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    US Biosimilar Contract Manufacturing Market

    ID: MRFR/Pharma/17404-HCR
    100 Pages
    Garvit Vyas
    September 2025

    US 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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    US Biosimilar Contract Manufacturing Market Infographic
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    Table of Contents

    US Biosimilar Contract Manufacturing Market Summary

    The US Biosimilar Contract Manufacturing market is poised for substantial growth, expanding from 2.2 billion USD in 2024 to 14.5 billion USD by 2035.

    Key Market Trends & Highlights

    US Biosimilar Contract Manufacturing Key Trends and Highlights

    • The market is projected to grow at a compound annual growth rate of 18.7 percent from 2025 to 2035.
    • By 2035, the market value is expected to reach 14.5 billion USD, indicating robust demand for biosimilar products.
    • In 2024, the market is valued at 2.2 billion USD, reflecting the current investment landscape in biosimilar manufacturing.
    • Growing adoption of biosimilars due to increasing healthcare costs is a major market driver.

    Market Size & Forecast

    2024 Market Size 2.2 (USD Billion)
    2035 Market Size 14.5 (USD Billion)
    CAGR (2025-2035) 18.7%

    Major Players

    Teva Pharmaceutical Industries, Samsung Biologics, Lonza, Sandoz, BristolMyers Squibb, Eli Lilly and Company, Boehringer Ingelheim, Fujifilm Diosynth Biotechnologies, Catalent, Pfizer, Generium, Amgen, AbbVie, Roche, Mylan

    US Biosimilar Contract Manufacturing Market Trends

    The US Biosimilar Contract Manufacturing Market is witnessing several significant trends driven by the increasing acceptance of biosimilars among healthcare providers and patients. This acceptance is largely fueled by the need for cost-effective alternatives to expensive biologics, which has led to growth in the number of biosimilars receiving regulatory approval from the FDA. Additionally, various initiatives by the US government focused on promoting competition in the pharmaceutical sector are encouraging greater investment in biosimilar manufacturing capabilities. This is creating opportunities for contract manufacturers to expand their services and enhance production capacity to meet rising demand.

    Furthermore, there is an emerging trend of collaboration between biosimilar developers and CMOs (Contract Manufacturing Organizations), aimed at bolstering the supply chain and ensuring high-quality production. As the regulatory landscape evolves, companies are increasingly seeking partnerships that can offer expertise in navigating complex approval processes, allowing for more efficient time-to-market for biosimilars. In recent times, with the growing focus on personalized medicine, manufacturers are also exploring opportunities in the development of tailor-made biosimilar solutions, appealing to niche markets within the broader healthcare landscape.

    The shift towards sustainability in manufacturing processes is also becoming prominent, as stakeholders are more focused on environmentally friendly production methods. With these trends, the US Biosimilar Contract Manufacturing Market is positioned for dynamic growth, driven by innovation, strategic partnerships, and an overall commitment to enhancing patient access to affordable medication alternatives.

    US Biosimilar Contract Manufacturing Market Drivers

    Market Segment Insights

    Biosimilar Contract Manufacturing Market Product Insights

    The US Biosimilar Contract Manufacturing Market, a crucial domain within the pharmaceutical industry, is experiencing exponential growth driven by the increasing demand for cost-effective biologics. This market is characterized by its focus on various products, particularly Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins. Recombinant Non-glycosylated Proteins play a vital role in therapeutic applications, often utilized in treatments for conditions such as cancer and autoimmune diseases. These proteins, typically produced using prokaryotic systems, have gained recognition for their consistency and ease of manufacturing, making them significant contributors to the market.

    Meanwhile, Recombinant Glycosylated Proteins, which are essential for proper biological functions and interactions, are produced using eukaryotic systems that enable more complex structures and post-translational modifications. This segment addresses the growing needs for innovative therapeutic solutions, particularly in the realms of biopharmaceuticals and personalized medicine. Both product categories are influenced by key market trends such as the shift towards biosimilars due to their potential for cost savings compared to original biologics. The increasing incidence of chronic diseases in the US further fuels the demand for these products, presenting vast opportunities for growth and development in contract manufacturing capabilities.

