In Vitro Diagnostics (IVD) Quality Control Market Size, Share, Growth, and Industry Analysis, By Types (Quality Controls, Whole Blood-based Controls, Serum/Plasma-based Controls, Urine-based Controls, Other IVD Quality Controls, Data Management Solutions, Quality Assurance Services), By Applications Covered (Hospitals, Laboratory, Research Institutes and Academics, Others) and Regional Insights and Forecast to 2034

In Vitro Diagnostics (IVD) Quality Control Market Size

The Global In Vitro Diagnostics (IVD) Quality Control Market size was USD 1310.95 million in 2024 and is projected to reach USD 1369.42 million in 2025, expanding to USD 2028.09 million by 2034, exhibiting a CAGR of 4.46% during the forecast period from 2025 to 2034. The Global In Vitro Diagnostics (IVD) Quality Control Market is witnessing growing demand due to the rise in clinical diagnostic testing, increased automation in laboratories, and stricter regulatory requirements. More than 61% of laboratories globally now use third-party quality controls to meet accreditation standards. Molecular diagnostics accounts for over 29% of the total IVD quality control market, reflecting a growing reliance on precise, real-time data.

The US Market contributes significantly to the Global In Vitro Diagnostics (IVD) Quality Control Market, accounting for approximately 37% of the global demand. Nearly 48% of clinical laboratories in the US have integrated multiplex control systems to meet CLIA and CAP guidelines, driving consistent quality assurance across complex test platforms.

Key Findings

• Market Size: Valued at 1369.42M in 2025, expected to reach 2028.09M by 2034, growing at a CAGR Of 4.46%.
• Growth Drivers: 72% labs using multi-analyte QC, 56% performing monthly assessments, 49% use molecular controls for assay accuracy.
• Trends: 42% product launches in multi-analyte kits, 31% automation-ready controls, 18% in digital QC integration.
• Key Players: Bio-Rad Laboratories, Roche Diagnostics, Technopath Clinical Diagnostics, Seracare Life Sciences, Randox Laboratories
• Regional Insights: Asia-Pacific holds 36% market share driven by diagnostic expansion, North America 29% due to automation, Europe 25% from regulatory compliance, and Middle East & Africa 10% via lab modernization.
• Challenges: 44% labs cite cost as barrier, 36% face shelf-life and transport issues, 29% report system integration challenges.
• Industry Impact: 38% investment in molecular QC, 27% in automation platforms, 19% labs standardizing controls across all analyzers.
• Recent Developments: 34% in consolidated QC panels, 31% in dried spot kits, 24% in real-time data-linked QC platforms.

The In Vitro Diagnostics (IVD) Quality Control Market plays a crucial role in ensuring the accuracy, consistency, and reliability of laboratory testing across diagnostic labs and hospitals. Quality control products are essential for identifying errors in analytical processes, calibration issues, or reagent problems, preventing misdiagnoses and ensuring patient safety. Third-party quality control providers now support 64% of test volume in independent labs, enabling unbiased performance benchmarking.

The market includes a wide range of quality control types, including liquid, lyophilized, and molecular controls, tailored to meet the requirements of various testing platforms such as immunoassays, hematology, clinical chemistry, and nucleic acid amplification tests. Among these, liquid-based quality control products make up nearly 52% of total usage due to their ease of use and longer shelf life. The demand for molecular quality controls is rising, contributing 21% of the total segment, primarily used in infectious disease testing and oncology diagnostics.

Automation and digital control platforms are also reshaping the market, with 33% of labs integrating software-linked control tracking systems to ensure compliance. Manufacturers are increasingly developing customizable controls to align with multiplex testing formats. With increased pressure on labs to deliver accurate results under time-sensitive conditions, the In Vitro Diagnostics (IVD) Quality Control Market is positioned as a critical enabler of diagnostic excellence.

