Korean Pharma and Biotech Firms Rush to Secure North American Production Bases

GC secures cell therapy manufacturing facility in New Jersey through U.S. subsidiary
SK Pharmteco and others also ramp up cell therapy production in the U.S.
High-value cell therapy market entry accelerates amid IRA and tariff pressures

Domestic pharmaceutical and biotech companies are accelerating investments to secure production bases in the United States and North America. This strategy aims to respond to global protectionism, the U.S. Inflation Reduction Act (IRA), and the threat of high tariffs, while also directly targeting the U.S., the world’s largest market, through local operations.

According to the industry on August 21, GC Holdings’ U.S. subsidiary, Made Scientific, opened a new pharmaceutical Good Manufacturing Practice (GMP) facility and its U.S. headquarters in Princeton, New Jersey, on August 13 (local time). The new facility has a total floor area of approximately 5,570 square meters (about 1,684 pyeong). This opening marks the first phase of investment, totaling $12 million (about 16.7 billion KRW). Made Scientific has established end-to-end production capabilities from clinical development to commercialization in the rapidly growing cell therapy market. The company plans to expand the plant in a second phase, hiring more than 100 additional specialists and adding a GMP cleanroom of about 1,200 square meters (about 363 pyeong). SK Pharmteco, SK’s contract development and manufacturing organization (CDMO) subsidiary, also became the largest shareholder of CBM, a U.S. CDMO company with the world’s largest cell and gene therapy production capacity, in 2023, thereby strengthening its local supply chain.

Cell and gene therapies, for which Korean companies are rapidly establishing production bases in the U.S., are advanced treatments that use a patient’s own cells or genes as direct therapeutic agents. Production is complex, and long-distance transport is challenging, making local manufacturing facilities essential. These therapies are high value-added products, with prices reaching hundreds of millions of won, and are expected to experience annual growth rates exceeding 30% in the future. Companies that secure production facilities early are likely to gain a dominant position in the market, which is accelerating entry into the high-demand U.S. market. Additionally, the U.S. government is focusing tax incentives and subsidies on companies that create domestic manufacturing and jobs through the IRA, and the Donald Trump administration has signaled the imposition of high tariffs, increasing uncertainty for pharmaceuticals produced overseas. As a result, there is a competitive push to establish local production facilities.

An industry insider commented, “Local production in the U.S. has become a survival strategy, going beyond regulatory compliance or market access,” and predicted, “Korean companies will take a leap forward on the global stage based on their North American bases.”

The U.S. manufacturing plans of Celltrion and Samsung Biologics, the two pillars of Korea’s biopharmaceutical industry, are also becoming more concrete. Celltrion is pursuing the acquisition of a large-scale biopharmaceutical plant in the U.S. for approximately 700 billion KRW. By producing locally, the company aims to respond to U.S. tariff policies and expand the market share of its biosimilars.

Samsung Biologics is still concentrating its production base in Songdo, Incheon, but is also considering building a new plant or acquiring existing facilities in the U.S. At the Bio USA event in June this year, John Rim, CEO of Samsung Biologics, stated, “We are considering both greenfield (new plant construction) and brownfield (facility acquisition) options, but there have been no suitable opportunities so far. However, we will always consider good opportunities if the timing is right.” Lotte Biologics has already secured a local production base, having acquired Bristol Myers Squibb’s Syracuse plant in the U.S. in 2022, and announced plans to invest $3 billion (about 4.1925 trillion KRW) over the next 10 years. The company has especially presented a vision to become a global top-10 CDMO by focusing on the antibody-drug conjugate (ADC) CDMO sector as a new growth engine.