2025 has been a year of major changes in the biopharma sector, with policy shifts and regulatory upheaval shaping the industry. President Donald Trump’s administration introduced tariffs on pharmaceutical imports and pushed for lower drug prices in the U.S., aiming to align them with other developed nations. The Department of Health and Human Services also underwent significant restructuring, leading to uncertainty within drug regulation.
Despite these challenges, biopharma companies continued developing new therapies and expanding their markets. The obesity drug market remained especially active, with Eli Lilly and Novo Nordisk maintaining their positions as leaders. However, competition intensified as more companies sought to enter this lucrative area, which could reach a value of $150 billion.
One notable development was Eli Lilly achieving a $1 trillion valuation—the first pharmaceutical company to do so—driven by its tirzepatide products Zepbound (for weight loss) and Mounjaro (for diabetes). These drugs surpassed Merck’s Keytruda in sales growth after only a few years on the market. BioSpace’s Annalee Armstrong analyzed these trends: “In this story, BioSpace’s Annalee Armstrong charted those growth curves, along with that of Lilly’s obesity rival, Novo Nordisk, whose semaglutide drugs have faltered after having first-to-market advantage. She also compiled revenue data for Zepbound and Mounjaro to display alongside their semaglutide competitors—Wegovy for weight loss and Ozempic for diabetes—creating an animated graphic that shows Lilly’s stunning sprint to market dominance.”
The FDA experienced significant turnover throughout 2025 following staff reductions at the Department of Health and Human Services. After Center for Biologics Evaluation and Research Director Peter Marks resigned in March, analysis showed that more than half of FDA senior leaders had left within six months; by December nearly 90% were gone. Jef Akst highlighted this change: “After the forced resignation of Center for Biologics Evaluation and Research Director Peter Marks in late March...after the sudden retirement of newly appointed Center for Drug Evaluation and Research Director Richard Pazdur...the number was up to almost 90%. Only three names on the organizational chart from a year ago remain today.” Regulatory consultant Steven Grossman commented: “The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.”
Companies also faced new difficulties due to leaks from within the FDA about internal decisions impacting product approvals. Capricor Therapeutics CEO Linda Marbán described her experience: “When you run a public company, you have to be able to respond when the investors call you, and so if you don’t know first, you really are sort of put off your game.” She learned through media rather than official channels about leadership changes affecting her company’s regulatory file.
A similar lack of transparency affected Sarepta Therapeutics during safety concerns around its gene therapy platform Elevidys. Chet Villa from Cincinnati Children’s Hospital said: “It’s the press and social media. There’s always been a little bit of that, but the sheer volume and the seriousness of the information that’s being conveyed makes this a different time than usual.”
Congress failed at year-end 2024 to renew its rare pediatric disease priority review program—a system credited with incentivizing development for rare conditions but criticized due to limited tracking of outcomes. Annalee Armstrong tracked voucher allocation data: “Her resulting research helped inform academics and companies as they lobbied for the program to be renewed.” A bill supporting renewal received bipartisan support in Congress but faces further debate.
Bluebird bio's acquisition by private equity firms The Carlyle Group and SK Capital Partners signaled changing dynamics in biotech investment amid prolonged financial downturns across life sciences markets. PitchBook Senior Biotech Analyst Kazi Helal referred to this trend as "the PE-ization of pharma." Private equity interest is increasing not just among service providers but now directly among drugmakers facing financial stress.
These five stories represent key developments reported by BioSpace throughout 2025 as biopharma adapted during ongoing disruption.
