目次

TABLE OF CONTENTS

1 INTRODUCTION
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.3 STUDY SCOPE
1.3.1 MARKETS COVERED & REGIONAL SCOPE
1.4 INCLUSIONS & EXCLUSIONS
1.4.1 YEARS CONSIDERED
1.5 CURRENCY CONSIDERED
1.6 KEY STAKEHOLDERS
1.7 SUMMARY OF CHANGES

2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
2.2 RESEARCH APPROACH
2.2.1 SECONDARY DATA
2.2.1.1 Key secondary sources
2.2.1.2 Key data from secondary sources
2.2.2 PRIMARY DATA
2.2.2.1 Primary sources
2.2.2.2 Key data from primary sources
2.2.2.3 Key industry insights
2.2.2.4 Breakdown of primary interviews
2.3 MARKET SIZE ESTIMATION
2.3.1 BOTTOM-UP APPROACH
2.3.1.1 Approach 1: Company revenue estimation approach
2.3.1.2 Approach 2: Presentations of companies and primary interviews
2.3.1.3 Growth forecast
2.3.1.4 CAGR projections
2.3.2 TOP-DOWN APPROACH
2.4 MARKET BREAKDOWN & DATA TRIANGULATION
2.5 MARKET SHARE ASSESSMENT
2.6 RESEARCH ASSUMPTIONS
2.6.1 PARAMETRIC ASSUMPTIONS
2.7 RESEARCH LIMITATIONS
2.8 RISK ASSESSMENT

3 EXECUTIVE SUMMARY

4 PREMIUM INSIGHTS
4.1 IVD QUALITY CONTROLS MARKET OVERVIEW
4.2 IVD QUALITY CONTROLS MARKET, BY PRODUCT & SERVICE, 2025 VS. 2030
4.3 IVD QUALITY CONTROLS MARKET, BY TECHNOLOGY, 2025 VS. 2030
4.4 IVD QUALITY CONTROLS MARKET, BY MANUFACTURER TYPE, 2025 VS. 2030
4.5 IVD QUALITY CONTROLS MARKET, BY END USER, 2025 VS. 2030
4.6 IVD QUALITY CONTROLS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES

