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市場調查報告書
商品編碼
1916505
全球合約研究組織 (CRO) 服務市場:市場規模、份額、成長率、行業分析、按類型、應用和地區劃分的考慮因素以及未來預測 (2026-2034)Contract Research Organization Services Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034 |
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預計全球合約研究組織 (CRO) 服務市場規模在 2025 年將達到 922.7 億美元,2026 年將成長至 998.7 億美元,並在 2034 年達到 1992.8 億美元。預計在預測期內(2026-2034 年),其複合年增長率 (CAGR) 為 9%。北美地區在 2025 年將以 50.10% 的市場份額引領 CRO 服務市場,這得益於主要 CRO 公司的強大實力、活躍的臨床試驗活動以及大規模的藥物研發投資。
合約研究組織 (CRO) 為製藥、生物技術和醫療器材公司提供外包研究服務,包括早期開發、臨床試驗、實驗室檢測、法規支援和資料管理。研發活動外包的日益增多以及藥物研發流程的日益複雜性是推動市場穩定擴張的關鍵因素。
市場驅動因素
全球臨床試驗數量的不斷增長是推動 CRO 服務需求的主要因素。根據世界衛生組織 (WHO) 統計,到 2024 年,全球註冊的臨床試驗數量將達到 38,788 項,較 2010 年的 28,432 項顯著增長,顯示研究活動正在擴大。藥物研發成本仍然非常高昂,據估計,每項臨床試驗的平均成本為:I 期 400 萬美元,II 期 1,300 萬美元,III 期 2,000 萬美元。此外,只有 12% 的候選藥物能夠進入臨床試驗階段並獲得監管部門的批准,因此,將臨床試驗外包給合約研究組織 (CRO) 是一種經濟高效且降低風險的策略,尤其對於中小生物製藥公司而言更是如此。
CRO 與生技公司之間的合作持續成長。 2024 年 11 月,諾沃泰克與北京百奧斯達藥業合作,以加強其臨床開發項目,凸顯了全球合作加速研發進程的趨勢。
市場限制因子
嚴格且具地域性的監管架構為 CRO 的營運帶來了挑戰。倫理審批、試驗中心審批和病患招募的監管延誤會延緩試驗啟動,並增加營運複雜性。根據美國國家生物技術資訊中心 (NCBI) 發表的一項研究,監管延誤是臨床試驗時間延長和招募困難的主要原因之一,限制了多國試驗的快速發展。
市場機會
在先天性異常和圍產期疾病等研究不足的治療領域進行新研究,蘊藏著巨大的未來機會。根據世界衛生組織的數據,到2024年,針對先天性異常的臨床試驗僅有328項,而針對惡性腫瘤的臨床試驗則高達5,306項,顯示該領域的研究潛力尚未充分開發。預計資金投入的增加和跨境合作將擴大合約研究組織(CRO)在這些專業領域的參與度。 2021年3月,Natera公司與Tesis Labs合作,以增強其基因檢測能力,這反映了市場對專業診斷研究服務日益增長的需求。
市場挑戰
區域監管差異增加了合規成本,並要求CRO保持多元化的監管專業知識。日益嚴峻的網路安全威脅也因更嚴格的資料保護法律而限制了病患參與臨床試驗。此外,熟練的臨床研究專業人員短缺和基礎設施成本不斷上漲,也增加了CRO供應商的服務交付成本和營運風險。
CRO服務市場趨勢
研發支出不斷成長,推動了臨床試驗外包。根據歐洲製藥工業協會聯合會(EFPIA)統計,2022年製藥業的研發支出將達到467.928億美元,比前一年成長7.2%。企業越來越依賴CRO來管理複雜的試驗、罕見疾病研究、腫瘤計畫和上市後監測。
人工智慧和機器學習工具正被用於優化病患招募、方案設計、預測分析和試驗監查。利用遠距監查、穿戴式裝置和數位平台的去中心化臨床試驗也越來越普遍,這有助於提高病患參與率並降低試驗中心成本。基因組分析和生物標記研究為個人化醫療的發展提供了支持,進一步推動了對專業CRO服務的需求。
按類型
市場細分為早期研發服務、臨床服務、檢測服務及其他服務。早期研發服務是市場成長的主要驅動力,這主要得益於對藥物發現、臨床前測試以及化學、生產和控制 (CMC) 服務的日益重視。臨床服務(包括I期至IV期臨床試驗)預計將實現強勁成長,主要得益於中後期研發管線的擴展。
按應用領域
腫瘤學在應用領域中佔據最大的市場份額,這主要得益於癌症發生率的上升和不斷擴大的抗癌藥物研發管線。預計2023年美國將新增1,958,310例癌症病例,反映出癌症臨床試驗的持續需求。由於阿茲海默症和神經退化性疾病的盛行率不斷上升,神經病學領域預計將保持穩定成長。傳染病和代謝性疾病的研究也推動了臨床試驗數量的增加。
依最終使用者劃分
由於研發管線日益複雜以及研發階段外包的增加,製藥和生技公司佔據了最大的市場份額。在註冊的醫療器材臨床試驗數量不斷增加的推動下,醫療器材製造商預計將以更快的速度成長。
北美將在2026年以498.8億美元的市場規模引領市場,其中美國佔447.8億美元。全球約30%的臨床試驗在美國註冊。歐洲將在2026年以257.7億美元的市場規模位居第二,這得益於強勁的製藥研發投資。亞太地區是成長最快的地區,預計到2026年將達到194.5億美元,這主要得益於成本優勢、製造能力的提升以及與合約研究組織(CRO)合作的拓展。其中,中國預計將佔56.9億美元,印度佔38.6億美元,日本佔35億美元。
The global Contract Research Organization (CRO) services market size was valued at USD 92.27 billion in 2025 and is projected to grow to USD 99.87 billion in 2026, reaching USD 199.28 billion by 2034, expanding at a CAGR of 9% during the forecast period (2026-2034). North America dominated the CRO services market with a 50.10% market share in 2025, supported by a strong presence of large CRO firms, high clinical trial activity, and substantial pharmaceutical R&D investments.
