Insights and Projections: IVD Quality Control Market to Cross $1.6 Billion by 2027

The global IVD quality control market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% from 2022 to 2027

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 according to a new report by MarketsandMarkets™. The growth of the IVD quality control market is driven by the rising number of accredited clinical laboratories, rising geriatric population and subsequent growth in the prevalence of chronic and infectious diseases and increasing adoption of third-party quality controls. The rising focus on multi-analyte controls and Increasing investments from government bodies and private players in healthcare sectors in emerging economies is also expected to offer significant growth opportunities for the market in the coming years. Lack of regulations for clinical laboratory accreditation in several emerging countries could be the challenges faced by the market in upcoming years.

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IVD Quality Control products are used by clinical laboratories, hospitals, and other healthcare facilities to ensure the reliability of test results. These products include control materials, calibrators, and proficiency testing samples that are specifically designed to mimic patient samples with known values.

Key factors driving the IVD Quality Control market growth include:

Increasing Demand for Accurate Diagnostic Tests: As the need for accurate and reliable diagnostic testing continues to rise, the demand for IVD Quality Control products also increases.

Advancements in IVD Technology: Technological advancements in the IVD industry have led to the development of more sophisticated and automated testing systems.

Growing Awareness of Patient Safety: Healthcare providers and regulatory authorities worldwide have recognized the importance of patient safety in diagnostic testing.

Rising Regulatory Compliance Requirements: Stringent regulatory requirements imposed by government agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), necessitate comprehensive quality control procedures in diagnostic testing.

Increasing Global Health Expenditure: As healthcare spending continues to rise across the globe, clinical laboratories and healthcare facilities are investing in advanced technologies and quality control systems to deliver accurate and efficient diagnostic services.

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IVD Quality Control Market Dynamics:


  • 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
  • Increasing adoption of POC instruments in developed regions


  • Additional costs and budget constraints in hospitals and laboratories
  • Unfavorable reimbursement scenario for IVD tests


  • Rising demand for multi-analyte controls


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

North America to dominate the global IVD quality control market

North America dominated the global IVD quality control market. Approvals of quality control products from the FDA and the College of American Pathologists (CAP) and the presence of leading companies in the US are driving the IVD quality control market in North America. US dominated the North America IVD quality control market. In the coming years, the increasing number of IVD tests; the growing need to ensure the accuracy, reliability, and reproducibility of test results; and the use of third-party quality controls among clinical laboratories in this region will play a key role in the market growth.

Key Market Players:

Some of the key 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).

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