查看购物车
  • Traditional Chinese
  • English
  • Japanese
大分子合约开发和生产原料药（CDMO）市场规模、份额和成长分析（按服务、原料来源、最终用户和地区划分）－2026-2033年产业预测
市场调查报告书
商品编码
1900018

大分子合约开发和生产原料药（CDMO）市场规模、份额和成长分析（按服务、原料来源、最终用户和地区划分）－2026-2033年产业预测

Large Molecule Drug Substance CDMO Market Size, Share, and Growth Analysis, By Service (Contract Manufacturing, Contract Development), By Source (Mammalian, Microbial), By End-user, By Region - Industry Forecast 2026-2033
出版日期: | 出版商: SkyQuest | 英文 278 Pages | 商品交期: 3-5个工作天内

价格
简介目录

全球大分子原料药CDMO市场规模预计在2024年达到128.8亿美元，从2025年的139.9亿美元成长到2033年的270.6亿美元，预测期（2026-2033年）复合年增长率为8.6%。

全球大分子原料药药物成分（API）的CDMO市场成长主要受生物製药核准增加、感染疾病率上升以及对新型疗法的需求不断增长的驱动。随着製药和生技公司投资先进技术并加强与CDMO的合作，对高品质、符合CGMP规范的生产服务的需求激增，在新冠疫情期间尤其重要。对有效疫苗和单株抗体的迫切需求凸显了CDMO在原料药（DS）和製剂（DP）开发中的关键作用，并强调了医药生态系内区域合作的重要性。儘管大分子的复杂性为成本效益和效率带来了挑战，但诸如包封等创新技术的出现，提高了药物的稳定性和疗效，使CDMO成为药物开发领域不可或缺的参与者。

推动全球大型聚合物药物原料药CDMO市场发展的因素

企业对生物製药和生物相似药研发的大量投资，显着提升了对大分子药物原料药合约研发生产机构（CDMO）的需求。目前处于探索阶段的大多数潜在治疗候选生物製药，例如胜肽、蛋白质和单株抗体。生物製药公司研发投入的激增，推动了创新生物製药的开发及其在研发管线中的推进。这些因素共同促进了大分子药物CDMO市场的扩张。

限制全球聚合物药物原料药CDMO市场的因素

全球大分子原料药CDMO市场面临许多挑战，主要源自于大分子表征固有的复杂性。在生物製药领域，全面的表征对于评估稳定性、纯度和功能等关键参数至关重要。有效的结构检验需要整合多种低解析度和高解析度技术。此外，重组合成过程通常会导致大分子上出现多种转译后修饰（PTM），进一步增加了表征的难度。儘管存在这些挑战，但不断增加的研发投入和产品创新正在支撑市场发展，并持续推动该领域的进步。

大分子药物活性原料药CDMO市场的全球趋势

全球大分子原料药CDMO市场正经历转型，其驱动力在于生物製药需求的不断增长及其生产流程日益复杂的挑战。与传统小分子药物不同，大分子生物製药，尤其是在肿瘤和个人化医疗领域，需要采用小规模批量、独特配方的专业化生产模式。这种环境促进了缺乏内部生产资源的创新Start-Ups的成长，使得提供客製化解决方案的灵活合约研发生产机构（CDMO）的重要性日益凸显。日益严格的监管标准迫使这些CDMO加强安全防护措施并调整营运策略，以满足高活性药物原料药（API）的需求，从而巩固其在快速发展且日益复杂的市场中的地位。

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（2025）
  • PESTEL 分析
  • 总体经济指标
  • 价值链分析
  • 定价分析

全球大分子药物原料药开发和生产组织（CDMO）市场规模（按服务类型和复合年增长率划分）（2026-2033 年）

  • 契约製造
    • 临床
    • 商业的
  • 合约开发
    • 细胞株构建
    • 製程开发

全球大分子药物原料药合约开发和生产组织（CDMO）市场规模（按来源和复合年增长率划分）（2026-2033 年）

  • 哺乳动物起源
  • 微生物来源
  • 其他的

全球大分子药物原料药开发和生产组织（CDMO）市场规模（按最终用户和复合年增长率划分）（2026-2033 年）

  • 生技公司
  • CRO
  • 其他的

全球合约开发生产原料药（CDMO）市场规模及复合年增长率（2026-2033）

  • 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（2025 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（2025 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
    • 2023-2025年营收年比比较

主要企业简介

  • Lonza Group（Switzerland）
  • Thermo Fisher Scientific（United States）
  • Catalent（United States）
  • WuXi Biologics（China）
  • Samsung Biologics（South Korea）
  • Siegfried Holding AG（Switzerland）
  • AGC Biologics（United States）
  • Avid Bioservices（United States）
  • Boehringer Ingelheim BioXcellence（Germany）
  • Fujifilm Diosynth Biotechnologies（United States）
  • Rentschler Biopharma SE（Germany）
  • Recipharm AB（Sweden）
  • Syngene International（India）
  • KBI Biopharma（United States）
  • JHL Biotech（Taiwan）
  • Emergent BioSolutions（United States）
  • Wuxi AppTec（China）
  • BioVectra（Canada）
  • Abzena（United Kingdom）

结论与建议

简介目录
Product Code: SQMIG35I2127

Global Large Molecule Drug Substance CDMO Market size was valued at USD 12.88 Billion in 2024 and is poised to grow from USD 13.99 Billion in 2025 to USD 27.06 Billion by 2033, growing at a CAGR of 8.6% during the forecast period (2026-2033).

