In Hit News’ 2025 keyword rankings, Celltrion and Samsung Bioepis placed 3rd and 5th, underscoring their central roles in Korea’s pharmaceutical and biotech industry. Samsung Biologics’ cumulative annual orders surpassing $3.73 billion and Celltrion’s annual revenue reaching $2.37 billion emerged as key indicators of the sector’s qualitative growth.

Beyond headline figures, 2025 was defined by strategic moves aimed at long-term sustainability. Celltrion responded to tariff uncertainty by securing U.S.-based manufacturing and accelerating supply-chain optimization through facility acquisitions. Samsung Biologics, meanwhile, completed a major structural overhaul by separating its CDMO and biosimilar businesses, sharpening specialization and reinforcing a multi-engine growth model across the group.

Industry data further highlight the momentum behind these shifts. According to the Korea Bio Association and the Ministry of Trade, Industry and Energy, Korea’s bio industry grew at a 6.5% CAGR over the past five years, reaching $14.9 billion in sales. Exports accounted for 59.8% of the total in 2024, marking a clear transition from a balanced domestic-export structure a decade ago to an export-led model.

Antibody therapeutics led exports, posting nearly 50% year-on-year growth and a 19% CAGR over five years. CMO services followed as a major export driver. These trends underscore the expanding role of Samsung Biologics’ CDMO orders and Celltrion’s biosimilar sales within the global supply chain.

Samsung Biologics recorded a record $3.73 billion in annual orders this year. Q3 consolidated revenue reached $1.12 billion, with operating profit of $494 million, driven by full utilization of Plants 1–4 and the successful ramp-up of Plant 5. With plans to acquire a second Bio Campus by 2032—expanding total capacity to 1.324 million liters—the company’s order momentum is expected to strengthen further.

The November spin-off marked a turning point. By separating Samsung Bioepis into Samsung Epis Holdings, Samsung Biologics addressed long-standing conflict-of-interest concerns among global clients and fully committed to a pure-play CDMO identity, enhancing trust and global competitiveness.

Under CEO Kyung-Ah Kim, Samsung Epis Holdings is sharpening its biosimilar focus while expanding into new growth areas. The company launched Epis Next Lab to develop next-generation platforms, entered an ADC co-development agreement with China’s Frontline, and joined a government-backed AI antibody drug development project aimed at significantly shortening clinical sample production timelines.

Facing external pressures—including proposed U.S. tariff hikes and drug price cuts—Celltrion pursued a direct response centered on local manufacturing. Chairman Jung-jin Seo acquired Eli Lilly’s Branchburg plant in New Jersey for approximately $312 million, effectively removing tariff risk while securing a large-scale U.S. production base roughly 1.5 times the capacity of Songdo Plant 2.

A parallel CMO agreement with Lilly ensured stable revenue from the outset. The strategy translated into results: in Q3, Celltrion posted $695 million in revenue and a 29.3% operating margin, driven by a growing share of high-margin products led by Remsima SC.

Looking ahead, Celltrion is accelerating its transition toward novel drug development. The company is advancing CT-P70, an ADC candidate, in global clinical trials and developing CT-G32, an oral obesity treatment, to secure next-generation modalities. Seo also pledged to expand the company’s biotech fund from $339 million to $695 million and outlined plans to build more than 20 novel pipelines by 2027.

Shifts in the global regulatory environment are expected to provide a strong tailwind. The U.S. FDA’s newly announced guidance streamlining biosimilar approvals effectively removes the requirement for comparative clinical efficacy trials, allowing similarity to be demonstrated through analytical data alone. The change could cut development costs by up to 90% and significantly shorten time to market.

In sum, 2025 marked a year of consolidation and repositioning. Celltrion secured U.S. manufacturing to manage macro risks, while Samsung Biologics completed a decisive structural reset. As regulatory easing converges with new business expansion, both companies are well positioned to strengthen their global footing in the year ahead.