Product Code: 978-1-68038-925-8
In Vitro Diagnostics Quality Control Market Growth & Trends:
The global in vitro diagnostics quality control market size is expected to reach USD 1.59 billion by 2030, registering a CAGR of 3.2% from 2024 to 2030, according to a new report by Grand View Research, Inc. The continually evolving technology-oriented changes in the diagnostics field and the growing requirement to ensure patient safety necessitate the execution of quality assurance programs in several medical domains including point-of-care devices and radiology.The patients rely on self-testing in vitro diagnostics (IVD) devices for long-term disease management and hence it is important for such IVD devices to be checked for quality in terms of result reproducibility and validity to guarantee patient safety.
The rising number of certified clinical laboratories offering dependable IVD-based diagnostic services directly correlates with increased patient confidence, thus driving market growth. Some of the key pathogens routinely diagnosed using multiplex PCR, but not limited to, are HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachoma (genital infections), G. lambardia, C. parvum (diarrheal diseases), and Leishmaniaspp (Leishmaniasis).In addition to assessments, amendments to the regulatory framework are made intermittently to enhance the present standards with the main objective of safeguarding the qualitative superiority of the diagnostic services rendered to patients.
Quality control in the laboratory is focused on ensuring that the results delivered to the patient are accurate. Control checks are usually undertaken while installing an instrument, after servicing, changing reagent lots, and when the instrument readings are not in range.Home care settings include a variety of devices, such as point-of-care (PoC) instruments used for near-patient bed testing, self-testing kits, and IVD devices in assisted healthcare settings. Self-testing kits giveease of convenience for patients who require everyday testing and further reduce hospital visits.
In Vitro Diagnostics Quality Control Market Report Highlights:
- In 2023, the clinical chemistry segment held the largest share of the market. The increasing demand for preventive medicine and the rapid transformation of clinical laboratories into highly automated and efficient businesses are some of the factors responsible for its high market share
- The quality control segment dominated the market in 2023 and is estimated to grow at the highest CAGR over the forecast period. Quality control in the research laboratory is concentrated on certifying the results provided to the individuals are precise
- The hospital segment held the largest share in 2023 due to the presence of highly advanced technology-based devices, such as Next Generation Sequencing (NGS), mass spectrophotometry, and microarrays, and the rising applications of the optimized quality-control procedures
- Many pharmaceutical companies are implementing the new draft guidance enforced by the U.S. FDA for data integrity on current Good Manufacturing Practices (cGMP)
- It provides information in relation to establishing robust operating procedures and strong management systems, obtaining high-quality raw materials, investigating deviations, and maintaining reliable diagnostic laboratories
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation
- 1.1.1. Regional scope
- 1.1.2. Market definitions
- 1.1.3. Estimates and forecasts timeline
- 1.2. Objectives
- 1.2.1. Objective - 1
- 1.2.2. Objective - 2
- 1.2.3. Objective - 3
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased database
- 1.4.2. GVR's internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.4.5. Details of primary research
- 1.5. Information or Data Analysis
- 1.5.1. Data analysis models
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.1.1. Approach 1: Commodity flow approach
- 1.7.1.2. Approach 2: Country wise market estimation using bottom-up approach.
