Market Size and Share Assessment

Regulatory Analysis Consulting for Life Sciences

Accurate, Data-Driven Market Size & Share Assessment Empowering Strategic Growth

Introduction

A leading biopharmaceutical client operating in the Nonalcoholic Steatohepatitis Market sought clarity on evolving market dynamics, patient pools, and competitive positioning. DelveInsight delivered a comprehensive, data-backed market size and share assessment that enabled the client to refine forecasting models, evaluate unmet needs, and strengthen long-term strategic planning.

Challenge

The client faced increasing uncertainty in the fast-expanding NASH landscape. Inconsistent epidemiology estimates, diverse diagnostic criteria, and limited therapeutic options made it difficult to establish:

• True patient pool distribution across key geographies
• Market size, segmentation opportunities, and asset value
• Competitive benchmarking for early and late-stage therapies
• Revenue potential under various launch and pricing scenarios

Without a validated market model, the client risked misaligned investments and inaccurate commercial projections.

Approach

DelveInsight designed a structured, evidence-driven methodology to deliver an accurate and actionable market size and share assessment.

Objective

To quantify the current and forecasted NASH market opportunity by analyzing epidemiology, treatment patterns, pricing dynamics, and emerging competition across major markets.

Problem Statement

The lack of standardized diagnostic pathways and significant variation in disease staging created major gaps in estimating true patient prevalence and therapy uptake. The client required a reliable, scientifically backed model to support portfolio decisions and commercial planning.

Our Methodology

DelveInsight executed a multi-layered analytical framework:

A. Epidemiology-Driven Market Modeling

• Built granular patient-pool models segmented by disease stage (F0–F4), risk groups, and diagnostic rates
• Leveraged peer-reviewed literature, registry inputs, KOL insights, and claims data to validate assumptions
  
  

B. Competitive Landscape Assessment

• Profiled clinical-stage and approved NASH therapies
• Assessed MoA, trial endpoints, geographical footprint, and regulatory strategy
• Benchmarked competitive assets using unmet-need prioritization
  
  

C. Pricing & Market Access Evaluation

• Modeled pricing scenarios based on analog therapies
• Evaluated reimbursement trends, payer attitudes, and access barriers
  
  

D. Forecasting & Opportunity Sizing

• Developed 10–15 year revenue forecasts
• Included multiple scenarios (base, optimistic, conservative)
• Quantified market share distribution and pipeline-driven shifts
  
  

Outcome

The engagement empowered the client with actionable insights and a future-ready market strategy:

• Delivered a validated, stage-wise epidemiology model for 7MM/Global markets
• Provided accurate NASH market size projections with clear segmentation
• Enhanced visibility into competitive risks and pipeline disruptions
• Supported evidence-based decision-making for portfolio prioritization
• Enabled the client to refine asset positioning, pricing strategy, and regional growth roadmap

The comprehensive assessment strengthened the client’s confidence in investment decisions, enabled better forecasting accuracy, and ensured strategic alignment with evolving NASH market dynamics.

With NASH now redefined as MASH, the industry landscape is rapidly evolving. Understanding market dynamics, competitive positioning, and regulatory pathways is crucial for success. Stay Ahead in the Evolving MASH Market

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