A biopharma company can survive a Phase 3 trial, clear an FDA review, and still fail within eighteen months of launch. That failure almost never shows up in the clinical data.
McKinsey’s analysis of pharmaceutical launches found that roughly two-thirds of new drugs fail to meet prelaunch consensus sales expectations in their first year on the market. First-time launchers fare worse than experienced ones by a wide margin: the median first-time launcher reaches only 63 percent of prelaunch forecasts, compared with 93 percent for companies that have launched products before. Every organization in this industry talks about that gap as a commercial problem, something to fix with better market research or a sharper sales strategy. We’d add that cross-functional education of how to commercialize is as critical as market research and strategy.
The Planning Gap Starts Years Before Launch
Most organizations begin serious commercial planning late in Phase 2, once the data looks promising enough to lead to Phase 3 and justify further investment. By that point, two phases of your clinical trials have been fully shaped. And what if: your clinical trials don’t match what your constituents need or want? What if your value proposition is still being formed, and yet that lack of formation is driving how you make internal organizational decisions – who’s doing what, when, how.
Companies that launch successfully tend to start that foundational work before Phase 2 because they know Phase 2 is going to inform Phase 3 and Phase 3 is going to inform whether you’re really successful or not. That earlier start matters less for when people get hired and more for how functions across the business are aligned and working toward common goals; well before the pressure of an approaching launch date forces decisions to get made (often badly) under time constraints.
Deloitte’s research into launch failures attributes 57 percent of them to limited market access and 47 percent to an inadequate understanding of market and customer needs, according to a summary of the report. Both of those causes trace back to organizational and educational choices made well before launch, not tactics executed poorly during it.
Commercial leadership hired during Phase 2 rather than Phase 3 has time to build market access relationships, weigh in on protocol design decisions that affect the real-world evidence payers will eventually ask for, and shape regulatory strategy with commercial reality already in view. Commercial leadership hired after Phase 3 inherits a set of decisions already made without them in the room and spends the runway before launch trying to work around those choices rather than shaping them. But that’s the obvious problem that most organizations have addressed.
The unobvious question, and somewhat dumbfounding is … why not educate the entire organization on what’s required to successfully launch commercially? What harm could there be, except better cross-functional awareness and alignment, and teams across the organization working toward the same shared goals.
The Same Problem, Different Regulatory Path
Medtech organizations run into a version of this gap that looks different on paper but produces the same outcome. A device company can secure FDA clearance or approval and still misjudge how much clinical education its sales and support teams need to drive adoption because the organization treated commercial readiness as a downstream activity rather than a parallel one. Hospital systems adopting new technology need training, workflow integration support, and change management, and the companies selling into that market often build the commercial plan around the sale itself while treating the adoption plan as an afterthought.
The pattern holds across the industry regardless of the product or regulatory pathway. Whenever commercial planning starts only after the scientific or regulatory milestone is secured, the organization has already lost the lead time it needs to drive the culture and mindset that would make the launch work.
It Is a Culture / Mindset / Education Problem, Not a Marketing Problem
The uncomfortable truth is that most early commercialization failures are not about the commercial team’s competence. They are about a structure that never assigned clear ownership for the transition from clinical development to commercial operations. Research teams keep operating with a clinical mindset well past the point where commercial thinking should start, because no one has built a governance or education structure that compels early cross-functional thinking.
We see this pattern across biopharma and medtech organizations of every size. A cross-functional governance model, established at the Phase 2 stage, with clear decision rights between R&D, regulatory, and commercial leadership and the education to go with this, are the key steps that separate organizations that launch well from organizations that scramble. Without it, commercial planning becomes a series of documents circulating for approval rather than an early mindset and culture of shared goals and clear understanding of what’s coming and what’s needed to succeed.
The Skills Gap No One Plans For
Early commercialization planning also runs into a workforce problem that rarely gets named directly. The scientific and clinical leaders who know the product best are frequently the same people asked to weigh in on commercial strategy, market access, and pricing, subjects that were never part of their training and rarely part of their prior experience.
That gap is not a knock on their capability. It is a predictable outcome of how life sciences organizations build careers. Deep scientific expertise gets someone into the room where commercial decisions get made. It does not automatically prepare them to evaluate a market access strategy or weigh in on pricing architecture, and organizations that assume otherwise end up with commercial plans built by people who understand the science and are guessing at the business.
This shows up most visibly in pricing conversations, where business leaders are asked to defend a value proposition to payers using clinical logic alone, without the advance cross-functional planning and integration to translate that value into the economic terms a payer evaluates.
What Early Commercialization Planning Requires
A commercialization plan built to hold up needs three things most organizations build too late. It needs a governance structure that assigns clear ownership across functions well before launch, ideally established during Phase 2. It needs an access strategy developed on the same timeline as the clinical strategy, not bolted on once trial results look favorable. It needs targeted capability building for the cross-functional teams who are all touching some aspect of commercial success.
None of that requires a bigger commercial budget. It requires treating early commercialization planning as an organizational development project with a deadline, not a marketing exercise that starts once the science is settled.
Where to Start
Before your next program reaches its Phase 2 data readout, identify who at the table owns the transition from clinical development to commercial operations. If the honest answer is no one yet, that gap is the real point of failure, not the commercialization plan itself.
