In Vitro Diagnostics (IVD) Quality Control Market Size, Share, Growth, and Industry Analysis, By Type (Plasma-based Control, Serum-based Control & Whole Blood-based Control), By Application (Immunochemistry, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation & Microbiology), and Regional Forecast to 2035

IN VITRO DIAGNOSTICS (IVD) QUALITY CONTROL MARKET OVERVIEW

The global In Vitro Diagnostics (IVD) Quality Control Market size estimated at USD 1368.23 million in 2026 and is projected to reach USD 1563.62 million by 2035, growing at a CAGR of 4.55% from 2026 to 2035.

The In Vitro Diagnostics (IVD) Quality Control market is all about enhancing the quality and efficiency of tests carried out of the body, which is used in settings such as commercial laboratories, hospitals, and POC facilities. Growth in the industries, advancement in technology, growth in the incidence of chronic illnesses, the growth in the population, and a resultant increase in demand for health care are some factors that promote growth in this sector, driven by the high-quality requirements and standards that are inevitable in a health care organization sector. The telemedicine market is growing at a fast pace as more entities penetrate the remote healthcare sector to offer accessible medical consultations, monitoring, and treatment through the internet. These are fueled by growth in mobile health solutions, use of the internet, evolution of virtual healthcare among other consumers and producers.

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KEY FINDINGS

• Market Size and Growth: The In Vitro Diagnostics (IVD) Quality Control Market size was USD 1251.73 Million in 2024, is projected to grow to USD 1287.25 Million by 2025 and exceed USD 1430.48 Million by 2033, with a CAGR of 4.55%.

• Key Market Driver: Rising global disease burden is driving more frequent diagnostic testing—over 70% of medical decisions now rely on laboratory test results, putting IVD quality control in the spotlight.

• Major Market Restraint: High setup and operational costs limit smaller diagnostic labs from implementing advanced quality controls; calibration kits alone can cost over $2,500 annually per device.

• Emerging Trends: Labs are leaning into third-party quality control solutions—more than 35% of North American labs now use multi-instrument compatible controls to streamline operations and reduce waste.

• Regional Leadership: North America leads the market with over 40% of global consumption, largely due to stringent CLIA and CAP accreditation requirements in the U.S.

• Competitive Landscape: Around 20+ key players actively compete in the space, with Bio-Rad Laboratories, Randox, and Thermo Fisher collectively holding over 50% of the global market share.

• Market Segmentation: Based on product type, the report notes that quality control materials dominate the market, accounting for a significant share of overall demand compared to data management solutions and services.

• Recent Development: In 2023, Bio-Rad introduced a next-gen liquid control system compatible with over 50 test platforms, aiming to reduce error rates by up to 15% in clinical workflows.

COVID-19 IMPACT

"In Vitro Diagnostics (IVD) Quality Control Industry Had a Positive Effect Due to Market demand during COVID-19 Pandemic"

The Global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The In Vitro Diagnostics (IVD) Quality Control Market has received a major push during the COVID-19 period as testing needs have increased around the world. Higher frequency to test the virus detection and monitor resulted in better investing in quality control systems to enhance test standards, which fueled market growth. The pandemic underscored the importance of safeguarding IVD quality control and boosted the pace of change and technological implementation all around the world in laboratories and clinics.

LATEST TREND

"AI-driven analytics propel market growth by enhancing diagnostic speed and accuracy"

The current development areas in the IVD Quality Control Market comprise automation, big data, and information technology, particularly AI in testing precision and speed. Among these, the AI-indented analytics appear to be giving forecasts and minimizing errors by machine learning that are revolutionizing how the laboratories observe and control the quality. The following trend contributes to the development of faster and more accurate diagnostics, which is increasingly in demand.

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IN VITRO DIAGNOSTICS (IVD) QUALITY CONTROL MARKET SEGMENTATION

By Type

Based on Type, the global market can be categorized into Plasma-based Control, Serum-based Control & Whole Blood-based Control

• Plasma-based Control Plasma-based controls are important for the validation of numerous diagnostic assays, with an emphasis on coagulation and immunoassay. Such controls are from human plasma to closely represent the patient samples so as to improve the real test outcomes. The need for plasma-based controls is increasing due to increased disease surveillance and management.

