In Vitro Diagnostics (IVD) Quality Control Market
The global IVD quality control market in terms of revenue was estimated to be worth $1.3 billion in 2022 and is poised to reach $1.6 billion by 2027, growing at a CAGR of 5.4% from 2022 to 2027. The increasing number of accredited clinical laboratories, an ageing population, increased demand for external quality assessment programmes, increased adoption of POC instruments in developed regions, and increased adoption of third-party quality controls are propelling the IVD quality control market forward. However, clinical laboratories are not obliged in many countries to use quality control products. The absence of regulation for these items is projected to stifle market expansion.
IVD Quality Control Market Dynamics
Drivers: Growing adoption of third-party quality controls
IVD quality controls on the market are produced by either IVD instrument manufacturers or independent producers. Quality controls are available from independent manufacturers in two varieties: instrument-specific controls and third-party controls. Third-party controls, in particular, provide several advantages, including reduced need for numerous instrument-specific controls, adaptability, extended shelf life, and value in long-term QC monitoring.
Innovative multi-analyte, multi-instrument and third-party controls allow laboratories to ensure the accuracy and reliability of multiple test parameters with a single control, reducing the time and cost of QC procedures. Additionally, advancements in technology have resulted in the introduction of Multi-Analyte and Multi-Instrument Controls, which combine multiple instrument-specific controls into one product, such as Randox'sAcusera (Serology) Multi-Analyte Infectious Disease Control. Laboratories, launched in 2019. Additionally, in third-party controls, the same control lot can be used on multiple reagent lots, allowing long-term monitoring of test performance. Given these advantages, the adoption of third-party quality controls is increasing in the market. Also, many regulatory bodies, such as Clinical and Laboratory Standards Institute (CLSI), National Association of Testing Authorities, Australia (NATA), College of American Pathologists (CAP), 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 the growth of the market in the coming years.
Restraints: Unfavorable reimbursement scenario for IVD tests
In many countries around the world, the reimbursement scenario for IVD tests is largely unfavorable. For example, in 2019 the Protecting Health Insurance Access Act (PAMA) announced significant changes to how Medicare pays for diagnostic lab tests. In 2018, reimbursement payments for nearly 90% of lab tests were reduced. Reimbursement for a rapid molecular influenza test for use at the point of care decreased by 18% from $117 in 2017 to $96 in 2019. Additionally, according to CMS, ~75% of tests showed reduced reimbursement rates 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 negatively impact the US molecular and genetic testing market, thereby hampering the growth of the IVD quality control market.
Medical test reimbursements have plummeted by 40% in the preceding 40 years, according to MedPAC. This, along with financial constraints in hospitals and clinical labs, represents a significant barrier to introducing novel diagnostic procedures in clinical laboratories, as funding for these tests is insufficient.
Opportunities: Rising demand for multi-analyte controls is serving as opportunity in this market
Advances in technology 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, allowing clinical laboratories to save costs and dramatically reduce the time taken by QC procedures.
Multi-analyte controls in the immunoassay market 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. Additionally, these controls do not need to be changed with reagent lots and therefore support long-term QC monitoring. The growing preference for these controls is therefore expected to provide 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 around the world. For example, accreditation of clinical laboratories is not mandatory in India. To establish a new medical laboratory in the country, a "Stores and Establishments" license is required. This license does not guarantee the incorporation of QC procedures into the laboratory. This means that the lab can operate without any QC mechanism.
In many countries, private organizations and voluntary accreditation bodies regulate QC products. Although there is no compulsory accreditation, the Indian government has launched a voluntary accreditation program through its registered body, the National Accreditation Council for Testing and Calibration Laboratories ( NABL). However, laboratories do not opt ??for such accreditations as it may increase the investment to meet the required accreditation standards. Thus, the absence of regulations making QC mechanisms mandatory for all diagnostic tests, along with non-compliance with existing regulations, is a major challenge for 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 are the fastest growing market by end-user segment in the global market. These independent private laboratories perform complex and specialized tests on samples received for analysis from various small/large hospitals, private practitioners, clinical research sites and insurance companies. Reference labs are equipped with state-of-the-art technology and can perform over 80,000 tests per day with longer turnaround times. These labs offer various advantages over small and medium-sized labs and hospital labs in terms of better and more specialized testing capabilities. The increasing burden of infectious diseases across the world, which demands greater testing volume capabilities, and the increasing volume of genetic testing are the major growth drivers for this end-user segment. Validated and accurate laboratory testing for SARS-CoV-2 is an important aspect of the rapid management of COVID-19, supporting the clinical decision-making process for infection control at the healthcare level and discovering cases asymptomatic.
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 2021. This segment is expected to have the highest CAGR during the forecast period. The strong growth of this segment is mainly attributed to regulatory bodies recommending these controls. Laboratories recommend the use of third-party controls rather than those offered by instrument or reagent manufacturers to achieve unbiased quality inputs and results. Independent controls help minimize misreporting and excessive repeat testing, reducing costs. The use of independent controls has been observed in vaccine manufacturing around the world amid the global COVID-19 pandemic. As a condition of regulatory authorization, vaccine manufacturers must perform a wide range of quality and safety tests on the components used in manufacturing and the final manufactured vaccines, under the supervision of the 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 those caused by a deficiency of blood coagulation factors such prothrombin, fibrinogen, calcium factor, and antihemophilic factors. Specific testing is required to diagnose and treat some ailments. Coagulation analyzers and reagents are used to test the coagulation profile of blood samples. They are employed in coagulation-based or chromogenic diagnostics, as well as in the diagnosis of clotting factor deficiency.
Various tests are performed in coagulation laboratories for proper diagnosis and safe management of patients with bleeding and thrombotic disorders. A laboratory error can lead to misdiagnosis, resulting in adverse clinical effects. Therefore, adequate quality control procedures are necessary to ensure precise and accurate test results for patients.
Coagulation and hemostasis will be a rising market with a 4.5% CAGR throughout the projection period.
North America is expected to account for the largest share of the IVD quality control market in 2021
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), MicrobixBiosystems (Canada), Streck, Inc. (US), Alpha-Tec Systems (US), Maine Molecular Quality Controls, Inc. (US), and Grifols, S.A. (Spain).
The study categorizes the global IVD quality control market into following segments an sub-segments:
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
- 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).