CASE - Evaluation of Market Potential: building pre-launch positioning, medical, regulatory, market access strategies

Client Need

First ex-US launch for a US Biotech requires the establishment of both a strong team and organization but also solid insights on which competitive, medical, regulatory, market access challenges the novel Oncology drug will face and which affect total market potential and the possibility of a successful launch.

The Client needed to:

  1. Assess key requirements for a successful EU launch,
  2. Estimate market potential and recommendations for targeting and distribution strategy,
  3. Identify Critical Success Factors for Access and opportunities to expand clinical experience for market preparation,
  4. Quantify potential gaps and risks in market and organizational preparation, simulation of external scenarios.


A Product's market potential is based on a series of building blocks, which help define priorities and gaps which need to be addressed with an articulated pre-launch strategy. The quantification of patient potential and dynamics 2013-2020 required a deep understanding of the clinical claims of the product vs. competitors (100+ study meta-analysis), a detailed mapping of current level of KOL experience and positioning of the drug, and a detailed quantification of potential patient pool. Three alternative scenarios were modelled (Best, Base, Worst) to reflect uncertainties in key assumptions, a sensitivity analysis was performed to guide prioritization of interventions.

For 10 EU countries, a detailed review of market access (pricing and reimbursement) outcomes was performed to determine Best, Base, Worst case pricing and reimbursement restrictions and launch delays. All these factors were considered in the model of Potential to obtain a final $ result. We assessed possible timing delays and label restrictions at EMA, together with most probable outcomes of local payer negotiations (national, regional, local). A detailed review of past decisions on competitor and analogue therapies provided key insights on payer thought processes.


  • On-boarding newly established EU management team on Product market and access landscape
  • Quantification of product market potential by label and by scenario 2013-2020
  • Identification and quantification of key gaps in pre-launch strategy (positioning & market share, KOL engagement and Medical, Timing & Regulatory strategy, Market Access

Designed and developed by: Brand039