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

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


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.

Global In-Vitro Diagnostics Quality Control Market 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 InsightsThe 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?

Note: PDF & Excel + Online Access - 1 Year


1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Limitations
1.7. Assumptions
1.8. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
4.1. Introduction
4.2. In-Vitro Diagnostics Quality Control Market, by Region
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Prevalence of chronic and infectious diseases and need for in-vitro diagnostics
5.1.1.2. Growing demand for point-of-care diagnostic technologies and third-party quality controls
5.1.1.3. Government regulations to ensure the safety of diagnostics devices and services
5.1.2. Restraints
5.1.2.1. High cost of IVD quality control services
5.1.3. Opportunities
5.1.3.1. R&D activities to introduce smart quality control for in-vitro diagnostics
5.1.3.2. Technological advancement in silicon technology and multianalyte controls
5.1.4. Challenges
5.1.4.1. Stringent regulations for approval of IVD test products and inaccuracy issues
5.2. Market Segmentation Analysis
5.3. Market Trend Analysis
5.4. Cumulative Impact of High Inflation
5.5. Porter’s Five Forces Analysis
5.5.1. Threat of New Entrants
5.5.2. Threat of Substitutes
5.5.3. Bargaining Power of Customers
5.5.4. Bargaining Power of Suppliers
5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework
6. In-Vitro Diagnostics Quality Control Market, by Offering
6.1. Introduction
6.2. Data Management Solutions
6.3. Quality Assurance Services
6.4. Quality Control Products
6.5.1. Serum/Plasma-Based Controls
6.5.2. Urine-Based Controls
6.5.3. Whole-Blood-Based Controls
7. In-Vitro Diagnostics Quality Control Market, by Distributor
7.1. Introduction
7.2. OEM
7.3. Third-Party Control Manufacturers
7.4.1. Independent Manufacturer Controls
7.4.2. Instrument-Specific Controls
8. In-Vitro Diagnostics Quality Control Market, by Application
8.1. Introduction
8.2. Clinical Chemistry
8.3. Coagulation or Hemostasis
8.4. Hematology
8.5. Immunochemistry
8.6. Microbiology
8.7. Molecular Diagnostics
9. In-Vitro Diagnostics Quality Control Market, by End-User
9.1. Introduction
9.2. Clinical Laboratories
9.3. Hospitals
9.4. Research & Academic Institutes
10. Americas In-Vitro Diagnostics Quality Control Market
10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States
11. Asia-Pacific In-Vitro Diagnostics Quality Control Market
11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.
10. South Korea
11.
11. Taiwan
11.
12. Thailand
11.
13. Vietnam
12. Europe, Middle East & Africa In-Vitro Diagnostics Quality Control Market
12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.
10. Nigeria
12.
11. Norway
12.
12. Poland
12.
13. Qatar
12.
14. Russia
12.
15. Saudi Arabia
12.
16. South Africa
12.
17. Spain
12.
18. Sweden
12.
19. Switzerland
12.
20. Turkey
12.
21. United Arab Emirates
12.
22. United Kingdom
13. Competitive Landscape
13.1. FPNV Positioning Matrix
13.2. Market Share Analysis, By Key Player
13.3. Competitive Scenario Analysis, By Key Player
13.3.1. Merger & Acquisition
13.3.1.1. Werfen Completes Acquisition of Immucor
13.3.1.2. EDX Completes Acquisition of IVD Products Developer Torax Biosciences
13.3.1.3. Veranex Acquires Devicia and Clarvin, Expanding Regulatory, Quality, and Clinical Expertise for IVD and Medical Devices
13.3.2. Agreement, Collaboration, & Partnership
13.3.2.1. Siemens Healthineers and Unilabs Launch Strategic Partnership For Latest Diagnostic Testing Infrastructure To Improve Patients’ Care
13.3.3. New Product Launch & Enhancement
13.3.3.1. Qiagen Unveils IVD Platform For Automated Sampling In Laboratories
13.3.4. Investment & Funding
13.3.4.1. InDevR Raises $9 Million in Series B Financing and Partners with bioMérieux
13.3.5. Award, Recognition, & Expansion
13.3.5.1. Indian Subsidiary Acquires ISO13
485 Certification
13.3.5.2. UL Solutions Expands Scope For In Vitro Diagnostics
14. Competitive Portfolio
14.1. Key Company Profiles
14.1.1. Abbott Laboratories
14.1.2. Agilent Technologies, Inc.
14.1.3. Becton, Dickinson and Company
14.1.4. Bio-Rad Laboratories, Inc.
14.1.5. Bio-Techne Corporation
14.1.6. bioMerieux Inc.
14.1.7. CalibreScientific Global Distribution, Inc.
14.1.8. Danaher Corporation
14.1.9. Devyser AB
14.1.
10. DiaSorin S.p.A.
14.1.
11. F. Hoffmann-La Roche Ltd.
14.1.
12. Fortress Diagnostics
14.1.
13. Grifols, S.A.
14.1.
14. Hologic, Inc.
14.1.
15. Illumina, Inc.
14.1.
16. LGC Limited
14.1.
17. Maine Molecular Quality Controls, Inc.
14.1.
18. Micro Bio Logics, Inc.
14.1.
19. Microbix Biosystems Inc.
14.1.
20. Ortho-Clinical Diagnostics, Inc.
14.1.
21. Qiagen N.V.
14.1.
22. Quidel Corporation
14.1.
23. Randox Laboratories Ltd.
14.1.
24. Seegene Inc.
14.1.
25. Siemens AG
14.1.
26. Streck, Inc.
14.1.
27. Sun Diagnostics, LLC
14.1.
28. Sysmex Corporation
14.1.
29. Thermo Fisher Scientific, Inc.
14.1.
30. ZeptoMetrix Corporation
14.2. Key Product Portfolio
15. Appendix
15.1. Discussion Guide
15.2. License & Pricing
FIGURE 1. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET RESEARCH PROCESS
FIGURE 2. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, 2023 VS 2030
FIGURE 3. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, 2018-2030 (USD MILLION)
FIGURE 4. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY REGION, 2023 VS 2030 (%)
FIGURE 5. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY REGION, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 6. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET DYNAMICS
FIGURE 7. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY OFFERING, 2023 VS 2030 (%)
FIGURE 8. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY OFFERING, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 9. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY DISTRIBUTOR, 2023 VS 2030 (%)
FIGURE 10. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY DISTRIBUTOR, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 11. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY APPLICATION, 2023 VS 2030 (%)
FIGURE 12. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY APPLICATION, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 13. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY END-USER, 2023 VS 2030 (%)
FIGURE 14. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY END-USER, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 15. AMERICAS IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
FIGURE 16. AMERICAS IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 17. UNITED STATES IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY STATE, 2023 VS 2030 (%)
FIGURE 18. UNITED STATES IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY STATE, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 19. ASIA-PACIFIC IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
FIGURE 20. ASIA-PACIFIC IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 21. EUROPE, MIDDLE EAST & AFRICA IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY COUNTRY, 2023 VS 2030 (%)
FIGURE 22. EUROPE, MIDDLE EAST & AFRICA IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SIZE, BY COUNTRY, 2023 VS 2024 VS 2030 (USD MILLION)
FIGURE 23. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET, FPNV POSITIONING MATRIX, 2023
FIGURE 24. IN-VITRO DIAGNOSTICS QUALITY CONTROL MARKET SHARE, BY KEY PLAYER, 2023

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