    The regulatory landscape also plays a pivotal role, as the US Food and Drug Administration has established pathways for the approval of biosimilars, thereby encouraging competition and novel approaches within the market. However, challenges like ensuring quality and compliance standards in production processes remain critical, driving manufacturers to invest in advanced technologies and stringent quality control measures. Overall, the focus on Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins highlights the importance of enhancing manufacturing efficiencies and leveraging scientific advancements to meet the evolving demands of healthcare markets across the United States.

    This sector is poised for significant transformations, supported by a robust framework encouraging the development of biosimilars that can address the complexities of patient care and treatment accessibility.

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

    Biosimilar Contract Manufacturing Market Production Technology Insights

    The Production Technology segment within the US Biosimilar Contract Manufacturing Market is crucial for the growth of this industry as it significantly impacts the overall supply chain efficiency and product quality. This segment encompasses various methodologies, including both Mammalian and Non-Mammalian approaches, which cater to diverse biopharmaceutical needs. The Mammalian processes are known for their complex post-translational modifications, which are essential for the functionality of therapeutic proteins, making them vital for the development of highly effective biosimilars.

    In contrast, Non-Mammalian systems, often utilizing microbial systems like yeast and bacteria, provide faster production times and lower costs, making them appealing for high-volume manufacturing. This diversification in production technology is particularly beneficial in the US, where regulatory frameworks encourage innovation while ensuring rigorous quality standards. The rising demand for affordable biologics and government initiatives supporting biosimilar development further enhance the significance of innovative production technologies in this market.

    In summary, the integration of both Mammalian and Non-Mammalian technologies facilitates adaptability and responsiveness to market needs, thus driving the overall progress of the US Biosimilar Contract Manufacturing Market.

    Biosimilar Contract Manufacturing Market Application Insights

    The Application segment of the US Biosimilar Contract Manufacturing Market plays a vital role in providing cost-effective and efficient biopharmaceutical solutions. This segment addresses various therapeutic areas including Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, and Rheumatoid Arthritis, among others. Oncology remains a critical focus area due to the rising incidence of cancer, necessitating innovative treatment options. Blood Disorders, which include conditions like hemophilia, are also significant as they require continuous and effective management.

    Moreover, Growth Hormonal Deficiency and Chronic and Autoimmune Disorders present opportunities, given the increasing prevalence of these conditions in the aging population of the US. Rheumatoid Arthritis, as a widespread autoimmune condition, underscores the demand for biosimilars that can offer similar efficacy at a reduced cost. The segment's diversification into these areas highlights its importance in addressing unmet medical needs and improving patient access to essential medications. As the market evolves, advancements in technology and increased regulatory support at the federal level further bolster growth in this vital sector.

    Together, these factors create a dynamic landscape for the US Biosimilar Contract Manufacturing Market, enhancing overall market data and statistics, while promoting sustainable market growth.

    Get more detailed insights about US Biosimilar Contract Manufacturing Market

    Regional Insights

    Key Players and Competitive Insights

    The US Biosimilar Contract Manufacturing Market is characterized by a complex and evolving landscape, with increasing focus on the development and production of biosimilar products aimed at improving patient access to essential medicines while reducing overall healthcare costs. This market has attracted considerable attention due to the growing acceptance of biosimilars among healthcare professionals and regulatory agencies, leading to a surge in demand for contract manufacturing services that cater to this specific segment. Competition within the market is fueled by the entry of numerous players, each vying for partnerships with established pharmaceutical companies.

    The dynamics of this market are influenced by factors such as technological advancements, regulatory challenges, and the need for robust quality assurance processes, all of which determine the operational capability and market reach of contract manufacturers.

    Teva Pharmaceutical Industries, a prominent player in the US Biosimilar Contract Manufacturing Market, has established a strong foothold through its extensive portfolio of biosimilar products. The company benefits from a well-developed infrastructure that supports large-scale manufacturing processes tailored for biosimilars, allowing Teva to deliver high-quality and competitively priced products to the market. Teva’s commitment to innovation is evident in its efforts to enhance manufacturing technologies and processes, which also accounts for its agility in responding to market demands.

    Additionally, the company's established relationships with healthcare providers and payers bolster its competitive position, ensuring greater market access and a strong reputation for reliability in biosimilar manufacturing.

