Regulatory Analysis Consulting for Life Sciences
Accurate, Data-Driven Market Size & Share Assessment Driving Strategic Growth
Introduction
A prominent biopharmaceutical company operating in the evolving Nonalcoholic Steatohepatitis (NASH), now termed Metabolic Dysfunction-Associated Steatohepatitis (MASH), market sought deep clarity on shifting market fundamentals, patient distribution, and competitive positioning. DelveInsight delivered a holistic, data-backed Market Size & Share Assessment that empowered the client to enhance forecasting, identify unmet needs, and refine long-term strategic planning.
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NASH Market Size & Share Assessment
Challenge
The rapidly advancing NASH/MASH landscape presented the client with significant uncertainty. Variability in diagnostic definitions, inconsistent epidemiology, and limited therapeutic options created difficulties in establishing:
Accurate patient pool distribution across major markets
True market size, segmentation pathways, and asset value
Comparable benchmarks for pipeline and marketed therapies
Revenue estimates across diverse launch, uptake, and pricing scenarios
Without a robust and validated market model, the client risked misaligned resource allocation and unreliable commercial forecasting.
Approach
DelveInsight deployed a structured, evidence-backed analytical framework to generate precise and strategic market size and share insights.
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Objective
To quantify current and projected opportunities in the NASH/MASH market by evaluating epidemiology, clinical practices, pricing dynamics, and emerging competitive threats across major global regions.
Problem Statement
A lack of standardized diagnostic pathways and considerable variation in disease staging significantly hindered accurate evaluation of patient prevalence and treatment adoption. The client needed a scientifically validated, dependable model to guide portfolio planning, risk assessment, and commercial strategy.
Our Methodology
DelveInsight implemented a multi-dimensional, research-driven approach:
A. Epidemiology-Led Market Modeling
Developed detailed patient pool models segmented by fibrosis stage (F0–F4), risk cohorts, and diagnostic penetration
Validated assumptions through peer-reviewed publications, patient registries, KOL insights, and claims databases
B. Competitive Landscape Analysis
Assessed approved and late-stage NASH/MASH therapies
Evaluated mechanisms of action, clinical endpoints, global trial distribution, and regulatory strategies
Benchmarked assets using unmet-need–driven prioritization
C. Pricing & Market Access Insights
Modeled pricing benchmarks using analog therapies
Evaluated reimbursement behavior, payer constraints, and access hurdles
D. Forecasting & Opportunity Assessment
Built 10–15 year market forecasts
Modeled multiple scenarios—base, optimistic, and conservative
Estimated evolving market share shifts driven by pipeline maturation
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Outcome
The engagement equipped the client with forward-looking, actionable insights:
Delivered a robust, stage-specific epidemiology model for 7MM and global markets
Produced accurate NASH/MASH market size assessments with clear segmentation
Strengthened visibility into competitive risks and potential pipeline disruptions
Improved portfolio prioritization, asset positioning, and regional strategy development
Enhanced confidence in investment planning and long-term forecasting
As NASH transitions to MASH and regulatory expectations evolve, understanding market dynamics, patient patterns, and competitive movements is more critical than ever.
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NASH Market Size & Share Assessment
