A healthy total of 61 novel drugs were approved in the US in the course of 2024, but just a handful of these look certain to generate the multi-billion dollar sales that big pharma increasingly needs.
A new Evaluate Pharma analysis of the top-12 most valuable drug launches from last year shows that just four are expected to earn over $3bn a year by 2030, and just one of these – Merck & Co’s pulmonary arterial hypertension therapy, Winrevair (sotatercept) – is predicted to exceed the $6bn mark.
Most alarmingly for big pharma companies, only half of the top-12 belong to them, the other six being developed and launched by small or first-time-to-market biopharma firms.
One drug that had been tipped for approval in 2024 was Daiichi Sankyo and AstraZeneca’s TROP-2 targeting antibody drug conjugate, datopotamab deruxtecan (Dato-DXd), in non-small cell lung cancer (NSCLC). However, feedback from the US and EU regulators about its Phase III data in non-squamous NSCLC saw the companies withdraw their filings in in November and December respectively.
The partners have already re-submitted it to the US Food and Drug Administration for the smaller indication of previously treated advanced EGFR-mutated NSCLC. An FDA decision is expected later this year, but Dato-DXd’s peak sales forecasts in lung cancer will now be adjusted down from $5bn by 2030 estimates.
Still Time For Forecast Upgrades
Whether or not 2024 will ultimately be a vintage year for drug approvals is not yet clear, however, as some of the most successful drugs only emerge as such after years on the market.
A number of factors often make a year’s crop of drugs appear less promising than they will ultimately prove to be. Analysts often take a conservative approach to forecasting sales five years after launch or peak revenues and do not initially include additional indications that can bump drugs up into the $5bn and above blockbuster category.
This may apply particularly to one of the listed drugs, Akeso and Summit’s dual PD-1/VEGF inhibitor ivonescimab, which last year became the first drug to outperform Merck & Co’s Keytruda (pembrolizumab) in a pivotal trial in non-small cell lung cancer (NSCLC).
It is included on the list despite not having not yet gained US Food and Drug Administration clearance, as it gained its first global approval in China in 2024 (in EGFR-mutant, non-squamous and in PD-L1 positive NSCLC). Consensus estimates of 2030 sales remain low, for now, at $2.2bn, although some analysts are more upbeat. An August investor note from H.C. Wainwright predicted $7bn in sales in NSCLC alone by 2027, with potential additional approvals in triple-negative breast cancer and colorectal cancer potentially adding another $5bn-6bn by 2029.
Nevertheless, replicating the outsized success of current pipelines-in-a-product blockbusters, such as Sanofi’s Dupixent (dupilumab) and AbbVie’s Skyrizi (risankizumab), may be getting tougher. Launched in 2017, within five years Sanofi’s atopic dermatitis drug was earning $8.76bn annually. Similarly, AbbVie’s plaque psoriasis drug is expected to have earned $9.5bn last year, its fifth full year on the market.
Concerns have been raised that this model may prove difficult to sustain, as one consequence of incoming Medicare price controls (via the US Inflation Reduction Act) could be to disincentivize multiple -indication drugs. That said, companies are now sounding more confident this challenge can be navigated.
The list also underlines the fact that groundbreaking innovation doesn’t always translate into commensurate commercial success. One of 2024’s most innovative new drugs was Vertex and CRISPR Therapeutics’ CRISRP-based Casgevy (exagamglogene autotemcel) for sickle cell disease and beta thalassemia. It is currently tipped to reach $3.08bn by 2030, but requires high production spending, limiting the profitability of the therapy.
Smaller Players On The Rise – M&A Inevitable?
The fact that that half of the listed products have been launched by small or first-time-to-market biopharma companies supports a growing trend.
Stand-out companies in 2024 included Madrigal and Verona Pharma with their respective first-in-class launches in metabolic-associated steatohepatitis (Rezdiffra) and chronic obstructive pulmonary disease (Ohtuvayre).
The paucity of new big earners and the closeness of the patent cliff is a major headache for many of the sector’s largest companies – not least Merck & Co, whose $30bn-a-year earning Keytruda will face loss of exclusivity in 2028. Smaller biopharma with already successfully launched blockbuster-tipped products make some of the most obvious and de-risked targets for big pharma, and in this environment, the drumbeat of M&A activity will grow louder in 2025.
