Samsung Biologics Co., the world’s largest contract drugmaker, will enter the contract research organization (CRO) market by leveraging its vast drug production capability and its home country’s position as a global hub for clinical trials.
On Monday, the company announced a plan to begin offering CRO services, using its proprietary organoid-based drug screening platform.
CRO services span clinical trial design, patient recruitment, data collection, regulatory compliance and results reporting, positioning them between contract development (CDO) and contract manufacturing (CMO) in the biopharmaceutical development process.
Samsung Biologics is the world’s No. 1 CDMO, with a drug production capacity of 784,000 liters, which will be ramped up to 964,000 liters by 2027. It also offers CMO services to 17 out of the world’s top 20 pharmaceutical companies, including US companies like Pfizer Inc., Merck & Co. Inc., Roche Holding AG and Novartis AG.
However, even after adding a CDO service to its portfolio, it still heavily relies on CMO services for revenue generation.
This is different from its global rivals, Lonza Group AG in Switzerland and China’s WuXi Biologics Inc., which offer a full-service pipeline, spanning CDO to CRO to CMO.
(Courtesy of Samsung Biologics) With the new CRO offering, the Korean CDMO giant hopes to enhance its own end-to-end platform and create synergies across development and manufacturing.
“With Samsung Organoid, we can engage clients at the earliest stages of drug discovery,” a company official said. “We expect this will create a lock-in effect that leads to future manufacturing contracts.”
Biopharma clients that sign on for CDO or CRO services often continue working with the same provider through to commercial-scale manufacturing.
ORGANOID SCREENING SERVICE
Samsung Biologics said it will offer advanced screening services for novel cancer immunotherapy candidates with its patient-derived organoid technology.
Organoids are tiny, three-dimensional structures grown in a laboratory from stem cells or patient-derived cells that mimic the structure and function of human organs, making them useful for research and drug development.
Aerial view of Samsung Biologics' manufacturing campus (Courtesy of Samsung Biologics) Samsung Biologics will run a laboratory within its antibody drug conjugate (ADC) facility to cultivate organoids and test them with new drug candidates.
Its new business prospect looks bright after the US Food and Drug Administration (FDA) announced last April a plan to phase out the animal testing requirement for monoclonal antibodies and other drugs.
Instead, it will facilitate more effective, human-relevant methods to improve drug safety and accelerate the evaluation process, which, in result, could reduce animal experimentation, lower research and development (R&D) costs and ultimately, drug prices.
SOUTH KOREA IS A GLOBAL CLINICAL TRIAL HUB
Samsung Biologics is also poised to accelerate its inroads into the CRO market, supported by Korea’s world-class clinical research and trial infrastructure.
Asia’s fourth-largest economy ranked sixth globally in clinical trial activity in 2024, with a 3.46% share, according to Korea National Enterprise for Clinical Trials (KoNECT). When excluding multinational studies, it was the third-largest single-country clinical trial market, accounting for 3.99% of global trials.
On a city basis, Seoul was the top clinical trial market from 2017 to 2023. It fell to second after Beijing in 2024 due to a prolonged domestic doctors’ strike against the government’s medical service reform policy.
Samsung Electronics Chairman Lee Jae-yong visits a Samsung Biologics plant in Songdo, Incheon (Courtesy of Samsung Biologics) The country’s top four hospitals – Seoul National University Hospital, Asan Medical Center, Samsung Medical Center and Severance Hospital (Yonsei University) – are designated by the government as national research hospitals, boasting the world’s leading medical R&D infrastructure, including top talent and advanced medical technology.
Backed by the country’s outstanding clinical research infrastructure, the local CRO market has grown rapidly.
According to KoNECT, the total revenue of homegrown CRO companies jumped to 546.3 billion won ($420 million) in 2023 from 102.3 billion won in 2014.
Over the same period, the revenue of multinational CRO companies’ Korean operations grew to 433.8 billion won from 191.7 billion won.
“Korea’s capabilities across the entire spectrum from clinical research to precision medicine-based development and manufacturing have evolved from catching up as a latecomer to taking a leading role on the global stage,” said Seo Jeong-sun, chairman of Microgen Inc., a Kosdaq-listed precision medicine and biotechnology company.
“South Korea’s role as a hub in global drug development will continue to grow.”
Write to Dae-Kyu Ahn and Yoo-Rim Kim at powerzanic@hankyung.com Sookyung Seo edited this article.
