合約開發與生產組織市場－全球產業規模、佔有率、趨勢、機會與預測：按服務類型分類的CMO、按研發階段分類的CRO、地區和競爭格局，2021-2031年

全球合約開發和生產組織 (CDMO/CMO) 市場預計將從 2025 年的 2,454.7 億美元成長到 2031 年的 3,638.6 億美元，複合年成長率為 6.78%。

這些機構為製藥業提供從早期藥物研發到商業化生產和包裝的全方位服務。這一成長主要源於生物製藥治療方法的日益複雜化以及對營運效率的策略性關注。這促使創新企業將生產外包給專業合作夥伴。藥物研發領域的強勁投資進一步強化了對外部專業知識的依賴。根據歐洲製藥工業協會聯合會 (EFPIA) 估計，到 2024 年，以研發為基礎的製藥業將在歐洲的研發領域投資 550 億歐元，從而產生對技術外包服務的巨大需求。

然而，市場在供應鏈韌性和監管合規性方面面臨嚴峻挑戰。日益緊張的地緣政治局勢以及法律規範的變化迫使企業重組其全球供應鏈網路。這種重組往往會導致產能受限和營運成本增加，進而可能造成計劃延長並擾亂基本藥物的供應。

市場促進因素

生物製藥和先進治療藥物的快速擴張正在從根本上改變市場格局，並引發對專業化生產能力的激增需求。隨著製藥公司專注於開發抗體藥物複合體（ADC）和GLP-1促效劑等複雜治療方法，它們越來越依賴外部合作夥伴來克服技術挑戰並擴大生產規模。這一趨勢在產業為確保產能而進行的重組工作中顯而易見。根據DCAT價值鏈洞察報告，截至2024年12月，最大的市場動態是諾和諾德控股斥資165億美元收購Catalent，以支持其減肥藥的生產。主要企業正從這項需求中直接獲益，三星生物製劑在訂單生物製藥生產訂單的增加。

同時，依賴合約合作夥伴提供端到端開發支援的小型新興生物技術公司正在對市場產生重大影響。這些小規模公司通常缺乏管理整個藥物生命週期的內部基礎設施，因此依賴合約研發生產機構（CDMO）來完成從臨床試驗到商業化的整個流程。該領域的活動與資金籌措環境密切相關，而近期融資環境呈現改善趨勢。正如龍沙在2025年4月發布的2024會計年度年度報告創業投資所述，生物製藥領域的資金籌措已顯著復甦，較去年同期成長超過20%。資金的流入使新興創新者能夠與服務供應商續約，並透過維持強大的早期計劃儲備來重振整個契約製造產業。

市場挑戰

地緣政治緊張局勢以及由此產生的嚴格監管要求，是全球合約研發（CDMO）市場成長的主要障礙。隨著各國政府加強對國家安全和供應鏈自主權的法律體制，製藥創新公司被迫重組現有的生產網路。這種被迫放棄既有夥伴關係的做法，造成了營運瓶頸，因為與整合服務供應商脫鉤會擾亂計劃的連續性，並推高採購成本。

這些干擾因素直接阻礙了市場發展勢頭，導致臨床試驗進度延誤，以及其他地區產能受限。這種高度依賴性凸顯了快速多元化的難度。根據2024年生物技術創新組織的數據，約79%的受訪生物製藥公司至少有一項合約或產品與中國的研發和生產合作夥伴有關。如此高的地區依賴性意味著供應鏈轉型是一個資本密集且緩慢的過程，資金被用於風險規避而非新的研發項目，從而有效地阻礙了市場擴張。

市場趨勢

人工智慧 (AI)數位雙胞胎技術的融合正在迅速改變契約製造生產環境。這使得供應商能夠從簡單的執行夥伴轉型為策略創新者。透過利用預測演算法和虛擬製程建模，合約開發和生產組織 (CDMO) 可以顯著縮短技術轉移時間，並在實際生產開始前最佳化批次產量。這種數位化成熟度正成為一項關鍵的競爭優勢，直接滿足了產業在複雜治療方法對效率和風險降低的需求。根據《合約製藥》(Contract Pharma) 2025 年 9 月號報導，一項調查發現，49% 的受訪者表示，營運效益是他們從智慧製造策略中尋求的主要價值。

