Global In-Vitro Diagnostics Quality Control Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product Type;
Quality Control Products, Data Management Solutions and Quality Assurance Services.By Application;
Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global In-Vitro Diagnostics Quality Control Market (USD Million), 2021 - 2031
In the year 2024, the Global In-Vitro Diagnostics Quality Control Market was valued at USD 1,187.19 million. The size of this market is expected to increase to USD 1,615.60 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 4.5%.
The increase in the number of certified clinical laboratories offering reliable IVD-based diagnostic services is significantly boosting patient confidence and driving market demand. Key pathogens routinely diagnosed using multiplex PCR include HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachomatis (genital infections), G. lambardia, C. parvum (diarrheal diseases), and Leishmania spp. (Leishmaniasis). To ensure the quality and reliability of these diagnostic services, regulatory frameworks are periodically updated, aiming to enhance current standards and safeguard the quality of diagnostic services provided to patients. The high prevalence of diseases such as diabetes, cardiovascular conditions, and infectious diseases has increased the demand for diagnostic laboratories. Both private and public laboratories undergo accreditation procedures to meet industry standards, boost their procedure volume, and attract more patients. As the number of laboratories grows, so does the global demand for IVD Quality Control (QC) products. Laboratories accredited by CLIA can receive reimbursement through Medicare and Medicaid services.
According to the American Clinical Laboratory Association, over 7 billion lab tests are conducted annually in the U.S., with 80% of clinical decisions based on laboratory testing. The International Diabetes Federation (IDF) reported that in 2021, approximately 537 million people worldwide had diabetes, a figure expected to rise to around 643 million by 2030 and 783 million by 2045. The increasing number of diagnostic service providers and the rising demand for clinical diagnostic tests are driving the increased usage of IVD QC products.
Global In-Vitro Diagnostics Quality Control Market Recent Developments
- In November 2023, Merck KGaA launched ChemisTwin to analyze the sample’s purity, identification, and degradation of compounds through calibrated algorithm-based digital references.
- In June 2023, Randox Laboratories Ltd acquired Cellix Limited to expand its market footprint in personalized medicine and improve preventative healthcare.
- In May 2023, ZeptoMetrix launched PROtrol, a new line of quality control products for antigen-based diagnostics methods, such as the lateral flow immunoassay for infectious diseases.
- In March 2023, SeraCare Life Sciences Inc. released Seraseq BRCA1/2 large genomic rearrangements reference materials to meet clinical laboratory testing needs for somatic and germline levels.
- In January 2023, QIAGEN launched the EZ2 Connect MDx IVD platform for automated sampling in diagnostic laboratories.
Segment Analysis
The Global In-Vitro Diagnostics (IVD) Quality Control Market report provides a detailed segmentation by Product Type, Application, and Geography, offering a comprehensive analysis of the market landscape. The segmentation by Product Type includes quality control materials such as serum/plasma-based controls, urine-based controls, data management solutions, and other control types. These products are essential in ensuring the accuracy, reliability, and consistency of in-vitro diagnostic tests, which are critical for accurate disease diagnosis and patient management. By categorizing the market based on these product types, the report highlights the specific roles and applications of each quality control material, helping stakeholders understand their unique benefits and market demands.
Additionally, the segmentation by Application encompasses various clinical areas where IVD quality controls are utilized, such as clinical chemistry, immunoassay, molecular diagnostics, hematology, and microbiology. This detailed breakdown provides insights into how quality control measures are applied across different diagnostic fields, reflecting the diverse needs and standards required for each application. Geographic segmentation further enriches the analysis by examining regional market dynamics, regulatory landscapes, and growth opportunities in key regions like North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. By segmenting the market in this manner, the report offers a holistic view of the Global IVD Quality Control Market, enabling stakeholders to identify trends, opportunities, and strategic areas for investment and development.
Global In-Vitro Diagnostics Quality Control Segment Analysis
In this report, the Global In-Vitro Diagnostics Quality Control Market has been segmented by Product Type, Application and Geography.
Global In-Vitro Diagnostics Quality Control Market, Segmentation by Product Type
The Global In-Vitro Diagnostics Quality Control Market has been segmented by Product Type into Quality Control Products, Data Management Solutions and Quality Assurance Services.
Quality Control Products include a variety of control materials such as serum/plasma-based controls, urine-based controls, and other standardized reagents. These products are vital for validating the accuracy and reliability of diagnostic tests, ensuring that laboratory results are consistent and precise. The use of these controls is essential for routine testing and calibration of diagnostic equipment, which helps maintain high standards of diagnostic accuracy and patient care.
