Pharmaceutical Market Europe • May 2025 • 14
INNOVATIVE IMPACT BLOG
Why local market input is the early commercialisation superpower
When global asset teams come together in the early commercialisation phase – right through to phase 3 design and governance – they’re typically packed with highly experienced specialists, each laser-focused on a single asset. But when it comes to the country representatives joining those same discussions, the dynamic shifts. These colleagues are juggling competing priorities, often dedicating only a sliver of their time to global projects while being deeply embedded in the existing portfolio needs of their own markets.
And yet, every pharmaceutical company recognises the same truth: the success of a global strategy depends on how well it’s shaped by real-world local insight translated into strategic foresight.
That’s why empowering local voices within global teams is mission critical. It’s not just about having someone in the seat; it’s about having the right person. Someone who knows how to tap into the right networks, who can speak up with confidence on behalf of the market and who feels trusted enough to challenge the global view when necessary.
If we don’t get this balance right – if local input remains an afterthought – there’s a real risk of missed opportunities, misaligned plans and exclusion from key priority markets. It’s time for both local and global leadership to think more carefully about representation, relationships and the commercial consequences of leaving local insights on the sidelines, in six key areas:
There are often different regulatory body requirements within regions and countries. These nuances need to be front and centre of early development and commercial plans. While the US will remain the major focus, for global success, other pivotal markets should be considered and lay out any risks, benefits and synergies that need to be considered in the clinical development and commercialisation process. Local input will ensure clinical trials meet the diverse regulatory requirements, submission strategies and data requirements.
Within key markets, the clinical approaches to treating conditions could vary significantly. As a result, there could be a divergence of standards of care globally and, therefore, different unmet needs across regions and countries that a new asset needs to address. In extreme cases, an indication could be prioritised or de-prioritised over other life cycle indications based on the value it would bring to an individual healthcare system.
The prevalence and incidence can also vary widely between countries and regions. Local market leads can give a specific view from multiple sources that will not only feed into forecast potential but also focus the clinical development plan structure and study sites.
Pricing, reimbursement and access models differ globally. Having this information in the global team as early as possible is important and only local teams can clearly lay out, with local analogues, what value evidence is critically required, enabling the global team to develop trials that generate the necessary efficacy and health outcome data with the appropriate comparators.
The global team will develop positioning and promotable claims within the programme for the priority market, usually the US. However, we often see local markets frustrated and spending considerable time trying to work out how to effectively translate this into their market after the phase 3 data is available. With early input from pivotal markets, key endpoints – either primary, secondary or exploratory – can be included in the studies with a statistical hierarchy that will allow optimal commercialisation across the globe.
Patient and clinician preferences and behaviours can vary between countries. Local input can ensure that this can be leveraged positively with the study designs and execution. A clear view of willingness to conduct trials with associated rationale could be vital in setting up protocols and avoiding recruitment delays. Understanding investigator attitude to risk will also enable the clinical development team to predict any issues that could arise with country study leads and trial centres. Having these insights should enable commercial teams to identify significant cultural drivers or barriers to adoption, such as willingness to use new therapies.
Altering processes to gain early, meaningful local input into global teams should be a strategic imperative – when regional insights shape clinical development planning, regulatory strategy, pricing guidance and commercial positioning from the outset, assets are both scientifically robust and well differentiated, leading to faster adoption and better outcomes for patients across the globe.
Jo Lopez is Practice Lead – Early Commercialisation and Launch at Uptake