Global IVD Quality Control Market Outlook
Revenue, 2024
$1.4B
Forecast, 2034
$4.7B
CAGR, 2025 - 2034
12.9%
The IVD Quality Control industry revenue is expected to be around $1.6 billion in 2025 and expected to showcase growth with 12.9% CAGR between 2025 and 2034. The ongoing development of IVD Quality Control systems continues to advance because of growing regulatory oversight and rising laboratory testing needs in hospitals and reference labs and worldwide healthcare system requirements for better laboratory quality management. The two segments of Dermatology and Pain Management combined represent 65.4% of total testing requirements while the Lokivetmab Animal segment produced 0.63 billion in 2024 to show how human and veterinary markets need advanced quality control systems for assay stability and error reduction and accreditation and external quality assessment participation.
The fundamental purpose of IVD Quality Control involves three main components which include specialized control materials and multi analyte panels and software tools that check assay precision and accuracy and consistency for clinical chemistry and immunoassay and hematology and coagulation and microbiology and molecular diagnostic assays. The main uses of IVD Quality Control occur in hospital laboratories and specialty dermatology and pain management testing and point of care testing sites; the market trends of consolidated multi parameter controls and automated data review and system integration and third party control adoption in human and animal healthcare sectors strengthen IVD Quality Controls essential position in contemporary diagnostic operations.
Market Key Insights
The Ivd Quality Control market will expand from $1.4 billion in 2024 to $4.7 billion during the period from 2024 to 2034. The market will experience 12.9% annual growth because Veterinary Hospitals and Veterinary Clinics and Veterinary Research facilities continue to increase their demand.
Zoetis Services, Elanco, and Merck & Co. Inc. are among the leading players in this market, shaping its competitive landscape.
The Ivd Quality Control market has the United States and China as its leading markets which will experience CAGR growth rates of 11.6% to 15.5% from 2024 to 2030.
The market research predicts that India, Brazil and South Korea will experience the highest growth rates at 9.0% to 13.5% CAGR.
Transition like Data-Driven QC Standardization is expected to add $383 million to the Ivd Quality Control market growth by 2030
.The Ivd Quality Control market will expand by $3.3 billion during 2024-2034 while Veterinary Clinics & Veterinary Research & Academic Institutes Application will become the leading market segment.
With
rising molecular diagnostics complexity and expanding point-of-care testing ecosystems driving advanced ivd quality control, and
Tightening global regulatory frameworks and accreditation requirements elevating performance expectations for ivd quality control, Ivd Quality Control market to expand 236% between 2024 and 2034.
Opportunities in the IVD Quality Control
The diagnostic market for companion animals continues to expand rapidly because veterinary IVD Quality Control products for dogs and cats and other species will also reach USD 0.06 billion in 2024 and USD 0.14 billion by 2030 with a 13.14% annual growth rate from 2025 to 2030. The market lacks products which combine multiple analytical tests for small veterinary laboratories and stable room temperature products for clinics without refrigeration capabilities. The market segment of canine and feline clinical chemistry QC will experience the highest global expansion rate.
Growth Opportunities in North America and Asia-Pacific
The Oncology segment leads North America as its most important market for IVD Quality Control because clinical laboratories expand their advanced in vitro diagnostics and molecular diagnostics and companion diagnostics operations to support precision medicine and high volume cancer screening workflows; this situation generates substantial market potential for high end IVD controls that support complex biomarker panels and next generation sequencing workflows and integrated quality assurance systems for centralized and decentralized testing networks. The market competition remains intense because established IVD manufacturers and specialized quality control providers continue to develop oncology specific products through software based proficiency testing and real time analytics and lab automation platform integration for enhanced regulatory compliance and data tracking. The region experiences growing demand for IVD Quality Control solutions because of its strict in vitro diagnostic performance regulations and payment system requirements for test precision and laboratory consolidation and expanding point of care testing in cancer related region's.
The Asia Pacific region has become a significant market for IVD Quality Control because Infectious Diseases stand as the primary therapy region due to their high impact on viral and bacterial infections and large microbiology testing requirements and growing decentralized in vitro diagnostics infrastructure investments. The region offers major business potential for affordable IVD controls which match the requirements of public health programs and hospital networks that use high throughput molecular diagnostics and rapid tests and point of care testing. The market competition involves multinational companies operating alongside regional manufacturers who expand their operations at a fast pace while their competitive edge depends on their ability to create localized infectious disease control panels and maintain supply chain stability and offer IVD Quality Control materials with training and validation support and external quality assessment services. The market adoption of standardized IVD Quality Control solutions increases because of government backed screening programs and pandemic readiness plans and expanding insurance coverage and regulatory standardization efforts. The combination of these factors drives laboratories to adopt standardized IVD Quality Control solutions which boost test accuracy and laboratory accreditation numbers and enable long term growth of infectious disease diagnostic services in various healthcare facilities.
Market Dynamics and Supply Chain
01
Driver: Rising molecular diagnostics complexity and expanding point of care testing ecosystems driving advanced IVD Quality Control
Molecular diagnostic technologies have also advanced rapidly through next generation sequencing panels and multiplex PCR platforms which produce complex assay results and dense data sets that need IVD Quality Control solutions with improved traceability and consistent lot production and patient sample like controls for high throughput clinical labs. The complex operational workflows need unified quality management platforms which unite control systems for instruments and assays and sites to perform risk based monitoring and detect analytical drift in invitro diagnostics. The growing number of decentralized and point of care testing locations requires IVD Quality Control solutions that maintain stability and performance in non traditional laboratory settings. The trend toward digital control materials and connected analyzers and remote proficiency testing and external quality assessment programs has also increased their use for protecting clinical choices made at healthcare delivery boundaries.
Manufacturers and laboratories must also establish strict IVD Quality Control systems because regulatory agencies have also increased their oversight and accreditation organizations have also developed new standards. The regulatory environment now requires manufacturers to show proof of analytical system stability and material traceability and ongoing market monitoring through control products which meet various international regulatory standards. Laboratories now use advanced external quality assessment systems and standardized control protocols and enhanced documentation methods to achieve better results in their in vitro diagnostic tests.
02
Restraint: Escalating regulatory complexity and compliance costs constrain IVD Quality Control adoption across emerging laboratory settings
The development and approval process for IVD QC manufacturers becomes longer because of strict worldwide regulations which demand better documentation and lot release verification and post market surveillance activities. The development of new control lots for molecular diagnostics faces delays or complete cancellation from smaller companies because of rising costs which leads to reduced product diversity and decreased market competition for pricing. The market consolidation of hospital and clinical laboratory purchasing activities toward major suppliers who prove strong regulatory compliance enables these suppliers to control market share while reducing buyer negotiating power in particular areas and creating unbalanced customer demand patterns between different geographic areas and customer segments.
03
Opportunity: Home based and decentralized chronic disease monitoring in North America needing integrated digital quality control solutions and Expanding molecular diagnostics for infectious diseases in Asia Pacific hospitals demanding high frequency third party quality controls
The healthcare sector in North America supports home testing for diabetes and coagulation and cardiac risk assessment but lacks standardized quality systems for these decentralized medical devices. Home testing manufacturers and home healthcare providers require digital IVD Quality Control systems which unite electronic QC with cloud connectivity and automated rule based analytics. The market potential for software based QC platforms exists because they can be integrated with point of care devices and offered through subscription models. The market will experience its most rapid expansion through digital QC solutions which enable remote disease management for telehealth programs and chronic disease monitoring systems.
The Asia Pacific healthcare sector operates at high speed to expand their molecular PCR testing capabilities for TB and respiratory viruses and sepsis but they continue using manufacturer established controls instead of independent third party IVD Quality Control services. The market lacks liquid commutable multi analyte controls which work with open platforms and mid throughput analyzers in tier 2 and tier 3 cities. The market for third party molecular QC for infectious disease panels will experience the fastest growth because accreditation bodies now require stricter external quality assessment standards.
04
Challenge: Budget pressures and price sensitivity in clinical diagnostics reduce investment in advanced IVD Quality Control solutions
Healthcare and laboratory funding restrictions force procurement teams to select affordable IVD Quality Control panels while they extend contract periods and request significant price reductions which reduces profit margins and delays premium QC portfolio value based pricing implementation. Facilities attempt to reduce operating expenses through two methods which result in decreased control material orders and reduced proficiency testing intensity yet fail to stop the growth of diagnostic procedures. The market shift toward basic multi analyte controls instead of specialized high performance products for complex assays and point of care diagnostics leads to commoditized offerings which hinders product differentiation and slows down new QC technology adoption and limits future market growth potential.
Supply Chain Landscape
1
in vitro diagnostics
Zoetis Services LLCMerck & Co. Inc
2
diagnostic reagents
ElancoBoehringer Ingelheim International GmbH
3
IVD Quality Control
VirbacZoetis Services LLC
4
clinical end users
clinical laboratorieslab quality assuranceveterinary diagnostics
1
in vitro diagnostics
Zoetis Services LLCMerck & Co. Inc
2
diagnostic reagents
ElancoBoehringer Ingelheim International GmbH
3
IVD Quality Control
VirbacZoetis Services LLC
4
clinical end users
clinical laboratorieslab quality assuranceveterinary diagnostics
Use Cases of IVD Quality Control in Veterinary Hospitals & Veterinary Research
Veterinary Hospitals : The veterinary hospital depends on IVD Quality Control to perform complex diagnostic tests for dermatology and pain management and oncology and infectious diseases because it needs strict internal controls and multiple serum control materials and external quality assurance programs for its chemistry and hematology and immunoassay analyzers. The hospitals lead infectious disease testing while generating 0.21 billion in diagnostic revenue during 2024 and expecting 15.6% annual growth until 2030 and continuing expansion in dermatology and pain management and oncology fields which requires dependable IVD Quality Control and thorough analyzer performance verification. Zoetis Services LLC and Merck & Co. Inc. maintain dominant positions in veterinary IVD hospital markets through their complete analyzer systems and reagent supplies and connectivity solutions and built in IVD Quality Control monitoring systems. The company Boehringer Ingelheim International GmbH together with Virbac use their market leadership in chronic dermatology and pain management to determine testing protocols and performance standards which support long term treatment plans. Elanco supports other players through its broad therapeutic range and hospital network partnerships which establish uniform IVD Quality Control procedures that improve treatment choices and maintain consistent results for dogs and cats.
