Gap analysis

What is gap analysis?

Gap analysis is a structured method for comparing the current state of evidence, strategy, capabilities or stakeholder alignment with a defined future state, goal or requirement. The difference between the two identifies what is missing, insufficient, inconsistent or not yet ready.

In pharmaceutical development and commercialisation, the comparison may cover clinical and real-world evidence, value communication, regulatory requirements, stakeholder insight, operational capabilities or cross-functional plans. The result should identify specific gaps that can be assessed, prioritised and assigned for action.

Why does gap analysis matter in medical affairs and market access?

Gap analysis helps teams focus resources on needs that could materially affect clinical decision-making, regulatory readiness, market access or stakeholder confidence. It can show, for example, that available evidence does not answer a payer question, that scientific narratives vary between markets, or that the organisation lacks the insight needed to plan engagement.

It is particularly useful when preparing for an HTA submission, an advisory board or a launch. Identifying gaps early allows evidence generation, insight collection and capability development to be included in cross-functional plans rather than addressed reactively.

How is a gap analysis run in practice?

The team first defines the decision, requirement or future state against which the current position will be assessed. Without a clear reference point, the exercise can become an unstructured list of concerns.

A typical process is:

• Define the scope, decision context, stakeholders and success criteria.
• Gather relevant evidence, plans, insights, requirements and capability information.
• Describe the current state and the required or desired state using consistent categories.
• Record the gap between them, including its cause and potential consequence.
• Assess each gap by strategic importance, urgency, feasibility and dependency.
• Agree actions, owners, timing and the evidence needed to confirm closure.
• Review the analysis as requirements, data or stakeholder expectations change.

The output may be a gap register, matrix or prioritised action plan. Scoring can help compare gaps, but the criteria and rationale should remain visible so that a numerical rank does not conceal uncertainty or disagreement.

What types of gap can the analysis identify?

Evidence gaps include missing outcomes, unsuitable comparators, limited subgroup data, uncertain long-term effects or a lack of information relevant to local decision-makers. An evidence gap does not always mean that no data exist; the available data may be inaccessible, poorly synthesised or unfit for the intended decision.

Other gaps may concern stakeholder insight, scientific communication, internal skills, processes or alignment. For example, medical and access teams may hold different assumptions about the evidence needed, or global materials may not address country-level requirements. Separating these categories helps avoid treating every issue as a request for a new study.

Who should own a gap analysis, and what does good look like?

Ownership should sit with the function accountable for the decision or deliverable, with contributions from the teams that create, interpret or use the relevant evidence. Depending on scope, this may involve medical affairs, HEOR, regulatory, clinical development, commercial, regional and affiliate teams. A named owner should maintain the analysis and track agreed actions.

A good gap analysis is decision-specific, evidence-based and transparent about assumptions. Each gap is described precisely, linked to a consequence and assigned an appropriate response. Common failures include setting an unclear target state, combining several issues into one gap, prioritising by opinion alone, and assuming that every gap must be closed rather than accepted, monitored or managed another way.

How does gap analysis differ from a needs assessment, risk assessment or action plan?

A needs assessment establishes what users, stakeholders or an organisation require. Gap analysis compares those requirements with the current position. Risk assessment then considers the likelihood and consequence of failing to address relevant gaps, while an action plan sets out what will be done, by whom and when.

These tools are connected but not interchangeable. Gap analysis sits between defining the required state and deciding the response: it makes the difference explicit, supports prioritisation and provides the basis for evidence-generation, engagement or readiness plans.