先进疗法药物CDMO市场－全球产业规模、份额、趋势、机会及预测（依产品、阶段、适应症、地区及竞争格局划分，2021-2031年）

全球先进疗法药物CDMO市场预计将从2025年的52.3亿美元成长到2031年的90.6亿美元，复合年增长率为9.59%。

这些合约研发生产机构 (CDMO) 提供专注于基因疗法、体细胞疗法和组织工程产品的研究、开发和生产的专业外包服务。这项市场成长的主要驱动力是生物製药公司日益增长的需求，即希望利用专业技术诀窍，同时避免承担自建生产设施所需的大量资本成本。此外，随着这些治疗方法日益复杂，创新者越来越依赖外部合作伙伴的监管经验和成熟的基础设施，以加速临床开发进程和商业化进程。

然而，该行业面临严峻的挑战，生产能力不足和高技能人才短缺限制了服务供应商有效应对日益增长的计划量的能力。根据再生医学联盟的预测，该产业预计在2025年保持强劲成长势头，全球研发企业数量将成长6%，临床试验数量将成长3%。不断扩大的开发平臺给现有生产资源带来了更大的压力，凸显了该产业迫切需要大幅提升产能。

市场驱动因素

细胞和基因治疗临床开发平臺的快速扩张是全球先进医疗产品CDMO市场的主要驱动力。随着研发人员积极扩大研究规模，大量进入临床前和临床阶段的候选疗法需要外部生产支援来管理生产流程。业界为支持候选疗法顺利度过高成本研发阶段而提供的强劲资金筹措进一步加剧了这一需求。例如，再生医学联盟在2024年10月发布的报告显示，该产业在上半年吸引了109亿美元的投资。因此，该行业对合约合作伙伴的依赖性日益增强。 Cyteline和美国基因与细胞治疗学会（ASGCT）在2024年4月发布的报告也证实了这一点，该报告指出，全球有超过4000种治疗方法正在研发中。

同时，先进治疗方法生产製造的日益复杂化正推动企业策略向端到端一体化外包模式转变。研发人员在扩大病毒载体生产和自体细胞处理规模方面面临着巨大的技术挑战，因此他们正在寻求单一来源的合作伙伴，以提供从早期研发到商业化的全程解决方案。这种综合办法最大限度地降低了多个供应商之间技术转移所带来的物流和监管风险。顺应这一趋势，领先的供应商正在对一体化设施进行大量投资。例如，FUJIFILM迪奥辛塔生物技术公司于2024年4月宣布，将追加投资12亿美元扩建其大型细胞培养设施，旨在打造北美最大的端到端生物製药製造地之一。

市场挑战

生产能力不足以及高技能人才短缺严重限制了先进疗法药物（ATMP）合约研发生产机构（CDMO）市场的成长。这些限制限制了服务供应商充分满足生物製药开发商需求的能力。由于这些治疗方法需要经验丰富的员工进行精准操作，合约研发生产机构（ 前置作业时间 ）无法快速扩大生产规模以满足客户需求，导致计划积压，临床和商业化生产的周期都过长。

这一瓶颈导致计划启动和里程碑达成延迟，直接影响市场收入成长。对开发服务的高需求与有限的技术资源供应之间的差距，有效地限制了市场表现。根据再生医学联盟（Alliance for Regenerative Medicine）预测，到2024年，全球再生医学领域将有超过1900项正在进行的临床试验。如此庞大的在研项目数量加剧了对有限生产资源的竞争，产能限制将持续存在，成为限制整个外包产业成长的主要因素。

市场趋势

随着CDMO业务向亚太地区中心扩张，服务供应商在该地区建立大规模製造群，以利用熟练劳动力和政府激励措施，全球供应链格局正在重塑。这种地理多元化满足了产业对冗余产能的需求，并降低了对以西方为中心的生产的依赖，尤其是在商业规模的生物製药和先进疗法生产方面。各公司正积极在新加坡和韩国等地建造大型工厂，以提供具竞争力的交货时间和成本，服务全球客户。例如，无锡生物製药于2025年7月宣布，将在新加坡大士生物医药园建设一座3万平方公尺的模组化製药生产设施，以加强其全球生产网路。

