Samsung Biologics announced on the 16th that it has launched a drug screening service called "Samsung Organoids," which can replace animal experiments using organoids (mini-organs).
The company has previously focused on contract development and manufacturing organization (CDMO) services, but now is expanding its business area by introducing clinical research organization (CRO) services for the first time.
Organoids are mini-organs created with three-dimensional structures using stem cells and tissue-derived cells, which partially mimic the structure and function of actual organs, allowing a physiological environment similar to human organs to be reproduced in the laboratory. In April, the U.S. Food and Drug Administration (FDA) announced it would encourage alternative technologies like organoids to reduce animal experiments in preclinical trials.
Samsung Biologics believes that the growth of the organoid industry will accelerate in line with this FDA stance. According to the market research firm Research and Markets, the patient-derived organoid market size is expected to grow from $1 billion (approximately 1.3678 trillion won) in 2024 to $3.3 billion (approximately 4.5137 trillion won) by 2030, with an average annual growth rate of 22%.
The company stated that among the organoid business areas, it will prioritize screening for anti-cancer drug candidates through "cancer-derived organoids." This involves verifying the efficacy and toxicity of client candidates using a mini-organ model that grows cells derived from cancer patients' tumor tissues using three-dimensional culture technology. The aim is to replace the conventional screening of candidate substances using cell or animal models.
The traditional methods of using cell lines and animal experiments have high expense burdens and ethical issues, and they also have limitations due to their low similarity to actual genetic variations or expression patterns of cancer patients. A company official noted, "Using organoids allows for a reduced expense burden compared to experiments using existing cell and animal models, while achieving a patient similarity of 85%, enabling more thorough and faster confirmation of the efficacy and toxicity of candidate substances."
The company said it will offer high-quality organoid services based on its experience operating under good manufacturing practice (GMP), having obtained 359 manufacturing approvals from regulatory agencies worldwide, including those in the United States and Europe, alongside its capabilities in sample processing and data management.
The launch of this organoid service is also a strategy to strengthen CDMO contract competitiveness. By starting collaboration with client companies from the early stage of discovery of new drug candidates, they aim to achieve an effect of "lock-in" to secure contract opportunities with clients as early as possible.
John Lim, CEO of Samsung Biologics, said, "By providing fast and accurate screening services from the initial development stage, we expect to significantly reduce the development risks for our clients and increase the development speed." He added, "We will continue to focus on developing innovative technologies and services to meet the diverse needs of our clients for their satisfaction."
Samsung Biologics stated it will consider "production capacity, portfolio diversification, and global expansion" as the three pillars of its growth strategy and plans to continue investing for portfolio expansion in areas such as antibodies, antibody-drug conjugates (ADCs), and adeno-associated viruses (AAVs), in addition to organoids.