Pipelines Under Pressure
Forecasting the Loss of Exclusivity Squeeze
Discover how pharma forecasting teams can navigate Loss of Exclusivity (LoE) with precision. Learn strategies to manage asset saturation, biosimilar impact, and regional planning in today’s competitive pipeline landscape.
Get In Contact
Loss of exclusivity is accelerating market disruption, and the next few years will test the resilience of pharmaceutical forecasting teams like never before. Data from Evaluate Pharma shows that Big Pharma faces over $300 billion in potential lost sales due to patent expiries by 2030 (see our report: Portfolio Tactics to Scale the Patent Cliff). That figure spikes in 2028, when Merck’s Keytruda is expected to lose exclusivity - accounting for nearly 7% of global market impact alone. AbbVie, J&J, Roche, and Bristol Myers Squibb each face over $30 billion in cumulative sales-at-risk by decade-end, with the top 25 firms averaging $24 billion apiece.
This looming cliff is driving a strategic shift across the industry. Companies are doubling down on pipeline-in-a-product strategies, targeting mechanisms that can support multiple indications across chronic diseases. Immunology and oncology are leading the charge, with assets like Skyrizi, Rinvoq, and Enhertu forecast to deliver blockbuster growth through multi-indication expansion. But even as next-generation therapies emerge, the scale of loss of exclusivity (LoE) risk demands sharper forecasting and lifecycle planning.
The scale of loss of exclusivity risk demands sharper forecasting and lifecycle planning.
We know loss of exclusivity is predictable, but its impact is anything but simple. Forecasting teams must simulate not just the timing of generic or biosimilar entry, but the ripple effects across pricing, prescriber behavior, and competitive dynamics.
Forecasters can take a practical approach to modeling these events, where future entrants are treated as discrete events with tailored uptake curves and source-of-business analysis. This method allows forecasters to visualize how much volume is cannibalized from the originator brand, and how the market reshapes around new entrants.
When building a forecast, it is important to first identify all relevant products - both current and future - that may be impacted by the LoE, including potential generic entrants. This comprehensive list is crucial for driving the product selections that will populate your forecast’s events section.
To remain effective in this environment, forecasting teams must evolve from reactive modelers to strategic enablers. This includes:
Incorporating pipeline intelligence and competitive timelines into forecasts well before launch.
Aligning forecasts with commercial, regulatory, and supply chain teams to ensure readiness for market shifts.
Simulating LoE events and mitigation strategies, such as authorized generics, secondary patents, and geographic sequencing.
Tailoring forecasts to reflect local market behavior, especially in regions with variable generic adoption rates.
On-Demand Webinar
The Road to Launch Excellence
Get expert guidance on how to stay ahead of industry best practices when transitioning products from Phase III to launch.
Catch up now
Modeling this using a pharma-specific solution such as FC+ is easy to do – in fact, using the events section of your forecast, this can be achieved in a very clear and transparent way.
In this example, we have set up the trending section to focus on five of the main on-market brands, and then grouped all remaining products into an ‘other’ grouping. This helps to simplify the model and ensures the focus is on those brands of greatest competitive threat. We have also included a generic entrant and a future biosimilar that we can then launch as specific future events.
Moving on to the event section, you can see that we have a Stelara biosimilar entering the market, with a Taltz generic the following year. These have slightly different peak shares, speed of uptake and uptake curves, but in the source of business section, this is often quite specific for biosimilar and generic entrants. In the first event, where we are modeling the arrival of an additional Stelara biosimilar, you can see that the source of this business is mostly coming from the originator brand. A similar situation can be seen for the patent expiry of Taltz.
Via the Source of Business section, you can determine the impact the generic entrant will have on the originator brand and also the wider market. Importantly, this approach also supports dynamic scenario planning. Forecasting teams can adjust assumptions around launch timing, peak share, and adoption speed to reflect real-world uncertainty. This ensures that the projections are transparent and understandable for all stakeholders, reducing the chance of disputes over the forecast’s accuracy - assuming everyone agrees on the underlying assumptions of course.
Source: FC+ (J+D Forecasting)
A suite of advanced forecasting software that redefines industry standards.
Whatever your forecasting needs, FC+ offers an Excel based solution that is quick, consistent and simple thanks to a range of add-ins across Epidemiology, Sales and Oncology.
