Celltrion Group has launched a new contract development and manufacturing organization, Celltrion BioSolutions, signaling its strategic ambition to position CDMO services as the group’s next growth engine beyond its core biosimilar business.

"We will start contract research and development services from 2025, with the facility construction set to start by the first half. By 2030, we aim to record 1.5 trillion won ($1.04 billion) in CDMO business," Chairman Seo Jung-jin said during a press conference Tuesday.

The new company will be led by Lee Hyuk-jae, Celltrion's senior vice president, who brings extensive experience in product approval, clinical trials and manufacturing within the group.

The group’s decision to expand into the CDMO market was formalized in September, driven by the growing global demand for biopharmaceuticals and increasing outsourcing requests both domestically and internationally, Seo recalled.

Celltrion BioSolutions aims to provide comprehensive end-to-end biopharmaceutical services, including drug candidate screening, cell line and process development, clinical trial planning, regulatory documentation and commercial production.

Seo announced the company’s strategy to minimize expansion costs by implementing "manufacturing automation" and designing "flexible, small-scale multi-product production systems" to efficiently secure production orders.

Meanwhile, Celltrion BioSolutions is currently reviewing potential sites for its production facility.

The first plant, designed for up to 100,000 liters, will commence construction next year, with full-scale commercial productions expected to commence by 2028. In the meantime, the group plans to evaluate optimal locations to ensure sustainable production and supply, potentially expanding capacity to 200,000 liters domestically.

“We will adjust the timeline for a second plant based on market needs. While continuously expanding our CDMO sales network, we will also consider building a 100,000-liter plant overseas, if needed," Seo explained.

In addition, the company plans to establish research centers globally in the coming years, particularly in the United States, Europe and India, to expand its R&D capabilities.

“While Korea will serve as the main research hub, we will also open research centers in some 40 countries, in conjunction with our direct sales networks there," Seo said.

Seo projected the need for some 500 personnel for the CDMO business alone, hinting that the company would recruit Ph.D.-level researchers in these regions.

The new venture will be financed through a combination of internal and external investments.

Celltrion Group will initially invest up to 1.5 trillion won for facility construction and CDO services. An additional 1.5 trillion won will be secured externally to fund the development of overseas specialized research centers and next-generation modality facilities.

According to global market research firm Mordor Intelligence, the global biopharmaceutical CDMO market is projected as $243.29 billion in 2024 and is expected to reach $331.98 billion by 2029, reflecting an annual growth rate of 6.41 percent. Celltrion Group plans to accelerate its CDMO business through the subsidiary to swiftly capture market share and establish a stronger foothold in the industry.