Industry Outlook

The global in-vitro diagnostics quality control market expected to grow at compound annual growth rate (CAGR) of 3.9% during the forecast period from 2025 to 2033. In-vitro diagnostics quality control are tests to validate the efficacy and reliability of the in-vitro diagnostic systems and ensure its accuracy and evaluate the impact of environmental conditions and other things that can affect the test results. Erroneous in-vitro diagnostic testing systems have significant side-effects on the patients. Moreover, it can delay in diagnosis and may also result in improper treatment leading to long-term complications and additional healthcare cost. Moreover, failure to identify the pathogen especially during an outbreak can delay in determining the true cause and thereby lead to inaccurate measures for the same. Poor diagnostic quality also leads to poor patient outcomes, increased mortality and morbidity posing a barrier in public health interventions. Growing usage of in-vitro diagnostic testing for various diseases such as infectious diseases, cardiovascular disorders and oncology testing is the major driver for the growth of in-vitro diagnostics quality control market. Moreover, growing inclination towards personalized medicine and molecular diagnostic to explore knowledge and treatment for rare diseases are boosting use of in-vitro diagnostics, thereby growing the market for in-vitro diagnostics quality control market. 

Quality Controls Segment Accounted for the Largest Share by Product Type  

The in-vitro diagnostics quality control market is segmented in to quality controls, data management solutions, and quality assurance services. In 2021, quality controls segment held the largest share in the market owing to high demand of these products for validating the accuracy and precision of the in-vitro diagnostic tests. Quality control is an important aspect in the clinical and laboratory based testing to ensure safety and accuracy as per standards set by Food and Drug Administration (FDA), European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) and Clinical Laboratory Improvement Amendments (CLIA).

The key players currently engaged in In-vitro diagnostics quality control market include Siemens Healthineers, Thermo Fisher Scientific, Inc., Roche Diagnostics, Bio-Rad Laboratories, Inc., Abbott Laboratories, Inc., Seracare Life Sciences, Inc., Sysmex Corporation, Helena Laboratories, Sun Diagnostics, LLC among others.

Historical & Forecast Period

This study report represents analysis of each segment from 2023 to 2033 considering 2024 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2025 to 2033.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of In-Vitro Diagnostics Quality Control market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the In-Vitro Diagnostics Quality Control market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of In-Vitro Diagnostics Quality Control market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2033.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the In-Vitro Diagnostics Quality Control market?
• Which is the largest regional market for In-Vitro Diagnostics Quality Control market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving In-Vitro Diagnostics Quality Control market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the In-Vitro Diagnostics Quality Control market worldwide?