As per MRFR analysis, the South Korea Biosimilar Contract Manufacturing Market Size was estimated at 130.03 (USD Million) in 2023. The South Korea Biosimilar Contract Manufacturing Market Industry is expected to grow from 154.6(USD Million) in 2024 to 1,097.6 (USD Million) by 2035. The South Korea Biosimilar Contract Manufacturing Market CAGR (growth rate) is expected to be around 19.505% during the forecast period (2025 - 2035).
The South Korea Biosimilar Contract Manufacturing Market is currently experiencing significant market trends that are being driven by the increasing emphasis on affordable treatment options and the growth in healthcare expenditures. The South Korean government has been supportive of biosimilars through a variety of initiatives, with the objective of enhancing access to biologic therapies.
Pharmaceutical companies are being incentivized to invest in biosimilar development and contract manufacturing capabilities within the country as a result of the favorable regulatory environment. Furthermore, the expansion of biopharmaceutical manufacturing facilities is a substantial trend, as companies strive to improve their production capacity and efficiency in order to satisfy the increasing global demand.
As an increasing number of global pharmaceutical companies seek local partners for contract manufacturing services, opportunities in the South Korean biosimilar market are arising. The country's state-of-the-art technologies, skilled workforce, and advanced biomanufacturing infrastructure make a compelling argument for attracting foreign investment. Additionally, the growing partnership between international corporations and local biopharmaceutical companies is facilitating the development of innovative production processes and biosimilars.
Recently, there has been a discernible trend in South Korea towards the acceleration of biosimilar research and development through collaboration between academia and the biopharmaceutical industry. It is anticipated that this trend will facilitate the commercialization of novel biosimilar products. Moreover, the demand for biosimilars, which are less expensive than biologic medications, is expected to increase as healthcare providers and patients become more cognizant of their advantages. In general, the South Korean Biosimilar Contract Manufacturing Market is experiencing growth, which is being driven by a robust manufacturing sector, supportive policies, and a growing number of collaborations that are designed to advance the biosimilar landscape.
Source: Primary Research, Secondary Research, MRFR Database, and Analyst Review
The South Korea Biosimilar Contract Manufacturing Market is experiencing significant growth driven by the increasing demand for biologics. According to the South Korean Ministry of Health and Welfare, the annual expenditure on biologics reached approximately 3.3 trillion KRW in recent years, with projections indicating a continual increase as the population ages and chronic diseases rise.
Major pharmaceutical companies, like Samsung Bioepis and Celltrion, have been proactively expanding their production capabilities to meet this growing demand. This trend is supported by a government initiative to increase the production of domestically developed biopharmaceuticals, creating a conducive environment for biosimilar production and contract manufacturing.
The South Korea Biosimilar Contract Manufacturing Market is heavily influenced by the supportive regulatory landscape that encourages biosimilar development. The Ministry of Food and Drug Safety in South Korea has established clear guidelines and fast-track processes for biosimilars, facilitating quicker market entry for these products.
As an example, the number of approved biosimilars in the country surged to over 30 in recent years, reflecting the robust pathways established for biosimilar approval and regulatory compliance. This acceleration in approval rates not only enhances the operational landscape for contract manufacturers but also fosters a competitive market conducive to growth.
The prevalence of chronic diseases in South Korea is a pivotal driver for the growth of the Biosimilar Contract Manufacturing Market Industry. Statistics from the Korea Centers for Disease Control and Prevention reveal that the rates of conditions such as diabetes and cardiovascular diseases have increased significantly, leading to a larger population requiring biologic treatments.
Furthermore, the World Health Organization estimates a projected 20% increase in the number of patients suffering from chronic diseases in South Korea over the next decade. This growing health burden necessitates cost-effective treatment options, positioning biosimilars as crucial alternatives, thereby enhancing the demand for contract manufacturing services within the region.
The South Korea Biosimilar Contract Manufacturing Market is characterized by a well-defined product segmentation, prominently featuring Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins. Recombinant Non-glycosylated Proteins serve as a critical component due to their role in several therapeutic applications, often offering a more streamlined production process and decreased costs for manufacturers.
This segment is gaining traction as companies aim to create cost-effective solutions, contributing to the overall efficiency in biopharmaceutical development. Furthermore, Recombinant Glycosylated Proteins hold significant importance as they closely mimic natural proteins, proving essential in developing complex biologics that require specific glycosylation patterns for functionality and efficacy.
The strategic position of South Korea as a hub for biomanufacturing enhances the capabilities of these subcategories, driven by a robust Research and Development infrastructure supported by governmental incentives aimed at fostering innovation. The country’s focus on enhancing manufacturing technologies positions it favorably for growth in the biosimilar sector, particularly in producing high-quality biologics that meet international standards.
