Biologics CDMO Global and Regional Market Analysis Report 2025-2035: Outsourcing Trend Accelerates as Biologics CDMOs Offer Speed, Scale, and Regulatory Expertise - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Biologics CDMO Market - A Global and Regional Analysis: Focus on Cell Type, Indication, Molecule Type, and Region - Analysis and Forecast, 2025-2035" report has been added to ResearchAndMarkets.com's offering.

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.

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.

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.

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.

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.

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.

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.

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.

Key Market Players

• 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

Key Topics Covered:

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

5.2.3 Asia-Pacific

5.2.4 Latin America

5.2.5 Middle East & Africa

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, 2023- 2023

6.3 Company Profiles

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