市场调查报告书
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1466587
临床前 CRO 市场:按服务、应用和最终用户划分 - 2024-2030 年全球预测Preclinical CRO Market by Services (Bioanalysis & DMPK Studies, Toxicology Testing), Application (Cardiovascular Disease, Dermatology, Gastrointestinal), End-User - Global Forecast 2024-2030 |
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预计2023年临床前CRO市场规模为62.5亿美元,预计2024年将达68.5亿美元,2030年将达到119.5亿美元,复合年增长率为9.68%。
临床前 CRO 是支援中心,提供必要的研发活动 (R&D) 专业知识,透过动物试验将候选药物带入临床阶段。临床前测试服务包括多项研究,这些研究对于评估药物在动物模型中的功效和安全性以及提交临床实验(IND) 申请非常重要。在临床前试验中,CRO受申办者(例如生物製药公司)聘请,代表申办者执行一系列业务,同时承担各种技术和行政职责。处于临床前阶段的药物数量迅速增加,以及药物开发的研发 (R&D) 预算不断增加,正在推动临床前 CRO 服务的使用。然而,临床前CRO服务涉及高成本和耗时的流程,阻碍了市场成长。高通量筛检和In Silico建模等技术进步预计将实现更有效率、更具成本效益的临床前研究,为市场成长创造机会。
主要市场统计 | |
---|---|
基准年[2023] | 62.5亿美元 |
预测年份 [2024] | 68.5亿美元 |
预测年份 [2030] | 119.5亿美元 |
复合年增长率(%) | 9.68% |
毒理学测试服务的使用率迅速增加,重点关注服务安全和监管合规方面
生物分析和 DMPK 研究对于了解潜在疗法的吸收、分布、代谢和排泄 (ADME) 特性至关重要。该部分提供了有关生物系统中药物行为的重要信息,对于确定剂量和评估安全性至关重要。这些研究优先在药物开发的早期阶段进行,此时需要详细了解药物的药物动力学特征。製药和生物技术公司通常依赖具有生物分析方法和最尖端科技专业知识的外部 CRO。毒理学测试服务对于评估候选药物的安全性、确保其进一步开发和人类消费的安全性至关重要。该领域涉及各种测试来评估化合物对生物体的潜在不利影响。这些测试在进行临床试验之前非常重要,主要解决药物必须通过才能获得核准的监管要求。对于所有需要证明其产品无毒的製药和生物技术公司来说,这一点至关重要。
最终用户:生物製药公司扩大临床前 CRO 的使用
生物製药公司是临床前 CRO 的主要客户,利用他们的服务来开发和测试生物製药。这些公司寻求与 CRO 合作,利用他们在药理学、毒理学和分子生物学方面的专业知识。向生物製药公司提供的服务通常包括功效和安全性评估、吸收、分布、代谢和排泄 (ADME) 测试以及监管支持。与临床前 CRO 合作使生物製药公司能够加快药物开发流程、有效管理成本并有效满足复杂的监管要求。政府机构和学术机构与临床前 CRO 合作,进行公共卫生目的的研究和发展。这些合作关係支持新药发现、疫苗开发和创新治疗方法等计划。临床前 CRO 为这些机构提供了获得其内部所没有的专业资源和专业知识的机会。此外,CRO 还帮助进行高品质、合规的研究,从而实现突破性的医学进步。政府/学术机构和 CRO 之间的合作对于弥合基础研究和临床应用之间的差距至关重要。医疗设备製造商依靠临床前 CRO 的服务来检验其产品的安全性和有效性,然后再进行临床试验。这些公司受益于 CRO 的技术和监管专业知识来进行全面的生物医学测试、动态评估和风险评估。为医疗设备公司量身定制的服务通常包括临床前研究设计、原型测试以及对遵守国际标准和法规的支援。透过与 CRO 合作,医疗设备公司可以确保其产品符合最高品质和安全标准,确保顺利过渡到临床阶段。
区域洞察
人口老化导致的非传染性疾病以及污染和虫害等环境条件变化引起的传染性疾病空前增加,催生了医疗保健领域对有效药物开发的需求,从而导致对临床前 CRO 服务的需求日益迫切。 、中东和非洲地区不断增加。亚太地区政府为促进医疗设备和药物开发领域的研发 (R&D) 活动而进行的投资预计将为临床前 CRO 市场的参与者提供成长机会。 2021年8月,澳洲政府投资7,900万美元用于医疗创新和研究计划。欧盟新兴经济体建立了政府支持体系,透过优先考虑新技术和药物开发的研究和创新来支持技术进步。各国政府推出了多项严格的法规和标准,以确保开发的药品和设备安全、可靠和高品质。 2022年1月,决定在欧盟启动修订临床试验流程的临床试验法规(Regulation (EU) No 536/2014)。政府引入了临床试验资讯系统(CTIS)来协调监督和评估流程。因此,政府对医疗设备和药物开发临床试验的持续支持预计将推动欧洲、中东和非洲临床前 CRO 市场的成长。
FPNV定位矩阵
FPNV定位矩阵对于评估临床前CRO市场至关重要。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,可以对临床前 CRO 市场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。这种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. 临床前CRO市场的市场规模与预测是多少?
2.临床前CRO市场预测期间需要考虑投资的产品、细分市场、应用和领域有哪些?
3. 临床前CRO市场的技术趋势和法规结构是什么?
4.临床前CRO市场主要厂商的市场占有率如何?
5. 进入临床前CRO市场的合适型态和策略手段是什么?
