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The Target Product Profile: Basics and Benefits

Defined by the US Food and Drug Administration (FDA) as a strategic development process tool, the Target Product Profile (TPP) “embodies the notion of beginning with the goal in mind.”[1] Broadly, the TPP is a template that summarizes key drug labeling concepts to focus discussions between sponsors and the FDA and is intended to be used throughout the drug development process.[1]


A TPP serves multiple functions, which work together to optimize the likelihood of regulatory and commercial success. Specifically, a TPP is a:

  • Strategic framework and living document used to confirm required product attributes and to highlight development priorities
  • Detailed regulatory document that defines labeling priorities and is used to negotiate with the FDA and international health authorities
  • Technical dossier that describes critical-to-quality product attributes and manufacturing processes
  • Due diligence tool used by professional investors and potential commercialization partners to evaluate assets and to negotiate valuations

Benefits of using a TPP

If it is strategically developed and incorporated into a pragmatic system of strategic decision-making, a TPP will decrease development risk, accelerate regulatory approval, and enhance market adoption.

Increased R&D efficiency

The primary cause of failure in biopharmaceutical development is inadequate coordination or communication between R&D and commercial functions. In a survey of 150 biopharmaceutical executives, 53% cited this disconnect as the main reason for poor productivity or lack of R&D success.[6] Therefore, it is not surprising that 24% of late-stage (Phase 2/3) clinical studies fail due to strategic or commercial reasons, rather than operational issues or product safety or efficacy.[7] When properly developed and incorporated into governance, TPPs facilitate coordination and collaboration among R&D and commercial groups, limiting unnecessary risks.

Improved regulatory outcomes

Data show that development programs which did not include a TPP in their new drug application (NDA) submission took significantly longer to review and were significantly more likely to receive a refuse-to-file notification. Compared to NDAs that referenced a TPP, applications that did not reference a TPP underwent a median review time that was 30 days longer. Nearly 5% of NDAs approved between 2008 and 2015 that did not reference a formal TPP in their FDA negotiations received an initial refuse-to-file notification, whereas none that referenced a formal TPP received that notification.[2],[3]

De-risked commercial outcomes

Products developed with TPPs are more likely to be successful. A survey by McKinsey showed that, while a record number of products have been approved by the FDA in the last three years, nearly two-thirds of recent drug launches failed to meet their first-year sales forecasts. Of those that did meet the first-year sales forecast, only 50% continued to meet forecasts in Year 3.[4]

Another survey, conducted by Deloitte to identify the root causes of underperformance, revealed three common reasons for commercial disappointment:[5]

  1. Poor understanding of the market, including the target audience and drivers and barriers to action
  2. Limited differentiation, including absence of the attributes necessary for compelling patients, providers, and payers to try the product
  3. Market access limitations, such as unfavorable placements or exclusions, or formulary restrictions leading to high pricing

This survey highlighted the TPP as both the cause of and the solution to product commercial performance issues, where poor performance reflects the tendency to progress products through clinical development at the expense of eroding TPP criteria. For sponsors, seeking early input on the TPP from payers and other stakeholders can help clarify which clinical trial endpoints should be prioritized for streamlining regulatory approval and solidifying market adoption.

Key takeaway

Creating and maintaining a well-thought-out TPP and utilizing it is a framework for strategic decision-making at every stage of development increases the probability of success. To learn more about TPPs, including practical challenges and best practices for using this strategic development process tool, stay tuned for our guide to leveraging TPPs to optimize the potential of your portfolio.

[1] US Food and Drug Administration. Target Product Profile – A Strategic Development Process Tool: Guidance for Industry.

[2] Premier Consulting, Proprietary Analysis.

[3] Breder CD, Du W, Tyndall A. What’s the regulatory value of a target product profile? Trends Biotechnol. 2017;35(7):576-579.

[4] McKinsey & Company. The secret of successful drug launches, March 1, 2014. Available at Accessed April 5, 2022.

[5] Deloitte Insights. Key factors to improve drug launches, 2020. Available at Accessed April 5, 2022.

[6] Life Science Leader. Creating A Culture Of Trust And Innovation In Pharma, January 28, 2015. Available at Accessed June 14, 2022.

[7] Harrison, R. Phase II and phase III failures: 2013–2015. Nat Rev Drug Discov 15, 817–818 (2016). Available at Access June 16, 2022.