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The FDA approved 28 peptide drugs from 2020 to mid-2026, with the 2025 draft guidance establishing macrocycles as a distinct regulatory category. Manufacturing deficiencies account for 41% of peptide CRLs — the single largest source of regulatory failure.
The global peptide therapeutics market crossed 8B in 2025, driven by GLP-1 agonists. With 212 candidates in clinical development and B+ in CDMO capacity expansion underway, peptides are transitioning from a single-class story to a multi-pillar growth narrative.
Global SPPS capacity has doubled since 2022, but demand from GLP-1 manufacturing keeps lead times at 12–18 months. Here’s the state of peptide synthesis technology in 2026.