How to produce semaglutide and how high is the cost? The core ingredients of Ozempic and Wegovy, dual effect drugs for reducing blood sugar and weight
Do you want to know how to produce and what the cost is for the "dual effect hypoglycemic and weight reducing drug" semaglutide (the core ingredient of Ozempic and Wegovy)?
The preprint "Semaglutide Manufacturing Process Modeling and Techno Economic Assessment" released by the Intelligent team in June 2025 was disassembled using the SuperPro Designer tool to analyze its entire process!
1. First understand: What is semaglutide? Long acting GLP-1 receptor agonist, developed by Novo Nordisk, is the core active ingredient (API) of Ozempic (hypoglycemic), Wegovy (weight loss), and Rybelsus (oral hypoglycemic).
Can control blood sugar, lose weight, and lower cardiovascular risk; The half-life is about 7 days, and only one injection per week is needed, which is much more convenient than the old GLP-1.
Key design: Long term effect achieved through 3 structural modifications - Ala8Ab replacement for anti degradation, C18 fatty acid coupling for extended action time, Lys34Arg optimized production.
2. Production is not simple: Four steps are taken to produce Simeglutide. Simeglutide has a complex structure and adopts a mixed process of "recombination+chemical synthesis". It is divided into four core steps (sub models) and accurately modeled using SuperPro Designer
1. Precursor production: Fermented with genetically engineered yeast (brewing yeast) to produce Lys ² ⁶ Arg ³ ⁴ GLP-1 precursor, which is then purified by centrifugation, filtration, and HPLC.
2. Making tetrapeptides: Using solid-phase peptide synthesis (Fmoc SPS) to create the "tetrapeptide terminal extension segment", which is the key fragment of semaglutide.
3. Making linkers: Similarly, solid-phase synthesis is used to make "linkers" containing C18 fatty acids, which are responsible for prolonging the drug's action time.
4. API assembly: The precursor, linker, and tetrapeptide are coupled together, deprotected, purified by HPLC, and freeze-dried to obtain a purity of 99.5% or higher for semaglutide powder.
How popular is the market? Rapid growth but significant challenges: The global GLP-1 market is expected to reach $49.3 billion in 2024 and $157.5 billion in 2035 (an annual increase of 11.1%);
Simeglutide monotherapy sold for $26.68 billion in 2024 and is expected to reach $42.36 billion in 2035.
Pain points highlighted: Out of stock since 2022, mainly due to "exceeding instructions for beauty and weight loss"+"complex production process"; In addition, the patent for semaglutide will expire in 2026, and generic drugs will gradually enter the market.
4. Cost account: 500kg/year production capacity, how much does it cost? Calculated based on the concept of a factory producing 500kg of purified semaglutide annually:
Total investment: approximately 175 million US dollars (mainly spent on fermentation and purification equipment);
Unit cost: 105500 US dollars per kilogram (raw materials account for 70%, such as high-purity glucose for fermentation and amino acid derivatives for synthesis, which are not cheap);
Operating expenses: Approximately 52.7 million US dollars per year (including equipment depreciation, labor, consumables, etc.).
