The IVD Quality Control Market Will Register a CAGR of 4.3% During the Forecast Period to Reach $2.19 Billion by 2030, Says Meticulous Research. IVD quality controls, also known as in vitro diagnostic (IVD) quality controls, are materials or samples used to assess the performance and accuracy of in vitro diagnostic tests. These controls are an essential component of the quality assurance process in clinical Laboratories and point-of-care testing settings. These are also utilized for External Quality Assessment (EQA) programs. In EQA, samples are distributed by external proficiency testing programs to laboratories. These blind samples are used to evaluate the laboratory’s performance in comparison to other facilities. By using appropriate quality controls, clinical laboratories can ensure the reliability and accuracy of their diagnostic tests, leading to better patient outcomes and enhanced overall laboratory performance.

The rising prevalence of chronic diseases, coupled with the increasing geriatric population, growing demand for third-party quality controls, need for internal and external quality assessment reports, increasing number of clinical laboratories, and growing demand for Point-of-Care (POC) and rapid Diagnostics are the driving factors for the market. Moreover, growing demand for multi-analyte and multi-instrument controls is expected to create growth opportunities for the market.

Here are the top 10 companies operating in the IVD Quality Control Market

Siemens Healthineers AG (Germany)

Founded in 1847 and headquartered in Erlangen, Germany, Siemens Healthineers AG is a provider of healthcare solutions and services. The company operates through four segments: Imaging, Diagnostics, Varian, and Advanced Therapies. The IVD quality control products are offered under the Diagnostics business segment.

The company has a direct presence in over 70 countries, with its main manufacturing sites in the U.S., China, and Germany. The company produces, develops, and sells various therapeutic and diagnostic services and products to healthcare providers in over 180 countries.

Some of the subsidiaries of the company are Siemens Healthcare Diagnostics Products GmbH, Marburg (Germany), Siemens Healthcare Diagnostics GmbH (Austria), Siemens Healthcare Diagnostics Ltd (U.K.), and Siemens Healthcare Diagnostics Manufacturing Limited (Ireland).

Bio-Rad Laboratories, Inc. (U.S.)

Founded in 1952 and headquartered in California, U.S., Bio-Rad Laboratories, Inc. is engaged in developing, manufacturing, and marketing products for life science research and clinical diagnosis. The company offers products and solutions that separate, purify, identify, analyze, and amplify biological materials, such as cells, bacteria, antibodies, proteins, and nucleic acids.

Bio-Rad Laboratories operates through two business segments: Life Science and Clinical Diagnostics. The Clinical Diagnostics segment develops, manufactures, sells, and services automated test systems, informatics systems, test kits, and specialized quality controls for the healthcare market.

Bio-Rad Laboratories has direct distribution channels in over 35 countries outside the U.S. through its subsidiaries. Some of its subsidiaries are Bio-Rad (Shanghai), Life Science Research & Development Co., Ltd. (China), and Bio-Rad Laboratórios Brasil Ltda. (Brazil), BioRad Laboratories S.r.l. (Italy), and Bio-Rad Laboratories AG (Switzerland).

Danaher Corporation (U.S.)

Founded in 1969 and headquartered in Washington, D.C., U.S., Danaher designs, manufactures, and markets professional, medical, industrial, and commercial products and services. The company operates through four reportable business segments: Biotechnology, Life Sciences, Diagnostics, and Environmental & Applied Solutions. The Diagnostics segment offers IVD quality control products. The Diagnostics segment offers various analytical instruments, reagents, consumables, software, and services that help diagnose disease, make crucial treatment decisions, and serve hospitals, physicians’ offices, reference laboratories, and other critical care settings.

The company has a geographical presence in over 60 countries. Besides the U.S., the company has a significant presence in China, Denmark, Germany, Singapore, Sweden, Switzerland, and the U.K. Furthermore, manufacturing facilities of the Diagnostics segment are located in North America, Europe, Asia, and Australia.

Some of its subsidiaries are Cepheid AB (Sweden), Cepheid Europe SAS (France), Cepheid GmbH (Germany), Cepheid UK Ltd., Radiometer K.K (Japan), Radiometer Medical Equipment (Shanghai) Co. Ltd. (China), and HemoCue AB (Sweden).

LGC Group (U.K.)

Founded in 1842 and headquartered in England, U.K., LGC is a leading provider of products in various market segments, including biotech and pharmaceuticals, clinical diagnostics, food & beverage, environment, and aquaculture. The company has nine business segments: Reference Materials and Analytical Standards, Oligonucleotides, Clinical Diagnostics, PCR Components and Solutions, Supply Chain Assurance, National Laboratories and Science, Drug Development Services, NGS Components and Solutions, and Others. The company offers IVD quality control products through the Clinical Diagnostics segment.

The Maine Standards Company (U.S.), SeraCare (U.S.), and Technopath Clinical Diagnostics (Ireland) are part of LGC that provides IVD quality controls.

Thermo Fisher Scientific Inc. (U.S.)

Founded in 2006 and headquartered in Massachusetts, U.S., Thermo Fisher Scientific offers a wide range of healthcare technologies, software, and services. The company operates through four reportable business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Biopharma Services. The company operates in the IVD quality control market through its Specialty Diagnostics segment. The Specialty Diagnostics segment offers various diagnostic test kits, reagents, instruments, culture media, and associated products used in healthcare, clinical, pharmaceutical, industrial, and food safety laboratories.