同时，随着生物製药产业寻求产能保障和供应链稳定性，市场正从一次性交易转向策略性的长期伙伴关係。与传统的专案型外包不同，这些长期合作可在多年内预留产能和专用生产线，合约研发生产机构（CDMO）则作为客户内部网路的延伸。这种模式既能为製造商提供财务保障，又能确保创新者在关键阶段能够立即获得资源。牛津生物医学公司公布了截至2025年9月的财年中期财务业绩，报告显示，上半年订单的客户合约总额达到1.49亿英镑，较去年同期增长166%。

目录

第一章概述

第二章调查方法

第三章执行摘要

第四章：客户评价

第五章 全球先进疗法药物CDMO市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 副产品（基因疗法、细胞疗法、组织工程等）
  • 依研发阶段（I期、II期、III期、IV期）
  • 依适应症（肿瘤科、心臟科、中枢神经系统、肌肉骨骼系统、感染疾病、免疫/发炎科、其他科）
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美先进疗法药物CDMO市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国家分析
  • 我们
  • 加拿大
  • 墨西哥

7. 欧洲先进疗法药物CDMO市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国家分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

8. 亚太地区先进疗法药物CDMO市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

9. 中东和非洲先进治疗药物CDMO市场展望

• 市场规模及预测
• 市占率及预测
• 中东和非洲：国家分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲先进疗法药物CDMO市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国家分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 司机
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 最新进展

第十三章：全球先进疗法药物CDMO市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的可能性
• 供应商电力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Celonic AG
• Rentschler Biopharma SE
• Catalent, Inc.
• Lonza Group AG
• WuXi Advanced Therapies
• Minaris Regenerative Medicine, LLC
• Pluri Biotech Ltd.
• REPROCELL USA Inc.
• BioPhorum Operations Group
• Cellares Corporation

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Advanced Therapy Medicinal Products CDMO Market is projected to increase from USD 5.23 Billion in 2025 to USD 9.06 Billion by 2031, reflecting a compound annual growth rate of 9.59%. These Contract Development and Manufacturing Organizations offer specialized outsourcing services dedicated to the development and production of gene therapies, somatic cell therapies, and tissue-engineered products. This market growth is primarily driven by the rising need for biopharmaceutical companies to utilize specialized technical expertise without incurring the massive capital costs associated with internal manufacturing facilities. Furthermore, the increasing complexity of these therapeutic modalities encourages innovators to rely on the regulatory experience and established infrastructure of external partners to expedite clinical timelines and commercialization efforts.

However, the sector faces a substantial challenge due to the scarcity of available manufacturing slots and a shortage of highly skilled personnel, which limits the capacity of service providers to effectively handle the surging volume of projects. According to the Alliance for Regenerative Medicine, the sector displayed robust activity in 2025, with a 6 percent rise in the number of global developers and a 3 percent increase in clinical trials. This expansion of the development pipeline intensifies the pressure on existing manufacturing resources, underscoring the critical necessity for significant capacity expansion within the industry.

Market Driver

The rapid expansion of cell and gene therapy clinical development pipelines serves as a primary catalyst for the Global Advanced Therapy Medicinal Products CDMO Market. As developers aggressively broaden their research initiatives, the immense volume of therapeutic candidates entering pre-clinical and clinical stages demands external manufacturing support to manage throughput. This demand is further amplified by strong sector financing, which supports the progression of these candidates through expensive development phases; for instance, the Alliance for Regenerative Medicine reported in October 2024 that the sector attracted USD 10.9 billion in investment during the first half of the year. Consequently, the industry depends heavily on contract partners, a reliance underscored by Citeline and the American Society of Gene & Cell Therapy's April 2024 report, which noted over 4,000 therapies in development globally.

Simultaneously, the complexity of manufacturing advanced therapies is driving a strategic shift toward end-to-end integrated outsourcing models. Innovators encounter significant technical difficulties in scaling viral vector production and autologous cell processing, leading them to seek partners capable of providing a single-source solution from early-phase development through to commercialization. This comprehensive approach minimizes the logistical and regulatory risks associated with transferring technology between multiple vendors. In line with this trend, leading providers are investing heavily in integrated facilities; for example, Fujifilm Diosynth Biotechnologies committed an additional USD 1.2 billion in April 2024 to expand its large-scale cell culture facility, aiming to establish one of North America's largest end-to-end biopharmaceutical manufacturing sites.

