Samsung Biologics sees big things ahead with spin-off, CDMO momentum and new anti-cancer drugs

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Samsung Biologics sees big things ahead with spin-off, CDMO momentum and new anti-cancer drugs

Published: 18 Jun. 2025, 17:13

LEE JAE-LIM
[email protected]

Audio report: written by reporters, read by AI

Samsung Biologics CEO John Rim speaks to the press about the company's future road map at a luncheon in Boston on June 17. Samsung Biologics is exhibiting at the 2025 BIO International Convention held between June 16 and 19. [SAMSUNG BIOLOGICS]

BOSTON — Samsung Biologics CEO John Rim pledged to expand the company’s core contract manufacturing business as it undergoes a major corporate restructuring with the planned spin-off of its biosimilar unit. At the same time, the company is stepping into early-stage drug discovery with the launch of a new organoid-based screening platform.

Speaking to Korean media at a luncheon on Tuesday, the CEO said the decision to divest Samsung Bioepis was driven by the need to streamline operations and address client concerns over competitive overlap.

“Many of our clients, while signing deals with us, requested contract clauses asking us not to manufacture biosimilars if we were producing for them,” Rim said. “Now, 17 of the top 20 global pharmaceutical companies are our clients. We saw this as the right time to make the move.”

Samsung Bioepis will be transferred to the newly formed Samsung Epis Holdings by Oct. 1, with both entities expected to be relisted on the market by the end of that month following an interim period.

CDMO market momentum

Rim dismissed concerns about overcapacity in the contract development and manufacturing organization (CDMO) sector, noting that demand is rising as biopharma pipelines diversify beyond traditional therapeutic areas.

“Previously, it was mostly immunology and oncology, but now we’re seeing growth in neurological diseases like Parkinson’s and amyotrophic lateral sclerosis,” he said. “There’s also a growing wave of anti-aging investments, and biotechs are driving much of this pipeline expansion.”

Samsung Biologics aims to achieve 1.5 trillion won ($1.1 billion) in annual operating profit this year, and has already secured over 3.35 trillion won in cumulative orders this year, already surpassing half of its total order volume in 2024. According to U.S.-based consulting firm Frost & Sullivan, the global CDMO market is projected to reach $43.9 billion by 2029, growing at an annual rate of 15 percent between 2024 and 2029.

To meet the surge in demand, the company continues to expand its manufacturing footprint. Plant 5, located at its second bio campus, was completed in April and is now fully operational, bringing Samsung Biologics' total production capacity to 784,000 liters (207,110 gallons). Construction of a sixth plant is pending board approval, and the company is bidding on additional land in Songdo to establish a third bio campus.

“We are already producing antibody-drug conjugates [ADCs] and actively negotiating new contracts,” Rim said. “In terms of modalities, we’re preparing to handle a broader range — including bispecific antibodies, ADCs and antibody-oligonucleotide conjugates — all within our existing facilities. We’ve also begun working with adeno-associated viruses, though we’re still in the early stages.”

Samsung Biologics also plans to offer clinical-stage contract development organization (CDO) services, though no new facilities will be built. Development capacity for these projects will be limited to 200 liters.

Entry into research and organoid services

The company’s newly launched Samsung Organoid platform marks its first major step into contract research organization (CRO) territory.

Lee Sang-myung, executive vice president and head of business strategy, speaks during a press conference held with the Korean media at the Boston Convention & Exhibition Center on June 17. [SAMSUNG BIOLOGICS]

Developed in partnership with Samsung Medical Center, the platform uses patient-derived 3-D cell cultures — commonly referred to as organoids or artificial organs — to screen for anti-cancer drug candidates, which have higher predictive accuracy than conventional animal models.

“In fact, based on our analysis using representative drugs, these organoids showed up to 85 percent consistency with actual patient responses,” said Lee Sang-myung, vice president and head of business strategy. “Once an organoid is banked, we can thaw, culture and process it to deliver testing results in just about five weeks — dramatically shortening the timeline compared to animal models. It costs are about one-tenth, and there are no ethical concerns.”

Although the organoid service is not expected to generate revenue on par with Samsung’s CMO and CDO businesses, the company sees long-term value in the data it generates, particularly for personalized drug development and early-stage decision-making.

“Testing drugs with organoids alone is one-dimensional,” Lee said. “But now, there is a vast amount of related data — imaging like CT and MRI, genomic profiles, treatment histories, recurrence outcomes — that has been accumulated but largely unused until now.

“The emergence of AI as a powerful tool allows us to combine organoids with this multidimensional data to enhance drug development. That technological momentum is what we see as the biggest driver.”

Samsung Biologics is also exploring partnerships with overseas hospitals to broaden its patient-derived organoid bank and is considering future data licensing models. While its organoid unit may start small, the company views it as a strategic foothold in precision medicine and an eventual bridge to broader CRO capabilities.

BY LEE JAE-LIM [[email protected]]