In-Vitro Diagnostics Quality Control

In-Vitro Diagnostics Quality Control Market by Offering (Data Management Solutions, Quality Assurance Services, Quality Control Products), Distributor (OEM, Third-Party Control Manufacturers), Application, End-User - Global Forecast 2024-2030

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[186 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 Market
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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.

In-Vitro Diagnostics Quality Control Market - Global Forecast 2024-2030
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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.

Recent Developments
  • Indian Subsidiary Acquires ISO13485 Certification

    The in-vitro diagnostics quality control market remains highly competitive, with companies striving to provide their customers with innovative solutions. Takara Bio Inc., a world leader in this space, recently launched its new Takara SYBR Premix Ex Taq II (Perfect Real Time) qPCR Kit. This kit provides users with enhanced performance and longer shelf life, thus enabling a more comprehensive range of applications and more reliable results. In addition, its improved sensitivity allows measurements that were once difficult or impossible to perform. With this next-generation qPCR Kit, Takara Bio further cements its place as the global leader in delivering effective and reliable in-vitro diagnostics solutions. [Published On: 2023-04-19]

  • Werfen Completes Acquisition of Immucor

    As part of its strategy to expand in the in-vitro diagnostics quality control market, Werfen recently acquired Immucor. This acquisition increases Werfen's portfolio in immunohematology and infectious disease products and strengthens its position as a leading global healthcare solutions provider. Immucor's presence in over 100 countries gives Werfen access to an international network of customers while also providing them with a comprehensive range of technologies, products, services, and support. Combining both companies will enable a better understanding and monitoring of patient health outcomes, which could lead to improved diagnostics that offer more accuracy and reliability for clinicians. This is a significant step ahead for the in-vitro diagnostics quality control market and will bring substantial growth opportunities. [Published On: 2023-03-16]

  • EDX Completes Acquisition of IVD Products Developer Torax Biosciences

    EDx's acquisition of Torax Biosciences is an exciting development to help equip laboratories with the necessary tools to deliver accurate results quickly and efficiently. This is especially beneficial for infectious disease testing, where speed and accuracy are essential for patient care. This move by EDx also increases its global presence and ability to respond quickly to customer needs across all time zones. Overall, this acquisition is essential in improving the quality of in vitro diagnostics globally. [Published On: 2023-02-20]

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?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. In-Vitro Diagnostics Quality Control Market, by Offering
  7. In-Vitro Diagnostics Quality Control Market, by Distributor
  8. In-Vitro Diagnostics Quality Control Market, by Application
  9. In-Vitro Diagnostics Quality Control Market, by End-User
  10. Americas In-Vitro Diagnostics Quality Control Market
  11. Asia-Pacific In-Vitro Diagnostics Quality Control Market
  12. Europe, Middle East & Africa In-Vitro Diagnostics Quality Control Market
  13. Competitive Landscape
  14. Competitive Portfolio
  15. List of Figures [Total: 24]
  16. List of Tables [Total: 558]
  17. List of Companies Mentioned [Total: 30]
Introduction to In-Vitro Diagnostics Quality Control
July 9, 2023
Introduction to In-Vitro Diagnostics Quality Control
In-vitro diagnostics are a critical part of modern healthcare delivery. They provide clinicians with vital information to guide appropriate medical decisions and treatment pathways. With the increasing demand and use of in-vitro diagnostic tests, testing procedures must remain accurate, reliable, and standardized. This is where quality control comes in. This blog post explores the importance of in-vitro diagnostics quality control and how it is evolving in response to smart technology advances.

Quality control measures must be in place to ensure the accuracy and reliability of in-vitro diagnostic tests. These measures should ensure that the test system performs within predetermined specifications and that any variation is detected and resolved. Quality control involves several steps, from specimen collection, handling, processing, and analysis. It requires using quality control materials or samples that mimic the patient specimen's characteristics and permit the assessment of laboratory performance.

Traditional quality control measures involve analyzing quality control materials alongside patient specimens to ensure the accuracy of results. However, this approach may not detect errors due to the system's stability or user errors. To address these limitations, smart quality control measures are being introduced. These measures involve using software and hardware to monitor performance continuously. The system generates alerts when performance characteristics deviate from predefined limits, enabling rapid response and instrument maintenance.

Smart quality control measures have several benefits, critical of which is increased efficiency. The continuous analysis and system performance monitoring reduces the need for manual testing at preset intervals and expedites issue resolution. Additionally, smart measures can provide real-time analysis of daily performance trends, enabling proactive decision-making for instrument maintenance and diagnostic performance.

In-vitro diagnostic quality control measures are also evolving in response to advances in testing technology. Point-of-care testing has gained popularity across different healthcare settings as it allows rapid, on-site diagnosis and treatment delivery. Introducing smart quality control measures for point-of-care testing will enable clinicians to receive real-time quality assurance results, which is critical in guiding treatment decisions.

In-vitro diagnostic quality control measures are important for ensuring the accuracy and reliability of laboratory diagnostic tests. Smart technology-driven approaches to quality control are gaining popularity, enabling continuous monitoring and swift error detection and resolution. With the increasing demand for rapid and accurate diagnostic tests, smart quality control measures are essential in ensuring clinicians can rely on accurate and reliable diagnostic performance. As technology continues to evolve, it is expected that in-vitro diagnostic smart quality control measures will continue to improve, ensuring that healthcare providers can deliver safe and effective care.

Frequently Asked Questions
  1. How big is the In-Vitro Diagnostics Quality Control Market?
    Ans. The Global 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.
  2. What is the In-Vitro Diagnostics Quality Control Market growth?
    Ans. The Global In-Vitro Diagnostics Quality Control Market to grow USD 2.41 billion by 2030, at a CAGR of 8.34%
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