Market Challenge

The scarcity of manufacturing slot capacity, coupled with a lack of highly skilled personnel, acts as a significant barrier to the growth of the Advanced Therapy Medicinal Products CDMO market. These constraints restrict the operational throughput of service providers, preventing them from fully absorbing the demand generated by biopharmaceutical innovators. Because these therapies require precise handling by experienced staff, Contract Development and Manufacturing Organizations are unable to rapidly scale their operations to meet client needs, which results in project backlogs and extended lead times for both clinical and commercial production.

This bottleneck directly impacts market revenue growth by causing delays in project initiation and milestone completion. The gap between the high demand for development services and the limited supply of technical resources effectively creates a ceiling on market performance. According to the Alliance for Regenerative Medicine, there were over 1,900 active clinical trials globally in the regenerative medicine sector in 2024. This substantial volume of pipeline activity intensifies the competition for limited manufacturing slots, ensuring that capacity constraints remain a primary factor slowing the overall trajectory of the outsourcing sector.

Market Trends

The expansion of CDMO operations into Asia-Pacific hubs is reshaping the global supply chain as service providers build large-scale manufacturing clusters in the region to take advantage of skilled labor and government incentives. This geographical diversification addresses the industry's need for redundant capacity and lessens reliance on Western-centric production, particularly for commercial-scale biologic and advanced therapy manufacturing. Companies are aggressively constructing mega-plants in locations such as Singapore and South Korea to serve global clients with competitive timelines and costs. For instance, WuXi Biologics announced in July 2025 the development of a 30,000-square-meter modular drug product facility at Tuas Biomedical Park in Singapore, designed to enhance its global manufacturing network.

concurrently, the market is shifting from transactional to strategic long-term partnerships, driven by the biopharmaceutical industry's need for guaranteed slot availability and supply chain security. Unlike traditional project-by-project outsourcing, these extended collaborations involve multi-year capacity reservations and dedicated production lines, effectively treating the CDMO as an extension of the client's internal network. This model provides financial stability for manufacturers while ensuring innovators have immediate access to resources during critical phases. According to Oxford Biomedica's interim results from September 2025, the company reported a contracted value of client orders totaling £149 million signed during the first half of the year, representing a 166 percent increase compared to the same period in 2024.

Key Market Players

• Celonic AG
• Rentschler Biopharma SE
• Catalent, Inc.
• Lonza Group AG
• WuXi Advanced Therapies
• Minaris Regenerative Medicine, LLC
• Pluri Biotech Ltd.
• REPROCELL USA Inc.
• BioPhorum Operations Group
• Cellares Corporation

Report Scope

In this report, the Global Advanced Therapy Medicinal Products CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Advanced Therapy Medicinal Products CDMO Market, By Product

• Gene Therapy
• Cell Therapy
• Tissue Engineered
• Others

Advanced Therapy Medicinal Products CDMO Market, By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

Advanced Therapy Medicinal Products CDMO Market, By Indication

• Oncology
• Cardiology
• Central Nervous System
• Musculoskeletal
• Infectious disease
• Immunology & inflammation
• Others

Advanced Therapy Medicinal Products CDMO 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 Advanced Therapy Medicinal Products CDMO Market.

Available Customizations:

Global Advanced Therapy Medicinal Products CDMO 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 Advanced Therapy Medicinal Products CDMO Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Gene Therapy, Cell Therapy, Tissue Engineered, Others)
  • 5.2.2. By Phase (Phase I, Phase II, Phase III, Phase IV)
  • 5.2.3. By Indication (Oncology, Cardiology, Central Nervous System, Musculoskeletal, Infectious disease, Immunology & inflammation, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America Advanced Therapy Medicinal Products CDMO Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Phase
  • 6.2.3. By Indication
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Advanced Therapy Medicinal Products CDMO 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 Product
      • 6.3.1.2.2. By Phase
      • 6.3.1.2.3. By Indication
  • 6.3.2. Canada Advanced Therapy Medicinal Products CDMO 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 Product
      • 6.3.2.2.2. By Phase
      • 6.3.2.2.3. By Indication
  • 6.3.3. Mexico Advanced Therapy Medicinal Products CDMO 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 Product
      • 6.3.3.2.2. By Phase
      • 6.3.3.2.3. By Indication

