체외진단(IVD) 품질 관리 시장 : 어세이 유형별, 실시 장소별, 제품별, 제조업체별, 국가별 예측을 포함한 전략과 동향 - 경영진 및 컨설턴트용 가이드 포함 시장 분석(2026-2030년)

Report Overview:

The IVD Quality Control industry rose to the challenge of the pandemic. Now new opportunities abound in this established industry that is immune from recession. New technology and new segments are driving runaway growth. Understand the opportunities and the threats in this comprehensive report.

Clinical laboratory quality control (QC) refers to the systems, materials, software tools, and procedures used to ensure accuracy, reliability, and consistency of diagnostic test results generated by clinical laboratories. Quality control is an essential component of laboratory operations because diagnostic test results are used to guide medical decision-making, monitor treatment effectiveness, and support disease diagnosis. Errors in laboratory testing can lead to incorrect clinical decisions, making robust quality control processes critical for patient safety and healthcare system effectiveness.

The Clinical Laboratory Quality Control market includes quality control materials, calibration standards, proficiency testing services, quality management software, and data analytics tools used to monitor laboratory performance. The market is estimated to be USD 1.39 billion in 2025, growing to 1.81 Billion in 2030 at a CAGR of 5.4%. Growth is generally expected to track overall expansion in clinical laboratory testing volumes.

Demand for laboratory quality control products and services is driven by increasing complexity of diagnostic testing technologies, expansion of molecular diagnostics and genetic testing, regulatory requirements for laboratory accreditation, and growing emphasis on healthcare quality assurance.

Role of Quality Control in Laboratory Testing

Quality control processes are used to verify that laboratory instruments, reagents, and workflows are performing correctly and producing accurate results. QC procedures typically involve analysis of control samples with known analyte concentrations to ensure that test results fall within defined performance ranges.

Quality control is applied across a wide range of laboratory disciplines including clinical chemistry, immunoassay testing, hematology, coagulation testing, microbiology, molecular diagnostics, and toxicology.

QC processes are designed to detect analytical errors resulting from instrument malfunction, reagent variability, calibration issues, or environmental conditions.

Laboratories typically perform both internal quality control and external quality assessment (EQA). Internal QC involves routine monitoring of assay performance within a laboratory. External quality assessment involves comparison of laboratory performance with peer laboratories using standardized proficiency testing samples.

Accreditation bodies and regulatory agencies require laboratories to maintain documented quality control programs.

Market Components

The clinical laboratory QC market includes several product and service categories.

• Quality control materials are samples containing known concentrations of analytes used to verify assay performance. These materials are available for a wide range of laboratory tests.
• Calibration standards are used to establish measurement accuracy and ensure traceability of test results.
• Proficiency testing programs provide external validation of laboratory performance by comparing results across multiple laboratories.
• Quality management software platforms enable laboratories to track QC data, monitor instrument performance, and identify trends indicating analytical variation.
• Data analytics tools are increasingly used to support statistical quality control methods.
• QC products are used across centralized laboratories, hospital laboratories, and point-of-care testing environments.
• Recurring demand for QC materials represents a stable revenue stream for suppliers.

Market Drivers

Several factors are supporting growth in the clinical laboratory quality control market.

• Increasing complexity of diagnostic technologies is creating demand for more sophisticated quality assurance tools.
• Expansion of molecular diagnostics and genetic testing requires specialized QC materials and validation processes.
• Regulatory requirements for laboratory accreditation are increasing emphasis on documented quality management systems.
• Growth in laboratory testing volumes is increasing demand for QC materials and services.
• Healthcare systems are increasingly focused on improving diagnostic accuracy and reducing medical errors.
• Automation of laboratory workflows requires integrated QC monitoring systems.
• Expansion of point-of-care testing requires quality control solutions suitable for decentralized testing environments.
• Globalization of clinical trials requires standardized quality assurance processes across laboratory networks.

Technology Trends

Technological innovation is influencing the clinical laboratory QC market.

• Automation of QC data collection and analysis is improving efficiency and reducing manual documentation requirements.
• Middleware software platforms integrate QC data from multiple instruments and provide centralized performance monitoring.
• Statistical quality control tools enable detection of analytical trends and performance drift.
• Cloud-based QC management platforms enable remote monitoring of laboratory performance.
• Digital connectivity between laboratory instruments and quality management systems improves traceability of results.
• Artificial intelligence tools are being developed to detect patterns in QC data and identify potential analytical issues.
• Advanced analytics may enable predictive quality control models.
• Integration of QC systems with laboratory information systems supports workflow efficiency.