Contract Research Organizations provide outsourced research services including early-phase development, clinical trials, laboratory testing, regulatory support, and data management to pharmaceutical, biotechnology, and medical device companies. Increasing outsourcing of R&D activities and rising complexity of drug development pipelines are major contributors to the market's steady expansion.
Market Drivers
The growing number of clinical trials globally is a primary driver of CRO services demand. According to the World Health Organization, 38,788 clinical trials were registered worldwide in 2024, rising significantly from 28,432 trials in 2010, indicating expanding research activity. Drug development remains highly expensive, with average clinical phase costs estimated at USD 4.0 million for Phase I, USD 13.0 million for Phase II, and USD 20.0 million for Phase III. Furthermore, only 12% of drug candidates entering clinical trials receive regulatory approval, making outsourcing to CROs a cost-efficient and risk-reducing strategy, especially for small and mid-sized biopharmaceutical firms.
Partnerships between CROs and biotech companies continue to increase. In November 2024, Novotech partnered with Beijing Biostar Pharmaceuticals to strengthen clinical development programs, highlighting the growing trend of global collaborations to accelerate development timelines.
Market Restraints
Stringent and region-specific regulatory frameworks pose challenges for CRO operations. Regulatory delays in ethical approvals, site authorization, and patient recruitment slow trial initiation and increase operational complexity. According to research published by NCBI, regulatory delays are among the primary reasons for postponed clinical study timelines and recruitment difficulties, limiting faster execution of trials across multiple countries.
Market Opportunities
Emerging research in under-studied therapeutic areas such as congenital anomalies and perinatal conditions offers strong future opportunities. WHO data shows that in 2024, only 328 clinical trials targeted congenital anomalies, compared to 5,306 trials for malignant neoplasms, indicating untapped research segments. Increasing funding and cross-border collaborations are expected to expand CRO involvement in these specialized areas. In March 2021, Natera Inc. collaborated with Tesis Labs to enhance genetic testing capabilities, reflecting rising demand for specialized diagnostic research services.
