Strategic lifecycle management has become a critical capability in the pharmaceutical industry, enabling companies to unlock the full value of multi-indication medicines across their lifecycle. By integrating cross-functional decision-making, early planning, and adaptive go-to-market strategies, organizations can transform innovative therapies into long-term value engines for patients and stakeholders.
Over the past two decades, the pharmaceutical industry has seen a surge in multi-indication medicines, reshaping how organizations create and sustain the value of their medicines. This shift requires companies to move beyond defining success solely by launch performance of the lead indication, towards maximizing value across the entire lifecycle of a medicine.
Blockbuster therapies such as Keytruda have shown what is possible: applying strategic lifecycle management to expand indications, sustain market relevance, and significantly outperform initial forecasts (see illustration).
This evolution has raised the strategic importance of lifecycle management as a true cross-functional capability, one that connects scientific, regulatory, access, and commercial decision-making from the prioritization of indications for clinical development through to access, launch, and sustained market performance.
Done well, a strong lifecycle management capability can transform a promising drug into a ‘decade-long value engine’, bringing life-changing innovation to more patients worldwide. Done poorly, it can prevent medicines from realizing their full value potential.
In this article, we aim to lay out the key success factors to do strategic lifecycle management right, drawing on our years of experience with numerous companies across therapeutic areas. We will highlight what separates medicines that become global, multi-indication powerhouses from those that don’t leverage their full potential.
While the strategic rationale for lifecycle management is clear, how to make it work in practice is less straightforward. Success depends on aligning strategic and operational decisions across the medicine’s entire journey: from clinical development to commercial execution.
Over the years, we have seen clear patterns emerge. Medicines that reach their full potential share five critical success factors. These factors are not sequential steps, but interlocking building blocks that reinforce each other throughout the lifecycle.
Start lifecycle management strategy early on: Most companies still treat lifecycle management as an afterthought, kicking in once the lead indication is on the market. By then, many key choices are already made, which may constrain options for lifecycle value optimization. Leading companies start lifecycle management strategic thinking much earlier, as early as post-Phase 1 clinical trial, when evidence packages and regulatory strategies still allow amendments.
Plan for multiple futures: Lifecycle management champions accept uncertainty as a given. They avoid anchoring to a single forecast and instead build scenario-based strategies that explore different clinical, competitive, and market outcomes, depending on where the key uncertainties lie. This approach helps teams anticipate divergent futures and stay agile as evidence and circumstances evolve. For lifecycle management champions, flexibility at this stage means being ready to adapt while maintaining focus on seamless execution and long-term value creation.
Start local and manage trade-offs: Each market has its own dynamics when it comes to specific pricing and reimbursement frameworks, evidence requirements, healthcare system structures, as well as patient and physician pathways. Successful lifecycle management strategies recognize this reality and begin by reviewing lifecycle management strategies locally before building upward to a global perspective. In doing so, companies must navigate the trade-offs that inevitably arise: decisions that optimize one country may constrain or delay options in another. These choices need to be made to shape Global plan for the medicines.
Scale through archetypes: Once major markets are addressed and trade-offs resolved, lifecycle management champions scale their approach by clustering similar countries into market archetypes. This approach enables efficiency and consistency without sacrificing local nuance, allowing teams to expand reach rapidly while sustaining strategic coherence.
Involve Commercial and Market Access early on: Winning companies bring Commercial and Market Access perspectives into R&D planning as strategic partners. Their early input helps for instance shape prioritization of indications to enter Phase 2, evaluate the potential for dual branding and determine sequencing of indications for Phase 3, informed by an in-depth understanding of the disease landscapes, including remaining unmet needs and price potential with payers, as well as drivers of adoption by physicians and patients. Embedding this cross-functional mindset early will help to ensure lifecycle management evolves into a sustained organizational capability in the entire organization.
Ensure stakeholder-centric decision-making in lifecycle management: Every decision for a medicine affects a wide range of stakeholders: patients, healthcare professionals, payers, advocacy groups, and policy makers. Leading companies proactively evaluate the broader impact of lifecycle management choices across key stakeholders before decisions are finalized. Public Affairs and Policy functions play a crucial role here: anticipating how choices (for example, not seeking registration for an indication in certain markets or shifting regional priorities or seeking registration with a more restricted label) may be perceived, and preparing communication and engagement strategies accordingly. This foresight helps sustain trust, avoid reputational risks, and maintain strong relationships with key external audiences.
Treat lifecycle strategy as a living process: A lifecycle management strategy is never static. Market conditions, competitors, and clinical evidence evolve continuously — and so must the medicine’s lifecycle management strategy. Leading organizations define explicit triggers for revisiting and updating their global lifecycle management plans. These include events such as competitor launches, pivotal trial readouts or regulatory shifts. Defining clear review points ensures the strategy remains current, actionable, and value-maximizing throughout the medicine’s lifecycle.
Set up structured governance: Strong governance is essential to ensure clarity on who decides what, when, and how in a medicine’s lifecycle management context. It also helps teams focus on the most critical, value-adding decisions, as the number of indications and markets grows and the volume of decisions quickly multiplies. Leading organizations concentrate their time on decisions with the greatest impact on a medicine’s value generation plan, for example, when key markets seek approval to deviate from global strategy or when trade-offs between countries must be made. To enable this focus, they streamline governance and approval processes for lower-priority decisions. This approach keeps oversight efficient, ensures transparency on deviations and trade-offs, and allows governance to serve its true purpose: enabling fast, coherent, and value-driven decision-making across markets.
Re-think go-to-market model: Multi-indication medicines require continuous adaptation of the go-to-market approach to sustain uptake across diverse customer groups, for example, field teams may need to navigate physicians treating one, several, or all approved indications. As indications multiply, successful teams evolve how they prioritize and engage with customers as well as articulate value of the medicine, ensuring the commercial strategy keeps pace with the medicine’s expansion. AI-enabled, omnichannel engagement is a key capability to drive this shift by enabling ‘next-best indication’, tailoring content and next-best actions across multiple indications for field teams, and orchestrating consistent multi-indication engagement across channels.
This article underscores the importance of building a robust lifecycle management capability as a critical driver to maximize value across the branded lifecycle. To translate the key success factors into action, we propose the following next steps:
✔ Assess your current lifecycle management maturity:
Evaluate your organization’s lifecycle management capability across the five key success factors outlined in this article. Identify strengths and critical gaps that may limit your ability to capture full lifecycle value.
✔ Develop a plan to close critical gaps:
Develop a targeted roadmap to close the most critical gaps. Prioritize a mix of quick wins that can be piloted to demonstrate early impact, and longer-term enablers, such as digital infrastructure (e.g., CRM).
✔ Pilot the new approach with one molecule:
Select one molecule or asset as a “lighthouse” to demonstrate the impact of an integrated lifecycle management model. Use early learnings to refine governance, roles, and processes before scaling across the portfolio.
✔ Mobilize senior leadership to “walk the talk”:
Engage executives across R&D, Commercial, Medical, Regulatory, and Market Access to understand the case for change, shifting the collective mindset.
✔ Measure, communicate, and scale success:
Define tangible KPIs to track the value created through enhanced lifecycle management, from extended revenue curves to slower price erosion, and communicate these results to reinforce the business case and sustain momentum.