# Target product profile (TPP)
> A target product profile defines the desired clinical, safety and commercial attributes of a future therapy. It aligns development, regulatory, medical affairs and market access teams on what success should look like.
Source: https://www.visfo.health/glossary/target-product-profile
Updated: 2026-08-16T21:55:00.714816+00:00

What is a target product profile (TPP)?
A target product profile is a strategic planning document that describes the desired clinical, safety and commercial attributes of a future therapy. It sets out the intended [indication](/glossary/indication), patient population, efficacy, safety profile, dosing and administration, and differentiation from current or expected alternatives.

The TPP acts as a living roadmap across development stages. It translates the product strategy into testable objectives and decision criteria, while making clear which attributes are essential, which are preferred and which remain uncertain.

Why does a TPP matter across regulatory, medical affairs and market access?
A TPP gives cross-functional teams a shared definition of what successful development would produce. Clinical teams can use it to shape endpoints, comparators and study populations; regulatory teams can assess whether the planned evidence supports the intended claims; and medical affairs can identify evidence gaps and future scientific communication needs.

For [market access](/glossary/market-access), it helps teams consider payer and health technology assessment requirements before pivotal evidence is fixed. It also supports portfolio decisions by showing whether a candidate could deliver enough clinical and commercial value to justify continued investment.

How is a TPP produced and maintained in practice?
Teams usually begin with the unmet need, treatment pathway, target population and expected competitive environment. They then define the product attributes required to address that opportunity, supported by clinical evidence, scientific assumptions, stakeholder insight and competitor benchmarks.

The TPP should be reviewed at major evidence and investment decisions, and when the treatment landscape or development plan changes. Each revision should record the rationale, supporting evidence, unresolved assumptions and implications for trials, regulatory plans, evidence generation and commercial forecasts.

What should a good TPP contain?
A useful TPP normally covers:
- Target indication, line of therapy and eligible patient population.
- Intended clinical benefits, endpoints and expected magnitude or duration of effect.
- Acceptable and preferred safety and tolerability characteristics.
- Dose, formulation, route, frequency and treatment duration.
- Diagnostic, biomarker or monitoring requirements.
- Intended claims and the evidence needed to support them.
- Relevant comparators and differentiation goals.
- Patient, clinician and payer needs that could affect adoption or reimbursement.
- Key assumptions, risks, dependencies and evidence gaps.

The level of detail should be sufficient to guide decisions without presenting uncertain assumptions as facts. Attributes should be specific enough to test and should have named evidence sources or a plan for generating them.

What is the difference between a minimum and a target product profile?
Many TPPs distinguish between a minimum acceptable profile and a target or preferred profile. The minimum describes the threshold below which the product may no longer be clinically useful, approvable, reimbursable or commercially viable. The target describes the stronger outcome the programme is aiming to achieve.

This distinction supports scenario planning. A product may meet its primary endpoint yet fail an important dosing, safety or differentiation threshold, so success should be assessed against the complete profile rather than a single trial result.

Who owns the TPP, and where do teams commonly go wrong?
Ownership is normally cross-functional, with a clearly accountable product or development leader coordinating input from clinical development, regulatory, medical affairs, health economics and outcomes research, market access and commercial teams. Individual functions may own particular assumptions, but no single function should create the document in isolation.

Common problems include treating the TPP as a static template, describing only the ideal scenario, omitting payer-relevant evidence, failing to reflect emerging competitors, and changing attributes without documenting why. A TPP also loses value when its objectives are not connected to trial design, investment decisions or evidence plans.

How does a TPP differ from related product and evidence documents?
The TPP defines the intended product and the evidence ambition before or during development. A clinical development plan explains how the clinical evidence will be generated, while an approved label records the uses and claims accepted by the regulator rather than the original ambition.

A [global value dossier](/glossary/global-value-dossier-gvd) assembles the product’s value evidence for access discussions, and a [health technology assessment](/glossary/health-technology-assessment-hta) evaluates available evidence for reimbursement or coverage decisions. The TPP sits upstream of both: it helps determine what evidence and product attributes teams should pursue.