The case for a smarter early commercialisation strategy when launching a pharma brand

Insight by Jo Lopez, Practice Lead Early Commercialisation and Launch, CELforPharma faculty member of Strategy & Planning for Global Commercial Launch Success in Pharma and Effectively Leading Country Launches in Pharma.

Often pharma brand launches underperform — not because the science fails, but because commercial strategy comes in too late to shape success. Traditional approaches often treat regulatory approval as the finish line, rather than a milestone within a broader commercial pathway. A smarter early commercialisation strategy challenges this mindset by ensuring that clinical development, regulatory, medical, access planning, and promotional readiness are built in from the beginning.

Pharma companies are increasingly operating in environments where differentiation is difficult, payer scrutiny is intense, and competition arrives earlier than expected. In this context, early commercialisation is no longer a nice to have, it is a critical component of launch planning.
 

📊 From Clinical Data to Commercial Impact

An effective early commercialisation approach begins by defining the long-term asset vision. This includes identifying the promotional claims that will truly differentiate the brand in the eyes of payers, prescribers, and patients with consideration of the future competitive landscape and unmet needs which are likely to persist. It also involves determining which claims can be made based on the pivotal trial’s endpoints — and whether these claims are promotable, payer-focused, or medical-only messages.

To enable this, early cross-functional collaboration is essential. Commercial, medical, regulatory, access and clinical teams must work together to ensure that pivotal studies are designed to also generate the data to support differentiating commercial claims required for launch.
 

🔬Rethinking the Role of Phase 3b

Pivotal trials alone may not be sufficient to deliver all required claims. That’s where Phase 3b studies come in — providing an opportunity to explore additional endpoints or generate aspirational data that strengthens differentiation. A well-planned Phase 3b programme can enhance a brand’s value story, inform pricing and reimbursement strategies, and support broader stakeholder engagement ahead of launch. But to deliver on that promise, it must be viewed as an integral part of early commercialisation — not a standalone medical activity.
 

🎯 Aligning Evidence with Market Needs

Early commercialisation also provides the opportunity to assess whether the evidence package being built will truly resonate with key audiences. A claims analysis should be conducted to categorise each potential claim as either 'cost of entry' or 'differentiating', relative to the expected competitive set. This clarity enables teams to focus investment on what will drive real-world uptake and reimbursement success.

Just as importantly, the feasibility of generating these claims must be assessed early. Some may be achievable within the pivotal programme; others may require supplemental studies, real-world evidence, or health economic modelling. By mapping this out early, companies can ensure they are not left scrambling for differentiation once the asset is nearing approval.
 

🚀 Preparing for Launch with Confidence

A smarter early commercialisation strategy equips pharma brands with more than a strong evidence base — it provides launch confidence. When commercial, regulatory, medical, access and clinical development plans are aligned from the start, the result is a coherent value narrative, a clear promotional platform, and a faster path to market uptake.

It is this integration — not just across functions, but across the entire asset lifecycle — that separates average launches from exceptional ones. In a market where access barriers are rising and differentiation is increasingly data-driven, early commercialisation is not just smart planning. It’s competitive advantage.