5 MARKET OVERVIEW
5.1 INTRODUCTION
5.2 MARKET DYNAMICS
5.2.1 DRIVERS
5.2.1.1 Increasing number of accredited clinical laboratories
5.2.1.2 Growing adoption of third-party quality controls
5.2.1.3 Rising demand for external quality assessment support
5.2.1.4 Rising geriatric population and subsequent growth in prevalence of chronic and infectious diseases
5.2.1.5 Increasing adoption of POC instruments in developed regions
5.2.2 RESTRAINTS
5.2.2.1 Additional costs and budget constraints in hospitals and laboratories
5.2.2.2 Unfavorable reimbursement scenario for IVD tests
5.2.3 OPPORTUNITIES
5.2.3.1 Rising demand for multianalyte controls
5.2.3.2 Increasing growth opportunities in emerging economies
5.2.4 CHALLENGES
5.2.4.1 Stringent product approval process
5.2.4.2 Lack of regulations for clinical laboratory accreditation in several emerging countries
5.3 PRICING ANALYSIS
5.3.1 AVERAGE SELLING PRICE TREND OF IVD QUALITY CONTROL PRODUCTS, 2023-2025
5.3.2 AVERAGE SELLING PRICE TREND OF IVD QUALITY CONTROLS, BY KEY PLAYER, 2023-2025
5.3.3 AVERAGE SELLING PRICE TREND OF IVD QUALITY CONTROL PRODUCTS, BY REGION, 2023-2025
5.4 PATENT ANALYSIS
5.4.1 LIST OF MAJOR PATENTS
5.5 VALUE CHAIN ANALYSIS
5.6 SUPPLY CHAIN ANALYSIS
5.7 TRADE ANALYSIS
5.7.1 IMPORT DATA (HS CODE 3822)
5.7.2 EXPORT DATA (HS CODE 3822)
5.8 ECOSYSTEM ANALYSIS
5.8.1 IVD QUALITY CONTROLS MARKET: ROLE OF COMPANIES IN ECOSYSTEM
5.9 PORTER'S FIVE FORCES ANALYSIS
5.9.1 THREAT OF NEW ENTRANTS
5.9.2 THREAT OF SUBSTITUTES
5.9.3 BARGAINING POWER OF BUYERS
5.9.4 BARGAINING POWER OF SUPPLIERS
5.9.5 INTENSITY OF COMPETITIVE RIVALRY
5.10 REGULATORY ANALYSIS
5.10.1 REGULATORY FRAMEWORK
5.10.1.1 North America
5.10.1.1.1 US
5.10.1.1.2 Canada
5.10.1.2 Europe
5.10.1.2.1 Germany
5.10.1.2.2 UK
5.10.1.2.3 France
5.10.1.2.4 Italy
5.10.1.3 Asia Pacific
5.10.1.3.1 China
5.10.1.3.2 Japan
5.10.1.3.3 India
5.10.1.4 Latin America
5.10.1.4.1 Brazil
5.10.1.4.2 Mexico
5.10.1.5 Middle East
5.10.1.6 Africa
5.10.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
5.11 TECHNOLOGY ANALYSIS
5.11.1 KEY TECHNOLOGIES
5.11.1.1 Immunoassays
5.11.2 COMPLEMENTARY TECHNOLOGIES
5.11.2.1 Molecular diagnostics
5.11.3 ADJACENT TECHNOLOGIES
5.11.3.1 Clinical chemistry
5.12 KEY CONFERENCES & EVENTS, 2025-2026
5.13 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS' BUSINESSES
5.14 KEY STAKEHOLDERS & BUYING CRITERIA
5.14.1 KEY STAKEHOLDERS IN BUYING PROCESS
5.14.2 BUYING CRITERIA
5.15 INVESTMENT & FUNDING SCENARIO
5.16 CASE STUDY ANALYSIS
5.16.1 CASE STUDY 1: QUALITY CONTROL DATA MANAGEMENT WITH UNITY REAL-TIME IN MOLECULAR VIROLOGY
5.16.2 CASE STUDY 2: ENHANCING RELIABILITY OF INFLUENZA DIAGNOSTICS WITH EXTERNAL QUALITY CONTROLS
5.17 IMPACT OF AI/GENERATIVE AI ON IVD QUALITY CONTROLS MARKET
5.17.1 INTRODUCTION
5.17.2 MARKET POTENTIAL OF AI
5.17.3 AI USE CASES
5.17.4 IMPLEMENTATION OF AI, BY KEY COMPANY AND USE CASE
5.17.5 FUTURE OF AI IN IVD QUALITY CONTROLS MARKET
5.18 IMPACT OF 2025 US TARIFFS ON IVD QUALITY CONTROLS MARKET
5.18.1 INTRODUCTION
5.18.2 KEY TARIFF RATES
5.18.3 PRICE IMPACT ANALYSIS
5.18.4 IMPACT ON COUNTRY/REGION
5.18.4.1 North America
5.18.4.2 Europe
5.18.4.3 Asia Pacific
5.18.5 IMPACT ON END-USE INDUSTRIES
5.18.5.1 Hospitals
5.18.5.2 Clinical laboratories
5.18.5.3 Academic & research institutes

6 IVD QUALITY CONTROLS MARKET, BY PRODUCT & SERVICE
6.1 INTRODUCTION
6.2 QUALITY CONTROL PRODUCTS
6.2.1 SERUM/PLASMA-BASED CONTROLS
6.2.1.1 Greater stability and accuracy of diagnostic test results to increase demand for serum/plasma-based controls
6.2.2 WHOLE BLOOD-BASED CONTROLS
6.2.2.1 Rising need to ensure high-quality clinical test results to drive market
6.2.3 URINE-BASED CONTROLS
6.2.3.1 Growing incidence of kidney diseases to drive demand for urine-based controls
6.2.4 OTHER CONTROLS
6.3 DATA MANAGEMENT SOLUTIONS
6.3.1 RISING FOCUS ON IMPROVING ANALYTICAL PERFORMANCE OF CLINICAL LABORATORIES TO SUPPORT MARKET GROWTH
6.4 QUALITY ASSURANCE SERVICES
6.4.1 GROWING NEED FOR PERFORMANCE ASSESSMENT OF CLINICAL LABORATORIES TO INCREASE DEMAND FOR QUALITY ASSURANCE SERVICES