In Vitro Diagnostics (IVD) Quality Control Market Trends

The In Vitro Diagnostics (IVD) Quality Control Market is being driven by major technological and clinical trends. One key trend is the widespread adoption of third-party controls, now used by 67% of laboratories to validate accuracy across multiple platforms. Additionally, multi-analyte control products have gained popularity, contributing to 34% of the total control kits in circulation due to their cost efficiency and versatility in diverse testing environments.

Another significant trend is the rise in molecular diagnostics quality control, which has increased by 27% in use among high-throughput laboratories focused on infectious disease detection and genetic analysis. Digital quality management systems are also transforming the market, with 31% of clinical laboratories implementing automated software to manage quality control tracking and documentation. In point-of-care testing environments, quality control adherence has risen by 22%, prompted by greater regulation and the need for immediate data verification. Furthermore, demand for personalized diagnostic controls is growing, especially in oncology, where 19% of labs now use patient-specific molecular QC materials. The trend toward precision medicine and lab standardization is fundamentally redefining how quality control is integrated into diagnostic workflows globally.

In Vitro Diagnostics (IVD) Quality Control Market Dynamics

DRIVERS

Rising demand for clinical accuracy in diagnostic testing

Increasing demand for diagnostic precision is driving greater adoption of IVD quality controls. Nearly 72% of laboratories globally now use multi-analyte quality control kits to reduce variability in results. In molecular diagnostics, over 49% of labs report regular use of third-party controls to enhance assay standardization. Regulatory compliance has become a key factor, with 56% of accredited labs undergoing monthly external quality assessments to validate their test performance and ensure result accuracy. Hospitals and private labs alike are prioritizing error reduction, boosting reliance on automated QC systems by 34% year-over-year.

OPPORTUNITY

Expansion of molecular and point-of-care diagnostics

The growing footprint of molecular diagnostics and decentralized testing is creating significant opportunity in the IVD quality control market. Approximately 26% of global diagnostic labs have incorporated PCR-based quality controls into infectious disease testing protocols. Point-of-care testing growth has prompted 38% of urgent care centers to adopt rapid QC solutions compatible with lateral flow and isothermal platforms. Customizable controls for NGS and RT-PCR assays have seen a 31% increase in adoption across oncology labs. Moreover, 22% of global health programs now include funding allocations for standardized quality control materials, reflecting a shift toward harmonized diagnostic practices and global laboratory accreditation efforts.

RESTRAINTS

"High cost of third-party quality control and data integration"

Cost remains a barrier to widespread adoption of high-quality IVD controls, especially in small and mid-sized laboratories. Over 44% of labs report hesitancy in shifting from manufacturer-provided controls due to pricing concerns. Integration of automated QC tracking software adds 18% to annual operational costs, limiting adoption in developing regions. Additionally, 29% of clinical settings cite compatibility issues between existing lab information systems and digital QC platforms. These constraints slow market penetration for data-driven quality assurance solutions and maintain dependence on conventional manual documentation.

CHALLENGE

"Short shelf life and stability limitations in biological controls"

Shelf-life and storage conditions pose ongoing challenges in IVD quality control logistics. Nearly 36% of labs encounter inventory waste due to expired control materials. Lyophilized products, while more stable, require reconstitution steps that can introduce 14% procedural errors in sample handling. Transportation constraints in warmer climates affect 22% of liquid-based control shipments, leading to performance deviations in assays. Maintaining stability of high-sensitivity molecular controls is particularly difficult, with 19% reporting fluctuations in amplification efficiency after extended storage. These issues drive additional training and quality checks, increasing laboratory workloads and administrative overhead.

Segmentation Analysis

The Global In Vitro Diagnostics (IVD) Quality Control Market is segmented by type and application, providing a comprehensive understanding of usage patterns across diagnostic environments. Among product types, Quality Controls lead with 36% market share due to widespread use in daily lab routines. Whole Blood-based Controls represent 18% share, supporting hematology and coagulation tests. Serum/Plasma-based Controls follow with 15% share, extensively applied in immunoassays. Urine-based Controls hold 9%, and Other IVD Quality Controls cover 6%, while Data Management Solutions and Quality Assurance Services together account for the remaining 16%, supporting regulatory and compliance workflows.

By Type

Quality Controls: Widely adopted across test categories for ensuring repeatability, reliability, and proficiency in routine diagnostics.

Major Dominant Countries in the Quality Controls Segment

• United States leads with 15% share due to widespread lab accreditation programs and automation integration.
• Germany holds 11% share backed by stringent QA regulations in hospital laboratories.
• China maintains 10% share driven by growing investments in public health testing infrastructure.

Whole Blood-based Controls: Designed for hematology, coagulation, and point-of-care applications, offering physiological matrix similarity.

Major Dominant Countries in the Whole Blood-based Controls Segment

• Japan accounts for 12% market share owing to demand for real-time hematology QC solutions.
• United Kingdom holds 9% share led by NHS-funded diagnostic centers.
• South Korea maintains 6% share driven by tech-enabled POCT implementation.

Serum/Plasma-based Controls: Applied primarily in immunoassays and clinical chemistry, enabling analyte stability in daily QC processes.

Major Dominant Countries in the Serum/Plasma-based Controls Segment

• France commands 8% share due to widespread immunoassay labs and biomarker testing programs.
• Italy has 6% share, supported by demand in academic medical labs.
• India contributes 5% with growing public-private diagnostic centers.

Other IVD Quality Controls: Includes rare matrix and synthetic controls for specialized assays in genetics and rare disease diagnostics.

Major Dominant Countries in the Other Controls Segment

• Israel holds 3% share due to its innovation in personalized medicine testing platforms.
• Canada has 2.5% share led by biotech startups in rare disorder diagnostics.
• Australia maintains 2% share through academic research lab usage.

Data Management Solutions: Offers digital tracking, QC analytics, and compliance auditing through LIMS and third-party platforms.

Major Dominant Countries in the Data Management Solutions Segment

• United States leads with 14% share due to digitized lab operations and software adoption.
• Germany has 10% share driven by EU regulatory reporting mandates.
• Singapore holds 4% with centralized lab networks.

Quality Assurance Services: Covers external proficiency testing and audit support to maintain laboratory certifications.

Major Dominant Countries in the Quality Assurance Services Segment

• United Kingdom holds 7% share with national EQAS programs.
• Japan commands 5% share through lab standardization initiatives.
• Brazil has 3% share in public sector diagnostic control adoption.

By Application

Hospitals: Largest end-users, driven by centralized testing and regulatory compliance demands.

Hospitals account for 39% market share with strong implementation of automated and multi-analyte controls.

Major Dominant Countries in the Hospitals Segment

• United States leads with 16% share through integrated lab networks and accreditation programs.
• China holds 13% share due to expansion of tier-1 diagnostic centers.
• Germany maintains 10% share with emphasis on ISO-certified lab operations.

Laboratory: Includes clinical reference labs, specialty labs, and outsourced diagnostic service providers.

This segment contributes 34% market share, reflecting broader testing volumes and third-party QC adoption.

Major Dominant Countries in the Laboratory Segment

• India holds 12% share with rapid diagnostic chain expansion.
• Brazil contributes 10% share due to outsourced lab partnerships.
• South Africa has 7% with expanding private lab setups.

Research Institutes and Academics: Focused on assay development, biomarker studies, and experimental diagnostics with tailored QC usage.

This group holds 17% share, with growing demand for custom and molecular quality controls.

Major Dominant Countries in the Research Institutes Segment

• Japan holds 7% share through translational medicine centers.
• France accounts for 6% via academic collaborations.
• Australia contributes 4% through biomedical R&D grants.

Others: Encompasses diagnostics used in home testing kits, POCT platforms, and veterinary applications.

This segment accounts for 10% share, driven by portable diagnostics and non-traditional testing environments.

Major Dominant Countries in the Others Segment

• South Korea holds 4% share with POC tech integration.
• United States contributes 3% in at-home test kit quality control.
• Netherlands has 3% due to veterinary lab adoption.

In Vitro Diagnostics (IVD) Quality Control Market Regional Outlook

The Global In Vitro Diagnostics (IVD) Quality Control Market is geographically segmented into four key regions—North America, Europe, Asia-Pacific, and Middle East & Africa. Asia-Pacific dominates with 36% of the global share, followed by North America at 29%, Europe at 25%, and Middle East & Africa at 10%. Growth across all regions is driven by increasing test volumes, regulatory compliance, and expansion of diagnostic capabilities.

North America

North America remains a mature and innovation-led market in IVD quality control, with widespread adoption of third-party and multi-analyte controls. Approximately 71% of labs in the region use automated QC systems integrated with lab information management software. Molecular control usage has surged by 31% due to infectious disease surveillance and oncology diagnostics.

North America held a 29% share in the global IVD Quality Control Market in 2025. This dominance is supported by large-scale diagnostic lab networks, government-funded quality programs, and frequent proficiency assessments.

North America - Major Dominant Countries in the IVD Quality Control Market

• United States led the North America market with a 21% share in 2025 due to CLIA-regulated lab adoption and high test volume.
• Canada held a 5% share, supported by its robust public healthcare diagnostics infrastructure.
• Mexico accounted for 3% share driven by rising investments in clinical laboratories and private healthcare systems.

Europe

Europe continues to evolve with a strong focus on quality assurance and regulatory harmonization. About 66% of labs use external quality assurance services, and 43% have adopted data-driven QC monitoring platforms. The demand for serum-based controls and hematology QC products has increased by 27% in high-throughput labs.

Europe captured a 25% market share in 2025, propelled by ISO-compliant lab practices and government-sponsored EQAS programs in diagnostic networks.

Europe - Major Dominant Countries in the IVD Quality Control Market

• Germany held a 10% market share due to regulatory leadership and automated diagnostic systems adoption.
• France contributed 8% with high usage in public hospital networks and oncology labs.
• Italy accounted for 7%, driven by lab standardization in university and specialty centers.

Asia-Pacific

Asia-Pacific is the fastest-growing region in the IVD quality control market, led by test volume expansion and infrastructure modernization. Over 58% of labs in the region utilize QC products, and demand for molecular-based controls has increased by 39% in high-volume urban diagnostics. Lab automation has expanded by 33% year-over-year.

Asia-Pacific held the largest share at 36% in 2025, driven by rising health investments, government screening programs, and diagnostic outsourcing trends.

Asia-Pacific - Major Dominant Countries in the IVD Quality Control Market

• China led the region with 16% share due to diagnostic capacity expansion in hospitals and public health labs.
• India held 12%, supported by national health schemes and private diagnostic chain growth.
• Japan captured 8% share driven by molecular diagnostics standardization and centralized testing hubs.

Middle East & Africa

The Middle East & Africa region is showing steady progress in diagnostic standardization. About 44% of labs use external QC services, while point-of-care test quality controls have seen a 22% growth. Regulatory bodies are increasingly mandating participation in proficiency testing programs for certification purposes.

Middle East & Africa held a 10% share in the global IVD quality control market in 2025, led by healthcare modernization and external quality assurance adoption.

Middle East & Africa - Major Dominant Countries in the IVD Quality Control Market

• Saudi Arabia led with 4% share due to investments in hospital labs and national lab quality programs.
• South Africa accounted for 3% through rising adoption of proficiency testing in private diagnostics.
• United Arab Emirates held 3%, supported by international lab partnerships and quality compliance initiatives.