Market Challenges
Regulatory heterogeneity across regions increases compliance costs and requires CROs to maintain diverse regulatory expertise. Rising cybersecurity threats also restrict patient participation in trials due to stricter data protection laws. Additionally, shortages of skilled clinical research professionals and growing infrastructure costs increase service delivery expenses and operational risks for CRO providers.
CRO Services Market Trends
Outsourcing of clinical trials continues to rise due to escalating R&D expenditure. According to EFPIA, pharmaceutical R&D spending reached USD 46,792.8 million in 2022, showing a 7.2% increase year-on-year. Companies increasingly rely on CROs to manage complex trials, rare disease research, oncology programs, and post-marketing surveillance studies.
AI and machine learning tools are being adopted for patient recruitment optimization, protocol design, predictive analytics, and trial monitoring. Decentralized clinical trials using remote monitoring, wearable devices, and digital platforms are also gaining adoption, improving patient participation and lowering site costs. Personalized medicine research supported by genomic and biomarker-based studies further increases demand for specialized CRO services.
By Type
The market is segmented into early phase development services, clinical services, laboratory services, and others. Early phase development services dominated the market, driven by increased focus on discovery, preclinical studies, and Chemistry, Manufacturing, and Controls (CMC) services. The clinical services segment, including Phase I-IV trials, is expected to witness strong growth due to expanding mid-stage and late-stage pipelines.
By Application
Oncology dominated application segments due to rising cancer incidence and increasing oncology drug pipelines. In the U.S., 1,958,310 new cancer cases were reported in 2023, reflecting continuous need for oncology trials. Neurology is expected to grow steadily due to increasing prevalence of Alzheimer's disease and neurodegenerative disorders, while infectious disease and metabolic disorder research also contributes to trial volume growth.
By End-User
Pharmaceutical and biotechnology companies accounted for the largest share due to rising pipeline complexity and increasing outsourcing of development stages. Medical device companies are expected to grow at a faster pace, supported by rising numbers of registered device-based clinical trials.
North America led the market with USD 49.88 billion in 2026, supported by the U.S. accounting for USD 44.78 billion in 2026. Approximately 30% of all global clinical trials are registered in the U.S. Europe ranked second with USD 25.77 billion in 2026, supported by strong pharmaceutical R&D investment. Asia Pacific is the fastest-growing region, valued at USD 19.45 billion in 2026, driven by cost advantages, rising manufacturing capabilities, and expanding CRO partnerships. China reached USD 5.69 billion, India USD 3.86 billion, and Japan USD 3.50 billion in 2026.
Competitive Landscape
Key players including IQVIA, ICON plc, Syneos Health, Charles River Laboratories, Parexel, Thermo Fisher Scientific, Medpace, and Fortrea focus on service expansion, digital integration, and global delivery models. Strategic partnerships, acquisitions, and technology investments remain central strategies for market positioning and long-term service scalability.
Conclusion
The Contract Research Organization (CRO) services market is positioned for strong long-term expansion, growing from USD 92.27 billion in 2025 to USD 99.87 billion in 2026, and further reaching USD 199.28 billion by 2034, supported by a 9% CAGR during 2026-2034. Market growth is driven by the rising number of global clinical trials, increasing R&D costs, low drug approval success rates, and the growing reliance of pharmaceutical, biotechnology, and medical device companies on outsourced research models. North America continues to lead with a 50.10% share in 2025, while Asia Pacific shows the fastest growth momentum due to cost efficiencies and expanding research infrastructure. Technological adoption such as AI-driven trial management, decentralized clinical trials, and personalized medicine research is reshaping service delivery models, while regulatory complexity and workforce shortages remain key operational challenges. Overall, CROs are becoming integral partners across the drug and device development lifecycle, playing a critical role in accelerating innovation, improving trial efficiency, and supporting global therapeutic advancement.
Segmentation By Type
By Application
By End-user
By Region