7. Europe Advanced Therapy Medicinal Products CDMO Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Phase
  • 7.2.3. By Indication
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Advanced Therapy Medicinal Products CDMO 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 Product
      • 7.3.1.2.2. By Phase
      • 7.3.1.2.3. By Indication
  • 7.3.2. France Advanced Therapy Medicinal Products CDMO 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 Product
      • 7.3.2.2.2. By Phase
      • 7.3.2.2.3. By Indication
  • 7.3.3. United Kingdom Advanced Therapy Medicinal Products CDMO 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 Product
      • 7.3.3.2.2. By Phase
      • 7.3.3.2.3. By Indication
  • 7.3.4. Italy Advanced Therapy Medicinal Products CDMO 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 Product
      • 7.3.4.2.2. By Phase
      • 7.3.4.2.3. By Indication
  • 7.3.5. Spain Advanced Therapy Medicinal Products CDMO 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 Product
      • 7.3.5.2.2. By Phase
      • 7.3.5.2.3. By Indication

8. Asia Pacific Advanced Therapy Medicinal Products CDMO Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Phase
  • 8.2.3. By Indication
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Advanced Therapy Medicinal Products CDMO 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 Product
      • 8.3.1.2.2. By Phase
      • 8.3.1.2.3. By Indication
  • 8.3.2. India Advanced Therapy Medicinal Products CDMO 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 Product
      • 8.3.2.2.2. By Phase
      • 8.3.2.2.3. By Indication
  • 8.3.3. Japan Advanced Therapy Medicinal Products CDMO 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 Product
      • 8.3.3.2.2. By Phase
      • 8.3.3.2.3. By Indication
  • 8.3.4. South Korea Advanced Therapy Medicinal Products CDMO 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 Product
      • 8.3.4.2.2. By Phase
      • 8.3.4.2.3. By Indication
  • 8.3.5. Australia Advanced Therapy Medicinal Products CDMO 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 Product
      • 8.3.5.2.2. By Phase
      • 8.3.5.2.3. By Indication

9. Middle East & Africa Advanced Therapy Medicinal Products CDMO Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Phase
  • 9.2.3. By Indication
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Advanced Therapy Medicinal Products CDMO 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 Product
      • 9.3.1.2.2. By Phase
      • 9.3.1.2.3. By Indication
  • 9.3.2. UAE Advanced Therapy Medicinal Products CDMO 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 Product
      • 9.3.2.2.2. By Phase
      • 9.3.2.2.3. By Indication
  • 9.3.3. South Africa Advanced Therapy Medicinal Products CDMO 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 Product
      • 9.3.3.2.2. By Phase
      • 9.3.3.2.3. By Indication

10. South America Advanced Therapy Medicinal Products CDMO Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Phase
  • 10.2.3. By Indication
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Advanced Therapy Medicinal Products CDMO 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 Product
      • 10.3.1.2.2. By Phase
      • 10.3.1.2.3. By Indication
  • 10.3.2. Colombia Advanced Therapy Medicinal Products CDMO 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 Product
      • 10.3.2.2.2. By Phase
      • 10.3.2.2.3. By Indication
  • 10.3.3. Argentina Advanced Therapy Medicinal Products CDMO 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 Product
      • 10.3.3.2.2. By Phase
      • 10.3.3.2.3. By Indication

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 Advanced Therapy Medicinal Products CDMO 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. Celonic AG
  • 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. Rentschler Biopharma SE
• 15.3. Catalent, Inc.
• 15.4. Lonza Group AG
• 15.5. WuXi Advanced Therapies
• 15.6. Minaris Regenerative Medicine, LLC
• 15.7. Pluri Biotech Ltd.
• 15.8. REPROCELL USA Inc.
• 15.9. BioPhorum Operations Group
• 15.10. Cellares Corporation

16. Strategic Recommendations

17. About Us & Disclaimer