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    South Korea Biosimilar Contract Manufacturing Market

    ID: MRFR/MED/50108-HCR
    200 Pages
    Garvit Vyas
    October 2025

    South Korea Biosimilar Contract Manufacturing Market Research Report By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Production Technology (Mammalian, Non-Mammalian) and By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic & Autoimmune Disorders, Rheumatoid Arthritis, Others)- Forecast to 2035

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    South Korea Biosimilar Contract Manufacturing Market Infographic
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    South Korea Biosimilar Contract Manufacturing Market Summary

    As per MRFR analysis, the South Korea biosimilar contract-manufacturing market size was estimated at 115.93 $ Million in 2024. The South Korea biosimilar contract-manufacturing market is projected to grow from 137.84 $ Million in 2025 to 778.53 $ Million by 2035, exhibiting a compound annual growth rate (CAGR) of 18.9% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The South Korea biosimilar contract-manufacturing market is poised for growth driven by innovation and demand for affordable therapies.

    • Regulatory support and innovation are fostering a conducive environment for biosimilar development.
    • The largest segment in this market is monoclonal antibodies, while the fastest-growing segment is insulin biosimilars.
    • Collaborative partnerships among manufacturers and research institutions are becoming increasingly prevalent.
    • Key market drivers include rising healthcare expenditure and advancements in manufacturing technologies.

    Market Size & Forecast

    2024 Market Size 115.93 (USD Million)
    2035 Market Size 778.53 (USD Million)

    Major Players

    Samsung Biologics (KR), Lonza Group (CH), Boehringer Ingelheim (DE), Fujifilm Diosynth Biotechnologies (JP), Wuxi Biologics (CN), Roche (CH), Amgen (US), Sandoz (CH)

    South Korea Biosimilar Contract Manufacturing Market Trends

    The biosimilar contract-manufacturing market is experiencing notable growth, driven by increasing demand for cost-effective alternatives to expensive biologics. South Korea, with its advanced biopharmaceutical infrastructure, is well-positioned to capitalize on this trend. The country boasts a robust regulatory framework that supports the development and approval of biosimilars, which enhances the attractiveness of its manufacturing capabilities. Furthermore, the presence of numerous biopharmaceutical companies and research institutions fosters innovation and collaboration, potentially leading to the development of high-quality biosimilars. As the market evolves, partnerships between local manufacturers and international firms are likely to strengthen, facilitating knowledge transfer and technological advancements. In addition, the rising prevalence of chronic diseases and the aging population in South Korea contribute to the increasing need for biosimilars. The government’s initiatives to promote biosimilar adoption, including financial incentives and educational programs, further support market expansion. As stakeholders recognize the potential of biosimilars to improve patient access to essential therapies, the biosimilar contract-manufacturing market is anticipated to experience significant growth. Overall, the combination of a supportive regulatory environment, strong industry collaboration, and growing healthcare needs positions South Korea as a key player in the biosimilar contract-manufacturing landscape.

    Regulatory Support and Innovation

    The regulatory environment in South Korea is conducive to the growth of the biosimilar contract-manufacturing market. The government has established clear guidelines for the approval of biosimilars, which encourages manufacturers to invest in research and development. This regulatory clarity, combined with a focus on innovation, allows local companies to enhance their manufacturing processes and produce high-quality biosimilars.

    Rising Demand for Cost-Effective Therapies

    There is a growing demand for cost-effective therapies in South Korea, driven by the increasing prevalence of chronic diseases. As healthcare costs continue to rise, biosimilars offer a viable solution for patients and healthcare providers. This trend is likely to propel the biosimilar contract-manufacturing market, as more stakeholders seek affordable alternatives to traditional biologics.

    Collaborative Partnerships

    Collaborative partnerships between local manufacturers and international firms are becoming more prevalent in the biosimilar contract-manufacturing market. These alliances facilitate knowledge sharing and technological advancements, enabling South Korean companies to enhance their production capabilities. Such collaborations may also lead to the development of innovative biosimilars that meet the evolving needs of the healthcare sector.

    South Korea Biosimilar Contract Manufacturing Market Drivers

    Increasing Healthcare Expenditure

    The rising healthcare expenditure in South Korea is a pivotal driver for the biosimilar contract-manufacturing market. As the government allocates more funds towards healthcare, the demand for affordable treatment options intensifies. In 2025, healthcare spending is projected to reach approximately $200 billion, reflecting a growth rate of around 5% annually. This increase in expenditure is likely to encourage healthcare providers to adopt biosimilars, which are generally more cost-effective than their reference biologics. Consequently, contract manufacturers are positioned to benefit from this trend, as they can offer tailored solutions to meet the growing demand for biosimilars. Thus, the biosimilar contract-manufacturing market is expected to expand. This growth is driven by the need for efficient production capabilities that align with the increasing healthcare budget.

