生物製劑CDMO市場規模、佔有率和成長分析（按服務類型、生產平台、治療模式、最終用戶和地區分類）－2025-2032年產業預測

預計到 2023 年，全球生物製劑 CDMO 市場規模將達到 213 億美元，到 2024 年將達到 246.2 億美元，到 2032 年將達到 785.2 億美元，預測期（2025-2032 年）的複合年成長率為 15.6%。

全球生物製劑CDMO市場正經歷顯著成長，這主要得益於對生物製劑（包括單株抗體、疫苗以及細胞和基因療法等先進治療方法）需求的不斷成長。隨著企業將營運外包以提高效率，他們正日益尋求更具成本效益且擴充性的研發和生產模式。 CDMO擁有加速生物製劑上市的專業技術，而快速成長的臨床研發管線和日益複雜的監管環境進一步推動了對經驗豐富的合作夥伴的需求。然而，高額的資本投入、複雜的生產流程以及監管方面的擔憂等挑戰，可能會阻礙發展中地區（尤其是那些缺乏熟練勞動力和基礎設施的地區）的市場成長。儘管存在這些障礙，但戰略合作、技術進步以及生物製造設施數量的不斷增加預計將推動市場的長期發展。

全球生物製藥CDMO市場促進因素

慢性病盛行率的上升以及生物製藥的日益普及，顯著增加了對大規模生物製藥生產的需求。隨著生物相似藥研發管線的不斷擴展，製藥和生技公司正積極尋求提高營運效率。這一趨勢促使這些企業加強與合約研發生產機構（CDMO）的合作，以利用其專業知識最佳化資源配置、簡化生產流程並縮短新治療方法的上市時間。這些策略聯盟不僅提高了生產效率，也促進了生物製藥這一新興領域的創新。

全球生技藥品CDMO市場的限制因素

全球生物製藥CDMO市場面臨著巨大的挑戰，因為生物製藥的生產需要大量的資本投入。這些投資包括建造複雜的基礎設施、專用設施和無塵室，這些都是維持品質標準所必需的。生物製藥過程尤其複雜，涉及細胞培養和純化技術，需要熟練的員工和全面的營運管理。這種複雜性造成了巨大的財務壁壘，可能會阻礙新的合約研發生產機構（CDMO）進入市場。此外，即使是現有的生物製藥CDMO，如果沒有足夠的資金支持，也可能難以有效地擴大業務，從而限制其在競爭激烈的市場環境中的成長潛力。

全球生技藥品CDMO市場趨勢

全球生物製藥CDMO市場的一大趨勢是單次使用技術的廣泛應用，顯著提高了營運效率和產品品質。這些創新系統透過提供無與倫比的靈活性並最大限度地降低生產過程中的污染風險，正在改變行業格局。採用單次使用生物反應器可實現快速切換和簡化工作流程，最終縮短週轉時間。對於擁有多種產品的工廠以及開發早期生物製劑（例如臨床和個人化治療藥物）的工廠而言，這項變更尤其有利。因此，CDMO正在利用這些技術建立擴充性且適應性強的生產模式，從而推動產業成長和創新。

目錄

介紹

• 調查目標
• 調查範圍
• 定義

調查方法

• 資訊收集
• 二手資料和一手資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分市場機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制與挑戰
• 波特分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 市場吸引力指數（2024）
• PESTEL 分析
• 總體經濟指標
• 價值鏈分析
• 定價分析
• 技術評估
• 監管環境

生物製劑CDMO市場規模（依服務類型分類）及複合年成長率（2025-2032年）

• 市場概覽
• 製程開發和細胞株開發
• 原料藥生產
• 藥品填充和包裝
• 分析/測試/品管服務
• 端到端/整合式CDMO服務

生物製劑CDMO市場規模（依生產平台及複合年成長率分類）（2025-2032年）

• 市場概覽
• 哺乳動物系統
• 微生物系統
• 其他平台

生物製劑CDMO市場規模依模式類型及複合年成長率分類（2025-2032年）

• 市場概覽
• 單株抗體（mAbs）
• 重組蛋白
• 生物相似藥
• 細胞和基因治療/病毒載體
• 其他生物製劑

生物製劑CDMO市場規模（依最終用戶分類）及複合年成長率（2025-2032年）

• 市場概覽
• 大型製藥企業
• 生技/中小型生技公司
• 學術和研究機構
• 政府和公共部門合約

生物製劑CDMO市場規模及複合年成長率（2025-2032年）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業的市場定位（2024 年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市佔率分析（2024 年）
• 主要企業公司簡介
  • 公司詳情
  • 產品系列分析
  • 依業務板塊進行公司股票分析
  • 2022-2024年營收年比比較

主要企業簡介

• 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.

結論與建議

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