Meticulous Research^®—a leading market research company, published a research report titled, ‘IVD Quality Control Market Size, Share, Forecast & Trends Analysis by Offering (Product [Serum, Blood], Data Management, Service) Technology (Biochemistry, Molecular, Immunoassay) Application (cardiology, Oncology) End User – Global Forecast to 2031’

According to this latest publication from Meticulous Research^®, the IVD quality control market is growing, but not too fast. It could reach about $2.28 billion by 2031. Growth is estimated around 4.3% per year. That seems reasonable. Chronic diseases are on the rise. People are living longer. More tests are being done in labs. That naturally increases the need for In Vitro Diagnostics (IVD) Quality Controls. Labs are taking Clinical Quality Control more seriously. It is not just about regulations. It is about trust in results. Some labs use third-party quality controls for extra verification. Point-of-Care (POC) tests and rapid diagnostics are also becoming common. Labs need controls they can trust, even when things get busy. Challenges exist, of course. Rules for IVD Quality Control Products can be strict. Smaller labs sometimes struggle. Access to materials is not always easy, especially in some regions. There are opportunities too. Multi-analyte and multi-instrument controls are catching on. They save time and reduce errors. Molecular Quality Control is improving, making labs more accurate even when testing volumes are high. The market isn’t booming overnight. It is steady. Labs need reliable tools. Regulations are tightening. Patients depend on accurate results. Companies that understand these pressures and offer practical, flexible solutions should see steady growth in the coming years.

Key Players

Key companies operating in the IVD quality control market are Seimens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), LGC Group (U.K.), Thermo Fisher Scientific Inc. (U.S.), SERO AS (Norway), Randox Laboratories Ltd. (U.K.), QuidelOrtho Corporation (U.S.), Streck LLC (U.S.), and Microbiologics, Inc. (U.S.), and Bio-Techne Corporation (U.S.)

The IVD quality control market is segmented by Offering (Quality Control Products {Quality Control Products, by Type [Serum/Plasma-based Controls, Whole Blood-based Controls, Urine-based Controls, Other Controls], Quality Control Products, by Function [Independent Controls, Instrument-specific Controls]}, Quality Assessment Services, Data Management Solutions); Technology (Immunoassay/Immunochemistry, Biochemistry/Clinical Chemistry, Molecular Diagnostics, Hematology, Coagulation/Hemostasis, Microbiology, Other Technologies); Application (Infectious Diseases, Oncology, Cardiology, Autoimmune Disorders, Neurology, Other Applications); End User (Hospitals & Clinics, Diagnostic Laboratories, Academic Institutes & Research Laboratories, Other End Users), and Geography. The study also evaluates industry competitors and analyzes the regional and country-level markets.

Among the Offerings: Why Quality Control Products Lead the Market

Looking at the market, quality control products are expected to take the largest share of the IVD quality control market in 2024. Within this segment, serum/plasma-based controls seem to be the most widely used. That makes sense because many diagnostic tests for glucose, cholesterol, electrolytes, liver enzymes, and cardiac markers rely on serum or plasma samples. These controls are practical. They give labs a straightforward way to check if their tests are accurate and precise. It is no surprise that In Vitro Diagnostics (IVD) Quality Controls rely heavily on them. For Clinical Quality Control, serum/plasma-based controls are often the first choice, which is why they hold the largest share of this segment.

Technology Insights: Immunoassay/Immunochemistry Leads the IVD Market

When we look at technologies, the immunoassay/immunochemistry segment seems set to take the largest slice of the IVD quality control market in 2024. That is not too surprising. Immunoassays are specific, sensitive, high-throughput, and relatively cheap. Labs rely on In Vitro Diagnostics (IVD) Quality Controls for these tests to make sure the results are trustworthy. Several factors are helping this segment grow. Point-of-Care (POC) tests and infectious disease testing increasingly use immunoassays. New tests keep being developed, miniaturized devices are appearing more often, and labs are running more immunoassay-based tests overall. All this naturally drives demand for Clinical Quality Control for immunoassays. At the end of the day, immunoassay/immunochemistry technologies are leading the market because they work well, cost less, and are becoming more essential in labs everywhere.

Among Applications: Why Infectious Diseases Dominate IVD Quality Controls

When we look at applications, the infectious diseases segment seems to take the biggest share of the IVD quality control market in 2024. Which is not surprising. HIV, dengue, influenza, pneumonia these diseases are still very common. Then there’s COVID-19, which pushed testing even further. Public health programs are encouraging more testing, so labs need In Vitro Diagnostics (IVD) Quality Controls more than ever. To give an idea, UNAIDS says that in 2021, around 38.4 million people were living with HIV 36.7 million adults and 1.7 million kids under 14. On top of that, 1.5 million new HIV cases were reported globally. With numbers like that, labs cannot afford mistakes. Clinical Quality Control for infectious disease tests is essential. That is why this segment leads the market the need for accurate and reliable testing keeps it in high demand.

Hospitals & Clinics: Leading End Users in the IVD Quality Control Market

Looking at end users, hospitals & clinics are expected to hold the largest share of the IVD quality control market in 2024. This makes sense. Hospitals handle a huge number of diagnostic tests every day, and they face constant pressure from healthcare-associated infections (HAIs). With higher test volumes, the need for In Vitro Diagnostics (IVD) Quality Controls becomes even more important. Several factors explain this dominance. Healthcare spending is rising, and new hospitals and clinics are opening, especially in emerging markets. During the COVID-19 pandemic, the number of hospital admissions surged, and with it came a greater reliance on Clinical Quality Control for COVID-19 testing. Many hospitals quickly adopted reliable test controls to ensure results were accurate under high demand. Overall, the strong presence of hospitals & clinics in diagnostic testing, along with their expansion and investment in reliable IVD Quality Control Products, explains why this segment continues to lead the market.

Regional Outlook: Strong Growth of IVD Quality Controls in Asia-Pacific

By geography, Asia-Pacific looks set to grow the fastest in the IVD quality control market over the next few years. Not surprising, given the region’s size and demand. The In Vitro Diagnostics (IVD) industry there is expanding quickly. Patients in Asia are asking for earlier diagnosis, and the numbers are huge. More hospitals are being built, more accredited labs are opening, and clinical pathology centres keep increasing. On top of that, healthcare spending is going up. Governments are putting more into healthcare systems, and the infrastructure is getting stronger each year. All of this creates a bigger need for reliable testing. Labs cannot run without Clinical Quality Control. The demand for IVD Quality Control Products keeps rising as facilities scale up. Asia-Pacific, with its large patient base and improving systems, is becoming one of the most important regions for growth.

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Key questions answered in the report:

Which key factors are driving growth in the In Vitro Diagnostics (IVD) Quality Controls market?

How are opportunities in Molecular Quality Control and multi-analyte solutions shaping the market?

Why do serum/plasma-based controls hold the largest share among quality control product types?

How do Clinical Quality Control needs differ across various product types?

What advantages make immunoassay/immunochemistry a preferred technology in IVD quality controls?

How is the growing use of Point-of-Care (POC) tests and miniaturized devices impacting technology adoption?

Which end user segment holds the largest share of the IVD quality control market?

Why are hospitals & clinics the leading end users for IVD Quality Control Products?

What factors are driving strong market growth in Asia-Pacific?

How are rising healthcare spending and accredited laboratories shaping the Asia-Pacific IVD quality control market?

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