At its core, a TPP is a strategic document that outlines what a drug must achieve to be safe, effective, commercially viable, and ultimately reimbursable.
The TPP defines and aligns product requirements (e.g., clinical, commercial, etc). The TPP clearly outlines how it will aim to address unmet needs of patients, physicians, and payers, through differentiation against SoC at the projected time of launch, and differentiation against pipeline competitors into the future.
The life sciences industry is navigating one of the most challenging and transformative decades in its history. Regulatory expectations are changing. Competitor pipelines are accelerating. Reimbursement/ recoupment windows are shortening – and becoming more unpredictable. And across therapeutic areas, the threshold for meaningful differentiation continues to rise.
In this atmosphere of uncertainty, one tried and true strategic tool has become indispensable: the Target Product Profile (TPP).
For decades, TPPs have helped drug developers articulate what good looks like. But today’s drug development environment demands more than a static PPT created once a year. It requires a living, evidence-connected blueprint that evolves as the landscape changes. .
Characteristics of a Target Product Profile?
A well-structured TPP typically includes:
Information on the disease and target patient population
Product characteristics
Minimum acceptable criteria for regulatory approval
Base case expectations for competitive viability
Aspirational targets that define true differentiation and market leadership
TPPs support cross-functional teams by aligning:
Clinical strategy
Regulatory expectations
Commercial goals
Market access requirements
Evidence generation needs
When executed effectively, a TPP serves as the organization’s north star for prioritization and decision-making. Too often, however, siloed teams and fragmented cross-functional processes prevent it from fulfilling this role.
The pressures on drug development have never been greater:
1. Funding constraints have reduced tolerance for late-stage surprises, increasing the cost of poorly defined differentiation
Stakeholders expect to see thoughtful scenarios, realistic assumptions, and data-driven differentiation before committing capital.
2. Payer expectations are intensifying
Market access hurdles are increasing, particularly in crowded categories. Negotiations hinge on the strength of evidence supporting clear value claims.
3. Regulatory agencies expect earlier engagement and better-prepared sponsors
From surrogate endpoints to trial design, regulators want proposals grounded in real-world precedent and targeted evidence strategies.
4. Greater influence of cross-functional stakeholders in clinical development
Due to the growing expectations of external stakeholders (i.e., payers and regulators), a much broader group of internal cross-functional stakeholders must provide input and share responsibility in influencing early development decisions … and each needs an aligned view and understanding.
A TPP can be a great medium, with its balance of structure and flexibility. Structured sections to ensure the most important needs are being met, yet flexible for scenario planning with base, best, and reference cases to prepare for a world of uncertainty.
Despite their strategic importance, most TPPs fail operationally once assets begin to evolve. And despite their widespread adoption – likely because of the widespread adoption – most TPPs are still captured in PowerPoint decks or Excel grids and stored in SharePoint folders.
This creates several challenges:
1. Little to no visibility into version history or change rationale
Teams often struggle to understand who changed what when – let alone have any understanding of the reasons for doing so or how recent decisions shaped the current profiles.
2. Evidence isn’t linked to show proof of support and credibility
The static PPTs have no convenient way to link the bullets of the TPP to the publications that support the claim, or – if aspirational – the ongoing evidence generation activities/studies that aim to close the evidence gap. Without these connections, TPP evolution outpaces QC and the TPPs devolve into a wish list rather than a grounded and supported strategic planning document.
3. Neither published evidence nor study read-outs cascade into the TPP
When studies read-out and new evidence becomes available, this data often lives in separate documents owned by the siloed function responsible for that evidence, but this often results in the TPP’s data elements becoming outdated. This creates a lag in TPP updates that prevents important strategic decisions from being made.
4. Scenario planning is cumbersome or limited by slide aesthetics
In this fast paced and quickly evolving modern drug landscape, many different scenarios should be compared and planned for. But the static approach to TPPs makes building out various scenarios all too time consuming for implementation.
5. Static TPPs cannot keep up with dynamic markets
Competitor entrants, new endpoints, and evolving standards of care demand faster iteration than static documents allow.
