Whitepaper

Strategic indication-selection in early-stage drug development to maximize a drug's lifetime value

Simon-Kucher insights_Strategic indication-selection for early drug development

Breakthrough innovations often come with broad potential, and equally broad uncertainty. When a new therapy or platform technology could be applied across multiple indications, early choices have outsized impact. Limited resources mean not every promising avenue can be pursued at once, making it essential to focus on the paths that will create the greatest long-term value.

Yet early-stage biopharmaceutical teams face this decision with incomplete evidence, varied data quality, and strong internal opinions. Executive leaders must navigate scientific ambiguity, commercial unknowns, and organizational bias - all while moving quickly. Getting these choices right is critical; getting them wrong can delay development, erode value, or constrain future strategic options.

What’s needed is a way to cut through the complexity.

This whitepaper introduces a structured, objective approach designed to help executive management manage uncertainty, minimize bias, and align decision-making across scientific, commercial, and strategic priorities. The framework provides a practical way to evaluate potential indications, balance opportunity and risk, and identify the path that maximizes the commercial lifetime value of an asset.

Among other topics, this paper outlines how to:

  • Evaluate commercial opportunity, including patient population, competitive dynamics, and price potential
  • Assess scientific-medical attractiveness using unmet need, relevance of mechanism, and strength of evidence
  • Prioritize indications and build a roadmap that balances risk, speed, and long-term value
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