市場調查報告書
商品編碼
1466084
委外研發機構服務市場:按類型、研究階段、治療領域、分子類型、最終用戶 - 2024-2030 年全球預測Contract Research Organization Services Market by Type (Clinical Research Services, Consulting Services, Data Management Services), Trial Phase (Phase I, Phase II, Phase III), Therapeutic Area, Molecule Type, End-User - Global Forecast 2024-2030 |
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預計2023年藥物委外研發機構服務市場規模為887.8億美元,預計2024年將達982.8億美元,2030年將達1842.1億美元,複合年成長率為10.98%。
委外研發機構(CRO) 服務包括為製藥、生物技術和醫療設備業提供的各種委託支援選項,用於藥物開發、臨床試驗管理和上市後監測。這些組織提供監管提交指導、臨床業務、資料管理、統計分析、醫學寫作以及將醫療產品推向市場的複雜過程所需的其他功能方面的專業知識。 CRO 服務在全球範圍內的普及主要是由於藥物開發成本的上升、對日益複雜的治療領域的專業知識的需求以及需要大量臨床試驗資料和文件的監管壓力的增加。然而,資料安全和智慧財產權管理的潛在問題正在影響 CRO 的採用。圍繞保密、智慧財產權和管治結構建立明確的合約協議對於解決這些問題至關重要。細胞和基因療法等先進治療方法的興起,以及精準醫學的發展,為 CRO 提供了開發專業服務的重大機會。在數位領域,透過採用人工智慧和機器學習進行資料分析並結合虛擬臨床試驗,預計將出現新的發展。
主要市場統計 | |
---|---|
基準年[2023] | 887.8億美元 |
預測年份 [2024] | 982.8億美元 |
預測年份 [2030] | 1842.1億美元 |
複合年成長率(%) | 10.98% |
聘請臨床研究服務來管理型式臨床試驗的複雜性和持續時間
臨床研究服務包括管理和進行臨床試驗,以測試新藥、設備和治療通訊協定,並確定其對人體的安全性和有效性。服務包括臨床試驗設計、病患招募、監管備案、地點選擇、監測、以及資料收集和分析。 CRO提供的諮詢服務包括有關藥物開發路徑、監管合規性和打入市場策略以及業務改善和財務規劃的策略建議。資料管理服務包括臨床試驗期間收集的資料的收集、清理和分析。這包括使用電子資料採集 (EDC)、生物統計學和臨床資料管理系統 (CDMS) 等先進技術。早期開發服務著重於藥物開發的早期階段,從發現到 I 期和 IIA 期試驗。這包括藥物化學、臨床前研究、藥物動力學和首次人體研究。這些服務對於需要專業知識將分子從實驗室轉移到臨床試驗的公司尤其重要。實驗室服務是指為支持藥物開發過程而進行的各種測試和分析,例如生物分析服務、臨床試驗的中心實驗室服務和生物標記研究。
測試階段:需要強大的真實資料和上市後支援的CRO
I期試驗是人體試驗的第一階段,主要著重於評估藥物的安全性、耐受性、藥物動力學和動態。此階段的服務包括設計和進行首次人體(FIH)試驗、健康志願者試驗和早期患者試驗。在二期試驗中,重點轉向確定藥物的療效並進一步評估其安全性,包括患者招募和入組策略、概念驗證研究以及監管支持和提交。 III 期試驗是大規模試驗,通常在多個國家進行,旨在確認藥物的有效性、監測副作用並將治療方法進行比較。一旦藥物獲得核准並投放市場,第四期試驗(也稱為上市後監測)就開始監測藥物的長期有效性以及對患者生活品質的影響。這裡的關鍵服務包括風險管理和藥物安全檢測、評估長期有效性的註冊研究以及市場准入和報銷援助。
治療領域:CRO服務一直是腫瘤藥物開發的首選
