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    Biosimilar Testing Development Services Market

    ID: MRFR/Pharma/7539-HCR
    128 Pages
    Garvit Vyas
    October 2025

    Biosimilar Testing and Development Service Market Research Report By Testing Type (Analytical Testing, Functional Testing, Immunogenicity Testing, Stability Testing, Other Testing Types), By Development Phase (Preclinical Development, Clinical Development, Regulatory Approval, Post-Approval Development), By Target Indication (Oncology, Autoimmune Diseases, Infectious Diseases, Rare Diseases, Other Target Indications), By Biosimilar Type (Monoclonal Antibodies, Growth Factors, Enzymes, Hormones, Other Biosimilar Types) and By Regional (North ...

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    Biosimilar Testing Development Services Market Summary

    The Global Biosimilar Testing and Development Service Market is projected to grow significantly from 5.03 USD Billion in 2024 to 20.50 USD Billion by 2035.

    Key Market Trends & Highlights

    Biosimilar Testing and Development Service Key Trends and Highlights

    • The market is expected to exhibit a compound annual growth rate (CAGR) of 13.62 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 20.5 USD Billion, indicating robust growth potential.
    • in 2024, the market is valued at 5.03 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of biosimilars due to increasing healthcare costs is a major market driver.

    Market Size & Forecast

    2024 Market Size 5.03 (USD Billion)
    2035 Market Size 20.50 (USD Billion)
    CAGR (2025-2035) 13.62%

    Major Players

    Charles River Laboratories, Eurofins Scientific, SGS, Wuxi AppTec, Thermo Fisher Scientific, Alcami, PPD, Inc., FUJIFILM Holdings Corporation, Abcam plc, Patheon N.V., Lonza Group Ltd, Merck KGaA, Laboratory Corporation of America Holdings, Parexel International Corporation, SGS SA, Accenture plc, General Electric Company, ICON plc

    Biosimilar Testing Development Services Market Trends

    Key market drivers include the rising demand for cost-effective treatments, increasing incidence of chronic diseases, and technological advancements. Opportunities lie in the development of novel biosimilars and the expansion into emerging markets.

    Recent trends include the adoption of analytical techniques to enhance biosimilarity assessment, the increasing utilization of in vitro and in vivo models for preclinical safety and efficacy evaluation, and the use of high-throughput screening technologies for rapid and efficient biosimilar characterization.

    These trends are driven by the need for comprehensive evaluation and cost-effective development of biosimilar products. By leveraging these trends and addressing the unmet needs in the market, players can position themselves for success in the Biosimilar Testing and Development Service Market.

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    The increasing complexity of biologics and the growing demand for cost-effective therapies are driving the evolution of biosimilar testing and development services, which are essential for ensuring the safety and efficacy of these products in the global market.

    U.S. Food and Drug Administration (FDA)

    Biosimilar Testing Development Services Market Drivers

    Rising Demand for Biologics

    The Global Biosimilar Testing and Development Service Market Industry experiences a notable surge in demand for biologics, driven by their efficacy in treating chronic diseases. As the global population ages, the prevalence of conditions such as cancer and autoimmune disorders increases, necessitating innovative therapeutic solutions. In 2024, the market is projected to reach 5.03 USD Billion, reflecting the growing reliance on biologics. This trend is expected to continue, with the market anticipated to expand significantly as more biosimilars enter the market, thereby enhancing patient access to essential therapies.

    Market Segment Insights

    Biosimilar Testing and Development Service Market Segment Insights:

    Biosimilar Testing and Development Service Market Segment Insights:

    Biosimilar Testing and Development Service Market Testing Type Insights

    Biosimilar Testing and Development Service Market Testing Type Insights

    Analytical Testing segment held the largest share in the Biosimilar Testing and Development Service Market in 2023 and is anticipated to maintain its dominance throughout the forecast period. Analytical Testing is crucial for ensuring the quality and safety of biosimilars, as it involves evaluating their physicochemical and biological properties to compare them with the reference product.

