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

IVD Quality Control Market Size

The global IVD quality control market size in 2023 was valued at USD 1.3 billion and is set to register growth at 4.2% CAGR over the forecast years. The increasing need for diagnostic testing, innovation in diagnostic tools, the growing need for point-of-care testing and strict regulations are the major factors contributing to the growth of this market.
 

The increase in healthcare expenditure and the widening access to modern diagnostic tools in emerging economies are other significant factors propelling business growth. With changes in the healthcare sector, there is an increasing volume of healthcare decisions that need to be supported with reliable and valid diagnostics. There is a correlation with this demand with the necessity for effective quality assurance strategies to be in place for the test results that are produced.
 

In addition, the prevalence of chronic and infectious diseases around the world has increased massively which has contributed to the need for sustained and reliable diagnostics. In 2021, for example, this global diabetes epidemic meant that 537 million adults living worldwide were classed as diabetic according to the statistic compiled by International Diabetes Federation that showed a large health burden with the need for effective IVD products and control of quality.
 

Further, IVD quality control encompasses the set of activities and processes designed to assess the reliability, validity, and reproducibility of tests completed outside a living organism (in vitro) and within a controlled environment. Such tests are usually conducted on biological tissues such as blood, urine or tissues. The assurance of diagnostic devices and assays in the clinical setting is an essential requirement to ensure sound diagnosis, appropriate treatment and excellent patient management.
 

IVD Quality Control Market Trends

• The market is greatly influenced by the growth of newer diagnostic methods.
   
• For instance, infectious disease, cancer, and genetic testing is done using PCR technology. The mass and sensitivity of such tests relatively increases and so does the necessity for quality control to guarantee their precision especially when the genetic information or pathogen in question is present in small quantities.
   
• PCR (polymerase chain reaction) and next-generation sequencing (NGS) are molecular diagnostic technologies that have changed the disease identification and genetic testing paradigm by allowing targeting specific genetic mutations, pathogens, and biomarkers at the molecular level.
   
• Certainly, in relation to this, it is worth noting that there is a trend toward improvement of immunoassays, for example, multiplex assays that can detect several biomarkers from a single sample. This biological system becomes complex and requires an increase in quality control measures to ensure that the assays are correctly distributed across all analytes. Especially in case of advanced immunoassay systems, a variety of control materials including multianalyte controls are required to check the accuracy of all assayable markers.
   
• As immunoassays become increasingly sophisticated, the demand for quality control products must also expand to ensure that they can assess the effectiveness of assays across multiple markers and concentrations of 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 such as measurements, materials and conditions are detrimental to the performance of IVD assays. It is also essential to recognize and correct the issues that impact the clinical reliability and accuracy of the IVD assays for the purpose of analytical validation.
   
• The safety of the patient, as well as the regulatory requirements, and even the integrity of the diagnostic laboratories, highly depend on the effective growth and control of the market. This is because these factors enable the provision of appropriate equipment that would guarantee the safety of a patient, accuracy and reliability of the diagnostic tests performed. Hence, it's clear that these factors are essential for the market growth.
   
• It is estimated that in the USA only, the number of people who died from heart disease in the year 2022 reached 702,880. With better telecommunications across the globe, IVD tests from India and China have started augmenting the need for quality control products due to the growing rate of chronic diseases like heart disease, obesity and hypertension.
   
• Such a high rate of disease burden recommends a considerable amount of IVD tests, necessitating a sound quality control system to be in place which would go on to motivate the 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 or standard materials form part of the diagnostic procedures relative to other sample types and their reliability in terms of tests performed to examine their performance. These are a requirement for the smooth functioning of diagnostic assays and are integral for the performance of reliable diagnostic tests.
   
• The control segment has recorded growth in revenue as a result of an increase in the spending level for the expenditure incurred in beginning in vitro diagnostic (IVD) testing procedures. For example, there was a spending of up to 23.4 USD on IVD tests per person, which is a significant spending amount and goes to highlight the fact that there is a lot of need for spending on IVD controls.
   
• The control materials technological advancement is projected to increase the growth rate during the forecast period. There has been a smooth introduction of control materials which use synthetic or even recombinant DNA Technology as resources because they offer more control options in their process.
   

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%.
 

• Because of the effectiveness to diagnose early disease conditions, which in turn is a crucial component in ensuring the patients have better outcomes, the market for immunoassays has been such a big share of the market.
   