心血管疾病 (CVD) 仍然是全球死亡的主要原因,因此需要專注於開發高血壓、心臟衰竭和心律不整等疾病治療方法的綜合研究服務。 CVD 領域的 CRO 服務通常包括臨床試驗管理、病患招募和監管支援。由於從乾癬到黑色素瘤等皮膚病的盛行率不斷上升,皮膚病學領域正受到越來越多的關注。該領域所需的服務包括臨床試驗設計、患者報告的結果和生物統計學,主要關注皮膚病學終點。胃腸道 (GI) 疾病包括大腸激躁症、克隆氏症和大腸癌等多種疾病,需要專門從事胃腸道檢測的 CRO 的專業知識。由於許多胃腸道疾病是慢性病,需要長期治療,因此對此類服務的需求強勁。血液學是血液相關疾病的研究,需要專門的 CRO 服務來指導白血病、淋巴瘤、血友病等的複雜臨床試驗。隨著加強治療方法和開發根治性治療方法的呼聲日益高漲,對這些服務的需求也不斷增加。類風濕性關節炎和狼瘡等免疫性疾病的特徵是慢性進展,需要熟練的免疫調節治療服務。該領域非常需要針對特定疾病的研究設計和終點。隨著新病原體的持續威脅和抗生素抗藥性的發展,感染疾病領域對 CRO 服務的需求不斷增加。這些服務包括疫苗開發、抗菌藥物抗藥性測試以及愛滋病毒、結核病和肝炎等疾病的治療試驗。阿茲海默症、多發性硬化症和帕金森氏症等神經系統疾病由於其複雜性和測量臨床結果的困難而面臨獨特的挑戰。能夠克服這種複雜性的 CRO 服務(例如神經影像和神經認知評估)的需求量很大。腫瘤學是最具活力的領域之一,由於癌症的侵襲性和對創新治療方法的持續需求,對 CRO 服務的需求持續高漲。服務範圍從早期檢測到後期臨床試驗,個人化醫療和免疫腫瘤學正受到越來越多的關注。
最終用戶:學術研究機構強大的基礎研究能力的需要
學術研究機構經常求助於 CRO 服務來加強其研究並利用專業技能,而無需支付內部基礎設施的管理費用。他們的願望通常與早期研究、教育資源和津貼資金籌措一致。醫療設備公司專注於醫療設備的開發、測試和商業化。與 CRO 的合作對於應對充滿挑戰的監管環境和管理多階段試驗至關重要。製藥和生物技術公司是 CRO 的主要客戶,因為它們需要整體的研發服務,從臨床前測試到後期臨床試驗和上市後監測。
區域洞察
由於強大的製藥和生物技術行業、嚴格的 FDA 法規以及對一致藥物開發的重視,美洲尤其是美國對 CRO 服務的需求很高。這導致了經驗豐富的 CRO 的集中,這些 CRO 擁有先進的基礎設施、複雜臨床試驗的專業知識和端到端服務交付。由於其具有成本效益的營運、龐大且多樣化的患者群體以及不斷改善的法規環境,亞太地區正在迅速成為 CRO 服務的首選目的地。在該地區,中國、印度等國家已成為臨床試驗活動的熱點,當地CRO的數量正在迅速增加。亞太地區的合約研究機構可能專注於數量主導的服務,但他們正在增加對品質和技術進步的投資,以在全球範圍內競爭。歐洲憑藉豐富的藥物研究歷史、重要的法律規範和高技能的勞動力保持著強大的地位,吸引了遵守嚴格合規標準的複雜 CRO 活動。儘管中東和非洲的 CRO 服務仍在發展中,但由於不斷成長的醫療保健投資以及開拓的多樣化基因庫,它們提供了商機。
FPNV定位矩陣
FPNV定位矩陣對於評估藥物委外研發機構服務市場極為重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對委外研發機構服務市場中供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4. 競爭評估和情報:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況和製造能力進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.藥物委外研發機構服務市場的市場規模和預測是多少?
2.在藥物委外研發機構服務市場的預測期內,需要考慮投資的產品、細分市場、應用和領域有哪些?
3.藥物委外研發機構服務市場的技術趨勢和法規結構是什麼?
4.藥品委外研發機構服務市場主要廠商的市場佔有率是多少?
5.進入藥物委外研發機構服務市場的適當型態和策略手段是什麼?
[188 Pages Report] The Contract Research Organization Services Market size was estimated at USD 88.78 billion in 2023 and expected to reach USD 98.28 billion in 2024, at a CAGR 10.98% to reach USD 184.21 billion by 2030.