The global market for large molecule drug substance CDMOs is driven by the rising approvals of biologics, escalating incidences of infectious diseases, and an increasing demand for novel therapeutics. As pharmaceutical and biotech companies invest more in advanced technologies and collaboration with CDMOs, the need for high-quality, CGMP-compliant manufacturing services has surged, particularly highlighted during the pandemic. The urgency for effective vaccines and monoclonal antibodies has showcased the critical role of CDMOs in drug substance (DS) and drug product (DP) development, emphasizing the importance of regional partnerships within the pharmaceutical ecosystem. Despite challenges in affordability and efficiency due to the complexity of large molecules, innovative techniques like encapsulation are emerging to enhance stability and efficacy, positioning CDMOs as essential players in the drug development landscape.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Large Molecule Drug Substance 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 Large Molecule Drug Substance CDMO Market Segments Analysis

Global Large Molecule Drug Substance CDMO Market is segmented by Service, Source, End-user and region. Based on Service, the market is segmented into Contract Manufacturing and Contract Development. Based on Source, the market is segmented into Mammalian, Microbial and Others. Based on End-user, the market is segmented into Biotech Companies, CRO and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Large Molecule Drug Substance CDMO Market

The demand for large molecule drug substance contract development and manufacturing organizations (CDMOs) has significantly increased due to substantial investments made by companies in the development of biologics and biosimilars. A large portion of potential therapeutic candidates currently in the discovery phase consists of biologics, including peptides, proteins, and monoclonal antibodies. This surge in investment in research and development by biopharmaceutical firms has led to a growing number of innovative biologics being developed and advanced through the pipeline. As a result, these factors collectively drive the expansion of the CDMO market for large molecule drugs.

Restraints in the Global Large Molecule Drug Substance CDMO Market

The Global Large Molecule Drug Substance CDMO market faces significant challenges due to the inherent complexity associated with characterizing large molecules. In the biopharmaceutical sector, thorough characterization is essential for assessing vital parameters such as stability, purity, and function. Achieving effective structural validation necessitates the integration of various low- and high-resolution techniques. Moreover, the recombinant synthesis process often leads to various post-translational modifications (PTMs) in large molecules, complicating their characterization further. Despite these hurdles, the market is supported by increasing investments in research and development as well as product innovation, which continue to drive advancements in the field.

Market Trends of the Global Large Molecule Drug Substance CDMO Market

The Global Large Molecule Drug Substance CDMO market is undergoing a transformative shift driven by the rising demand for biopharmaceuticals and the complexities of their production. Unlike traditional small-molecule drugs, large biologics require specialized manufacturing that often involves smaller batch sizes and unique formulations, particularly in oncology and personalized medicine. This environment has spurred the growth of innovative startups that lack the resources for in-house manufacturing, emphasizing the need for agile contract development and manufacturing organizations (CDMOs) to offer tailored solutions. As regulatory standards tighten, these CDMOs must enhance containment methods and adapt operational strategies to meet the demands of high-potency active pharmaceutical ingredients (APIs), solidifying their role in a market characterized by rapid advancements and increasing complexity.

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, 2025
  • PESTEL Analysis
  • Macro-Economic Indicators
  • Value Chain Analysis
  • Pricing Analysis

Global Large Molecule Drug Substance CDMO Market Size by Service & CAGR (2026-2033)

  • Market Overview
  • Contract Manufacturing
    • Clinical
    • Commercial
  • Contract Development
    • Cell Line Development
    • Process Development

Global Large Molecule Drug Substance CDMO Market Size by Source & CAGR (2026-2033)

  • Market Overview
  • Mammalian
  • Microbial
  • Others

Global Large Molecule Drug Substance CDMO Market Size by End-user & CAGR (2026-2033)

  • Market Overview
  • Biotech Companies
  • CRO
  • Others

Global Large Molecule Drug Substance CDMO Market Size & CAGR (2026-2033)

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

Competitive Intelligence

  • Top 5 Player Comparison
  • Market Positioning of Key Players, 2025
  • Strategies Adopted by Key Market Players
  • Recent Developments in the Market
  • Company Market Share Analysis, 2025
  • Company Profiles of All Key Players
    • Company Details
    • Product Portfolio Analysis
    • Company's Segmental Share Analysis
    • Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

  • Lonza Group (Switzerland)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Thermo Fisher Scientific (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Catalent (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • WuXi Biologics (China)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Samsung Biologics (South Korea)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Siegfried Holding AG (Switzerland)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • AGC Biologics (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Avid Bioservices (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Boehringer Ingelheim BioXcellence (Germany)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Fujifilm Diosynth Biotechnologies (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Rentschler Biopharma SE (Germany)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Recipharm AB (Sweden)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Syngene International (India)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • KBI Biopharma (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • JHL Biotech (Taiwan)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Emergent BioSolutions (United States)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Wuxi AppTec (China)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • BioVectra (Canada)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Abzena (United Kingdom)
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments

Conclusion & Recommendations