同時，由於監管壓力和客戶對範圍3減排排放的需求，採用永續的綠色化學實踐已成為市場參與企業的關鍵要求。契約製造製造商正積極重新設計合成路線並採用再生能源來源，以配合其製藥合作夥伴的脫碳目標。然而，儘管有此策略重點，但對許多供應商而言，轉型仍需要大量資金投入，且在營運上充滿挑戰。根據CPHI Online在2025年7月報道，Pharmapack 2025策略洞察與研究調查發現，76%的受訪者認為資源限制是有效實施永續性舉措的主要障礙。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球合約研發生產組織（CDMO/CMO）市場展望

• 市場規模及預測
  • 按金額
• 市佔率及預測
  • 按服務類型分類的合約生產商（原料原料藥生產、最終劑型（FDF）開發與生產、二級包裝）
  • 依研究階段分類的CRO（非臨床試驗、I期、II期、III期、IV期）
  • 按地區
  • 按公司（2025 年）
• 市場地圖

第6章：北美合約研發生產組織（CDMO/CMO）市場展望

• 市場規模及預測
• 市佔率及預測
• 北美洲：國別分析
  • 美國
  • 加拿大
  • 墨西哥

第7章：歐洲合約研發生產機構（CDMO/CMO）市場展望

• 市場規模及預測
• 市佔率及預測
• 歐洲：國別分析
  • 德國
  • 法國
  • 英國
  • 義大利
  • 西班牙

第8章：亞太地區合約研發生產力機構（CDMO/CMO）市場展望

• 市場規模及預測
• 市佔率及預測
• 亞太地區：國別分析
  • 中國
  • 印度
  • 日本
  • 韓國
  • 澳洲

第9章：中東和非洲合約研發生產力組織（CDMO/CMO）市場展望

• 市場規模及預測
• 市佔率及預測
• 中東與非洲：國別分析
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 南非

第10章：南美洲合約研發生產機構（CDMO/CMO）市場展望

• 市場規模及預測
• 市佔率及預測
• 南美洲：國別分析
  • 巴西
  • 哥倫比亞
  • 阿根廷

第11章 市場動態

• 促進因素
• 任務

第12章 市場趨勢與發展

• 併購
• 產品發布
• 近期趨勢

第13章：全球合約開發與生產組織（CDMO/CMO）市場：SWOT分析

第14章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商的議價能力
• 顧客權力
• 替代品的威脅

第15章 競爭格局

• Lonza
• Catalent
• Thermo Fisher Scientific
• Samsung Biologics
• WuXi Biologics
• Recipharm
• Boehringer Ingelheim BioXcellence
• Jubilant Biosys/Jubilant Pharmova
• Fareva
• Rentschler Biopharma

第16章 策略建議

第17章：關於研究公司及免責聲明

The Global Contract Development & Manufacturing Organization (CDMO and CMO) Market is projected to expand from USD 245.47 Billion in 2025 to USD 363.86 Billion by 2031, reflecting a Compound Annual Growth Rate of 6.78%. These organizations provide comprehensive services to the pharmaceutical sector, encompassing everything from early-stage drug development to commercial production and packaging. This growth is primarily driven by the rising complexity of biologic therapies and a strategic emphasis on operational efficiency, which prompts innovators to entrust manufacturing to specialized partners. This reliance on external expertise is bolstered by strong funding in drug discovery; the European Federation of Pharmaceutical Industries and Associations estimated that the research-based pharmaceutical industry invested 55 billion Euros in R&D in Europe in 2024, generating substantial demand for outsourced technical services.

However, the market faces significant hurdles regarding supply chain resilience and regulatory compliance. Escalating geopolitical tensions and shifting legislative frameworks are compelling companies to reorganize their global supply networks. This restructuring often results in capacity constraints and higher operational costs, which can delay project timelines and hinder the delivery of essential medicines.

