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市场调查报告书
商品编码
1725006
全球医药临床开发业务服务（2025-2030 ）Pharmaceutical Clinical Contract Peripheral Services, Global, 2025-2030 |
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由于产业融合以及对功能服务供应商(FSP) 模式的依赖性增加，CRO 产业正在经历转型成长。
随着 COVID-19 疫情后临床试验量恢復正常，製药和生物製药公司正在重新调整其药物开发平臺。因此，临床试验外包机会对于 CRO 来说正在增加，这些服务供应商也在改进其流程以改善临床试验的周转时间和上市时间。在此背景下，全球 CRO 产业价值预计在 2024 年将达到 663.9 亿美元，到 2030 年将达到 1,221.3 亿美元，2024 年至 2030 年的复合年增长率为 10.7%。在全球製药市场中，CRO 外包渗透率从 45% 到 50% 不等，具体取决于服务类型。
在全球CRO产业中，除了提供全方位服务的CRO外，专门提供週边服务的CRO数量正在快速增加。这些公司专门从事生物统计、实验室测试、药物安全检测、上市后监测和临床实验产品（IP）管理等支援功能。这些业务支持临床研究的核心功能，确保及时完成并取得所需的结果。
随着药物开发对生技药品的重视程度不断提高，中小型新兴生物製药公司目前占据了药物研发管线的 50% 以上。除了临床实验试验相关的业务（如患者招募、地点选择和管理、临床实验招募）之外，其他临床实验业务（如药物安全检测、安全测试、中央实验室服务、医学写作、知识产权临床实验、数据管理、生物统计学等）也越来越受欢迎，製药赞助商越来越多地将这些特定业务委託给CRO。
因此，功能服务提供者（FSP）模式因提供特定业务或外围临床开发相关业务而变得流行。虽然大部分临床管线来自中型和新兴生物製药公司，但透过 FSP 模式提供週边服务的需求预计将快速成长，尤其是希望优化试验成本的大型製药企业。
此外，随着公司寻求透过更好的风险缓解来加强临床试验活动，该行业可能会转向混合模式。因此，这些公司将寻求外包合作伙伴来满足其临床研究需求，为全方位服务外包和专注于支援分析测试、资料管理和生物统计等外围业务的 FSP 模式铺平道路。
主要问题
- 整体产业趋势是怎样的？临床试验相关的周边业务具体有哪些趋势？
- 大规模临床开发外包的关键驱动因素是什么？
- 哪些新的经营模式将为製药公司带来竞争优势？这一趋势如何支持产业融合？
- 哪些市场参与企业正在推动成长？
- 面对超过1500家竞争对手，中小型CRO公司有哪些成长机会？
- 技术的运用如何支持CRO週边业务的成长？ CRO产业中成长最快的外围业务是什么？
目录
成长机会：研究范围
- 分析范围
- 分割
- CRO 週边业务：业务服务中关键活动的定义
成长环境：医药临床业务委託业务服务週边环境的变化
- 为何成长变得越来越困难？
- The Strategic Imperative 8（TM）
- 三大业务问题对临床委託服务业的影响
医药临床业务委託产业生态系统
- 市场趋势分析
- 週边业务委託服务：供应商生态系统
- CRDMO：早期药物研发的新常态
- CRO市场的伙伴关係模式不断演变
- FSP 模型类型
- FSP 模型的展望
竞争环境
- 主要竞争对手：按地区
最佳实践：临床业务委託产业
- 投资趋势
- 透过併购扩大投资组合
- 透过策略伙伴关係获得针对特定计划的 CRO 专业知识
- 投资自身，实现长期发展
成长要素：临床业务委託产业
- 成长指标
- 成长动力
- 成长抑制因素
- 预测先决条件
- 市场预测：限制和注意事项
- 收益预测方法
- 收益预测
- 收益预测分析
按临床开发阶段预测收益
- 按临床开发阶段收益占有率
- 按临床开发阶段进行的收益分析
- 收益占有率
- 收益占有率分析
- 各地区收益预测
- 各地区收益百分比预测
- 收益预测分析：北美
- 收益预测分析：欧洲
- 收益预测分析：亚太地区
- 收益预测分析：拉丁美洲和加勒比海地区
- 收益预测分析：中东和非洲
- 週边业务和核心业务收益收益
- 週边业务与核心服务收益预测比例
- 週边业务部门的收益和预测
- 收益预测分析
成长要素：临床研究委託产业
- 中央实验室测试服务
- 中央实验室测试服务：收益预测
- 中央实验室测试服务：按地区分類的收益预测
- 中央实验室测试服务：收益预测考量因素
成长要素：临床研究委託产业
- 生物统计服务
- 生物统计服务：收益预测
- 生物统计服务：按地区分類的收益预测
- 生物统计服务：收益预测考虑因素
成长要素：临床研究委託产业
- 资料管理服务
- 资料管理服务：收益预测
- 资料管理服务：按地区分類的收益预测
- 资料管理服务：收益预测考量因素
成长要素：临床研究委託产业
- 药物安全检测和安全测试服务
- 药物安全检测和安全测试服务：收益预测
- 药物安全检测和安全测试服务：按地区分類的收益预测
- 药物安全检测与安全测试服务：收益预测洞察
成长要素：临床研究委託产业
- 智慧财产权管理服务
- IP管理服务：收益预测
- 知识产权管理服务：按地区分類的收益预测
- IP管理服务：收益预测考量
成长要素：临床研究委託产业
- 医学写作服务
- 医学写作服务：收益预测
- 医学写作服务：按地区分類的收益预测
- 医学写作服务：收益预测考虑因素
成长要素：临床研究委託产业
- 监管和医学事务服务
- 监管与医疗事务服务：收益预测
- 监管和医疗事务服务：按地区分類的收益预测
- 监管和医疗事务服务：收益预测考虑因素
成长机会领域
- 成长机会1：利用 Medical Copilot 进行临床试验资料管理
- 成长机会2：为澳洲生技公司提供中央化验服务
- 成长机会三：监管与医疗事务客製化服务
- 成长机会#4：药物安全检测即服务
- 成长机会五：外包业务服务以顾客为中心的伙伴关係模式
附录与后续步骤
- 成长机会的益处和影响
- 后续步骤Next steps
- 附件列表
- 免责声明
The CRO Industry is Witnessing Transformational Growth Due to Industry Convergence and an Increasing Reliance on the Functional Service Provider (FSP) Model
