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Case Study

Target Product Profile (TPP) Development for a
Product for a Key Indication Within Nephrology...
Background and Objectives

A global pharmaceutical company was developing a drug (Product X) for a key indication within nephrology. The commercial and market research teams requested SmartAnalyst to support them in developing and testing a TPP

Approach and Recommendations (Methodology)

SmartAnalyst utilized a structured approach and conducted extensive secondary and primary research to develop and test the TPP:

Phase I: Gap Analysis Vs. Emerging Competition
  • Performed a gap analysis to understand the current/future treatment landscape. Completed and ongoing competitor trials were evaluated for trial design, comparators, size/duration, patient segments, etc. Product X profile was mapped vis-à-vis competition to identify potential gaps and their implications. The attributes identifie d included efficacy/safety parameters as endpoints such as patient reported outcomes (PRO)
Phase II: Identification of Key Differentiators
  • Identified clinically meaningful key differentiators and potential claims compared to competitive assets in clinical development. The focus was on identifying clinical attributes required to make Product X the drug of choice, the corresponding clinical trial endpoints to target and the key patient segments that should be included.
Phase III: TPP Development
  • Developed TPP based on findings from Phase I/ II and preliminary data for Product X. The TPP was tested through in-depth qualitative interviews with KOLs and practicing physicians for validation of differentiators and potential augmentation of claims.
Stakeholder Engagement

Stakeholders from functional areas (e.g. regulatory, clinical, medical affairs, marketing, and strategy) were engaged through on-site workshops and interactions throughout the project.

Time Frame

12 weeks


Based on the assessment, two TPPs were developed; the ‘must have’ TPP required for regulatory success and ‘good to have’ TPP required to make Product X the drug of choice. Additionally, identified clinical data/claims required for Product X to become the therapy of choice in desired patient subsegments.

About SmartAnalyst: Driving pipeline and portfolio value for global biopharma and life science companies
SmartAnalyst helps biopharma companies make key decisions at the Disease, Asset, and Portfolio levels, utilizing proprietary strategic frameworks. We provide comprehensive, integrated solutions based on our deep understanding of the science, the market, and the key business decisions that our clients face. We deploy agile, cross-functional project teams that are responsive to client needs.