List of Key In Vitro Diagnostics (IVD) Quality Control Market Companies Profiled

Investment Analysis and Opportunities

The In Vitro Diagnostics (IVD) Quality Control Market is attracting increasing investments across technology innovation, automation, and precision diagnostics. Around 38% of new funding initiatives are being directed towards molecular quality control solutions, especially in infectious disease and oncology testing. Digital transformation is another key investment area, with 27% of laboratories adopting integrated quality tracking platforms that support remote audits and compliance analytics. Strategic acquisitions have contributed to 22% of recent capital flows, as major players seek to expand their portfolios across data-driven QC tools and third-party reference materials. In Asia-Pacific, over 19% of investments are focused on expanding manufacturing and logistics capabilities for lyophilized and liquid controls. Startups and SMEs are also gaining ground, accounting for 14% of innovation-driven funding aimed at personalized control solutions. Government health initiatives have allocated approximately 17% of diagnostic budgets toward standardized QC infrastructure in public laboratories, creating regional opportunities. Overall, robust funding pipelines and international quality mandates are expected to shape high-growth potential across the IVD QC landscape.

New Products Development

Product innovation in the In Vitro Diagnostics (IVD) Quality Control Market is driven by the shift toward high-throughput testing, multiplex assay compatibility, and digital integration. More than 42% of new product launches focus on multi-analyte controls, enabling simultaneous performance monitoring across several biomarkers. Molecular-based control products now account for 29% of new developments, especially in RT-PCR, NGS, and infectious disease panels. Automation-ready liquid controls make up 31% of recent releases, targeting centralized labs and diagnostic chains. Lyophilized QC materials with extended shelf life are being adopted by 23% of labs to reduce waste and ensure logistical efficiency. Digital-enabled QC kits with barcode tracking and cloud-based data storage represent 18% of the innovation pipeline, facilitating remote quality oversight. In response to increasing demand for flexibility, 21% of manufacturers are introducing modular kits with customizable control components. The development of synthetic matrix controls and AI-powered QC platforms is also emerging, making up 11% of the next-generation solutions under validation and pilot programs.

Recent Developments

• Bio-Rad Laboratories – Molecular QC Panel Launch (2023): Bio-Rad introduced a molecular control kit covering 12 respiratory pathogens, adopted by 26% of high-throughput labs within its first year.
• Technopath Clinical – Consolidated Controls Expansion (2023): Technopath released a consolidated QC panel combining clinical chemistry and immunoassays, reducing QC material usage by 34% across multisite labs.
• Roche Diagnostics – Cloud-Linked QC Platform (2024): Roche launched a cloud-based QC data system, enabling 24% of labs to automate performance trending and regulatory documentation in real-time.
• Randox Laboratories – Custom NGS Control Development (2024): Randox developed a customizable NGS QC solution that improved assay calibration accuracy by 18% in genetic and oncology testing labs.
• Seracare Life Sciences – Dried Blood Spot Control Kits (2024): Seracare introduced dried blood spot QC kits for neonatal and metabolic disorder testing, resulting in a 31% increase in test reliability reports.

Report Coverage

The In Vitro Diagnostics (IVD) Quality Control Market report provides a detailed view of the global industry landscape, highlighting trends, growth drivers, market segmentation, and regional performance. It covers all major product types including quality controls, whole blood-based, serum/plasma-based, urine-based, and data management solutions. Quality controls account for 36% of the market, with data management solutions representing 10%. Applications span hospitals (39% share), laboratories (34%), and research institutes (17%). Regionally, Asia-Pacific leads with 36% of global share, followed by North America at 29%, Europe at 25%, and Middle East & Africa at 10%. The report highlights investment shifts, with 38% focused on molecular QC and 27% on automation. It also identifies restraints such as high cost (44% impact) and QC material stability issues (36%). The report features company profiles, including market shares of top players and product portfolio strategies. It supports stakeholders in making data-driven decisions based on global regulatory shifts and clinical diagnostic advancements.