Global In Vitro Diagnostic Quality Control Market Forecast By Assay, Setting, Product, Manufacturer, And Country Genomics, Molecular Diagnostics, And Automation Fuel Growth
Dublin, Oct. 16, 2026 (GLOBE NEWSWIRE) -- "In Vitro Diagnostic Quality Control Market: Strategy & Trends with Forecasts by Assay Type, by Place, by Product, by Manufacturer and by Country - Situation Analysis with Executive & Consultant Guides" has been added to ResearchAndMarkets.com's offering.
The IVD quality control industry demonstrated significant resilience during the pandemic and is now entering a period of expanding commercial opportunity. Supported by continuing demand for reliable clinical laboratory testing, the market remains well positioned amid economic uncertainty. Emerging technologies, evolving testing requirements and the development of new market segments are creating additional growth prospects for established companies, technology providers and investors.
The report delivers comprehensive IVD quality control market intelligence designed to help industry participants assess opportunities, identify potential threats and plan for changing competitive conditions. It examines the fundamental factors influencing the sector while providing the data required to support strategic planning, market analysis, investment evaluation and business development.
Clinical laboratory testing is expected to benefit directly from continued advances across biotechnology, particularly genomics. As laboratories adopt more sophisticated testing platforms and expand their diagnostic capabilities, quality control remains essential to maintaining dependable performance and supporting regulatory compliance. These developments are contributing to market expansion and influencing company valuations across the in vitro diagnostics landscape.
New testing regimes and technologies are also reshaping demand. Market participants must evaluate how innovation, laboratory trends and shifting testing volumes may affect future requirements for IVD quality control products and services. The report helps analysts and planners examine these changes, forecast demand and assess where research funding and commercial investment may generate the strongest returns.
Featuring hundreds of pages of detailed market information, the report explores clinical laboratory trends and the role of IVD quality control within the broader diagnostics industry. Its analysis supports informed decisions regarding product development, technology adoption, research investment, market entry and portfolio strategy. Companies can use the findings to evaluate market potential, compare geographic opportunities and strengthen long-term planning.
Geographic coverage includes detailed breakouts for 15 countries and 4 regions, providing insight into market conditions across key international territories. Purchasers may also request a detailed breakout for any country in the world, enabling organizations to investigate specific national markets and align their strategies with local demand, competitive dynamics and industry development.
The report includes five year market forecasts that allow readers to assess expected growth and prepare for changes in the IVD quality control market. These forecasts provide a forward-looking basis for estimating demand, evaluating commercial potential and identifying areas where technological progress may create new revenue opportunities.
Investors, diagnostics companies, clinical laboratory suppliers, biotechnology organizations, market analysts and corporate planners can use the report to make investment decisions and valuations with greater confidence. By combining current market data, country-level analysis, industry trends and forecasts, it provides a structured view of an established sector benefiting from advances in genomics, laboratory technology and diagnostic testing.
As clinical laboratories continue to modernize and testing capabilities become more advanced, the need for effective IVD quality control is expected to remain central to laboratory operations. The report equips decision-makers with actionable intelligence for navigating this changing environment, prioritizing opportunities and developing strategies based on the latest available market evidence.
Key Topics Covered:
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
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 Sources
2.3.2 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 New FDA Quality Regulations Spark Questions
5.3 Waters MassTrak Steroid Serum (IVD) Sets
5.4 Cancer Test Harmonization Efforts Progress
5.5 Bio-Techne Expanding With Ella Immunoassay Instrument
5.6 ZeptoMetrix QC Products Receive IVDR Certification
5.7 Coverage Criteria for Cancer Genetic Tests Creates Alarm
5.8 IVDR Rollout Brings QC Hurdles for Clinical Labs
5.9 LGC Clinical Diagnostics Acquires QC Product Maker Kova International
5.10 FDA Probing Lab Test Quality in Cancer Care
5.11 Sensible Diagnostics to Launch 10-Minute POC PCR System
5.12 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
List of Tables [35]
List of Figures [52]
Companies Featured
- Abbott Laboratories Alpha-Tec Systems Beckman Coulter Diagnostics (Danaher) Becton, Dickinson and Company Bio-Rad Laboratories, Inc Bio-Techne BioFire Diagnostics (bioMerieux) bioMerieux Diagnostics Danaher Corporation Diasorin S.p.A. Fortress Diagnostics Grifols Helena Laboratories Hologic Kova International LGC Clinical Diagnostics LGC Standards Maine Molecular Quality Controls Microbiologics Microbix Systems Novacyt QuidelOrtho Randox Toxicology Seegene Sensible Diagnostics SERO Siemens Healthineers Streck Sun Diagnostics Sysmex Thermo Fisher Scientific Waters ZeptoMetrix
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