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The South Korea Biosimilars Market is all about making more affordable, copycat versions of expensive biologic drugs once their patents run out, kind of like generic versions but for complex, large-molecule medicines. Since these “biosimilars” must prove they are highly similar to the original drug in terms of safety and effectiveness, South Korea has become a major global player, with companies focusing heavily on R&D and manufacturing to roll out these drugs for treating diseases like cancer and autoimmune disorders, ultimately making advanced treatments more accessible within the country’s healthcare system.
The Biosimilars Market in South Korea is expected to reach US$ XX billion by 2030, growing at a CAGR of XX% from 2025. The market is estimated at US$ XX billion for the period 2024–2025.
The global biosimilars market was valued at $32.75 billion in 2024, reached $35.04 billion in 2025, and is projected to grow at a CAGR of 7.5%, reaching $72.29 billion by 2035.
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Drivers
The South Korean Biosimilars Market is primarily driven by the national goal of increasing healthcare cost-efficiency and boosting the domestic biopharmaceutical industry. A major factor is the aggressive government support and clear regulatory pathways established by the Ministry of Food and Drug Safety (MFDS), which has positioned South Korea as a global leader in biosimilar manufacturing and development. Companies like Celltrion and Samsung Bioepis are key global players, providing a strong domestic ecosystem of expertise, advanced manufacturing facilities, and robust R&D investment. Furthermore, the rising burden of chronic and complex diseases, particularly cancer and autoimmune disorders, drives demand for advanced biological therapies. As original biologics patents expire, biosimilars offer a cost-effective alternative, expanding patient access to essential treatments while relieving pressure on the National Health Insurance (NHI) budget. The highly competitive nature of the South Korean pharmaceutical landscape encourages hospitals and prescribing physicians to adopt these lower-cost alternatives, especially given the established clinical equivalence and positive real-world evidence supporting biosimilars. This combination of national policy support, domestic industrial strength, and clinical necessity ensures a strong and sustained growth trajectory for the market, which is projected to reach significant revenues by 2027 with a CAGR of 22.5% from 2021 to 2027.
Restraints
Despite its global leadership in manufacturing, the South Korean biosimilars market faces significant restraints, notably achieving deeper market penetration against established reference biologics. While the regulatory framework is supportive, market uptake remains challenging, especially in comparison to some European markets. For instance, the market share for certain biosimilars, such as trastuzumab biosimilars, has historically been relatively low (around 26.79%), indicating a persistent preference for originator products among some clinicians and patients. This reluctance is often rooted in concerns over perceived differences in efficacy, immunogenicity risk, or simply prescribing habits and lack of adequate education about biosimilars. Another key restraint is the intense domestic and global competition, which drives down prices and compresses profit margins, making sustained investment in new biosimilar development increasingly risky. The high cost and complexity associated with clinical trials required to prove biosimilarity, especially for newer, complex molecules, act as a barrier to entry for smaller domestic firms. Moreover, managing the sophisticated supply chain and distribution channels for temperature-sensitive biopharmaceuticals presents logistical challenges. Lastly, while policies favor biosimilars, administrative hurdles in switching protocols within hospitals can slow down the adoption rate, restraining faster growth within the domestic healthcare system.
Opportunities
The South Korea Biosimilars Market is ripe with opportunities, primarily stemming from its established manufacturing prowess and export potential. The country’s strong foundation, demonstrated by major players aiming for multi-billion dollar global sales, allows it to become a global contract development and manufacturing organization (CDMO) hub for biosimilars. The pipeline for next-generation biosimilars, targeting therapeutic areas like ophthalmic and rare diseases, presents substantial new revenue streams as more blockbuster biologics lose patent protection. Furthermore, domestic market penetration can be significantly enhanced through targeted public and physician education campaigns, aimed at building confidence and accelerating switching rates from reference products. The focus on personalized medicine also offers opportunities for biosimilars to be integrated into comprehensive therapeutic plans, especially if supported by robust data analytics. Developing and launching interchangeable biosimilars, which are permitted to be substituted at the pharmacy level without the prescriber’s intervention, represents a major market opportunity to drive rapid volume growth, mirroring successful strategies in other countries. Lastly, strategic partnerships between Korean biosimilar manufacturers and international pharmaceutical companies looking to enter the Asia Pacific market offer a pathway to leverage Korean expertise and infrastructure for both domestic and global expansion.
Challenges
The core challenge for South Korea’s Biosimilars Market lies in balancing global ambitions with domestic adoption. A crucial technical challenge is the constant need to improve analytical methods and manufacturing consistency to meet increasingly stringent global regulatory standards for proving biosimilarity and interchangeability. The global patent environment is complex and evolving, posing risks related to intellectual property litigation and market exclusivity, which domestic companies must navigate to sustain international sales. Domestically, changing established prescribing patterns remains a behavioral challenge. Overcoming the initial high development costs and the subsequent low profit margins due to aggressive pricing competition requires operational excellence and scale. Furthermore, the market must address the “biosimilar fatigue” phenomenon, where the introduction of multiple biosimilars for the same reference product can dilute market share and confuse prescribers. Ensuring sustained and timely access to clinical trial data and real-world evidence for all newly launched biosimilars is critical but logistically difficult. Lastly, while R&D funding is high, ensuring skilled labor availability—specifically in areas like advanced bioprocessing engineering and regulatory affairs for biopharmaceuticals—remains a necessary focus to maintain the country’s competitive edge.
Role of AI
Artificial Intelligence (AI) is becoming indispensable in advancing the competitiveness and efficiency of South Korea’s biosimilars industry. AI tools are increasingly used in the early stages of biosimilar development, specifically for characterizing the critical quality attributes (CQAs) of both the reference product and the biosimilar candidate. Machine learning algorithms can analyze vast datasets from structural and functional assays, accelerating the process of confirming similarity and identifying subtle variations faster than traditional methods. In biomanufacturing, AI is crucial for optimizing fermentation and purification processes. Predictive modeling and real-time process monitoring enable manufacturers to enhance yield, reduce batch-to-batch variability, and minimize production costs—factors vital for competitive pricing in the biosimilar space. AI also plays a significant role in managing clinical trial data, particularly in pharmacovigilance, by analyzing safety profiles across large patient populations more efficiently. Furthermore, AI-powered tools can help forecast market demand and optimize supply chain logistics, ensuring that complex biological products are distributed efficiently both domestically and internationally, thereby improving overall operational agility and supporting the high-volume needs of global biosimilar leaders.
Latest Trends
Several key trends are defining the future landscape of the South Korean Biosimilars Market. One major trend is the ongoing shift toward developing “biobetters” or second-generation biosimilars, which aim to offer improved characteristics, such as enhanced efficacy or more convenient dosing schedules, to gain a competitive advantage over both the reference product and first-wave biosimilars. Another cutting-edge trend is the heavy investment in automated and continuous biomanufacturing technologies, which allows South Korean firms to achieve unprecedented scale and cost-efficiency in producing biosimilars, cementing their status as global leaders. There is also a significant move towards diversifying the therapeutic pipeline beyond traditional areas like immunology and oncology into complex products such as enzyme replacement therapies and gene therapy-related biologics. Domestically, the regulatory push for interchangeability designation is a strong trend, aiming to streamline the adoption of biosimilars through automatic substitution at the pharmacy level. Finally, Korean biosimilar companies are actively pursuing market expansion into emerging Asian and Latin American markets, leveraging their proven quality and competitive pricing strategies to secure first-mover advantage in regions with rapidly growing demand for affordable biological medicines.
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