In Vitro Diagnostic Device Consulting

IVD Strategy, Insight, and Execution. Connected.

From early development through commercialization, IQVIA MedTech helps IVD innovators turn complexity into opportunity. Our integrated consulting, analytics, and execution capabilities connect clinical, regulatory, market access, commercial, and data strategies to accelerate market readiness and long-term growth. 

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Strategic guidance and execution through a rapidly evolving landscape

The IVD market is evolving rapidly as diagnostic testing becomes more decentralized, software-enabled, and increasingly used to guide treatment decisions. Advancing regulatory requirements, growing evidence expectations, and increasing pressure to demonstrate clinical and market value are creating new challenges for manufacturers. IQVIA MedTech provides the specialized expertise needed to navigate this complexity.

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In Vitro Diagnostic (IVD) Market Data

Stay ahead of evolving diagnostics trends with IQVIA MedTech's specialized IVD market intelligence and post-market safety surveillance.

Understand Global Diagnostics Markets

Quantitative and qualitative analyses include market size, revenue, technology trends, competitive performance, and emerging innovations across North America, EMEA, Asia Pacific, and Latin America.

Quantify Market Opportunities

Detailed segmentation is provided by company, region, clinical area, analyte, and testing channel — including laboratory, ambulatory, and patient self-testing markets.

Track Market Performance

The evidence generated during development supports more than regulatory submissions. It can help inform market access, physician adoption, stakeholder engagement, and commercial strategy— long before launch.

Why Use IVD Market Data?

IQVIA MedTech's suite of IVD market reports is powered by a proprietary database spanning more than 20 years of historical market data and an industry network built over 40 years, delivering region-specific analysis, competitive benchmarking, and actionable market intelligence.


Reports include:


  • The IVD Market Book – detailing industry revenue and instrument installations
  • The Cardiac Annual Review – analyzing trends in cardiac diagnostics
  • Nucleic Acid Testing (NAT) Quarterly Report – tracking global molecular diagnostics
  • Worldwide Diabetes Products Quarterly Report – monitoring glucose and insulin markets.

Drive Strategic Growth

Benchmark competitors, identify new market and investment opportunities, and support M&A, due diligence, and data-driven decision-making with robust, validated data.,

Leverage IQVIA MedTech IVD market intelligence to inform your next strategic decision

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Specialized solutions for end-to-end diagnostic excellence

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IVD Regulatory Consulting

Navigate complex global pathways with targeted IVD regulatory consulting. Our teams provide end-to-end execution for FDA 510(k), De Novo, PMA, and EU IVDR submissions to streamline market access through specialized regulatory services.
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Quality Assurance & Compliance

Establishing robust quality systems under ISO 13485 from design freeze to scale is critical. We optimize analytical verification and maintain strict audit readiness across your entire development lifecycle using proactive quality assurance.
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Clinical Research & Trial Execution (CRO)

We design and execute clinical trials tailored directly to analytical and clinical validation endpoints. Partnering with our full-service CRO secures the real-world evidence (RWE) required to prove clinical utility via clinical research.
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Market Access & Reimbursement

Securing adequate coverage requires expert in vitro diagnostic consulting. By translating clinical utility data into compelling evidence packages, we satisfy payers, establish coding, and optimize pricing pathways early through reimbursement.
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Diagnostic Commercialization Strategy

We help IVD companies identify, assess, and prioritize commercial opportunities through market sizing and forecasting, competitor analysis, emerging technology evaluations, M&A due diligence, opportunity assessments, portfolio strategy support, and conference coverage.
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Lifecycle Management & Post-Market Support

To proactively maximize long-term asset value, our experts help you seamlessly manage menu expansions, software upgrades, and field actions while connecting instrument performance to patient journeys.
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Driven by data. Proven by diagnostic commercial success.

SPECIALIZED IVD EXPERTISE
Top 15

GLOBAL DIAGNOSTICS LEADERS RELY ON IQVIA MEDTECH FOR LIFECYCLE EXECUTION

PROPRIETARY DATABASE
20 YEARS

WORTH OF HISTORIC DATA CAPTURED

UNPARALLELED NETWORK
30 YEARS

SPENT CURATING INDUSTRY CONTACTS

INTEGRATED PATIENT DATA
100M+

PATIENT PROFILES LINKED VIA DATA DEVICE LINK (DDL) FOR TRACKING OUTCOMES

COMPREHENSIVE GLOBAL FOOTPRINT
80+

COUNTRIES SUPPORTED FOR MULTI-MARKET REGULATORY SUBMISSIONS AND LAUNCHES

UNMATCHED CLINICAL DEPTH
100+

IVD AND COMPANION DIAGNOSIC STUDIES CONDUCTED

Transform your diagnostic innovation into an adopted standard of care
Whether you are defining early biomarker feasibility, navigating EU IVDR, or designing an integrated global diagnostic commercialization strategy, IQVIA MedTech delivers the technical depth and global scale your asset demands.
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MCRA is now part of IQVIA MedTech
Your Strategic Partner in Regulatory Success
By uniting MCRA's premier, deep-dive IVD regulatory consulting with IQVIA MedTech’s global scale, data, and clinical trial infrastructure, we help you seamlessly navigate the complex in vitro diagnostic lifecycle.
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... MCRA’s extensive regulatory knowledge of cancer IVDs [was] instrumental in the development of our breakthrough device submission for our bladder and upper tract urothelial cancer test, Bladder CARE™.
Yap Ching Chew
Chief Operating Officer, Pangea Laboratory

Frequently asked questions about In Vitro Diagnostic Consulting

In vitro diagnostic consulting focuses specifically on the unique analytical validity, clinical validity, and clinical utility parameters required for assays and instrumentation. Unlike standard devices, IVD commercialization requires deep integration with lab environments, reference networks, evolving LDT frameworks, and companion diagnostic (CDx) drug-co-development timelines.
We deliver end-to-end execution support, including performance evaluation reports (PER), scientific validity documentation, analytical and clinical performance verification, and Post-Market Performance Follow-up (PMPF) strategy to maintain market access under strict European regulations.
Payers and health systems no longer look solely at whether a test works analytically; they look at whether it changes clinical decisions and improves downstream patient outcomes. Designing studies that demonstrate clinical utility early ensures you secure adequate pricing, coding, and coverage at launch.
Yes. We provide specialized global ivd consulting that perfectly coordinates clinical, regulatory, and commercial timelines between the therapeutic molecule and the corresponding biomarker assay to ensure simultaneous drug-diagnostic approval and launch.
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