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    Japan Biosimilar Contract Manufacturing Market

    ID: MRFR/Pharma/50110-HCR
    200 Pages
    Garvit Vyas
    October 2025

    Japan 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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    Japan Biosimilar Contract Manufacturing Market Infographic
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    Japan Biosimilar Contract Manufacturing Market Summary

    As per MRFR analysis, the Japan biosimilar contract-manufacturing market size was estimated at 174.0 USD Million in 2024. The Japan biosimilar contract-manufacturing market is projected to grow from 206.87 USD Million in 2025 to 1167.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 18.89% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Japan biosimilar contract-manufacturing market is poised for substantial growth driven by various factors.

    • The market is witnessing a rising demand for cost-effective therapies, particularly in the oncology and autoimmune disease segments.
    • Technological advancements in manufacturing processes are enhancing production efficiency and product quality.
    • Collaborative partnerships in development are becoming increasingly prevalent, fostering innovation and market entry.
    • Key market drivers include increasing healthcare expenditure and regulatory support for biosimilars, which are likely to propel market growth.

    Market Size & Forecast

    2024 Market Size 174.0 (USD Million)
    2035 Market Size 1167.0 (USD Million)

    Major Players

    Samsung Biologics (KR), Lonza Group (CH), Boehringer Ingelheim (DE), Fujifilm Diosynth Biotechnologies (JP), WuXi AppTec (CN), Catalent (US), Rentschler Biopharma (DE), KBI Biopharma (US), Amgen (US)

    Japan Biosimilar Contract Manufacturing Market Trends

    The biosimilar contract-manufacturing market in Japan is experiencing notable growth, driven by increasing demand for cost-effective alternatives to expensive biologics. The Japanese government has implemented supportive policies to encourage the development and production of biosimilars, which has led to a more favorable environment for contract manufacturers. This trend is further bolstered by the rising prevalence of chronic diseases, necessitating a greater supply of biologic therapies. As a result, contract manufacturers are expanding their capabilities to meet the evolving needs of pharmaceutical companies, which are seeking reliable partners to navigate the complexities of biosimilar production. Moreover, the competitive landscape of the biosimilar contract-manufacturing market is evolving, with both domestic and international players vying for market share. Japanese firms are increasingly investing in advanced technologies and facilities to enhance their production processes. Collaborations between pharmaceutical companies and contract manufacturers are becoming more common, as they seek to leverage each other's strengths. This synergy is likely to foster innovation and improve the overall efficiency of biosimilar production, positioning Japan as a key player in the biosimilar landscape. The future of this market appears promising, with continued advancements in manufacturing techniques and regulatory support paving the way for sustained growth.

    Rising Demand for Cost-Effective Therapies

    The biosimilar contract-manufacturing market is witnessing a surge in demand for affordable treatment options. As healthcare costs continue to rise, stakeholders are increasingly turning to biosimilars as a viable alternative to traditional biologics. This trend is particularly pronounced in Japan, where the government is actively promoting the use of biosimilars to alleviate financial pressures on the healthcare system.

    Technological Advancements in Manufacturing

    Innovations in manufacturing technologies are playing a crucial role in shaping the biosimilar contract-manufacturing market. Japanese companies are adopting cutting-edge techniques to enhance production efficiency and ensure product quality. These advancements not only streamline processes but also reduce time-to-market for new biosimilars, thereby benefiting both manufacturers and healthcare providers.

    Collaborative Partnerships in Development

    The trend of forming strategic partnerships between pharmaceutical companies and contract manufacturers is gaining traction. In Japan, such collaborations are essential for navigating the complexities of biosimilar development. By pooling resources and expertise, these partnerships facilitate faster and more efficient production, ultimately leading to a more robust biosimilar market.

    Japan Biosimilar Contract Manufacturing Market Drivers

    Focus on Personalized Medicine

    The shift towards personalized medicine in Japan is emerging as a notable driver for the biosimilar contract-manufacturing market. As healthcare providers increasingly recognize the importance of tailoring treatments to individual patient needs, the demand for biosimilars that can be customized is likely to rise. In 2025, the market for personalized medicine is projected to grow by approximately 10%, reflecting a broader trend towards individualized therapies. This shift encourages contract manufacturers to develop flexible production processes that can accommodate varying specifications for biosimilars. The biosimilar contract-manufacturing market is thus expected to expand as manufacturers adapt to the evolving landscape of personalized medicine, providing innovative solutions that align with the needs of healthcare providers and patients alike.

