IVD Quality Control Market is expected to reach USD 2.15 billion by 2030, up from USD 1.65 billion in 2025, growing at a CAGR of 5.5% from 2025 to 2030. 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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Market Dynamics and Drivers
- Technological Advancements: The rapid evolution of diagnostic technologies, including molecular diagnostics, point-of-care testing, and automation, is significantly boosting the demand for high-quality IVD quality controls. These advancements ensure precision, accuracy, and reliability in diagnostic tests, which is crucial for early disease detection and management.
- Rising Prevalence of Chronic Diseases: The increasing incidence of chronic diseases such as diabetes, cardiovascular diseases, and cancer is propelling the growth of the IVD quality control market. Accurate and reliable diagnostics are essential for the effective monitoring and treatment of these conditions, necessitating the use of stringent quality controls.
- Regulatory Requirements: Stringent regulatory frameworks and guidelines set by health authorities such as the FDA and EMA mandate the use of quality controls in diagnostic laboratories. These regulations are designed to ensure the safety and efficacy of diagnostic tests, further driving the market growth.
Segment Analysis
- Product Types: The market is segmented into quality control products and data management solutions. Quality control products, including serum/plasma-based controls, whole blood-based controls, urine-based controls, and other matrix-based controls, dominate the market. These products are essential for verifying the performance of diagnostic assays.
- Application: The IVD quality control market serves various applications such as clinical chemistry, immunoassay, molecular diagnostics, hematology, coagulation, microbiology, and others. Molecular diagnostics is anticipated to witness the fastest growth due to its increasing adoption in detecting infectious diseases and genetic disorders.
- End-Users: Diagnostic laboratories, hospitals, academic and research institutes, and others constitute the end-users of IVD quality controls. Diagnostic laboratories hold the largest market share, driven by the high volume of diagnostic tests conducted and the need for reliable quality control measures
Regional Insights
- North America: North America leads the IVD quality control market owing to the advanced healthcare infrastructure, high adoption rate of innovative diagnostic technologies, and favorable regulatory environment. The presence of major market players in the region further supports market growth.
- Europe: Europe follows North America in market share due to the increasing focus on healthcare quality and patient safety. Countries like Germany, France, and the UK are significant contributors to the regional market.
- Asia-Pacific: The Asia-Pacific region is expected to witness the highest growth rate during the forecast period. Factors such as improving healthcare infrastructure, growing medical tourism, and rising awareness about early disease diagnosis contribute to this growth. China, India, and Japan are key markets in the region.
Key Players and Competitive Landscape
Prominent players in the IVD quality control market include Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Randox Laboratories Ltd., Roche Diagnostics, and Abbott Laboratories, among others. These companies focus on strategic collaborations, mergers and acquisitions, and new product launches to strengthen their market position and expand their product portfolios.
IVD Quality Control Market – Report Highlights
Refinement in the segments of the global IVD Quality Control market:
The current edition of the report consists of an updated market overview, average selling price trends, value chain analysis, Porter’s Five Forces analysis, ecosystem map, pricing analysis, patent analysis, and new industry insights.
The report also consists of the impact of recession on the global IVD Quality Control market.
The competitive landscape chapter has been updated with the market evaluation framework and updated product portfolio matrix. The competitive landscape also includes the revenue share analysis of the top market players and an updated competitive situation and trends section.
Competitive leadership mapping for SMEs/start-ups has also been updated for the IVD Quality Control market.
Updated financial information/product portfolio of players:
The new edition of the report provides updated financial information in the IVD Quality Control market till 2021 for each listed company in a single diagram. This will easily help analyze the present status of profiled companies in terms of their financial strength, profitability, key revenue-generating region/country, business segment focus in terms of the highest revenue-generating segment, and investments in R&D.
Updated market developments of profiled players:
Recent developments are important to understand market trends and the growth strategies adopted by players. The current edition of this report provides updated developments of profiled players from January 2019 to October 2022, indicating a continuation from the previous version. Product launches, expansions, acquisitions, agreements, partnerships, and collaborations have been the principal growth strategies adopted by market players within this period.
Recession Impact:
The impact of recession has been considered in the research methodology and market forecast for the years 2020 and 2021. It has also been analyzed in the product, application, end user and geographic segmentation. The market dynamics have also been updated taking into consideration the current scenario.
Research for this report involved the use of a large number of secondary and primary sources. Secondary sources include directories; databases such as Bloomberg Business, and Factiva; white papers; annual reports; company house documents; investor presentations; and SEC filings of companies. During the primary research process, in-depth interviews were conducted with various primary respondents, which include key opinion leaders, subject matter experts, directors, and C-level executives of distributors and suppliers, to obtain and verify critical qualitative and quantitative information. This primary data was collected mainly through questionnaires, emails, and telephonic interviews.
Conclusion
The IVD quality control market is poised for significant growth, reaching $1.6 billion by 2027. This growth is fueled by technological advancements, increasing chronic disease prevalence, and stringent regulatory requirements. As the market continues to evolve, stakeholders across the healthcare sector must prioritize the integration of advanced quality control measures to ensure accurate and reliable diagnostic outcomes.
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