세계의 체외진단제 품질관리 시장 : 제공, 판매업자, 용도, 최종 사용자별 예측(2025-2030년)

The In-Vitro Diagnostics Quality Control Market was valued at USD 1.37 billion in 2023, expected to reach USD 1.48 billion in 2024, and is projected to grow at a CAGR of 8.34%, to USD 2.41 billion by 2030.

In-Vitro Diagnostics (IVD) Quality Control refers to the processes and materials used to ensure accuracy and reliability in diagnostic tests performed outside the living body, such as blood tests and other lab analyses. This market's necessity lies in the critical role it plays in ensuring test accuracy, reducing false positives/negatives, and ensuring compliance with stringent regulatory standards. Applications range across clinical laboratories, hospitals, and academic/research institutions, with an end-use scope extending to monitoring disease progression, diagnosis of medical conditions, and drug therapy management. Key growth drivers include the increasing prevalence of chronic diseases, advancements in laboratory automation, and growing adoption of point-of-care testing. Recent technological innovations like molecular diagnostics and the integration of artificial intelligence in quality control processes offer fresh opportunities, especially as the demand for personalized medicine grows. To capitalize on these opportunities, companies should invest in R&D to develop more sophisticated, adaptive quality control solutions that address both existing and emerging diagnostic platforms. Nevertheless, the market faces certain limitations and challenges, including high costs associated with quality control products, regulatory hurdles, and a lack of standardization across different diagnostic devices. These challenges can hinder market growth by creating barriers to entry for smaller players. Despite these challenges, innovation should particularly focus on cost-effective solutions and interoperability between devices from different manufacturers to enhance market penetration. Overall, the IVD quality control market is characterized by rapid technological advancements and stringent oversight, requiring players to continuously adapt and innovate to maintain their competitive edge. Investment in targeted R&D, coupled with strategic partnerships and acquisitions, can further drive growth and increase market presence in this dynamic and evolving sector.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving In-Vitro Diagnostics Quality Control Market

The In-Vitro Diagnostics Quality Control Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Prevalence of chronic and infectious diseases and need for in-vitro diagnostics
  • Growing demand for point-of-care diagnostic technologies and third-party quality controls
  • Government regulations to ensure the safety of diagnostics devices and services
• Market Restraints
  • High cost of IVD quality control services
• Market Opportunities
  • R&D activities to introduce smart quality control for in-vitro diagnostics
  • Technological advancement in silicon technology and multianalyte controls
• Market Challenges
  • Stringent regulations for approval of IVD test products and inaccuracy issues

Porter's Five Forces: A Strategic Tool for Navigating the In-Vitro Diagnostics Quality Control Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the In-Vitro Diagnostics Quality Control Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the In-Vitro Diagnostics Quality Control Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the In-Vitro Diagnostics Quality Control Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the In-Vitro Diagnostics Quality Control Market

A detailed market share analysis in the In-Vitro Diagnostics Quality Control Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the In-Vitro Diagnostics Quality Control Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the In-Vitro Diagnostics Quality Control Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the In-Vitro Diagnostics Quality Control Market

A strategic analysis of the In-Vitro Diagnostics Quality Control Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the In-Vitro Diagnostics Quality Control Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Agilent Technologies, Inc., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, bioMerieux Inc., CalibreScientific Global Distribution, Inc., Danaher Corporation, Devyser AB, DiaSorin S.p.A., F. Hoffmann-La Roche Ltd., Fortress Diagnostics, Grifols, S.A., Hologic, Inc., Illumina, Inc., LGC Limited, Maine Molecular Quality Controls, Inc., Micro Bio Logics, Inc., Microbix Biosystems Inc., Ortho-Clinical Diagnostics, Inc., Qiagen N.V., Quidel Corporation, Randox Laboratories Ltd., Seegene Inc., Siemens AG, Streck, Inc., Sun Diagnostics, LLC, Sysmex Corporation, Thermo Fisher Scientific, Inc., and ZeptoMetrix Corporation.

