distribution channels in over 35 countries outside the US through subsidiaries, and they focus on sales, customer service, and product distribution.
Thermo Fisher Scientific, Inc. holds the second position in the global IVD quality control market. The company is a leading provider of IVD quality control products and services. The company offers a robust portfolio of quality controls for clinical chemistry, molecular control, microbiology, serology, serum toxicology testing, specimen validity testing, and therapeutic drug monitoring (TDM). With its strong geographic presence and wide distribution networks, the company has established itself as a leader in the global IVD quality control market. To sustain its leading position and further increase its share in the market, the company focuses on organic and inorganic growth strategies.
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North America is expected to account for the largest share
- Recommendations for and approvals of quality control products from the FDA and the College of American Pathologists (CAP)
- Presence of well-established distribution channels and leading companies in the US are driving the IVD quality control market in North America
Recent Developments
- In August 2021, Zeptometrix Corporation (US) announced the immediate availability of its ready-to-use NATSARS(COV2)-ERC for laboratory QC and test validation
- In July 2021, Quidel Corporation (US) received the CE Mark for its innovative Savanna multiplex molecular analyzer and Savanna RVP4 Assay (Respiratory Viral Panel-4).
- In June 2021, LGC SeraCare (US) expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex SARS-CoV-2 Variant Panel 1.
- In June 2021, Abbott Laboratories (US) received CE mark for its Panbio Rapid Antigen self-test. It helped the company expand its reach throughout Europe for fast, reliable COVID-19 testing
According to the new market research report "In Vitro Diagnostics Quality Control Market by Source (Plasma, Whole Blood, Urine), Technology (Immunoassay, Hematology, Microbiology, Molecular Diagnostics), Manufacturer (Third-party, OEM), End Users (Hospitals, Lab) - Global Forecast to 2026", published by MarketsandMarkets™, the global IVD Quality Control Market is projected to reach USD 1.4 billion by 2026 from USD 1.1 billion in 2021, at a CAGR of 5.3% during the forecast period.Browse in-depth TOC on "In Vitro Diagnostics Quality Control Market"252 – Tables59 – Figures342 – PagesDownload PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=198032582 The IVD testing plays a significant role in clinical decision-making.
To ensure technological competitiveness, companies are continuously launching innovative and advanced quality control products in the market for a variety of applications.The growth of the Quality Control in IVD Market is primarily driven by the rising number of accredited clinical laboratories, rising geriatric population, rising demand for external quality assessment programs, increasing adoption of and POC instruments in developed regions and increasing adoption of third-party quality controls.
The rising focus on multi-analyte controls is also expected to offer significant growth opportunities for the market in the coming years.
The lack of regulations for these products is expected to adversely affect market growth.The product & service segment holds the highest share of the total IVD quality control market during the forecast period.Based on product & service, the IVD Quality Control Market is segmented into quality control products, data management solutions, and quality assurance services.
The large share of this segment can be attributed to the increasing use of third-party quality controls across the globe to verify the accuracy and reliability of testsHospitals accounted for the highest share of the global IVD quality control marketThe key end users of IVD quality controls studied in this report include hospitals, clinical laboratories, research & academic institutes, and other end users.
Recommendations for and approvals of quality control products from the FDA and the College of American Pathologists (CAP) and the presence of well-established distribution channels and leading companies in the US are driving the market in North America.Request For Report Sample: https://www.marketsandmarkets.com/requestsampleNew.asp?id=198032582 Some of the key players in the In Vitro Diagnostics (IVD) Quality Control Market include Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US).
The global In Vitro Diagnostics (IVD) Quality Control Market is anticipated to reach USD 1.13 billion by 2024.
The rising number of certified clinical laboratories requires quality control (QC) services to maintain their standards, associated with the increasing acceptance of third party providers of quality control services, to ensure the accurate and reproducible test results, and better outcomes which is anticipated to drive the growth.For the establishment of definite standards of quality, the internal Quality Control (QC) programs and the external QAS (Quality Assurance Schemes) is very important to ensure validity and reliability of the test results obtained by the IVD devices.
These programs are essential in confirming the delivery of patient diagnostic outcomes, which are reliable and without errors, such as misdiagnosis because of device-related errors, which can impact the health of the patient.Download Free Sample Report @ https://www.millioninsights.com/industry-reports/in-vitro-diagnostics-ivd-quality-control-market/request-sampleThe regulation of these In vitro diagnostics devices are controlled by the respective regulatory bodies, which includes the U.S. FDA (Food and Drug Administration), the International Medical Device Regulators Forum (IMDRF), the European Commission, the Australian Therapeutic Goods Administration (TGA), the Eurasian Economic Union (EEU) and the Brazilian National Health Surveillance Agency (ANVISA).The currently undergoing, extensive R related activities beside the introduction of new laws with the aim of improving the efficacy and safety levels of the IVD services are anticipated to drive market growth.
For example, in September 2012, a new regulation for IVD devices was published by the European Commission targeted to enhance the transparency, safety and the traceability without constraining innovation.
The QC schemes are appropriate to plasma-based, whole blood-based and serum-based products.
In 2016, QC market was one of the largest segments because of the rapidly developing IVD technologies and the existence of numerous internal QC programs for the different features of the IVD device-based procedures of testingApplication InsightsThere are numerous applications of the IVDs, which includes haematology, immunology, coagulation, clinical chemistry, molecular diagnostics and microbiology.
11 February 2020 - The global In Vitro Diagnostics (IVD) Quality Control Market is anticipated to reach USD 1.13 billion by 2024.
The rising number of certified clinical laboratories requires quality control (QC) services to maintain their standards, associated with the increasing acceptance of third party providers of quality control services, to ensure the accurate and reproducible test results, and better outcomes which is anticipated to drive the growth.For the establishment of definite standards of quality, the internal Quality Control (QC) programs and the external QAS (Quality Assurance Schemes) is very important to ensure validity and reliability of the test results obtained by the IVD devices.
These programs are essential in confirming the delivery of patient diagnostic outcomes, which are reliable and without errors, such as misdiagnosis because of device-related errors, which can impact the health of the patient.Request a Sample Copy of This Report @ https://www.millioninsights.com/industry-reports/in-vitro-diagnostics-ivd-quality-control-marketThe regulation of these In vitro diagnostics devices are controlled by the respective regulatory bodies, which includes the U.S. FDA (Food and Drug Administration), the International Medical Device Regulators Forum (IMDRF), the European Commission, the Australian Therapeutic Goods Administration (TGA), the Eurasian Economic Union (EEU) and the Brazilian National Health Surveillance Agency (ANVISA).The currently undergoing, extensive R related activities beside the introduction of new laws with the aim of improving the efficacy and safety levels of the IVD services are anticipated to drive market growth.
For example, in September 2012, a new regulation for IVD devices was published by the European Commission targeted to enhance the transparency, safety and the traceability without constraining innovation.
In 2016, QC market was one of the largest segments because of the rapidly developing IVD technologies and the existence of numerous internal QC programs for the different features of the IVD device-based procedures of testingApplication InsightsThere are numerous applications of the IVDs, which includes haematology, immunology, coagulation, clinical chemistry, molecular diagnostics and microbiology.
The home care market segment is anticipated to observe a lucrative progression owing to the persistent increase in the usage devices for point-of-care testing.
