The global In Vitro Diagnostics (IVD) Quality Control Market is projected to grow at a CAGR of 3.8% from 2024 to 2031, reaching USD 1.2 billion by 2031. North America dominates the market, accounting for 35% of the global share. Key metrics include increasing demand for accurate diagnostic tests, rising prevalence of chronic and infectious diseases, and growing awareness about the importance of quality control in laboratory testing.
Driven by the expanding domain of in vitro diagnostics, tight regulatory standards for laboratory testing, and the need of standardising diagnostic processes, the IVD Quality Control Market is gradually increasing. As healthcare systems all around focus on improving patient outcomes by accurate and reliable diagnostics, the market for premium IVD quality control products and services keeps growing.
Market Trend: Integration of AI and machine learning in IVD quality control
The mix of artificial intelligence (AI) and machine learning (ML) is a significant development in IVD quality control processes. These technologies are helping to increase the accuracy, efficiency, and predictability of quality control systems in diagnostic laboratories. AI-powered quality control systems can identify trends and anomalies in massive amounts of data from multiple instruments and tests that might not be obvious with more traditional methods. This tendency is demonstrated by the development of advanced quality control tools able to predict prospective instrument failures or reagent problems before they influence test findings. For instance, Roche Diagnostics is implementing artificial intelligence algorithms into their quality control systems to provide real-time insights and automate decision-making processes. Adoption of artificial intelligence and machine learning in IVD quality control not only improving the dependability of diagnostic tests but also simplifying laboratory operations and decreasing of danger of mistakes.
Market Driver: Increasing regulatory scrutiny and quality standards fuel market growth
Strict regulatory regulations and evolving quality standards are the primary drivers of IVD Quality Control Market growth in the in vitro diagnostics industry. Globally, authorities including the FDA in the United States and the IVDR in Europe are enforcing tougher rules for laboratory testing and quality control processes. These guidelines emphasise the need of consistent performance of diagnostic tests and comprehensive quality control systems. For example, the EU In Vitro Diagnostic Regulation (IVDR) set in place in 2022 has significantly increased the bar for quality control standards in Europe, therefore creating more need for complex quality control products and services. Furthermore motivating laboratories to apply more sophisticated quality control techniques are accreditation programs including ISO 15189 requirements and the College of American Pathologists (CAP). IVD producers and diagnostic labs are driven to invest in robust quality control systems by this regulatory environment, therefore fostering significant market development and quality control product and solution innovation.
Market Restraint: Cost pressures and budget constraints in healthcare systems
Particularly in settings with limited resources, the substantial costs involved in setting and maintaining comprehensive IVD quality control systems seriously impede market development. While correct diagnosis results depend on quality control, the ongoing expenses related to supplies, proficiency testing, and advanced data management systems might be somewhat significant. Many smaller labs and medical facilities in poor areas struggle to devote enough money for modern quality control systems. Moreover, the pressure of many countries to reduce healthcare expenditures leads to analysis of laboratory expenses including quality control budgets. This cost sensitivity can cause some facilities to use less comprehensive systems in place of careful quality control practices. The IVD Quality Control Market struggles to supply competitively cost solutions that maintain high standards of quality assurance while nevertheless being within reaching range for a greater spectrum of healthcare providers. Reaching general acceptance of modern IVD quality control strategies still rely on balancing the requirement for comprehensive quality control with financial constraints.
Quality Control Products: Driven by its basic relevance in ensuring the accuracy and dependability of diagnostic tests, the Quality Control Products segment controls the In Vitro Diagnostics (IVD) Quality Control Market. Among the items discussed in this section are third-party controls, instrument-specific controls, and calibrators placed across many diagnostic fields.
Recently included into the quality control products market are multi-analyte controls, which may be employed across different test platforms and thereby reduce the complexity and cost of quality control processes. For instance, Bio-Rad Laboratories launched its Unity Interlaboratory Program, which provides data management tools and peer comparison capabilities for numerous types of quality control components.
Statistics reveal that the IVD quality control products market is expected to reach USD 850 million by 2026, with a substantial portion of development ascribed to the increasing acceptance of molecular diagnostics tests. These are highly sought for since almost 40% of the income of the market comes from demand for quality control products in clinical chemistry and immunoassay testing.
