Biopharmaceutical companies are focusing on streamlining regulatory submissions for new products in an effort to enhance research and development productivity and boost financial outcomes. Leading pharmaceutical companies have accelerated their regulatory submission processes threefold compared with the industry median in 2020, Senior Partner Gaurav Agrawal and colleagues note. Companies that deliver filings eight to 12 weeks after database lock could extend patent exclusivity during peak revenue years, with the potential to generate $180 million in net present value for a $1 billion peak sales asset.
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A bar chart compares the duration of median regulatory filing for leading pharma companies between 2020 and 2024–25, measured in working weeks. The chart is divided into 2 stages: “Last patient visit to database lock” and “Database lock to filing.” In 2020, the total duration was 31.3 weeks, with 8.0 weeks for the first stage and 23.3 weeks for the second stage. By 2024–25, the total duration decreased to 23.6 weeks, with 5.0 weeks for the first stage and 18.6 weeks for the second stage. The chart also highlights the reduction in duration between the 2 periods, with a decrease of 3.0 weeks for the first stage and 4.7 weeks for the second stage, resulting in a total reduction of 7.7 weeks.
Note: This image description was completed with the assistance of Writer, a gen AI tool.
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To read the article, see “Rewiring pharma’s regulatory submissions with AI and zero-based design,” August 1, 2025.