    Regulatory Framework Enhancements

    Enhancements in the regulatory framework surrounding biosimilars in South Korea are fostering growth in the biosimilar contract-manufacturing market. The government has implemented streamlined approval processes and guidelines that facilitate the entry of biosimilars into the market. These regulatory improvements are designed to ensure safety and efficacy while expediting the availability of biosimilars to patients. As a result, the number of approved biosimilars has increased, leading to a more competitive market landscape. This regulatory support is likely to encourage contract manufacturers to invest in biosimilar production, as they can navigate the approval process more efficiently. The biosimilar contract-manufacturing market is thus benefiting from a more favorable regulatory environment that promotes innovation and accessibility.

    Aging Population and Chronic Diseases

    The aging population in South Korea is a critical driver for the biosimilar contract-manufacturing market. With a significant portion of the population over 65 years old, the prevalence of chronic diseases such as diabetes and cancer is on the rise. This demographic shift is expected to increase the demand for biologic therapies, including biosimilars, which are often more affordable alternatives. By 2025, it is estimated that nearly 20% of the population will be aged 65 and older, further amplifying the need for cost-effective treatment options. As healthcare providers seek to manage the growing burden of chronic diseases, the biosimilar contract-manufacturing market is poised for expansion, driven by the need for scalable production of these essential therapies.

    Growing Focus on Personalized Medicine

    The growing focus on personalized medicine in South Korea is emerging as a significant driver for the biosimilar contract-manufacturing market. As healthcare shifts towards tailored therapies that cater to individual patient needs, the demand for biosimilars that can be customized is likely to increase. This trend is supported by advancements in genomics and biotechnology, which enable the development of more targeted treatments. The biosimilar contract-manufacturing market is expected to adapt to this shift by offering flexible manufacturing solutions that accommodate the production of personalized biosimilars. As healthcare providers seek to enhance patient outcomes through personalized approaches, the demand for contract manufacturing services in the biosimilar sector is anticipated to grow.

    Technological Advancements in Manufacturing

    Technological advancements in biomanufacturing processes are significantly influencing the biosimilar contract-manufacturing market. Innovations such as single-use technologies and continuous manufacturing are enhancing production efficiency and reducing costs. In South Korea, the adoption of these technologies is becoming more prevalent, with a reported increase in productivity by up to 30% in some facilities. This shift not only streamlines operations but also allows for quicker responses to market demands. As manufacturers leverage these advancements, they can produce high-quality biosimilars at a lower cost, making them more accessible to healthcare providers. Thus, the biosimilar contract-manufacturing market is likely to grow as companies invest in cutting-edge technologies to enhance their production capabilities.

    Market Segment Insights

    Biosimilar Contract Manufacturing Market Product Insights

    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.

    Biosimilar Contract Manufacturing Market Production Technology Insights

    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.

    Biosimilar Contract Manufacturing Market Application Insights

    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.

    Get more detailed insights about South Korea Biosimilar Contract Manufacturing Market

    Key Players and Competitive Insights

    The biosimilar contract-manufacturing market in South Korea is characterized by a dynamic competitive landscape, driven by increasing demand for cost-effective biologics and the growing acceptance of biosimilars among healthcare providers. Major players such as Samsung Biologics (KR), Lonza Group (CH), and Boehringer Ingelheim (DE) are strategically positioned to leverage their extensive manufacturing capabilities and technological expertise. Samsung Biologics (KR) focuses on expanding its production capacity and enhancing its service offerings, while Lonza Group (CH) emphasizes innovation through advanced bioprocessing technologies. Boehringer Ingelheim (DE) is actively pursuing partnerships to strengthen its market presence, indicating a trend towards collaborative strategies that enhance operational efficiencies and market reach.

    Key business tactics within this market include localizing manufacturing to reduce costs and optimize supply chains. The competitive structure appears moderately fragmented, with several key players exerting influence over market dynamics. This fragmentation allows for a variety of strategic approaches, as companies seek to differentiate themselves through unique value propositions and operational efficiencies.

    In October 2025, Samsung Biologics (KR) announced the completion of its new state-of-the-art manufacturing facility, which is expected to increase its production capacity by 30%. This expansion is strategically significant as it positions the company to meet the rising global demand for biosimilars, thereby enhancing its competitive edge in the market. The facility is designed to incorporate advanced automation and digital technologies, aligning with industry trends towards efficiency and scalability.

    In September 2025, Lonza Group (CH) entered into a strategic partnership with a leading biopharmaceutical company to co-develop a new biosimilar product. This collaboration is indicative of Lonza's commitment to innovation and its strategy to enhance its product portfolio. By leveraging its partner's expertise in drug development, Lonza aims to accelerate the time-to-market for new biosimilars, which could significantly impact its market share and revenue growth.