• Serum-based Control Serum-based controls serve a great purpose in practicing laboratories to check the performance of IVDs, particularly for biochemical and immunological tests. These controls are from human serum, which gives a constant background to emulate the fluctuations in the patient samples to ensure efficiency of the test. Thus, such complex diagnostic methods as multiplex as well as Creation of New Lines place high demands on the serum-based controls that prove their relevance to the processes of quality control.

• Whole Blood-Based Control Whole blood-based controls are important in the quality assurance of tests done on cell constituents that include whole blood counts and blood gases. These controls are intended to mimic the variability of blood and give laboratories a realistic ideal of the precision of their tests. The rise of point of care and rapid diagnostics indicates the importance of whole blood-based controls in a clinical environment.

By Application

Based on Application, the global market can be categorized into Immunochemistry, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation & Microbiology

• Immunochemistry The use of antibodies and antigens in immunochemical procedures is required in the diagnosis of various diseases; hence, its use is applicable in the IVD Quality Control Market. Mentioned control measures in immunochemistry are aimed at increasing the reproducibility and specificity of tests like ELISA or immunofluorescence. The increase in autoimmune diseases and infections is the primary reason for this high requirement for immunochemistry quality control standards.

• Hematology In the haematology segment, quality control is essential in the determination of absolute and relative blood cell counts and differential for the diagnosis of diseases like anaemia and leukaemia. Hematology quality control aids in the verification of the results of either the automated analysers or the manual methods used widely in laboratories. Hematology Quality Control as a demand for a broad range of blood testing has grown steadily.

• Clinical Chemistry Clinical chemistry includes testing blood and body fluids for metabolic and organ function, which must have good precision and accuracy. This segment applies quality controls to confirm the correctness of glucose, electrolyte, and enzyme checks to safeguard a patient and initiate proper treatment. Because the prevalence of chronic illnesses is escalating, the need for accurate clinical chemistry quality controls increases.

• Molecular Diagnostics Molecular diagnostics is based on sophisticated methods of detection of genetic material, pathogens, and biomarkers and therefore requires quality control. Hurdles in quality management guarantee accuracy in molecular diagnostic assays, PCR, and next-generation sequencing or assays that are crucial in identifying infectious diseases as well as genetic disorders. The enhancement of molecular diagnostic quality controls is rapid as the demand increases for personalized medicine and fast diagnoses.

• Coagulation Coagulation tests are of paramount importance when determining the blood coagulation processes in any patient, especially in cases where such a patient is on anticoagulation or with bleeding disorders. Quality control in this application assures the efficiency of tests that measure the prothrombin time (PT) and activated partial thromboplastic in time (aPTT) in the management of patients. The growing population in patients with thromboembolic states stimulates the need for a coagulation QC method.

• Microbiology A quality control is critical to the microbiology segment to identify the pathogen and resistance to an antimicrobial agent in an infection control process. QC in microbiology is applied for specific culture techniques and other faster methods to provide accurate final reports for further management. In the case of resistance to antibiotics, the need for good microbiology quality control is on the increase.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factors

"Rising chronic diseases drive investment in quality control, boosting market growth"

Coupled with chronic diseases like diabetes, cardiovascular problems, and the normal infectious diseases, there is a need for medical diagnosis technologies. This demand leads to investment in quality control mechanisms needed to produce accurate results, thus promoting the IVD quality control market growth.

"Technological advancements in automation and digitalization drive market growth"

Discontinuous improvements include technological advancements in automation and use of digital platforms in the testing process, hence supporting quality control. These advancements enable laboratories to attain the required measures to meet regulatory requirements and also help in increased testing volumes, propelling the market in the process.

Restraining Factor

"High costs of advanced systems slow market growth despite demand"

The implementation and maintenance of sophisticated and high-technology quality control systems may be expensive and beyond the reach of several, especially the developing healthcare facilities and labs. This factor in particular somewhat hinders the degree of penetration since it brings about a slow rate of growth in the overall market despite augmentioning demand for better diagnostic capabilities.