As trial volumes normalize after the COVID-19 pandemic, pharma and biopharma companies are re-focusing on their drug development pipelines. As a result, the market has been creating an increasing number of clinical trial outsourcing opportunities for CROs, with these service providers also refining their processes to ensure better clinical trial turnarounds and improved time to market. In this context, the global CRO industry was valued at $66.39 billion in 2024, and it is expected to register a CAGR of 10.7% from 2024 to 2030, reaching $122.13 billion in 2030. Across the global pharma market, the overall CRO outsourcing penetration rate ranges from 45%-50%, depending on the service type.
In addition to full-service CROs operating in the global CRO industry, there is a surge of peripheral service-focused CROs, also referred to as specialized/niche CROs. These companies exclusively focus on supportive functions, including biostatistics, lab testing, pharmacovigilance, post-market surveillance, and investigational product (IP) management. These activities support the core clinical research functions, ensuring timely completion and required outcomes.
As the emphasis on biologics drug development grows, small-to-mid-sized and emerging biopharma companies are contributing more than 50% of the pipelines. Apart from trial-related services, such as patient recruitment, site selection and management, and investigator recruitment, clinical trial peripheral services, such as pharmacovigilance, safety testing, central lab services, medical writing, IP management, data management, and biostatistics, have been gaining traction, with pharma sponsors increasingly outsourcing these specific activities to CROs.
This is leading to the extensive use of the functional service provider (FSP) model targeting specific trial-related ancillary or peripheral activities. Though a significant share of the clinical pipeline is contributed by small-to-mid-sized and emerging biopharma companies, the need for peripheral services through FSP models is expected to witness a sharp rise, especially from large pharma companies looking to optimize trial costs.
Moreover, the industry will witness a shift to a hybrid FSO/FSP model, as companies aim to augment their clinical trial activities through better risk mitigation. As a result, these companies will look for outsourcing partners to meet their clinical research needs, paving the way for both full-service outsourcing and FSP models, which focus on supporting peripheral activities, such as analytical testing, data management, and biostatistics.
Key Issues Addressed
- What are the general industry trends? What are the specific trends for peripheral activities within clinical trials?
- What are the key drivers triggering large-scale outsourcing of clinical development?
- What key emerging business models are providing a competitive advantage to pharma sponsors? How is this trend supporting industry convergence?
- Who are the leading participants driving market growth?
- What is the growth opportunity for small-to-mid-sized CRO companies amidst 1,500+ competitors?
- How is the application of technology supporting the growth of the CRO peripheral activities landscape? Which are the fastest-growing peripheral activities in the CRO industry?
Table of Contents
Growth Opportunities: Research Scope
- Scope of Analysis
- Segmentation
- CRO Peripheral Services-Defining Key Activities Across Peripheral Services
Growth Environment: Transformation in the Pharmaceutical Clinical Contract Peripheral Services Landscape
- Why Is It Increasingly Difficult to Grow?
- The Strategic Imperative 8™
- The Impact of the Top 3 Strategic Imperatives on the Pharmaceutical Clinical Contract Peripheral Services Industry
Ecosystem in the Pharmaceutical Clinical Contract Research Organization Industry
- Market Trend Analysis
- Contract Peripheral Services-Vendor Ecosystem
- CRDMO-The New Normal in Early-stage Drug Development
- Evolving Partnership Models Across the CRO Market
- FSP Model Types
- FSP Model Outlook
Competitive Environment
- Key Competitors-By Regions
Best Practices in the Pharmaceutical Clinical Contract Research Organization Industry
- Investment Trends
- Portfolio Expansion with M&As
- Project-specific CRO Expertise With Strategic Partnerships
- In-house Investments for Long-term Growth
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Growth Metrics
- Growth Drivers
- Growth Restraints
- Forecast Assumptions
- Market Forecast-Limitations and Caveats
- Revenue Forecast Methodology
- Revenue Forecast
- Revenue Forecast Analysis
Revenue Forecast by Clinical Development Phase
- Percent Revenue Share by Clinical Development Phase
- Revenue Forecast Analysis by Clinical Development Phase
- Revenue Share
- Revenue Share Analysis
- Revenue Forecast by Region
- Percent Revenue Forecast by Region
- Revenue Forecast Analysis-North America
- Revenue Forecast Analysis-Europe
- Revenue Forecast Analysis-APAC
- Revenue Forecast Analysis-LATAM and Caribbean
- Revenue Forecast Analysis-MEA
- Revenue Forecast by Peripheral Services Versus Core Services
- Percent Revenue Forecast by Peripheral Services Versus Core Services
- Revenue Forecast by Peripheral Service Segments
- Revenue Forecast Analysis
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Central Lab Testing Services
- Central Lab Testing Services-Revenue Forecast
- Central Lab Testing Services-Revenue Forecast by Region
- Central Lab Testing Services-Revenue Forecast Discussion
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Biostatistics Services
- Biostatistics Services-Revenue Forecast
- Biostatistics Services-Revenue Forecast by Region
- Biostatistics Services-Revenue Forecast Discussion
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Data Management Services
- Data Management Services-Revenue Forecast
- Data Management Services-Revenue Forecast by Region
- Data Management Services-Revenue Forecast Discussion
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Pharmacovigilance and Safety Testing Services
- Pharmacovigilance and Safety Testing Services-Revenue Forecast
- Pharmacovigilance and Safety Testing Services-Revenue Forecast by Region
- Pharmacovigilance and Safety Testing Services-Revenue Forecast Discussion
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- IP Management Services
- IP Management Services-Revenue Forecast
- IP Management Services-Revenue Forecast by Region
- IP Management Services-Revenue Forecast Discussion
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Medical Writing Services
- Medical Writing Services-Revenue Forecast
- Medical Writing Services-Revenue Forecast by Region
- Medical Writing Services-Revenue Forecast Discussion
Growth Generator in the Pharmaceutical Clinical Contract Research Organization Industry
- Regulatory and Medical Affairs Services
- Regulatory and Medical Affairs Services-Revenue Forecast
- Regulatory and Medical Affairs Services-Revenue Forecast by Region
- Regulatory and Medical Affairs Services-Revenue Forecast Discussion
Growth Opportunity Universe
- Growth Opportunity 1: Medical Co-pilot-powered Clinical Trial Data Management
- Growth Opportunity 2: Central Lab Services for Biotechnology Companies in Australia
- Growth Opportunity 3: Customized Services for Regulatory and Medical Affairs
- Growth Opportunity 4: Pharmacovigilance-as-a-Service
- Growth Opportunity 5: Customer-centric Partnership Models for Peripheral Service Outsourcing
Appendix & Next Steps
- Benefits and Impacts of Growth Opportunities
- Next Steps
- List of Exhibits
- Legal Disclaimer
