In Vitro Diagnostics (IVD) Quality Control Product Market - Global Industry Research Analysis

In Vitro Diagnostics (IVD) Quality Control Product Market Insights

According to Market Research Store, the global in vitro diagnostics (IVD) quality control product market size was valued at around USD 1789.5 million in 2023 and is estimated to reach USD 3776.49 million by 2032, to register a CAGR of approximately 7.8% in terms of revenue during the forecast period 2024-2032.

The in vitro diagnostics (IVD) quality control product report provides a comprehensive analysis of the market, including its size, share, growth trends, revenue details, and other crucial information regarding the target market. It also covers the drivers, restraints, opportunities, and challenges till 2032.

Global In Vitro Diagnostics (IVD) Quality Control Product Market: Overview

The In Vitro Diagnostics (IVD) Quality Control Product Market centers on products designed to monitor the accuracy and reliability of diagnostic test results produced by IVD devices. These quality control products are essential for ensuring compliance with regulatory standards, maintaining test reliability, and detecting errors in diagnostic procedures. They include controls, calibrators, and other materials used across a range of diagnostic tests, including immunoassays, molecular diagnostics, clinical chemistry, hematology, and microbiology.

The increasing prevalence of chronic and infectious diseases, coupled with the growing use of IVD tests in disease diagnosis, monitoring, and treatment planning, drives the demand for quality control products. The market is also influenced by the rising adoption of point-of-care (POC) testing and the need for stringent regulatory compliance to ensure the accuracy of diagnostic results.

Key Highlights

• The in vitro diagnostics (IVD) quality control product market is anticipated to grow at a CAGR of 7.8% during the forecast period.
• The global in vitro diagnostics (IVD) quality control product market was estimated to be worth approximately USD 1789.5 million in 2023 and is projected to reach a value of USD 3776.49 million by 2032.
• The growth of the in vitro diagnostics (IVD) quality control product market is being driven by the increasing demand for accurate and reliable diagnostic results, stringent regulatory requirements, and the growing emphasis on quality assurance in healthcare settings.
• Based on the product, the quality control products segment is growing at a high rate and is projected to dominate the market.
• On the basis of application, the molecular diagnostics segment is projected to swipe the largest market share.
• By region, North America is expected to dominate the global market during the forecast period.

In Vitro Diagnostics (IVD) Quality Control Product Market: Dynamics

Key Drivers:

• Enhanced Diagnostic Accuracy: Accurate and reliable IVD test results are crucial for patient diagnosis and treatment decisions. Quality control products play a vital role in ensuring the accuracy and precision of diagnostic tests.
• Regulatory Compliance: Stringent regulatory requirements for IVD manufacturers and laboratories emphasize the importance of quality control procedures and the use of validated control materials.
• Rising Prevalence of Chronic Diseases: The increasing prevalence of chronic diseases like diabetes, cancer, and cardiovascular diseases ¹ necessitates accurate and reliable diagnostic testing, driving the demand for high-quality control materials.  
• Technological Advancements: Advancements in IVD technologies, such as molecular diagnostics and point-of-care testing, require the development of new and improved quality control materials.

Restraints

• High Cost: High-quality IVD quality control products can be expensive, particularly for specialized tests and advanced technologies.
• Limited Reimbursement: Limited reimbursement coverage for quality control materials can constrain their use in some settings.
• Storage and Handling Requirements: Many quality control materials have specific storage and handling requirements, which can be challenging to maintain.
• Competition: Competition from a range of IVD manufacturers and suppliers can impact pricing and market share.

Opportunities

• Development of Novel Control Materials: Development of novel control materials with improved stability, accuracy, and performance characteristics.
• Automation and Digitalization: Integrating quality control processes with laboratory automation and digital platforms for improved efficiency and data management.
• Personalized Medicine: Development of personalized quality control materials tailored to specific patient populations and diagnostic tests.
• Expanding into Emerging Markets: Expanding into emerging markets with growing healthcare needs and increasing demand for diagnostic testing.

Challenges

• Maintaining Product Quality and Consistency: Ensuring consistent quality and performance of quality control materials over time.
• Addressing Regulatory Requirements: Meeting evolving regulatory requirements related to IVD manufacturing and quality control.
• Ensuring Data Accuracy and Integrity: Ensuring the accuracy and integrity of data generated from quality control tests.
• Staying Competitive: Staying competitive in a dynamic market with continuous advancements in IVD technologies and quality control methodologies.

In Vitro Diagnostics (IVD) Quality Control Product Market: Report Scope

In Vitro Diagnostics (IVD) Quality Control Product Market: Segmentation Insights

The global in vitro diagnostics (IVD) quality control product market is divided by product, application, and region.

Segmentation Insights by Product

Based on Product, the global in vitro diagnostics (IVD) quality control product market is divided into quality control products, quality assurance services, data management solutions, and others.

Quality Control Products as the dominant segment in the IVD Quality Control Product Market, supported by regulatory needs, market dynamics, and technological advancements. The increasing adoption of IVD tests in diagnostics and the need for consistent and accurate results drive this segment. Regulatory requirements for laboratory accreditation further fuel demand for quality control products.

