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South Korea Biosimilar Contract Manufacturing Market

ID: MRFR/MED/50108-HCR
200 Pages
Garvit Vyas
February 2026

South Korea Biosimilar Contract Manufacturing Market Research Report: Size, Share, Trend Analysis By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Production Technology (Mammalian, Non-Mammalian) and By Applications (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic & Autoimmune Disorders, Rheumatoid Arthritis, Others) - Growth Outlook & Industry Forecast 2025 To 2035

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South Korea Biosimilar Contract Manufacturing Market Summary

As per Market Research Future 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% 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)
CAGR (2025 - 2035) 18.9%

Major Players

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

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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

By Product: Recombinant Non-glycosylated Proteins (Largest) vs. Recombinant Glycosylated Proteins (Fastest-Growing)

In the South Korea biosimilar contract-manufacturing market, recombinant non-glycosylated proteins hold the largest market share, reflecting their established presence and adoption among consumers. These proteins are widely used in various therapeutic applications, giving them an edge in market demand. On the other hand, recombinant glycosylated proteins, although currently smaller in share, are rapidly gaining traction due to their enhanced efficacy and specificity, making them appealing for progressive biotechnology firms. Growth trends in this segment are buoyed by advancements in biomanufacturing technologies and increased investments in biosimilar development by key players. The demand for innovative therapies is leading to a surge in the development of recombinant glycosylated proteins, which are expected to witness the highest growth rates. Factors such as rising healthcare needs and supportive government policies for biosimilars are further propelling this market segment's expansion.

Recombinant Non-glycosylated Proteins (Dominant) vs. Recombinant Glycosylated Proteins (Emerging)

Recombinant non-glycosylated proteins are currently the dominant force in the South Korea biosimilar contract-manufacturing market, characterized by their reliable performance in therapeutic applications including hormones and enzymes. Their established manufacturing processes and regulatory approvals contribute to their widespread acceptance. In contrast, recombinant glycosylated proteins represent an emerging category, known for their uniquely advanced functionality in mimicking natural proteins, crucial in treating diseases with high specificity. The growing interest in personalized medicine and the drive for more complex biologics enhances the potential for recombinant glycosylated proteins, setting the stage for them to become significant players in the biosimilar landscape.

By Production Technology: Mammalian (Largest) vs. Non-Mammalian (Fastest-Growing)

In the South Korea biosimilar contract-manufacturing market, the production technology segment reveals a distinct division between mammalian and non-mammalian technologies. The mammalian segment holds the largest market share, favored for its ability to produce complex proteins that resemble human biology closely. This preference translates into a significant portion of the market, as biopharmaceutical companies increasingly rely on mammalian cells for high-quality biosimilar development. Conversely, non-mammalian technologies, while currently smaller in terms of market share, are recognized as the fastest-growing segment. The rise of these technologies aligns with innovations aimed at reducing production costs and time, making them attractive for companies focused on efficiency and scalability. As regulatory agencies continue to evolve, non-mammalian processes are expected to gain traction, driven by their potential to enhance production flexibility and throughput.

Production Technology: Mammalian (Dominant) vs. Non-Mammalian (Emerging)

Mammalian production technology dominates the South Korea biosimilar contract-manufacturing market, primarily due to its established processes and proven track record in producing high-quality therapeutic proteins. This dominance reflects the growing demand for complex biologics that require intricate post-translational modifications, which mammalian systems are well-equipped to handle. On the other hand, non-mammalian technology is emerging rapidly, characterized by its promise of lower production costs and faster turnaround times. As these technologies continue to mature, they are expected to carve out their niche in the market, appealing to cost-sensitive manufacturers and those looking to innovate their production pipelines. This dynamic between dominant and emerging technologies highlights the competitive landscape in the market.

By Application: Oncology (Largest) vs. Chronic & Autoimmune Disorders (Fastest-Growing)

In the South Korea biosimilar contract-manufacturing market, the application segment is diverse, with oncology representing the largest share of the market. This segment showcases strong demand driven by the increasing incidence of cancer and the need for effective treatments. Blood disorders and growth hormonal deficiency also hold notable shares, while chronic & autoimmune disorders, rheumatoid arthritis, and others follow closely behind in terms of market presence. Growth trends indicate a significant shift towards chronic & autoimmune disorders, positioning it as the fastest-growing application. This rise is attributed to the increasing prevalence of autoimmune diseases and advancements in biosimilar technologies. Additionally, the health policies in South Korea favoring cheaper treatment options support the expansion of biosimilars in various therapeutic areas, enabling greater access to effective therapies.

Oncology (Dominant) vs. Chronic & Autoimmune Disorders (Emerging)

Oncology remains the dominant application in the South Korea biosimilar contract-manufacturing market, characterized by a high volume of biosimilar products aimed at treating various types of cancers. The oncology segment benefits from robust support in research and development, with continuous innovations leading to new therapeutic options. Conversely, chronic & autoimmune disorders are emerging rapidly, demonstrating a growing market interest due to the rising cases of conditions such as rheumatoid arthritis and other autoimmune diseases. The diverse therapeutic needs and a push for cost-effective alternatives make this segment highly appealing for biosimilar manufacturers, indicating a proactive shift in market dynamics.

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 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 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 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 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 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 2025 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 2024 115.93(USD Million)
MARKET SIZE 2025 137.84(USD Million)
MARKET SIZE 2035 778.53(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 18.9% (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 Samsung Biologics (KR), Lonza Group (CH), Boehringer Ingelheim (DE), Fujifilm Diosynth Biotechnologies (JP), Wuxi Biologics (CN), Roche (CH), Amgen (US), Sandoz (CH)
Segments Covered Product, Production Technology, Application
Key Market Opportunities Emerging technologies in biomanufacturing enhance efficiency in the biosimilar contract-manufacturing market.
Key Market Dynamics Rising demand for biosimilars drives competitive contract-manufacturing partnerships amid evolving regulatory frameworks in South Korea.
Countries Covered South 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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