In Vitro Diagnostics Quality Control Market is growing rapidly as an industry due to 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.

Currently, In Vitro Diagnostics Quality Control Market is growing at a Compound Annual Growth Rate (CAGR) of 5.3 % to reach USD 1.4 billion by 2026. 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 the market growth.

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Growth Drivers

• Increasing number of accredited clinical laboratories
• Growing adoption of third-party quality controls
• Rising demand for external quality assessment support
• Rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases

Growth Opportunities

• Rising demand for multi-analyte controls

Challenges

• Stringent product approval process
• Lack of regulations for clinical laboratory accreditation in several emerging countries

Trends

• Lyophilized/freeze-dried Controls
• Trends On Analyte Source: Human Vs. Animal Origin
• Consolidation of Laboratories

The prominent players operating in the In Vitro Diagnostics Quality Control Market are

Bio-Rad Laboratories, Inc. (US), Randox Laboratories Ltd. (UK), Thermo Fisher Scientific, Inc. (US), LGC Limited (UK), and Abbott Laboratories (US).

Bio-Rad Laboratories, Inc. holds the leading position in the IVD quality control market. The company provides innovative quality control products and services. It also offers a range of third-party quality controls, data management solutions, and external quality assurance services for hospital laboratories, reference laboratories, transfusion laboratories, and physician office laboratories. Under its leading brands, such as Lyphochek and Liquichek, the company offers various IVD quality controls to customers globally. The company is expected to sustain its leading market position in the coming years owing to its strong product portfolio, geographic presence, and brand name in the global market. Its market leadership can also be attributed to its strong distribution and subsidiary network across the globe, enabling it to serve customers in North America, Europe, and the Asia Pacific. Bio-Rad Laboratories has direct distribution channels in over 35 countries outside the US through subsidiaries, and they focus on sales, customer service, and product distribution.

Thermo Fisher Scientific, Inc. holds the second position in the global IVD quality control market. The company is a leading provider of IVD quality control products and services. The company offers a robust portfolio of quality controls for clinical chemistry, molecular control, microbiology, serology, serum toxicology testing, specimen validity testing, and therapeutic drug monitoring (TDM). With its strong geographic presence and wide distribution networks, the company has established itself as a leader in the global IVD quality control market. To sustain its leading position and further increase its share in the market, the company focuses on organic and inorganic growth strategies.

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North America is expected to account for the largest share

• Recommendations for and approvals of quality control products from the FDA and the College of American Pathologists (CAP)
• Presence of well-established distribution channels and leading companies in the US are driving the IVD quality control market in North America

Recent Developments

• 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).
• In June 2021, LGC SeraCare (US) expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex SARS-CoV-2 Variant Panel 1.
• In June 2021, Abbott Laboratories (US) received CE mark for its Panbio Rapid Antigen self-test. It helped the company expand its reach throughout Europe for fast, reliable COVID-19 testing