Contract research organization (CRO) services encompass a range of outsourced support options provided to pharmaceutical, biotechnology, and medical device industries for drug development, clinical trial management, and post-marketing surveillance. These organizations offer expertise in regulatory submission guidance, clinical operations, data management, statistical analysis, medical writing, and other functions necessary to navigate the complex processes of bringing a medical product to market. The global proliferation of CRO services is mainly driven by the escalating costs of drug development, the need for specialized knowledge in increasingly complex therapeutic areas, and mounting regulatory pressures that require extensive clinical trial data and documentation. However, potential issues with data security and management of intellectual property impact their adoption. Establishing clear contractual agreements delineating confidentiality obligations, IP rights, and governance structures is essential to address these concerns. The rise of advanced therapies like cell and gene therapies, along with the growth of precision medicine, presents a substantial opportunity for CROs to develop specialized services. In the digital realm, the employment of artificial intelligence and machine learning for data analysis and the incorporation of virtual clinical trials are trends expected to offer new avenues for expansion.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 88.78 billion |
Estimated Year [2024] | USD 98.28 billion |
Forecast Year [2030] | USD 184.21 billion |
CAGR (%) | 10.98% |
Type: Adoption of clinical research services to manage the complexity and duration of clinical trials
Clinical research services involve the management and execution of clinical trials to test new drugs, devices, and treatment protocols to determine their safety and efficacy in humans. Services include trial design, patient recruitment, regulatory submissions, site selection, monitoring, and data collection and analysis. Consulting services by CROs involve strategic advice on drug development pathways, regulatory compliance, and market entry strategies, and they also extend to operational improvements and financial planning. Data management services encompass the collection, cleaning, and analysis of data gathered during clinical trials. This includes the use of advanced technologies such as electronic data capture (EDC), biostatistics, and clinical data management systems (CDMS). Early phase development services are focused on the initial stages of drug development, from drug discovery through Phase I and Phase IIA studies. This includes medicinal chemistry, preclinical studies, pharmacokinetics, and first-in-human trials. These services are particularly relevant for companies that require specialized expertise in transitioning a molecule from the lab to clinical testing. Laboratory services refer to a range of tests and analyses conducted in support of the drug development process, including bioanalytical services, central lab services for clinical trials, and biomarker studies.
Trial Phase: Need for CROs with strong capabilities in real-world data and post-market support
Phase I trials are the first stage of testing in human subjects and primarily focus on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. Services in this phase include first-in-human (FIH) trial design and execution, healthy volunteer studies, and early-stage patient trials, among others. In Phase II, the focus shifts towards determining the efficacy of the drug and further evaluating its safety, including patient recruitment and enrollment strategies, proof-of-concept studies, and regulatory support and filings. Phase III trials involve large-scale studies, often multinational, to confirm the drug's efficacy, monitor side effects, and compare it with standard or equivalent treatments. Once a drug is approved and marketed, Phase IV studies, also known as post-marketing surveillance, are initiated to monitor the drug's long-term effectiveness and impact on the patient's quality of life. Key services here include risk management and pharmacovigilance, registry studies to assess long-term effects, and market access and reimbursement support.
Therapeutic Area: Consistent preference for CRO services in oncology drug development activities
Cardiovascular diseases (CVD) remain a major cause of mortality globally, driving the need for comprehensive research services focusing on the development of treatments for conditions such as hypertension, heart failure, and arrhythmias. CRO services for CVD often include clinical trial management, patient recruitment, and regulatory support. The dermatology sector is increasingly attracting attention due to the rising prevalence of skin disorders ranging from psoriasis to melanoma. Services required in this area predominantly encompass clinical trial design specific to dermatological endpoints, patient-reported outcomes, and biostatistics. Gastrointestinal (GI) disorders include a wide range of conditions, such as irritable bowel syndrome, Crohn's disease, and colorectal cancer, requiring the expertise of CROs specialized in GI studies. Demand for such services is strong due to the chronic nature of many GI diseases and the necessity for long-term treatment regimens. Hematology, the study of blood-related diseases, demands specialized CRO services to navigate complex clinical trials for conditions like leukemia, lymphoma, and hemophilia. These services are in high demand as the quest to enhance treatment regimens and develop curative therapies intensifies. Immunological disorders, such as rheumatoid arthritis and lupus, are marked by chronic progression and require services that are adept at handling immune-modulating treatments. This segment reveals a strong preference for disease-specific trial designs and endpoints. With the continuous threat of emerging pathogens and the development of antibiotic resistance, there is a substantial need for CRO services within infectious diseases. These services include vaccine development, antimicrobial resistance studies, and treatment trials for diseases, including HIV, tuberculosis, and hepatitis. Neurological conditions, such as Alzheimer's disease, multiple sclerosis, and Parkinson's disease, pose unique challenges due to their complexity and the difficulty in measuring clinical outcomes. CRO services that can navigate this complexity, including neuroimaging and neurocognitive assessments, are in high demand. Oncology is one of the most dynamic segments with a persistently high demand for CRO services due to the aggressive nature of cancer and the ongoing need for innovative therapies. Services span early-stage discovery to late-stage clinical trials, with an increasing focus on personalized medicine and immuno-oncology.
