[BIO USA] Samsung Biologics: "Organoid Business Serves as a Stepping Stone for CRO Expansion"

First New Business Venture in Seven Years Since Entering the CDO Sector in 2018
"Strengthening Understanding of New Drug Development Needed for CRO Expansion"

Samsung Biologics has announced its entry into the organoid business as a stepping stone for expanding into the clinical research organization (CRO) sector. The company aims to accelerate the expansion of its CRO business by enhancing its overall understanding of new drug development through the organoid business.

Sangmyung Lee, Head of Business Strategy Team at Samsung Biologics, held a press conference on the 17th (local time) at the '2025 BIO International Convention (BIO USA)' held in Boston, USA, explaining the background of entering the organoid business. Photo by BIO USA joint press team

At a press conference held on the 17th (local time) during the '2025 BIO International Convention (BIO USA)' in Boston, USA, Sangmyung Lee, Head of Business Strategy Team at Samsung Biologics, stated, "Entering the organoid business serves as a forward base for expanding our CRO business."

Previously, on the 16th, Samsung Biologics launched 'Samsung Organoids,' a drug screening service utilizing organoids. At this year's BIO USA, a variety of companies, including the global top 20 big pharma, have already shown interest, and it is reported that actual meetings are underway with some clients.

The entry into the organoid business marks Samsung Biologics' first new business venture in seven years since its entry into the contract development organization (CDO) sector in 2018. With the expansion into the CRO business, Samsung Biologics will broaden its business scope from manufacturing to development and research.

The motivation behind Samsung Biologics' foray into the organoid business lies in expanding its business portfolio beyond contract development and manufacturing organization (CDMO) services to include CRO services. In particular, the company plans to use the organoid business as a bridgehead for its CRO business. Understanding new drug development is crucial in the CRO sector, and Samsung Biologics intends to strengthen this understanding through its organoid business.

Lee commented, "The research field has a different culture compared to the manufacturing and development that Samsung Biologics has traditionally engaged in. To expand into the CRO business in the future, a high level of understanding of new drug development is essential, and I believe the organoid business will help us gain a comprehensive understanding." He added, "We will be able to acquire capabilities such as understanding what the biggest concerns of clients are when developing new drugs, how discussions are taking place, as well as securing technical expertise and talent."

He also expressed expectations for synergy with the CDO business. Lee explained, "Even for products that clients have already launched, organoids can be used to test the potential for new indications. We plan to provide services that enable clients to succeed in new drug development with minimal costs and the highest success rates."

Samsung Biologics is also pursuing strategic collaboration with Samsung Medical Center, which was selected by Newsweek as one of the global top three hospitals for cancer treatment in 2025. As of May last year, Samsung Medical Center possessed clinical data and experience from over 450 million patients and more than 19 billion clinical records.

The distinguishing features of Samsung Organoids are its 'quality-focused service,' which generates and manages high-quality data based on Good Manufacturing Practice (GMP) operational experience recognized by 359 manufacturing approvals from major global regulatory agencies, and its 'customized service,' which provides organoids tailored to individual clients by identifying patients that meet specific requirements.

Other differentiators include 'highly reliable data generation' through strict analytical validation, standardized protocols, and an integrated quality system, as well as 'data-driven clinical insights' that provide insights into therapeutic targets using diverse clinical data linked to organoids.

Organoids, named by combining the word 'organ' with the suffix '-oid' meaning 'resembling,' are 'mini-organ models' created by aggregating and culturing stem cells or tissue-derived cells in three dimensions. Compared to traditional experimental methods, organoids offer lower costs and exhibit high patient similarity of up to 85%. They allow for more detailed and rapid assessment of the efficacy and toxicity of candidate substances, which has recently attracted significant market attention.

According to market research firm Research and Markets, the global patient-derived organoid market is estimated to grow at an average annual rate of 22%, from $1 billion (approximately 1.3678 trillion KRW) in 2024 to $3.3 billion (approximately 4.5137 trillion KRW) by 2030. In particular, expectations for accelerated industry growth have risen since the US Food and Drug Administration (FDA) announced in April that it plans to reduce animal testing and promote alternatives such as organoids.