Why phase 2 decisions are locking out pharma’s best launch positions
September 14, 2026 | Commercialisation strategy, Launch Performance, Success Factors, pharma launch, phase 2, positioning, value proposition
Half of the 2023 US pharmaceutical launch class missed pre-launch first-year forecasts .
That gap is usually explained away as a data problem, a market access problem, or a timing problem.
But the real cause sits much earlier in the process in how Phase 2 studies are designed and who’s designing them.
Positioning and commercial strategy are typically treated as downstream work, something that starts once the clinical data exists. By the time that happens, the evidence base is already fixed, and the strongest commercial positions may simply not be supportable by the data on hand.
This sequencing, science first, positioning second, can quickly contribute to launch underperformance. The thing is, it rarely gets registered as a commercialisation strategy failure because the decision that caused it was made years earlier and filed under science.
What is the sequencing failure behind pharma launch underperformance?
Positioning work typically starts once Phase 2 data exists. By that point, the evidence base is fixed.
Teams generate positioning ideas, then discard the strongest ones because the dataset doesn’t support them.
What survives isn’t the position most likely to change prescriber, patient or payer behaviour, but the position the data happens to allow.
Teams have great ideas but not always the permission to use them. The positioning idea that would shift behaviour often gets killed because the data isn’t being generated to support it.
Why isn’t clinical differentiation enough to guarantee a successful launch?
Strong data alone doesn’t close the gap. Research suggests that clinical differentiation lifts a launch’s overperformance rate from 44% to only 49%,[i] a small margin given the scale of investment behind most Phase 2 and Phase 3 programmes.
The real divide is between evidence designed to satisfy a regulator and evidence capable of compelling a behaviour. A clinical trial can clear every regulatory hurdle and still fail to give commercial teams anything to work with at launch.
When should positioning and value proposition work begin?
Positioning and the value proposition need to sit in front of the Phase 2 protocol, not behind it. The sequence should look like this:
- Start with the disease state and the people living in it. What motivates them to engage with the healthcare system, to start a therapy, and to stay on it for as long as it delivers benefit.
- Define the unmet need precisely. The gap between what motivates people and how far current therapies close it.
- Build the positioning idea. How the asset needs to be perceived by patients, prescribers and payers to compel the behaviours commercial success depends on.
- Derive the value proposition. This follows directly from the positioning.
- Identify the claims that would substantiate it. These claims determine what the study has to measure, in which population, against which comparator and which indications to prioritise.
Does this mean deciding the asset’s position before the science is proven?
You can’t know at Phase 2 where you’ll land. The goal is to identify which positions are worth being able to occupy, and to design the Phase 2 programme so those positions stay open.
The science still leads; it’s just designed to keep commercially meaningful options alive rather than to fit whatever data happens to emerge.
How does Nmblr’s Define toolkit put this into practice?
Define is Nmblr’s toolkit for building positioning, value proposition and success factors early, starting from the patient’s perspective and the people who serve them, before critical endpoints are locked in.
It’s designed to ground the case for a medicine in real human motivation from the outset, rather than reverse-engineering a position from whatever the trial data ends up showing.
Discover more about the Define toolkit.
[i] https://www.zs.com/insights/build-a-pharmaceutical-launch-strategy-and-operating-system
This content was provided by Nmblr
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