[195 Pages Report] The Preclinical CRO Market size was estimated at USD 6.25 billion in 2023 and expected to reach USD 6.85 billion in 2024, at a CAGR 9.68% to reach USD 11.95 billion by 2030.
A preclinical CRO is a support center providing expertise in research and development activities (R&D) essential for navigating a drug candidate through animal testing and forwarding it into the clinical phase. Preclinical research services encompass several studies critical to assessing drug efficacy & safety in animal models and complete Investigational New Drug (IND) filing studies. In a preclinical trial, CROs are hired by sponsors such as biopharma companies to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor's behalf. A surge in the number of drugs in the preclinical phase and an increased research & development (R&D) budget for drug development are driving the usage of preclinical CRO services. The high cost and time-consuming process of preclinical CROS services hamper the market growth. Advances in technology, which include high-throughput screening and in silico modeling, enable more efficient and cost-effective preclinical research and are expected to create opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 6.25 billion |
Estimated Year [2024] | USD 6.85 billion |
Forecast Year [2030] | USD 11.95 billion |
CAGR (%) | 9.68% |
Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects
Bioanalysis and DMPK studies are crucial for understanding potential therapeutic agents' absorption, distribution, metabolism, and excretion (ADME) properties. This segment provides vital information on the drug's behavior in a biological system, which is paramount for dosage determination and safety assessment. These studies are preferred in the early stages of drug development when detailed insight into the drug's pharmacokinetic profile is required. Pharmaceutical companies and biotechnology firms often rely on external CROs with specialized expertise in bioanalytical methodologies and state-of-the-art technologies. Toxicology testing services are vital for evaluating the safety profile of drug candidates, ensuring they are safe for further development and human consumption. This segment encompasses a range of studies to assess the potential adverse effects of compounds on living organisms. These tests are critical before advancing to clinical trials, catering mainly to regulatory requirements that drugs must pass for approval. They are indispensable for all pharmaceutical and biotechnological companies needing to demonstrate the non-toxic nature of their products.
