生物製剂CDMO市场规模、份额和成长分析（按服务类型、生产平台、治疗模式、最终用户和地区划分）－2025-2032年产业预测

预计到 2023 年，全球生物製剂 CDMO 市场规模将达到 213 亿美元，到 2024 年将达到 246.2 亿美元，到 2032 年将达到 785.2 亿美元，预测期（2025-2032 年）的复合年增长率为 15.6%。

全球生物製剂CDMO市场正经历显着成长，这主要得益于对生物製剂（包括单株抗体、疫苗以及细胞和基因疗法等先进治疗方法）需求的不断增长。随着企业将营运外包以提高效率，他们正日益寻求更具成本效益且扩充性的研发和生产模式。 CDMO拥有加速生物製剂上市的专业技术，而快速成长的临床研发管线和日益复杂的监管环境进一步推动了对经验丰富的合作伙伴的需求。然而，高额的资本投入、复杂的生产流程以及监管方面的担忧等挑战，可能会阻碍发展中地区（尤其是那些缺乏熟练劳动力和基础设施的地区）的市场成长。儘管存在这些障碍，但战略合作、技术进步以及生物製造设施数量的不断增加预计将推动市场的长期发展。

全球生物製药CDMO市场驱动因素

慢性病盛行率的上升以及生物製药的日益普及，显着增加了对大规模生物製药生产的需求。随着生物相似药研发管线的不断扩展，製药和生技公司正积极寻求提高营运效率。这一趋势促使这些企业加强与合约研发生产机构（CDMO）的合作，以利用其专业知识优化资源配置、简化生产流程并缩短新治疗方法的上市时间。这些策略联盟不仅提高了生产效率，也促进了生物製药这一新兴领域的创新。

全球生技药品CDMO市场的限制因素

全球生物製药CDMO市场面临着巨大的挑战，因为生物製药的生产需要大量的资本投入。这些投资包括建造复杂的基础设施、专用设施和无尘室，这些都是维持品质标准所必需的。生物製药过程尤其复杂，涉及细胞培养和纯化技术，需要熟练的员工和全面的营运管理。这种复杂性造成了巨大的财务壁垒，可能会阻碍新的合约研发生产机构（CDMO）进入市场。此外，即使是现有的生物製药CDMO，如果没有足够的资金支持，也可能难以有效地扩大业务，从而限制其在竞争激烈的市场环境中的成长潜力。

全球生技药品CDMO市场趋势

全球生物製药CDMO市场的一大趋势是单次使用技术的广泛应用，显着提高了营运效率和产品品质。这些创新系统透过提供无与伦比的灵活性并最大限度地降低生产过程中的污染风险，正在改变行业格局。采用单次使用生物反应器可实现快速切换和简化工作流程，最终缩短週转时间。对于拥有多种产品的工厂以及开发早期生物製剂（例如临床和个人化治疗药物）的工厂而言，这项变更尤其有利。因此，CDMO正在利用这些技术建立扩充性且适应性强的生产模式，从而推动产业成长和创新。

目录

介绍

• 调查目标
• 调查范围
• 定义

调查方法

• 资讯收集
• 二手资料和一手资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态与展望

• 市场概览
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特分析

关键市场考察

• 关键成功因素
• 竞争程度
• 关键投资机会
• 市场生态系统
• 市场吸引力指数（2024）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析
• 技术评估
• 监管环境

生物製剂CDMO市场规模（依服务类型划分）及复合年增长率（2025-2032年）

• 市场概览
• 製程开发和细胞株开发
• 原料药生产
• 药品填充和包装
• 分析/测试/品管服务
• 端到端/整合式CDMO服务

生物製剂CDMO市场规模（依生产平台及复合年增长率划分）（2025-2032年）

• 市场概览
• 哺乳动物系统
• 微生物系统
• 其他平台

生物製剂CDMO市场规模依模式类型及复合年增长率划分（2025-2032年）

• 市场概览
• 单株抗体（mAbs）
• 重组蛋白
• 生物相似药
• 细胞和基因治疗/病毒载体
• 其他生物製剂

生物製剂CDMO市场规模（依最终用户划分）及复合年增长率（2025-2032年）

• 市场概览
• 大型製药企业
• 生技/中小型生技公司
• 学术和研究机构
• 政府和公共部门合约

生物製剂CDMO市场规模及复合年增长率（2025-2032年）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业的市场定位（2024 年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市占率分析（2024 年）
• 主要企业公司简介
  • 公司详情
  • 产品系列分析
  • 依业务板块进行公司股票分析
  • 2022-2024年营收年比比较

主要企业简介

• Lonza Group Ltd.
• Samsung Biologics
• Catalent, Inc.
• WuXi Biologics Cayman Inc.
• Thermo Fisher Scientific Inc.
• AGC Biologics
• Boehringer Ingelheim BioXcellence
• 3P Biopharmaceuticals
• FUJIFILM Diosynth Biotechnologies
• Binex Co. Ltd.
• Patheon（part of Thermo Fisher）
• Recipharm AB
• BioVectra Inc.
• Janssen Biotechnology Services（Johnson & Johnson）
• AbbVie Contract Manufacturing（AbbVie）
• Charles River Laboratories（Biologics CDMO division）
• Catalent Biologics（subsidiary of Catalent）
• Philips-Morris Scientific Services（CDMO arm）
• Celltrion Technologies Corporation
• KanaBio Sciences Inc.

结论与建议

Global Biologics CDMO Market size was valued at USD 21.3 billion in 2023 and is poised to grow from USD 24.62 billion in 2024 to USD 78.52 billion by 2032, growing at a CAGR of 15.6% during the forecast period (2025-2032).