Data Management Solutions represent another crucial segment, focusing on software and systems designed to manage, analyze, and report quality control data. These solutions enable laboratories to track performance trends, detect anomalies, and ensure compliance with regulatory standards. Quality Assurance Services, the third segment, encompasses consulting, training, and auditing services aimed at helping laboratories establish and maintain robust quality management systems. These services ensure that all processes adhere to the highest quality standards, further enhancing the reliability of diagnostic outcomes. By segmenting the market into these categories, the report provides a comprehensive overview of the various tools and services that support quality control in the IVD industry, highlighting their importance in achieving accurate and dependable diagnostic results.
Global In-Vitro Diagnostics Quality Control Market, Segmentation by Application
The Global In-Vitro Diagnostics Quality Control Market has been segmented by Application into Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis and Others. Immunochemistry involves the use of quality control products to ensure the accuracy of tests that detect and measure specific proteins, hormones, and other substances in the blood, which are critical for diagnosing conditions such as autoimmune diseases, infections, and cancer. Hematology focuses on the study and analysis of blood and its components. Quality control in hematology ensures the precision of blood counts, blood cell morphology, and other diagnostic tests crucial for identifying blood disorders like anemia and leukemia.
Molecular Diagnostics is another key application, utilizing quality control measures to verify the accuracy of tests that analyze genetic material. This segment is vital for detecting infectious diseases, genetic disorders, and monitoring disease progression. Coagulation/Hemostasis involves tests that assess the blood's ability to clot, with quality control being essential to ensure the reliability of these tests, which are critical for managing patients with bleeding disorders or those undergoing anticoagulant therapy. The "Others" category encompasses various additional diagnostic fields that utilize quality control measures to maintain the accuracy and reliability of their specific tests. By segmenting the market into these applications, the report provides a detailed understanding of how quality control products and services are utilized across different diagnostic domains, highlighting their importance in ensuring accurate and reliable diagnostic outcomes in diverse clinical settings.
Global In-Vitro Diagnostics Quality Control Market, Segmentation by Geography
In this report, the Global In-Vitro Diagnostics Quality Control Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global In-Vitro Diagnostics Quality Control Market Share (%), by Geographical Region, 2024
North America, with its advanced healthcare infrastructure and high adoption of innovative diagnostic technologies, represents a significant portion of the market. The region's stringent regulatory requirements and emphasis on accuracy in diagnostic testing drive the demand for robust quality control measures. Europe follows closely, with a strong focus on maintaining high standards in healthcare and diagnostics, supported by rigorous regulatory frameworks and a well-established network of diagnostic laboratories.
In the Asia Pacific region, rapid economic growth and increasing investments in healthcare infrastructure are propelling the market forward. The rising prevalence of chronic diseases and infectious diseases necessitates reliable diagnostic testing, thereby boosting the demand for quality control products and services. The Middle East and Africa, while currently experiencing moderate growth, show potential due to increasing healthcare investments and a growing focus on improving diagnostic capabilities. Latin America is also witnessing gradual market growth driven by advancements in healthcare infrastructure and increasing awareness about the importance of accurate diagnostics. By segmenting the market into these geographical regions, the report provides a comprehensive view of regional market dynamics, highlighting the unique opportunities and challenges in each area and offering insights into how stakeholders can strategically navigate and capitalize on these diverse markets.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global In-Vitro Diagnostics Quality Control Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers :
- Increasing demand for accurate and reliable IVD testing
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Stringent regulatory - The Global In-Vitro Diagnostics (IVD) Quality Control Market is significantly influenced by stringent regulatory requirements imposed by health authorities worldwide. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international health organizations mandate rigorous standards for the accuracy, reliability, and consistency of diagnostic tests. These stringent regulations ensure that IVD products, including quality control materials, meet high safety and efficacy standards before they can be approved for clinical use. Compliance with these regulatory requirements is crucial for manufacturers, driving the development and adoption of advanced quality control products and practices to ensure diagnostic accuracy and patient safety.
Additionally, the regulatory landscape necessitates continuous monitoring and validation of diagnostic tests, leading to a sustained demand for quality control solutions. Laboratories and diagnostic centers must adhere to these regulations to maintain accreditation and operational standards, further fueling the market growth for IVD quality control products and services. This regulatory emphasis not only underscores the importance of quality control in the IVD market but also propels innovation and advancements in quality control technologies, ensuring that diagnostic practices keep pace with evolving clinical needs and regulatory expectations. As a result, the market for IVD quality control is expected to continue its growth trajectory, driven by the need for regulatory compliance and the overarching goal of achieving high-quality diagnostic outcomes.
