SHERIDAN, Wyo., Oct. 5, 2026 /PRNewswire/ — The global IVD quality control market is projected to grow from USD 1.7 billion in 2026 to USD 2.2 billion by 2031, registering a CAGR of 5.3% during the forecast period (2026–2031), according to a new study by Wissen Research.
Growth is being driven by rising testing volumes and complexity across clinical chemistry, immunoassay, hematology, and molecular diagnostics, alongside tightening regulatory requirements for laboratory quality assurance. Quality control materials and systems help laboratories verify the accuracy and precision of diagnostic results, and increasing adoption of internal quality controls, third-party control materials, and external quality assessment (EQA) programs is becoming a standard part of laboratory practice worldwide.
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Where Laboratory QC Is Heading: From Manual Checks to Connected Monitoring
Laboratories are shifting quality control from a manual, standalone activity into an automated process embedded directly within daily testing workflows. Commercial platforms such as Roche’s navify Lab Operations now provide integrated QC management, configurable QC rules, Levey-Jennings charting, third-party QC integration, and automated suspension of result transmission when a QC issue is detected, illustrating how QC is moving from a periodic check into a continuously monitored system.
A related development is patient-based real-time quality monitoring, which uses results from normal patient populations to flag shifts in analyzer performance between scheduled QC events, offering earlier warning of analytical drift without replacing conventional QC materials. At the same time, risk-based and individualized QC approaches are gaining ground: in the United States, the CDC’s Individualized Quality Control Plan (IQCP) allows laboratories to design QC procedures around their specific testing process and environment rather than applying fixed, one-size-fits-all QC frequencies. As testing continues to expand into decentralized and point-of-care settings, platforms like Roche’s navify POC Operations are extending centralized oversight, audit trails, and configurable alerts to testing locations outside the traditional laboratory.
What’s Fueling Growth in the IVD Quality Control Market
- Rising Testing Volume and Complexity: Expansion of molecular diagnostics, immunodiagnostics, and multiplex testing is increasing the number of analytical parameters laboratories must monitor.
- Regulatory Requirements: Frameworks such as CLIA require laboratories to maintain documented QC procedures, directly supporting adoption of internal QC, proficiency testing, and external quality assessment.
- Laboratory Automation: Growth in automated, high-throughput diagnostic systems is increasing demand for digital QC monitoring, statistical analysis, and automated rule evaluation.
- Point-of-Care Expansion: Decentralized testing is creating demand for simplified, easy-to-use QC products that verify performance outside centralized laboratories.
- Laboratory Standardization: Growing emphasis on standardized laboratory practices is driving utilization of third-party control reagents and external quality assessment programs.
Challenges Facing the IVD Quality Control Market
Laboratories operating multiple analyzers, assay types, and control materials face real difficulty standardizing QC requirements, acceptance criteria, and calibration procedures across platforms, making cross-platform performance comparison more complex. Implementation costs add a further constraint, particularly for smaller laboratories and decentralized testing sites, which must weigh not just the cost of QC materials but also investment in digital QC systems, staff training, and data management.
QC alone cannot guarantee accurate patient results. The World Health Organization emphasizes that quality control should form part of a broader quality-management system that also includes staff training, standard operating procedures, and proficiency testing, underscoring that QC materials are a necessary but not sufficient piece of laboratory quality assurance.
Recent Strategic Developments in the IVD Quality Control Market
In May 2026, RealBio of China signed a strategic agreement with Thermo Fisher Scientific to collaborate on comprehensive quality control solutions for in vitro diagnostics, combining Thermo Fisher’s global standards and technical depth with RealBio’s strengths in local regulatory support and IVD raw material development.
In July 2025, Siemens Healthineers became the first IVD manufacturer to earn the My Green Lab ACT Ecolabel for both its Atellica analyzers and more than 150 reagents, a certification that provides transparent environmental impact data covering factors such as energy use and waste.
These moves reflect an industry where established diagnostics companies are pairing global technical standards with local regulatory expertise to expand QC solutions internationally, alongside a growing focus on sustainability credentials for QC product lines.
Key Insights from IVD Quality Control Market Analysis
- Immunoassay/immunochemistry dominated the market by technology in 2025, supported by widespread use of automated immunochemistry systems and high testing volumes for hormones, tumor markers, cardiac markers, and infectious disease panels; a survey of 21 large academic medical centers found widespread use of third-party QC materials specifically for immunochemistry testing.
- Hospitals dominated the market by end user in 2025, driven by the sheer volume and diversity of testing performed across clinical chemistry, immunoassay, hematology, microbiology, and molecular platforms; a multicenter study across 13 hospitals in China found that automated QC reduced QC processing time from 30 minutes to 10 minutes while also producing a lower out-of-control rate than manual QC.
- North America held the largest regional share in 2025, supported by well-established clinical laboratory infrastructure, high adoption of automated IVD systems, and CLIA’s federal quality standards; the CDC notes that more than 14 billion laboratory tests are performed annually in the US alone.
