체외진단(IVD) 품질관리 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the in-Vitro diagnostics quality control market size was valued at USD 1.45 billion in 2025 and is estimated to grow from USD 1.51 billion in 2026 to reach USD 1.85 billion by 2031, at a CAGR of 4.15% during the forecast period (2026-2031).

This report is Segmented by Products & Services (Quality Control Products, Data Management Solutions, and Quality Assurance Services), Application (Immunochemistry, and More), End User (Hospitals, Independent Labs, IVD Manufacturers, Academic Institutes, and Ambulatory Labs), and Geography (North America, Europe, Asia-Pacific, MEA, and South America). Market Forecasts are in Value (USD).

Global In-Vitro Diagnostics Quality Control Market Trends and Insights

Growing Global Disease Burden

Chronic and infectious diseases are expanding test volumes that need daily quality oversight, driving direct growth in the in-vitro diagnostics quality control market. Non-communicable ailments accounted for 74% of global deaths in 2024, and rising diabetes prevalence boosts demand for glycated hemoglobin controls that laboratories must run at multiple levels each day. Oncology laboratories increased liquid biopsy volumes by 28% in 2025, yet fewer than 40% stock circulating tumor DNA materials with defined allele frequencies, leaving a compliance gap regulators have begun to question. Public health facilities in Brazil and Thailand tripled molecular control inventories during 2024-2025 outbreaks, underscoring how epidemiological swings escalate per-test quality costs. Quality spending now aligns more with disease volatility than routine growth, favoring vendors that can scale multi-analyte reference kits quickly. This trend will keep upward pressure on consumable demand even as laboratories adopt data platforms.

Expansion of Accredited Clinical Laboratories

Accreditation has shifted quality control from optional to mandatory spending, enlarging the in-vitro diagnostics quality control market across mature regions. The College of American Pathologists counted 8,200 accredited U.S. labs by December 2025, a 6% rise since 2023, after Medicare tied reimbursement eligibility to deemed-status recognition. ISO 15189 became a prerequisite for public procurement in Germany and France, prompting 1,400 private labs to launch compliance programs that require documented controls on every platform. China ordered all tertiary hospitals to secure ISO 15189 status by 2027, influencing roughly 3,000 facilities and fueling short-term spikes in bulk control purchases. Accreditation also pushes buyers toward suppliers that can provide certificates traceable to international reference methods, consolidating share among multinational vendors. Laboratories now treat control documentation as a credential for payer negotiations and public tenders.

Unfavorable Reimbursement Landscape

Payment cuts force laboratories to ration control use, weighing on near-term growth of the in-vitro diagnostics quality control market. Medicare's schedule has reduced test fees by a cumulative 8.5% since 2021 and more reductions are scheduled through 2027, prompting 42% of U.S. hospital labs to move from twice-daily to once-daily runs for stable analytes in 2025 surveys. Commercial insurers introduced prior authorization on molecular tests, shrinking volumes by 18% and delaying purchases of high-cost next-generation sequencing controls. German statutory payers negotiated a 3.2% tariff cut in 2025 that hit small independent labs hardest, as they lack the volume discounts enjoyed by national chains. Consolidation accelerated, with 127 U.S. independents acquired in 2025 because shrinking margins made standalone quality programs unsustainable. Suppliers face pressure to lower per-test costs or risk being replaced by in-house electronic quality schemes.

Other drivers and restraints analyzed in the detailed report include:

1. Technological Advancements in IVD Platforms
2. Shift Toward Decentralized and Point-of-Care Testing
3. Limited Laboratory Infrastructure in Emerging Regions

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Quality control products accounted for 71.32% of 2025 revenue, equal to about two-thirds of the in-vitro diagnostics quality control market, reflecting laboratories' continuing need for multi-level liquid and lyophilized reagents for daily instrument checks. Data management solutions, although still a smaller slice, are expanding at a 6.75% CAGR as laboratories adopt cloud platforms that automate Westgard rule application and flag instrument drift in real time. Roche's navify Quality Control Management demonstrated a 19% cut in unplanned downtime across 34 hospitals by triaging service calls before errors reached patients. Bio-Rad broadened its Liquichek line to 42 analytes per vial, lowering inventory complexity and sustaining reagent demand. At the same time, subscription analytics generate recurring revenue that offsets slowing vial growth.

Laboratories now evaluate suppliers on the combined value of reagents, middleware, and proficiency testing programs, a shift that re-orders procurement criteria toward end-to-end ecosystems. As a result, data platforms win share even when offered at premium prices because they quantify cost avoidance from prevented errors. The in-vitro diagnostics quality control market share for pure-play software is poised to rise as younger lab directors prioritize workflow efficiency over per-vial cost. Suppliers that cannot complement reagents with predictive analytics risk being relegated to second-tier status. Demand therefore tilts toward companies owning ISO-17025 plants plus software development teams, giving multinationals a scale edge.

Complete Report Scope:

• By Products & Services
  • Quality Control Products
  • Data Management Solutions
  • Quality Assurance Services
• By Application
  • Immunochemistry
  • Clinical Chemistry
  • Hematology
  • Molecular Diagnostics
  • Coagulation / Hemostasis
  • Microbiology & Infectious Disease
  • Point-Of-Care Testing
• By End User
  • Hospitals
  • Independent Clinical Laboratories
  • IVD Manufacturers & CROs
  • Academic & Research Institutes
  • Ambulatory & Physician Office Labs
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America captured 44.12% of 2025 revenue, underpinned by stringent CAP accreditation and CMS payment rules that reward documented quality, but growth now moderates as reimbursement cuts pressure laboratories to reduce daily control frequency. The United States alone accounts for more than three-quarters of regional spending, yet its cost-containment climate is pushing suppliers to offer value-based contracts that tie price to instrument uptime. Canada shows steadier momentum because provincial health plans have ring-fenced laboratory budgets through 2028.