- 1.8. List of Secondary Sources
- 1.9. List of Abbreviations
Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. By Product and Type Segment Snapshot
- 2.3. By application and Manufacturer Type Segment Snapshot
- 2.4. By End-use Segment Snapshot
- 2.5. Competitive Landscape Snapshot
Chapter 3. Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. ancillary market outlook
- 3.2. Market Dynamics
- 3.2.1. Market driver analysis
- 3.2.1.1. Rising number of accredited clinical laboratories
- 3.2.1.2. Increasing third-party quality control services
- 3.2.1.3. Presence of favorable regulatory bodies
- 3.2.2. Market restraint analysis
- 3.2.2.1. High cost of IVD quality control services
- 3.2.2.2. Unfavorable reimbursement scenario in IVD industry
- 3.2.3. Opportunity analysis
- 3.2.4. Supply chain analysis
- 3.3. Business Environment Analysis
- 3.3.1. PESTEL analysis
- 3.3.2. Porter's five forces analysis
Chapter 4. In Vitro Diagnostics Quality Control Market: Segment Analysis, by Product, 2018 - 2030 (USD Million)
- 4.1. In Vitro Diagnostics Quality Control Market: Product movement Analysis
- 4.2. In Vitro Diagnostics Quality Control Market Estimates & Forecast, by Product (USD Million)
- 4.2.1. Controls
- 4.2.1.1. Total protein
- 4.2.1.2. Albumin
- 4.2.1.3. Blood urea nitrogen
- 4.2.1.4. Uric acid
- 4.2.1.5. Creatinine
- 4.2.1.6. Sodium
- 4.2.1.7. Potassium
- 4.2.1.8. Chloride
- 4.2.1.9. Calcium
- 4.2.1.10. Magnesium
- 4.2.1.11. Inorganic phosphorus
- 4.2.1.12. Aspartate transaminase
- 4.2.1.13. Creatine kinase
- 4.2.1.14. Gamma glutamyl transferase
- 4.2.1.15. Total bilirubin
- 4.2.1.16. C-Reactive Protein
- 4.2.1.17. Glucose
- 4.2.1.18. Iron
- 4.2.1.19. Alanine transaminase
- 4.2.1.20. Alkaline phosphatase
- 4.2.1.21. Alpha-amylase
- 4.2.1.22. Total cholesterol
- 4.2.1.23. Triglyceride
- 4.2.1.24. Lactate dehydrogenase
- 4.2.1.25. Immunoglobulin G
- 4.2.1.26. Immunoglobulin A
- 4.2.1.27. Immunoglobulin M
- 4.2.1.28. Complement 3
- 4.2.1.29. Complement 4
- 4.2.1.30. Rheumatoid factor
- 4.2.1.31. Anti-Streptolysin -O
- 4.2.1.32. Beta 2 microglobulin
- 4.2.1.33. Cystatin-C
- 4.2.1.34. Myoglobin
- 4.2.1.35. Troponin T and I
- 4.2.1.36. Others
- 4.2.2. Calibrators
- 4.2.3. Others
Chapter 5. In Vitro Diagnostics Quality Control Market: Segment Analysis, by Type, 2018 - 2030 (USD Million)
- 5.1. In Vitro Diagnostics Quality Control Market: Type Movement Analysis
- 5.2. In Vitro Diagnostics Quality Control Market Estimates and & Forecast, by Type (USD Million)
- 5.2.1. Quality Controls
- 5.2.1.1. Plasma-based control
- 5.2.1.2. Serum-based control
- 5.2.1.3. Whole blood-based Control
- 5.2.1.4. Others
- 5.2.2. Quality Assurance Services
- 5.2.3. Data Management Solutions
Chapter 6. In Vitro Diagnostics Quality Control Market: By Application Estimates & Trend Analysis
- 6.1. In Vitro Diagnostics Quality Control Market: Application Movement Analysis
- 6.2. In Vitro Diagnostics Quality Control Market Estimates and & Forecast, by Application (USD Million)
- 6.3. Immunochemistry
- 6.4. Hematology
- 6.5. Clinical Chemistry
- 6.5.1.1. Alkaline Phosphatase (ALP)
- 6.5.1.2. Alanine Transaminase (ALT)
- 6.5.1.3. Aspartate Transaminase (AST)
- 6.5.1.4. Creatine Kinase MB (CK-MB)
- 6.5.1.5. Albumin
- 6.5.1.6. Creatinine
- 6.5.1.7. Glucose
- 6.5.1.8. Triglycerides
- 6.5.1.9. Amylase
- 6.5.1.10. Others
- 6.5.2. Molecular diagnostics
- 6.5.3. Coagulation
- 6.5.4. Microbiology
- 6.5.5. Others
Chapter 7. In Vitro Diagnostics Quality Control Market: By Manufacturer Type Estimates & Trend Analysis
- 7.1. In Vitro Diagnostics Quality Control Market: Manufacturer Type Movement Analysis
- 7.2. In Vitro Diagnostics Quality Control Market Estimates and & Forecast, by Manufacturer Type (USD Million)
- 7.2.1. Third-party controls
- 7.2.1.1. Independent controls
- 7.2.1.2. Instrument specific controls
- 7.2.2. OEM controls
Chapter 8. In Vitro Diagnostics Quality Control Market: End-use Estimates & Trend Analysis
- 8.1. In Vitro Diagnostics Quality Control Market: End-use Movement Analysis
- 8.2. In Vitro Diagnostics Quality Control Market Estimates and & Forecast, by End-use (USD Million)
- 8.2.1. Hospitals
- 8.2.2. Laboratories
- 8.2.3. Home care
- 8.2.4. Others
Chapter 9. In Vitro Diagnostics Quality Control Market: Regional Estimates & Trend Analysis, by Product, Type, Application, Manufacturer Type, and End-use
- 9.1. In Vitro Diagnostics Quality Control Market: Regional Outlook
- 9.2. North America
- 9.2.1. North America in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.2.2. U.S.