Quality Assurance Services these services include external quality assessment (EQA) and proficiency testing programs designed to monitor the accuracy and reliability of laboratory results. Rising emphasis on regulatory compliance and the demand for standardized testing across laboratories are key growth drivers. The segment also benefits from an increased focus on minimizing diagnostic errors.

Data Management Solutions these solutions enable laboratories to manage and analyze quality control data efficiently. They provide tools for identifying trends, ensuring compliance, and integrating data with laboratory information systems (LIS). The growing trend of digital transformation in healthcare, coupled with the need for real-time data analysis and regulatory reporting, is propelling this segment.

Segmentation Insights by Application

On the basis of Application, the global in vitro diagnostics (IVD) quality control product market is bifurcated into molecular diagnostics, clinical chemistry, immunochemistry, hematology, and others.

Molecular Diagnostics as the dominant and fastest-growing segment in the IVD Quality Control Product Market, driven by technological advancements, expanding applications, and the growing importance of precision medicine. The rising demand for molecular diagnostics, driven by the increasing prevalence of infectious diseases (e.g., COVID-19) and genetic testing applications, supports growth. The shift towards precision medicine further enhances demand in this segment.

Clinical Chemistry this segment includes quality control products and services for diagnostic tests related to blood glucose, liver function, renal function, and electrolytes. The increasing prevalence of chronic diseases such as diabetes, cardiovascular disorders, and liver diseases drives demand in this segment. Regulatory requirements for laboratory accreditation further boost adoption.

Immunochemistry including hormone testing, cancer markers, and infectious disease diagnostics. Growing demand for immunochemistry tests due to the rising prevalence of chronic diseases and advancements in biomarker discovery is driving this segment.

Hematology Includes quality control products for analyzing blood parameters, such as complete blood counts (CBC) and coagulation profiles. The increasing burden of hematological disorders such as anemia and leukemia, coupled with the expansion of hematology testing in diagnostics, is driving this segment.

In Vitro Diagnostics (IVD) Quality Control Product Market: Regional Insights

• North America currently leads the global in vitro diagnostics (IVD) quality control product market

North America dominates the IVD Quality Control Product Market, with the U.S. being a significant contributor due to its well-established healthcare infrastructure, high adoption of advanced diagnostics, and stringent regulatory standards from agencies like the FDA. The prevalence of chronic and infectious diseases, coupled with extensive R&D activities, drives the demand for quality control products. Major global players headquartered in the region further enhance its dominance.

Europe holds a significant share of the market, driven by countries like Germany, the UK, and France. The region benefits from a strong focus on healthcare quality and compliance with EU regulations, which necessitate the use of robust quality control measures in diagnostic laboratories. Additionally, an aging population and the increasing incidence of chronic diseases bolster the demand for IVD quality control products.

The Asia-Pacific region is witnessing rapid growth in the IVD quality control market. Countries like China, India, and Japan are at the forefront due to the increasing adoption of advanced diagnostic technologies, rising healthcare expenditures, and the growing burden of diseases like diabetes and cancer. Expanding laboratory networks and the rising demand for point-of-care testing solutions further fuel market growth in this region.

Latin America is an emerging market for IVD quality control products, with growth driven by improving healthcare infrastructure in countries like Brazil and Mexico. The rising prevalence of infectious diseases and increasing investments in healthcare technologies are propelling the adoption of quality control products in diagnostic laboratories.

The Middle East and Africa have a smaller market share but are experiencing steady growth. The demand is driven by the modernization of healthcare systems in countries like Saudi Arabia, the UAE, and South Africa. The growing focus on accurate diagnostics and the implementation of quality standards in laboratory settings contribute to market expansion in this region.

In Vitro Diagnostics (IVD) Quality Control Product Market: Competitive Landscape

The report provides an in-depth analysis of companies operating in the in vitro diagnostics (IVD) quality control product market, including their geographic presence, business strategies, product offerings, market share, and recent developments. This analysis helps to understand market competition.

Some of the major players in the global in vitro diagnostics (IVD) quality control product market include:

• Abbott Diagnostics
• Bio-Rad Laboratories
• Fortress Diagnostics
• Future Diagnostics Solutions
• Helena Laboratories
• ISOLAB
• Meril Life Sciences
• Multiplicom
• Randox Laboratories
• Roche Diagnostics
• Seracare Life Sciences
• Sun Diagnostics
• Surmodics
• Sysmex Corporation
• Technopath Clinical Diagnostics
• Thermo Fisher Scientific
• Zeptometrix Corporation

The global in vitro diagnostics (IVD) quality control product market is segmented as follows:

By Product

• Quality Control Products
• Quality Assurance Services
• Data Management Solutions
• Others

By Application

• Molecular Diagnostics
• Clinical Chemistry
• Immunochemistry
• Hematology
• Others

By Region

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • France
  • Germany
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• The Middle East and Africa
  • GCC Countries
  • South Africa
  • Rest of Middle East Africa

Frequently Asked Questions