Source page: McKinsey & Company
Commentary
Pharma submission speedup
Pharmaceuticals & Medical Products
September 11, 2025 – 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.
To read the article, see “Rewiring pharma’s regulatory submissions with AI and zero-based design,” August 1, 2025.
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Visual form
Two-point stacked bar chart with a bridge-style reduction overlay.
Layout / body structure
The chart has two stacked columns, one for 2020 and one for 2024 to 2025, read left to right. A shaded bridge between the columns shows how each stage of the filing process shortened over time.
What is being compared
It compares the duration of median regulatory filing in working weeks across two periods and splits that duration into the time from last patient visit to database lock and the time from database lock to filing.
Measurement system
The units are number of working weeks. Totals sit above each column, stage values sit inside the stacked segments, and the bridge labels show the reduction in weeks between the earlier and later period.
Visible structure inside the graphic
The 2020 bar stacks an 8.0-week dark-blue base with a 23.3-week lighter-blue upper segment, summing to 31.3 weeks. The 2024 to 2025 bar stacks 5.0 weeks on the bottom and 18.6 weeks on top, totaling 23.6 weeks. Between them, the sloped bridge is labeled minus 3.0 for the lower stage and minus 4.7 for the upper stage, with a total reduction label of minus 7.7 above.
Main takeaway from the visual
The visual makes the speedup concrete by showing that both parts of the filing process shortened, which pulled the total median filing duration down materially from the 2020 benchmark to the latest period.
Key standout values or extremes
Median filing duration falls from 31.3 weeks in 2020 to 23.6 weeks in 2024 to 2025. The database-lock-to-filing stage remains the larger share in both periods at 23.3 weeks versus 18.6 weeks, while the last-patient-visit-to-database-lock stage declines from 8.0 to 5.0 weeks.
Controls / sequence, when applicable
This is a static chart image with no in-chart controls to operate.
Companion media, when applicable
There is no separate companion audio or video; the chart image is the full visual on this page.