The global in vitro diagnostics quality control market size is expected to reach USD 1.87 billion by 2032, according to a new study by Polaris Market Research. The report “In Vitro Diagnostics Quality Control Market Share, Size, Trends, Industry Analysis Report – By Product & Services, Technology, Manufacturing Type, End User, and Region; Segment Forecast, 2019–2032” gives a detailed insight into the current market dynamics and provides analysis on future market growth.
The increasing demand for in vitro diagnostic (IVD) quality control solutions is driven by the rising healthcare needs of aging populations and the surging prevalence of chronic conditions such as diabetes and cardiovascular diseases. Healthcare systems are under pressure to ensure the accuracy and reliability of diagnostic tests, leading to a high focus on quality control in IVD testing. Strict quality control in IVD helps maintain consistency of diagnostic results, minimize errors, and ensure effective treatments.
In April 2024, the US Food and Drug Administration announced its assistance for developing higher-performing laboratory-manufactured tests by amending IVD devices within the Federal Food, Drug, and Cosmetic Act (FD&C Act), particularly when the producer of these tools is a laboratory.
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The increasing use of healthcare devices to monitor patients’ conditions and provide effective treatments is driving the production of devices such as diagnostic test kits, medical imaging devices, POC diagnostic devices, and others, which creates a strong demand for quality control systems to ensure compliance with government standards. Additionally, the growing innovations from major market players are expected to boost market growth during the forecast period. In January 2024, ELITechGroup launched the GI Bacterial PLUS ELITe MGB Kit, an advanced diagnostic tool targeting major bacterial pathogens responsible for gastrointestinal infections. The CE-IVDR-certified kit is fully validated with their sample-to-result instruments. The company announced its plans to release three additional kits in the future, covering parasitic and viral pathogens, to offer a comprehensive diagnostic solution for gastrointestinal infections.
By Product & Service Outlook (Revenue – USD Billion, 2019–2032)
By Technology Outlook (Revenue – USD Billion, 2019–2032)
By Manufacturing Type Outlook (Revenue – USD Billion, 2019–2032)
By End User Outlook (Revenue – USD Billion, 2019–2032)
By Regional Outlook (Revenue – USD Billion, 2019–2032)
Report Attributes |
Details |
Market Size Value in 2024 |
USD 1.26 billion |
Revenue Forecast by 2032 |
USD 1.87 Billion |
CAGR |
5.1% from 2024 to 2032 |
Base Year |
2023 |
Historical Data |
2019–2022 |
Forecast Period |
2024–2032 |
Quantitative Units |
Revenue in USD billion and CAGR from 2024 to 2032 |
Segments Covered |
By Product & Services By Technology By Manufacturing Type By End User
|
Regional Scope |
North America Europe Asia Pacific Latin America Middle East & Africa |
Competitive Landscape |
In Vitro Diagnostics Quality Control Industry Trend Analysis (2023) Company Profiles/Industry participants profiling includes company overview, financial information, product/service benchmarking, and recent developments |
Report Format |
PDF + Excel |
Customization |
Report customization as per your requirements with respect to countries, regions, and segmentation. |
For Specific Research Requirements |