Restraints :
- High initial investment costs
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Reimbursement challenges - The Global In-Vitro Diagnostics (IVD) Quality Control Market faces significant challenges related to reimbursement. One of the primary issues is the variation in reimbursement policies across different regions and countries. Inconsistent reimbursement frameworks can create financial barriers for laboratories and healthcare providers, making it difficult to invest in advanced quality control products and technologies. This inconsistency can lead to disparities in the quality of diagnostic services offered, as some regions may have limited access to state-of-the-art quality control measures due to financial constraints imposed by inadequate reimbursement. Furthermore, complex and stringent reimbursement criteria often require extensive documentation and justification, which can delay the adoption of new quality control technologies and impede innovation in the field.
Additionally, the reimbursement rates for IVD quality control products and services are often not aligned with the actual costs incurred by laboratories. This misalignment can strain laboratory budgets, forcing them to choose between maintaining high-quality standards and managing operational costs. As healthcare systems increasingly emphasize cost containment, the pressure on laboratories to deliver accurate and reliable diagnostic results without adequate financial support becomes more pronounced. Addressing these reimbursement challenges is crucial for ensuring that laboratories can sustain high standards of diagnostic accuracy and reliability, ultimately improving patient outcomes and advancing the overall quality of healthcare. Enhanced collaboration between policymakers, payers, and industry stakeholders is essential to develop fair and supportive reimbursement frameworks that reflect the true value and necessity of quality control in in-vitro diagnostics.
Opportunity :
- Development of new and innovative quality
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Increasing focus on personalized medicine - The Global In-Vitro Diagnostics (IVD) Quality Control Market is witnessing an increasing focus on personalized medicine, which is significantly influencing its growth and development. Personalized medicine involves tailoring medical treatment to the individual characteristics of each patient, often based on genetic, biomarker, phenotypic, or psychosocial characteristics that distinguish one patient from another. As this approach gains traction, the demand for precise and reliable diagnostic tests is surging, necessitating robust quality control measures. Quality control products and services are essential in ensuring that diagnostic tests used in personalized medicine provide accurate and consistent results, which are crucial for making informed decisions about individualized patient care.
This focus on personalized medicine is driving innovation in the IVD quality control market, leading to the development of advanced control materials and data management solutions that can accommodate the complexity and specificity required in personalized diagnostics. Enhanced quality control measures ensure the validity and reliability of diagnostic tests that guide personalized treatment plans, such as those used in pharmacogenomics, targeted therapies, and disease risk assessment. Consequently, the integration of personalized medicine into healthcare is not only enhancing patient outcomes but also propelling the growth of the IVD quality control market, as the need for high-quality, precise, and reliable diagnostic tools becomes increasingly paramount.
- Abbott Laboratories
- Bio-Rad Laboratories Inc
- F. Hoffmann-La Roche AG
- Quidel Corporation
- bioMerieux Inc
- Qnostics Ltd
- Microbiologics Inc
- SeraCare Life Sciences Inc
- Thermo Fisher Scientific
- ZeptoMetrix Corporation
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product Type
- Market Snapshot, By Application
- Market Snapshot, By Region
- Global In-Vitro Diagnostics Quality Control Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing demand for accurate and reliable IVD testing
- Stringent regulatory
- Restraints
- High initial investment costs
- Reimbursement challenges
- Opportunities
- Development of new and innovative quality
- Increasing focus on personalized medicine
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
-
Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global In-Vitro Diagnostics Quality Control Market, By Product Type, 2021 - 2031 (USD Million)
- Quality Control Products
- Data Management Solutions
- Quality Assurance Services
- Global In-Vitro Diagnostics Quality Control Market, By Application, 2021 - 2031 (USD Million)
- Immunochemistry
- Hematology
- Molecular Diagnostics
- Coagulation/Hemostasis
- Others
- Global In-Vitro Diagnostics Quality Control Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global In-Vitro Diagnostics Quality Control Market, By Product Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Abbott Laboratories
- Bio-Rad Laboratories Inc
- F. Hoffmann-La Roche AG
- Quidel Corporation
- bioMerieux Inc
- Qnostics Ltd
- Microbiologics Inc
- SeraCare Life Sciences Inc
- Thermo Fisher Scientific
- ZeptoMetrix Corporation
- Company Profiles
- Analyst Views
- Future Outlook of the Market