Market dynamics reveal a growing demand for biosimilars as healthcare costs continue to rise globally, with South Korea emerging as a leader due to its advanced manufacturing capabilities and a supportive regulatory environment that encourages biosimilar production. Moreover, both segments are witnessing an increase in investment and partnerships that facilitate technological advancements, thereby enhancing their contributions to the South Korea Biosimilar Contract Manufacturing Market.
The market is also propelled by factors such as an aging population, increased prevalence of chronic diseases, and a proactive healthcare policy that emphasizes accessibility and affordability of biologic therapies. As these segments continue to evolve, they promise to play a vital role in the overall expansion of the biosimilar landscape in South Korea, catering to both domestic and international demands and significantly influencing the country's economic growth in the healthcare sector.
Source: Primary Research, Secondary Research, MRFR Database, and Analyst Review
The Production Technology segment of the South Korea Biosimilar Contract Manufacturing Market showcases significant innovation and expansion. In South Korea, this market has seen a robust evolution, driven by advancements in biotechnology and a growing demand for cost-effective biosimilars. The country’s strong emphasis on Research and Development has propelled the growth of the mammalian production systems, which are crucial for producing complex biologics such as monoclonal antibodies.
The demand for high-quality, reliable biosimilars ensures that mammalian systems maintain a prominent position in the market. Meanwhile, non-mammalian production technologies, such as those utilizing microorganisms or plant systems, are gaining traction, offering scalability and efficiency for various applications.
This diversification in production methodologies not only enhances the supply chain resilience but also responds to the increasing global competition in the biopharmaceutical sector. As regulatory frameworks evolve, South Korea's proactive approach to biosimilar development positions it as a key player on the global stage, ensuring the Production Technology segment remains integral to the overall market progression. The continuous advancements in biotechnology signify substantial opportunities for optimization within both mammalian and non-mammalian production technologies, leading to improved productivity and reduced time-to-market for biosimilars.
The South Korea Biosimilar Contract Manufacturing Market, particularly in the Application segment, exhibits significant potential and is driven by diverse therapeutic areas, including Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, and Rheumatoid Arthritis, among others. Oncology remains a crucial focus due to the high prevalence of cancer and the demand for cost-effective biologics to improve patient outcomes.
Blood Disorders, such as hemophilia, constitute a vital segment, presenting strong opportunities for biosimilars designed to manage chronic conditions. Growth Hormonal Deficiency applications cater to pediatric and adult populations, highlighting the importance of biosimilars in promoting metabolic health.
Chronic and Autoimmune Disorders form a considerable part of the clinical landscape, requiring ongoing management through biologic therapies. The Rheumatoid Arthritis segment is particularly noteworthy, reflecting the growing number of patients requiring long-term treatment plans. The South Korean government supports biosimilar development through favorable regulations aimed at accelerating market entry, enhancing the competitive edge of local manufacturers.
As a result, the Application segment within the South Korea Biosimilar Contract Manufacturing Market displays robust growth potential, driven by an aging population, increasing healthcare expenditures, and a rising preference for biosimilars due to their affordability compared to originator biologics.
The South Korea Biosimilar Contract Manufacturing Market has become a dynamic and competitive landscape characterized by rapid advancements in biotechnology and an increasing demand for cost-effective therapeutic alternatives. As the global focus shifts towards biosimilars due to their potential to enhance patient access to biologic therapies, South Korea has positioned itself as a leader in the biosimilar industry.
The convergence of government support, strong research and development capabilities, and a robust regulatory framework has facilitated a conducive environment for both established firms and new entrants. The competitive landscape is marked by a blend of local companies, which leverage technological expertise and innovation, as well as multinational corporations seeking to capitalize on the region’s strategic advantages.
Severance Hospital has a notable presence in the South Korea Biosimilar Contract Manufacturing Market, thus strengthening the local healthcare infrastructure. The facility is recognized for its integration of cutting-edge research and clinical practices, which contributes significantly to the development and manufacturing of biosimilars.
Its strengths lie in its comprehensive approach to patient care and the establishment of collaborations with various research entities, driving innovation in treatment modalities. The hospital’s commitment to advancing biopharmaceutical sciences is complemented by access to world-class expertise in therapeutics, clinical trials, and regulatory affairs, thereby facilitating moldable pathways for biosimilar product development and effective market navigation.
