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委外研发机构服务市场:按类型、研究阶段、治疗领域、分子类型、最终用户 - 2024-2030 年全球预测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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预计2023年药物委外研发机构服务市场规模为887.8亿美元,预计2024年将达982.8亿美元,2030年将达1842.1亿美元,复合年增长率为10.98%。
委外研发机构(CRO) 服务包括为製药、生物技术和医疗设备业提供的各种委託支援选项,用于药物开发、临床试验管理和上市后监测。这些组织提供监管提交指导、临床业务、资料管理、统计分析、医学写作以及将医疗产品推向市场的复杂过程所需的其他功能方面的专业知识。 CRO 服务在全球范围内的普及主要是由于药物开发成本的上升、对日益复杂的治疗领域的专业知识的需求以及需要大量临床试验资料和文件的监管压力的增加。然而,资料安全和智慧财产权管理的潜在问题正在影响 CRO 的采用。围绕保密、智慧财产权和管治结构建立明确的合约协议对于解决这些问题至关重要。细胞和基因疗法等先进治疗方法的兴起,以及精准医学的发展,为 CRO 提供了开发专业服务的重大机会。在数位领域,透过采用人工智慧和机器学习进行资料分析并结合虚拟临床试验,预计将出现新的发展。
主要市场统计 | |
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基准年[2023] | 887.8亿美元 |
预测年份 [2024] | 982.8亿美元 |
预测年份 [2030] | 1842.1亿美元 |
复合年增长率(%) | 10.98% |
聘请临床研究服务来管理型式临床试验的复杂性和持续时间
临床研究服务包括管理和进行临床试验,以测试新药、设备和治疗通讯协定,并确定其对人体的安全性和有效性。服务包括临床试验设计、病患招募、监管备案、地点选择、监测、以及资料收集和分析。 CRO提供的咨询服务包括有关药物开发路径、监管合规性和打入市场策略以及业务改善和财务规划的策略建议。资料管理服务包括临床试验期间收集的资料的收集、清理和分析。这包括使用电子资料采集 (EDC)、生物统计学和临床资料管理系统 (CDMS) 等先进技术。早期开发服务着重于药物开发的早期阶段,从发现到 I 期和 IIA 期试验。这包括药物化学、临床前研究、药物动力学和首次人体研究。这些服务对于需要专业知识将分子从实验室转移到临床试验的公司尤其重要。实验室服务是指为支持药物开发过程而进行的各种测试和分析,例如生物分析服务、临床试验的中心实验室服务和生物标记研究。
测试阶段:需要强大的真实资料和上市后支援的CRO
I期试验是人体试验的第一阶段,主要着重于评估药物的安全性、耐受性、药物动力学和动态。此阶段的服务包括设计和进行首次人体(FIH)试验、健康志愿者试验和早期患者试验。在二期试验中,重点转向确定药物的疗效并进一步评估其安全性,包括患者招募和入组策略、概念验证研究以及监管支持和提交。 III 期试验是大规模试验,通常在多个国家进行,旨在确认药物的有效性、监测副作用并将治疗方法进行比较。一旦药物获得核准并投放市场,第四期试验(也称为上市后监测)就开始监测药物的长期有效性以及对患者生活品质的影响。这里的关键服务包括风险管理和药物安全检测、评估长期有效性的註册研究以及市场准入和报销援助。
治疗领域:CRO服务一直是肿瘤药物开发的首选
心血管疾病 (CVD) 仍然是全球死亡的主要原因,因此需要专注于开发高血压、心臟衰竭和心律不整等疾病治疗方法的综合研究服务。 CVD 领域的 CRO 服务通常包括临床试验管理、病患招募和监管支援。由于从干癣到黑色素瘤等皮肤病的盛行率不断上升,皮肤病学领域正受到越来越多的关注。该领域所需的服务包括临床试验设计、患者报告的结果和生物统计学,主要关注皮肤病学终点。胃肠道 (GI) 疾病包括大肠激躁症、克隆氏症和大肠癌等多种疾病,需要专门从事胃肠道检测的 CRO 的专业知识。由于许多胃肠道疾病是慢性病,需要长期治疗,因此对此类服务的需求强劲。血液学是血液相关疾病的研究,需要专门的 CRO 服务来指导白血病、淋巴瘤、血友病等的复杂临床试验。随着加强治疗方法和开发根治性治疗方法的呼声日益高涨,对这些服务的需求也不断增加。类风湿性关节炎和狼疮等免疫性疾病的特征是慢性进展,需要熟练的免疫调节治疗服务。该领域非常需要针对特定疾病的研究设计和终点。随着新病原体的持续威胁和抗生素抗药性的发展,感染疾病领域对 CRO 服务的需求不断增加。这些服务包括疫苗开发、抗菌药物抗药性测试以及爱滋病毒、结核病和肝炎等疾病的治疗试验。阿兹海默症、多发性硬化症和帕金森氏症等神经系统疾病由于其复杂性和测量临床结果的困难而面临独特的挑战。能够克服这种复杂性的 CRO 服务(例如神经影像和神经认知评估)的需求量很大。肿瘤学是最具活力的领域之一,由于癌症的侵袭性和对创新治疗方法的持续需求,对 CRO 服务的需求持续高涨。服务范围从早期检测到后期临床试验,个人化医疗和免疫肿瘤学正受到越来越多的关注。
最终用户:学术研究机构强大的基础研究能力的需要
学术研究机构经常求助于 CRO 服务来加强其研究并利用专业技能,而无需支付内部基础设施的管理费用。他们的愿望通常与早期研究、教育资源和津贴资金筹措一致。医疗设备公司专注于医疗设备的开发、测试和商业化。与 CRO 的合作对于应对充满挑战的监管环境和管理多阶段试验至关重要。製药和生物技术公司是 CRO 的主要客户,因为它们需要整体的研发服务,从临床前测试到后期临床试验和上市后监测。
区域洞察
由于强大的製药和生物技术行业、严格的 FDA 法规以及对一致药物开发的重视,美洲尤其是美国对 CRO 服务的需求很高。这导致了经验丰富的 CRO 的集中,这些 CRO 拥有先进的基础设施、复杂临床试验的专业知识和端到端服务交付。由于其具有成本效益的营运、庞大且多样化的患者群体以及不断改善的法规环境,亚太地区正在迅速成为 CRO 服务的首选目的地。在该地区,中国、印度等国家已成为临床试验活动的热点,当地CRO的数量正在迅速增加。亚太地区的合约研究机构可能专注于数量主导的服务,但他们正在增加对品质和技术进步的投资,以在全球范围内竞争。欧洲凭藉丰富的药物研究历史、重要的法律规范和高技能的劳动力保持着强大的地位,吸引了遵守严格合规标准的复杂 CRO 活动。儘管中东和非洲的 CRO 服务仍在发展中,但由于不断增长的医疗保健投资以及开拓的多样化基因库,它们提供了商机。
FPNV定位矩阵
FPNV定位矩阵对于评估药物委外研发机构服务市场极为重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对委外研发机构服务市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4. 竞争评估和情报:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况和製造能力进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.药物委外研发机构服务市场的市场规模和预测是多少?
2.在药物委外研发机构服务市场的预测期内,需要考虑投资的产品、细分市场、应用和领域有哪些?
3.药物委外研发机构服务市场的技术趋势和法规结构是什么?
4.药品委外研发机构服务市场主要厂商的市场占有率是多少?
5.进入药物委外研发机构服务市场的适当型态和策略手段是什么?
[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?