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The Challenge

A novel combination therapy was in development for a chronic cardiorenal condition, targeting a 2028+ commercial horizon. The landscape it would enter was evolving rapidly: existing foundational therapies were becoming standard of care, new entrants were expected to gain expanded indications, and the competitive set was shifting faster than clinical development timelines could track.

The brand team needed to make strategic decisions about clinical development priorities, comparator positioning, and value proposition framing before much of the competitive data existed. The central question was not “what does this therapy do?” but “for which specific patient populations, in what clinical contexts, does this therapy have the most defensible right to win?” Without a rigorous answer, clinical development decisions and commercial investments risked being made against a market landscape that would look very different by launch.

CONTEXT

  • A first-in-class combination mechanism entering a rapidly evolving standard-of-care environment
  • Multiple new competitive entrants expected before the 2028+ launch horizon
  • Strategic development and commercial decisions required before comparative data existed
  • Five-market global launch scope demanded insight that held across diverse healthcare system contexts
  • Internal prioritization frameworks needed external physician validation to drive commercial conviction

Our Approach

Shapiro+Raj executed a four-stage research program that moved from KOL futurecasting through community physician validation, with explicit co-creation with the client team at each prioritization stage.

RESEARCH OBJECTIVES

  • 01

    Establish a credible, externally validated view of the 2028+ treatment landscape and unmet need across five global markets — before competitive data was available

  • 02

    Identify and prioritize the patient opportunities where the novel dual-mechanism profile offered the most defensible competitive differentiation

  • 03

    Develop a right-to-win framework that could guide clinical development prioritization and commercial investment decisions with physician-validated conviction

Stage 1 deployed 16 KOL interviews across five markets to establish a forward-looking view of the treatment landscape in 2028+, mapping unmet needs, evolving treatment algorithms, competitive threats, and the specific clinical scenarios where the novel combination would be most differentiated.

Stage 2 used findings from the KOL phase to develop and shortlist patient opportunity candidates, generating more than 20 distinct patient “pools” through the combined analytical lens of KOL insight and internal commercial team input, then jointly prioritizing a focused set for deep validation.

Stage 3 deployed 50 community physician interviews across the same five markets to validate each patient pool in real-world clinical practice testing whether KOL-identified needs reflected the experience of the physicians managing the majority of patients, and how the dual-mechanism profile would fit each opportunity relative to expected competitors.

Stage 4 produced a risk-reward prioritization matrix and value proposition framework, mapping each opportunity against market potential and right-to-win.

Stella was deployed throughout to synthesize cross-market physician language patterns — identifying where the vocabulary physicians used to describe patient need mapped onto the clinical attributes the therapy was designed to deliver, and where gaps in that alignment required messaging bridging.

Insights Delivered

KEY FINDINGS

  • A focused set of patient opportunities emerged as clear commercial priorities differentiated by clinical urgency, market size, and unmet need no single available agent could meet

  • Across all five markets and physician types, the combination profile was seen as addressing multiple clinical triggers at once, a differentiation that held under competitive comparison

  • Community physician experience diverged from KOL views — real-world adoption barriers were rooted in healthcare system structure, not physician knowledge or clinical evidence

  • Stella's cross-market language analysis exposed gaps between how physicians describe patient need and the clinical attributes the therapy delivers with direct implications for messaging

Strategic Impact

The co-creation program delivered three distinct strategic assets with direct commercial and clinical development utility.

The patient opportunity framework gave the clinical development and commercial teams a shared, externally validated prioritization structure for the 2028+ launch strategy replacing internal assumption-based prioritization with physician-validated market intelligence. The risk-reward matrix enabled evidence-based resource allocation across indication, population, and market dimensions.

The right-to-win analysis identified the combination therapy’s clearest competitive advantages across the physician populations that would determine adoption producing a competitive positioning foundation built from the ground up in physician language, not internal messaging assumptions.

The system-level barrier finding — which identified a structural gap in the healthcare environment suppressing adoption independent of clinical evidence — produced a specific non-clinical commercial investment brief, directly shaping the patient support program architecture before launch investment decisions were made.

KEY DELIVERABLES

  • Prioritized patient opportunities with right-to-win assessment across five global markets
  • Risk-reward prioritization matrix for clinical development and commercial resource allocation
  • Value proposition framework grounded in cross-market physician language
  • Competitive positioning analysis mapping the dual-mechanism profile against expected 2028+ entrants
  • Non-clinical commercial investment brief addressing identified system-level adoption barriers
We needed to make development and commercial decisions against a market that doesn’t fully exist yet. The co-creation approach — KOLs first, then validation with the physicians who’ll actually be prescribing — gave us a conviction level we couldn’t have gotten any other way.

Strategic decisions made without a validated view of the future competitive landscape are expensive to reverse. Talk to us about patient opportunity mapping that builds commercial conviction before the Phase 3 data arrives.