End-User: Evolving usage of preclinical CRO by biopharmaceutical companies
Biopharmaceutical companies are primary clients of preclinical CROs, leveraging their services for the development and testing of biologic drugs. These companies seek CRO partnerships to access specialized expertise in pharmacology, toxicology, and molecular biology. Services offered to biopharmaceutical companies often include drug efficacy and safety assessments, absorption, distribution, metabolism, excretion (ADME) studies, and regulatory support. Collaborating with preclinical CROs enables biopharmaceutical companies to accelerate their drug development process, manage costs effectively, and navigate complex regulatory requirements efficiently. Government and academic institutes often engage with preclinical CROs for research and development initiatives fundamental to public health objectives. These partnerships support projects, including new drug discoveries, vaccine development, and innovative medical treatments. Preclinical CROs provide these institutions with access to specialized resources and expertise that may not be available in-house. Additionally, CROs assist in conducting high-quality, regulatory-compliant research studies that can lead to groundbreaking medical advancements. Collaborations between government / academic institutes and CROs are pivotal in bridging the gap between basic research and clinical application. Medical device companies utilize preclinical CRO services to validate the security and efficacy of their products before proceeding to clinical trials. These companies benefit from CROs' technical and regulatory expertise to conduct comprehensive biomedical testing, biomechanical evaluation, and risk assessment. Services tailored to medical device companies often encompass preclinical study design, prototype testing, and support in complying with international standards and regulations. By partnering with CROs, medical device companies can assure their products meet the highest quality and safety standards, facilitating smoother transitions into clinical phases.
Regional Insights
The unprecedented rise in non-communicable diseases among the geriatric population and communicable diseases caused by changing environmental conditions, such as pollution, and insect infestation, create a demand for effective drug development in the healthcare sector, subsequently increasing the need for preclinical CRO services across the Americas, Asia-Pacific, and EMEA. The investments made by the governments of Asia-Pacific to push research and development (R&D) activities of medical devices and drug development are estimated to provide growth opportunities for the preclinical CRO market players. In August 2021, the Australian government invested USD 79 million in medical innovation and research projects. The developed economies in the European Union have established a supportive government framework to boost technological advancements by prioritizing research and innovation of new technologies and drug development. The government introduces several stringent regulations and standards to ensure that the medicines and devices developed are safe, reliable, and of high quality. In January 2022, the Clinical Trials Regulation (Regulation (EU) No 536/2014) was set to launch in the EU to modify the clinical trial processes. The government introduced a Clinical Trials Information System (CTIS) to harmonize the supervision and assessment processes. Thus, the ongoing government support for clinical trials for medical devices and drug development is expected to fuel the growth of the preclinical CRO market in EMEA.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Preclinical CRO 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 Preclinical CRO 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 Preclinical CRO Market, highlighting leading vendors and their innovative profiles. These include 10x Genomics, Inc., AmplifyBio, Atuka Inc., BenchSci, Bioserve Biotechnologies (India) PVT Ltd. by REPROCELL Inc., Biotrofix, Inc., Celerion, Charles River Laboratories International, Inc., Crown Bioscience, Inc., CTI Clinical Trial and Consulting, Inc., Diag2Tec SAS, Eurofins Scientific SE, F. Hoffmann-La Roche Ltd., Gubra, Hera Biolabs, ICON PLC, Immusmol SAS, ImQuest BioSciences, Inotiv, Inc., Intertek Group PLC, Invivotek by Genesis Biotechnology Group, LLC, IQVIA Inc., Jubilant Biosys Ltd. byJubilant Pharmova Limited Company, Laboratory Corporation of America Holding, MCI Group Holding SA, MD Biosciences, Medpace Holdings, Inc., Novartis AG, Parexel International Corporation., PharmaCircle LLC, Phenos GmbH, PPD by Thermo Fisher Scientific Inc., PsychoGenics Inc., QPS Holdings, LLC, Sanofi S.A., SCiAN Services Inc., SGS SA, Shanghai Medicilon Inc., Syneos Health, Inc., Transpharmation, Veristat, LLC, Vimta Labs Limited, and WuXi AppTec Co., Ltd..
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 Preclinical CRO Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Preclinical CRO Market?
3. What are the technology trends and regulatory frameworks in the Preclinical CRO Market?
4. What is the market share of the leading vendors in the Preclinical CRO Market?
5. Which modes and strategic moves are suitable for entering the Preclinical CRO Market?