Global In-Vitro Diagnostics Quality Control Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

By Product Type;

Quality Control Products, Data Management Solutions and Quality Assurance Services.

By Application;

Immunochemistry, Hematology, Molecular Diagnostics, Coagulation/Hemostasis and Others.

By Geography;

North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).
Report ID: Rn772117726 Published Date: January, 2025 Updated Date: February, 2025

Introduction

Global In-Vitro Diagnostics Quality Control Market (USD Million), 2021 - 2031

In the year 2024, the Global In-Vitro Diagnostics Quality Control Market was valued at USD 1,187.19 million. The size of this market is expected to increase to USD 1,615.60 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 4.5%.

The increase in the number of certified clinical laboratories offering reliable IVD-based diagnostic services is significantly boosting patient confidence and driving market demand. Key pathogens routinely diagnosed using multiplex PCR include HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachomatis (genital infections), G. lambardia, C. parvum (diarrheal diseases), and Leishmania spp. (Leishmaniasis). To ensure the quality and reliability of these diagnostic services, regulatory frameworks are periodically updated, aiming to enhance current standards and safeguard the quality of diagnostic services provided to patients. The high prevalence of diseases such as diabetes, cardiovascular conditions, and infectious diseases has increased the demand for diagnostic laboratories. Both private and public laboratories undergo accreditation procedures to meet industry standards, boost their procedure volume, and attract more patients. As the number of laboratories grows, so does the global demand for IVD Quality Control (QC) products. Laboratories accredited by CLIA can receive reimbursement through Medicare and Medicaid services.

According to the American Clinical Laboratory Association, over 7 billion lab tests are conducted annually in the U.S., with 80% of clinical decisions based on laboratory testing. The International Diabetes Federation (IDF) reported that in 2021, approximately 537 million people worldwide had diabetes, a figure expected to rise to around 643 million by 2030 and 783 million by 2045. The increasing number of diagnostic service providers and the rising demand for clinical diagnostic tests are driving the increased usage of IVD QC products.

  1. Introduction
    1. Research Objectives and Assumptions
    2. Research Methodology
    3. Abbreviations
  2. Market Definition & Study Scope
  3. Executive Summary
    1. Market Snapshot, By Product Type
    2. Market Snapshot, By Application
    3. Market Snapshot, By Region
  4. Global In-Vitro Diagnostics Quality Control Market Dynamics
    1. Drivers, Restraints and Opportunities
      1. Drivers
        1. Increasing demand for accurate and reliable IVD testing
        2. Stringent regulatory
      2. Restraints
        1. High initial investment costs
        2. Reimbursement challenges
      3. Opportunities
        1. Development of new and innovative quality
        2. Increasing focus on personalized medicine
    2. PEST Analysis
      1. Political Analysis
      2. Economic Analysis
      3. Social Analysis
      4. Technological Analysis
    3. Porter's Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of Substitutes
      4. Threat of New Entrants
      5. Competitive Rivalry

  5. Market Segmentation
    1. Global In-Vitro Diagnostics Quality Control Market, By Product Type, 2021 - 2031 (USD Million)
      1. Quality Control Products
      2. Data Management Solutions
      3. Quality Assurance Services
    2. Global In-Vitro Diagnostics Quality Control Market, By Application, 2021 - 2031 (USD Million)
      1. Immunochemistry
      2. Hematology
      3. Molecular Diagnostics
      4. Coagulation/Hemostasis
      5. Others
    3. Global In-Vitro Diagnostics Quality Control Market, By Geography, 2021 - 2031 (USD Million)
      1. North America
        1. United States
        2. Canada
      2. Europe
        1. Germany
        2. United Kingdom
        3. France
        4. Italy
        5. Spain
        6. Nordic
        7. Benelux
        8. Rest of Europe
      3. Asia Pacific
        1. Japan
        2. China
        3. India
        4. Australia & New Zealand
        5. South Korea
        6. ASEAN (Association of South East Asian Countries)
        7. Rest of Asia Pacific
      4. Middle East & Africa
        1. GCC
        2. Israel
        3. South Africa
        4. Rest of Middle East & Africa
      5. Latin America
        1. Brazil
        2. Mexico
        3. Argentina
        4. Rest of Latin America
  6. Competitive Landscape
    1. Company Profiles
      1. Abbott Laboratories
      2. Bio-Rad Laboratories Inc
      3. F. Hoffmann-La Roche AG
      4. Quidel Corporation
      5. bioMerieux Inc
      6. Qnostics Ltd
      7. Microbiologics Inc
      8. SeraCare Life Sciences Inc
      9. Thermo Fisher Scientific
      10. ZeptoMetrix Corporation
  7. Analyst Views
  8. Future Outlook of the Market