    In August 2025, Boehringer Ingelheim (DE) launched a new initiative focused on sustainability in its manufacturing processes. This initiative aims to reduce carbon emissions by 25% over the next five years, reflecting a growing trend towards environmentally responsible practices in the industry. Such moves not only enhance corporate reputation but also align with the increasing regulatory pressures for sustainability in biopharmaceutical manufacturing.

    As of November 2025, current competitive trends in the biosimilar contract-manufacturing market include a strong emphasis on digitalization, sustainability, and the integration of artificial intelligence (AI) in manufacturing processes. Strategic alliances are increasingly shaping the landscape, as companies recognize the value of collaboration in driving innovation and efficiency. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, supply chain reliability, and innovative product offerings, suggesting a transformative shift in how companies position themselves in the market.

    Key Companies in the South Korea Biosimilar Contract Manufacturing Market market include

    Industry Developments

    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.

    Future Outlook

    South Korea Biosimilar Contract Manufacturing Market Future Outlook

    The biosimilar contract-manufacturing market is projected to grow at 18.9% CAGR from 2024 to 2035, driven by increasing demand for cost-effective biologics and regulatory support.

    New opportunities lie in:

    • Invest in advanced bioreactor technologies to enhance production efficiency.
    • Develop strategic partnerships with local biotech firms for market penetration.
    • Implement robust quality assurance systems to meet regulatory compliance and build trust.

    By 2035, the market is expected to achieve substantial growth, positioning itself as a leader in biopharmaceutical manufacturing.

    Market Segmentation

    South Korea Biosimilar Contract Manufacturing Market Product Outlook

    • Recombinant Non-glycosylated Proteins
    • Recombinant Glycosylated Proteins

    South Korea Biosimilar Contract Manufacturing Market Application Outlook

    • Oncology
    • Blood Disorders
    • Growth Hormonal Deficiency
    • Chronic & Autoimmune Disorders
    • Rheumatoid Arthritis
    • Others

    South Korea Biosimilar Contract Manufacturing Market Production Technology Outlook

    • Mammalian
    • Non-Mammalian

    Report Scope

    MARKET SIZE 2024115.93(USD Million)
    MARKET SIZE 2025137.84(USD Million)
    MARKET SIZE 2035778.53(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR)18.9% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Million
    Key Companies Profiled["Samsung Biologics (KR)", "Lonza Group (CH)", "Boehringer Ingelheim (DE)", "Fujifilm Diosynth Biotechnologies (JP)", "Wuxi Biologics (CN)", "Roche (CH)", "Amgen (US)", "Sandoz (CH)"]
    Segments CoveredProduct, Production Technology, Application
    Key Market OpportunitiesEmerging technologies in biomanufacturing enhance efficiency in the biosimilar contract-manufacturing market.
    Key Market DynamicsRising demand for biosimilars drives competitive contract-manufacturing partnerships amid evolving regulatory frameworks in South Korea.
    Countries CoveredSouth Korea

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    FAQs

    What is the anticipated market value of the South Korea Biosimilar Contract Manufacturing Market in 2024?

    The anticipated market value of the South Korea Biosimilar Contract Manufacturing Market in 2024 is expected to be 154.6 million USD.

    How fast is the South Korea Biosimilar Contract Manufacturing Market projected to grow by 2035?

    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.

    What is the market value for Recombinant Non-glycosylated Proteins in the South Korea Biosimilar Contract Manufacturing Market by 2035?

    By 2035, the market value for Recombinant Non-glycosylated Proteins is expected to reach 435.0 million USD.

    What will be the market size for Recombinant Glycosylated Proteins in 2035?

    The market size for Recombinant Glycosylated Proteins in 2035 is anticipated to be 662.6 million USD.

    Who are the key players in the South Korea Biosimilar Contract Manufacturing Market?

    Major players in the market include Severance Hospital, Celltrion, Chugai Pharmaceutical, and Samsung BioLogics among others.

    What challenges does the South Korea Biosimilar Contract Manufacturing Market face?

    The market faces challenges such as regulatory hurdles and the need for extensive clinical trials before biosimilars can gain market approval.

    What opportunities exist in the South Korea Biosimilar Contract Manufacturing Market?

    Opportunities exist due to rising healthcare costs, increased acceptance of biosimilars, and ongoing advancements in biopharmaceutical technologies.

    What are the expected growth drivers for the South Korea Biosimilar Contract Manufacturing Market?

    Key growth drivers include a rising prevalence of chronic diseases and the increasing demand for affordable treatment options.

    How does the South Korea Biosimilar Contract Manufacturing Market compare regionally?

    South Korea is considered one of the leading markets in Asia for biosimilar contract manufacturing due to strong innovation and investment in biotechnology.

    What are the impacts of global market trends on the South Korea Biosimilar Contract Manufacturing Market?

    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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