생물제제 CDMO 시장 : 세계 및 지역별 분석 - 세포 유형별, 적응증별, 분자 유형별, 지역별 - 분석과 예측(2025-2035년)

Global Biologics CDMO Market Overview

The global biologics CDMO market is experiencing rapid growth, driven by the increasing demand for biologic therapies and the growing trend of outsourcing development and manufacturing processes. Pharmaceutical companies are increasingly relying on biologics CDMOs to handle the complexities of biologic drug production, which requires specialized expertise, advanced infrastructure, and stringent regulatory compliance. By outsourcing to biologics CDMOs, companies can streamline operations, reduce costs, and accelerate time-to-market, allowing them to focus more on their core competencies in research and development.

Several factors are fueling the expansion of the biologics CDMO market, including the rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders, which drive the need for innovative biologic treatments. Additionally, advancements in biotechnology are enabling the development of next-generation biologics, including monoclonal antibodies, cell and gene therapies, and recombinant proteins. The aging global population is further increasing the demand for these therapies, prompting pharmaceutical companies to seek flexible and scalable manufacturing solutions. As a result, the biologics CDMO market is expected to continue its strong growth trajectory, playing a crucial role in the evolving pharmaceutical landscape.

The biologics CDMO market is well-positioned for continued growth as pharmaceutical companies increasingly turn to biologics CDMOs to accelerate the development and commercialization of biologic therapies. Biologics CDMOs offer a comprehensive range of services, including upstream processing, downstream processing, and analytical services, enabling pharmaceutical companies to bring their biologics products to market more quickly and efficiently. As the demand for biologics continues to rise, biologics CDMOs are playing a crucial role in optimizing production and ensuring high-quality manufacturing.

The biologics CDMO market is also benefiting from significant investments in expanding CDMO capacity to meet the increasing demand for biologics manufacturing services. To stay competitive and enhance operational efficiency, biologics CDMOs are adopting advanced technologies such as single-use bioreactors and continuous manufacturing. These innovations help improve scalability, reduce costs, and enhance flexibility in biologics production. With continuous advancements and increasing reliance on outsourced services, the biologics CDMO market is poised for sustained growth in the coming years.

Industry Impact

The emergence and expansion of the biologics CDMO market have profoundly reshaped the biopharmaceutical industry. Biologics CDMOs serve as critical enablers of accelerated drug development and manufacturing, offering specialized expertise, cutting-edge technologies, and scalable solutions. By providing cost-efficient alternatives, particularly for startups and smaller enterprises, biologics CDMOs reduce the need for substantial capital investment while mitigating risks associated with complex regulatory landscapes. Additionally, the global reach and diverse capabilities of biologics CDMOs have contributed to the globalization of biomanufacturing, allowing pharmaceutical companies to navigate regional regulatory frameworks with greater ease. The competitive nature of the biologics CDMO sector fosters continuous innovation and technological advancements, driving progress across the entire biopharmaceutical ecosystem. Leading CDMOs specializing in biologics leverage advanced protein expression systems to accelerate the development and scalable production of therapeutic proteins, ensuring high yield, purity, and regulatory compliance. As strategic partners, biologics CDMOs enhance industry capacity, flexibility, and efficiency, playing an indispensable role in meeting the growing demand for biologic drugs worldwide.

Market Segmentation:

Segmentation 1: by Cell Type

• Mammalian
• Microbial
• Others

Mammalian Segment to Dominate the Global Biologics CDMO Market (by Cell Type)

The mammalian segment dominated the global biologics CDMO market (by cell type) in FY2024, driven by its ability to accurately replicate complex proteins with high bioactivity and minimal post-translational modifications. Widely preferred for biopharmaceutical production, mammalian cell lines are particularly suited for manufacturing monoclonal antibodies, which constitute a significant share of biologic drugs. Offering scalability, robust performance, and compatibility with the intricate demands of therapeutic protein production, mammalian cell cultures play a crucial role in advancing biomanufacturing. As the biologics CDMO market continues to grow, the prominence of mammalian cell culture technology underscores its importance in meeting the global demand for cutting-edge biopharmaceuticals.