    Functional Testing evaluates the biological activity of biosimilars to ensure that they exhibit similar functionality to the reference product. This segment is expected to witness significant growth due to the increasing demand for biosimilars in various therapeutic areas.

    Immunogenicity Testing assesses the immune response elicited by biosimilars, which is critical for determining their safety and efficacy. The growing awareness of immunogenicity concerns is driving the growth of this segment.

    Stability Testing evaluates the stability of biosimilars over time to ensure their shelf life and storage conditions. The increasing focus on maintaining the integrity and potency of biosimilars is fueling the growth of this segment.

    Biosimilar Testing and Development Service Market Development Phase Insights

    Biosimilar Testing and Development Service Market Development Phase Insights

    The Biosimilar Testing and Development Service Market segmentation by Development Phase includes Preclinical Development, Clinical Development, Regulatory Approval, and Post-Approval Development.

    The Preclinical Development segment accounted for the largest share of the Biosimilar Testing and Development Service Market revenue in 2023, and it is expected to continue to dominate the market over the forecast period. This is due to the increasing demand for preclinical testing services to evaluate the safety and efficacy of biosimilar products before they enter clinical trials.

    The Clinical Development segment is expected to grow at a significant CAGR during the forecast period, owing to the increasing number of biosimilar products entering clinical development. The Regulatory Approval segment is expected to grow steadily over the forecast period, as biosimilar products gain regulatory approval in various countries.

    The Post-Approval Development segment is expected to grow at a moderate CAGR during the forecast period, as biosimilar products are monitored for safety and efficacy after they are approved for marketing.

    Biosimilar Testing and Development Service Market Target Indication Insights

    Biosimilar Testing and Development Service Market Target Indication Insights

    The Biosimilar Testing and Development Service Market is segmented by Target Indication into Oncology, Autoimmune Diseases, Infectious Diseases, Rare Diseases, and Other Target Indications. Oncology held the largest share of the market in 2023, accounting for over 50% of the Biosimilar Testing and Development Service Market revenue.

    The high prevalence of cancer and the increasing demand for biosimilar therapies for cancer treatment are driving the growth of this segment. Autoimmune Diseases is another major segment, accounting for over 20% of the market share.

    The rising incidence of autoimmune diseases and the need for effective and affordable treatments are fueling the growth of this segment. Infectious Diseases and Rare Diseases are also significant segments, with growing demand for biosimilar therapies for the treatment of infectious diseases and rare diseases, respectively.

    Other Target Indications include cardiovascular diseases, respiratory diseases, and metabolic disorders, which are also expected to contribute to the growth of the Biosimilar Testing and Development Service Market.

    Biosimilar Testing and Development Service Market Biosimilar Type Insights

    Biosimilar Testing and Development Service Market Biosimilar Type Insights

    The Biosimilar Type segment plays a crucial role in the Biosimilar Testing and Development Service Market. Monoclonal Antibodies hold a significant market share, driven by the presence of various approved biosimilars, such as rituximab, trastuzumab, and bevacizumab.

    Growth Factors, particularly erythropoietin biosimilars, are also gaining traction due to their increasing usage in treating anemia associated with chronic kidney disease. Enzymes, such as hyaluronidase, are witnessing growing demand in biopharmaceutical manufacturing processes.

    Hormones, including insulin biosimilars, are expected to contribute to market growth as they offer cost-effective alternatives to branded products. Other Biosimilar Types, such as interferons and interleukins, are also expected to gain prominence in specific therapeutic areas.

    The Biosimilar Testing and Development Service Market revenue for Biosimilar Type is projected to reach USD 5.2 billion by 2024, exhibiting a steady growth rate.

