IVD Quality Control Market – By Type, By Product, By Application, By Manufacturer Type, By End Use – Global Forecast, 2024 – 2032

IVD Quality Control Market Size

The global IVD quality control market size was valued at USD 1.3 billion in 2023 and is set to register growth at 4.2% CAGR from 2024 to 2032. The growth of this market is primarily driven by the increasing demand for accurate diagnostic testing, advancements in diagnostic technologies, rising demand for point-of-care testing, and stringent regulatory requirements.
 

Another significant growth factor is the rise in healthcare expenditure and improved access to advanced diagnostic tools in emerging markets. As the healthcare industry evolves, the need for precise and reliable diagnostics to guide medical decisions is increasing. This demand directly impacts the need for robust quality control systems to ensure the accuracy and reliability of diagnostic tests. Furthermore, the global prevalence of chronic and infectious diseases has surged, driving the need for continuous and accurate diagnostics. According to the International Diabetes Federation, nearly 537 million adults were diabetic in 2021, highlighting the high disease burden that requires precise diagnostic tools and reliable IVD quality control products.
 

IVD quality control refers to the procedures and measures used to verify the accuracy, precision, and consistency of tests conducted in a controlled laboratory environment (in vitro). These tests are typically performed on biological samples such as blood, urine, or tissue. IVD quality control is crucial for ensuring that diagnostic devices and assays used in clinical laboratories yield reliable results, which are essential for proper diagnosis, treatment, and patient care.
 

IVD Quality Control Market Trends

• Advancements in diagnostic technologies are a significant driver of the market.
   
• For instance, PCR technology is widely used for infectious disease testing, cancer diagnostics, and genetic testing. As the sensitivity and complexity of these tests increase, quality control becomes essential to ensure accuracy, particularly when detecting low-abundance genetic material or pathogens.
   
• Molecular diagnostic technologies such as PCR (polymerase chain reaction) and next-generation sequencing (NGS) have revolutionized disease detection and genetic testing by enabling the identification of specific genetic mutations, pathogens, and biomarkers at the molecular level.
   
• Additionally, advancements in immunoassays, such as multiplex assays, allow for the simultaneous detection of multiple biomarkers from a single sample. This complexity requires higher levels of quality control to ensure the assays perform correctly across all analytes. Advanced immunoassay systems, in particular, demand a wide range of control materials, including multianalyte controls, to verify the accuracy of all detectable markers.
   
• As immunoassays become more complex, quality control products must be capable of validating the performance of assays across various biomarkers and concentrations, further driving the market growth for IVD quality controls.
   

IVD Quality Control Market Analysis

Based on type, the market is segmented into quality control, data management solutions, and quality assurance services. The quality control segment dominated the market in 2023 and accounted for USD 859.6 million.
 

• Variations in measurements, materials, and conditions can significantly impact the performance of IVD assays. Identifying and addressing the factors that affect clinical reliability and accuracy is crucial for analytical validation.
   
• Quality control plays a vital role in monitoring and evaluating diagnostic tests and equipment to ensure they meet established standards and deliver accurate results. This is essential for ensuring patient safety, achieving regulatory compliance, and maintaining the credibility of diagnostic laboratories, which drives the growth of the market.
   
• The increasing incidence of chronic conditions like heart disease, hypertension, and lifestyle-related disorders has led to a surge in demand for IVD tests, further boosting the need for quality control products. For example, according to CDC data, nearly 702,880 people died due to heart conditions in the U.S. in 2022. This high disease burden elevates the demand for IVD testing, making quality control measures essential to ensure accurate test results, thus stimulating market growth.
   

Based on product, the IVD quality control market is segmented into control, calibrators, calibration verifiers, and other products. The control segment dominated the market in 2023 with a market share of 50.6%.
 

• Controls refer to standardized materials or samples used to validate the accuracy, precision, and reliability of diagnostic tests. These are essential for ensuring consistent performance of diagnostic assays and producing reliable results.
   
• Increasing expenditure on in vitro diagnostic (IVD) testing procedures is driving revenue growth in the control segment. For instance, capital expenditure on IVD testing amounted to about USD 23.4 per capita. Such significant capital spending reflects the high demand for IVD controls.
   
• Technological advancements in control materials are expected to accelerate their demand over the forecast period. The development of innovative control materials, such as synthetic controls or those derived from recombinant DNA technology, is driving market growth by offering more accurate and stable quality control options.
   

Based on application, the IVD quality control market is segmented into immunoassay, clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation and hemostasis, and other applications. The immunoassay segment dominated the market in 2023 and is expected to witness growth at a CAGR of 4.4%.
 

• Immunoassays hold a significant market share due to their effectiveness in early disease diagnosis, which is crucial for improving patient outcomes.
   
• Additionally, the rising incidence of chronic diseases, coupled with technological advancements in immunoassay technology, is fueling demand and positively impacting the market.
   
• For instance, according to the Pan American Health Organization, non-communicable diseases cause nearly 41 million deaths per year, accounting for 71% of global deaths. This underscores the high disease burden, driving the need for precise and reliable diagnostic tests that require quality control to ensure accuracy, further expanding the industry.
   

Based on manufacturer type, the IVD quality control market is segmented into third party controls and original equipment manufacturer controls. The third party controls segment is anticipated to reach USD 1.3 billion by 2032.
 

• Laboratories are increasingly focusing on continuous quality improvement and risk management. Third-party controls provide an independent measure of assay performance, helping to identify areas for improvement. As the global market for diagnostic testing expands, the demand for standardized quality control materials usable across international markets is growing.
   
• In laboratories utilizing diagnostic instruments and assays from multiple manufacturers, third-party controls offer a uniform approach to quality control, simplifying performance monitoring across different devices and platforms. These factors are expected to drive the demand for third-party controls in the coming years.
   

Based on end use, the IVD quality control market is segmented into hospitals, clinical laboratories, academic institutes & research institutes, and other end users. The clinical laboratories segment is anticipated to reach USD 839.5 million by 2032.
 

• Stringent regulations from agencies like the FDA, along with international standards such as ISO 15189, mandate that clinical labs adopt robust quality control processes, driving the demand for IVD quality control solutions.
   
• Furthermore, the need to ensure accurate and reliable diagnostic results is crucial for patient safety. Quality control helps identify errors, reduce variability, and ensure test result reliability, boosting its adoption in clinical laboratories. For instance, according to the CDC’s Division of Laboratory Systems (DLS), nearly 70% of medical decisions are based on laboratory test results, underscoring the importance of precise testing for patient care. These factors will drive the growth of this segment in the coming years.
   

North America dominated the global IVD quality control market in 2023 with a revenue of USD 493.2 million and is anticipated to reach USD 697.6 million by 2032.
 

• The region's dominance is largely attributed to the expanding elderly population, which has higher diagnostic testing needs due to age-related conditions, fueling demand for IVD quality control products. According to the U.S. Census Bureau, approximately 4.4 million people in the U.S. will be over the age of 65 in 2024, highlighting the significant need for diagnostic testing and, consequently, IVD quality controls.
   
• High patient awareness and access to advanced diagnostic options also contribute to North America's leading position in the global market.
   

The U.S. IVD quality control market was valued at USD 444.5 million in 2023.
 

• The country’s advanced healthcare infrastructure, high prevalence of chronic diseases, and strong emphasis on accurate disease diagnosis play a key role in its market leadership.
   
• Additionally, substantial investments in healthcare infrastructure and laboratory modernization further increase the need for advanced quality control systems, ensuring high standards in new and upgraded facilities.
   
• These factors combined make the U.S. a dominant player in the market, driving market growth and technological advancements.
   

Germany is expected to witness robust growth of 4.2% in the global IVD quality control market.
 

• A heightened focus on diagnostic accuracy and reliability in Germany, led by regulatory bodies and healthcare providers, has created a significant demand for quality control measures.
   
• Furthermore, the increasing incidence of infectious diseases, including emerging and re-emerging pathogens, drives the need for reliable diagnostic tests and robust quality control.
   
• According to the Robert Koch Institute, nearly 4,076 cases of tuberculosis were reported in Germany in 2022, illustrating the disease burden and the corresponding demand for IVD quality control products.
   