Market Segmentation

The clinical laboratory QC market can be segmented by product type, laboratory discipline, end user, and geographic region.

By laboratory discipline, clinical chemistry and immunoassay testing represent large segments due to high test volumes. Molecular diagnostics and genetic testing represent growing segments requiring specialized QC solutions.

End users include hospital laboratories, reference laboratories, physician office laboratories, and diagnostic testing networks.

• North America represents the largest regional market due to established regulatory frameworks and advanced diagnostic infrastructure.
• Europe represents a significant market supported by laboratory accreditation requirements.
• Asia-Pacific markets are expanding due to increasing healthcare investment and growing diagnostic testing volumes.

Competitive Landscape

The clinical laboratory QC market includes specialized QC material manufacturers, diagnostic instrument companies, proficiency testing providers, and laboratory informatics companies.

• Competition is influenced by breadth of QC product portfolio, compatibility with major diagnostic platforms, and ability to support multiple laboratory disciplines.
• Suppliers often develop QC materials designed for specific diagnostic assays or instrument platforms.
• Strategic partnerships between QC suppliers and diagnostic instrument manufacturers may influence product adoption.
• Recurring revenue from QC materials provides stable market demand.
• Quality and reliability of QC materials are critical competitive factors.
• Regulatory compliance and traceability are important considerations for suppliers.

Future Outlook

The clinical laboratory QC market is expected to experience steady growth as diagnostic testing technologies become more complex and regulatory expectations increase.

• Expansion of molecular diagnostics and genetic testing may increase demand for specialized QC materials.
• Automation of laboratory workflows may require integrated quality management systems.
• Digital connectivity between laboratory instruments and QC software may improve monitoring capabilities.
• Artificial intelligence tools may improve detection of analytical variation and enhance predictive maintenance.
• Decentralized testing environments may create demand for simplified QC solutions.

Overall, clinical laboratory quality control represents a critical component of diagnostic testing infrastructure. Continued advances in laboratory technology and increasing emphasis on diagnostic accuracy are expected to support sustained demand for quality control products and services.

Table of Contents

1 Market Guides

• 1.1 Strategic Situation Analysis
• 1.2 Guide for Executives, Marketing, Sales and Business Development Staff
• 1.3 Guide for Management Consultants and Investment Advisors
• 1.4 Impact of Artificial Intelligence

2 Introduction and Market Definition

• 2.1 What is IVD Quality Control?
• 2.2 Defining the Opportunity
  • 2.2.1 Revenue Market Size
• 2.3 Methodology
  • 2.3.1 Methodology
  • 2.3.2 Sources
  • 2.3.3 Authors
• 2.4 Perspective: Healthcare and the IVD Industry
  • 2.4.1 Global Healthcare Spending
  • 2.4.2 Spending on Diagnostics
  • 2.4.3 Important Role of Insurance for Diagnostics

3 Overview of a Dynamic Market

• 3.1 Players in a Dynamic Market
  • 3.1.1 Academic Research Lab
  • 3.1.2 Diagnostic Test Developer
  • 3.1.3 Instrumentation Supplier
  • 3.1.4 Chemical/Reagent Supplier
  • 3.1.5 Pathology Supplier
  • 3.1.6 Independent Clinical Laboratory
  • 3.1.7 Public National/regional Laboratory
  • 3.1.8 Hospital Laboratory
  • 3.1.9 Physicians Office Lab (POLS)
  • 3.1.10 Audit Body
  • 3.1.11 Certification Body
• 3.2 Segmentation - Different Approaches
  • 3.2.1 Traditional Market Segmentation
  • 3.2.2 Laboratory Focus and Segmentation
• 3.3 Structure of Clinical Testing Industry
  • 3.3.1 The Hospital Lab - Share of the Pie
  • 3.3.2 Key Role for Economies of Scale
  • 3.3.3 Physician Office Lab's are Still Here
  • 3.3.4 Physician's and POCT - Reviving Patient Service in China
• 3.4 National and Regional Diversity

4 Trends Driving a Changing Market

• 4.1 Growth Is Pushed from Many Sides
  • 4.1.1 Demographic Impacts on Consumption
  • 4.1.2 Alternative Suppliers
  • 4.1.3 Impact of POC
  • 4.1.4 Impact of Accreditation
  • 4.1.5 Genetic and Molecular Issues
• 4.2 Factors at Work to Shrink the Market
  • 4.2.1 Where are Costs Going?
  • 4.2.2 Management Practices
  • 4.2.3 Cannabilization
  • 4.2.4 Point of Care
• 4.3 Automation and Laboratory Trends
  • 4.3.1 Traditional Automation and Centralization
  • 4.3.2 The New Automation, Decentralization and Point Of Care
  • 4.3.3 Instruments Key to Market Share
  • 4.3.4 Bioinformatics Plays a Role
  • 4.3.5 PCR Takes Command
  • 4.3.6 Next Generation Sequencing Fuels a Revolution
  • 4.3.7 NGS Impact on Pricing
  • 4.3.8 Whole Genome Sequencing, A Brave New World
  • 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
  • 4.3.10 Shifting Role of Diagnostics

5 IVD Quality Control Recent Developments

• 5.1 Recent Developments - Importance and How to Use This Section
  • 5.1.1 Importance of These Developments
  • 5.1.2 How to Use This Section
• 5.2 Lab Missteps Lead to Dismissed Charges
• 5.3 bioMerieux Launches Diagnostic Solution for Food Industries
• 5.4 Automation from Siemens Tackles Lab Challenges
• 5.5 New FDA Quality Regulations Spark Questions
• 5.6 Waters MassTrak Steroid Serum (IVD) Sets
• 5.7 Cancer Test Harmonization Efforts Progress
• 5.8 Bio-Techne Expanding With Ella Immunoassay Instrument
• 5.9 ZeptoMetrix QC Products Receive IVDR Certification
• 5.10 Coverage Criteria for Cancer Genetic Tests Creates Alarm
• 5.11 IVDR Rollout Brings QC Hurdles for Clinical Labs
• 5.12 LGC Clinical Diagnostics Acquires QC Product Maker Kova International
• 5.13 FDA Probing Lab Test Quality in Cancer Care
• 5.14 Sensible Diagnostics to Launch 10-Minute POC PCR System
• 5.15 Streck Gets FDA Clearance for BioFire Sepsis Panel Control Material

6 Profiles of Key Companies

• 6.1 Abbott Laboratories
• 6.2 Alpha-Tec Systems
• 6.3 Beckman Coulter Diagnostics (Danaher)
• 6.4 Becton, Dickinson and Company
• 6.5 BioFire Diagnostics (bioMerieux)
• 6.6 bioMerieux Diagnostics
• 6.7 Bio-Rad Laboratories, Inc
• 6.8 Bio-Techne
• 6.9 Danaher Corporation
• 6.10 Diasorin S.p.A.
• 6.11 Fortress Diagnostics
• 6.12 Grifols
• 6.13 Helena Laboratories
• 6.14 Hologic
• 6.15 LGC Standards
• 6.16 Maine Molecular Quality Controls
• 6.17 Microbiologics
• 6.18 Microbix Systems
• 6.19 Novacyt
• 6.20 QuidelOrtho
• 6.21 Randox Toxicology
• 6.22 Seegene
• 6.23 SERO
• 6.24 Siemens Healthineers
• 6.25 Streck
• 6.26 Sun Diagnostics
• 6.27 Sysmex
• 6.28 Thermo Fisher Scientific
• 6.29 ZeptoMetrix