Take a look
Evaluate's World Preview report highlights how companies are responding to LoE risk by investing in assets with broad applicability. Skyrizi, for instance, is forecast to be the world’s second-largest drug by 2030, with approvals across psoriasis, Crohn’s disease, and arthritis. Rinvoq is expected to reach $15 billion in sales across eight indications. Oncology is seeing a similar trend, with bispecific antibodies and ADCs targeting multiple tumor types to maximize commercial potential. For forecasting teams, this means modeling not just individual product trajectories, but portfolio-level dynamics. Competitive entry is accelerating, launch intervals are shrinking, and pricing pressures are intensifying - especially in the U.S. under the Inflation Reduction Act (IRA). Forecasts must now account for compressed lifecycles, front-loaded revenue strategies, and geographic variability in generic adoption.
Competitive entry is accelerating, launch intervals are shrinking, and pricing pressures are intensifying.
Register for the upcoming World Preview webinar to access the most up‑to‑date outlook on LoE risk and portfolio strategy across global pharma.
16th June 2026 | 10am BST
Register now
Forecasting for loss of exclusivity isn’t just about predicting decline, it’s about enabling strategic response. Teams must simulate mitigation options such as authorized generics to retain partial revenue, secondary patents or regulatory extensions to delay entry, and geographic sequencing to stagger impact across markets. Brand repositioning also plays a role, helping originator products maintain relevance in niche segments through differentiated messaging or real-world evidence.
These strategies must be modeled early (ideally two years before anticipated LoE) to inform production planning, sales force deployment, and market access strategy. Forecasting teams should also collaborate closely with regulatory and legal functions to track patent cliffs and exclusivity windows, ensuring that assumptions are grounded in the latest intelligence.
Forecasting as a Cross-Functional Catalyst
One of the most valuable aspects of LoE forecasting is its ability to unify internal stakeholders. When modeled transparently, LoE scenarios can serve as a catalyst for cross-functional planning, bringing together commercial, supply chain, medical affairs, and finance teams around a shared understanding of risk and opportunity.
The source-of-business analysis is particularly effective in this context. By showing exactly where volume is expected to shift - from originator to entrant, or across the competitive set - forecasting teams can support targeted mitigation strategies. This might include adjusting production volumes, refining sales messaging, or prioritizing geographic markets based on expected erosion curves.
Analyze historical trends, understand the state of the market, and see what’s coming down the pipeline.
Looking Ahead: Strengthening Forecasting for the Future
Forecasting is becoming a strategic compass, guiding smarter lifecycle decisions in a more complex market environment. Its role is no longer a retrospective check or a supporting tool, it’s becoming integral to strategy formation. From planning around loss of exclusivity to anticipating competitive entry and pricing shifts, forecasting teams are well-positioned to shape how organizations prepare for the future.
Looking forward, the focus will be on building models that not only reflect current dynamics but are flexible enough to simulate tomorrow’s possibilities. That includes scenario planning across geographies, mapping portfolio dependencies, and linking forecasting outputs to earlier-stage investment decisions.
Businesses that embrace forecasting as a collaborative, forward-looking capability will be better equipped to respond, not just to disruption, but to opportunity.
We help our clients to refine and transform their understanding of the global pharmaceutical market to drive better decisions. When you partner with Evaluate, our constantly expanding solutions and our transparent methodologies and datasets are instantly at your disposal, along with personalized, expert support.
Discover the difference our solutions can make to your competitive advantage.
Connect today
Evaluate’s suite of forecasting solutions enables you to make confident investment, partnering, and commercial decisions. Gold-standard consensus forecasts provide an unmatched view into your markets, while custom forecast models, and proprietary analogs enable you to develop informed forecasts for your key assets. The result? A comprehensive view of the market – and your place in it.
Find out more
Every deal is different and requires a clear view of potential partners, comparable deals, and market potential. To support you, we go beyond asset assessment. Our solutions provide a systematic approach to enable you to compare candidates based on commercial, clinical, and scientific criteria such as market novelty, potential revenue, competitive intensity, and partner suitability.
In an ever-evolving market landscape, you must understand the intricacies of clinical and commercial differentiation. Our comprehensive suite of solutions and insights give you the competitive edge you need to navigate the market’s complexities, optimize your pipeline, develop comprehensive scenario planning, and prioritize the right indications.
For biotech and pharma companies alike, a comprehensive view of the competitive landscape is vital. Evaluate’s blend of data-driven solutions and expert analysis provide real-time tracking, analysis, and strategic intelligence to support decision-making processes across drug development, manufacturing, and market competition. So nothing need take you by surprise.