Market Segmentation & Coverage

This research report categorizes the In-Vitro Diagnostics Quality Control Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Offering, market is studied across Data Management Solutions, Quality Assurance Services, and Quality Control Products. The Quality Control Products is further studied across Serum/Plasma-Based Controls, Urine-Based Controls, and Whole-Blood-Based Controls.
• Based on Distributor, market is studied across OEM and Third-Party Control Manufacturers. The Third-Party Control Manufacturers is further studied across Independent Manufacturer Controls and Instrument-Specific Controls.
• Based on Application, market is studied across Clinical Chemistry, Coagulation or Hemostasis, Hematology, Immunochemistry, Microbiology, and Molecular Diagnostics.
• Based on End-User, market is studied across Clinical Laboratories, Hospitals, and Research & Academic Institutes.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Prevalence of chronic and infectious diseases and need for in-vitro diagnostics
    • 5.1.1.2. Growing demand for point-of-care diagnostic technologies and third-party quality controls
    • 5.1.1.3. Government regulations to ensure the safety of diagnostics devices and services
  • 5.1.2. Restraints
    • 5.1.2.1. High cost of IVD quality control services
  • 5.1.3. Opportunities
    • 5.1.3.1. R&D activities to introduce smart quality control for in-vitro diagnostics
    • 5.1.3.2. Technological advancement in silicon technology and multianalyte controls
  • 5.1.4. Challenges
    • 5.1.4.1. Stringent regulations for approval of IVD test products and inaccuracy issues
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. In-Vitro Diagnostics Quality Control Market, by Offering

• 6.1. Introduction
• 6.2. Data Management Solutions
• 6.3. Quality Assurance Services
• 6.4. Quality Control Products
  • 6.4.1. Serum/Plasma-Based Controls
  • 6.4.2. Urine-Based Controls
  • 6.4.3. Whole-Blood-Based Controls

7. In-Vitro Diagnostics Quality Control Market, by Distributor

• 7.1. Introduction
• 7.2. OEM
• 7.3. Third-Party Control Manufacturers
  • 7.3.1. Independent Manufacturer Controls
  • 7.3.2. Instrument-Specific Controls

8. In-Vitro Diagnostics Quality Control Market, by Application

• 8.1. Introduction
• 8.2. Clinical Chemistry
• 8.3. Coagulation or Hemostasis
• 8.4. Hematology
• 8.5. Immunochemistry
• 8.6. Microbiology
• 8.7. Molecular Diagnostics

9. In-Vitro Diagnostics Quality Control Market, by End-User

• 9.1. Introduction
• 9.2. Clinical Laboratories
• 9.3. Hospitals
• 9.4. Research & Academic Institutes

10. Americas In-Vitro Diagnostics Quality Control Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific In-Vitro Diagnostics Quality Control Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa In-Vitro Diagnostics Quality Control Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Indian Subsidiary Acquires ISO13485 Certification
  • 13.3.2. Werfen Completes Acquisition of Immucor
  • 13.3.3. EDX Completes Acquisition of IVD Products Developer Torax Biosciences
  • 13.3.4. Siemens Healthineers and Unilabs Launch Strategic Partnership For Latest Diagnostic Testing Infrastructure To Improve Patients' Care
  • 13.3.5. UL Solutions Expands Scope For In Vitro Diagnostics
  • 13.3.6. Qiagen Unveils IVD Platform For Automated Sampling In Laboratories
  • 13.3.7. InDevR Raises $9 Million in Series B Financing and Partners with bioMerieux
  • 13.3.8. Veranex Acquires Devicia and Clarvin, Expanding Regulatory, Quality, and Clinical Expertise for IVD and Medical Devices
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Abbott Laboratories
• 2. Agilent Technologies, Inc.
• 3. Becton, Dickinson and Company
• 4. Bio-Rad Laboratories, Inc.
• 5. Bio-Techne Corporation
• 6. bioMerieux Inc.
• 7. CalibreScientific Global Distribution, Inc.
• 8. Danaher Corporation
• 9. Devyser AB
• 10. DiaSorin S.p.A.
• 11. F. Hoffmann-La Roche Ltd.
• 12. Fortress Diagnostics
• 13. Grifols, S.A.
• 14. Hologic, Inc.
• 15. Illumina, Inc.
• 16. LGC Limited
• 17. Maine Molecular Quality Controls, Inc.
• 18. Micro Bio Logics, Inc.
• 19. Microbix Biosystems Inc.
• 20. Ortho-Clinical Diagnostics, Inc.
• 21. Qiagen N.V.
• 22. Quidel Corporation
• 23. Randox Laboratories Ltd.
• 24. Seegene Inc.
• 25. Siemens AG
• 26. Streck, Inc.
• 27. Sun Diagnostics, LLC
• 28. Sysmex Corporation
• 29. Thermo Fisher Scientific, Inc.
• 30. ZeptoMetrix Corporation