End-User: Need for strong foundational research capabilities by academic and research institutions
Academic Institutes often engage CRO services to bolster research without the overhead costs of internal infrastructure and to access specialized skill sets. Their preferences are generally aligned with early-phase research, educational resources, and grant-based funding integration. Medical device companies focus on the development, testing, and commercialization of medical devices. CRO partnerships are vital in navigating the stringent regulatory landscape and managing multi-phase trials. Pharmaceutical and Biotechnology firms are the primary clients for CROs due to their extensive need for full-spectrum research and development services ranging from preclinical studies to late-stage clinical trials and post-marketing surveillance.
Regional Insights
In the Americas, particularly the United States, there is a high demand for CRO services owing to a substantial pharmaceutical and biotechnology sector, stringent FDA regulations, and a consistent emphasis on drug development. This results in a concentration of seasoned CROs equipped with advanced infrastructure, expertise in complex clinical trials, and end-to-end service offerings. The APAC region is rapidly emerging as a favorable destination for CRO services, owing to its cost-effective operations, large and diverse patient population, and improving regulatory environment. This region has seen a surge in local CROs, with countries such as China and India becoming hotspots for clinical trial activities. APAC's CROs may focus on volume-driven services but are increasingly investing in quality and technological advancements to compete on a global level. Europe maintains a strong position with a rich history of pharmaceutical research, a key regulatory framework, and a highly skilled workforce, attracting CRO activities that are sophisticated and adhere to strict compliance standards. The Middle East and Africa, though still nascent in terms of CRO services, offer opportunities due to growing healthcare investments and untapped diverse genetic pools.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Contract Research Organization Services Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Contract Research Organization Services Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Contract Research Organization Services Market, highlighting leading vendors and their innovative profiles. These include AccuLab Life Sciences, ACTIVA-CRO, Advanced Clinical Research Services, LLC, BioAgile Therapeutics Pvt. Ltd., Caidya, Calian Group Ltd., Celerion, Inc., Charles River Laboratories International, Inc., Clinical Trial Service B.V. by PCM Trials, Cromsource by ClinChoice, CTI Clinical Trial & Consulting, Distefar del Sur SL, Ergomed PLC, Firma Clinical Research, LLC, Frontage Holdings Corporation, Geistek Pharma S.L., HCL Technologies Limited, Icon PLC, INQUIS, IQVIA Holdings Inc., KCR S.A., Laboratory Corporation of America Holdings, Leon Research, S.L., Linical Co., Ltd., Medpace Holdings, Inc., Novotech Health Holdings, OPIS S.r.l., Oxon Epidemiology, S.L., Parexel International Corporation, Pepgra, Pharmaron Beijing Co., Ltd., Pivotal, S.L.U., PPD Inc. by Thermo Fisher Scientific Inc., Prometrika, LLC, ProRelix Services LLP, PSI CRO AG, QualitecFarma S.L., SGS S.A., Syncro Clinical Research SRL, Syneos Health, Inc., The Emmes Company, LLC, Veeda Clinical Research Limited, Vial Health Technology, Inc., Worldwide Clinical Trials Holdings Inc., WuXi AppTec Co., Ltd., and X7 Research.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Contract Research Organization Services Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Contract Research Organization Services Market?
3. What are the technology trends and regulatory frameworks in the Contract Research Organization Services Market?
4. What is the market share of the leading vendors in the Contract Research Organization Services Market?
5. Which modes and strategic moves are suitable for entering the Contract Research Organization Services Market?