In Vitro Diagnostics Quality Control Market Size Worth $1.87 Billion By 2032 | CAGR: 5.1%

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.

In Vitro Diagnostics Quality Control Market Report Highlights

• The quality control products segment is expected to experience the highest growth during the forecast period, driven by increasing government policies promoting the availability of safety tools.
• The third-party control segment dominates the IVD quality control market due to a wide range of diagnostic instruments from various manufacturers, providing flexibility and compatibility for laboratories using different types of analyzers.
• In 2023, North America held the largest share of the in vitro diagnostics quality control market due to its highly developed healthcare infrastructure, which includes numerous hospitals, clinical laboratories, and research institutions.
• The APAC market is expected to experience the fastest growth during the forecast period due to the increasing expansion activities of market players.
• A few global players include Abbott Laboratories; Alpha-Tec Systems; Bio-Rad Laboratories; Bio-Techne Danaher; Fortress Diagnostics; and Grifols.

Polaris Market Research has segmented the in vitro diagnostics quality control market report on the basis of product & services, technology, manufacturing type, end user, and region:

By Product & Service Outlook (Revenue – USD Billion, 2019–2032)

• Quality Control Products
  • Serum/ Plasma Based Controls
  • Whole Blood Based Controls
  • Urine Based Controls
  • Other Controls
• Data Management Solutions
• Quality Assurance Services

By Technology Outlook (Revenue – USD Billion, 2019–2032)

• Immunochemistry
• Clinical Chemistry
• Molecular Diagnostics
• Microbiology
• Hematology
• Coagulation/ Hemostasis
• Other Technologies

By Manufacturing Type Outlook (Revenue – USD Billion, 2019–2032)

• Third-Party Controls
  • Independent Controls
  • Instrument Specific Controls
• Original Equipment Manufacturer Controls

   By End User Outlook (Revenue – USD Billion, 2019–2032)

• Hospitals
• Clinical Laboratories
• Academic and Research Institutes
• Other End Users

   By Regional Outlook (Revenue – USD Billion, 2019–2032)

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Indonesia
  • Malaysia
• Latin America
  • Argentina
  • Brazil
  • Mexico
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Israel
  • South Africa

In Vitro Diagnostics Quality Control Market Report Scope