Pharma Product Launch
Launching a pharmaceutical product is far from a one-team effort. It’s a collaborative process that usually requires alignment across global, regional, and country teams, with many different stakeholders being involved across these teams. Understanding the nuances of these relationships is key to navigating a successful launch.
Different pharmaceutical companies approach this collaboration in various ways, depending on their structure and corporate culture. Some may have strong global teams driving strategy with regional and country teams supporting, while others empower country teams to take the lead, especially in major markets like the US. Regardless of the structure, the ultimate goal remains the same: to launch the product effectively, and this involves balancing input from multiple stakeholders at every level.
The Balancing Act: Global, Regional, and Country Teams
Pharmaceutical companies vary greatly in how they manage their global, regional, and country teams. Large organisations may have dedicated teams at each level, while smaller companies might operate with a leaner structure, sometimes bypassing regional roles altogether. The US market, due to its sheer size and revenue potential, often operates independently, with limited influence from global teams. In contrast, other large markets like Germany or France work in closer alignment with global or regional offices, as collaboration and coordination are critical for product success across multiple territories.
Navigating these dynamics is a balancing act. Global teams often drive the initial strategy and planning, especially in the early stages of a product’s lifecycle. However, as the product nears launch, regional and country teams become more involved, providing insights that shape localised strategies. Countries like the US may develop their own plans due to market specifics, but their collaboration with global teams remains vital to ensure overall alignment.
Stakeholder Involvement Throughout the Product Lifecycle
As a product progresses through its lifecycle, from early development to launch, more and more stakeholders become involved. In the early stages, global teams tend to manage the product with a limited budget, focusing on longer-term planning. However, as the product advances into Phase 3, a commercial team forms around it, bringing in functional experts like forecasters, market researchers, pricing specialists, and market access professionals. This team works to build launch strategies and key messages, all while carefully balancing the allocation of resources.
At this point, stakeholder involvement becomes increasingly important, particularly in forecasting. Forecasting during the pre-launch phase is often led by global teams, who provide top-down estimates for key markets. As launch approaches, country teams take over much of the forecasting, with global and regional teams reviewing and collaborating on the numbers. Countries typically focus on mid-to-short-term forecasts, such Annual Operational Plans (AOP) for the next year or Latest Best Estimate (LBE) for the current year, while global teams look further ahead to ensure alignment with long-term strategic goals. Countries will often feed into forecasts up to 3 years into the future, but beyond this time period is not usually a focus for individual countries.
Forecasting and Decision-Making: Who Does What?
Stakeholders can generally be divided into those who “do” the forecasting, those who “influence” the forecast, and then those who are impacted by it.
At the global level, forecasters work with inputs from various teams, including market access, pricing, and strategy, to develop a top-down view of potential market performance. These forecasts are then shared with regional and country teams, who input their localised assumptions and make adjustments based on their knowledge of the market.
Influencing the forecast comes from various sources. Market access teams might indicate that only a portion of the market will be accessible, while pricing teams set price targets based on market conditions. Operational teams may influence by outlining how hospitals or healthcare facilities must be prepared to administer complex treatments, like CAR-T therapies, which require extensive training. These inputs don’t necessarily directly feed into the forecast but are essential to shaping the assumptions used to develop it.
On the receiving end of the forecast are manufacturing and supply chain teams who use these numbers to plan production volumes and distribution strategies as the launch draws closer. These teams are heavily impacted by forecast accuracy, as any deviations can affect inventory levels and supply to market.
Building Teams for a Successful Launch
As a product nears launch, global teams often expand, adding specialised resources to support the commercialisation efforts. Forecasting, market research, and access teams become more embedded into the product’s strategy, building detailed plans where country teams now start to collaborate and prepare for their execution. This expansion timing decision has multiple drivers and challenges. Committing resources too early may pull those resources away from other critical projects, while leaving it too late can create bottlenecks that slow down the launch process.
The closer the product gets to launch, the more integrated the forecasting and planning process becomes, with country teams taking on a larger role. In many cases, global teams continue to provide top-line forecasts for key markets and scale these estimates across other regions, but country-specific forecasts are critical for ensuring that the product performs well in local markets. It’s common for global teams to maintain their own forecasts even after countries submit theirs, allowing for comparison and adjustments based on local insights.
The Role of BD&L in Product Forecasting
Another crucial aspect of forecasting in pharma is Business Development & Licensing (BD&L). This team is often responsible for evaluating external assets for acquisition or partnership, providing a forecast to determine the commercial viability of in-licensing a product. The BD&L forecasting process may differ from the typical internal forecasting structure, as it often involves a specialised team operating globally, with minimal input from country teams—especially when the product is still far from launch.