Segmentation 2: by Indication

• Oncology
• Auto-Immune Diseases
• Infectious Diseases
• Neurology
• Others

Oncology Segment to Dominate the Global Biologics CDMO Market (by Indication)

The oncology segment led the global biologics CDMO market (by indication) in FY2024, driven by the surge in cancer research and the development of targeted therapies and immunotherapies. A significant portion of biopharmaceutical innovations is focused on oncology, leading biologics CDMOs to increasingly specialize in manufacturing monoclonal antibodies, cell-based therapies, and other cancer-targeting biologics. This trend underscores the growing emphasis on personalized medicine and the need for advanced manufacturing capabilities to address the complexities of oncology treatments, reinforcing the pivotal role of biologics CDMOs in supporting the evolving landscape of cancer therapeutics.

Segmentation 3: by Molecule Type

• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Hormones
• Others

Monoclonal Antibodies Segment to Dominate the Global Biologics CDMO Market (by Molecule Type)

The monoclonal antibodies (mAbs) segment dominated the global biologics CDMO market (by molecule type) in FY2024, driven by their widespread adoption in treating cancer, autoimmune disorders, and infectious diseases. As precision medicine continues to gain momentum, mAbs offer highly targeted and specific therapeutic approaches, further increasing their demand. This surge has led biologics CDMOs to experience growing requests for the development and manufacturing of monoclonal antibodies, reinforcing their critical role in the evolving landscape of biologic drug development and advanced therapeutics.

Segmentation 4: by Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

The biologics CDMO market in the Asia-Pacific (APAC) region is experiencing rapid growth, driven by increasing demand for biopharmaceuticals, technological advancements, and the rising burden of chronic diseases. Among APAC countries, China is leading the market, fueled by strong government support, a growing biosimilars industry, and an expanding biomanufacturing infrastructure. The country's strategic investments in biologics production, coupled with evolving regulatory frameworks that favor contract biomanufacturing, have positioned China as a key hub for biologics CDMO services in the region.

Recent Developments in the Global Biologics CDMO Market

• In November 2023, Boehringer Ingelheim International GmbH expanded the application of gene data biologics to DMPK operations.
• In November 2023, Lonza introduced the GS Effex cell line to support biotech companies in advancing the development of therapeutic antibodies.
• In October 2023, Lonza entered into a commercial agreement with Vaxcyte for the global production of broad-spectrum pneumococcal conjugate vaccines (PCVs).
• In August 2023, AGC Biologics completed the expansion of its cell and gene therapy (CGT) manufacturing facility in Milan.
• In August 2023, AGC Biologics announced a partnership with Asahi Kasei Pharma Corporation to manufacture clinical drug substances for antibody-based therapies.
• In July 2023, Boehringer Ingelheim International GmbH launched its adalimumab biosimilar, adalimumab-adbm (Cyltezo), for commercial use in the U.S.
• In July 2023, Biocon Biologics introduced a biosimilar version of AbbVie's rheumatoid arthritis drug Humira in the U.S.
• In March 2023, Catalent, Inc. obtained a license for Bhami Research Laboratory Technology to enhance biologics formulation development.

Demand - Drivers, Restraints, and Opportunities

Market Drivers:

• Growing Biologics Approvals and Development: The global biologics CDMO market is witnessing significant expansion, driven by the rising number of approvals for biologics and biosimilars. This surge highlights the increasing importance of biopharmaceuticals in addressing diverse medical conditions and the growing pipeline of innovative biologic drugs. As regulatory bodies worldwide continue to approve new biologics and biosimilars, pharmaceutical companies are increasingly relying on biologics CDMO services to fulfill the rising demand for specialized manufacturing expertise. The growing role of biologics CDMO providers underscores their critical contribution to the evolving biopharmaceutical landscape.
• Rising Prevalence of Chronic Infectious Diseases
• Advantages of Investments in Contract Manufacturing Facilities

Market Restraints:

• Stringent Regulatory Requirements: The biologics CDMO market encounters significant constraints due to stringent regulatory requirements. The highly regulated nature of the biopharmaceutical industry, marked by rigorous compliance standards and stringent quality control measures, poses challenges for biologics CDMO providers. Navigating complex regulatory frameworks demands substantial expertise, resources, and continuous adaptation to evolving compliance expectations, making regulatory adherence a critical hurdle for biologics CDMO operations.
• Shortage of Skilled Professionals in Bioprocessing and Biomanufacturing