7 IVD QUALITY CONTROLS MARKET, BY TECHNOLOGY
7.1 INTRODUCTION
7.2 IMMUNOASSAYS
7.2.1 FOCUS ON MONITORING PRECISION OF IMMUNOASSAY TESTS TO DRIVE ADOPTION OF IMMUNOASSAY CONTROLS
7.3 CLINICAL CHEMISTRY
7.3.1 RISING INCIDENCE OF LIFESTYLE DISEASES TO PROVIDE OPPORTUNITIES FOR MARKET GROWTH
7.4 MOLECULAR DIAGNOSTICS
7.4.1 GROWING INCIDENCE OF INFECTIOUS DISEASES TO DRIVE DEMAND FOR MOLECULAR DIAGNOSTIC CONTROLS
7.5 MICROBIOLOGY
7.5.1 INCREASING ADOPTION OF AUTOMATED CLINICAL MICROBIOLOGY TESTING INSTRUMENTS TO SUPPORT MARKET GROWTH
7.6 HEMATOLOGY
7.6.1 NEED FOR ACCURACY IN HEMATOLOGICAL TEST RESULTS TO DRIVE RELIANCE ON HEMATOLOGY QUALITY CONTROLS
7.7 COAGULATION & HEMOSTASIS
7.7.1 GROWING NUMBER OF CARDIOVASCULAR SURGERIES TO DRIVE DEMAND FOR COAGULATION & HEMOSTASIS TESTING
7.8 OTHER TECHNOLOGIES

8 IVD QUALITY CONTROLS MARKET, BY MANUFACTURER TYPE
8.1 INTRODUCTION
8.2 THIRD-PARTY CONTROLS
8.2.1 INDEPENDENT CONTROLS
8.2.1.1 Unbiased and independent performance assessment for analytical processes to drive adoption
8.2.2 INSTRUMENT-SPECIFIC CONTROLS
8.2.2.1 Dependence on instrument-specific compatibility to restrict demand
8.3 ORIGINAL EQUIPMENT MANUFACTURER CONTROLS
8.3.1 OEM CONTROLS TO WITNESS LOWER ADOPTION AS THEY ARE LESS SENSITIVE TO QC-RELATED ISSUES

9 IVD QUALITY CONTROLS MARKET, BY END USER
9.1 INTRODUCTION
9.2 HOSPITALS
9.2.1 LARGE VOLUME OF IVD PROCEDURES PERFORMED TO DRIVE MARKET
9.3 CLINICAL LABORATORIES
9.3.1 GROWING NUMBER OF ACCREDITED LABORATORIES TO DRIVE MARKET
9.4 ACADEMIC & RESEARCH INSTITUTES
9.4.1 RISING FOCUS ON ACCURATE RESEARCH RESULTS TO SUPPORT MARKET GROWTH
9.5 OTHER END USERS

