SITUATION
A mid-sized global biopharma company was preparing for the potential label expansion of its complement pathway inhibitor into rare renal indications. While early-phase data showed promising efficacy in conditions like C3G and IC-MPGN, the competitive landscape was becoming increasingly complex, with multiple complement-targeting agents being explored across similar pathways.
The company’s internal teams needed clarity on how to position their molecule distinctly — both clinically and commercially — while aligning global stakeholders around a unified narrative ahead of regulatory submissions.
CHALLENGE
Although the asset was scientifically differentiated, there were challenges in translating that into a clear market-facing strategy. The team faced the following issues:
- Overlapping mechanism claims from competitors made it difficult to articulate a unique clinical value
- Lack of clarity on what differentiation actually mattered to regulators, payers, and clinicians
- Internal misalignment between medical, regulatory, and commercial teams on messaging priorities
- Concerns that clinical data alone might not support a strong enough market entry if differentiation wasn’t clearly communicated
With rare renal diseases being poorly understood across payer and provider audiences, the need for clear, tailored messaging became critical.
APPROACH
ConsaInsights was engaged to lead a comprehensive differentiation strategy project focused on three pillars: scientific clarity, stakeholder relevance, and market readiness. Our work centered on refining the positioning of the asset in a way that would resonate with all key decision-makers.
Competitive Messaging & Claims Mapping
We benchmarked 8 key competitor programs across complement-mediated diseases. This included analysis of core scientific claims, clinical endpoints, MOA narratives, and commercial messaging. The mapping helped identify messaging overlaps, white space, and overused narratives that no longer held impact.
Stakeholder Relevance Workshops
Through interviews and secondary research, we gathered insights into how nephrologists, regulators, and payers interpret value in this category. We looked at what aspects of complement inhibition (e.g., durability, precision, administration route) were most likely to drive uptake and access.
Cross-Functional Narrative Development
We collaborated with internal teams to build a structured positioning framework that aligned clinical strengths with stakeholder expectations. This included modular messaging for regulatory submissions, payer dossiers, and future promotional use.
Validation and Alignment
We tested the refined differentiation pillars with cross-functional internal stakeholders and refined the final framework to ensure consistency across clinical, regulatory, and commercial teams.