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大分子合約開發和生產原料藥（CDMO）市場規模、佔有率和成長分析（按服務、原料來源、最終用戶和地區分類）－2026-2033年產業預測
市場調查報告書
商品編碼
1900018

大分子合約開發和生產原料藥（CDMO）市場規模、佔有率和成長分析（按服務、原料來源、最終用戶和地區分類）－2026-2033年產業預測

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個工作天內

價格
簡介目錄

全球大分子原料藥CDMO市場規模預計在2024年達到128.8億美元，從2025年的139.9億美元成長到2033年的270.6億美元，預測期（2026-2033年）複合年成長率為8.6%。

全球大分子原料藥藥物成分（API）的CDMO市場成長主要受生物製藥核准增加、感染疾病率上升以及對新型療法的需求不斷成長的驅動。隨著製藥和生技公司投資先進技術並加強與CDMO的合作，對高品質、符合CGMP規範的生產服務的需求激增，在新冠疫情期間尤其重要。對有效疫苗和單株抗體的迫切需求凸顯了CDMO在原料藥（DS）和製劑（DP）開發中的關鍵作用，並強調了醫藥生態系內區域合作的重要性。儘管大分子的複雜性為成本效益和效率帶來了挑戰，但諸如包封等創新技術的出現，提高了藥物的穩定性和療效，使CDMO成為藥物開發領域不可或缺的參與者。

推動全球大型聚合物藥物原料藥CDMO市場發展的因素

企業對生物製藥和生物相似藥研發的大量投資，顯著提升了對大分子藥物原料藥合約研發生產機構（CDMO）的需求。目前處於探索階段的大多數潛在治療候選生物製藥，例如胜肽、蛋白質和單株抗體。生物製藥公司研發投入的激增，推動了創新生物製藥的開發及其在研發管線中的推進。這些因素共同促進了大分子藥物CDMO市場的擴張。

限制全球聚合物藥物原料藥CDMO市場的因素

全球大分子原料藥CDMO市場面臨許多挑戰，主要源自於大分子表徵固有的複雜性。在生物製藥領域，全面的表徵對於評估穩定性、純度和功能等關鍵參數至關重要。有效的結構檢驗需要整合多種低解析度和高解析度技術。此外，重組合成過程通常會導致大分子上出現多種轉譯後修飾（PTM），進一步增加了表徵的難度。儘管存在這些挑戰，但不斷增加的研發投入和產品創新正在支撐市場發展，並持續推動該領域的進步。

大分子藥物活性原料藥CDMO市場的全球趨勢

全球大分子原料藥CDMO市場正經歷轉型，其驅動力在於生物製藥需求的不斷成長及其生產流程日益複雜的挑戰。與傳統小分子藥物不同，大分子生物製藥，尤其是在腫瘤和個人化醫療領域，需要採用小規模批量、獨特配方的專業化生產模式。這種環境促進了缺乏內部生產資源的創新Start-Ups的成長，使得提供客製化解決方案的靈活合約研發生產機構（CDMO）的重要性日益凸顯。日益嚴格的監管標準迫使這些CDMO加強安全防護措施並調整營運策略，以滿足高活性藥物原料藥（API）的需求，從而鞏固其在快速發展且日益複雜的市場中的地位。

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（2025）
  • PESTEL 分析
  • 總體經濟指標
  • 價值鏈分析
  • 定價分析

全球大分子藥物原料藥開發和生產組織（CDMO）市場規模（按服務類型和複合年成長率分類）（2026-2033 年）

  • 契約製造
    • 臨床
    • 商業的
  • 合約開發
    • 細胞株構建
    • 製程開發

全球大分子藥物原料藥合約開發和生產組織（CDMO）市場規模（按來源和複合年成長率分類）（2026-2033 年）

  • 哺乳動物起源
  • 微生物來源
  • 其他

全球大分子藥物原料藥開發和生產組織（CDMO）市場規模（按最終用戶和複合年成長率分類）（2026-2033 年）

  • 生技公司
  • CRO
  • 其他

全球合約開發生產原料藥（CDMO）市場規模及複合年成長率（2026-2033）

  • 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（2025 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（2025 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
    • 2023-2025年營收年比比較

主要企業簡介

  • 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）

結論與建議

簡介目錄
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