首尔经济日报行业分析：药明生物去年IND申报数量超三星生物累计三倍以上，讨论韩国CDO能力差距

INCHEON — Groundwork was under way on the 20th of last month along Songdobio-daero in Incheon's Yeonsu district to bury 154,000-volt ultra-high-voltage power lines. The project follows demands for additional electricity supply through 2032 from major companies and hospitals in the area, including Celltrion, Samsung Biologics, SK bioscience, Lotte Biologics, Sartorius and Severance Hospital.
An official from Samsung Biologics who visited the site said biopharmaceutical production processes cannot afford even a momentary interruption. "If production stops for even one second, the cell growth environment changes and all the culture medium grown up to that point must be discarded," the official said. "That is why a stable power supply capable of running 24 hours a day, 365 days a year, is as important here as it is at a semiconductor facility."
Infrastructure construction has continued for 20 years at the Songdo bio cluster in Incheon, which took shape after Celltrion completed its plant there, because the production capacity of biotech companies keeps expanding. Incheon's biopharmaceutical production capacity will grow to more than 2.14 million liters by 2032, according to a report on trends in Incheon's bio industry and its impact on the regional economy published in July by the Bank of Korea's Incheon branch.
The bio industry, which is technology-intensive, posts operating margins of 20% to 50%, far above the roughly 6% typical of established manufacturing, making it a leading candidate to drive future growth. Yet despite Korea's commanding capacity in contract manufacturing, or CMO, the country lags China in contract development, or CDO, which covers the design of new drugs.
China's WuXi Biologics supported 156 investigational new drug, or IND, applications last year alone, according to the pharmaceutical and bio industry on the 2nd. That is more than triple the 49 IND approvals Samsung Biologics had received on a cumulative basis through last year. IND applications are the product of collaboration between drug developers and contract development and manufacturing organizations, or CDMOs, from the earliest stages of development, giving CDMOs a chance to accumulate next-generation technology and manufacturing experience. They also carry a strong lock-in effect, since they often lead to CMO orders once a drug wins approval.
Those results helped lift WuXi Biologics' revenue last year to 4.56 trillion won, about 150 billion won ahead of Samsung Biologics. Lonza, the top CDMO, and WuXi Biologics draw 30% to 40% of revenue from CDO, while Samsung Biologics is still in the 10% range. An industry official said the difference lies in origins: WuXi Biologics built its business around CDO from the start, while Samsung Biologics began in CMO and expanded into CDO later. "There has been a range of support, including the CDMO act with its tax benefits and the K-NIBRT program that trains 2,000 bio manufacturing workers a year, but CDO requires an active domestic new drug ecosystem, so closing the gap in a short time does not look easy," the official said.
Global clients account for more than 70% of Samsung Biologics' CDO business. A senior CDMO industry official said global big pharma mainly needs contract manufacturing, while CDO and contract clinical trial services are more useful to biotech firms developing new drugs. "It is important that domestic biotechs build out their new drug development infrastructure quickly," the official said.
The Korea Health Industry Development Institute made a similar point this year in a report on 25 years of domestic new drugs and the birth of a blockbuster. "Korea has accumulated its own new drug development capabilities and results over 25 years despite being a latecomer," the report said, "but it has not reached the qualitative leap of a global blockbuster drug." Global blockbusters are medicines with annual sales above $1 billion; more than 100 such drugs worldwide account for over 40% of total pharmaceutical sales.
Lee Seung-gyu, vice chairman of the Korea Biotechnology Industry Organization, said many domestic bio companies stall or abandon development because they cannot shoulder the cost of reaching proof of concept in Phase 2 trials, the core of new drug development. "We need packages that support preclinical work and IND preparation together, early-stage development funds for Phase 1 and 2 trials, and shorter review periods," he said.
Industry figures also say Korea needs to move quickly to reduce external risks such as pharmaceutical tariffs. The concentration of domestic biopharmaceutical production facilities in Songdo is seen as a particular vulnerability. WuXi Biologics and other global CDMOs such as Fujifilm and Lonza have spread production bases across the United States, Europe and Asia, while major Korean bio companies have expanded capacity around Songdo. If the United States imposes additional tariffs, Korean CDMOs could lose price and order competitiveness against global rivals with diversified production footprints.
A CDMO industry official said the priority is preventing tariffs beyond the 15% set through trade negotiations and the Section 232 investigation. "Beyond that, we need to press the case that Korea is a U.S. ally so that biopharmaceuticals can be excluded from Section 232 measures," the official said.