7 The Global Market for IVD Quality Control

• 7.1 Global Market Overview by Country
  • 7.1.1 Table - Global Market by Country
  • 7.1.2 Chart - Global Market by Country
• 7.2 Global Market by Assay Type - Overview
  • 7.2.1 Table - Global Market by Assay Type
  • 7.2.2 Chart - Global Market by Assay Type - Base/Final Year Comparison
  • 7.2.3 Chart - Global Market by Assay Type - Base Year
  • 7.2.4 Chart - Global Market by Assay Type - End Year
  • 7.2.5 Chart - Global Market by Assay Type - Share by Year
  • 7.2.6 Chart - Global Market by Assay Type - Segments Growth
• 7.3 Global Market by Place - Overview
  • 7.3.1 Table - Global Market by Place
  • 7.3.2 Chart - Global Market by Place - Base/Final Year Comparison
  • 7.3.3 Chart - Global Market by Place - Base Year
  • 7.3.4 Chart - Global Market by Place - End Year
  • 7.3.5 Chart - Global Market by Place - Share by Year
  • 7.3.6 Chart - Global Market by Place - Segments Growth
• 7.4 Global Market by Product - Overview
  • 7.4.1 Table - Global Market by Product
  • 7.4.2 Chart - Global Market by Product - Base/Final Year Comparison
  • 7.4.3 Chart - Global Market by Product - Base Year
  • 7.4.4 Chart - Global Market by Product - End Year
  • 7.4.5 Chart - Global Market by Product - Share by Year
  • 7.4.6 Chart - Global Market by Product - Segments Growth
• 7.5 Global Market by Manufacturer- Overview
  • 7.5.1 Table - Global Market by Manufacturer
  • 7.5.2 Chart - Global Market by Manufacturer - Base/Final Year Comparison
  • 7.5.3 Chart - Global Market by Manufacturer - Base Year
  • 7.5.4 Chart - Global Market by Manufacturer - End Year
  • 7.5.5 Chart - Global Market by Manufacturer - Share by Year
  • 7.5.6 Chart - Global Market by Manufacturer - Segments Growth

8 Global IVD Quality Control Markets - By Assay Type

• 8.1 Chemistry
  • 8.1.1 Table Chemistry - by Country
  • 8.1.2 Chart - Chemistry Growth
• 8.2 Microbiology
  • 8.2.1 Table Microbiology - by Country
  • 8.2.2 Chart - Microbiology Growth
• 8.3 Hematology
  • 8.3.1 Table Hematology - by Country
  • 8.3.2 Chart - Hematology Growth
• 8.4 Anatomic Pathology
  • 8.4.1 Table Anatomic Pathology - by Country
  • 8.4.2 Chart - Anatomic Pathology Growth
• 8.5 Molecular Diagnostics
  • 8.5.1 Table Molecular Diagnostics - by Country
  • 8.5.2 Chart - Molecular Diagnostics Growth
• 8.6 Esoteric
  • 8.6.1 Table Esoteric - by Country
  • 8.6.2 Chart - Esoteric Growth

9 Global IVD Quality Control Markets - By Place

• 9.1 Hospital
  • 9.1.1 Table Hospital - by Country
  • 9.1.2 Chart - Hospital Growth
• 9.2 Outpatient Laboratory
  • 9.2.1 Table Outpatient Laboratory - by Country
  • 9.2.2 Chart - Outpatient Laboratory Growth
• 9.3 Research Laboratory
  • 9.3.1 Table Research Laboratory - by Country
  • 9.3.2 Chart - Research Laboratory Growth
• 9.4 Physicians Office Laboratory
  • 9.4.1 Table Physicians Office Laboratory - by Country
  • 9.4.2 Chart - Physicians Office Laboratory Growth
• 9.5 Other Laboratory
  • 9.5.1 Table Other Laboratory - by Country
  • 9.5.2 Chart - Other Laboratory Growth

10 Global IVD Quality Control Markets - By Product

• 10.1 Whole Blood
  • 10.1.1 Table Whole Blood - by Country
  • 10.1.2 Chart - Whole Blood Growth
• 10.2 Plasma
  • 10.2.1 Table Plasma - by Country
  • 10.2.2 Chart - Plasma Growth
• 10.3 Urine
  • 10.3.1 Table Urine - by Country
  • 10.3.2 Chart - Urine Growth
• 10.4 Control Material Other
  • 10.4.1 Table Control Material Other - by Country
  • 10.4.2 Chart - Control Material Other Growth

11 Global IVD Quality Control Markets - By Manufacturer

• 11.1 Original Equipment Manufacturer
  • 11.1.1 Table Original Equipment Manufacturer - by Country
  • 11.1.2 Chart - Original Equipment Manufacturer Growth
• 11.2 Third Party Generic
  • 11.2.1 Table Third Party Generic - by Country
  • 11.2.2 Chart - Third Party Generic Growth
• 11.3 Third Party Instrument Specific
  • 11.3.1 Table Third Party Instrument Specific - by Country
  • 11.3.2 Chart - Third Party Instrument Specific Growth
• 11.4 Custom Other
  • 11.4.1 Table Custom Other - by Country
  • 11.4.2 Chart - Custom Other Growth