    Samsung Biologics is another key player in the US Biosimilar Contract Manufacturing Market, renowned for its state-of-the-art biomanufacturing facilities and comprehensive service offerings. The company provides a wide range of services including cell line development, process development, and comprehensive manufacturing solutions that ensure timely delivery of high-quality biosimilars. Samsung Biologics has made significant investments in expanding its operational capacity, ensuring it remains flexible and responsive to the unique demands of the biosimilar space. Additionally, strategic collaborations and partnerships with various pharmaceutical companies have enhanced its market presence and operational capabilities in the US.

    Through its commitment to innovation and quality, Samsung Biologics aims to be a leader in the biopharmaceutical contract manufacturing space, further solidifying its position by leveraging advanced technologies and maintaining a strong focus on regulatory compliance and customer satisfaction.

    Key Companies in the US Biosimilar Contract Manufacturing Market market include

    Industry Developments

    Recent developments in the US Biosimilar Contract Manufacturing Market indicate significant activity among key players. Companies like Teva Pharmaceutical Industries, Samsung Biologics, and Lonza continue to expand their manufacturing capabilities to meet rising industry demand. Bristol-Myers Squibb and Eli Lilly and Company have actively engaged in partnerships aimed at enhancing their biosimilar pipelines, which were highlighted in the market earlier this year.

    Notably, in September 2023, Catalent announced a major strategic collaboration with Amgen to bolster its biosimilar production capabilities, demonstrating a commitment to addressing the growing need for affordable biologic medicines. Similarly, Pfizer and Boehringer Ingelheim each reported advancements in their respective manufacturing processes, with a focus on increasing efficiency and compliance with regulatory standards.

    Additionally, the US government's initiatives to support the biosimilars market have catalyzed a competitive landscape, affecting valuations and investment strategies for companies like Roche and Mylan. Over the past two to three years, the market has witnessed an upward trend, with numerous investments aimed at strengthening production and reducing costs for biosimilar medications, aligning with ongoing healthcare reforms that emphasize affordability and access.

    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 1.82(USD Billion)
    MARKET SIZE 2024 2.2(USD Billion)
    MARKET SIZE 2035 14.5(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 18.7% (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 Billion
    KEY COMPANIES PROFILED Teva Pharmaceutical Industries, Samsung Biologics, Lonza, Sandoz, BristolMyers Squibb, Eli Lilly and Company, Boehringer Ingelheim, Fujifilm Diosynth Biotechnologies, Catalent, Pfizer, Generium, Amgen, AbbVie, Roche, Mylan
    SEGMENTS COVERED Product, Production Technology, Application
    KEY MARKET OPPORTUNITIES Increasing demand for cost-effective therapies, Expanding regulatory support for biosimilars, Enhanced focus on oncology biosimilars, Rising prevalence of chronic diseases, Growing partnerships with biotech firms
    KEY MARKET DYNAMICS growing demand for cost-effective alternatives, increasing regulatory approvals, advancements in biomanufacturing technologies, rising healthcare expenditure, strategic partnerships and collaborations
    COUNTRIES COVERED US

    Market Highlights

    Author
    Garvit Vyas
    Analyst

    Explore the profile of Garvit Vyas, one of our esteemed authors at Market Research Future, and access their expert research contributions in the field of market research and industry analysis

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    FAQs

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

    The US Biosimilar Contract Manufacturing Market is expected to be valued at 2.2 billion USD in 2024.

    What is the projected market size for the US Biosimilar Contract Manufacturing Market in 2035?

    The market is projected to reach a size of 14.5 billion USD by 2035.

    What is the expected compound annual growth rate (CAGR) of the market from 2025 to 2035?

    The expected CAGR for the US Biosimilar Contract Manufacturing Market from 2025 to 2035 is 18.7 percent.

    Which segment of the US Biosimilar Contract Manufacturing Market is expected to dominate by 2035?

    By 2035, the Recombinant Glycosylated Proteins segment is expected to hold significant market value at 8.7 billion USD.

    What are the values of the Recombinant Non-glycosylated Proteins segment in 2024 and 2035?

    The Recombinant Non-glycosylated Proteins segment is valued at 0.9 billion USD in 2024 and 5.8 billion USD in 2035.

    Who are some major players in the US Biosimilar Contract Manufacturing Market?

    Major players include Teva Pharmaceutical Industries, Samsung Biologics, Lonza, and Sandoz among others.

    What growth opportunities exist in the US Biosimilar Contract Manufacturing Market?