Thermo Fisher has a geographical presence in approximately 50 countries outside the U.S. The company has major manufacturing and distribution facilities in the U.S., Australia, Canada, China, Denmark, Finland, France, Germany, Japan, Singapore, Sweden, and the U.K. Furthermore, it serves more than 400,000 end customers, including pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research & academic institutions, and government firms.

Meticulous Research in its latest publication on IVD Quality Control Market has predicted the growth of 4.3% during the forecast year 2023-2030.

Randox Laboratories Ltd. (U.K.)

Founded in 1982 and headquartered in Northern Ireland, U.K., Randox Laboratories Ltd. is a prominent company in the field of in-vitro diagnostics. The company operates through multiple business segments, which include Chemistry Analyzers, Toxicology, Molecular Diagnostics, Food Diagnostics, Reagents, Quality Control, Point-of-Care, Testing Services, Immunoassay Analyzers, and Health. The company offers IVD quality controls through the Quality Control segment. The company also offers customized quality controls.

Through Randox Health clinics, the company offers a range of health checks across general health, sexual health, and respiratory health. The company’s products and services cater to a diverse range of end users, including hospitals, clinics, research and molecular laboratories, food testing facilities, forensic toxicology laboratories, life sciences institutions, and veterinary laboratories.

Randox Laboratories has offices and distributors in over 145 countries worldwide. The company’s products are supplied to over 100,000 end users. Furthermore, Randox Laboratories has approximately 3,300 employees, including 650 research scientists and engineers. The company is certified by ISO 13845:2016, ISO/IEC 17025:2017, and ISO/IEC 17043:2010.

QuidelOrtho Corporation (U.S.)

Founded in 1979 and headquartered in California, U.S., QuidelOrtho Corporation develops and manufactures diagnostic solutions. The company operates through four business segments: Labs, Molecular Diagnostics, Point of Care, and Transfusion Medicine. The IVD quality control products are offered under the Labs segment.

QuidelOrtho Corporation directly sells its products to end users through a direct sales force channel and a network of distributors. The company has a geographical presence in more than 130 countries, with manufacturing facilities located in the U.S. and U.K. As of January 2023, the company had approximately 7,000 employees, among which approximately 4,200 employees were located in the U.S. and approximately 2,800 outside the U.S.

Some of the subsidiaries of QuidelOrtho Corporation are Ortho-Clinical Diagnostics France SAS (France), Quidel Ireland Limited (Ireland), and Ortho-Clinical Diagnostics K.K. (Japan).

Microbiologics, Inc. (U.S.)

Founded in 1971 and headquartered in Minnesota, U.S., Microbiologics provides biological control materials, assay services, and consulting for microbiology, molecular diagnostics, and virology markets. The products are served for clinical, education, cannabis, food safety, medical devices, nutraceutical/dietary supplements, personal care/cosmetics, pharmaceutical, research, and water and environmental industries. The company’s Proficiency Solutions division provides custom microbiological controls for large ISO-certified proficiency testing facilities. The company is certified by ISO 13485:2016, ISO/IEC 17025:2017, and ISO 17034:2016.

Microbiologics, Inc. has an indirect presence through distributors in countries such as Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Mexico, Japan, Israel, India, Singapore, and Sweden. Its products are sold in more than 150 countries. The company employs more than 200 people.

Streck LLC (U.S.)

Founded in 1971 and headquartered in Nebraska, U.S., Streck provides quality control and diagnostic products in hematology, immunology, molecular diagnostics, infectious diseases, and urinalysis for clinical and research laboratories. The company holds over 120 patents on more than 20 products. The testing and reagent materials are provided to instrument manufacturers such as Abbott Laboratories (U.S.), Siemens AG (Germany), and Sysmex Corporation (Japan). The company is MDSAP/ISO 13485:2016 certified.

The company has production facilities in La Vista, Nebraska. Its products are manufactured and delivered to over 13,000 labs in 65 countries worldwide. The company has international distributors in Argentina, Belgium, Brazil, Canada, Denmark, France, India, Japan, Malaysia, Mexico, Poland, Saudi Arabia, and other countries.

SERO AS (Norway)

Founded in 1963 and headquartered in Billingstad, Norway, SERO AS is a biotechnology company that manufactures quality control materials for laboratories. These quality control materials cover immunoassay, clinical chemistry, lipids, hormones, proteins, tumor markers, cardiac markers, diabetes, trace elements, and drugs. These quality controls are independent control products. The company also customizes control materials for IVD companies. The company is ISO 9001/ISO 13485 certified.

SERO AS exports more than 90% of its products to more than 60 countries worldwide with the help of independent distributors. The company has distributors in Australia, Austria, Belgium, Bulgaria, Chile, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hong Kong, Hungary, Ireland, Italy, Jordan, Korea, Luxembourg, the Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, the U.K., and the U.S.

Authoritative Research on the IVD Quality Control Market – Global Opportunity Analysis and Industry Forecast (2023-2030)

Need more information? Meticulous Research®’s new report covers each of these companies in much more detail, providing analysis on the following:

• Recent financial performance
• Key products
• Significant company strategies
• Partnerships and acquisitions

The Comprehensive report provides global market size estimates, market share analysis, revenue numbers, and coverage of key issues and trends.