Japan is a crucial market for Samsung Biologics (207940) to sustain its growth trajectory. We are intensifying our efforts to secure contracts with Japanese pharmaceutical and biotech firms. John Rim, CEO of Samsung Biologics, held a press conference near the Pacifico Yokohama International Peace Conference Center on October 8, where he unveiled plans to bolster the company’s presence in the Japanese and Asian biotech markets by leveraging its unparalleled production capacity, diverse modality service capabilities, and superior quality standards.
Rim noted, “Our Japanese operations are thriving. We’ve already inked deals with four of Japan’s top ten pharmaceutical and biotech companies, and we’re in the final stages of negotiations with a fifth.”
Japan, the world’s third-largest pharmaceutical and biotech market, is renowned for its high medical standards and cutting-edge technologies. It is at the forefront of next-generation therapeutics, particularly in antibody-drug conjugates (ADCs) and cell and gene therapies (CGTs).
The Japanese CDMO market is poised for substantial growth. The global market research firm Research and Markets estimates its value at about 13 billion USD as of 2023. Projections indicate a 6.8% annual growth rate, potentially reaching approximately 20.8 billion USD by 2030.
Samsung Biologics cites several factors driving its push into the Japanese market: rising demand for CDMO services, the geographical proximity between South Korea and Japan, and potential partnerships with major Japanese pharma companies. The company plans to capitalize on the lack of time difference, fostering stronger relationships through face-to-face meetings with Japanese clients.
Earlier this year, the company expanded its Asian footprint by opening a sales office in Tokyo. Since last year, they have been running a program to develop professionals well-versed in Japanese business culture.
Samsung Biologics aims to expand its market share among the top 20 global pharmaceutical companies while also ramping up contract activities with firms in the top 40 bracket.
PMDA approvals surge: Global total hits 91 in just one year
Rim emphasized, “Japanese firms prioritize quality above all else, making a strong track record of approvals crucial. Samsung Biologics strives to be a trusted partner for Japanese pharmaceutical and biotech companies by leveraging our strengths in quality management, technological innovation, and regulatory compliance.”
Samsung Biologics has secured 18 manufacturing approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), with 12 of these coming in the last three years alone, demonstrating rapid progress in drug supply within Japan.
The company’s global regulatory agency manufacturing approvals have surpassed 391 in just 14 years since its inception. After crossing the 300-approval milestone last October, they maintained momentum by adding 91 more approvals within a year, further solidifying their global growth potential and competitiveness.
Samsung Biologics is building a robust track record through enhanced capabilities, including close collaboration with global clients, professional talent development, implementation of electronic data management systems, and standardization of regulatory compliance procedures.
The company has trained and retained about 500 staff members who are capable of handling global manufacturing approvals. This enables them to swiftly analyze the latest regulatory guidelines and respond agilely to audits.
Moreover, they have implemented a comprehensive system that digitizes all production data through electronic documentation and quality management systems, allowing real-time tracking, storage, and retrieval. This setup facilitates immediate responses to regulatory agencies’ data verification requests.
New CMO brand ‘ExellenS’ launched: Enhancing global leadership image
Samsung Biologics unveiled its contract manufacturing (CMO) brand ‘ExellenS™’ for the first time at BioJapan 2025.
Rim explained, “ExellenS embodies our commitment to swiftly deliver consistently high-quality biopharmaceuticals to our customers. This manufacturing framework prioritizes equivalency and speed, built on our accumulated production technologies and process standardizations.”
Equivalency refers to establishing an optimized production design based on accumulated expertise, which will be implemented in future facilities to ensure consistency in quality and production systems across all plants.
Speed signifies the development of an agile production system capable of rapidly supplying pharmaceuticals to global clients when needed, based on optimized production design and operating processes.
Rim emphasized, “We aim to maintain our production edge as a top-tier global CDMO by integrating our four core values – customer satisfaction, operational excellence, top quality, and exceptional employee capabilities – along with the principles of simplification, standardization, and scalability.”
Expanding portfolio with ADCs, AAVs, and organoids: Securing future growth drivers
Rim stated, “We’re enhancing our service competitiveness by diversifying into new technology-based modalities such as antibody-drug conjugates (ADCs), adeno-associated viruses (AAVs), and organoids. Our dedicated ADC production facility began operations in March, and we’re in contract negotiations with several clients, including major global pharmaceutical companies.”
Samsung Biologics offers end-to-end ADC services, from process development to drug manufacturing and quality control approval. They can perform all active pharmaceutical ingredient (API) production steps, including antibody production, payload preparation, and linker conjugation, at their Songdo facility. Plans are underway to establish a dedicated line for ADC finished pharmaceuticals by Q1 2027, further enhancing their end-to-end service capabilities.
Rim added, “We’re working to bolster our capabilities in antibodies and oligonucleotides (AOCs), building on our strengths in mRNA and ADCs. We’re preparing to enter the CDO industry with a dedicated lab and development team for AAVs. We’re also continuously researching peptides and closely monitoring market conditions for various business opportunities.”
Samsung Biologics is expanding from CDMO to clinical trial outsourcing (CRO) with its ‘Samsung Organoid’ service. This offering provides high-quality, customized organoid services, leveraging their established CDMO track record with GMP standards.
By collaborating with clients from early clinical stages, they aim to achieve early client lock-in while expanding their industry value chain to enhance customer satisfaction.
Smooth ramp-up of Plant 5: Planning domestic and international expansions to meet growing demand
Rim reported, “Our Plant 5, the world’s most efficient production facility, began full operations in April and is ramping up smoothly. We’re engaged in positive contract discussions for all our plants, including Plant 5.”
Plant 5 incorporates automation and systemization to ensure both efficiency and stability throughout the production process. They have implemented a new Manufacturing Execution System (MES) through digital transformation, transitioning to a digital-based framework.
To maximize operational efficiency, various automation and AI technologies have been applied, including smart warehousing and autonomous transport robots (AMRs). Digital twin technology is utilized to maintain and manage optimized quality.
Samsung Biologics plans to complete its second bio campus by 2032, encompassing Plants 5 to 8, to achieve a production capacity of 1.324 million liters. This expansion will enable swift and flexible responses to customer demands. The expansion of Plant 6 is currently under investment approval review.
Rim emphasized, “We’re actively exploring production facility expansions both domestically and internationally. We recently bid for the 11th plot in Incheon Songdo and were selected as the preferred negotiator. We’re also actively considering strategic production bases in the United States to lay the groundwork for long-term growth and strengthen our global competitiveness.”
Despite global uncertainties, Samsung Biologics is performing well, achieving over 2 trillion KRW (about 1.5 billion USD) in first-half sales for the first time on a standalone basis. They’ve revised their annual sales growth forecast upward from 20-25% to 25-30%.
The company continues to secure contracts consistently. Last September, they signed a 1.3 billion USD CMO contract with a U.S.-based pharmaceutical company, nearly matching last year’s total contract amount in just nine months. As of this month, their cumulative contract amount for the year stands about 3.9 billion USD. The total cumulative contract amount since the company’s inception has surpassed approximately 21.3 billion USD.
Rim concluded, “Despite the uncertain global environment, we will maximize customer satisfaction and maintain our growth trajectory based on our four core values, the ‘4E’.”