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    Italy Biosimilar Contract Manufacturing Market

    ID: MRFR/Pharma/50113-HCR
    200 Pages
    Garvit Vyas
    September 2025

    Italy 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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    Italy Biosimilar Contract Manufacturing Market Infographic
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    Italy Biosimilar Contract Manufacturing Market Summary

    The Italy Biosimilar Contract Manufacturing market is poised for substantial growth, projected to reach 1479.3 USD Million by 2035.

    Key Market Trends & Highlights

    Italy Biosimilar Contract Manufacturing Key Trends and Highlights

    • The market valuation is expected to grow from 193.2 USD Million in 2024 to 1479.3 USD Million by 2035.
    • A compound annual growth rate (CAGR) of 20.33% is anticipated for the period from 2025 to 2035.
    • The increasing demand for cost-effective biologics is likely to drive market expansion in Italy.
    • Growing adoption of biosimilars due to rising healthcare costs is a major market driver.

    Market Size & Forecast

    2024 Market Size 193.2 (USD Million)
    2035 Market Size 1479.3 (USD Million)
    CAGR (2025-2035) 20.33%

    Major Players

    Celltrion, Sandoz, Aubay, Mylan, Roche, Amgen, Teva Pharmaceutical Industries, Samsung BioLogics, Lonza, Generium, Corden Pharma, AbbVie, Fujifilm Diosynth Biotechnologies, Pfizer, Boehringer Ingelheim

    Italy Biosimilar Contract Manufacturing Market Trends

    The Italy biosimilar contract manufacturing market is undergoing substantial growth, which is being driven by a number of critical market drivers. The growing demand for cost-effective biologic alternatives, particularly in light of the expiration of numerous original biologic patents, is a significant factor. This trend is indicative of a more extensive initiative to decrease healthcare expenditures while simultaneously guaranteeing patients access to high-quality treatment options.

    Furthermore, Italy's government policies are promoting an environment that is conducive to the development of biosimilars. The Italian Medicines Agency (AIFA) is actively promoting the use of biosimilars to enhance access to therapies, which has prompted manufacturers to enter the biosimilar contract space.

    The market offers a plethora of opportunities for exploration, particularly in light of the Italian healthcare system's efforts to enhance patient access to biologic treatments. As a means of expediting the development of biosimilars, strategic partnership opportunities are emerging between contract manufacturers and innovative pharmaceutical companies. Companies that acquire substantial market share are likely to invest in high-quality manufacturing capabilities and comply with rigorous regulatory standards.

    Lately, there has been an increasing trend in Italy towards increasing investment in research and development for new biosimilar products. In response to the increasing demand, Italian companies are emphasizing the development of their technological capabilities and the expansion of their manufacturing facilities. Additionally, there is an increase in collaboration with academic institutions and biotechnology firms, with the objective of leveraging local innovation and expertise.

    In addition, the market is on the brink of further expansion as patient awareness and acceptability of biosimilars continue to increase, thereby improving the overall landscape of the Italy biosimilar contract manufacturing sector.

    Market Segment Insights

    Biosimilar Contract Manufacturing Market Product Insights

    The Italy Biosimilar Contract Manufacturing Market, particularly within the Product segment, focuses significantly on Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins, which are pivotal in driving the industry forward. Recombinant Non-glycosylated Proteins serve as essential components in the treatment of various chronic diseases.

    They are known for their ability to mirror natural proteins produced by the body, making them crucial in therapeutic applications. Their role becomes increasingly significant as healthcare professionals seek innovative solutions for patient treatment, particularly in areas like oncology and endocrinology, where biologics are becoming the standard of care.

    On the other hand, Recombinant Glycosylated Proteins continue to dominate the landscape due to their complex structures that closely resemble human proteins. These proteins exhibit higher efficacy and fewer side effects compared to traditional therapies, which satisfies the growing demand for advanced biopharmaceuticals in Italy's healthcare system.

    The Italian government's initiative to promote biosimilars within the pharmaceutical industry aligns with this trend, as it is set to enhance patient access to effective treatments while ensuring cost-effectiveness in healthcare spending. The market is witnessing a trend toward increased investments in Research and Development, aiming at optimizing manufacturing processes to enhance protein yield and purity.

    Both Recombinant Non-glycosylated and Recombinant Glycosylated Proteins present substantial opportunities for contract manufacturers as they adapt to the evolving regulatory framework and technological advancements. The ability of manufacturers to provide high-quality biosimilars is becoming more critical, as they navigate challenges associated with compliance and market entry.

