South Korea Biosimilars Market Research Report, 2030

Driven by the country’s advanced clinical research infrastructure and government support, South Korea has, over the last decade, emerged as a global leader in the biopharmaceutical industry. Key companies like Celltrion, a biopharmaceutical company with an extensive pipeline portfolio which includes antibody biosimilars for the treatment of rheumatoid arthritis and colorectal cancer as well as drugs to treat hepatitis B, influenza, rabies, breast cancer, and seasonal influenza, and Samsung Bioepis dominate the biosimilars market, contributing significantly to the approvals and pipelines. In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration. The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in South Korea. In the ever-evolving pharmaceutical landscape, the demand for biosimilars and generic medicines is experiencing a significant surge. Despite variations in uptake rates among different products, biosimilars are swiftly gaining momentum, presenting lucrative opportunities for pharmaceutical innovation. Notably, the South Korean Government has committed substantial investments to propel the biosimilar industry forward. Regulatory oversight of RLD sourcing in South Korea falls under the purview of the Ministry of Food and Drug Safety (MFDS). This governing body plays a pivotal role in ensuring the safety and efficacy of pharmaceuticals, serving as a gatekeeper for drug approval processes. Compliance with the MFDS’s stringent regulations and guidelines is paramount for companies navigating the intricate landscape of drug approval, particularly for those entering the South Korean market. According to the research report, “South Korea Biosimilars Market Research Report, 2030” published by Actual Market Research, the South Korea Biosimilars market is projected to add USD 1.01 Billion from 2025 to 2030. South Korea implements a hierarchical legal structure comprising acts, regulations, and guidance to govern its laws. The Ministry of Food and Drug Safety oversees cellular therapies regulation primarily through the Pharmaceutical Affairs Act (PAA), categorizing cellular therapy products as biological products. Within the PAA framework, regulations and guidelines provide detailed oversight for biologic products, including seven regulations and eight guidelines. Key regulations granting marketing authorization for biological products include those governing the review and authorization of biological products and the investigation of new drug applications for medicinal products. The Biosimilar industry in Korea is a rapidly growing sector that has shown significant progress in recent years. Biosimilars are biological products that are highly similar to already approved biologic drugs and are designed to provide cost-effective alternatives for patients. Initiatives such as the Osong Life Science Complex exemplify this commitment, providing a collaborative space for companies, universities, and research institutes to engage in comprehensive biopharmaceutical processes, from R&D to manufacturing and sales. This integrated approach facilitates streamlined development and accelerates time-to-market for biosimilar products. The global demand for affordable biologic therapies has further propelled South Korea's biosimilars industry. With the expiration of patents for major biologics, there is an increasing opportunity for biosimilars to enter the market, offering cost-effective alternatives for patients worldwide. South Korean manufacturers are well-positioned to meet this demand, given their advanced manufacturing facilities and adherence to international quality standards.

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South Korea's biosimilars industry is experiencing significant growth across several key cities, each contributing uniquely to the sector's expansion. Incheon, particularly the Songdo International Business District, has become a central hub for biopharmaceutical manufacturing, housing major players like Samsung Biologics and Celltrion. These companies have established large-scale facilities, leveraging advanced infrastructure and proximity to Incheon International Airport to streamline global distribution. Daejeon, known for its research and development prowess, hosts the Daedeok Innopolis, a science park that fosters innovation through a concentration of research institutes and biotech firms. This environment supports the development of cutting-edge biosimilar technologies. Cheongju's Osong Life Science Complex serves as a comprehensive center for biopharmaceutical activities, integrating research, manufacturing, and regulatory functions. The complex's collaborative ecosystem accelerates the biosimilar development process. Additionally, Pangyo Techno Valley in Seongnam has emerged as a biotech innovation cluster, attracting startups and established companies focused on biosimilar research and development. These cities collectively underscore South Korea's strategic approach to nurturing its biosimilars industry through regional specialization and infrastructure investment. Erythropoietin (EPO) biosimilars are experiencing significant growth in South Korea's biosimilars industry, driven by a combination of demographic trends, healthcare needs, and strategic governmental support. The increasing prevalence of chronic kidney disease (CKD) and chemotherapy-induced anemia, particularly among the aging population, has heightened the demand for effective and affordable treatments like EPO biosimilars. These biosimilars offer a cost-effective alternative to original biologics, making them accessible to a broader patient base and alleviating financial pressures on the healthcare system. The South Korean government's proactive stance, including the introduction of a regulatory pathway for biosimilars in 2009 and substantial financial investments, has fostered a conducive environment for biosimilar development and commercialization. This support has enabled domestic pharmaceutical companies to advance in the biosimilars market, with EPO biosimilars emerging as a significant revenue generator between 2013 and 2016. Furthermore, the global trend towards cost containment in healthcare has amplified the appeal of biosimilars, positioning South Korea as a competitive player in the international biosimilars arena. Collectively, these factors underscore the robust growth trajectory of EPO biosimilars in South Korea, reflecting the nation's commitment to innovation and healthcare accessibility. The growth of biosimilars targeting chronic and autoimmune disorders in South Korea is propelled by a confluence of demographic trends, healthcare demands, and strategic industry initiatives. The nation's aging population and the rising prevalence of conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel diseases have amplified the need for cost-effective biologic therapies. Biosimilars offer a more affordable alternative to original biologics, enhancing patient access and alleviating financial pressures on the healthcare system. South Korean biopharmaceutical companies, notably Celltrion and Samsung Bioepis, have capitalized on this demand by developing and commercializing biosimilars for key autoimmune treatments. For instance, Celltrion's Remsima, a biosimilar of infliximab, has achieved significant market penetration both domestically and internationally . The government's proactive support, including regulatory frameworks and financial incentives, has further facilitated the rapid development and approval of these biosimilars. Additionally, South Korea's robust clinical trial infrastructure and commitment to innovation have positioned it as a leader in biosimilar research and development, ensuring the continued growth of treatments for chronic and autoimmune disorders.

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Nikita Jabrela

Business Development Manager

The expansion of contract research and manufacturing services (CRAMS) within South Korea's biosimilars industry is driven by the country's advanced infrastructure, skilled workforce, and strategic governmental support. South Korea has established itself as a global hub for biopharmaceutical manufacturing, with facilities like the Osong Life Science Complex providing integrated services from research and development to production . Major players such as Samsung Biologics have significantly contributed to this growth, offering comprehensive contract development and manufacturing services to both domestic and international clients . The government's initiatives, including tax incentives and funding programs, have attracted substantial foreign investment and encouraged the establishment of state-of-the-art manufacturing facilities. Furthermore, South Korea's adherence to international quality standards and its strategic location in Asia make it an attractive destination for global pharmaceutical companies seeking reliable CRAMS partners. This combination of factors has solidified South Korea's position as a leading provider of contract research and manufacturing services in the biosimilars sector. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

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By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.