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What will shape the Pharma landscape in Q3 2025?

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Upcoming drug approvals and clinical progress will be pivotal during the third quarter of the year, says GlobalData.

Pharma Q3 2025

The upcoming financial quarter for the pharmaceutical industry is set to see changes driven by “innovation, competitive positioning, and regulatory momentum”, according to a report by GlobalData.

Key influences include late-stage clinical trial results and regulatory decisions by the US Food and Drug Administration (FDA). In the current quarter, the US agency approved the first new on-demand treatment for hereditary angioedema (HAE) in over a decade.

Additionally, earlier this month Amgen released top-line data from its late-stage clinical trial for gastric cancer. The findings suggest that the fibroblast growth factor receptor 2b (FGFR2b)-targeted monoclonal antibody bemarituzumab plus chemotherapy provided a statistically significant and clinically meaningful improvement in overall survival.

Anticipated drug approvals in Q3 2025

As such, other drug authorisations are expected to follow in Q3 2025, such as Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for adult growth hormone deficiency (GHD).

In 2021, the FDA first approved the long-acting somatropin prodrug for children aged one year and over with paediatric growth hormone deficiency (GHD) who weigh at least 25.4 pounds. 

“This once-weekly treatment could reduce treatment burden and potentially replace the daily somatropin therapies, which have been the standard of care for over 30 years,” commented Paul Thornton, MB, B.Ch., MRCPI, clinical investigator and paediatric endocrinologist at the time of the approval.

With clinical data showing superior efficacy to other once-weekly growth hormone therapies, Skytrofa is expected to generate $658 million sales worldwide by 2031, GlobalData reported.

“As the [pharmaceutical] industry navigates a pivotal quarter marked by regulatory approval decisions and late-stage trial readouts, the outcomes of these catalysts [will]… reveal larger trends in treatment paradigms and disease landscapes”

On the other hand, Eli Lilly and Company’s oral orforglipron is emerging as a promising oral glucagon-like peptide (GLP)-1 receptor agonist. Clinical data for diabetes supports the drug’s potential as an obesity medicine, stated GlobalData.

Key clinical results from the obesity trials ATTAIN-1 and ATTAIN-2 are expected throughout this year.

Continuing its work to address unmet need in major diseases, last month, Eli Lilly announced a cardiovascular-focused acquisition of approximately $1.3 billion. The deal involves a potential first-in-class in vivo gene editing therapy from Verve Therapeutics.

GlobalData projects worldwide sales of $14.36 billion for orforglipron in 2031. The drug’s “superior bioavailability and better safety profile could help it gain a strong market share even though its efficacy might be lower than injectable GLP-1 therapies,” Irena Maragkou, Senior Healthcare Researcher, GlobalData remarked.

“As the [pharmaceutical] industry navigates a pivotal quarter marked by regulatory approval decisions and late-stage trial readouts, the outcomes of these catalysts will not only influence individual asset trajectories but also reveal larger trends in treatment paradigms and disease landscapes,” Maragkou concluded.

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