    Emerging trends, technological advancements, and increasing demand for cost-effective biologics present several growth opportunities.

    How has the competitive landscape changed in the US Biosimilar Contract Manufacturing Market recently?

    A rise in collaborations and strategic partnerships among key players has notably transformed the competitive landscape.

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

    The market for Recombinant Glycosylated Proteins is valued at 1.3 billion USD in 2024.

    What is the strategic implication of the expected growth rate in the US Biosimilar Contract Manufacturing Market?

    The significant growth rate suggests that companies may need to enhance their operational capabilities and expand their portfolios.

    1. EXECUTIVE SUMMARY
    2. Market Overview
    3. Key Findings
    4. Market Segmentation
    5. Competitive Landscape
    6. Challenges and Opportunities
    7. Future Outlook
    8. MARKET INTRODUCTION
    9. Definition
    10. Scope of the study
    11. Research Objective
    12. Assumption
    13. Limitations
    14. RESEARCH METHODOLOGY
    15. Overview
    16. Data Mining
    17. Secondary Research
    18. Primary Research
    19. Primary Interviews and Information Gathering Process
    20. Breakdown of Primary Respondents
    21. Forecasting Model
    22. Market Size Estimation
    23. Bottom-Up Approach
    24. Top-Down Approach
    25. Data Triangulation
    26. Validation
    27. MARKET DYNAMICS
    28. Overview
    29. Drivers
    30. Restraints
    31. Opportunities
    32. MARKET FACTOR ANALYSIS
    33. Value chain Analysis
    34. Porter's Five Forces Analysis
    35. Bargaining Power of Suppliers
    36. Bargaining Power of Buyers
    37. Threat of New Entrants
    38. Threat of Substitutes
    39. Intensity of Rivalry
    40. COVID-19 Impact Analysis
    41. Market Impact Analysis
    42. Regional Impact
    43. Opportunity and Threat Analysis
    44. US Biosimilar Contract Manufacturing Market, BY Product (USD Billion)
    45. Recombinant Non-glycosylated Proteins
    46. Recombinant Glycosylated Proteins
    47. US Biosimilar Contract Manufacturing Market, BY Production Technology (USD Billion)
    48. Mammalian
    49. Non-Mammalian
    50. US Biosimilar Contract Manufacturing Market, BY Application (USD Billion)
    51. Oncology
    52. Blood Disorders
    53. Growth Hormonal Deficiency
    54. Chronic & Autoimmune Disorders
    55. Rheumatoid Arthritis
    56. Others
    57. Competitive Landscape
    58. Overview
    59. Competitive Analysis
    60. Market share Analysis
    61. Major Growth Strategy in the Biosimilar Contract Manufacturing Market
    62. Competitive Benchmarking
    63. Leading Players in Terms of Number of Developments in the Biosimilar Contract Manufacturing Market
    64. Key developments and growth strategies
    65. New Product Launch/Service Deployment
    66. Merger & Acquisitions
    67. Joint Ventures
    68. Major Players Financial Matrix
    69. Sales and Operating Income
    70. Major Players R&D Expenditure. 2023
    71. Company Profiles
    72. Teva Pharmaceutical Industries
    73. Financial Overview
    74. Products Offered
    75. Key Developments
    76. SWOT Analysis
    77. Key Strategies
    78. Samsung Biologics
    79. Financial Overview
    80. Products Offered
    81. Key Developments
    82. SWOT Analysis
    83. Key Strategies
    84. Lonza
    85. Financial Overview
    86. Products Offered
    87. Key Developments
    88. SWOT Analysis
    89. Key Strategies
    90. Sandoz
    91. Financial Overview
    92. Products Offered
    93. Key Developments
    94. SWOT Analysis
    95. Key Strategies
    96. BristolMyers Squibb
    97. Financial Overview
    98. Products Offered
    99. Key Developments
    100. SWOT Analysis
    101. Key Strategies