    Biosimilar Contract Manufacturing Market Production Technology Insights

    The Production Technology segment of the Italy Biosimilar Contract Manufacturing Market is significant in shaping the landscape of biopharmaceuticals, with robust applications in the development of therapies. This segment predominantly consists of Mammalian and Non-Mammalian technologies, each catering to the unique requirements of biosimilars in terms of efficacy, safety, and regulatory compliance.

    Mammalian cell lines are extensively utilized due to their ability to produce complex proteins that closely resemble human biology, making them critical for developing high-quality biosimilars.The Non-Mammalian segment, often incorporating microbial systems, offers cost-effective and efficient processes for manufacturing simpler biologics.

    The Italy government promotes the production of biosimilars as part of its healthcare strategy, encouraging innovation and ensuring that patients have access to effective treatment options. Moreover, with increasing investment in Research and Development and a growing pipeline of biosimilars, the Production Technology segment is poised for expansion, driven by rising demand for affordable medications.The unique capabilities of both Mammalian and Non-Mammalian technologies allow manufacturers to optimize their production processes, adapt to market needs, and significantly impact the Italy Biosimilar Contract Manufacturing Market revenue.

    Biosimilar Contract Manufacturing Market Application Insights

    The Application segment of the Italy Biosimilar Contract Manufacturing Market showcases a diverse range of therapeutic areas, reflecting the sector's growth and adaptability. This market is marked by pivotal applications such as Oncology, where the increasing incidence of cancer drives demand for affordable and effective treatment options.

    Similarly, Blood Disorders are witnessing rising attention, with a focus on developing biosimilars that improve patient outcomes and address the high costs associated with traditional therapies. Growth Hormonal Deficiency also represents a significant area, as there is a consistent need for reliable alternatives to existing treatments.

    Chronic and Autoimmune Disorders contribute to the market's expansion, propelled by the growing prevalence of diseases requiring long-term management, which in turn creates an increasing demand for biosimilar medications. Additionally, Rheumatoid Arthritis remains a prominent focus, as it is one of the most common autoimmune conditions, underscoring the need for innovative and cost-effective treatment solutions.

    The overall dynamics of these therapeutic areas play a vital role in shaping the Italy Biosimilar Contract Manufacturing Market, highlighting both opportunities and challenges faced in an evolving healthcare landscape.

    Get more detailed insights about Italy Biosimilar Contract Manufacturing Market -Forecast to 2035

    Key Players and Competitive Insights

    The Italy Biosimilar Contract Manufacturing Market is a dynamic sector driven by the increasing demand for cost-effective treatment alternatives to biologic medications. With the growth of biosimilars, various players are entering the market, each leveraging their strengths to gain competitive advantages.

    Market participants are focusing on enhancing their manufacturing technologies to ensure high-quality production processes, which is crucial in meeting stringent regulatory requirements. The competitive landscape is characterized by strategic partnerships, collaborations, and a strong emphasis on research and development to innovate and expand product portfolios.

    Additionally, the landscape is evolving with the ongoing regulatory updates aimed at fostering the biosimilars sector, which further intensifies competition among manufacturers.Celltrion has established a solid presence in the Italy Biosimilar Contract Manufacturing Market, leveraging its advanced manufacturing capabilities and expertise in biotechnology.

    One of the company's strengths lies in its robust manufacturing infrastructure, which allows for the efficient production of high-quality biosimilars. The company is recognized for its commitment to innovation, as evident in its investment in research and development initiatives aimed at expanding its product offerings tailored for the Italian market.

    Celltrion's ability to rapidly adapt to market needs and regulatory changes further enhances its competitive position. Moreover, the company's strategic collaborations with local stakeholders facilitate market access and distribution, ensuring its products reach a wider range of healthcare providers across Italy.

    Sandoz, a key player in the Italy Biosimilar Contract Manufacturing Market, is known for its extensive portfolio of biosimilar products, which addresses the growing need for affordable biologic alternatives. With strong market penetration, Sandoz has positioned itself as a leader by prioritizing quality and regulatory compliance in its manufacturing processes.

    The company’s strengths include a well-established supply chain and robust partnerships with healthcare professionals to foster trust in its products. Sandoz has engaged in strategic mergers and acquisitions that enhance its capabilities and expand its market presence, thereby solidifying its role within the biosimilars sector in Italy. Furthermore, Sandoz continuously invests in innovative solutions and cutting-edge technologies, which enables it to maintain a competitive edge and meet the evolving demands of the Italian healthcare market efficiently.