Asia Pacific region is anticipated to witness high growth in IVD quality control market, growing at a CAGR of 4.6% over the analysis years.
 

• Many countries in the region are heavily investing in healthcare infrastructure, leading to the establishment of new diagnostic labs and modernization of existing ones, thereby requiring the adoption of quality control measures to ensure reliable diagnostics.
   
• For instance, China’s healthcare spending has been rising. According to the National Institutes of Health, China's healthcare expenditure was 6.5% of GDP in 2021.
   
• The Asia-Pacific region, especially countries like Thailand, India, and Malaysia, is also a hub for medical tourism. According to Statista, nearly 3 million foreign patients are expected to visit Thailand in 2024. This drives the need for high-quality and reliable diagnostic services, thereby increasing the adoption of IVD quality controls and fueling market growth.
   

IVD Quality Control Market Share

The competitive landscape in the market is dynamic and highly competitive. Major players, such as Bio-Rad Laboratories, Thermo Fisher Scientific, and F. Hoffmann-La Roche Ltd. hold a significant share due to their robust R&D capabilities, extensive distribution networks, and a broad product portfolio. However, smaller, niche players are emerging, offering specialized quality control solutions, which increases competition. Additionally, these market participants are actively engaged in strategic collaborations, partnerships, mergers, etc., to maintain their position in the market, capture the highest market share, and outperform the competition.
 

For instance, in March 2021, Bio-Rad Laboratories, Inc. announced a global partnership with F. Hoffmann-La Roche AG. This collaboration granted customers access to Bio-Rad Laboratories, Inc.'s extensive InteliQ product lineup and Unity QC data management solutions, complemented by training and support services.
 

IVD Quality Control Market Companies

Prominent players operating in the IVD quality control industry include:

• Abbott
• Agilent Technologies
• Becton, Dickinson and Company
• Bio-Rad Laboratories
• Bio-Techne Corporation
• Danaher Corporation
• F. Hoffmann-La Roche
• Helena Laboratories Corporation
• Hologic
• Merck
• QIAGEN
• QuidelOrtho Corporation
• Randox Laboratories
• Siemens Healthineers
• Sysmex Corporation
• Technopath Manufacturing
• Thermo Fisher Scientific
   

IVD Quality Control Industry News:

• In March 2024, Bio-Techne Corporation announced that its subsidiary Asuragen, part of Bio-Techne's molecular diagnostics division, had successfully obtained Class C Certification under the European Union's new In Vitro Diagnostic Regulation (IVDR) for the QuantideX qPCR BCR-ABL IS kit. This certification boosted the product's credibility and marketability in the EU and underscored the company's dedication to delivering top-tier diagnostic solutions that adhere to rigorous regulatory standards, further solidifying its foothold in the molecular diagnostics arena.
   

The IVD quality control market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Type

• Quality control
  • Serum/plasma-based controls
  • Whole blood-based controls
  • Urine-based controls
  • Other quality controls 
• Data management solutions
  • Laboratory information management systems (LIMS)
  • Standalone software
• Quality assurance services

Market, By Product

• Control
  • Total protein
  • Albumin
  • Blood urea nitrogen
  • Uric acid
  • Creatinine
  • Sodium
  • Potassium
  • Chloride
  • Calcium
  • Magnesium
  • Aspartate transaminase
  • Creatine kinase
  • Gamma glutamyl transferase
  • Total bilirubin
  • Other controls 
• Calibrators
• Calibration verifiers
• Other products

Market, By Application

• Immunoassay
• Clinical chemistry
  • Electrolytes and minerals
  • Renal function
  • Liver function
  • Proteins and enzymes
  • Cardiac markers
  • Other clinical chemistry applications 
• Molecular diagnostics
  • Nucleic acid amplification tests
  • DNA sequencing
  • Genetic testing
  • Other molecular diagnostic applications
• Microbiology
• Hematology
• Coagulation and hemostasis
• Other applications

Market, By Manufacturer Type

• Third party controls
  • Independent controls
  • Instrument specific controls 
• Original equipment manufacturer controls

Market, By End Use

• Hospitals
• Clinical laboratories
• Academic and research institutes
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE