Celltrion is expected to achieve annual sales of 1 trillion KRW with its biosimilar ‘Remsima’ as a single product, while key companies such as Alteogen, Orum Therapeutics, and LegoChem Biosciences are promoting the capabilities of K-Bio on the global stage through technology exports and collaborations with global pharmaceutical companies. Additionally, Yuhan Corporation has once again demonstrated K-Bio’s technological prowess in the global market with the U.S. FDA approval of its anticancer drug LECLAZA. In particular, K-Bio is strategically maximizing treatment efficacy through combination therapies with innovative drugs from major pharmaceutical companies or by leveraging cutting-edge platform technologies to create a strong market presence rather than competing directly with global big pharma. However, for K-Bio to sustain its growth, additional investment and support for global expansion are essential. Many companies are currently pointing to insufficient research funding and a lack of infrastructure to navigate global regulatory requirements as major obstacles, and to overcome these challenges, proactive government policies, regulatory easing, and large-scale investments are necessary.
The year 2024 is expected to be a milestone in the history of K-Bio. This is because domestic biotech companies, including Yuhan Corporation and Hanmi Phar maceutical Co., have successfully developed new drugs, either making inroads into the global market or preparing for entry, while biotech ventures such as Alteogen have proven K-Bio’s technological capabilities by securing large-scale technology export deals. In particular, Celltrion’s biosimilar ‘Remsima’ (a biologic drug replicating an existing reference product) is on track to achieve 1 trillion KRW in sales as a single product this year. Analysts predict that producing a blockbuster drug in the United States and Europe— the world’s largest and second-largest pharmaceutical and biotech markets—will serve as a catalyst for renewed global recognition of Korea’s pharmaceutical and biotech industries. Additionally, the Contract Manufacturing Organization (CMO) sector, led by Samsung Biologics, one of the world’s top- tier biopharmaceutical contract manufacturers, continues to demonstrate its competitiveness.
The rise of K-Bio is closely linked to global trends in the biotechnology market. In 2023, as global liquidity tightened, investor sentiment plummeted, leading many big pharma and biotech companies to implement workforce reductions and restructuring measures. However, despite these harsh conditions, the U.S. Food and Drug Administration (FDA) achieved notable results, approving a total of 55 new drugs in 2023 (based on CDER criteria). This marks a nearly 50% increase compared to 37 approvals in 2022, serving as a positive signal for the broader biotech industry. In particular, global interest in antibody-drug conjugates (ADC) has continued into 2024. As an essential technology for developing highly advanced and personalized treatments, such as cancer therapies, ADC technology is expected to emerge as a key driver of growth in the biopharmaceutical industry.
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