    Key Companies in the Italy Biosimilar Contract Manufacturing Market market include

    Industry Developments

    In recent months, the Italy Biosimilar Contract Manufacturing Market has seen notable developments, particularly with companies like Celltrion, Sandoz, and Mylan focusing on expanding their production capabilities in response to increasing demand for biosimilars. In October 2023, Teva Pharmaceutical Industries announced a strategic partnership with local Italian firms to enhance the manufacturing of biosimilar medications, contributing to the growth of the sector.

    Meanwhile, Roche and Amgen have been actively involved in collaborations aimed at strengthening their biosimilar pipelines within Italy. Over the past two years, there has been a steady growth trend in the market valuation of these companies, driven largely by regulatory support and an increasing focus on cost-effective biologic drugs, reflecting Italy's commitment to improving healthcare affordability.

    Notably, in April 2022, Samsung BioLogics expanded its facility in Italy, solidifying its capabilities in biosimilar production. Furthermore, recent enhancements in technological advancements and increased investments from companies like Lonza and Fujifilm Diosynth Biotechnologies have positioned Italy as a key player in the global biosimilar manufacturing landscape, fostering innovation and competitiveness in the region.

    Market Segmentation

    Biosimilar Contract Manufacturing Market Product Outlook

    • Recombinant Non-glycosylated Proteins
    • Recombinant Glycosylated Proteins

    Biosimilar Contract Manufacturing Market Application Outlook

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

    Biosimilar Contract Manufacturing Market Production Technology Outlook

    • Mammalian
    • Non-Mammalian

    Report Scope

    Report Attribute/Metric Source: Details
    MARKET SIZE 2018 162.53(USD Million)
    MARKET SIZE 2024 193.25(USD Million)
    MARKET SIZE 2035 1479.29(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 20.325% (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 Celltrion, Sandoz, Aubay, Mylan, Roche, Amgen, Teva Pharmaceutical Industries, Samsung BioLogics, Lonza, Generium, Corden Pharma, AbbVie, Fujifilm Diosynth Biotechnologies, Pfizer, Boehringer Ingelheim
    SEGMENTS COVERED Product, Production Technology, Application
    KEY MARKET OPPORTUNITIES Growing demand for affordable biologics, Increased collaboration with biopharma companies, Advancements in bioprocessing technologies, Favorable regulatory environment for biosimilars, Expansion into emerging therapeutic areas
    KEY MARKET DYNAMICS increasing demand for cost-effective therapies, regulatory support for biosimilars, rising incidence of chronic diseases, partnerships between manufacturers and biotech firms, growing adoption of personalized medicine
    COUNTRIES COVERED Italy

    FAQs

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

    The Italy Biosimilar Contract Manufacturing Market is expected to be valued at 193.25 million USD in 2024.

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

    By 2035, the market is projected to grow significantly to 1,479.29 million USD.

    What is the expected CAGR for the Italy Biosimilar Contract Manufacturing Market from 2025 to 2035?

    The market is expected to grow at a CAGR of 20.325% between 2025 and 2035.

    Which product segment in the Italy Biosimilar Contract Manufacturing Market has the highest value in 2024?

    In 2024, the Recombinant Glycosylated Proteins segment is valued at 115.95 million USD.

    What is the value of the Recombinant Non-glycosylated Proteins segment in 2035?

    The Recombinant Non-glycosylated Proteins segment is expected to reach 586.07 million USD by 2035.

    Who are the major players in the Italy Biosimilar Contract Manufacturing Market?

    Key players include Celltrion, Sandoz, Mylan, Roche, and Amgen among others.

    What key applications are driving growth in the Italy Biosimilar Contract Manufacturing Market?

    The market is driven by the increasing demand for cost-effective biologics and biosimilars.

    Which product segment is projected to show significant growth over the forecast period?

    Both Recombinant Non-glycosylated and Recombinant Glycosylated Proteins are set to show significant growth.

    What are the emerging trends in the Italy Biosimilar Contract Manufacturing Market?

    Emerging trends include the rise of biopharmaceutical collaborations and technological advancements in manufacturing.

    How might the current global scenario affect the Italy Biosimilar Contract Manufacturing Market?

    Global supply chain dynamics and regulatory changes may impact market growth and operations.

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