Foreword
Data run in Evaluate Pharma & Evaluate Omnium in Nov/Dec 2024.
Biotech will remain in recovery mode next year, after hitting rock bottom in 2023 amid a post-pandemic rout. The sector has taken its time recuperating from those lows, and there are few reasons to expect a rapid rally in 2025.
This is not to say that pessimism prevails. Investors and corporates alike expect more deal making next year and improved access to capital. But with much uncertainty as the US transitions to a new presidential administration, the sector is skittish.
Incoming President Trump has signalled his willingness to rip up the status quo with unconventional nominations to head departments that matter a lot to biopharma. For now, it remains unclear what Robert F. Kennedy Jr., Martin Makary and Mehmet Oz mean for Health and Human Services, the Food and Drug Administration and Centers for Medicare and Medicaid Services. It could be mid-2025 until the appointments are all confirmed, and longer for policy shifts to emerge.
These US political changes are not necessarily negative. A less hawkish Federal Trade Commission should inject life into a moribund M&A market, hence the expectations for a pickup in dealmaking. The equity markets, meanwhile, are slowly opening to new issues and that trend is expected to continue next year. More IPOs and M&A are good news for venture investors, and private financings are also seen rising in 2025.
But the first half of the year, and possibly longer, will be dominated by questions about the Trump administration and what it means for the world’s largest healthcare market. And investors hate uncertainty.
Against this backdrop, biopharma’s biggest news story will continue to unfold in 2025: the roaring success of the GLP-1s, also known as the incretin class. Efforts by incumbents Novo Nordisk and Lilly to tighten their grip on this space will be a big focus. Data from follow-on agents and trials attempting to expand these drugs into ever more adjacent metabolic conditions are among 2025’s most anticipated datasets. The first half will see the first phase 3 data on orforglipron, Lilly’s leading oral obesity candidate; later in the year Novo could release early pivotal data on semaglutide in Alzheimer’s disease, a hugely important but high-risk readout.
The incretin space is also likely to see much dealmaking next year, as developers keen to gain a foothold make a move on smaller players. Dramatic expansion of the class is forecast, and Big Pharma is being warned that it cannot afford to miss out on what many believe to be the most impactful drug mechanism to be discovered.
That impact is already being felt, of course, as this report reveals. Ozempic,
Mounjaro, Zepbound and Wegovy, and manufacturers Novo Nordisk and Lilly, lead the league tables of biggest drugs and fastest growing companies, compiled from Evaluate Pharma’s consensus forecasts.
The once dominant cancer field has been pushed into second place in many of these analyses. The anti-PD-(L)1 mechanism still features, though its impact is waning and next year will see Merck & Co and Bristol Myers Squibb try to prolong the franchises of Keytruda and Opdivo with subcutaneous versions of these mega-blockbusters. The failure of numerous follow-on immuno-oncology approaches means that much focus in cancer has shifted to new modalities like antibody-drug conjugates, T cell engagers and radiopharmaceuticals.
Two trends for 2025 collide here: bispecifics and China. Western biopharma is enthusiastically looking east for in-licensing opportunities, and this journey will continue next year. One such quest yielded one of the highest profile bispecifics, Summit and Akeso’s anti-PD-1xVEGF ivonescimab. This project promises one of 2025’s most keenly anticipated cancer readouts: overall survival from a head-to-head trial versus Keytruda could emerge mid-year, and the outcome will help determine whether the hype around ivonescimab, and this mechanism, is justified.
Immunology and anti-inflammatory medicines remain another huge area of interest for biopharma, with several so-called “pipeline in a drug” products like Dupixent and Skyrizi looming over the
league tables. Much effort is ongoing to find the next blockbusters in this fields, with the FcRn mechanism featuring heavily in analyses of highly valued research projects.
This report, drawn from Evaluate Pharma and Evaluate Omnium, pinpoints these and other many other pivotal events on the horizon for biopharma in 2025.
Investors and corporates alike expect more deal making next year and improved access to capital.
The incretin space is also likely to see much dealmaking next year, as developers keen to gain a foothold make a move on smaller players.
