2024. 10. 22
Envisioning a Korean edition of 'Q-Square': GCCL Next celebrates its 5th anniversary
GCCL is the first 'clinical trial sample analysis organization' in Korea, often referred to as an 'analysis CRO'. It operates differently from the typical clinical trial contract research organizations (CROs) that most people are familiar with. A notable global example of an analytical CRO is 'QSquare (Q2 solutions, now IQVIA Lab)'. GCCL shares several similarities with QSquare, such as being formed through company mergers, and is positioning itself as the ‘Korean version of Qsquare’. Celebrating its 5th anniversary this year, GCCL posted its first profit last year, affirming the viability of its business model and operational success.Over the next five years, GCCL plans to focus on going ‘global’, a goal that is clearly reflected in its mission. GCCL stands for ‘Global Clinical Central Lab,’ and the company’s primary objective is to capture a share of the clinical trial sample analysis market, which is currently dominated by global analytical CROs. Presently, about one-third of GCCL’s projects involve global clinical trials. In a recent interview with , GCCL’s CEO, Yang Song-hyun, shares the company’s achievements over the past five and its future plans, emphasizing its role as an ‘All in One Lab for Clinical Trials in Asia’ catering to both Korean and international pharmaceutical and biotechnology companies.Yang Song-hyun, CEO of GCCL, poses with the company's Corporate Identity (CI) in the background. (Source: GCCL)◇Korea's first clinical trial sample analysis institution (GCLP): An all-in-one lab from early to late clinical trial stagesEstablished in August 2019, GCCL is a joint venture (JV) formed through a collaboration between GC Bioscience Lab (now GC Labs), GC Cell (formerly GC Lab Cell), and CRO C&R Research, which were Korea’s first commercial laboratories. GCCL is the first joint venture between a CRO and a laboratory in Korea and the country’s first clinical trial sample analysis institution."We founded GCCL to offer specialized clinical trial analysis services similar to GlobalLab," CEO Yang Song-hyun said. "With the implementation of the GCLP certification system in Korea in 2019, we aimed to establish a professional analysis institution that adheres to these standards. In 2020, we became the first institution in Korea to achieve GCLP (Good Clinical Laboratory Practice) certification."“While the traditional CRO focuses on ‘project management’ and overseeing the entire clinical trial process, an analytical CRO like GCCL specializes in analyzing human-derived samples, such as blood and urine, collected during clinical trials,” Yang further explained.GCCL operates as an all-in-one lab, providing services that span from early-stage clinical trial analysis to late-stage clinical trials within the same facility. The company offers sample analysis services based on client needs through its ‘Bio-Analytical Lab’ for early clinical trials and its ‘Central Lab’ for late-stage trials.“By offering all services from early- to late-stage clinical trials in a single location, we can reduce logistics costs and ensure optimal sample stability,” Yang emphasized. “Previously, most samples generated in Korea were sent abroad, often to places like Singapore, for analysis. However, with the establishment of GCCL, we have taken the lead in analyzing samples domestically, marking our first major milestone.”Since its founding, GCCL has completed more than 1,000 projects, with around 27% of these being global clinical trial projects. Yang pointed out that the share of global projects is steadily increasing. "GCCL is the only company in Korea to implement solutions like Watson LIMS (Laboratory Information Management System) and ddPCR (Digital Droplet PCR, a high-precision genetic analysis technology) in compliance with global regulatory standards, setting the trend for clinical trial sample analysis in Korea," Yang further highlighted.Yang Song-hyun, CEO of GCCL, engages in an interview. (Source: GCCL)◇Global market entry strategy: ‘Success in customer-driven novel drug development’—aiming for investment attraction in 2025 and IPO in 2028In response to the growing demand for advanced analytical methods alongside the advancement of clinical trials in line with novel drug development trends, GCCL launched a specialized analysis method development and verification organization this year and introduced the ‘R&D Lab’ service. The R&D Lab has developed biosimilar analysis methods for drugs like Keytruda, Yervoy, and Perjeta, as well as a cell therapy analysis method using ddPCR technology. Additionally, Yang mentioned that the Global Business Development (GBD) team was also established this year, actively participating in international exhibitions and academic conferences, where it has achieved meaningful results.“The most assured path for GCCL to enter the global market is through the success of our customers’ new drug development,” Yang stated. “If the projects entrusted to our company gain new drug approval from global regulatory authorities’ bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we anticipate that the company will also secure a global portfolio.”“Last year, GCCL was the only Korean company selected as one of the ‘Top 10 Bioanalytical Service Providers in APAC 2023’,” Yang further commented. “After entering the Asian analysis service market in 2025, our goal is to expand into advanced markets by 2028 through participation in multinational clinical trials and to achieve a smooth entry into the global market by 2030.”According to an overseas research institute, the global analysis service market was valued at around KRW 10 trillion (approximately USD 7.3 billion) last year. The bioanalytical market is estimated to be over KRW 5 trillion, while the central lab market is valued at more than KRW 4 trillion. In comparison, the Korean analysis service market is worth about KRW 200-250 billion. As Korean pharmaceutical and biotechnology companies expand R&D efforts and conduct more clinical trials, the clinical trial sample analysis market is also expected to experience continued growth.“GCCL is dedicated to offering fast and proactive, customer-centered services that cater to client needs, as reflected in the positive feedback from customers who have used Global Lab,” Yang emphasized. “By providing high-complexity analysis services typically offered by Global Lab at more affordable prices, in line with novel drug development trends, we are helping to reduce Korean customers’ reliance on overseas markets.”Yang highlighted that GCCL’s parent company, GC Cell, specializes in cell-gene therapy (CGT), which positions the company to also target antibody-drug conjugate (ADC) clinical trial sample analysis, a sector currently receiving significant attention in the global biotech market. “The domestic ADC market is still in its early stages, and next year we expect to see ADC development companies beginning their clinical trials in earnest,” he further added. “GCCL plans to concentrate on the biosimilar and ADC clinical trial sample analysis markets.”GCCL has experienced continuous growth since its inception, but this year it anticipates achieving sales figures similar to those of the previous year due to challenges in the Korean market situation, including the medical crisis. The company has also forecast a shift to an operating loss as a result of significant investments made to expand its service capabilities this year. “We are working to expand our global project order base to mitigate the impact of domestic market conditions, and we expect to see tangible results and stable revenue generation in two or three years,” Yang remarked. “Next year, we plan to seek investments during this crucial period. We are targeting an initial public offering (IPO) in 2028.”Yang emphasized that GCCL’s objective is to become the leading Korean clinical trial sample analysis service provider before expanding into the global market. “We aspire to develop into a trusted company that facilitates the success of clinical trials for developers and partners, not just in Korea but throughout Asia and globally, backed by world-class infrastructure, quality, and service,” Yang stated. “You can expect to see tremendous changes in the next five years,” he added.Source : Envisioning a Korean edition of 'Q-Square': GCCL Next celebrates its 5th anniversary with a global focus < The interview < ENGLISH NEWS < 기사본문 - 더바이오 (thebionews.net)
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