    Increasing Healthcare Expenditure

    The rising healthcare expenditure in Japan 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, Japan's healthcare spending is projected to reach approximately $500 billion, reflecting a growth rate of around 3% annually. This increase in expenditure is likely to encourage healthcare providers to seek cost-effective alternatives, such as biosimilars, which can significantly reduce treatment costs. Consequently, contract manufacturers are positioned to capitalize on this trend by offering tailored solutions that meet the evolving needs of healthcare providers. The biosimilar contract-manufacturing market is thus expected to expand as stakeholders recognize the potential for biosimilars to alleviate financial pressures while maintaining high-quality standards.

    Regulatory Support for Biosimilars

    Japan's regulatory environment is increasingly supportive of biosimilars, which serves as a crucial driver for the biosimilar contract-manufacturing market. The Pharmaceuticals and Medical Devices Agency (PMDA) has streamlined the approval process for biosimilars, enhancing the market's attractiveness for manufacturers. In 2025, the PMDA is anticipated to approve several new biosimilars, further encouraging investment in contract manufacturing. This regulatory support not only fosters innovation but also instills confidence among stakeholders regarding the safety and efficacy of biosimilars. As a result, contract manufacturers are likely to experience heightened demand for their services, as pharmaceutical companies seek to navigate the regulatory landscape effectively. The biosimilar contract-manufacturing market is thus poised for growth, driven by favorable policies that promote the development and commercialization of biosimilars.

    Aging Population and Chronic Diseases

    Japan's aging population is a significant driver for the biosimilar contract-manufacturing market. With over 28% of the population aged 65 and older, the prevalence of chronic diseases is on the rise, necessitating effective and affordable treatment options. The demand for biologics, which are often expensive, is expected to increase as the population ages. Biosimilars present a viable solution to this challenge, offering similar therapeutic benefits at reduced costs. In 2025, it is estimated that the market for biosimilars in Japan could reach $1 billion, driven by the need for cost-effective therapies for chronic conditions. Consequently, contract manufacturers are likely to play a vital role in meeting this demand, as pharmaceutical companies look to leverage biosimilars to address the healthcare needs of an aging demographic. The biosimilar contract-manufacturing market is thus positioned for substantial growth.

    Rising Competition Among Biopharmaceutical Companies

    The competitive landscape among biopharmaceutical companies in Japan is intensifying, which serves as a key driver for the biosimilar contract-manufacturing market. As more companies enter the biosimilar space, the need for efficient and cost-effective manufacturing solutions becomes paramount. In 2025, the number of biosimilar products in development is expected to increase significantly, leading to heightened competition. This scenario compels companies to seek contract manufacturing partners that can provide high-quality production capabilities at competitive prices. The biosimilar contract-manufacturing market is likely to benefit from this trend, as manufacturers strive to differentiate themselves through innovation and operational efficiency. As competition escalates, the demand for specialized contract manufacturing services is expected to grow, further propelling the market forward.

    Market Segment Insights

    Biosimilar Contract Manufacturing Market Product Insights

    In the Japan Biosimilar Contract Manufacturing Market, the Product segment demonstrates significant potential, particularly in the realms of Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins. This market segment has gained traction owing to the rising prevalence of chronic diseases and the subsequent demand for cost-effective biologic therapies.

    The Recombinant Non-glycosylated Proteins are noted for their essential role in various therapeutic applications, making them a critical component in the drug development lifecycle.

    Their manufacturing process is relatively simpler, which often leads to lower production costs and quicker market entry, aligning with the increasing need for rapid patient access to effective treatments.

    On the other hand, Recombinant Glycosylated Proteins hold significant importance due to their complex structures and biological functions. These proteins often exhibit higher efficacy and bioactivity, which is crucial in therapeutic applications such as monoclonal antibodies, hormone therapies, and various enzyme replacements.

    As the Japanese regulatory framework continues to evolve, manufacturers are encouraged to invest in advanced technologies to enhance production capabilities for both types of proteins. The Japanese government prioritizes biopharmaceutical innovations, offering support for Research and Development, which further drives growth in this segment.

    Biosimilar Contract Manufacturing Market Production Technology Insights

    The Japan Biosimilar Contract Manufacturing Market showcases significant growth potential within the Production Technology segment, reflecting a strategic shift towards cost-effective and efficient biopharmaceutical production. This segment is broadly categorized into Mammalian and Non-Mammalian technologies, each holding distinct advantages in the manufacturing of biosimilars.

    Mammalian systems, widely adopted for their ability to produce complex glycoproteins, dominate due to their higher fidelity in post-translational modifications, which are crucial for therapeutic efficacy.