Market Opportunities:

• New Outsourcing Opportunities in China: The surge in investments in China's biologics CDMO market is fueled by the growing influx of biosimilars and innovative drugs, the rising demand for expanded manufacturing capacity, and evolving regulatory policies. To address both global and domestic market needs, Chinese regulatory authorities took a significant step by permitting contract biomanufacturing within the country. This regulatory shift has accelerated the growth of biologics CDMO services in China, attracting increased investment and strengthening the nation's position in the global biopharmaceutical landscape.
• Potential for Additional CDMO and Big Pharma Alliances

How can this report add value to an organization?

Workflow/Innovation Strategy: The biologics CDMO market (by molecule type) is categorized based on various molecular types utilized in biologics development. Additionally, the study offers a comprehensive analysis of different cell types and indications, providing readers with a deeper understanding of the key components shaping the biologics manufacturing landscape.

Growth/Marketing Strategy: The biologics CDMO market's growth and marketing strategy are driven by a combination of technical excellence, strategic collaborations, and global market positioning. Biologics CDMOs capitalize on their specialized expertise in bioprocessing and manufacturing to provide comprehensive solutions tailored to the needs of biopharmaceutical companies. By leveraging advanced technologies, regulatory expertise, and scalable production capabilities, CDMOs strengthen their competitive edge and expand their market presence in the evolving biopharmaceutical landscape.

Competitive Strategy: The study provides an in-depth analysis and profiling of key players in the global biologics CDMO market, highlighting new product launches, acquisitions, expansions, and strategic collaborations. A detailed competitive benchmarking has been conducted to offer insights into how these players compare, presenting a clear view of the market landscape. Additionally, a comprehensive examination of competitive strategies, including partnerships, agreements, and collaborations, helps identify untapped revenue opportunities, enabling a deeper understanding of growth prospects within the biologics CDMO market.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

• This report primarily focuses on the various cell types, molecule types, and indications within the global biologics CDMO market.
• The market analysis is conducted in US dollars (US$), with all other currencies converted to US$ based on the average exchange rate for the respective year.
• Currency conversion rates have been sourced from the historical exchange rates available on the Oanda website.
• The insights presented in this report are derived from comprehensive primary interviews, surveys, and secondary research.
• In cases where direct data was unavailable, proxy indicators and extrapolation methods were utilized.
• Future economic downturns have not been factored into the market estimations and forecasts.
• The current technologies used in the industry are assumed to remain consistent throughout the forecast period, with no major technological breakthroughs anticipated.

Primary Research

The primary sources involve industry experts from the biologics CDMO stakeholders. Respondents such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

Secondary Research

This research study involves the usage of extensive secondary research, directories, company websites, and annual reports. It also makes use of databases, such as Hoovers, Bloomberg, Businessweek, and Factiva, to collect useful and effective information for an extensive, technical, market-oriented, and commercial study of the global market. In addition to the aforementioned data sources, the study has been undertaken with the help of other data sources and websites, such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), World Health Organization (WHO), National Center for Biotechnology Information, and others.

The key data points taken from the secondary sources include:

• Segmentations, split-ups, and percentage shares
• Data for market value
• Key industry trends of the top players in the market
• Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
• Quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

The biologics CDMO market is undergoing rapid expansion, solidifying its role as a crucial component of the biopharmaceutical industry. This dynamic sector is driven by the increasing demand for outsourcing services in the development and manufacturing of biologic drugs. Biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, constitute a rapidly growing segment within the pharmaceutical landscape. As pharmaceutical and biotech companies strive to bring innovative biologics to market, they increasingly rely on biologics CDMO providers for specialized expertise, cutting-edge technologies, and cost-efficient solutions. The market is characterized by a diverse range of biologics CDMO players, each offering unique capabilities across the entire biologics development and manufacturing value chain.