Celltrion stands out as a pivotal player in the South Korea Biosimilar Contract Manufacturing Market, enjoying a favorable reputation for its high-quality biosimilars and a wide array of offerings. The company specializes in the production of monoclonal antibodies and has successfully launched several biosimilar products in both domestic and international markets.
Key strengths include its state-of-the-art manufacturing facilities, which utilize advanced technologies that meet stringent regulatory standards. Celltrion has also engaged in strategic mergers and acquisitions to expand its operational capabilities and market reach, fortifying its competitive advantage. By establishing partnerships with various stakeholders, Celltrion demonstrates its commitment to innovation and sets a benchmark for quality in biosimilar manufacturing, solidifying its standing within the South Korean market.
Recent developments in the South Korea Biosimilar Contract Manufacturing Market have been significant, showcasing the country's prowess in biotechnology. Samsung BioLogics has been actively expanding its contract manufacturing capabilities, aiming to meet the increasing global demand for biosimilars.
In October 2023, Celltrion announced a collaboration with a prominent European pharmaceutical company to enhance its biosimilar portfolio, reinforcing its position in the competitive landscape. Severance Hospital and the Korean Cancer Center Hospital have been integral in advancing clinical trials for biosimilars, ensuring regulatory compliance and safety.
The market has seen a substantial growth in valuation, driven by innovations from Hanmi Pharmaceutical and Alteogen, who are investing heavily in Research and Development to optimize their offerings. Furthermore, Yuhan Corporation and SK Holdings are positioning themselves strategically through partnerships and technology sharing.
In July 2022, LG Chem announced a merger with Ilyang Pharmaceutical to enhance production efficiencies and broaden its reach in biosimilar manufacturing. This collaborative environment is fostering a robust ecosystem that propels South Korea as a global leader in biomanufacturing and biosimilars, positioning companies like Medytox and DaeWoong Pharmaceutical favorably in the expanding market.
| Report Attribute/Metric Source: | Details |
| MARKET SIZE 2018 | 130.03(USD Million) |
| MARKET SIZE 2024 | 154.6(USD Million) |
| MARKET SIZE 2035 | 1097.6(USD Million) |
| COMPOUND ANNUAL GROWTH RATE (CAGR) | 19.505% (2025 - 2035) |
| REPORT COVERAGE | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| BASE YEAR | 2024 |
| MARKET FORECAST PERIOD | 2025 - 2035 |
| HISTORICAL DATA | 2019 - 2024 |
| MARKET FORECAST UNITS | USD Million |
| KEY COMPANIES PROFILED | Severance Hospital, Celltrion, Chugai Pharmaceutical, Hanmi Pharmaceutical, Korean Cancer Center Hospital, Alteogen, Yuhan Corporation, Samsung BioLogics, LG Chem, SK Holdings, Medytox, DaeWoong Pharmaceutical, Posco International, Ilyang Pharmaceutical, Green Cross |
| SEGMENTS COVERED | Product, Production Technology, Application |
| KEY MARKET OPPORTUNITIES | Increasing demand for affordable biologics, Growing regulatory support for biosimilars, Expansion of collaborative partnerships, Advancements in biomanufacturing technologies, Rising prevalence of chronic diseases |
| KEY MARKET DYNAMICS | increasing healthcare expenditure, growing aging population, rising prevalence of chronic diseases, favorable regulatory environment, expanding biopharmaceutical industry |
| COUNTRIES COVERED | South Korea |
Frequently Asked Questions (FAQ) :
The anticipated market value of the South Korea Biosimilar Contract Manufacturing Market in 2024 is expected to be 154.6 million USD.
The market is projected to grow to 1,097.6 million USD by 2035, reflecting a compound annual growth rate (CAGR) of approximately 19.505% from 2025 to 2035.
By 2035, the market value for Recombinant Non-glycosylated Proteins is expected to reach 435.0 million USD.
The market size for Recombinant Glycosylated Proteins in 2035 is anticipated to be 662.6 million USD.
Major players in the market include Severance Hospital, Celltrion, Chugai Pharmaceutical, and Samsung BioLogics among others.
The market faces challenges such as regulatory hurdles and the need for extensive clinical trials before biosimilars can gain market approval.
Opportunities exist due to rising healthcare costs, increased acceptance of biosimilars, and ongoing advancements in biopharmaceutical technologies.
Key growth drivers include a rising prevalence of chronic diseases and the increasing demand for affordable treatment options.
South Korea is considered one of the leading markets in Asia for biosimilar contract manufacturing due to strong innovation and investment in biotechnology.
Global market trends towards personalized medicine and the adaption of advanced biomanufacturing technologies significantly influence the growth potential of the South Korean market.
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