    Get more detailed insights about Biosimilar Testing and Development Services Market Research Report - Global Forecast till 2034

    Regional Insights

    The Biosimilar Testing and Development Service Market is segmented into North America, Europe, APAC, South America, and MEA. Among these regions, North America held the largest market share in 2023, owing to the presence of a large number of biopharmaceutical companies and favorable regulatory policies.

    The European market is also expected to grow significantly, driven by increasing demand for biosimilars and government initiatives to promote their adoption.

    The APAC region is expected to witness the fastest growth over the forecast period, due to the rising prevalence of chronic diseases and increasing healthcare expenditure.

    South America and MEA are expected to account for a smaller share of the global market, but are expected to grow at a steady pace over the forecast period.

    Biosimilar Testing and Development Service Market 3

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    Major players in the Biosimilar Testing and Development Service Market are constantly striving to gain competitive advantage by investing in research and development, expanding their service offerings, and forming strategic partnerships.

    Leading Biosimilar Testing and Development Service Market players are focusing on providing comprehensive solutions that encompass the entire biosimilar development lifecycle, from early-stage concept development to regulatory approval and commercialization.

    The Biosimilar Testing and Development Service Market is highly competitive, with a number of established players and emerging companies vying for market share. Key players in the Biosimilar Testing and Development Service Market include Charles River Laboratories, Eurofins Scientific, SGS, Wuxi AppTec, and Thermo Fisher Scientific.

    These companies offer a range of services, including bioanalytical testing, cell-based assays, and immunogenicity testing.

    A leading player in the Biosimilar Testing and Development Service Market, Charles River Laboratories, provides a comprehensive suite of services to support biosimilar development, including bioanalytical testing, cell-based assays, and immunogenicity testing.

    The company has a global network of laboratories and a team of experienced scientists who are dedicated to providing high-quality data and timely results. Charles River Laboratories is committed to working closely with its clients to develop and execute customized testing plans that meet their specific needs.

    A major competitor in the Biosimilar Testing and Development Service Market, Eurofins Scientific, offers a wide range of biosimilar testing services, including bioanalytical testing, cell-based assays, and immunogenicity testing. The company has a global network of laboratories and a team of experienced scientists who are dedicated to providing high-quality data and timely results.

    Eurofins Scientific is committed to working closely with its clients to develop and execute customized testing plans that meet their specific needs. The company's strong track record and commitment to quality make it a trusted partner for biosimilar developers around the world.

    Key Companies in the Biosimilar Testing Development Services Market market include

    Industry Developments

    The rising prevalence of chronic diseases, increasing demand for affordable biologics, and technological advancements in biosimilar development drive market growth. Key recent developments include:

    In January 2023, Merck entered a strategic partnership with Samsung Biologics to enhance its biosimilar development and manufacturing capabilities.

    In February 2024, Lonza announced the expansion of its biosimilar manufacturing facility in Singapore to meet the growing demand for biosimilars in the Asia-Pacific region.

    The US Food and Drug Administration (FDA) has issued several guidance documents to streamline the biosimilar approval process, further propelling market growth.

    Future Outlook

    Biosimilar Testing Development Services Market Future Outlook

    The Biosimilar Testing and Development Service Market is projected to grow at a 13.62% CAGR from 2025 to 2035, driven by increasing demand for affordable biologics and regulatory advancements.

    New opportunities lie in:

    • Invest in advanced analytics for biosimilar development to enhance efficiency and reduce time-to-market.
    • Develop strategic partnerships with regulatory bodies to streamline approval processes for biosimilars.
    • Leverage AI technologies to optimize testing protocols and improve accuracy in biosimilar assessments.

    By 2035, the market is expected to be robust, reflecting substantial growth and innovation in biosimilar testing and development services.