6. Missing opportunity to connect with public data sources and AI
PPT documents make taking advantage of the publicly available data sources (e.g., OpenFDA, PubMed, ClinicalTrials.gov) and the time savings of the AI revolution all but impossible. Shifting from a static PPT to a software solution will enable faster – possibly automated – updates.
Static documents can no longer support the complexity, pace, and interconnected decision-making required in modern drug development. PowerPoint slides and spreadsheets can capture intent at a moment in time, but they cannot scale as living systems of record.
As assets evolve, teams must continuously reconcile differentiation targets with emerging evidence, competitive shifts, regulatory expectations, and payer requirements. In document-based workflows, these updates occur in silos – often asynchronously – making it difficult to maintain alignment, governance, or confidence in the latest version of the TPP.
A software-based TPP platform addresses these structural limitations by transforming the TPP from a static artifact into a structured, queryable data model. This enables consistent versioning, traceability, role-based ownership, and direct linkage between differentiation claims and the evidence that supports them.
A web-based digital framework opens the door for the next generation of capabilities:
Interconnected linking of the best available evidence and the planned/ongoing studies
Mapping of many future scenarios for differentiation against the unknowns of a crowded landscape
Proactive identification of unmet evidence needs and evidence gaps with real-time and AI-enabled horizon scanning of competitors and payer expectations
Automated evidence-readiness scoring and other key metrics for each asset and across the entire portfolio
Initiating workflows and enabling tighter alignment with other workflows like Integrated Evidence Plans and Scientific Communications Platforms
The future TPP will not be a file — it will be a living, collaborative planning environment.
In a world where clinical, regulatory, and commercial expectations evolve faster than ever, teams cannot afford static strategic tools. Organizations that continue to rely on static TPPs risk making tomorrow’s decisions using yesterday’s assumptions.
With a software-based, dynamic, data-driven, and AI-enabled TPP, biotech and pharma companies will benefit from:
1. Faster, more confident decision-making across the asset lifecycle – with fewer late-stage surprises
Leadership teams can rapidly assess new clinical, competitive, and regulatory signals without lengthy update cycles or confusion over version history. A governed, shared view of the TPP enables broader cross-functional input earlier—improving decision quality while preserving validity, accountability, and development momentum.
2. Higher-impact, better-aligned product strategy and execution
By explicitly linking differentiation goals to evidence requirements, teams can focus investment on the evidence generation tactics that matter most—maximizing return on evidence spend and ensuring clinical, access, and commercial strategies reinforce the same value story.
3. Lower cost and effort to build evidence generation plans and communications platforms
By using the TPP as a structured source of truth—and leveraging AI to generate first-draft evidence generation plans (e.g., IEGPs) and communication platforms (e.g., SCPs)—teams can significantly reduce or eliminate upfront consulting effort, internal rework, and redundant planning cycles.
Keywords & phrases:
strategic planning
value proposition
commercialization strategy
market access
pipline
competitive intelligence
competitive strategy
portfolio prioritization
evidence generation
IEGP
product valuation
patient segmentation
References and Further Reading:
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (2007). Guidance for industry and review staff: Target product profile—A strategic development process tool (Draft guidance). https://fda.report/media/72566/Target-Product-Profile----A-Strategic-Development-Process-Tool.pdf
World Health Organization. (n.d.). WHO target product profiles.
https://www.who.int/observatories/global-observatory-on-health-research-and-development/analyses-and-syntheses/target-product-profile/who-target-product-profilesNational Institute on Drug Abuse. (n.d.). Target product profiles (TPPs) for medical product development. National Institutes of Health.
https://nida.nih.gov/funding/small-business-innovation-research-sbir-technology-transfer-sttr-programs/target-product-profilesNational Institutes of Health, SEED. (2023). Creating a target product profile for new drug products. https://seed.nih.gov/sites/default/files/2023-12/Creating-Target-Profile-for-New-Drug-Products.pdf
KPMG. (2023). Target product profiles in pharmaceutical development. https://assets.kpmg.com/content/dam/kpmgsites/uk/pdf/2023/01/target-product-profiles-in-pharmaceutical-development.pdf
Fisher, I., Chen, J., & Bedder, M. (2025). Maximizing drug development success: The strategic role of target product profiles (TPPs). IQVIA.
https://www.iqvia.com/blogs/2025/05/maximizing-drug-development-success
