In Vitro Diagnostics (IVD) Quality Control Market by Source (Plasma, Whole Blood, Urine), Technology (Immunoassay, Hematology, Microbiology, Molecular Diagnostics), Manufacturer (Third-party, OEM), End Users (Hospitals, Lab)- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The global In Vitro Diagnostics (IVD) Quality Control market size was exhibited at USD 1.97 billion in 2022 and is projected to hit around USD 2.89 billion by 2032, growing at a CAGR of 3.90% during the forecast period 2023 to 2032.

The In Vitro Diagnostics (IVD) Quality Control testing plays a significant role in clinical decision-making. Over the years, In Vitro Diagnostics (IVD) Quality Control quality control products and procedures have become mandatory in accredited clinical or medical laboratories. The applications of In Vitro Diagnostics (IVD) Quality Control quality control products have also widened over the years, with a number of quality controls currently available in the market for clinical chemistry, immunochemistry, hematology, molecular diagnostics, coagulation, and microbiology. To ensure technological competitiveness, companies are continuously launching innovative and advanced quality control products in the market for a variety of applications.

The growth of the In Vitro Diagnostics Quality Control Market is primarily driven by the rising number of accredited clinical laboratories, rising geriatric population, rising demand for external quality assessment programs, increasing adoption of and POC instruments in developed regions and increasing adoption of third-party quality controls. The rising focus on multi-analyte controls is also expected to offer significant growth opportunities for the market in the coming years. The use of quality control products is, however, not mandatory for all clinical laboratories in many countries. The lack of regulations for these products is expected to adversely affect market growth.

This research report purposes at stressing the most lucrative growth prospects. The aim of the research report is to provide an inclusive valuation of the In Vitro Diagnostics (IVD) Quality Control market and it encompasses thoughtful visions, actualities, industry-validated market findings, historic data, and prognoses by means of appropriate set of assumptions and practice. Global In Vitro Diagnostics (IVD) Quality Control market report aids in comprehending market structure and dynamics by recognizing and scrutinizing the market sectors and predicted the global market outlook.

In Vitro Diagnostics (IVD) Quality Control Market Report Scope

IVD Quality Control Market Dynamics

Drivers: Growing adoption of third-party quality controls

The IVD quality controls available in the market are manufactured by either IVD instrument manufacturers or independent manufacturers. Independent manufacturers offer two types of quality controls—instrument-specific controls and third-party controls. Among these, third-party controls offer various advantages, such as a reduced need for multiple instrument-specific controls, versatility, longer shelf-life, and utility in long-term QC monitoring.

Innovative multi-analyte, multi-instrument, third-party controls enable laboratories to ensure the accuracy and reliability of multiple testing parameters with a single control, which reduces the time and cost of QC procedures. In addition, technological advancements have resulted in the introduction of multi-analyte and multi-instrument controls, which consolidate multiple instrument-specific controls into a single product—such as Randox Laboratories’ multi-analyte Acusera infectious disease (serology) control, launched in 2019. Moreover, in third-party controls, the same control lot can be used across multiple reagent lots, allowing long-term monitoring of assay performance. Considering these advantages, the adoption of third-party quality controls is increasing in the market. In addition, many regulatory bodies, such as the Clinical and Laboratory Standards Institute (CLSI), the National Association of Testing Authorities, Australia (NATA), the College of American Pathologists (CAP), the Quality Council of India (QCI), and Clinical Laboratory Improvement Amendments (CLIA) recommend the use of third-party quality controls. This trend is expected to support market growth in the coming years.

Restraints: Unfavorable reimbursement scenario for IVD tests

In many countries globally, the reimbursement scenario for IVD tests is largely unfavorable. For instance, in 2019, the Protecting Access to Medicare Act (PAMA) announced significant changes to how Medicare pays for laboratory diagnostic tests. In 2018, reimbursement payments for almost 90% of laboratory tests were lowered. The reimbursement for a rapid molecular flu test intended for use at the point of care was decreased by 18%, from USD 117 in 2017 to USD 96 in 2019. Furthermore, according to the CMS, ~75% of tests showed reductions in the reimbursement rate from January 2017. Some of these are molecular tests, targeted NGS analysis panels of five to fifty genes, and cancer tests. These developments are expected to adversely affect the US molecular and genetic testing market, thereby hindering the growth of the IVD quality control market.

According to MedPAC, medical testing has seen a 40% decline in reimbursement in the past 40 years. This, along with budgetary considerations in hospitals and clinical laboratories, acts as a major obstacle for the implementation of novel diagnostic techniques in clinical laboratories, as the reimbursement for these tests is low.

Opportunities: Rising demand for multi-analyte controls is serving as opportunity in this market

Technological advancements have led to the development of a new range of multi-analyte and multi-instrument controls. These innovative controls consolidate multiple instrument-specific controls into a single control, thereby enabling clinical laboratories to cut costs and greatly reduce the time taken by QC procedures.

Multi-analyte controls in the market for immunoassay testing help laboratories perform QC tests for fifty or more parameters—including cardiac and tumor markers, hormones, therapeutic drugs, kidney functions, and vitamins—in the same serum. In addition, these controls need not be changed with reagent lots and hence support long-term QC monitoring. The increasing preference for these controls is thus expected to offer significant growth opportunities for players in the IVD quality control market.

