Global IVD quality control Market is segmented By Product and Services (Quality Control Products (Whole blood-based quality controls, Serum & Plasma-based quality controls, Urine based quality controls, Others), Data Management Solutions, Quality Assurance Services), By Application (Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis, Others), By End-user (Hospitals, Clinical Laboratories, Research, and Academic Institutes, Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030
Market - Overview
The global IVD quality control market is estimated to reach at a CAGR of 3.7% over the forecast period (2023-2030).
Various infectious and non-communicable disorders are detected using in-vitro diagnostic tests performed on obtained blood tissue samples. They are used to track a patient's health, cure diseases, and assist medical experts in determining the most appropriate treatment technique or therapy for them. IVQ Quality Controls are items used to assess the test's quality and precision.
Market Dynamics
Clinical laboratories are becoming more and more accredited to drive market growth.
Laboratory tests have increased globally as the global burden of various diseases has increased. To accommodate this need, the public and commercial sectors have built more laboratories. With the development of the COVID-19 pandemic in December 2019, the demand for diagnostic testing has skyrocketed. Many government agencies have opened additional facilities and expanded laboratory testing capabilities in response to the epidemic.
Moreover, clinical laboratories must obtain regulatory approval before performing diagnostic tests in most countries. Furthermore, ISO 15189:2012 and comparable standards are becoming required in many nations. Authorities analyze the quality system and competency-based on specified standards during the accreditation procedure. Thus, the market is expected to drive in the forecast period from the above statements.
Restraint:
In low- and middle-income countries, there are stringent quality-control regulations. Implementing QC procedures for clinical laboratories that do limited volumes of diagnostic tests is very expensive. It is projected that, when combined with funding constraints in many hospitals and laboratories in both developed and developing economies, QC procedures adoption will decrease. Thus, the market is expected to get hampered in the forecast period from the above statements.
Industry Analysis
Porter’s Five Forces:
Supply Chain Analysis:
Source: DataM Intelligence Analysis (2022)
COVID-19 Impact Analysis
The COVID-19 pandemic has positively impacted healthcare systems and the market. The extremely contagious nature of this respiratory disease puts current viral detection technology to the test in terms of speed, scalability, affordability, and accuracy. Immunoassays have been utilized to surveillance individuals by detecting antibodies against SARS-CoV-2, whereas molecular tests have been the gold standard for direct detection of viral RNA in suspected individuals. Immunoassays, unlike molecular testing, are non-invasive tests of viral infection. As of this date, more than 140 diagnostic assays have been created and have been granted emergency use authorization by the Food and Drug Administration (FDA) (EUA).
Moreover, Government regulators have also expressed their support for these tests in the fight against the pandemic. As a result, the IVD business has seen both positive and bad consequences, and important participants have made strategic decisions to deal with the situation. As the number of fast diagnostic tests, point-of-care tests, and IVD devices grow, the demand for control and calibrator kits to ensure that patients' sample findings are accurate and precise. Therefore, Companies and laboratories emphasize the quality of their test results, which has aided market growth.
Segment Analysis
Molecular Diagnostics segment is expected to hold the largest market share in IVD quality control market
The molecular diagnostics segment is expected to dominate in 2020. The segment benefits because of the rising global frequency of cancer, greater research on cancer biomarkers, enhanced diagnosis infrastructure, and additional applications in detecting multiplex PCR, HIV, respiratory tract infections, and genital infections. Moreover, molecular diagnostic testing plays an increasingly important role in clinical laboratory evaluation. Nucleic acid isolation, gel electrophoresis, various forms of PCR, RT-PCR and real-time PCR, microarray, sequencing, and restriction enzyme analysis are all common molecular procedures utilized in a molecular diagnostic lab. NGS has recently become a necessary component in a molecular lab.
Additionally, due to the increasing technical complexity of molecular diagnostic testing and the need for quality evaluation to ensure standards, and the U.S. Food & Drug Administration (FDA) has written regulations citing quality control material as medical devices. For instance, 21 CFR 862.1660, Mulit-Analyte Controls Unassayed under Clinical Chemistry, and more recently 21 CFR 866.3920, classify Class II controls requiring FDA 510(k) review under microbiology. These are some factors that the market is expected to hold the largest market share in the forecast period.
Geographical Analysis
North America region holds the largest market share in the global IVD quality control market
In 2020, North America accounted for the highest revenue share. The rising number of diagnostic facilities and accredited clinical laboratories, as well as the high rate of adoption of technological infrastructure, well-developed healthcare infrastructure, as well as an increase in lifestyle diseases in the region and expansion of the product approval by the key players, are some of the factors due to which the market is expected to boost in the forecast period. For instance, During the five years between 2017 and 2022, the number of enterprises in the Diagnostic & Medical Laboratories industry in the United States increased by 2.3 percent per year on average. There are 29,151 Diagnostic & Medical Laboratories businesses in the US as of 2022, an increase of 2.3% from 2021.
Moreover, Abbott Laboratories (US) gained CE approval for their Panbio Rapid Antigen self-test in June 2021. It aided the company in expanding its reach throughout Europe for COVID-19 testing that was quick and accurate. Therefore, it has increased the demand for IVD quality control products, due to which the North American region is expected to hold the largest market share in the forecast period.
Competitive Landscape
Major key players in the IVD quality control market are Bio-Rad Laboratories Inc ., bioMerieux Inc., F. Hoffmann-La Roche AG, SeraCare Life Sciences Inc., ZeptoMetrix Corporation, Thermo Fisher Scientific, Inc., Quidel Corporation, Grifols, S.A., Bio-Techne Corporation and Streck, Inc.
Comper Healthcare:
Overview:
Bio-Rad Laboratories, Inc. is an American company that continues to produce innovative and useful products in the healthcare industry that assist life science researchers in accelerating the discovery process, and medical diagnostic labs obtain faster, better results. Bio-Rad's life science products essentially include instruments, software, consumables, reagents, and content for the areas of cell biology, gene expression, protein purification, protein quantitation, drug discovery and manufacture, food safety, and science education. These products are based on technologies to separate, purify, identify, analyze, and amplify biological materials such as antibodies, proteins, nucleic acids, cells, and bacteria. Moreover, Bio-Rad's diagnostic products and systems use various technologies and provide clinical information in the blood transfusion, diabetes monitoring, autoimmune, and infectious disease testing markets. These products support the diagnosis, monitoring, and treatment of diseases and other medical conditions. The company has over 8,000 employees and a global network of operations that serves customers' life science research and clinical diagnostics, helping people live longer, healthier lives.
InteliQ Immunology Control: Liquid control available in barcoded, load-and-go tube configuration, designed to monitor the precision of immunology assays. Comprehensive menu of serum proteins, including Rheumatoid Factor.
Why Purchase the Report?
- Visualize the composition of the IVD quality control market segmentation by product and Services, application, end user and region highlighting the key commercial assets and players.
- Identify commercial opportunities in IVD quality control market by analyzing trends and co-development deals.
- Excel data sheet with thousands of data points of IVD quality control market- level 4/5 segmentation.
- PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
- Product mapping in excel for the key product of all major market players
The global IVD quality control market report would provide an access to an approx. 45+market data table, 40+figures and 190 pages.
Target Audience
- Service Providers/ Buyers
- Industry Investors/Investment Bankers
- Education & Research Institutes
- Research Professionals
- Emerging Companies
- Manufacturers