세계의 체외진단(IVD) 품질관리 시장 : 전략과 동향, 어세이 유형별, 장소별, 제품별, 제조업체별, 국가별 예측 - 경영진 컨설턴트 가이드 포함(2025-2029년)

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.

The fundamentals are still here. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. A range of dynamic trends are pushing market growth and company valuations. The Quality Control industry stands to gain.

The report provides data that analysts and planners can use. Hundreds of pages of information including detailed information on clinical laboratory trends and the role of IVD. Forecast demand for new testing regimes or technologies. Make research investment decisions.

The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

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