- 9.2.2.1. Key country dynamics
- 9.2.2.2. U.S. in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.2.2.3. Competitive/ market scenario
- 9.2.2.4. Regulatory framework
- 9.2.3. Canada
- 9.2.3.1. Key country dynamics
- 9.2.3.2. Canada in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.2.3.3. Competitive/ market scenario
- 9.2.3.4. Regulatory framework
- 9.3. Europe
- 9.3.1. Europe in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.2. UK
- 9.3.2.1. Key country dynamics
- 9.3.2.2. UK in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.2.3. Competitive/ market scenario
- 9.3.2.4. Regulatory framework
- 9.3.3. Germany
- 9.3.3.1. Key country dynamics
- 9.3.3.2. Germany in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.3.3. Competitive/ market scenario
- 9.3.3.4. Regulatory framework
- 9.3.4. France
- 9.3.4.1. Key country dynamics
- 9.3.4.2. France in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.4.3. Competitive/ market scenario
- 9.3.4.4. Regulatory framework
- 9.3.5. Italy
- 9.3.5.1. Key country dynamics
- 9.3.5.2. Italy in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.5.3. Competitive/ market scenario
- 9.3.5.4. Regulatory framework
- 9.3.6. Spain
- 9.3.6.1. Key country dynamics
- 9.3.6.2. Spain in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.6.3. Competitive/ market scenario
- 9.3.6.4. Regulatory framework
- 9.3.7. Denmark
- 9.3.7.1. Key country dynamics
- 9.3.7.2. Denmark in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.7.3. Competitive/ market scenario
- 9.3.7.4. Regulatory framework
- 9.3.8. Sweden
- 9.3.8.1. Key country dynamics
- 9.3.8.2. Sweden in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.8.3. Competitive/ market scenario
- 9.3.8.4. Regulatory framework
- 9.3.9. Norway
- 9.3.9.1. Key country dynamics
- 9.3.9.2. Norway in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.3.9.3. Competitive/ market scenario
- 9.3.9.4. Regulatory framework
- 9.4. Asia Pacific
- 9.4.1. Asia Pacific in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.2. Japan
- 9.4.2.1. Key country dynamics
- 9.4.2.2. Japan in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.2.3. Competitive/ market scenario
- 9.4.2.4. Regulatory framework
- 9.4.3. China
- 9.4.3.1. Key country dynamics
- 9.4.3.2. China in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.3.3. Competitive/ market scenario
- 9.4.3.4. Regulatory framework
- 9.4.4. India
- 9.4.4.1. Key country dynamics
- 9.4.4.2. India in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.4.3. Competitive/ market scenario
- 9.4.4.4. Regulatory framework
- 9.4.5. Australia
- 9.4.5.1. Key country dynamics
- 9.4.5.2. Australia in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.5.3. Competitive/ market scenario
- 9.4.5.4. Regulatory framework
- 9.4.6. Thailand
- 9.4.6.1. Key country dynamics
- 9.4.6.2. Thailand in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.6.3. Competitive/ market scenario
- 9.4.6.4. Regulatory framework
- 9.4.7. South Korea
- 9.4.7.1. Key country dynamics