In some cases, BD&L teams may engage with countries if the in-licensing is close to launch, but generally, it remains a centralised effort. Forecasts generated by BD&L may be based on commercial assumptions, with inputs from market research or competitive intelligence teams. These forecasts are critical in shaping the strategic decisions around whether to pursue the licensing or acquisition of a product. Later, when products are brought in-house, a more detailed forecast is developed which supersedes the BD forecast.
While in-licensing doesn’t typically involve the same level of cross-functional and cross-country collaboration as internal product launches, the BD&L process still requires alignment with broader corporate strategy. This ensures that any newly licensed product fits within the company’s overall portfolio and is supported by the necessary global and regional resources for a successful market entry.
Varying Structures Across Pharma Companies
The organisational structure around product launches can vary significantly across companies, especially when considering the roles of global, regional, and country teams. Some companies operate with large global teams and extensive regional oversight, while others function with smaller, more country-focused approaches. A key challenge lies in balancing global oversight with local execution – particularly in how forecasts are developed and managed across these layers.
As best practice, we advocate for implementing a standardised forecasting model across all countries. This approach brings numerous benefits, including greater consistency, improved comparability, and easier consolidation of data at a regional or global level. Allowing countries to develop their own models can lead to discrepancies, inefficiencies, and challenges in aligning the overall strategic direction. Ensuring a standard model helps mitigate these risks and fosters a more unified, streamlined approach.
In some cases, individual countries, especially larger ones like the US, tend to operate independently due to their size and market significance. However, even in these cases, adopting consistent forecasting methodologies is still important for ensuring alignment across the company. While there may be some flexibility to account for unique market conditions, a harmonised approach should be maintained to ensure global coherence and accurate forecasting outputs that can be used across regions.
The adoption of syndicated software and/or a centralised forecasting platform such as FC365 and the value that brings around managing files, consolidating and comparing forecasts becomes more impactful here.
Historical Practices and Change Management
One significant challenge in aligning global, regional, and country teams comes from historical practices. Different countries may have established methods for forecasting, pricing, or product access that can be difficult to change. While consistency is ideal from an overall company perspective, it’s crucial to engage countries in the process of change management, explaining the rationale for harmonizing practices and demonstrating how this consistency benefits the organisation as a whole.
However, a one-size-fits-all approach rarely works, especially when dealing with diverse markets. Many markets claim unique characteristics or specific needs that they believe justify a different forecasting model or approach. While some distinctions are valid, it’s equally important to critically assess whether these market differences truly necessitate a fundamental departure from the standard model. Often, markets can work within a consistent global framework while making adjustments to address local nuances.
One client case study example:
Needing to forecast for personalised treatments, a different model was developed for larger EU markets like the UK compared to smaller ones like Switzerland. The structure of these markets differs so significantly that applying the same model across the board would have been inefficient and frustrating for the smaller markets.
By consciously allowing flexibility in the methodology while maintaining consistent outputs, global and regional teams could still consolidate data to understand how the product would perform across the business.
This highlights a key point in change management: while consistency is critical, it’s equally important to provide countries the flexibility to adjust processes based on local market needs. Engaging them early in the process, listening to their concerns, and allowing room for tailored approaches creates a sense of ownership and helps ensure that any changes are implemented smoothly. This balance between flexibility and consistency helps foster collaboration, ensuring that local nuances are respected without compromising the overall integrity of the data and forecasts.
Effective Collaboration and Adaptability Drive Success
In our experience, the key to a successful product launch lies in effective collaboration between global, regional, and country teams. Aligning strategies, forecasts, and goals across these levels ensures that the product enters the market smoothly and performs well in different territories. However, this collaboration must account for the historical practices and market-specific considerations that countries bring to the table.
Providing flexibility while maintaining consistency is essential to balancing local needs with global goals. Engaging stakeholders early, accommodating country-specific practices where necessary, and creating tailored approaches that still deliver consistent outputs will ultimately ensure that the product succeeds in diverse markets. As product teams expand, forecasts evolve, and markets are prepared for launch, this balancing act between global oversight and local execution becomes the foundation for driving the product’s success.
Author
Andrew Ward, Consulting Director at J+D Forecasting. An expert in the pharmaceutical analytics space since 2002 and leading a consultancy team in delivering forecasting solutions including software application development at J+D since 2014.
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