IVD市场导航：商业成功的验证策略

Navigating the IVD Market: ProvenStrategies for Commercial Success ERIC KONG, PH.D.,Associate Director, IVD Regulatory Affairs, IQVIA MedTechMICHELLE BULLIARD,Vice President, MedTech Strategy, Clinical & RWE, IQVIA MedTechDAVID KOWALSKI,Principal, Global Head of IVD Consulting, IQVIA MedTechNICOLE FITZPATRICK,Director, Reimbursement, Health Economics and Market Access, IQVIA MedTech Table of contents Introduction1The IVD market at a glance1Risk class: The regulatoryfoundation2Clinical evidence: From siloed studies to integrated strategy3Case study: Two analytes, one device3Reimbursement plan early to save later4Case study: One study, four objectives4Final take: Start early, coordinate cross-functionally5About the authors6 Introduction Bringing an InVitroDiagnostic (IVD) to market requires strong clinical, regulatory,and reimbursement strategy. Misalignment in any area can delay market access,limit adoption, or diminish long term value. As the IVD industry becomes more diversified,competitive, and global, proactive coordination acrossdisciplines is a prerequisite for competitive marketentry. By aligning regulatory strategy, clinical evidencegeneration, and reimbursement planning early in thedevelopment process, IVD developers can build both thedata and strategies for global commercial success. •Abbott’s acquisition of Exact Sciences, a major moveinto oncology and consumer-facing diagnostics •Waters’ acquisition of BD’s life sciences and diagnosticsolutions business, which expands Waters into clinicaldiagnostics and flow cytometry Other high-value deals include Quidel Ortho’s acquisitionof Lex Diagnostics and Blackstone and TPG’s acquisitionof Hologic. Here, expert insights and case studies illustratehowproactive planning and an integrated approachtoevidence generation can expedite timelines andlowercosts. Geographically, the IVD market is shifting. The APACregion is expected to outpace China by 2030 due to highgrowth in Southeast Asia and India. In the United States,the Protecting Access to Medicare Act, which mandatesrate cuts for clinical lab tests, is postponed to 2027,which gives the U.S. a short but strong tailwind. Globalmarket growth is projected at 3% through 2030. The IVD market at a glance An uptick in M&A activity and private equity investmentsignals that major players recognize the value andpotential for both consumer and clinical testing. As atestament to that value, the global IVD market generatedabout $80 billion in 2025, up from $65 billion in 2019. COVID testing revenue has normalized to roughly $4billion and now represents 6% of total market revenue.That $4 billion represents net new demand, the majorityof which falls under molecular Nucleic Acid Testing (NAT). M&A activity accelerated sharply in 2025, with deal valuereaching $60 billion — nearly double the $35 billionrecorded across the prior seven years combined. Twonotable transactions include: 2025-2026 market factors and trends •Major increase ininvestment andAcquisition Activity•Major playersexpandinginto newdisease segments•Private Equity entranceinto market withsignificant investments Influx of investment andacquisitions with a focuson areas of high unmetneed. Multi-analytetesting remains a prioritywithin MD despitesome reimbursementchallenges. POCremains a focus areawith momentumin decentralizedcardiac testing Financial performance •COVID sales normalizedinto overall performance•Total market flat withCOVID representing 6%of revenue•MSD growth in multiplexNAT testing Slide highlights key areas ofdisruption; not exhaustive. fit-for-purpose), which may necessitate a repeat clinicalstudy. Moreover, older studies and data may have beengenerated on a prior version of the IVD device and, assuch, may no longer be relevant to the current iteration.Identifying such deficiencies early on can allow for amore effective approach in developing the regulatorystrategy. However, if such deficiencies are identifiedand raised during a formal regulatory review, this canbe a critical set back to your submission and result in adelayed time-to-mart. Risk class: Theregulatoryfoundation The totality of an IVD’s intended use statement definesthe device’s risk level, which is a critical componentin determining es its device classification and theassociated regulatory pathway. Becausethe device classdirectly impacts regulatory requirements and time tomarket, IVD developers should understand how theirdevice will be classified early-on in development. Withan accurate understanding of the device’s risk level andclassification, IVD developers can tailor analytical andclinical validation studies to support its intended use andregulatory pathway. To avoid a regulatory setback and expedite timeto market, IVD developers should seek out specificregulatory expertise and ask these critical questions asearly as possible. Regulatory strategies can be highlycomplexed and nuanced and certain approaches shouldnot simply be assumed to be acceptable. In