- 9.4.7.2. South Korea in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.4.7.3. Competitive/ market scenario
- 9.4.7.4. Regulatory framework
- 9.5. Latin America
- 9.5.1. Latin America in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.5.2. Brazil
- 9.5.2.1. Key country dynamics
- 9.5.2.2. Brazil in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.5.2.3. Competitive/ market scenario
- 9.5.2.4. Regulatory framework
- 9.5.3. Mexico
- 9.5.3.1. Key country dynamics
- 9.5.3.2. Mexico in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.5.3.3. Competitive/ market scenario
- 9.5.3.4. Regulatory framework
- 9.5.4. Argentina
- 9.5.4.1. Key country dynamics
- 9.5.4.2. Argentina in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.5.4.3. Competitive/ market scenario
- 9.5.4.4. Regulatory framework
- 9.6. MEA
- 9.6.1. MEA in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.6.2. South Africa
- 9.6.2.1. Key country dynamics
- 9.6.2.2. South Africa in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.6.2.3. Competitive/ market scenario
- 9.6.2.4. Regulatory framework
- 9.6.3. Saudi Arabia
- 9.6.3.1. Key country dynamics
- 9.6.3.2. Saudi Arabia. in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.6.3.3. Competitive/ market scenario
- 9.6.3.4. Regulatory framework
- 9.6.4. UAE
- 9.6.4.1. Key country dynamics
- 9.6.4.2. UAE in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.6.4.3. Competitive/ market scenario
- 9.6.4.4. Regulatory framework
- 9.6.5. Kuwait
- 9.6.5.1. Key country dynamics
- 9.6.5.2. Kuwait in vitro diagnostics quality control market estimates and forecasts, 2018 - 2030 (USD Million)
- 9.6.5.3. Competitive/ market scenario
- 9.6.5.4. Regulatory framework
Chapter 10. Competitive Landscape
- 10.1. Company Categorization
- 10.2. Participant's Overview
- 10.3. Financial Performance
- 10.4. Product Benchmarking
- 10.4.1. In vitro diagnostics quality control market share analysis, 2023
- 10.4.2. Company market share, 2023 for plasma-based controls
- 10.4.3. Company market share, 2023 for serum-based controls
- 10.4.4. Company market share, 2023 for whole blood-based controls
- 10.5. Strategy Mapping
- 10.5.1. Mergers & acquisitions
- 10.5.2. Partnerships & collaborations
- 10.5.3. Expansion
- 10.5.4. Product approval & launch
- 10.5.5. Others
Chapter 11. Company Profiles
- 11.1. Company Categorization
- 11.2. Participant's Overview
- 11.2.1. Siemens Healthineers AG
- 11.2.2. Abbott
- 11.2.3. Bio-Rad Laboratories, Inc.
- 11.2.4. Danaher
- 11.2.5. F. Hoffmann-La Roche Ltd
- 11.2.6. Sysmex Corporation
- 11.2.7. QuidelOrtho Corporation
- 11.2.8. Randox Laboratories Ltd
- 11.2.9. Helena Laboratories Corporation
- 11.2.10. Thermo Fisher Scientific, Inc.
- 11.2.11. SeraCare Life Sciences, Inc.
- 11.2.12. BD
- 11.2.13. Merck KGaA
- 11.2.14. QIAGEN
- 11.2.15. Hologic, Inc.
- 11.2.16. Bio-Techne
- 11.2.17. Fortress Diagnostics
- 11.2.18. Microbiologics
- 11.2.19. TRINA BIOREACTIVES AG
- 11.2.20. ConeBioproducts
- 11.2.21. Biorex Diagnostics
- 11.3. Financial Performance
- 11.4. Product Benchmarking