Market Driver

The rapid expansion of biologics and Advanced Therapy Medicinal Products is fundamentally transforming the market, creating a surge in demand for specialized manufacturing capabilities. As pharmaceutical companies focus on developing complex modalities like antibody-drug conjugates and GLP-1 agonists, they increasingly rely on external partners to overcome technical challenges and scale production. This trend is highlighted by significant sector consolidation to secure capacity; according to DCAT Value Chain Insights in December 2024, the largest market move was Novo Holdings' $16.5 billion acquisition of Catalent to support obesity treatment manufacturing. Major players are seeing direct financial benefits from this demand, with Samsung Biologics reporting a full-year consolidated revenue of KRW 4.55 trillion in January 2025, a 23% increase driven largely by expanded biologic production orders.

Simultaneously, the market is heavily influenced by small and emerging biotech companies that depend on contract partners for end-to-end development support. These smaller entities often lack the internal infrastructure to manage the entire drug lifecycle and rely on CDMOs to progress from clinical trials to commercialization. This segment's activity is closely linked to capital availability, which has recently improved. As noted in Lonza's 'Annual Report 2024' released in April 2025, venture capital funding in the biopharma sector rebounded significantly, showing over 20% year-on-year investment growth. This influx of capital allows emerging innovators to re-engage service providers, maintaining a robust pipeline of early-stage projects that fuels the broader contract manufacturing industry.

Market Challenge

Geopolitical tensions and the consequent need for strict regulatory compliance present a major barrier to the growth of the Global Contract Development and Manufacturing Organization market. As governments enforce tighter legislative frameworks regarding national security and supply chain independence, pharmaceutical innovators face intense pressure to restructure their existing manufacturing networks. This forced migration from established partnerships creates operational bottlenecks, as decoupling from integrated service providers disrupts project continuity and inflates procurement costs.

These disruptions directly impede market momentum by delaying clinical timelines and limiting available production capacity in alternative regions. The extent of this dependency highlights the difficulty of rapid diversification. Data from the Biotechnology Innovation Organization in 2024 revealed that approximately 79 percent of responding biopharmaceutical companies held at least one contract or product linked to a development or manufacturing partner in China. Such high reliance on specific geographies means that shifting supply chains is a capital-intensive and slow process, effectively stalling broader market expansion as funds are diverted toward risk mitigation rather than new development programs.

Market Trends

The Integration of Artificial Intelligence and Digital Twin Technology is rapidly reshaping the operational landscape of contract manufacturing, allowing providers to evolve from simple execution partners into strategic technical innovators. By utilizing predictive algorithms and virtual process modeling, CDMOs can significantly shorten technology transfer timelines and optimize batch yields before physical production begins. This digital maturity is becoming a key competitive factor, directly addressing the industry's need for efficiency and risk reduction in complex modalities. According to a September 2025 article in Contract Pharma titled 'AI in Pharma Manufacturing: Trends & Applications Shortening Timelines', a study indicated that 49% of respondents viewed operational benefits as the primary value sought from smart manufacturing strategies.

In parallel, the Implementation of Sustainable Green Chemistry Practices has become a critical requirement for market participants, driven by increasing regulatory pressure and client mandates to reduce Scope 3 emissions. Contract organizations are actively re-engineering synthetic pathways and adopting renewable energy sources to align with the decarbonization goals of their pharmaceutical partners. Despite this strategic focus, the transition remains capital-intensive and operationally challenging for many providers. As reported by CPHI Online in July 2025, the Pharmapack 2025 Strategic Insights & Research survey revealed that 76% of respondents cited resource constraints as the dominant barrier to effectively implementing sustainability initiatives.