• Moreover, chronic disease cases are on the rise and as immunoassay technology becomes more advanced the demand increases and this in turn helps the market on IVD quality control.
   
• For instance, it is estimated that non-communicable diseases account for 71% out of 41 million deaths globally in a year. This has been reported to the Pan American Health Organization. It further highlights the burden of disease, which creates a market for more precise and reliable diagnostic tests that are subject to quality control to ensure accuracy, and so the industry continues to grow.
   

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.
 

• A third-party control provides some element of independence to an assay performance so as to determine some issues that may require attention. As the global market for diagnostic testing expands, the need for universal quality control materials for the international markets also expands.
   
• In laboratories that use diagnostic instruments from different vendors, third-party controls enable an international standard for quality assurance which eases the evaluation of performance between different instruments and platforms. These factors are expected to foster the growth of third-party controls in the near future.
   

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

• The IVD quality control solutions output has been positively impacted due to the robust quality control systems that have had to be implemented as a result of regulatory body requirements such as the FDA or ISO 15189.
   
• Also, the control of quality ensures that errors are detected, variability is diminished, and the test results do have reliability which in turn improves the uptake of clinical labs.
   
• To illustrate, almost seventy percent of laboratory test results have the ability to drive medical decisions in people according to CDC's DLS thus highlighting the significance of accurate lab tests in quality medical care. The above discussed factors will enhance the growth for this specific segment throughout the years to come.

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

• High incidence of chronic diseases, availability of better healthcare systems, and the focus on better diagnosis of diseases together enable the country to have a better standing in the market.
   
• Further, large investments made toward improvement of healthcare systems and modernization of laboratories does enhance the demand for sophisticated quality control systems, which ensures that there are very high standards in new and upgraded facilities.
   
• All these factors put together allow the U.S. to be a leader in market, which facilitates growth of the market and improvement in technology.
   

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

• The healthcare providers in Germany, alongside the regulatory bodies, have been stressing the diagnostic reliability and accuracy, which has led to an increased demand for quality control processes.
   
• There has also been an increasing need for reliable diagnostic tests and robust quality control due to the rise in the incidences of infectious diseases around the globe.
   
• Further, 4,076 cases of spinal tuberculosis were documented by the German authorities in 2022; this data was cited by the Robert Koch Institute and sheds light on the nowadays demand for DVI quality control products and the disease burden. Germany, for one, has the potential to profit significantly from the DVI devices and proteins market mushroom, especially with its 2022 IVD quality control agenda in view. Until that, and barring regulatory constraints, the profitability of the German market is limited.
   

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.
 

• A healthcare expenditure of 6.5% out of the GDP was recorded for China over 2021, indicated by National health institutes.
   
• The concept of medical tourism is common in the Asia-Pacific region, especially in Thailand, India, and Malaysia. As per a report by Statista, the number of medical tourists visiting Thailand is expected to reach around three million in the year 2024. This, in turn, increases the demand for high quality and dependable diagnostics, thus increasing the utilization of IVD quality controls, consequently growing the market.
   

IVD Quality Control Market Share

The competitive landscape of the market is ever-changing and cut-throat with competition. Competitors such as Bio-Rad Laboratories, Thermo Fisher Scientific, and F. Hoffmann La Roche Ltd, due to their strong R&D investments, wide distribution channels, and large number of novel products, have a large chunk of the market. However, new niche players with a more specific aim of providing quality control management solutions are beginning to flood the marketplace, which increases competition.
 

Also, these players in the market engage in strategic cooperation, alliances, acquisitions, etc., to enhance their presence in the market to gain maximum share and beat the competition. For example, in March 2021, Bio-Rad Laboratories, Inc. announced a partnership agreement with F. Hoffmann-La Roche AG for InteliQ Products. This allowed clients and customers of Bio-Rad Laboratories, Inc. to engage with a website that offers extensive support for a wide range of their products.
 

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
   

• Abbott, equipped with an extensive network across the globe and the strongest commitment to research and development, Abbott guarantees the same level of durable performance with the same level of quality assurance all over the clinical laboratories of the world.
   
• Bio-Rad is famous for its concentration on accuracy as well as on monitoring steps in real-time and enhancing a lab's effectiveness and accurate clinical results.
   
• Thermo Fisher offers powerful IVD QC products such as MAS Quality Controls for a wide variety of diagnostic assays, which are designed to consistently perform within a specified range.
   

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 and 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