10 IVD QUALITY CONTROLS MARKET, BY REGION
10.1 INTRODUCTION
10.2 NORTH AMERICA
10.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA
10.2.2 US
10.2.2.1 High healthcare expenditure to propel market growth
10.2.3 CANADA
10.2.3.1 Government initiatives and research funding to support market growth
10.3 EUROPE
10.3.1 MACROECONOMIC OUTLOOK FOR EUROPE
10.3.2 GERMANY
10.3.2.1 Rising volume of high-quality tests performed to support market growth
10.3.3 UK
10.3.3.1 Growing number of diagnostic centers to drive market
10.3.4 FRANCE
10.3.4.1 Increasing prevalence of infectious diseases and growing demand for early diagnosis to drive market
10.3.5 ITALY
10.3.5.1 Growing disease prevalence to drive demand for better and more accurate disease diagnosis
10.3.6 SPAIN
10.3.6.1 Rising incidence of chronic diseases to support market growth
10.3.7 RUSSIA
10.3.7.1 Increasing access to quality healthcare and growing incidence of lifestyle and infectious diseases to drive market
10.3.8 REST OF EUROPE
10.4 ASIA PACIFIC
10.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC
10.4.2 CHINA
10.4.2.1 Growing access to modern healthcare and government support to boost market growth
10.4.3 JAPAN
10.4.3.1 Well-developed healthcare system and demand for improvements in quality of IVD test results to drive market
10.4.4 INDIA
10.4.4.1 Rising need to secure NABL accreditations to drive demand for quality controls
10.4.5 AUSTRALIA
10.4.5.1 Initiatives to enhance access to healthcare and improve infrastructure to propel market growth
10.4.6 SOUTH KOREA
10.4.6.1 Rising healthcare expenditure and growing number of hospitals to drive market
10.4.7 REST OF ASIA PACIFIC
10.5 LATIN AMERICA
10.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA
10.5.2 BRAZIL
10.5.2.1 Brazil to dominate Latin American IVD quality controls market
10.5.3 MEXICO
10.5.3.1 Increasing number of accredited clinical laboratories to support market growth
10.5.4 REST OF LATIN AMERICA
10.6 MIDDLE EAST & AFRICA
10.6.1 MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA
10.6.2 SAUDI ARABIA
10.6.2.1 Rising government healthcare expenditure to boost market
10.6.3 UAE
10.6.3.1 Improvements in healthcare infrastructure to support growth
10.6.4 REST OF MIDDLE EAST & AFRICA

11 COMPETITIVE LANDSCAPE
11.1 INTRODUCTION
11.2 KEY PLAYER STRATEGIES/RIGHT TO WIN
11.2.1 OVERVIEW OF STRATEGIES DEPLOYED BY PLAYERS IN IVD QUALITY CONTROLS MARKET
11.3 REVENUE ANALYSIS, 2022-2024
11.4 MARKET SHARE ANALYSIS, 2024
11.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024
11.5.1 STARS
11.5.2 EMERGING LEADERS
11.5.3 PERVASIVE PLAYERS
11.5.4 PARTICIPANTS
11.5.5 COMPANY FOOTPRINT: KEY PLAYERS, 2024
11.5.5.1 Company footprint
11.5.5.2 Region footprint
11.5.5.3 Product & service footprint
11.5.5.4 Technology footprint
11.5.5.5 Manufacturer type footprint
11.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024
11.6.1 PROGRESSIVE COMPANIES
11.6.2 RESPONSIVE COMPANIES
11.6.3 DYNAMIC COMPANIES
11.6.4 STARTING BLOCKS
11.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2024
11.6.5.1 Detailed list of key startups/SMEs
11.6.5.2 Competitive benchmarking of key emerging players/startups, by product & service and manufacturer type
11.6.5.3 Competitive benchmarking of key startups/SMEs, by region
11.7 COMPANY VALUATION & FINANCIAL METRICS
11.7.1 FINANCIAL METRICS
11.7.2 COMPANY VALUATION
11.8 BRAND/PRODUCT COMPARISON
11.8.1 BRAND/PRODUCT COMPARATIVE ANALYSIS
11.9 COMPETITIVE SCENARIO
11.9.1 PRODUCT & SERVICE LAUNCHES AND APPROVALS
11.9.2 DEALS
11.9.3 EXPANSIONS

