IVD Quality Control Market

In Vitro Diagnostics Quality Control Market Size, Share & Trends

The global In Vitro Diagnostics (IVD) quality control market was valued at $1.3 billion in 2022 and is projected to reach $1.6 billion by 2027, growing at a CAGR of 5.4%. Key drivers include the increasing adoption of third-party quality controls and the rising demand for multi-analyte controls. However, the market faces challenges due to unfavorable reimbursement scenarios and a lack of mandatory regulations for quality control in many countries. Notable players in the market include Bio-Rad Laboratories, Randox Laboratories, Thermo Fisher Scientific, and Abbott Laboratories. Regional growth is led by North America, and the market is segmented by product types, technology, manufacturer types, end users, and regions.

The growth of the 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 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 the market growth.

IVD Quality Control Market Trends

To know about the assumptions considered for the study, Request for Free Sample Report

IVD Quality Control Market Dynamics

Driver: 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.

Restraint: 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 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.

Opportunity: 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 market.

Challenge: 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 market.

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

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

The independent controls segment accounted for the largest share of the IVD Quality Control Market in 2021. 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 Industry 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.

The coagulation and hemostasis segment will be a growing market with 4.5% CAGR in the forecasted period

North America is expected to account for the largest share of the IVD quality control Industry in 2021

To know about the assumptions considered for the study, download the pdf brochure

The prominent players in the market include Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US). Other prominent payers in the market include Roche Diagnostics (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), Fortress Diagnostics (UK), SERO AS (US), Sysmex Corporation (Japan), Ortho-Clinical Diagnostics (US), Helena Laboratories Corporation (US), Quidel Corporation (US), Sun Diagnostics, LLC (US), Seegene Inc. (South Korea), ZeptoMetrix Corporation (US), Qnostics (UK), Bio-Techne Corporation (US), Microbiologics (US), Microbix Biosystems (Canada), Streck, Inc. (US), Alpha-Tec Systems (US), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain).

Scope of the In Vitro Diagnostics (IVD) Quality Control Market Report

The study categorizes the global In Vitro Diagnostics (IVD) quality control market to forecast revenue and analyze trends in each of the following submarkets:

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

By Technology

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

By Manufacturer Type

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

By End User

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

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

Recent Developments of IVD Quality Control Industry:

• In November 2022, Bio Rad Laboratories, Inc. made an agreement with Abbott Laboratories (US), to expand their portfolio of independent quality controls (QC) products, including Inteliq and liquichek compact vials, for the Abbott alinity ci-series integrated clinical chemistry and immunoassay testing instruments
• In October 2022, Thermo Fisher Scientific, Inc. (US) acquired The Binding Site Group (UK). The acquisition will enhance the specialty diagnostic segment of Thermo Fisher Scientific.
• In August 2021, Zeptometrix Corporation (US) announced the immediate availability of its ready-to-use NATSARS(COV2)-ERC for laboratory QC and test validation
• In July 2021, Quidel Corporation (US) received the CE Mark for its innovative Savanna multiplex molecular analyzer and Savanna RVP4 Assay (Respiratory Viral Panel-4).

Frequently Asked Questions (FAQ):

To speak to our analyst for a discussion on the above findings, click Speak to Analyst