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    South America Biosimilar Contract Manufacturing Market

    ID: MRFR/Pharma/50114-HCR
    200 Pages
    Garvit Vyas
    October 2025

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

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    South America Biosimilar Contract Manufacturing Market Summary

    The South America Biosimilar Contract Manufacturing market is poised for substantial growth, projected to reach 4152.0 USD Million by 2035 from a base of 618.4 USD Million in 2024.

    Key Market Trends & Highlights

    South America Biosimilar Contract Manufacturing Key Trends and Highlights

    • The market is expected to grow from 618.4 USD Million in 2024 to 4152.0 USD Million by 2035.
    • A compound annual growth rate (CAGR) of 18.9% is anticipated for the period between 2025 and 2035.
    • This growth trajectory suggests a robust expansion in the biosimilar contract manufacturing sector across South America.
    • Growing adoption of biosimilars due to increasing healthcare costs is a major market driver.

    Market Size & Forecast

    2024 Market Size 618.4 (USD Million)
    2035 Market Size 4152.0 (USD Million)
    CAGR (2025-2035) 18.9%

    Major Players

    Biocon, Sandoz, Eli Lilly, Merck KGaA, Mylan, Fresenius Kabi, Roche, Amgen, Bristol-Myers Squibb, Samsung Biologics, Teva Pharmaceutical, Lonza, AbbVie, Celltrion, Pfizer

    South America Biosimilar Contract Manufacturing Market Trends

    The South American Biosimilar Contract Manufacturing Market is undergoing substantial growth as a result of a variety of market drivers that are influencing the landscape. The increasing prevalence of chronic diseases in the region is a significant market driver. The demand for affordable and effective biologics is on the rise as healthcare systems endeavor to effectively manage these conditions. Biosimilars are capable of meeting this demand.

    In addition, the development and production of biosimilars are being promoted by government initiatives in countries such as Argentina and Brazil to guarantee patient access and develop domestic healthcare solutions. This has resulted in increased investments in contract manufacturing infrastructures and biotechnology in South America. Collaborations between international biotechnology firms and local manufacturers are among the opportunities to be investigated in this market.

    These partnerships can expedite the market entry of biosimilars and improve production capabilities by capitalizing on local expertise. In addition, the robust regulatory framework being established by agencies such as ANVISA in Brazil is fostering opportunities for increased consumer confidence in biosimilars, which will result in a greater adoption. There has been a recent trend in South America towards a more supportive policy environment for biosimilars.

    Biosimilars are emerging as an appealing alternative to original biologics amid the growing emphasis on healthcare cost reduction. Additionally, there is an increasing commitment to sustainability and local manufacturing, which is consistent with the broader global trend of minimising the carbon footprint of medical supplies. These factors are collectively influencing the South America Biosimilar Contract Manufacturing Market, as stakeholders adjust to the region's changing healthcare needs. The future is promising.

    Market Segment Insights

    Biosimilar Contract Manufacturing Market Product Insights

    The South America Biosimilar Contract Manufacturing Market is increasingly diverse, with the product segment serving as a foundation for its expansion. A key focus within this segment is recombinant proteins, which have been instrumental in the development of biologic therapies. The market is predominantly influenced by two main categories recombinant non-glycosylated proteins and recombinant glycosylated proteins, each playing a distinct role in advancing therapeutic applications.

    Recombinant non-glycosylated proteins, known for their stability and cost-effectiveness, are commonly used in various therapeutic contexts, such as hormones and enzymes.

    They have seen demanding growth due to rising healthcare needs in the region.

    Conversely, recombinant glycosylated proteins, essential for mimicking complex human proteins, dominate due to their crucial role in developing monoclonal antibodies and other advanced therapies. The importance of these proteins lies in their ability to offer treatments that are often more effective and economically viable than their traditional counterparts, thus providing a solid foundation for innovation in the biosimilar space.

    The regulatory landscape in South America also reflects an increasing focus on biosimilars, which aligns with global trends towards cost-containment in healthcare, driving the demand for these products. As countries in the region invest in healthcare infrastructure and biotechnology, the biosimilar contract manufacturing market stands to benefit significantly, with both recombinant non-glycosylated and glycosylated proteins expected to play pivotal roles in transforming patient access to essential medicines.

    Biosimilar Contract Manufacturing Market Production Technology Insights

    The Production Technology segment within the South America Biosimilar Contract Manufacturing Market has emerged as a critical pillar driving market dynamics. This sector is primarily divided into Mammalian and Non-Mammalian technologies, both playing pivotal roles in the development and manufacturing processes of biosimilars.

    Mammalian cell culture systems are often preferred due to their capability to produce complex proteins that closely mimic human biological characteristics, contributing significantly to the efficacy and acceptance of biosimilar products.

    Conversely, Non-Mammalian systems, including microbial fermentation, are gaining traction for their cost-effectiveness and rapid production cycles, catering to a diverse range of therapeutic applications.

    The growing need for efficient and scalable manufacturing processes, driven by increased demand for affordable biologics in South America, is propelling investments in both technologies. Additionally, regional regulatory frameworks are evolving to support the growth of biosimilars, fostering an environment that encourages innovation in production techniques. Overall, the balance between Mammalian and Non-Mammalian technologies exemplifies the efforts toward enhancing quality and reducing production costs in the ever-evolving landscape of the South America Biosimilar Contract Manufacturing Market.

    Biosimilar Contract Manufacturing Market Application Insights

    The South America Biosimilar Contract Manufacturing Market, specifically within the Application segment, encompasses various critical therapeutic areas, each playing a significant role in addressing diverse patient needs. Oncology has emerged as a pivotal focus area due to the increasing prevalence of cancer and the rising demand for effective treatment options, where biosimilars contribute to enhanced patient access and affordability.

    Blood Disorders also represent a substantial segment, with biosimilars assisting in the management of conditions like hemophilia, promoting cost-effective treatment strategies in healthcare systems across South America. Additionally, the segment addressing Growth Hormonal Deficiency has gained traction, as the region experiences a heightened awareness of growth-related disorders.

    Chronic and Autoimmune Disorders, including Rheumatoid Arthritis, signify another important area, driven by a growing aging population and an upsurge in autoimmune conditions. The diversity in these applications reflects the South America Biosimilar Contract Manufacturing Market dynamics, where strategic investments and collaborations are expected to drive innovations, improve patient outcomes, and adapt to evolving healthcare demands.

    Overall, these various applications highlight the ongoing trends and opportunities within the South America Biosimilar Contract Manufacturing Market, responding to pressing healthcare challenges and ensuring that patients have better access to biologic therapies.

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

    Regional Insights

    The South America Biosimilar Contract Manufacturing Market is characterized by significant growth potential in its regional segmentation, comprising Brazil, Mexico, Argentina, and the Rest of South America. Brazil stands out as a leader in the market, driven by robust investments in healthcare infrastructure and a rising demand for cost-effective biologics, presenting ample opportunity for contract manufacturers.

    Mexico is emerging as a competitive market due to its strategic location and favorable regulatory environment, facilitating partnerships between domestic and international manufacturers. Argentina is gaining traction as a significant player, where local pharmaceutical companies are increasingly adopting biosimilars to enhance patient access to biologic therapies.

    The Rest of South America, including countries such as Chile and Colombia, is also contributing to the overall market dynamics through growing healthcare expenditure and a rising awareness of biosimilars. The entire region benefits from a combination of rising chronic disease prevalence and increasing healthcare costs, pushing stakeholders toward biosimilar solutions. This landscape allows for targeted strategies and innovative collaborations, making the South America Biosimilar Contract Manufacturing Market an attractive segment for investments and growth.

    South America Biosimilar Contract Manufacturing Market Region

    Source Primary Research, Secondary Research, MRFR Database, and Analyst Review

    Key Players and Competitive Insights

    The South America Biosimilar Contract Manufacturing Market is gaining significant traction due to several factors, including increasing demand for affordable medicinal alternatives, growing investments in biopharmaceutical manufacturing, and favorable regulations promoting the use of biosimilars. With more companies seeking partnerships to leverage existing manufacturing capabilities, the competitive landscape in this market has become increasingly dynamic.

    Companies are focusing on establishing robust supply chains, investing in advanced technologies, and enhancing their manufacturing capabilities to meet the burgeoning demand for biosimilars across various therapeutic areas. This heightened competition is pushing organizations to develop strategic alliances and expand their product portfolios to effectively capture market share, thereby leading to innovative solutions that cater to the nuanced needs of healthcare providers and patients alike in South America.

    Biocon has established a prominent presence in the South America Biosimilar Contract Manufacturing Market, primarily focusing on delivering high-quality biosimilars at a competitive price point. The company's strengths lie in its extensive experience in biologics manufacturing, advanced research and development capabilities, and a commitment to quality assurance.

    Biocon has been instrumental in expanding the biosimilars market in the region through strategic collaborations and local partnerships that enhance its ability to navigate various regulatory environments. By prioritizing innovation and patient-centric approaches, Biocon has strengthened its foothold in South America, providing essential biopharmaceutical solutions that align with the growing demand for affordable healthcare.

    Sandoz, a leader in the biosimilars sector, has made significant strides within the South America Biosimilar Contract Manufacturing Market through a comprehensive portfolio of products that includes monoclonal antibodies and biologics targeting various chronic diseases. The company is recognized for its commitment to quality and cost-effective solutions that help improve patient accessibility to biopharmaceuticals.

