A quick guide for pharma professionals covering the four factors that shape LOE impact, from generic competition to local policy environments and stakeholder dynamics.
LOE is predictable. Its impact does not have to be a surprise.
Most pharmaceutical brands lose between 60% and 90% of their revenue within two years of generic or biosimilar entry. Yet the speed and depth of that decline varies enormously across products, companies, and markets.
The difference is rarely luck. It is preparation, and preparation requires understanding the right variables. This resource breaks down the four factor categories that collectively determine how your brand will perform post-LOE.
The Four Key Factors Covered in This Deck
Each factor contains distinct sub-dimensions that need to be assessed before a meaningful LOE strategy can be built.
Product Factors
How difficult is it for a generic or biosimilar competitor to enter your space? What is the long-term sustainability of your molecule regardless of competition? Key product factors shape how attractive your brand is as a target and the strategies likely to be employed by different types of generic or biosimilar competitors.
Company Factors
Generics companies think and operate very differently from their branded counterparts. Understanding their strategic logic is essential for anticipating their moves and planning your response accordingly.
Local Policy & Access Environment
Pricing mechanisms, procurement approaches, and substitution policies differ significantly across markets. These local rules often determine the speed and depth of brand erosion more than the product itself.
Market Segment Factors
At LOE, the stakeholders who matter, and how much influence they carry, change. Pharmacists and payers may gain power, while physicians often retain less. Mapping the evolution of stakeholder balance of power through LOE is key, as is understanding whether dynamics are sufficiently different between market segments to warrant tailored strategies.
What You Will Find in the Deck
- A four-factor framework for assessing LOE impact before it happens
- How to characterise the post-LOE competitive landscape for small molecules and biologics
- The key factors that determine molecule sustainability at LOE
- Four models of how post-LOE policy and usage environments may evolve
- What to consider when mapping stakeholder balance of power following LOE
"Once generics or biosimilars are available, many of the key competitive differentiators are immediately nullified. Efficacy, safety, side effects can all be matched — making other differentiators such as cost much more important."
— Align Strategy, The Loss of Exclusivity Planning Course for Pharma
Who This Resource Is For
This deck is designed for professionals who manage or advise on pharmaceutical brands approaching loss of exclusivity. It is particularly relevant for teams working in:
Brand & Marketing Management · Market Access · Medical Affairs · Business Development & Licensing · Late Lifecycle Management · Regional & Global Strategy · Portfolio Planning
Download the Slide Deck
This slide deck is taken from The Loss of Exclusivity Planning Course for Pharma, developed by Align Strategy and delivered through CELforPharma. The full course covers the complete journey from global LOE strategy to local execution.
Ready to Go Deeper?
Continue your learning from Neal and James
If you’d like to learn more from Neal and James, CELforPharma also offers a 1-day, hands-on course where you'll learn:
- What Loss of Exclusivity (LOE) means and the factors that determine both its timing and its impact
- How and why markets can behave very differently after generics or biosimilars enter across countries and within a single market
- The processes and frameworks that support effective LOE planning at global, regional, and local levels
- The toolkit of tactical options available for late-lifecycle planning, illustrated with real-world case studies
The Loss of Exclusivity Planning Course for Pharma
From Global Strategy to Local Execution
With Dr Neal Hansen & James Kettlewell
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