12 COMPANY PROFILES
12.1 KEY PLAYERS
12.1.1 BIO-RAD LABORATORIES, INC.
12.1.1.1 Business overview
12.1.1.2 Products & services offered
12.1.1.3 Recent developments
12.1.1.3.1 Product & service launches
12.1.1.3.2 Deals
12.1.1.4 MnM view
12.1.1.4.1 Key strengths
12.1.1.4.2 Strategic choices
12.1.1.4.3 Weaknesses & competitive threats
12.1.2 THERMO FISHER SCIENTIFIC, INC.
12.1.2.1 Business overview
12.1.2.2 Products & services offered
12.1.2.3 Recent developments
12.1.2.3.1 Deals
12.1.2.4 MnM view
12.1.2.4.1 Key strengths
12.1.2.4.2 Strategic choices
12.1.2.4.3 Weaknesses & competitive threats
12.1.3 ABBOTT
12.1.3.1 Business overview
12.1.3.2 Products & services offered
12.1.3.3 MnM view
12.1.3.3.1 Key strengths
12.1.3.3.2 Strategic choices
12.1.3.3.3 Weaknesses & competitive threats
12.1.4 LGC LIMITED
12.1.4.1 Business overview
12.1.4.2 Products & services offered
12.1.4.3 Recent developments
12.1.4.3.1 Deals
12.1.4.4 MnM view
12.1.4.4.1 Key strengths
12.1.4.4.2 Strategic choices
12.1.4.4.3 Weaknesses & competitive threats
12.1.5 F. HOFFMANN-LA ROCHE LTD.
12.1.5.1 Business overview
12.1.5.2 Products & services offered
12.1.5.3 Recent developments
12.1.5.3.1 Deals
12.1.5.4 MnM view
12.1.5.4.1 Key strengths
12.1.5.4.2 Strategic choices
12.1.5.4.3 Weaknesses & competitive threats
12.1.6 RANDOX LABORATORIES LTD.
12.1.6.1 Business overview
12.1.6.2 Products & services offered
12.1.6.3 Recent developments
12.1.6.3.1 Product & service launches
12.1.6.3.2 Deals
12.1.7 SIEMENS HEALTHINEERS AG
12.1.7.1 Business overview
12.1.7.2 Products & services offered
12.1.8 QUIDELORTHO CORPORATION
12.1.8.1 Business overview
12.1.8.2 Products & services offered
12.1.8.3 Recent developments
12.1.8.3.1 Deals
12.1.8.3.2 Expansions
12.1.9 DANAHER CORPORATION
12.1.9.1 Business overview
12.1.9.2 Products & services offered
12.1.10 SYSMEX CORPORATION
12.1.10.1 Business overview
12.1.10.2 Products & services offered
12.1.10.3 Recent developments
12.1.10.3.1 Product & service launches
12.1.10.3.2 Deals
12.1.10.3.3 Expansions
12.1.11 BIO-TECHNE CORPORATION
12.1.11.1 Business overview
12.1.11.2 Products & services offered
12.1.11.3 Recent developments
12.1.11.3.1 Product & service launches
12.1.11.3.2 Deals
12.1.11.3.3 Expansions
12.1.12 MICROBIX BIOSYSTEMS INC.
12.1.12.1 Business overview
12.1.12.2 Products & services offered
12.1.12.3 Recent developments
12.1.12.3.1 Product & service launches
12.1.12.3.2 Deals
12.1.13 GRIFOLS, S.A.
12.1.13.1 Business overview
12.1.13.2 Products & services offered
12.1.14 MICROBIOLOGICS, INC.
12.1.14.1 Business overview
12.1.14.2 Products & services offered
12.1.14.3 Recent developments
12.1.14.3.1 Deals
12.1.15 ZEPTOMETRIX
12.1.15.1 Business overview
12.1.15.2 Products & services offered
12.1.15.3 Recent developments
12.1.15.3.1 Product & service launches & approvals
12.1.16 FORTRESS DIAGNOSTICS
12.1.16.1 Business overview
12.1.16.2 Products & services offered
12.2 OTHER PLAYERS
12.2.1 HELENA LABORATORIES CORPORATION
12.2.2 STRECK, INC.
12.2.3 MAINE MOLECULAR QUALITY CONTROLS, INC.
12.2.4 SUN DIAGNOSTICS, LLC
12.2.5 SERO AS
12.2.6 CONEBIOPRODUCTS
12.2.7 ALPHA-TEC
12.2.8 EUROTROL B.V.
12.2.9 BIOREX DIAGNOSTICS

13 APPENDIX
13.1 DISCUSSION GUIDE
13.2 KNOWLEDGESTORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL
13.3 CUSTOMIZATION OPTIONS
13.4 RELATED REPORTS
13.5 AUTHOR DETAILS