Veterinary Clinics : The veterinary clinics use IVD Quality Control systems which integrate control materials into compact benchtop analyzers and point of care testing platforms to help front line veterinarians run chemistry profiles and hematology counts and infectious disease tests with fast results and reduced need for duplicate tests. The expanding number of pain management and dermatology visits at primary care facilities requires consistent IVD Quality Control systems which non specialist staff members can operate without affecting analytical precision or test speed. Zoetis Services LLC leads point of care instrument deployment in clinics through its user friendly IVD Quality Control systems while Elanco and Virbac use their wide companion animal health field presence to promote pain and skin care testing protocols. The clinic segment receives additional support from Merck & Co. Inc. and Boehringer Ingelheim International GmbH through their diagnostic guidance programs and staff training and remote quality assurance services which enhance clinic adherence to daily and batch quality inspection protocols.
Veterinary Research : The veterinary research environment uses IVD Quality Control to verify complex assays and innovative studies which include cancer biomarker research and advanced disease monitoring and pain management and dermatology investigations. The laboratories depend on advanced molecular diagnostic controls and multi level calibrators and cross platform reference panels to validate new assays and maintain instrument and site reproducibility and support canine and feline disease progression studies. The research and academic institutions work with Zoetis Services LLC and Merck & Co. Inc. to access assay platforms and technical support and IVD Quality Control systems which help them validate methods and produce regulatory compliant data. The market position of Boehringer Ingelheim International GmbH and Elanco and Virbac strengthens through their support of investigator led trials and collaborative research initiatives which result in quality assurance program development and customized IVD Quality Control solutions for new oncology and infectious disease and chronic pain indications.
Recent Developments
The IVD Quality Control market experiences fast paced changes because laboratories need better measurement precision and product origin verification and follow regulatory standards for their clinical diagnostic work. The market has seen three major developments which include third party quality control material expansion and multi analyte control consolidation and automated point of care testing systems. The market shows growing interest in digital quality management systems which provide real time performance tracking and proficiency testing matching and data based risk assessment capabilities.
February 2024 : The U.S. Food and Drug Administration published its final Quality Management System Regulation which unifies medical device and IVD manufacturer standards with ISO 13485 to create new market opportunities for advanced IVD Quality Control materials and independent in vitro diagnostic controls and laboratory quality management solutions in clinical diagnostics.
October 2023 : The U.S. Food and Drug Administration released its proposed rule to stop using enforcement discretion for laboratory developed tests which will require laboratories to establish IVD Quality Control programs and use third party external quality assessment schemes and purchase standardized quality control reagents for complex molecular and clinical chemistry assays.
Impact of Industry Transitions on the IVD Quality Control Market
As a core segment of the Medical Device industry,
the IVD Quality Control market develops in line with broader industry shifts.
Over recent years, transitions such as Data Driven QC Standardization and Convergence Of Lab And POC have redefined priorities
across the Medical Device sector,
influencing how the IVD Quality Control market evolves in terms of demand, applications and competitive dynamics.
These transitions highlight the structural changes shaping long-term growth opportunities.
01
Data Driven QC Standardization
The digital transformation of IVD Quality Control systems is reshaping the landscape from traditional manual checks to advanced, data driven quality monitoring. This shift enables continuous performance tracking, proactive risk identification, and enhanced proficiency testing through integrated middleware and automation. As a result, molecular diagnostic assay stability improves, equipment failures decrease, and regulatory compliance strengthens. Importantly, this transition is projected to contribute an additional $373 million to the IVD Quality Control market by 2030, unlocking significant growth opportunities for the medical device and digital health sectors through standardized data formats and interoperable quality systems. This strategic evolution not only enhances operational efficiency but also positions stakeholders to capitalize on emerging market demands. This industry transition is expected to add $383 million in the industry revenue between 2024 and 2030.
02
Convergence Of Lab And POC
The fast growth of point of care testing requires IVD Quality Control to shift from traditional lab based systems to networked systems which support both hospital and home based diagnostic testing. The combination of new control materials with connectivity solutions and remote QC dashboards enables decentralized in vitro diagnostics networks to maintain consistent performance in hospital settings and pharmacies. The transition process transforms medical procedures by speeding up emergency care decisions and supporting telemedicine services while pharmaceutical companies and population screening programs gain better diagnostic accuracy through real world data.