[187 Pages Report] The In-Vitro Diagnostics Quality Control Market size was estimated at USD 1.37 billion in 2023 and expected to reach USD 1.48 billion in 2024, at a CAGR 8.34% to reach USD 2.41 billion by 2030.

In-vitro diagnostics quality control is primarily utilized to ensure the accuracy and precision of diagnostic tests by observing and assessing the performance and functioning of medical instruments, equipment, processes, reagents, and personnel involved in the testing procedure. This quality control process involves various activities to assess the validity of results produced by in-vitro diagnostic tests. The growing incidence of non-communicable diseases and infectious diseases has expanded the need for high-quality in-vitro diagnostics testing methods. Third-party quality controls are in high demand due to the various services offered. Government regulations to ensure the safety of diagnostics devices and services are among the main factors increasing the use of in-vitro diagnostic quality control components. The high cost of IVD quality control services and the concerns associated with the inaccuracy of the testing methods impede their adoption in clinical laboratories and hospitals. Market players are conducting R&D activities to introduce efficient and smart quality control methods to sustain their utilization in healthcare & life sciences applications.

Regional Insights

The Americas is home to several large multinational companies that produce in-vitro diagnostic quality control instruments and accessories, with strong product lines distinguished by reliable performance and competitive pricing. Strict government regulations to maintain the quality of diagnostics products, powered by the U.S. FDA, Health Canada, and other regulatory authorities, have been elevating the need for effective in-vitro quality control methods in the Americas. Asia has various suppliers offering different in-vitro diagnostic quality control products at varying prices. Global players in Europe are conducting R&D activities to offer more comprehensive solutions, including multiple platforms and formats such as instrumentation, software, and consumables for quality control. With the growing prevalence of diseases and the need for in-vitro diagnostics across the Americas, Europe, and Asia, market players have been constantly working on acquiring approvals for their products from the respective regulatory bodies in the region.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the In-Vitro Diagnostics Quality Control Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the In-Vitro Diagnostics Quality Control Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

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:

  • Offering
    • Data Management Solutions
    • Quality Assurance Services
    • Quality Control Products
      • Serum/Plasma-Based Controls
      • Urine-Based Controls
      • Whole-Blood-Based Controls
  • Distributor
    • OEM
    • Third-Party Control Manufacturers
      • Independent Manufacturer Controls
      • Instrument-Specific Controls
  • Application
    • Clinical Chemistry
    • Coagulation or Hemostasis
    • Hematology
    • Immunochemistry
    • Microbiology
    • Molecular Diagnostics
  • End-User
    • Clinical Laboratories
    • Hospitals
    • Research & Academic Institutes

  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

The report offers valuable insights on the following aspects:

  1. Market Penetration: It presents comprehensive information on the market provided by key players.
  2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
  3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
  4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
  5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

  1. What is the market size and forecast of the In-Vitro Diagnostics Quality Control Market?
  2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the In-Vitro Diagnostics Quality Control Market?
  3. What are the technology trends and regulatory frameworks in the In-Vitro Diagnostics Quality Control Market?
  4. What is the market share of the leading vendors in the In-Vitro Diagnostics Quality Control Market?
  5. Which modes and strategic moves are suitable for entering the In-Vitro Diagnostics Quality Control Market?