探索设备与诊断领域的市场规模：机会有多大？

How Big Is the Opportunity? Navigating market sizing in devices and diagnostics space ANN MAYER, Senior Principal, US Primary Intelligence Lead, IQVIA MedTechMEGHA MAHESHWARI, Principal, Consulting, IQVIA MedTechPRACHI DESHPANDE, Engagement Manager, US Primary Intelligence, IQVIA MedTechMEHAR AMENA, Senior Consultant, US Primary Intelligence, IQVIA MedTechANMOL ARORA, Consultant, Consulting, IQVIA MedTech Table of contents Introduction1A deep dive into market sizing1Why do MedTech companies conduct market sizing?2Estimating demand across MedTech markets2Common foundational variables for market sizing in the devices and diagnostics space4IQVIA MedTech’s gold standard integrated market sizing methodology5IQVIA MedTech’s proven step-by-step framework6Case study 18Case study 29Case study 310Decades of experience. Global reach. Unmatched precision. IQVIA MedTech makes11market sizing a strategic advantageReferences12About the authors14 Introduction As growth continues to plateau across manyestablished medical device categories in the USand Europe, companies are increasingly turningto international markets and emerging productsegments to fuel their next wave of expansion.But unlocking these opportunities—whethergeographical or technological—is anythingbut straightforward. segments demand nuanced approaches to sizing,beyond what traditional models can offer. This challenge is further compounded by leanstrategic marketing teams and constrained marketresearch budgets. As a result, critical decisionsaround acquisitions, resource deployment, pricingstrategy, and go-to-market models are often madewith limited confidence. In underpenetrated regions, reliable secondarydata is often scarce, particularly outside top-volume device categories, making it difficult togauge true market potential. Simultaneously, manycompanies are venturing into complex and fast-evolving domains (e.g., AI-enabled diagnostics,molecular point-of-care testing, digital therapeutics,personalized implants, etc.) where clinical adoptioncurves are unpredictable, reimbursement structuresremain unsettled, and data availability is even morelimited. These geographical and technological This white paper explores the concept of marketsizing as it applies to both international expansionand emerging MedTech innovations. It highlightshow well-executed sizing enables companies toidentify untapped demand, prioritize productpipelines, and shape commercialization strategiesacross evolving markets. From early-stage startupsto global incumbents, market sizing supports strategicdecisions at pivotal moments—whether entering anew region or launching a next-generation device. potential demand—measured in revenue, customerbase, or sales volume—companies gain the strategicinsight needed to make informed decisions aboutmarket entry, investment, and growth. Effective marketsizing typically involves a tiered approach (figure 1): A deep dive into market sizing Market sizing is a foundational exercise for any businessseeking to evaluate the true commercial opportunitybehind its product or service. By estimating the Why do MedTech companies conduct market sizing? Companies in the devices and diagnostics space turn to market sizing for a range of strategic and operationalpurposes, including but not limited to: Investor and stakeholder engagementBack up fundraising, M&A, or joint venturediscussions with well-founded estimatesof opportunity size and path to revenue Strategic planning and portfolioprioritization Understand which markets, modalities, orproduct categories offer high-growth potentialand warrant deeper investment or expansion Sales and marketing optimizationTailor targeting, segmentation, and channelallocation based on the true scale andstructure of demand Commercial model design Determine if the market justifies transitioningfrom distributor-led models to direct sales,or if partnerships and joint ventures may bemore effective Risk mitigation and market entryvalidation Clinical and regulatory strategy alignmentAlign product development, regulatorypathways, and clinical trial investments withregions that offer scalable opportunities Avoid entering markets where limited demand,reimbursement constraints, or infrastructuregaps would hinder adoption Common challenges in estimating demand acrossMedTech markets Accurately estimating demand is a foundational step in any growth strategy. Yet, through IQVIA MedTech’s workwith medical device and diagnostic manufacturers over the years, we’ve consistently observed several commonissues that complicate effective market sizing: Limited visibility into sub-segment dynamicsEven within a single device category, demandcan vary widely by indication, care setting,or patient profile. Market sizing that overlooksthese intra-segment nuances can mask realopportunities or exaggerate market viability Fragmented secondary data In many emerging markets, data availabilityis limited and inconsistent. Without robustvalidatio