Market Size & Forecast Assessment

Unlocking Actionable Insights to Drive Strategic Growth

Helping Clients Understand Market Potential, Identify Opportunities, and Make Confident Investment Decisions

In an ever-evolving healthcare and life sciences landscape, understanding the true size and growth trajectory of a market is critical for success. DelveInsight’s Market Size & Forecast Assessment enables clients to navigate complex markets confidently by providing accurate, data-driven estimations and long-term growth projections.

Client Challenge

A leading global biopharmaceutical company sought to evaluate the commercial potential of its upcoming therapy in a highly competitive therapeutic area. The client needed a comprehensive market size assessment covering multiple geographies and segmentation across disease types, lines of therapy, and patient demographics. However, the available data in public sources was fragmented and inconsistent, making it difficult to validate patient pool sizes, competitor share, and emerging market opportunities. The client required robust market modeling and reliable forecasts to guide strategic planning, portfolio investment, and resource allocation.

Our Approach

DelveInsight adopted a multi-layered analytical framework that combined primary and secondary research, disease epidemiology modeling, and market analytics to generate an accurate and validated market forecast.

1. Objective

The objective of this engagement was to enable a European-based medical-device company to assess the commercial potential of entering the Patent Foramen Ovale (PFO) closure-device market in the European Union. Specifically, the client sought to understand the current and addressable patient pool, device market size and competitor share, and importantly the reimbursement scenario all in order to align their business development and market-entry strategy on a robust commercial foundation. 

2. Problem Statement

The client faced multiple challenges:

• Lack of clear data on the total treatable patient pool for PFO across indications (such as cryptogenic stroke, Migraine, decompression sickness) and across EU geographies, limiting accurate estimation of market size.
• Uncertainty around current treatment practices, device pricing, procedure volumes, and average pricing per device, which raised the risk of mis-estimating the addressable market.
• An opaque competitive landscape in which current device players, their market shares and segmentation across sub-regions were not fully mapped, making it difficult to identify true market entry opportunities or gaps.
• A need for reimbursement scenario assessment (pricing, payer access) to inform strategic decisions on access, pricing, and market launch planning  an area where the client had limited

3. Our Methodology

To address these challenges, DelveInsight employed a multi-layered, data-driven methodology including:

• Patient-Pool and Epidemiology Analysis: We quantified the population at risk across relevant indications (cryptogenic stroke, migraine, decompression sickness) and then narrowed down to the treatable pool for PFO devices, by region and segment.
• Treatment-Practice Evaluation: We reviewed current treatment pathways, device usage, procedure volumes, and market penetration of existing PFO closure devices in key EU markets to establish baseline adoption levels and market dynamics.
• Device-Pricing and Procedure Assessment: Conducted deep-dive assessments into device pricing, average cost per procedure, treatment process flows, and adoption rates  thereby enabling more precise modelling of revenue potential per patient and per region.
• Market Size & Forecast Modelling: Utilising the above patient-pool data, treatment practice metrics, pricing inputs, and competitive share inputs, we built a forecast model projecting market size over a defined horizon, segmented by country, product, and indication.
• Competitive Landscape & Market Dynamics: We mapped existing competitors, their market shares, and positioned the client’s potential offering. We also analysed key market drivers, restraints, and opportunities (e.g., reimbursement changes, technology shifts).

4. Results

• We delivered a full market-entry blueprint: the current market size for PFO devices across EU markets, addressable market projections over the forecast period, and revenue potential by country and indication.
• The client gained clarity on the key segments with the highest opportunity (in terms of patient volume and revenue potential), enabling them to prioritise geographies and patient pools for initial launch.
• Our competitive share and device-pricing insights enabled the client to refine their positioning and anticipate competitor pricing strategies and market entry threats.
• We provided reimbursement scenario mapping, which allowed the client to design access strategies aligned with payer requirements and device adoption levers.
• Ultimately, the insights enabled the client to craft a targeted sales-and-marketing plan and roadmap, minimize risk in resource deployment, and align internal teams around realistic market potential and launch planning.

Why Choose DelveInsight

With a strong foundation in epidemiology-based forecasting, therapeutic expertise, and competitive intelligence, DelveInsight has become a trusted partner for global pharmaceutical companies seeking clarity in complex market environments. Our team ensures every forecast is transparent, evidence-based, and tailored to your business objectives.

Conclusion

This case study underscores how a rigorous market size and forecast assessment can transform strategic uncertainty into actionable insights. By quantifying the patient pool, understanding treatment dynamics, pricing, and competitive environment, and projecting market size, organisations like our client can make informed market-entry decisions, optimise resource allocation, and position themselves for commercial success.

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