With a global footprint, biologics CDMO providers are well-equipped to meet the industry's growing demand for flexible, high-quality, and efficient solutions in biologics development and manufacturing. As the biopharmaceutical market continues to expand, the biologics CDMO market is set to play a pivotal role in accelerating the transition of innovative therapies from concept to commercialization. By leveraging advanced technologies, regulatory expertise, and scalable production capabilities, biologics CDMO firms are becoming indispensable partners in the evolving biopharmaceutical landscape.

Some of the prominent companies in this market are:

• AbbVie Inc.
• AGC Biologics
• Binex Co. Limited
• Boehringer Ingelheim International GmbH
• Catalent, Inc
• Lonza
• Novartis AG
• Parexel International Corporation
• Samsung Biologics
• Toyobo Co., Ltd.
• WuXi Bio
• Catalent
• Fujifilm Diosynth

Companies that are not a part of the aforementioned pool have been well-represented across different sections of the report (wherever applicable).

Table of Contents

Executive Summary

Scope of the Study

Research Methodology

1. Global Biologics CDMO Market Overview

• 1.1 Market Outlook
  • 1.1.1 Definitions
  • 1.1.2 Inclusion and Exclusion Criteria
  • 1.1.3 Market Size, 2024 - 2035 (US$)
  • 1.1.4 Market Growth Scenario
    • 1.1.4.1 Realistic Scenario
    • 1.1.4.2 Optimistic Scenario
    • 1.1.4.3 Pessimistic Scenario
• 1.2 Industry Outlook
  • 1.2.1 Introduction
  • 1.2.2 Market Overview and Ecosystem
  • 1.2.3 Key Trends
  • 1.2.4 Market Footprint
  • 1.2.5 Patent Analysis
  • 1.2.6 Factors Considered while Outsourcing to CDMO
  • 1.2.7 Regulatory Landscape / Compliances
• 1.3 Market Dynamics
  • 1.3.1 Market Opportunities and Trends
  • 1.3.2 Market Drivers
    • 1.3.2.1 Impact Analysis
  • 1.3.3 Market Restraints
    • 1.3.3.1 Impact Analysis

2. Global Biologics CDMO Market Analysis (By Cell Type), $ Million, 2024-2035

• 2.1 Cell Type Summary
• 2.2 Mammalian
• 2.3 Microbial
• 2.4 Others

3. Global Biologics CDMO Market Analysis (By Indication), $ Million, 2024-2035

• 3.1 Indication Summary
• 3.2 Oncology
• 3.3 Auto-Immune Diseases
• 3.4 Infectious Diseases
• 3.5 Neurology
• 3.6 Others

4. Global Biologics CDMO Market Analysis (By Molecule Type), $ Million, 2024-2035

• 4.1 Molecule Type Summary
• 4.2 Monoclonal Antibodies
• 4.3 Recombinant Proteins
• 4.4 Vaccines
• 4.5 Hormones
• 4.6 Others