12 Appendices

• 12.1 Growth of Approved IVD Test Menu
• 12.2 Growth of Approved Average IVD Test Fee
• 12.3 The Most Used IVD Assays
• 12.4 The Highest Grossing Assays
• 12.5 Laboratory Fees Schedule

Table of Tables

• Table 1 Market Players by Type
• Table 2 Clinical Laboratory Departments and Segments
• Table 3 Laboratory Management Focus - Different Approaches
• Table 4 Key Segmentation Variables Going Forward
• Table 5 Factors Affecting Local Clinical Testing Demand
• Table 6 Seven Factors Driving Growth
• Table 7 Six Factors Limiting Growth
• Table 8 Seven Key Diagnostic Laboratory Technology Trends
• Table 9 - Global Market by Region
• Table 10 Global Market by Assay Type
• Table 11 Global Market by Place
• Table 12 Global Market by Product
• Table 13 Global Market by Manufacturer
• Table 14 Chemistry by Country
• Table 15 Microbiology by Country
• Table 16 Hematology by Country
• Table 17 Anatomic Pathology by Country
• Table 18 Molecular Diagnostics by Country
• Table 19 Esoteric by Country
• Table 20 Hospital by Country
• Table 21 Outpatient Laboratory by Country
• Table 22 Research Laboratory by Country
• Table 23 Physicians Office Laboratory by Country
• Table 24 Other Laboratory by Country
• Table 25 Whole Blood by Country
• Table 26 Plasma by Country
• Table 27 Urine by Country
• Table 28 Control Material Other by Country
• Table 29 Original Equipment Manufacturer by Country
• Table 30 Third Party Generic by Country
• Table 31 Third Party Instrument Specific by Country
• Table 32 Custom Other by Country
• Table 33 The Most Common Assays
• Table 34 Largest Revenue Assays
• Table 35 Clinical Lab Fee Schedule

Table of Figures

• Figure 1 Global Healthcare Spending
• Figure 2 The Road to Diagnostics
• Figure 3 The Changing Age of The World's Population
• Figure 4 Health Care Consumption by Age
• Figure 5 Cancer Incidence - Age at Diagnosis
• Figure 6 Centralized vs. Decentralized Laboratory Service
• Figure 7 A Highly Multiplexed Syndromic Testing Unit
• Figure 8 The Real Cost to Sequence the Human Genome
• Figure 9 The Codevelopment Process
• Figure 10 Comparing MDx Diagnostic and Traditional Testing
• Figure 11 Global Market Pareto Chart
• Figure 12 Global Market by Assay Type - Base vs. Final
• Figure 13 Global Market by Assay Type Base Year
• Figure 14 Global Market by Assay Type End Year
• Figure 15 Assay Type Share by Year
• Figure 16 Assay Type Segments Growth
• Figure 17 Global Market by Place - Base vs. Final
• Figure 18 Global Market by Place Base Year
• Figure 19 Global Market by Place End Year
• Figure 20 Place Share by Year
• Figure 21 Place Segments Growth
• Figure 22 Global Market by Product - Base vs. Final
• Figure 23 Global Market by Product Base Year
• Figure 24 Global Market by Product End Year
• Figure 25 Product Share by Year
• Figure 26 Product Segments Growth
• Figure 27 Global Market by Manufacturer - Base vs. Final
• Figure 28 Global Market by Manufacturer Base Year
• Figure 29 Global Market by Manufacturer End Year
• Figure 30 Manufacturer Share by Year
• Figure 31 Manufacturer Segments Growth
• Figure 32 Chemistry Growth
• Figure 33 Microbiology Growth
• Figure 34 Hematology Growth
• Figure 35 Anatomic Pathology Growth
• Figure 36 Molecular Diagnostics Growth
• Figure 37 Esoteric Growth
• Figure 38 Hospital Growth
• Figure 39 Out Patient Laboratory Growth
• Figure 40 Research Laboratory Growth
• Figure 41 Physicians Office Laboratory Growth
• Figure 42 Other Laboratory Growth
• Figure 43 Whole Blood Growth
• Figure 44 Plasma Growth
• Figure 45 Urine Growth
• Figure 46 Control Material Other Growth
• Figure 47 Original Equipment Manufacturer Growth
• Figure 48 Third Party Generic Growth
• Figure 49 Third Party Instrument Specific Growth
• Figure 50 Custom Other Growth
• Figure 51 IVD Test Menu Growth
• Figure 52 IVD Test Average Fees - A Ten Year View