Andre Moa
6 Feb 2025
5 minute read
In Launch Readiness 2025, our latest update on the dominant trends for new drugs taking their final steps into the marketplace, we consider how launch prospects can best be evaluated and actualised in the post-COVID era. In some respects, this signals a return to normality for pharmaceutical companies, their R&D pipelines, and the commercial activities those pipelines support.
Yet market access challenges, both established and emerging, continue to accumulate. This may be due to legislative activity and political change in key territories, such as Europe and the US; to the partial shift from pipeline-in-a-product strategies towards big disease products for high-demand conditions like Alzheimer’s disease or weight management and the continuing need for budget holders to manage the often-daunting costs of drug innovation.
We examine where and why these challenges arise, and how pharmaceutical companies can address them by steering conversations with regulators, healthcare professionals and payers towards more holistic conceptions of drug value. We also look at ways in which digital transformation can help companies to optimise their pharma product launch impact, by tracking, visualising and coordinating associated activities in real-time across diverse functions and markets.
2025 looks to be a year of consolidation and technology-aided momentum for the pharmaceutical industry, especially with the aftershocks of the COVID-19 pandemic now largely absorbed. Drug approvals in the key US and EU markets during 2024 fell in line following the disruptions and opportunities brought on by the pandemic.
Innovation continues to flourish with R&D pipeline growth, clinical trial productivity, launches of new active substances and prospects for blockbusters or therapeutic breakthroughs. Nonetheless, this undoubted potential still needs to prove its worth in markets where drug costs and the sustainability of healthcare systems remain very much front of mind.
These systems are wrestling not just with the legacy effects of COVID-19 and the new reality of endemic viral outbreaks but also with critical trends such as population aging, rising obesity, and lifestyle changes associated with chronic disease. The implications for pharma market access and launch excellence are further complicated by uncertainties about the emerging legislative and regulatory climate in crucial markets such as the EU and the US.
This includes the EU’s wide-ranging and ongoing pharmaceutical review and Donald Trump's appetite for confronting the status quo in his second term as US President. Parallel trends in R&D pipelines and launch profiles raise further questions about how pricing, demand, cost management and patient outcomes can be reconciled in an evolving pharmaceutical market.
Big disease gains traction
Orphan and other premium-priced speciality drugs continue to dominate the market. At the same time, ultra-expensive cell and gene therapies have raised the stakes for accommodating therapeutic breakthroughs that otherwise risk draining healthcare budgets through advanced pricing and payment models.
There is also new momentum from big disease therapies, whose challenges for payers reside not only in premium pricing but also in the sheer volume of demand created by broad population categories, such as Alzheimer’s disease and obesity, that have hitherto been starved of breakthrough innovation. The restrictions imposed on access to repurposed GLP-1 inhibitors for weight management give some idea of how the balancing act between cost and value may play out in the future as big disease segments gain traction.
Pharmaceutical companies will be relying on these new dynamics in the launch landscape to stave off price erosion and the looming impact of patent expiries on current big sellers, such as Keytruda (pembrolizumab; Merck & Co.) or Eliquis (apixaban; BMS/Pfizer). Nonetheless, prescription drug sales worldwide continue to expand. Evaluate Pharma, for example, forecasts a compound annual growth rate of nearly 7.7% over the next five years.
In short, the launch outlook for new medicines in 2025 continues to hover between excitement and trepidation. The promise of enormous commercial success and meaningful therapeutic gains for patients balances against the risk that years of R&D effort and investment will pay only meagre dividends if market access barriers prove insurmountable.
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Optimising launch readiness
In this environment, it is more imperative than ever that launch readiness strategies are powered for maximum impact and uptake on market entry. At the same time, they must be flexible enough to handle the many and varied market access challenges confronting new medicines as they roll out globally.
This calls for cutting-edge launch management software capable of real-time insights that will keep product launch teams on the same page and ensure that launch plans do not fall prey to misalignment, poor timing or the unexpected reversals that thwart the most promising of pipeline assets. Read Launch Readiness 2025 to discover what this year has in store for the latest aspirants to either breakthrough status, with financial rewards to match, or a thankless existence as also-rans.
Then take a look at SmartLaunch®, our agile launch software designed to drive agility, transparency, efficiency and collaboration across your launch teams. With SmartLaunch®, you can feel more confident that your launch trajectories will always be heading in the right direction in another year of rich opportunities and tough challenges for new medicines.