Opportunity

"Rising point-of-care testing drives market growth and quality"

Increased adoption of point-of-care testing as a means of diagnosis in clinics, chemist shops, and others makes a promising growth opportunity for the IVD quality control market. And as this market grows with the need for quick, definitive results, so does the drive towards the creation of higher-quality quality assurance measures, the importance of which would also increase as more people have a personal stake in ensuring that the customer gets what they paid for.

Challenge

"Strict regulations hinder innovation and slow market growth progression"

In Vitro Diagnostics (IVD) Quality Control Market faces the major issue of compliance with sundry and stringent regulations today. Compliance requires constant changes, strict validation, and costs, placing constraints within the product availability rate of development, dwarfing accessibility for small-scale providers. He noted that such regulations suffocate innovation and also stifle the market’s progress most of the time.

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IN VITRO DIAGNOSTICS (IVD) QUALITY CONTROL MARKET REGIONAL INSIGHTS

North America

In Vitro Diagnostics (IVD) Quality Control Market is most developed in North America because of its highly elevated facilities in the field of healthcare and splendid investment in R&D, along with high demand among users for reliable diagnostic solutions. Among all the countries, the United State In Vitro Diagnostics (IVD) Quality Control Market dominates the growth because of increased laboratory facilities and a sound regulatory environment for the reliability of testing. Growing adoption of advanced technologies in the United States and the increased emphasis toward technological development enhance market growth across the North American region.

Europe

Europe holds a strong market share in the terms of IVD quality control market share due to the strong health care sector and concern for regulation in the region. It has many top IVD manufacturers and research institutes within the area, which create new technologies and ideas. Moreover, measures aimed at enhancing the healthcare sector and the rising growth rate of the aging population increase the demand for more accurate diagnostic devices, which will strengthen Europe’s position in the global IVD quality control market.

Asia

Asia has the opportunity to contribute to the In Vitro Diagnostics (IVD) Quality Control Market through economic development, increasing expenditure on healthcare services, and getting more attention to precise diagnosis. Currently, there is an increasing demand for IVD products in the region relating to the increasing numbers of people and the increasing incidence of chronic diseases. Moreover, if local manufacturers continue to appear and enter into partnerships with global players, the availability and pricing of quality control solutions will improve significantly and fuel market growth across Asia.

KEY INDUSTRY PLAYERS

"Global leaders drive market growth through innovation and compliance investments"

Global market leaders are defining the pathways of the In Vitro Diagnostics (IVD) Quality Control Market through innovations, collaborations, and the release of innovative quality control products. He makes points that ensuring broken market demands means improving product accuracy and efficiency through investing in research and development. Measures to accomplish compliance with regulations and increasing distribution channels also consolidate their position and promote market development.

List of Top in Vitro Diagnostics (IVD) Quality Control Companies

• Quidel Corp. (U.S)
• Bio-Techne (U.S)
• Alere, Inc. (U.S)
• Qiagen N.V. (Netherland)
• Bio-Rad Laboratories, Inc. (U.S)

KEY INDUSTRY DEVELOPMENT

October 2024, the new product for Roche Diagnostics was introduced COV2T Quality Control Kit, whose purpose is to optimize the SARS-CoV-2 testing. The quality control solutions in this kit contribute to improved quality assurance procedures critical in laboratories diagnosing COVID-19. This development shows how Roche continues to ensure IVD quality control to address continued global health concerns in the future.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential Applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

This research report examines the segmentation of the market by using both quantitative and qualitative methods to provide a thorough analysis that also evaluates the influence of strategic and financial perspectives on the market. Additionally, the report's regional assessments consider the dominant supply and demand forces that impact market growth. The competitive landscape is detailed meticulously, including shares of significant market competitors. The report incorporates unconventional research techniques, methodologies and key strategies tailored for the anticipated frame of time. Overall, it offers valuable and comprehensive insights into the market dynamics professionally and understandably.