    On the other hand, Non-Mammalian systems, including microbial platforms, are gaining traction for their rapid production cycles and lower operational costs, appealing to organizations seeking to augment their production capabilities.

    The increasing prevalence of chronic diseases in Japan, paired with the government's supportive regulatory framework for biosimilars, acts as a catalyst for the market's expansion. Furthermore, the strategic investments in Research and Development within these technologies are paving the way for innovative solutions that address the growing healthcare demands of the aging population in Japan. Overall, the Production Technology segment is a vital component of the Japan Biosimilar Contract Manufacturing Market, driving advancements that contribute to improved patient access and affordability of biopharmaceutical therapies.

    Biosimilar Contract Manufacturing Market Application Insights

    The Japan Biosimilar Contract Manufacturing Market, particularly within the Application segment, is characterized by significant growth and diversification. The Oncology segment plays a crucial role, driven by the increasing incidence of cancer, leading to a growing demand for effective therapeutic options. Blood Disorders also represent an important area, given Japan's aging population and the rising prevalence of conditions such as hemophilia.

    Furthermore, the need for treatments addressing Growth Hormonal Deficiency is growing due to the advancement in biotechnology and heightened awareness about growth disorders. Chronic and Autoimmune Disorders, including Rheumatoid Arthritis, are gaining attention as the prevalence of these conditions rises, driving the need for innovative and cost-effective biosimilar treatments.

    The Japan Biosimilar Contract Manufacturing Market segmentation reflects a robust landscape of opportunities, where the complexities of healthcare in the region are met with increasing competition and the ongoing commitment to research and development. Moreover, supportive government policies and regulations favoring biosimilars further empower this market segment, fostering growth and innovation within each therapeutic area.

    Get more detailed insights about Japan Biosimilar Contract Manufacturing Market

    Key Players and Competitive Insights

    The biosimilar contract-manufacturing market in Japan 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 Fujifilm Diosynth Biotechnologies (JP) are strategically positioned to leverage their extensive manufacturing capabilities and technological expertise. Samsung Biologics (KR) focuses on expanding its production capacity and enhancing its technological offerings, while Lonza Group (CH) emphasizes partnerships and collaborations to strengthen its market presence. Fujifilm Diosynth Biotechnologies (JP) is actively investing in innovation and digital transformation, which collectively shapes a competitive environment that is increasingly reliant on advanced manufacturing techniques and strategic alliances.

    Key business tactics within this market include localizing manufacturing to reduce lead times and optimize supply chains. The competitive structure appears moderately fragmented, with several key players exerting influence over market dynamics. This fragmentation allows for a diverse range of offerings, yet the presence of dominant players like Amgen (US) and Boehringer Ingelheim (DE) suggests a competitive tension that drives innovation and efficiency.

    In October 2025, Fujifilm Diosynth Biotechnologies (JP) announced the opening of a new state-of-the-art facility in Kanagawa, aimed at enhancing its biosimilar production capabilities. This strategic move is likely to bolster its position in the market by increasing production capacity and enabling faster turnaround times for clients, thereby addressing the growing demand for biosimilars in Japan. The facility is expected to incorporate advanced manufacturing technologies, aligning with the industry's shift towards more efficient production processes.

    In September 2025, Lonza Group (CH) entered into a partnership with a leading Japanese pharmaceutical company to co-develop a biosimilar product. This collaboration underscores Lonza's commitment to expanding its footprint in the Japanese market and highlights the importance of strategic alliances in navigating the complexities of biosimilar development. By leveraging local expertise and resources, Lonza aims to enhance its competitive edge and accelerate the time-to-market for new biosimilars.

    In August 2025, Boehringer Ingelheim (DE) launched a new initiative focused on sustainability in its manufacturing processes. This initiative aims to reduce the environmental impact of biosimilar production by implementing greener technologies and practices. As sustainability becomes a critical factor in the pharmaceutical industry, this move positions Boehringer Ingelheim as a forward-thinking player, likely appealing to environmentally conscious stakeholders and enhancing its brand reputation.

    As of November 2025, current trends in the biosimilar contract-manufacturing market include a strong emphasis on digitalization, sustainability, and the integration of artificial intelligence (AI) in production processes. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to navigate regulatory challenges and accelerate innovation. The competitive differentiation is expected to evolve from traditional price-based competition towards a focus on technological advancements, supply chain reliability, and sustainable practices, indicating a transformative shift in how companies position themselves in the market.

    Key Companies in the Japan Biosimilar Contract Manufacturing Market market include

    Industry Developments

    The Japan Biosimilar Contract Manufacturing Market is experiencing notable developments, particularly with companies such as Fujifilm Diosynth Biotechnologies and Takeda enhancing their manufacturing capabilities to meet the growing demand for biosimilars. In June 2023, Merck KGaA made strides by expanding its production facility in Japan to support its biosimilar portfolio, aiming to boost its market presence.

    Furthermore, in August 2023, Samsung Biologics announced the establishment of a new biosimilar manufacturing plant in Japan, emphasizing the strategic importance of this market for global biopharmaceutical supply chains. The market is showing a positive growth trend, driven by increased healthcare expenditure and an aging population in Japan, which is projected to elevate the market valuation of major players like Amgen and Roche significantly over the coming years.

    Notable mentions in the past few years include the merger of Mylan with Upjohn, a division of Pfizer, in November 2020, enhancing their capabilities in producing biosimilars. The Japanese government continues to promote the development of biosimilars, aligning with international standards and encouraging local and foreign investments, further positioning Japan as a hub for biosimilar manufacturing excellence.

    Future Outlook

    Japan Biosimilar Contract Manufacturing Market Future Outlook

    The biosimilar contract-manufacturing market is projected to grow at an 18.89% CAGR from 2024 to 2035, driven by increasing demand for cost-effective biologics and regulatory support.

    New opportunities lie in:

    • Investment in advanced bioreactor technologies for enhanced production efficiency.
    • Development of strategic partnerships with local biotech firms for market penetration.
    • Implementation of robust quality assurance systems to meet regulatory standards.

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

    Market Segmentation

    Japan Biosimilar Contract Manufacturing Market Product Outlook

    • Recombinant Non-glycosylated Proteins
    • Recombinant Glycosylated Proteins

    Japan Biosimilar Contract Manufacturing Market Application Outlook

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

    Japan Biosimilar Contract Manufacturing Market Production Technology Outlook

    • Mammalian
    • Non-Mammalian

    Report Scope

    MARKET SIZE 2024174.0(USD Million)
    MARKET SIZE 2025206.87(USD Million)
    MARKET SIZE 20351167.0(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR)18.89% (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 AppTec (CN)", "Catalent (US)", "Rentschler Biopharma (DE)", "KBI Biopharma (US)", "Amgen (US)"]
    Segments CoveredProduct, Production Technology, Application
    Key Market OpportunitiesEmerging technologies in bioprocessing enhance efficiency in the biosimilar contract-manufacturing market.
    Key Market DynamicsRising demand for cost-effective biosimilars drives competitive contract-manufacturing partnerships in Japan's pharmaceutical landscape.
    Countries CoveredJapan

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    FAQs

    What is the expected market size of the Japan Biosimilar Contract Manufacturing Market in 2024?

    The Japan Biosimilar Contract Manufacturing Market is expected to be valued at 231.9 million USD in the year 2024.

    What is the projected market size for the Japan Biosimilar Contract Manufacturing Market by 2035?

    By 2035, the market is projected to reach a valuation of 1333.0 million USD.

    What is the expected Compound Annual Growth Rate (CAGR) for the Japan Biosimilar Contract Manufacturing Market from 2025 to 2035?

    The market is anticipated to grow at a CAGR of 17.233 % from 2025 to 2035.

    Which product segment holds the largest market share in the Japan Biosimilar Contract Manufacturing Market?

    The Recombinant Glycosylated Proteins segment is projected to hold a significant market share, valued at 141.9 million USD in 2024.

    What is the projected market value for Recombinant Non-glycosylated Proteins by 2035?

    The market value for Recombinant Non-glycosylated Proteins is expected to reach 480.0 million USD by 2035.

    Who are the key players in the Japan Biosimilar Contract Manufacturing Market?

    Major players include Fujifilm Diosynth Biotechnologies, Merck KGaA, Takeda, Mylan, Roche, and Amgen.

    What challenges does the Japan Biosimilar Contract Manufacturing Market currently face?

    Ongoing regulatory complexities and competitive pricing pressures are significant challenges in the market.

    How does the growth rate of the Japan Biosimilar Contract Manufacturing Market compare to global trends?

    The 17.233 % CAGR reflects a robust growth trend compared to many other regions within the global biosimilar market.

    What are the main applications driving growth in the Japan Biosimilar Contract Manufacturing Market?

    The primary applications driving growth include pharmacological treatments for various diseases, particularly in oncology and autoimmune conditions.

    How has the competitive landscape evolved in the Japan Biosimilar Contract Manufacturing Market?

    The landscape has evolved with increasing collaborations and mergers among major pharmaceutical companies to enhance production capabilities.

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