On May. 13., upon entering the second floor of Samsung Biologics’ Plant 4 in Songdo International City, Incheon, twelve bioreactors, each of which was as tall as a person, were arranged behind glass walls. These devices, which are employed to cultivate cells for biopharmaceuticals, reach a height of 5.1 m, including the portion that is embedded in the factory floor. Adjacent to them were silver pipelines and auxiliary equipment that were intricately intertwined, thereby facilitating the movement of pharmaceutical raw materials. The entire manufacturing process is conducted in a confined system due to the characteristics of biopharmaceuticals, which can cause critical issues if contaminated. The pipelines, which span a total of 216 km, are all slightly inclined to prevent the accumulation of raw materials. A Samsung Biologics representative stated, “Plant 4, with an annual production capacity of 240,000 L, is the world’s largest single plant. We do not disclose the interior to our clients, as the pipe structure alone can serve as a benchmark for other companies.”
South Korean biotech companies are intensifying their endeavors to penetrate the Contract Development and Manufacturing Organization (CDMO) market. CDMOs are responsible for the development and production of pharmaceuticals on behalf of their customers. The CDMO industry is expanding at a rapid pace as more biotech companies in the global pharmaceutical market strive to reduce costs and improve development efficiency. The US Congress has also proposed the “Biosecure Act,” which designates China’s WuXi Biologics, the world’s fourth-largest CDMO, as a regulatory target. The law is expected to be announced within the year. The domestic biotech industry is actively pursuing consumers in anticipation of the advantages the US movement will bring.
According to market research firm Frost & Sullivan, the global CDMO market size, which was $20.28 billion (approximately 27.8 trillion won) in 2022, is expected to grow more than double to $47.7 billion by 2028. Switzerland’s Lonza, the US’ Thermo Fisher Scientific, and Catalent are leading in the first to third positions. Samsung Biologics, which is vying with WuXi Biologics for the fourth to fifth positions, focuses on production capacity.
Following the full functioning of Plant 4 in June last year, Samsung Biologics intends to finish Plant 5 by April of next year, increasing its manufacturing capacity to 784,000 L. This is approximately equivalent to Lonza’s estimated production capacity of 790,000 L for next year. If Samsung Biologics completes Plants 6–8 by 2032, its total production capacity will be 1.324 million L. Its performance is also impressive. Last year, quarterly sales exceeded 1 trillion won (about $729.87 million) in both the third and fourth quarters, and this year’s first quarter sales were 946.9 billion won (approximately $691.31 million), a record high. This year, the corporation expects to generate 4 trillion won (about $2.92 billion) in revenue.
WuXi Biologics will be essentially barred from entering the US market by 2032 if the Biosecure Act is enforced. To meet the increased demand, Samsung Biologics is boosting its technological development. On June 4, Samsung Biologics announced the “S-Tensify” platform, a bio-contract development platform. This method uses advanced culture techniques to aid in the early development of high-concentration biopharmaceuticals. A biotech industry insider stated, “While WuXi Biologics excels in early-stage biopharmaceutical consignment development, Samsung Biologics is strong in large-scale contract manufacturing,” adding, “The launch of the latest contract platform is intended to attract WuXi Biologics’ customers.”
Along with Samsung Biologics, other South Korean CDMO companies are seeking new opportunities by participating in the “2024 BIO International Convention” in the US, which started on June. 3. (local time). LOTTE BIOLOGICS is promoting its antibody-drug conjugate (ADC) production facilities under construction in the US and the ongoing construction of its Songdo plants to local clients. SK Biopharmaceuticals and SK bioscience opened promotional booths at this event for the first time, and ST Pharm showcased its nucleic acid therapeutic CDMO capabilities.
Heo Hye-min, a researcher at Kiwoom Securities, observed, “With the Biosecure Act awaiting complete congressional approval and the President’s signature, clients contracting with Chinese enterprises are already seeking other CDMOs. South Korean CDMOs are expected to benefit from this situation, and obtaining FDA and EMA approval experience and production capacity would be critical.”
