Market Definition
The effectiveness of in vitro diagnostic tests, including those for pathogen identification using in vitro nucleic acid testing, healthcare-associated illnesses (HAIs) such as pneumonia, urinary tract infections, and others, is assessed using IVD quality controls.
Market Outlook
The global in vitro diagnostics quality control market was valued at USD 1.5 billion in 2021 and it is anticipated to grow further up to USD 2.2 billion by 2031, at a CAGR of 3.7% during the forecast period.
The effectiveness of in vitro diagnostic tests, including those for pathogen identification using in vitro nucleic acid testing, healthcare-associated illnesses (HAIs) such as pneumonia, urinary tract infections, and others, is assessed using IVD quality controls. These products primarily concentrate on defect detection, quality control, and validation panels like the Blood Culture (BCID) Control Panel, Human Papillomavirus (HPV) Control Panel, and others to support in the implementation and monitoring of the performance of clinical and research laboratories, blood diagnostic centers, and IVD manufacturers.
As the burden of various diseases increases globally, so has the number of laboratory tests. The number of laboratories in both the public and private sectors has increased in response to this need. With the start of the COVID-19 pandemic in December 2019, the demand for diagnostic tests has skyrocketed. Many government organizations have established new laboratories in response to this epidemic and to increase laboratory testing capacity. The majority of nations need clinical laboratories to get regulatory body accreditation before performing diagnostic tests. Additionally, accreditation to ISO 15189:2012 and other comparable standards is turning into a requirement in many nations. Authorities assess a laboratory’s competency and quality system during the accreditation process using predetermined standards. While some European nations, including Belgium, France, Hungary, Ireland, and Lithuania, require accreditation for a variety of laboratory tests, others, like Finland, the Netherlands, Sweden, Switzerland, and the UK, have practically finished the process.
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Research Objectives
- Estimates and forecast the overall market size for the total market, across product, service type, type, end-user, and region
- Detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling
- Identify factors influencing market growth and challenges, opportunities, drivers and restraints
- Identify factors that could limit company participation in identified international markets to help properly calibrate market share expectations and growth rates
- Trace and evaluate key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities
- Thoroughly analyze smaller market segments strategically, focusing on their potential, individual patterns of growth, and impact on the overall market
- To thoroughly outline the competitive landscape within the market, including an assessment of business and corporate strategies, aimed at monitoring and dissecting competitive advancements.
- Identify the primary market participants, based on their business objectives, regional footprint, product offerings, and strategic initiatives
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Global In Vitro Diagnostics Quality Control Market Segmental Overview
The report analyses the global in vitro diagnostics quality control market based on product & service, technology, manufacturer type, end user, and region.
Based on products & services, it is segmented into quality control products, data management solutions, and quality assurance services. The quality control products segment is anticipated to dominate the market during the forecast period. The growth of the segments is primarily attributed to the upsurge in demand for quality controls to validate the accuracy, precision, and reliability of IVD test results.
Based on the technology, it is segmented into immunochemistry, clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation/hemostasis, and other technologies. The immunochemistry segment is anticipated to dominate the market during the forecast period. The increase in geriatric population, the number of accredited clinical laboratories, the adoption of third-party quality controls and POC instruments in developed regions, as well as the rising demand for external quality assessment programs, are the main factors driving the growth of the IVD quality control market.
Based on the manufacturer type, it is segmented into third party controls, and original equipment manufacturer control. The third-party controls segment is anticipated to dominate the market during the forecast period. The key factors such as the rising need for faster and error-free laboratory results coupled with improving laboratory efficiency, and technological advancements in multi-analyte third-party IVD quality controls are the major factors that significantly impacted the development in the market.
Based on the end user, it is segmented into hospitals, clinical laboratories, academic & research institutes, and other end users. The hospitals end user segment dominated the market during the forecast period. The increasing demand for multi-analyte and third-party controls is boosting the growth of the market.
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Major Players in the Global In Vitro Diagnostic Quality Control Market
The key players studied in the global in vitro diagnostic quality control market are Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), Abbott Laboratories (US), Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), and Helena Laboratories Corporation (US) among others.
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Research Scope
- Scope – Highlights, Trends, Insights. Attractiveness, Forecast
- Market Sizing – Product Type, End User, Offering Type, Technology, Region, Country, Others
- Market Dynamics – Market Segmentation, Demand and Supply, Bargaining Power of Buyers and Sellers, Drivers, Restraints, Opportunities, Threat Analysis, Impact Analysis, Porters 5 Forces, Ansoff Analysis, Supply Chain
- Business Framework – Case Studies, Regulatory Landscape, Pricing, Policies and Regulations, New Product Launches. M&As, Recent Developments
- Competitive Landscape – Market Share Analysis, Market Leaders, Emerging Players, Vendor Benchmarking, Developmental Strategy Benchmarking, PESTLE Analysis, Value Chain Analysis
- Company Profiles – Overview, Business Segments, Business Performance, Product Offering, Key Developmental Strategies, SWOT Analysis
- Market Size in 2024 – US$ 1.5 Billion
- Market Size in 2033 – US$ 2.2 Billion
- CAGR – 3.7%
- Historic Period – 2015-2022
- Forecast Period – 2024-2033
- Base Year – 2024
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