    Market Segmentation

    Biosimilar Testing and Development Service Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Biosimilar Testing and Development Service Market Testing Type Outlook

    • Analytical Testing
    • Functional Testing
    • Immunogenicity Testing
    • Stability Testing
    • Other Testing Types

    Biosimilar Testing and Development Service Market Biosimilar Type Outlook

    • Monoclonal Antibodies
    • Growth Factors
    • Enzymes
    • Hormones
    • Other Biosimilar Types

    Biosimilar Testing and Development Service Market Development Phase Outlook

    • Preclinical Development
    • Clinical Development
    • Regulatory Approval
    • Post-Approval Development

    Biosimilar Testing and Development Service Market Target Indication Outlook

    • Oncology
    • Autoimmune Diseases
    • Infectious Diseases
    • Rare Diseases
    • Other Target Indications

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024    5.03 (USD Billion)
    Market Size 2025    5.72 (USD Billion)
    Market Size 2035 20.50 (USD Billion)
    Compound Annual Growth Rate (CAGR) 13.62% (2025 - 2035)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2020 - 2024
    Market Forecast Units USD Billion
    Key Companies Profiled Alcami, PPD, Inc., Charles River Laboratories International, Inc., FUJIFILM Holdings Corporation, Abcam plc, Eurofins Scientific, Patheon N.V., Lonza Group Ltd, Merck KGaA, Laboratory Corporation of America Holdings, Parexel International Corporation, SGS SA, Accenture plc, General Electric Company, ICON plc
    Segments Covered Testing Type, Development Phase, Target Indication, Biosimilar Type, Regional
    Key Market Opportunities Growing demand for biosimilar drug development Increasing government support for biosimilar development Technological advancements in biosimilar testing Rising prevalence of chronic diseases Expanding healthcare infrastructure in emerging markets-
    Key Market Dynamics Rising adoption of biosimilars, increasing demand for cost-effective alternatives, technological advancements, patent expiry of biologics, and growing incidence of chronic diseases.
    Countries Covered North America, Europe, APAC, South America, MEA

    FAQs

    What was the market size of the Biosimilar Testing and Development Service Market in 2023?

    The Biosimilar Testing and Development Service Market reached a valuation of approximately 3.9 billion USD in 2023.

    What is the projected CAGR of the Biosimilar Testing and Development Service Market from 2024 to 2034?

    The Biosimilar Testing and Development Service Market is estimated to grow at a CAGR of 13.62% from 2024 to 2032.

    What is the anticipated market size of the Biosimilar Testing and Development Service Market in 2034?

    The Biosimilar Testing and Development Service Market is expected to reach a valuation of around 12.3 billion USD by the end of 2032.

    Which region is expected to hold the largest market share in the Biosimilar Testing and Development Service Market?

    North America is anticipated to dominate the Biosimilar Testing and Development Service Market throughout the forecast period.

    What are the key factors driving the growth of the Biosimilar Testing and Development Service Market?

    Rising prevalence of chronic diseases, increasing demand for cost-effective healthcare solutions, and technological advancements are major growth drivers for the Biosimilar Testing and Development Service Market.

    Who are some of the major competitors in the Biosimilar Testing and Development Service Market?

    Key players in the Biosimilar Testing and Development Service Market include Charles River Laboratories, SGS SA, Eurofins Scientific, and Intertek Group plc.

    What are the major applications of Biosimilar Testing and Development Services?

    Biosimilar Testing and Development Services are primarily used for preclinical and clinical testing of biosimilar products to ensure their safety and efficacy.

    How is the competitive landscape expected to evolve in the Biosimilar Testing and Development Service Market?

    The competitive landscape of the Biosimilar Testing and Development Service Market is anticipated to remain competitive, with established players and emerging companies vying for market share.

    What are the key trends shaping the future of the Biosimilar Testing and Development Service Market?

    Technological advancements, such as automation and digitalization, are expected to shape the future of the Biosimilar Testing and Development Service Market.

    What are the potential challenges facing the Biosimilar Testing and Development Service Market?

    Regulatory complexities and reimbursement issues pose potential challenges to the growth of the Biosimilar Testing and Development Service Market.

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