IVD Quality Control Market Size, Share, and Growth Analysis, By Product and Service, By Technology, By Manufacturer Type, By End User, By Region - Industry Forecast 2025-2032

Global IVD Quality Control Market size was valued at USD 1.11 billion in 2023 and is poised to grow from USD 1.16 billion in 2024 to USD 1.59 billion by 2032, growing at a CAGR of 4.1% during the forecast period (2025-2032).

The global in vitro diagnostics (IVD) quality control market is experiencing significant growth, driven by factors such as the rising elderly population, an uptick in demand for external quality assessment programs, and the adoption of point-of-care (POC) instruments in developed regions. The increase in infectious diseases, HIV, and cancers necessitates innovative diagnostics for effective treatment and stringent quality monitoring. For instance, as of 2019, approximately 24.5 million individuals were receiving antiretroviral therapy for HIV, highlighting the need for rapid diagnostic systems. Nevertheless, challenges remain, including added burdens on laboratories, unfavorable reimbursement scenarios for IVD tests, and a lack of mandatory accreditation regulations in many emerging markets, which may hinder market progression.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Ivd Quality Control market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Ivd Quality Control Market Segments Analysis

Global IVD Quality Control Market is segmented by Product and Service, Technology, Manufacturer Type, End User and region. Based on Product and Service, the market is segmented into Quality control products, Data Management Solutions and Quality Assurance Services. Based on Technology, the market is segmented into Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation/ Hemostasis and Other Technologies. Based on Manufacturer Type, the market is segmented into Third-party controls and Original Equipment Manufacturer controls. Based on End User, the market is segmented into Hospitals, Clinical Laboratories, Academic and Research Institutes and Other End users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Ivd Quality Control Market

The rise in the prevalence of various diseases has led to an increase in laboratory testing, driving growth in the global IVD quality control market. With the surge in demand for diagnostic testing due to the COVID-19 pandemic that began in December 2019, both public and private laboratories have expanded significantly. Governments around the world have responded by establishing additional laboratories to enhance testing capacity and meet the growing need for accurate diagnostics. This increase in laboratory infrastructure and testing capabilities has been a key factor propelling the market forward, as the demand for reliable quality control in diagnostics continues to escalate.

Restraints in the Global Ivd Quality Control Market

The global IVD quality control market faces significant restraints due to the high costs associated with establishing quality control (QC) procedures in hospitals and clinical laboratories. Implementing effective QC requires both substantial investment and specialized expertise, which can be a barrier, especially for clinical laboratories that operate with low volume QC processes. Additionally, many hospitals and laboratories are constrained by tight budgets, which further hampers the implementation and adoption of these crucial QC procedures. Consequently, these financial and resource challenges can lead to slower growth and limited utilization of quality control systems in the IVD market.

Market Trends of the Global Ivd Quality Control Market

The Global IVD Quality Control market is experiencing significant growth, driven by the rising prevalence of chronic diseases and an increased focus on precision medicine. Medical device companies are investing in the development of innovative, technologically advanced diagnostic devices to enhance testing accuracy and efficiency. Concurrently, hospitals and laboratories are increasingly adopting point-of-care testing solutions, facilitating immediate access to real-time data for better clinical decision-making. This shift towards rapid diagnostics, combined with stringent regulatory standards for quality control, is propelling market expansion. As healthcare's demand for reliability and speed continues to rise, the IVD quality control sector is poised for robust growth.