Dominating Region: North America North America leads in IVD quality control innovation and adoption
North America controls the In Vitro Diagnostics (IVD) Quality Control Market thanks to its advanced healthcare system, rigorous regulatory environment, and strong acceptance of innovative diagnostic technologies. The leadership of the region is driven by a combination of factors including a mature IVD market, significant investment in healthcare quality improvement, and the presence of major IVD manufacturers and quality control product providers.
Especially the United States explains the largest share of the North American IVD Quality Control Market. This dominance can be explained in part by the huge volume of diagnostic tests performed annually, a strong emphasis on laboratory accreditation and quality assurance, and active adoption of new quality control technology by clinical laboratories. The robust local healthcare reimbursement system also encourages the implementation of comprehensive quality control measures.
Recent occurrences highlight the area's will to raise IVD quality control. Strong quality control systems in diagnosis testing are even more important shown by the FDA's constant efforts to harmonise quality control techniques and implementation of new guidelines for laboratory-developed tests (LDTs).Notable people stress North America's market supremacy. From USD 350 million in 2023, the IVD Quality Control Market in the region is estimated to reach USD 420 million by 2031. Clinical chemistry and immunoassay quality control products account about 45% of the regional market share; molecular diagnostics comes second at 25%.
The In Vitral Diagnostics (IVD) Quality Control Market is defined by the presence of several well-known companies and specialised quality control product makers. Key companies such Bio-Rad Laboratories, Roche Diagnostics, and Thermo Fisher Scientific rule with full quality control product ranges and huge worldwide presence. Market leaders give expanding their product lines top importance both through strategic acquisitions and internal R&D.
Mergers and acquisitions are somewhat typical as Thermo Fisher Scientific bought Mesa Biotech to enhance its molecular diagnostics and quality control offers. Emerging trends include the development of industry-specific quality control materials—such those suited for SARS-CoV-2 testing—and the integration of data analytics technologies for better quality management.
Aiming for instrument-specific control materials and integrated quality management solutions, relationships between IVD manufacturers and quality control product providers are on the increase. Furthermore drawing increased interest in the sector are multi-analyte control materials that can be used across many test systems and offer laboratories cost-effective and simpler inventory management. Future improvements in molecular diagnostic quality control products, greater attention on growing nations with changing laboratory infrastructure, and extension of quality control solutions for point-of-care testing devices lead to continuous increase.
Driven by the increased focus on precision medicine and the growing complexity of diagnostic tests, the In Vitro Diagnostics (IVD) Quality Control Market is at a key junctur. Our studies reveal that the market is switching from a compliance-oriented strategy to a more proactive, data-driven quality control one.
Rising IVD quality control of "Continuous Quality Improvement" (CQI) models is one especially observed trend. This approach continually monitors and maximises diagnostic test performance using real-time data analytics and machine learning beyond traditional quality control techniques. In accordance with the broader shift towards value-based healthcare, the CQI paradigm offers enormous potential to greatly increase the dependability and efficiency of diagnostic testing processes.
Bio-Rad Laboratories, Inc.
Roche Diagnostics
Thermo Fisher Scientific Inc.
Siemens Healthineers AG
Abbott Laboratories
Randox Laboratories Ltd.
Qnostics
Seracare Life Sciences, Inc. (LGC Clinical Diagnostics)
Technopath Clinical Diagnostics
Sysmex Corporation
Ortho Clinical Diagnostics
Sero AS
Bio-Rad Laboratories has introduced a new range of multi-analyte quality control solutions for clinical chemistry and immunoassay testing, featuring enhanced stability and compatibility with key analyser platforms.
