ST Pharm Co. Ltd., an API CDMO company in Republic of Korea, announced to build the second oligonucleotide manufacturing plant for an expansion of production facilities and to preoccupy the rapidly growing oligonucleotide therapeutics market.
ST Pharm will invest in total $126 million USD at Banwol campus located in Ansan until 2025 and this will construct the second oligonucleotide plant with four to six large production lines.
The second oligonucleotide manufacturing plant will be designed to maximise efficiency by shortening the production period through a parallel cross-production process design. In addition, ST Pharm will be installing a solvent recycling system for cost reduction and to make eco-friendly manufacturing process.
In 2018, ST Pharm has established its first oligonucleotide plant at Banwol campus and this had a production capacity of 1.5 mole per year. In 2020, ST Pharm has decided to retrofit the plant for further capacity expansion and when completed, ST Pharm will have a production capacity of 6.4 mole per year. Furthermore, the establishment of the second oligonucleotide plant will provide a production capacity of 14 mole per year, which forecasts ST Pharm to become the world's largest leading CDMO in oligonucleotide production in 2025, in terms of capacity.
Research & Market expects a rapid growth in oligonucleotide therapeutics market from $7.15 billion USD in 2021 to $18.8 billion USD in 2026 at a CAGR of 21.4 %. (Reference: Research and Markets, 2021, Oligonucleotide Synthesis Market Research Report). Starting with FDA approval on inclisiran (Novartis) for hyperlipidemia treatment, the demand for raw materials and APIs is expected to surge if new blockbuster oligonucleotide drugs approved for commercialisation from 2024. This includes Pelacarsen (Novartis), Vupanorsen (Pfizer), Olezarsen (Ionis) for cardiovascular diseases and Zilebesiran (Alnylam) for adults with hypertension and JNJ-3989 (Janssen) for chronic HBV.
ST Pharm official stated, "The expansion of the second oligonucleotide manufacturing plant and production facilities is for a preparation towards commercialisation of many new oligonucleotide pipelines for chronic diseases from 2024 that APIs are currently supplied by ST Pharm." And "ST Pharm will achieve our goal of ₩1 trillion KRW in sales of oligonucleotide CDMO in 2030 and we would utilise our capabilities from oligonucleotide CDMO to also become global top 5 CDMO company for mRNA and various next generation RNA therapy."