PSVA Framework: An LOE Planning Toolkit

Better prepare for loss of exclusivity and turn your strategies into robust tactical planning with Align’s PSVA framework and guide.

How do you translate strategy into an actionable late lifecycle plan?

Loss of exclusivity (LOE) fundamentally changes how value is created, assessed, and sustained. As competition intensifies and pricing pressure increases, pharmaceutical brands can no longer rely on clinical differentiation alone. Instead, success in the late lifecycle depends on a deliberate, structured approach to how value is protected, evolved and delivered in-market.

In earlier parts of our late lifecycle (LLC) management series, we explored the dynamics that shape post‑LOE environments and how archetyping can help global teams set a clear strategic direction while allowing for local market variation.

But, the critical question remains: how do global and local teams translate strategy into an actionable, coherent late lifecycle plan?

Introducing the PSVA Framework

Through our work across many different assets and markets, we consistently see late lifecycle tactics cluster into four interconnected categories: Product, Solution, Value, and Asset optimization. Together, these form the PSVA framework.

This PDF guide reveals:

🔹 What is the PSVA framework – and why is it useful?

🔹 A closer look at each component and the late lifecycle tactics available

🔹 10 pharma case studies illustrating real-world examples

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Authors and contributors

Neal Hansen, PhD

Managing Director

As co-founder of Align Strategy, Neal brings over 20 years of experience advising leading pharmaceutical and biotech firms on lifecycle management and brand strategy.

Qualifications

PhD, Pharmacology (University of Cambridge)

MA (Hons), Natural Sciences (University of Cambridge)

James Kettlewell

Principal Consultant

James, with over 10 years in healthcare, specializes in shaping the strategic direction for brands approaching loss of exclusivity.

Qualifications

MSc, Drug Discovery & Translational Biology (University of Edinburgh)

BSc (Hons), Cell Biology (University of St Andrews)

Hannah Freedman

Principal Consultant

Hannah, with over 5 years in healthcare, specializes in analyzing therapeutic assets and competitive market landscapes.

Qualifications

BSc (Hons), Neuroscience (University of Nottingham)

Deana Scott

Principal Consultant

Deana brings nearly 10 years of experience in pharmaceutical strategic consultancy, specializing in commercial strategy and market research.

Qualifications

MSc, Biotechnology and Enterprise (University of Manchester)

BSc (Hons), Biochemistry (University of Leeds)

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