    102. Eli Lilly and Company
    103. Financial Overview
    104. Products Offered
    105. Key Developments
    106. SWOT Analysis
    107. Key Strategies
    108. Boehringer Ingelheim
    109. Financial Overview
    110. Products Offered
    111. Key Developments
    112. SWOT Analysis
    113. Key Strategies
    114. Fujifilm Diosynth Biotechnologies
    115. Financial Overview
    116. Products Offered
    117. Key Developments
    118. SWOT Analysis
    119. Key Strategies
    120. Catalent
    121. Financial Overview
    122. Products Offered
    123. Key Developments
    124. SWOT Analysis
    125. Key Strategies
    126. Pfizer
    127. Financial Overview
    128. Products Offered
    129. Key Developments
    130. SWOT Analysis
    131. Key Strategies
    132. Generium
    133. Financial Overview
    134. Products Offered
    135. Key Developments
    136. SWOT Analysis
    137. Key Strategies
    138. Amgen
    139. Financial Overview
    140. Products Offered
    141. Key Developments
    142. SWOT Analysis
    143. Key Strategies
    144. AbbVie
    145. Financial Overview
    146. Products Offered
    147. Key Developments
    148. SWOT Analysis
    149. Key Strategies
    150. Roche
    151. Financial Overview
    152. Products Offered
    153. Key Developments
    154. SWOT Analysis
    155. Key Strategies
    156. Mylan
    157. Financial Overview
    158. Products Offered
    159. Key Developments
    160. SWOT Analysis
    161. Key Strategies
    162. References
    163. Related Reports
    164. US Biosimilar Contract Manufacturing Market SIZE ESTIMATES & FORECAST, BY PRODUCT, 2019-2035 (USD Billions)
    165. US Biosimilar Contract Manufacturing Market SIZE ESTIMATES & FORECAST, BY PRODUCTION TECHNOLOGY, 2019-2035 (USD Billions)
    166. US Biosimilar Contract Manufacturing Market SIZE ESTIMATES & FORECAST, BY APPLICATION, 2019-2035 (USD Billions)
    167. PRODUCT LAUNCH/PRODUCT DEVELOPMENT/APPROVAL
    168. ACQUISITION/PARTNERSHIP
    169. MARKET SYNOPSIS
    170. US BIOSIMILAR CONTRACT MANUFACTURING MARKET ANALYSIS BY PRODUCT
    171. US BIOSIMILAR CONTRACT MANUFACTURING MARKET ANALYSIS BY PRODUCTION TECHNOLOGY
    172. US BIOSIMILAR CONTRACT MANUFACTURING MARKET ANALYSIS BY APPLICATION
    173. KEY BUYING CRITERIA OF BIOSIMILAR CONTRACT MANUFACTURING MARKET
    174. RESEARCH PROCESS OF MRFR
    175. DRO ANALYSIS OF BIOSIMILAR CONTRACT MANUFACTURING MARKET
    176. DRIVERS IMPACT ANALYSIS: BIOSIMILAR CONTRACT MANUFACTURING MARKET
    177. RESTRAINTS IMPACT ANALYSIS: BIOSIMILAR CONTRACT MANUFACTURING MARKET
    178. SUPPLY / VALUE CHAIN: BIOSIMILAR CONTRACT MANUFACTURING MARKET
    179. BIOSIMILAR CONTRACT MANUFACTURING MARKET, BY PRODUCT, 2025 (% SHARE)
    180. BIOSIMILAR CONTRACT MANUFACTURING MARKET, BY PRODUCT, 2019 TO 2035 (USD Billions)
    181. BIOSIMILAR CONTRACT MANUFACTURING MARKET, BY PRODUCTION TECHNOLOGY, 2025 (% SHARE)
    182. BIOSIMILAR CONTRACT MANUFACTURING MARKET, BY PRODUCTION TECHNOLOGY, 2019 TO 2035 (USD Billions)
    183. BIOSIMILAR CONTRACT MANUFACTURING MARKET, BY APPLICATION, 2025 (% SHARE)
    184. BIOSIMILAR CONTRACT MANUFACTURING MARKET, BY APPLICATION, 2019 TO 2035 (USD Billions)
    185. BENCHMARKING OF MAJOR COMPETITORS

    US Biosimilar Contract Manufacturing Market Segmentation

    • Biosimilar Contract Manufacturing Market By Product (USD Billion, 2019-2035)

      • Recombinant Non-glycosylated Proteins
      • Recombinant Glycosylated Proteins
    • Biosimilar Contract Manufacturing Market By Production Technology (USD Billion, 2019-2035)

      • Mammalian
      • Non-Mammalian
    • Biosimilar Contract Manufacturing Market By Application (USD Billion, 2019-2035)

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

     

     

     

     

     

     

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