5. Global Biologics CDMO Market Analysis (By Region), $ Million, 2024-2035

• 5.1 Regional Summary
• 5.2 Drivers and Restraints
  • 5.2.1 North America
    • 5.2.1.1 By Cell Type
    • 5.2.1.2 By Molecule Type
      • 5.2.1.2.1 North America (by Country)
        • 5.2.1.2.1.1 U.S
        • 5.2.1.2.1.1.1 By Cell Type.
        • 5.2.1.2.1.1.2 By Molecule Type
        • 5.2.1.2.1.2 Canada
        • 5.2.1.2.1.2.1 By Cell Type.
        • 5.2.1.2.1.2.2 By Molecule Type
  • 5.2.2 Europe
    • 5.2.2.1 By Cell Type
    • 5.2.2.2 By Molecule Type
      • 5.2.2.2.1 Europe (by Country)
        • 5.2.2.2.1.1 Germany
        • 5.2.2.2.1.1.1 By Cell Type
        • 5.2.2.2.1.1.2 By Molecule Type
        • 5.2.2.2.1.2 U.K.
        • 5.2.2.2.1.2.1 By Cell Type
        • 5.2.2.2.1.2.2 By Molecule Type
        • 5.2.2.2.1.3 France
        • 5.2.2.2.1.3.1 By Cell Type
        • 5.2.2.2.1.3.2 By Molecule Type
        • 5.2.2.2.1.4 Italy
        • 5.2.2.2.1.4.1 By Cell Type
        • 5.2.2.2.1.4.2 By Molecule Type
        • 5.2.2.2.1.5 Spain
        • 5.2.2.2.1.5.1 By Cell Type
        • 5.2.2.2.1.5.2 By Molecule Type
        • 5.2.2.2.1.6 Rest of Europe
        • 5.2.2.2.1.6.1 By Cell Type
        • 5.2.2.2.1.6.2 By Molecule Type
  • 5.2.3 Asia-Pacific
    • 5.2.3.1 By Cell Type
    • 5.2.3.2 By Molecule Type
      • 5.2.3.2.1 Asia-Pacific (by Country)
        • 5.2.3.2.1.1 Japan
        • 5.2.3.2.1.1.1 By Cell Type
        • 5.2.3.2.1.1.2 By Molecule Type
        • 5.2.3.2.1.2 China
        • 5.2.3.2.1.2.1 By Cell Type
        • 5.2.3.2.1.2.2 By Molecule Type
        • 5.2.3.2.1.3 India
        • 5.2.3.2.1.3.1 By Cell Type
        • 5.2.3.2.1.3.2 By Molecule Type
        • 5.2.3.2.1.4 Australia
        • 5.2.3.2.1.4.1 By Cell Type
        • 5.2.3.2.1.4.2 By Molecule Type
        • 5.2.3.2.1.5 Rest-of-Asia-Pacific
        • 5.2.3.2.1.5.1 By Cell Type
        • 5.2.3.2.1.5.2 By Molecule Type
  • 5.2.4 Latin America
    • 5.2.4.1 By Cell Type
    • 5.2.4.2 By Molecule Type
      • 5.2.4.2.1 Latin America (by Country)
        • 5.2.4.2.1.1 Brazil
        • 5.2.4.2.1.1.1 By Cell Type
        • 5.2.4.2.1.1.2 By Molecule Type
        • 5.2.4.2.1.2 Mexico
        • 5.2.4.2.1.2.1 By Cell Type
        • 5.2.4.2.1.2.2 By Molecule Type
        • 5.2.4.2.1.3 Rest-of-Latin America
        • 5.2.4.2.1.3.1 By Cell Type
        • 5.2.4.2.1.3.2 By Molecule Type
  • 5.2.5 Middle East & Africa
    • 5.2.5.1 By Cell Type
    • 5.2.5.2 By Molecule Type
      • 5.2.5.2.1 Middle East Africa (by Country)
        • 5.2.5.2.1.1 KSA
        • 5.2.5.2.1.1.1 By Cell Type
        • 5.2.5.2.1.1.2 By Molecule Type
        • 5.2.5.2.1.2 U.A.E.
        • 5.2.5.2.1.2.1 By Cell Type
        • 5.2.5.2.1.2.2 By Molecule Type
        • 5.2.5.2.1.3 Rest-of-Middle East and Africa
        • 5.2.5.2.1.3.1 By Cell Type
        • 5.2.5.2.1.3.2 By Molecule Type

6. Global Biologics CDMO Market - Competitive Benchmarking and Company Profiles

• 6.1 Competitive Benchmarking
• 6.2 Competitive Landscape
  • 6.2.1 Key Strategies and Developments by Company
    • 6.2.1.1 Funding Activities
    • 6.2.1.2 Mergers and Acquisitions
    • 6.2.1.3 Regulatory Approvals
    • 6.2.1.4 Partnerships, Collaborations, and Business Expansions
  • 6.2.2 Key Developments Analysis
  • 6.2.3 Company Share Analysis/ Company Position Analysis
• 6.3 Company Profiles
  • 6.3.1 AbbVie
  • 6.3.2 AGC Biologics
  • 6.3.3 Binex Co. Ltd.
  • 6.3.4 Catalent, Inc.
  • 6.3.5 Lonza Group
  • 6.3.6 Novartis AG
  • 6.3.7 Paraxel International Corporation
  • 6.3.8 Samsung Biologics
  • 6.3.9 Toyobo Co. Ltd.
  • 6.3.10 Boehringer Ingelheim International GmbH