The global biologics CDMO market is experiencing significant growth driven by the escalating demand for biologics, including monoclonal antibodies, vaccines, and advanced therapies like cell and gene therapies. Companies are increasingly seeking cost-effective and scalable development and manufacturing models, alongside a trend toward outsourcing operations to enhance efficiency. CDMOs possess specialized expertise that accelerates time-to-market for biologics, while a surge in clinical pipelines and regulatory complexities further propels the need for experienced partners. However, challenges such as high capital investments, intricate manufacturing processes, and regulatory concerns may restrain market growth in less-developed regions, where skilled labor and infrastructure shortages are prevalent. Despite these hurdles, strategic partnerships, technological advancements, and the rise of biomanufacturing facilities are expected to bolster long-term market momentum.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biologics CDMO market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Biologics CDMO Market Segments Analysis

Global Biologics CDMO Market is segmented by Service Type, Production Platform, Modality Type, End-User and region. Based on Service Type, the market is segmented into Process Development & Cell Line Development, Drug Substance Manufacturing, Drug Product / Fill-Finish & Packaging, Analytical / Testing / QC Services and End-to-End / Integrated CDMO Services. Based on Production Platform, the market is segmented into Mammalian Systems, Microbial Systems and Other Platforms. Based on Modality Type, the market is segmented into Monoclonal Antibodies (mAbs), Recombinant Proteins, Biosimilars, Cell & Gene Therapies / Viral Vectors and Other Biologics. Based on End-User, the market is segmented into Large Pharmaceutical Companies, Biotechnology / Small & Mid-Sized Biotechs, Academic & Research Institutes and Government / Public Sector Contracts. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Biologics CDMO Market

The rising prevalence of chronic diseases, coupled with the growing adoption of biologic products, has fueled a significant surge in demand for large-scale biologics manufacturing. As the pipeline for biosimilars continues to expand, companies in the pharmaceutical and biotechnology sectors are actively seeking greater operational efficiencies. This trend has prompted these organizations to increasingly collaborate with contract development and manufacturing organizations (CDMOs), leveraging their specialized expertise to optimize resource allocation, streamline production processes, and accelerate time-to-market for new therapies. This strategic partnership not only enhances productivity but also fosters innovation in the evolving landscape of biologics.

Restraints in the Global Biologics CDMO Market

The Global Biologics CDMO market faces significant challenges due to the high capital investment required for biologics manufacturing. This investment encompasses advanced infrastructure, specialized equipment, and the establishment of cleanrooms, all essential for maintaining quality standards. Biologics processes are particularly intricate, involving cell culture and purification techniques that demand a skilled workforce and comprehensive operational controls. Such complexities create substantial financial barriers that can hinder the entry of new Contract Development and Manufacturing Organizations (CDMOs) into the market. Additionally, existing biological CDMOs may struggle to scale their operations effectively without considerable financial backing, limiting their growth potential in this competitive landscape.

Market Trends of the Global Biologics CDMO Market

The Global Biologics CDMO market is witnessing a notable trend toward the increasing utilization of single-use technologies, which significantly enhance operational efficiency and product quality. These innovative systems are transforming the landscape by providing unparalleled flexibility and minimizing contamination risks in manufacturing processes. The adoption of single-use bioreactors allows for quicker changeovers and streamlined workflows, ultimately leading to reduced turnaround times. This shift is particularly advantageous for facilities handling multiple products or developing early-stage biologics, such as clinical and personalized therapeutics. As a result, CDMOs are leveraging these technologies to establish scalable and adaptive production models, fostering growth and innovation within the sector.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Technology Assessment
• Regulatory Landscape

Global Biologics CDMO Market Size by Service Type & CAGR (2025-2032)

• Market Overview
• Process Development & Cell Line Development
• Drug Substance Manufacturing
• Drug Product / Fill-Finish & Packaging
• Analytical / Testing / QC Services
• End-to-End / Integrated CDMO Services

Global Biologics CDMO Market Size by Production Platform & CAGR (2025-2032)

• Market Overview
• Mammalian Systems
• Microbial Systems
• Other Platforms

Global Biologics CDMO Market Size by Modality Type & CAGR (2025-2032)

• Market Overview
• Monoclonal Antibodies (mAbs)
• Recombinant Proteins
• Biosimilars
• Cell & Gene Therapies / Viral Vectors
• Other Biologics

Global Biologics CDMO Market Size by End-User & CAGR (2025-2032)

• Market Overview
• Large Pharmaceutical Companies
• Biotechnology / Small & Mid-Sized Biotechs
• Academic & Research Institutes
• Government / Public Sector Contracts

Global Biologics CDMO Market Size & CAGR (2025-2032)

• North America (Service Type, Production Platform, Modality Type, End-User)
  • US
  • Canada
• Europe (Service Type, Production Platform, Modality Type, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Service Type, Production Platform, Modality Type, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Service Type, Production Platform, Modality Type, End-User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Service Type, Production Platform, Modality Type, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Lonza Group Ltd.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Catalent, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi Biologics Cayman Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AGC Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Boehringer Ingelheim BioXcellence
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• 3P Biopharmaceuticals
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• FUJIFILM Diosynth Biotechnologies
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Binex Co. Ltd.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Patheon (part of Thermo Fisher)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Recipharm AB
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BioVectra Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Janssen Biotechnology Services (Johnson & Johnson)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AbbVie Contract Manufacturing (AbbVie)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories (Biologics CDMO division)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Catalent Biologics (subsidiary of Catalent)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Philips-Morris Scientific Services (CDMO arm)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celltrion Technologies Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• KanaBio Sciences Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations