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.

➡️ Explore the full case study here:
 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.

➡️ Unlock deeper insights with our complete analysis:
 View the detailed methodology

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

➡️ See how we refine forecasting accuracy for clients:
 Access the full case study

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.

➡️ Stay ahead in the fast-changing MASH landscape — read the complete case study now:
 NASH Market Size & Share Assessment

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