Challenges: Lack of regulations for clinical laboratory accreditation in several emerging countries

There are no mandatory regulations for clinical laboratory accreditations in many emerging countries across the globe. For instance, the accreditation of clinical laboratories is not mandatory in India. To establish a new medical laboratory in the country, a ‘Shops and Establishment’ license is required. This license does not ensure the incorporation of QC procedures in the laboratory. This means the laboratory can function without any QC mechanism.

In many countries, private organizations and voluntary accreditation bodies regulate QC products. Even though there is no mandatory accreditation, the Indian government has started a voluntary accreditation program through its registered body—the National Accreditation Board for Testing and Calibration Laboratories (NABL). However, laboratories are not opting for such accreditations as this may increase investments to meet the required accreditation standards. Thus, the lack of regulations to make QC mechanisms compulsory for all diagnostic tests, along with non-compliance to existing regulations, is a major challenge to the growth of the IVD quality control market.

Clinical Laboratories is the fastest growing market in by end user segment of the IVD Quality Control Market

Clinical Laboratories is the fastest growing market in by end user segment of the global market. These independent private laboratories conduct complex and specialized tests on samples received for analysis from various small/large hospitals, private practitioners, clinical research sites, and insurance companies. Reference laboratories are equipped with advanced technologies and can carry out more than 80,000 tests daily with higher turnaround times. These laboratories offer various advantages over small- and medium-sized laboratories and hospital laboratories in terms of better and more specialized testing capabilities. The increasing burden of infectious diseases across the globe, which demands larger testing volume capacities, and the growing volume of genetic testing are the key factors driving the growth of this end-user segment. Validated and accurate laboratory testing for SARS-CoV-2 is an important aspect of the timely management of COVID-19, supporting the clinical decision-making process for infection control at the healthcare level and discovering asymptomatic cases.

Independent Controls sub-segment is the fastest growing market in by manufcaturer segment of the IVD Quality Control Market

The independent controls segment accounted for the largest share of the third-party controls market in 2022. This segment is projected to have highest CAGR during the forecast period. The high growth of this segment is mainly attributed to the fact that regulatory bodies recommend these controls. Laboratories recommend the use of third-party controls over those offered by instrument or reagent manufacturers to gain unbiased quality inputs and results. Independent controls help minimize erroneous results reporting and excessive repetition of analytical runs, which reduces costs. The use of independent controls has been seen in the manufacturing of vaccines worldwide amidst the global COVID-19 pandemic. As a condition for regulatory clearance, vaccine manufacturers must conduct a wide range of quality and safety tests on the components used in manufacturing and the final manufactured vaccines, under the scrutiny of regulatory bodies in their respective countries.

Coagulation & Hemostasis sub-segment in by Technology segment of the IVD Quality Control Market Is growing market during the forecast period

Blood coagulation disorders include disorders arising due to the deficiency of blood coagulation factors, such as prothrombin, fibrinogen, calcium factor, and antihemophilic factors. Specific tests are required to diagnose and treat these disorders. Coagulation analyzers and reagents are used to evaluate the coagulation profile of blood samples. They are utilized for clotting-based or chromogenic assays and for diagnosing clotting factor deficiency.

Various tests are performed in coagulation laboratories for the correct diagnosis and safe management of patients with bleeding and thrombotic disorders. A laboratory error may lead to misdiagnosis, resulting in adverse clinical effects. Therefore, adequate quality control procedures are required to ensure accurate and precise patient test results.

Regional analysis:

North America was the largest regional market in 2022 and accounted for a revenue share of 50.9% owing to the presence of the U.S. FDA and many accredited diagnostic laboratories coupled with strong QC regulation systems. U.S. FDA along with GHTF regulates the North America region for the IVD QC market, from the production to pre- and post-marketing surveillance. The Asia Pacific is expected to be the fastest-growing region over the forecast period as the region has a high potential for this market due to the increasing number of product manufacturing companies.

Moreover, the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB) has been encouraging the use of IVDs. Thus, a rise in awareness for early and precise diagnosis fosters the product demand. Also, the presence of key regulatory authorities in the region, such as the Ministry of Health, Labor and Welfare (MHLW), Pharmaceuticals and Medical Devices Evaluation Agency (PMDA), and Ministry of Agriculture and Fisheries and Food, will support the market growth.

Some of the prominent players in the In Vitro Diagnostics (IVD) Quality Control Market include:

Bio-Rad Laboratories, Inc., Randox Laboratories Ltd., Thermo Fisher Scientific, Inc., LGC Limited, and Abbott Laboratories.  Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Fortress Diagnostics, SERO AS, Sysmex Corporation, Ortho-Clinical Diagnostics, Helena Laboratories Corporation, Quidel Corporation, Sun Diagnostics, LLC, Seegene Inc., ZeptoMetrix Corporation, Qnostics, Bio-Techne Corporation, Microbiologics, Microbix Biosystems, Streck, Inc., Alpha-Tec Systems, Maine Molecular Quality Controls, Inc..

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global In Vitro Diagnostics (IVD) Quality Control market.

Global IVD quality control market, by product and service

• Quality control products
  • Serum/ Plasma based controls
  • Whole blood based controls
  • Urine based controls
  • Other controls
• Data Management Solutions
• Quality Assurance Services

Global IVD quality control market, by technology

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

Global IVD quality control market, by manufacturer type

• Third-party controls
  • Independent controls
  • Instrument specific controls
• Original Equipment Manufacturer controls

Global IVD quality control market, by end user

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

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)