In August 2023 Roche Diagnostics unveiled an artificial intelligence-powered quality control management system with predictive maintenance capabilities and automated result interpretation for their coba analysers.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope & Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking -- Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies list by Country) (Premium)
5. COMPANY PROFILES
5.1. Bio-Rad Laboratories, Inc.
5.2. Roche Diagnostics
5.3. Thermo Fisher Scientific Inc.
5.4. Siemens Healthineers AG
5.5. Abbott Laboratories
5.6. Randox Laboratories Ltd.
5.7. Qnostics
5.8. Seracare Life Sciences, Inc. (LGC Clinical Diagnostics)
5.9. Technopath Clinical Diagnostics
5.10. Sysmex Corporation
5.11. Ortho Clinical Diagnostics
5.12. Sero AS (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Integration of AI and machine learning in IVD quality control
6.1.2. Emergence of Continuous Quality Improvement (CQI) models
6.1.3. Development of multi-analyte control materials
6.2. Market Drivers
6.2.1. Increasing regulatory scrutiny and quality standards fuel market growth
6.2.2. Rising prevalence of chronic and infectious diseases
6.2.3. Technological advancements in diagnostic testing
6.3. Market Restraints
6.3.1. Cost pressures and budget constraints in healthcare systems
6.3.2. Complexity in implementing comprehensive quality control systems
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY PRODUCT (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2024-2031)
7.1. Quality Control Products
7.2. Data Management Solutions
7.3. Quality Assurance Services
8. BY APPLICATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2024-2031)
8.1. Clinical Chemistry
8.2. Immunochemistry
8.3. Hematology
8.4. Molecular Diagnostics
8.5. Coagulation/Hemostasis
8.6. Microbiology
8.7. Others
9. BY END-USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2024-2031)
9.1. Hospitals
9.2. Clinical Laboratories
9.3. Academic & Research Institutes
9.4. Others
10. BY SOURCE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2024-2031)
10.1. Serum-based Controls
10.2. Plasma-based Controls
10.3. Whole Blood-based Controls
10.4. Urine-based Controls
11. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2024-2031)
11.1. North America
11.1.1. United States
11.1.2. Canada
11.1.3. Mexico
11.2. South America
11.2.1. Brazil
11.2.2. Argentina
11.2.3. Rest of South America
11.3. Europe
11.3.1. Germany
11.3.2. United Kingdom
11.3.3. France
11.3.4. Italy
11.3.5. Spain
11.3.6. Russia
11.3.7. Rest of Europe
11.4. Asia-Pacific
11.4.1. China
11.4.2. Japan
11.4.3. India
11.4.4. Australia
11.4.5. South Korea
11.4.6. Rest of Asia-Pacific
11.5. Middle-East
11.5.1. UAE
11.5.2. Saudi Arabia
11.5.3. Turkey
11.5.4. Rest of Middle East
11.6. Africa
11.6.1. South Africa
11.6.2. Egypt
11.6.3. Rest of Africa
BY PRODUCT:
Quality Control Products
Data Management Solutions
Quality Assurance Services
BY APPLICATION:
Clinical Chemistry
Immunochemistry
Hematology
Molecular Diagnostics
Coagulation/Hemostasis
Microbiology
Others
BY END USER:
Hospitals
Clinical Laboratories
Academic & Research Institutes
Others
BY SOURCE:
Serum-based Controls
Plasma-based Controls
Whole Blood-based Controls
Urine-based Controls
BY REGION
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
We at Aurorawave Intellects Market Report gives total market analysis that suit our customer business need and permit decision maker to run organizations without any problem. We have accomplished greatness in giving start to finish market research arrangements. Our detachment of industry specialists accumulate key data and get ready substance that lines up with our customer's business/specialty.
We at aurorawaveintellects.com offer mainly 3 types of licenses:
• Single User: Research Report copy can be distributed to a single user only
• Multi User: Research Report distribution is restricted up to 5 users.
• Corporate License :Research Report can be distributed across the company.
Based on the nature of the topic or research, the formats vary. The different formats of the report are as following:
• Word Document
• PPT
Following modes are available for making the payment:
• Online Payment (Visa Card, Master Card, Stripe)
• Razorpay
• Net Banking
• Bank Wire Transfer
Our customer service and research specialist team are available by phone and by email. Customer service hours are 24X7 Indian Standard Time (IST). You may reach us at:
• Email: info@aurorawaveintellects.com
• United Kingdom: ++91 7382742511