Key Market Players

• Lonza
• Catalent
• Thermo Fisher Scientific
• Samsung Biologics
• WuXi Biologics
• Recipharm
• Boehringer Ingelheim BioXcellence
• Jubilant Biosys / Jubilant Pharmova
• Fareva
• Rentschler Biopharma

Report Scope

In this report, the Global Contract Development & Manufacturing Organization (CDMO and CMO) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Contract Development & Manufacturing Organization (CDMO and CMO) Market, By Service Type CMO

• Active Pharmaceutical Ingredient (API) Manufacturing
• Finished Dosage Formulation (FDF) Development and Manufacturing
• Secondary Packaging

Contract Development & Manufacturing Organization (CDMO and CMO) Market, By Research Phase CRO

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

Contract Development & Manufacturing Organization (CDMO and CMO) Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Contract Development & Manufacturing Organization (CDMO and CMO) Market.

Available Customizations:

Global Contract Development & Manufacturing Organization (CDMO and CMO) Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service Type CMO (Active Pharmaceutical Ingredient (API) Manufacturing, Finished Dosage Formulation (FDF) Development and Manufacturing, Secondary Packaging)
  • 5.2.2. By Research Phase CRO (Pre-clinical, Phase I, Phase II, Phase III, Phase IV)
  • 5.2.3. By Region
  • 5.2.4. By Company (2025)
• 5.3. Market Map

6. North America Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service Type CMO
  • 6.2.2. By Research Phase CRO
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Service Type CMO
      • 6.3.1.2.2. By Research Phase CRO
  • 6.3.2. Canada Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Service Type CMO
      • 6.3.2.2.2. By Research Phase CRO
  • 6.3.3. Mexico Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Service Type CMO
      • 6.3.3.2.2. By Research Phase CRO

7. Europe Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service Type CMO
  • 7.2.2. By Research Phase CRO
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Service Type CMO
      • 7.3.1.2.2. By Research Phase CRO
  • 7.3.2. France Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Service Type CMO
      • 7.3.2.2.2. By Research Phase CRO
  • 7.3.3. United Kingdom Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Service Type CMO
      • 7.3.3.2.2. By Research Phase CRO
  • 7.3.4. Italy Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Service Type CMO
      • 7.3.4.2.2. By Research Phase CRO
  • 7.3.5. Spain Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Service Type CMO
      • 7.3.5.2.2. By Research Phase CRO

8. Asia Pacific Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service Type CMO
  • 8.2.2. By Research Phase CRO
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Service Type CMO
      • 8.3.1.2.2. By Research Phase CRO
  • 8.3.2. India Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Service Type CMO
      • 8.3.2.2.2. By Research Phase CRO
  • 8.3.3. Japan Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Service Type CMO
      • 8.3.3.2.2. By Research Phase CRO
  • 8.3.4. South Korea Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Service Type CMO
      • 8.3.4.2.2. By Research Phase CRO
  • 8.3.5. Australia Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Service Type CMO
      • 8.3.5.2.2. By Research Phase CRO

9. Middle East & Africa Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service Type CMO
  • 9.2.2. By Research Phase CRO
  • 9.2.3. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Service Type CMO
      • 9.3.1.2.2. By Research Phase CRO
  • 9.3.2. UAE Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Service Type CMO
      • 9.3.2.2.2. By Research Phase CRO
  • 9.3.3. South Africa Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Service Type CMO
      • 9.3.3.2.2. By Research Phase CRO

10. South America Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service Type CMO
  • 10.2.2. By Research Phase CRO
  • 10.2.3. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Service Type CMO
      • 10.3.1.2.2. By Research Phase CRO
  • 10.3.2. Colombia Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Service Type CMO
      • 10.3.2.2.2. By Research Phase CRO
  • 10.3.3. Argentina Contract Development & Manufacturing Organization (CDMO and CMO) Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Service Type CMO
      • 10.3.3.2.2. By Research Phase CRO

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Contract Development & Manufacturing Organization (CDMO and CMO) Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Lonza
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Catalent
• 15.3. Thermo Fisher Scientific
• 15.4. Samsung Biologics
• 15.5. WuXi Biologics
• 15.6. Recipharm
• 15.7. Boehringer Ingelheim BioXcellence
• 15.8. Jubilant Biosys / Jubilant Pharmova
• 15.9. Fareva
• 15.10. Rentschler Biopharma

16. Strategic Recommendations

17. About Us & Disclaimer