    Sandoz's strengths lie in its strong global network, advanced manufacturing facilities, and a robust pipeline of sequential biosimilars, all of which bolster its influence in the South American market. Additionally, Sandoz has been active in forging mergers and acquisitions that enhance its operational capabilities and extend its product offerings, thereby ensuring a sustained competitive edge. This focus on innovation and strategic growth has positioned Sandoz favorably to meet the healthcare needs of South American patients while maintaining a strong presence in the industry.

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

    Industry Developments

    Recent developments in the South America Biosimilar Contract Manufacturing Market indicate significant growth driven by increasing healthcare needs and regulatory support for biosimilars. Biocon has expanded its presence in Brazil, emphasizing partnerships to enhance local production capabilities. Sandoz has also made strides in this market, focusing on the accessibility of affordable biologics.

    Eli Lilly and Amgen continue to invest in Research and Development to bring innovative biosimilars to the region. In September 2023, Pfizer and Lonza announced a collaboration to boost biomanufacturing capacity in South America, reinforcing their commitment to local market growth. Additionally, Roche is enhancing its supply chain efficacy to meet growing demands.

    The market has experienced notable movements in valuations, with companies like Fresenius Kabi and Mylan also reporting positive growth trajectories. In 2022, the Brazilian government initiated funding for biosimilar projects, fostering an environment conducive to growth, while the regulatory landscape is increasingly favorable for new entrants. Recent partnerships and investments signal a robust outlook as these companies align their strategies to capture market opportunities in the region, propelling the South America Biosimilar Contract Manufacturing Market forward.

    Market Segmentation

    Biosimilar Contract Manufacturing Market Product Outlook

    • Recombinant Non-glycosylated Proteins
    • Recombinant Glycosylated Proteins

    Biosimilar Contract Manufacturing Market Regional Outlook

    • Brazil
    • Mexico
    • Argentina
    • Rest of South America

    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 520.1(USD Million)
    MARKET SIZE 2024 618.4(USD Million)
    MARKET SIZE 2035 4151.99(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 Biocon, Sandoz, Eli Lilly, Merck KGaA, Mylan, Fresenius Kabi, Roche, Amgen, BristolMyers Squibb, Samsung Biologics, Teva Pharmaceutical, Lonza, AbbVie, Celltrion, Pfizer
    SEGMENTS COVERED Product, Production Technology, Application, Regional
    KEY MARKET OPPORTUNITIES Growing demand for affordable medicines, Strong government support and regulations, Increasing investment in biopharmaceuticals, Expanding healthcare infrastructure, Rising prevalence of chronic diseases
    KEY MARKET DYNAMICS Regulatory framework complexity, Growing demand for affordable healthcare, Increasing investment in biopharmaceuticals, Rise of chronic diseases, Expanding manufacturing capabilities
    COUNTRIES COVERED Brazil, Mexico, Argentina, Rest of South America

    FAQs

    What is the projected market size of the South America Biosimilar Contract Manufacturing Market in 2024?

    The South America Biosimilar Contract Manufacturing Market is projected to be valued at 618.4 million USD in 2024.

    What is the expected market size for the South America Biosimilar Contract Manufacturing Market by 2035?

    By 2035, the South America Biosimilar Contract Manufacturing Market is expected to reach a value of 4151.99 million USD.

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

    The expected CAGR for the South America Biosimilar Contract Manufacturing Market from 2025 to 2035 is 18.9%.

    Which region holds the largest market share within the South America Biosimilar Contract Manufacturing Market?

    Brazil is anticipated to hold the largest market share within the South America Biosimilar Contract Manufacturing Market.

    What will be the value of the South America Biosimilar Contract Manufacturing Market in Brazil by 2035?

    The value of the South America Biosimilar Contract Manufacturing Market in Brazil is projected to be 1188.56 million USD by 2035.

    How much is the Recombinant Non-glycosylated Proteins segment expected to be valued at by 2035?

    The Recombinant Non-glycosylated Proteins segment is expected to be valued at 1650.0 million USD by 2035.

    What is the market value for Recombinant Glycosylated Proteins in 2024?

    The market value for Recombinant Glycosylated Proteins is 368.4 million USD in 2024.

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

    Key players in the South America Biosimilar Contract Manufacturing Market include Biocon, Sandoz, Eli Lilly, Merck KGaA, and Mylan.

    What is the projected market value for Mexico in the South America Biosimilar Contract Manufacturing Market by 2035?

    Mexico's projected market value in the South America Biosimilar Contract Manufacturing Market is 920.05 million USD by 2035.

    What challenges are influencing the growth of the South America Biosimilar Contract Manufacturing Market?

    Challenges such as regulatory hurdles and competition from pharmaceuticals are influencing the growth of the South America Biosimilar Contract Manufacturing Market.

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