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. 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.
Market Outlook
The in vitro diagnostics (IVD) quality control market, valued at $1.5 billion in 2021, is projected to reach $2.2 billion by 2031, growing at a 3.7% CAGR. IVD quality controls are crucial for assessing diagnostic tests, especially for pathogens and healthcare-associated infections like pneumonia and UTIs. These controls support clinical labs, diagnostic centers, and IVD manufacturers through defect detection and validation. Key market developments include Zeptometrix's NAT SARS-ERC for lab QC, Quidel’s CE-marked Savanna multiplex analyzers, LGS Sera Care’s SARS-CoV-2 variant panels, and Abbott's Panbio Rapid Antigen self-test expansion in Europe.
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.
It costs a lot of money to set up a QC process in a clinical laboratory. Additionally, laboratories must keep a specialized staff on hand to oversee the QC system. Moreover, regardless of the number of tests conducted, QC procedures are expensive. As a result, QC methods are particularly expensive to adopt for clinical laboratories that perform few diagnostic tests. This is predicted to lead to a lesser adoption of QC procedures, along with budgetary restrictions in many hospitals and laboratories in developed and emerging nations.
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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
Recent Developments
August 2021, Zeptometrix Corporation announced the immediate availability of its ready to use NAT SARS-ERC for laboratory QC and test validation.
July 2021, Quidel Corporation received the CE Marke for its innovative Savanna multiplex molecular analyzers and Savanaa RVP4 Assay.
June 2021, LGS Sera Care expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex SARS-CoV-2 variant panel 1.
June 2021, Abbott Laboratories received CE mark for its Panbio Rapid Antigen self-test. It helped the company expand its reach throughput Europe for fast, reliable COVID-19 testing.
Major Players
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.
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
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