Andre Moa
13 Feb 2024
8 minute read
In our latest report, Launch Readiness 2024, we look at the prospects and obstacles facing new medicines in markets still recovering from the COVID-19 pandemic. We consider the current state of companies’ R&D pipelines, where there are opportunities for launch excellence, and how launch planners can best negotiate the many and varied market-access challenges further complicated by the legacy effects of COVID-19.
With healthcare funding under relentless pressure, pharmaceutical product launches must now more than ever be designed, timed and executed for optimal and lasting impact. They must also deliver meaningful, measurable value across a broad range of parameters. We explain how, in this demanding environment, digital transformation and agile launch software can help companies track, manage and align their launch activities in real-time, across functions and markets.
COVID-19 has a long tail. If the post-pandemic world is largely acclimatised to the risk of further disruption from viral variants, the healthcare and business consequences of COVID-19 continue reverberating throughout the pharmaceutical industry and health systems. Those consequences include the economic, cultural and logistical upheavals that have embedded remote working, digital communications and virtual interactions in social and business practices.
In particular, the pandemic has left healthcare systems with depleted resources, substantial patient backlogs and difficult choices to make about how to divide up limited funds. New medicines with high sticker prices, however innovative and need-driven in principle, will always be easy targets for budgetary restraint. And market access, even in traditionally more flexible territories such as the US, is not getting any easier.
These issues will be central in shaping the pharma product launch landscape over the year ahead. There is some cause for optimism, despite payers’ ever-tightening grip on drug funding and uptake, further drug-price controls, blockbuster patent expiries, dilution of market exclusivity, and second thoughts on accelerated approvals. For example, new drug approvals in the key US market have picked up again following a marked slowdown in 2022. At the same time, though, China continues to gain share as a first-launch market for new active substances (NASs), while Japan has consolidated its position as the third most favoured destination for NAS debuts.
Citeline Clinical’s list of NAS launches in 2022, and its broader Pharma R&D Annual Review 2023, alongside updated launch projections by Evaluate Pharma and Clarivate, make clear that drug pipelines and the resulting launch environment still have innovation to spare, some of it with blockbuster potential. Nonetheless, innovation comes at a cost, and market access conditions for new medicines are more taxing than ever.
In Launch Readiness 2024, we consider why companies need to be confident that new product launches, and the way these assets enter the market, offer sustainable, meaningful and measurable value applicable to a broad range of healthcare stakeholders. That includes prospective cost offsets, quality-of-life gains, and other value components that will ease financial and logistical pressures on healthcare systems while extending and enhancing patients’ lives.
Orphan drugs may be losing their mojo
Pharma market access and launch management are also muddied by the continuing market shift towards premium-priced speciality drugs, particularly targeted therapies for rare diseases that cash in by launching a succession of costly indications for the same product. There are signs, though, that the orphan drug boom may have peaked, especially as increasingly prevalent neurological conditions such as Alzheimer’s are at last becoming amenable to disease-modifying treatment.
New drugs for managing obesity, another fast-growing health burden with significant and broad-ranging economic and societal impact, are also on a roll. In parallel, recent developments such as dilution of market exclusivity under the new US Medicare price controls, or in the EU’s pharmaceutical-reform proposals, threaten to clip the wings of rare-disease franchises.
Meanwhile, the whole patient journey to diagnosis and product uptake has changed since COVID-19 remodelled interactions between industry, healthcare professionals and patients, intensified budgetary challenges in health systems and lengthened patient backlogs. As IQVIA has warned, the gap between the demands of innovation and depleted healthcare system capacity is only getting wider. Companies need to revisit or rethink their launch frameworks and promotional mixes if they are to restore new medicines to sustainable growth under ‘long COVID’ conditions.
At the same time, the fundamentals for successful pharmaceutical product launches in 2024 have held firm. These include continued growth (+5.9%) in companies’ R&D pipelines during 2023, albeit slower than in 2022. And plenty of potential blockbusters and game-changing therapies are still emerging from those pipelines.
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Furthermore, despite the lingering impact of COVID-19 on healthcare funding, the pharmaceutical market continues to expand. IQVIA, for example, expects the global market to deliver a compound annual growth rate (CAGR) of 5-8% in 2024-2028, reaching around $2.3 trillion at list prices by the end of that period.
Evaluate Pharma predicts that worldwide prescription drug sales will increase at a CAGR of 5.9% to $1,580 billion between 2022 and 2028. It also warns, though, of some dark clouds on the horizon, such as direct price negotiations for patent-protected Medicare drugs in the US; tighter controls on drug pricing in Germany and Japan, potentially shorter data exclusivity periods in Europe; and the series of patent ‘cliffs’ faced by some of the market’s leading blockbusters over the next several years.
For all that, pharmaceutical innovation and acumen still rely on agility and effectiveness in product launch plans and their implementation. In Launch Readiness 2024, we consider how launch strategists can best navigate this fast-changing yet still fertile terrain. We show how digital transformation and cutting-edge launch management software can help companies track the status of launch activities and manage global launch challenges, in real-time and across business functions and countries.
Please read our updated report to understand how global product launches in pharma adapt to the post-COVID environment and address a wide range of associated challenges.
Then discover how SmartLaunch® ̶ our agile launch execution software ̶ , can help you drive agility, transparency, efficiency and collaboration across your launch teams, making 2024 another year in which innovative verve translates into genuine launch excellence.
