Global-Local Governance in Pharma Launches: Enabler of Success or Hidden Bottleneck?

Achieving global launch ambitions requires well-coordinated ex-US execution

Biopharma companies are best positioned for success when launches are designed with a truly global footprint. While many U.S.-based organizations prioritize their home market, the majority of patients, and often a substantial share of commercial opportunity, reside outside the U.S. Even though net profit per patient in many ex-U.S. markets is typically 20% to 40% lower due to stricter pricing controls and slower uptake (see Figure 1), global launches remain vital. They deliver:

• Risk diversification across price reference baskets and portfolio exposure
• Evidence generation that strengthens global value narratives
• Life cycle value extension from later-launch markets with slower but durable growth

Globalization and advances in scalable and increasingly advanced digital platforms provide unprecedented opportunities to coordinate and streamline across borders. Yet achieving global launch success remains tricky if local conditions and expertise are not incorporated into global decision-making. In addition, global strategic intent often fails locally when governance is unclear or fragmented and country organizations are insufficiently resourced to execute according to global expectations and guidance.

Five characteristics of best-in-class global launch governance

Drawing on L.E.K. Consulting’s experience with leading biopharma companies, we have identified five governance practices that consistently distinguish high-performing global launches. Together, these practices balance speed, alignment, agility and resilience while maintaining strategic control.

1. Early strategic alignment
   Effective governance begins by translating the global value proposition into ambitions that resonate locally. Leading companies convene cross-functional, cross-geography workshops 24 to 30 months before first launch to cocreate the product’s value story, define market-specific success metrics and align on a single approach. By involving a country’s medical, market access and commercial leaders early, alignment becomes organic and last-minute rework is largely avoided.
2. Clear decision rights and accountability
   Ambiguity about “who decides, when and with what authority” remains one of the most common barriers to launch execution. Best-in-class organizations anchor every critical milestone — for example, price corridor approval, health technology assessment (HTA) dossier sign-off and supply allocation — in a rigorously maintained governance matrix supported by a clear escalation ladder. A disciplined decision log, owned by the global launch excellence team and visible across all functions, accelerates decision-making and preserves institutional memory.
3. Modular launch plans tailored to specific country needs
   Over-customization drives cost inflation, while under customization risks market share loss. High performers segment countries into archetypes such as “HTA-driven innovators,” “private out of pocket” and “tender-centric” and deploy modular playbooks. Core claims, safety narratives and brand assets remain consistent globally, while pricing dossiers, healthcare professional content and advocacy strategies are plug-and-play. This approach balances brand consistency with local adaptability.
4. Sequenced resources and investment that mirror market readiness
   Affiliates often face near-term profit-and-loss (P&L) pressure that discourages early spending on medical or market access preparation. Leading organizations mitigate this tension through central funding, cost-sharing pools and a single transparent demand forecast enriched with local assumptions. Tiered funding gates, tied to scenario planning, release investments in head count, marketing and supply only when predefined indicators are met. This protects global resources while ensuring priority markets can advance.
5. Disciplined performance management and course correction
   Governance succeeds only when it can identify risks early and pivot quickly. Monthly cross-functional steering meetings, biweekly functional huddles and milestone-based readiness reviews establish a predictable execution rhythm. Digital dashboards tracking around 25 leading key performance indicators, such as formulary wins, early prescribing breadth and inventory sufficiency, provide real-time visibility. A dedicated project management office (PMO), staffed for at least nine months, enforces adherence, escalates risks and activates predefined “green-yellow-red” playbooks when assumptions shift.

Together, these five characteristics create a governance model that aligns global and local teams, enables agile execution and powers talent. This combination consistently separates launches that outperform forecasts from those that fall short.

Strategic frameworks to tailor level of support

Governance must be flexible enough to reflect both market importance and local resource capacity. A pragmatic 2x2 segmentation, mapping market importance (high vs. low) against resourcing relative to need (well- vs. under-resourced), helps calibrate support (see Figure 2).

Market archetypes in action: Tailoring support based on criticality and resourcing

More important/fewer resources: Provide individual resource support

These markets are often in a first or second launch wave but lack local capacity for end-to-end execution. Companies should proactively deploy targeted regional resources to augment affiliate teams.

More important/more resources: Involve early and guide

These markets are typically in the first launch wave and have strong local teams with deep expertise. Strategy should be cocreated early with alignment on life cycle planning and seamless integration of local insights into global decisions.

Less important/fewer resources: Provide cluster support

These are often later-wave markets with limited infrastructure in which a clustered governance model, led by a regional general manager or hub, can manage shared resources efficiently while escalating critical decisions to global teams, emphasizing lean execution.

Less important/more resources: Guide team (to ensure overall alignment)

Though smaller, these markets often have capable local teams and fall in later waves. Global teams should focus on ensuring alignment with value messaging, medical strategy and launch timing.

This framework provides guidance for launch readiness reviews, highlighting mismatches and prompting governance recalibration.

Outlook: Clearer governance will define the next generation of global launches

The path to global launch success is smarter, clearer governance with appropriate resource allocation, not tighter control. Models that enable agile decision-making, build mutual trust and adapt to local needs will outperform those that rely on rigid structures.

As you prepare for global launch execution, consider the following questions as a quick diagnostic. Misalignment in any of these areas may signal the need to reassess your governance approach.

• Have local market priorities and insights been incorporated into global strategy development?
• Are decision rights clearly defined and understood across global, regional and affiliate teams and supported by formal governance forums and escalation protocols?
• Do budget structures allow priority markets to begin launch readiness activities without near-term P&L constraints?
• Have you assessed markets by archetype and defined which elements of the launch plan must be standardized versus adapted?
• Are performance indicators, risk signals and readiness milestones tracked consistently through a centralized launch PMO, global launch excellence team and transparent reporting system?

If your answer is uncertain or inconsistent in any area, now is the time to recalibrate. Strong governance is not a back-office function; it is a front-line enabler of global launch success.

For more information, please contact us.

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