- Asia-Pacific is the fastest-growing region, driven by expanding diagnostic infrastructure, rising testing volumes, and growing laboratory automation across China, India, Japan, and South Korea.
Key Players in the IVD Quality Control Market
Leading companies in the IVD quality control market are focused on innovation, strategic partnerships, and expansion of QC portfolios to strengthen their market position.
|
Company |
Key Focus Area |
|
Abbott Laboratories (US) |
QC materials for automated diagnostic platforms |
|
Roche Diagnostics (Switzerland) |
Integrated QC management and navify platforms |
|
QuidelOrtho Corporation (US) |
QC solutions across diagnostic instrument platforms |
|
Danaher Corporation (US) |
Diagnostics instruments and QC materials |
|
Siemens Healthineers AG (Germany) |
Atellica analyzer QC and sustainability-certified reagents |
|
Bio-Rad Laboratories, Inc. (US) |
Third-party QC and Unity interlaboratory comparison platform |
|
Thermo Fisher Scientific Inc. (US) |
QC reagents and diagnostics instrumentation |
|
Sysmex Corporation (Japan) |
Hematology QC materials |
|
Randox Laboratories Ltd. (UK) |
Third-party quality control materials |
|
LGC Limited (UK) |
Reference materials and QC standards |
|
Bio-Techne Corporation (US) |
QC reagents and controls |
|
Microbiologics Inc. (US) |
Microbiology QC reference materials |
Regional Analysis and Growth Opportunities
North America leads the IVD quality control market, supported by well-established clinical laboratory infrastructure, high adoption of automated IVD systems, and stringent laboratory quality requirements under CLIA. Strong adoption of third-party QC and digital QC management solutions, including platforms such as Bio-Rad’s Unity QC, which offers interlaboratory comparison and QC data management across major US diagnostic platforms, continues to reinforce the region’s leading position.
Asia-Pacific is the fastest-growing region, supported by expanding diagnostic infrastructure, increasing testing volumes, laboratory automation, and growing emphasis on standardized quality practices across China, India, Japan, and South Korea. Expansion of decentralized testing is creating parallel demand for simplified QC and quality-management systems suited to non-laboratory settings across the region.
Europe, Latin America, and the Middle East & Africa complete the report’s regional coverage, with growth supported by expanding laboratory accreditation requirements and rising adoption of digital QC management systems.
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Market Segmentation Snapshot
The global IVD quality control market is segmented across product, technology, manufacturer type, end user, and region:
- By Product:
- Quality Control Products (Whole Blood-Based, Serum/Plasma-Based, Urine-Based, Other Sample-Based)
- Data Management Solutions
- Quality Assurance Services
- By Technology:
- Immunochemistry
- Molecular Diagnostics
- Clinical Chemistry
- Microbiology
- Hematology
- Coagulation & Hemostasis
- Other Technologies
- By Manufacturer Type:
- Original Manufacturer Equipment Control
- Third-Party Control
- By End User:
- Clinical Laboratories
- Hospitals
- Research Laboratories & Institutes
- Other End Users
- By Region:
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa
Frequently Asked Questions
Q: What is the size of the IVD quality control market? A: The global IVD quality control market is estimated at USD 1.7 billion in 2026 and is projected to reach USD 2.2 billion by 2031.
Q: What is the growth rate of the IVD quality control market? A: The IVD quality control market is projected to grow at a CAGR of 5.3% between 2026 and 2031.
Q: Which technology segment leads the IVD quality control market? A: Immunoassay/immunochemistry dominated the market by technology in 2025, supported by widespread use of automated immunochemistry systems and high testing volumes for hormone, tumor marker, and infectious disease panels.
Q: Which end-user segment leads the IVD quality control market? A: Hospitals dominated the market by end user in 2025, driven by the volume and diversity of testing performed across clinical chemistry, immunoassay, hematology, microbiology, and molecular platforms.
Q: Which region leads the IVD quality control market? A: North America held the largest share of the IVD quality control market in 2025, while Asia-Pacific is the fastest-growing region through 2031.
Q: Who are the top players in the IVD quality control market?
A: Leading players in the IVD quality control market include Abbott Laboratories, Roche Diagnostics, QuidelOrtho Corporation, Danaher Corporation, and Siemens Healthineers AG.
As automated QC workflows, risk-based quality management, and point-of-care QC oversight continue to mature, IVD quality control is becoming an increasingly integrated part of laboratory operations rather than a standalone compliance task. For manufacturers, the path forward lies in continued investment in digital QC platforms, third-party control offerings, and solutions built for decentralized testing environments.
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Expert Profile | Mayur Jain, Wissen Research
Mayur Jain is a Research Expert at Wissen Research with multidomain expertise with more than 12+ years of experience in market research industry.
Email: mayur@wissenresearch.com
LinkedIn: https://www.linkedin.com/in/mayur-jain-0190542a/
About Wissen Research
Wissen Research is a global market intelligence and consulting firm specializing in healthcare, life sciences, technology, and emerging industries. The company provides data-driven insights, strategic market analysis, and industry forecasts to help organizations make informed business decisions and identify new growth opportunities across global markets
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