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市場調查報告書
商品編碼
1725006
全球醫藥臨床開發業務服務（2025-2030 ）Pharmaceutical Clinical Contract Peripheral Services, Global, 2025-2030 |
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由於產業融合以及對功能服務供應商(FSP) 模式的依賴性增加，CRO 產業正在經歷轉型成長。
隨著 COVID-19 疫情後臨床試驗量恢復正常，製藥和生物製藥公司正在重新調整其藥物開發平臺。因此，臨床試驗外包機會對於 CRO 來說正在增加，這些服務供應商也在改進其流程以改善臨床試驗的周轉時間和上市時間。在此背景下，全球 CRO 產業價值預計在 2024 年將達到 663.9 億美元，到 2030 年將達到 1,221.3 億美元，2024 年至 2030 年的複合年成長率為 10.7%。在全球製藥市場中，CRO 外包滲透率從 45% 到 50% 不等，具體取決於服務類型。
在全球CRO產業中，除了提供全方位服務的CRO外，專門提供周邊服務的CRO數量正在快速增加。這些公司專門從事生物統計、實驗室測試、藥物安全檢測、上市後監測和臨床實驗產品（IP）管理等支援功能。這些業務支持臨床研究的核心功能，確保及時完成並取得所需的結果。
隨著藥物開發對生技藥品的重視程度不斷提高，中小型新興生物製藥公司目前佔據了藥物研發管線的 50% 以上。除了臨床實驗試驗相關的業務（如患者招募、地點選擇和管理、臨床實驗招募）之外，其他臨床實驗業務（如藥物安全檢測、安全測試、中央實驗室服務、醫學寫作、知識產權臨床實驗、數據管理、生物統計學等）也越來越受歡迎，製藥贊助商擴大將這些特定業務委託給CRO。
因此，功能服務提供者（FSP）模式因提供特定業務或外圍臨床開發相關業務而變得流行。雖然大部分臨床管線來自中型和新興生物製藥公司，但透過 FSP 模式提供周邊服務的需求預計將快速成長，尤其是希望最佳化試驗成本的大型製藥企業。
此外，隨著公司尋求透過更好的風險緩解來加強臨床試驗活動，該行業可能會轉向混合模式。因此，這些公司將尋求外包合作夥伴來滿足其臨床研究需求，為全方位服務外包和專注於支援分析測試、資料管理和生物統計等外圍業務的 FSP 模式鋪平道路。
主要問題
- 整體產業趨勢是怎樣的？臨床試驗相關的周邊業務具體有哪些趨勢？
- 大規模臨床開發外包的關鍵促進因素是什麼？
- 哪些新的經營模式將為製藥公司帶來競爭優勢？這一趨勢如何支持產業融合？
- 哪些市場參與企業正在推動成長？
- 面對超過1500家競爭對手，中小型CRO公司有哪些成長機會？
- 技術的運用如何支持CRO周邊業務的成長？ CRO產業中成長最快的外圍業務是什麼？
目錄
成長機會：研究範圍
- 分析範圍
- 分割
- CRO 周邊業務：業務服務中關鍵活動的定義
成長環境：醫藥臨床業務委託業務服務周邊環境的變化
- 為何成長變得越來越困難？
- The Strategic Imperative 8（TM）
- 三大業務問題對臨床委託服務業的影響
醫藥臨床業務委託產業生態系統
- 市場趨勢分析
- 周邊業務委託服務：供應商生態系統
- CRDMO：早期藥物研發的新常態
- CRO市場的夥伴關係模式不斷演變
- FSP 模型類型
- FSP 模型的展望
競爭環境
- 主要競爭對手：按地區
最佳實踐：臨床業務委託產業
- 投資趨勢
- 透過併購擴大投資組合
- 透過策略夥伴關係獲得針對特定計劃的 CRO 專業知識
- 投資自身，實現長期發展
成長要素：臨床業務委託產業
- 成長指標
- 成長動力
- 成長抑制因素
- 預測先決條件
- 市場預測：限制和注意事項
- 收益預測方法
- 收益預測
- 收益預測分析
按臨床開發階段預測收益
- 按臨床開發階段收益佔有率
- 按臨床開發階段進行的收益分析
- 收益佔有率
- 收益佔有率分析
- 各地區收益預測
- 各地區收益百分比預測
- 收益預測分析：北美
- 收益預測分析：歐洲
- 收益預測分析：亞太地區
- 收益預測分析：拉丁美洲和加勒比海地區
- 收益預測分析：中東和非洲
- 周邊業務和核心業務收益收益
- 周邊業務與核心服務收益預測比例
- 周邊業務部門的收益和預測
- 收益預測分析
成長要素：臨床研究委託產業
- 中央實驗室測試服務
- 中央實驗室測試服務：收益預測
- 中央實驗室測試服務：按地區分類的收益預測
- 中央實驗室測試服務：收益預測考量因素
成長要素：臨床研究委託產業
- 生物統計服務
- 生物統計服務：收益預測
- 生物統計服務：按地區分類的收益預測
- 生物統計服務：收益預測考慮因素
成長要素：臨床研究委託產業
- 資料管理服務
- 資料管理服務：收益預測
- 資料管理服務：按地區分類的收益預測
- 資料管理服務：收益預測考量因素
成長要素：臨床研究委託產業
- 藥物安全檢測和安全測試服務
- 藥物安全檢測和安全測試服務：收益預測
- 藥物安全檢測和安全測試服務：按地區分類的收益預測
- 藥物安全檢測與安全測試服務：收益預測洞察
成長要素：臨床研究委託產業
- 智慧財產權管理服務
- IP管理服務：收益預測
- 知識產權管理服務：按地區分類的收益預測
- IP管理服務：收益預測考量
成長要素：臨床研究委託產業
- 醫學寫作服務
- 醫學寫作服務：收益預測
- 醫學寫作服務：按地區分類的收益預測
- 醫學寫作服務：收益預測考慮因素
成長要素：臨床研究委託產業
- 監管和醫學事務服務
- 監管與醫療事務服務：收益預測
- 監管和醫療事務服務：按地區分類的收益預測
- 監管和醫療事務服務：收益預測考慮因素
成長機會領域
- 成長機會1：利用 Medical Copilot 進行臨床試驗資料管理
- 成長機會2：為澳洲生技公司提供中央化驗服務
- 成長機會三：監管與醫療事務客製化服務
- 成長機會#4：藥物安全檢測即服務
- 成長機會五：外包業務服務以顧客為中心的夥伴關係模式
附錄與後續步驟
- 成長機會的益處和影響
- 後續步驟Next steps
- 附件列表
- 免責聲明
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