Europe is the second-largest region, driven by Germany, France, and the United Kingdom, which together contributed roughly 62% of 2025 sales after the EU IVDR mandated lot-to-lot surveillance for every control shipment. Laboratories fast-tracked ISO 15189 certification to qualify for public tenders, adding about 1,400 new accredited sites in 2024-2025. Southern Europe lags due to fragmented payer systems, but convergence toward Northern standards is expected by 2028. The in-vitro diagnostics quality control market size tied to European public hospitals will likely edge higher as digital quality records become compulsory.

Asia-Pacific advances at a 5.65% CAGR through 2031, led by China's mandate that all tertiary hospitals secure ISO 15189 status by 2027, a move that touches about 3,000 institutions. India's private chains continue rolling out tier-2 city labs, broadening reach where facility density is under one lab per 100,000 people. Japan and South Korea remain mature but demand premium multi-level controls as ministries enforce daily QC logs. Emerging ASEAN markets wrestle with refrigeration gaps, so ambient-stable kits dominate orders. The Middle East and Africa still represent a small share, yet Gulf Cooperation Council spending on reference labs positions the region for mid-single-digit growth. South America's outlook hinges on Brazil and Argentina, where currency swings hinder capital equipment buys but keep consumable purchases resilient, anchoring a baseline for the in-vitro diagnostics quality control market share in the region.

1. Abbott Laboratories
2. Alpha Laboratories Ltd.
3. Bio-Rad Laboratories
4. Bio-Techne
5. bioMerieux
6. Danaher
7. DiaSorin
8. Roche
9. Fortress Diagnostics Ltd.
10. Grifols Diagnostic Solutions
11. Instand e.V.
12. LGC Clinical Diagnostics (SeraCare & Maine Standards)
13. Maine Molecular Quality Controls
14. Microbiologics
15. Qnostics Ltd.
16. QuidelOrtho
17. Randox Laboratories
18. Seegene
19. Seronorm AS
20. Siemens Healthineers
21. Streck Inc.
22. Sun Diagnostics LLC
23. Sysmex
24. Technopath Clinical Diagnostics
25. Thermo Fisher Scientific
26. ZeptoMetrix

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Growing Global Disease Burden
  • 4.2.2 Expansion of Accredited Clinical Laboratories
  • 4.2.3 Technological Advancements in IVD Platforms
  • 4.2.4 Shift Toward Decentralized and Point-of-Care Testing
  • 4.2.5 Increasing Regulatory Focus on Diagnostic Accuracy
  • 4.2.6 Digital Transformation and Data Integration in Laboratories
• 4.3 Market Restraints
  • 4.3.1 Unfavorable Reimbursement Landscape
  • 4.3.2 Limited Laboratory Infrastructure in Emerging Regions
  • 4.3.3 High Compliance and Validation Costs
  • 4.3.4 Supply Chain Vulnerabilities and Material Shortages
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Bargaining Power Of Suppliers
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Products & Services
  • 5.1.1 Quality Control Products
  • 5.1.2 Data Management Solutions
  • 5.1.3 Quality Assurance Services
• 5.2 By Application
  • 5.2.1 Immunochemistry
  • 5.2.2 Clinical Chemistry
  • 5.2.3 Hematology
  • 5.2.4 Molecular Diagnostics
  • 5.2.5 Coagulation / Hemostasis
  • 5.2.6 Microbiology & Infectious Disease
  • 5.2.7 Point-Of-Care Testing
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Independent Clinical Laboratories
  • 5.3.3 IVD Manufacturers & CROs
  • 5.3.4 Academic & Research Institutes
  • 5.3.5 Ambulatory & Physician Office Labs
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(Includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)}
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Alpha Laboratories Ltd.
  • 6.3.3 Bio-Rad Laboratories Inc.
  • 6.3.4 Bio-Techne Corporation
  • 6.3.5 bioMerieux SA
  • 6.3.6 Danaher Corporation (Beckman Coulter)
  • 6.3.7 DiaSorin S.p.A.
  • 6.3.8 F. Hoffmann-La Roche AG
  • 6.3.9 Fortress Diagnostics Ltd.
  • 6.3.10 Grifols Diagnostic Solutions
  • 6.3.11 Instand e.V.
  • 6.3.12 LGC Clinical Diagnostics (SeraCare & Maine Standards)
  • 6.3.13 Maine Molecular Quality Controls
  • 6.3.14 Microbiologics Inc.
  • 6.3.15 Qnostics Ltd.
  • 6.3.16 QuidelOrtho Corporation
  • 6.3.17 Randox Laboratories Ltd.
  • 6.3.18 Seegene Inc.
  • 6.3.19 Seronorm AS
  • 6.3.20 Siemens Healthineers AG
  • 6.3.21 Streck Inc.
  • 6.3.22 Sun Diagnostics LLC
  • 6.3.23 Sysmex Corporation
  • 6.3.24 Technopath Clinical Diagnostics
  • 6.3.25 Thermo Fisher Scientific Inc.
  • 6.3.26 ZeptoMetrix Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment