(Samsung Biologics)

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Samsung Biologics has signed a $1.29 billion (1.8 trillion won) contract manufacturing organization (CMO) deal with a U.S. pharmaceutical company, the second-largest agreement in its history. The contract follows an over 2 trillion won deal earlier in 2025, reinforcing the company’s competitiveness despite growing global trade uncertainties.

The deal, announced on Tuesday, will run through December 2029, but the client and product name remain undisclosed under confidentiality terms.

As of September 9th, 2025, Samsung Biologics’ cumulative contracts in the year totaled 5.24 trillion won, nearly reaching the previous year’s record of 5.4 trillion won in just eight months. Since its founding, the company’s aggregate order intake topped $20 billion or 27.7 trillion won.

The firm’s growth trajectory has been steep, with annual orders climbing from 1.16 trillion won in 2021 to 1.78 trillion won in 2022, 3.50 trillion won in 2023, and breaking the 5 trillion won mark in 2024, a nearly sixfold increase over five years.

The latest deal is particularly notable as it materialized despite U.S. tariff risks on overseas-produced biologics. Industry analysts said the U.S. client’s choice of Samsung Biologics underscores its unrivaled production scale, extensive regulatory approvals, and proven quality control.

All of the company’s facilities are in Songdo, Incheon. Its fifth plant, which began full-scale operations in April 2025, adds 180,000 liters of capacity raising its total to 784000 liters - the world’s largest for a single company. Samsung Biologics also plans to expand with three new plants in its second bio campus.

Regulatory strength is another differentiator, with 382 approvals from agencies in the United States, Europe, and Japan as of September 2025 and consistently high inspection clearance rates. To diversify its client base, the firm expanded its focus from the top 20 to the top 40 global pharma companies, backed by sales offices in Boston New Jersey, and Tokyo.

Samsung Biologics has also been active in industry events such as the J.P. Morgan Healthcare Conference, DCAT Week, the BIO International Convention, and Interphex Week Tokyo, with plans to pursue new opportunities at BioJapan and CPHI Worldwide in October.

An industry insider commented, “Samsung Biologics has overcome external risks such as tariffs and reshoring pressures with its world-class production capacity and regulatory track record, and it is poised to keep strengthening partnerships with global pharmaceutical firms for stable growth.”