市场调查报告书
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2030 年临床前 CRO(委外研发机构)市场预测:按模型类型、服务、动物模型、最终用户和地区进行的全球分析Preclinical Contract Research Organization Market Forecasts to 2030 - Global Analysis By Model Type, Service, Animal Model, End User and By Geography |
根据Stratistics MRC预测,2023年全球临床前CRO(委外研发机构)市场规模将达到49.9亿美元,预测期内复合年增长率为9.5%,预计到2030年将达到94.2亿美元。
临床前委外研发机构(CRO)是製药和生物技术行业的专业服务供应商,在实验药物和治疗方法进入临床试验之前对其进行研究和测试。临床前 CRO 提供广泛的服务来评估新化合物的安全性、有效性和风险。此外,临床前 CRO 的知识和资源可以透过提供关键资讯和监管支援以及遵守监管和行业规范来帮助优化药物开发。
根据IFPMA 2021年报告,国际生物製药产业的年度研发支出比航太和国防工业高7.3倍,比化学工业高6.5倍,比软体和电脑服务业高出1.5倍。
全球化进程
CRO 是一家国际企业,为製药和生技公司提供多个司法管辖区的广泛资源、知识和监管管道。透过利用监管优势、多样化的患者群体和新兴市场,公司可以透过全球化优化其药物开发策略。此外,透过促进合作和创新以及加快新药的上市时间和效率,我们可以改善医疗保健成果并改善公众获得尖端治疗的机会。
高成本
遵守严格法规和维持品质标准的需要增加了费用。为了正确地进行临床前研究,CRO 必须投入大量资金购买最先进的设施、机械和高素质的员工。激烈的竞争对 CRO 来说是常见的,提高了市场竞争的价格和业务开拓。此外,由于这些高昂的成本,小型或新的 CRO 可能很难进入市场,从而阻碍市场成长。
技术进步
製药和生物技术公司可以利用先进技术做出更好的药物开发决策。 CRO 利用这些特定知识来降低开发风险,加快识别有前途的候选药物,并提高新治疗方法的整体品质和安全性。此外,CRO 的专业知识和经验使他们成为在严格的政府监管范围内推动药物开发和创新、扩大市场规模的有利盟友。
严格的法规环境
在这一领域运营的 CRO 面临复杂法律规范的挑战,这可能导致合规成本增加和计划进度延迟。严格的法规环境也会影响製药和生技公司选择 CRO 合作伙伴时的决策流程。此外,监管负担导致核准流程延长和检查增加,影响 CRO 进行临床前研究的整体有效性和进度。这种不利的环境抑制了创新,降低了临床前研究服务的可用性,并抑制了市场扩张。
COVID-19的疫情对临床前CRO(委外研发机构)市场产生了显着的负面影响。延迟或取消的临床前试验数量减少了对 CRO 服务的需求。疫情造成的财务不确定性减少了研发投资,影响了为外包临床前测试预留的资金。此外,景气衰退和疫情造成的不确定性导致一些客户推迟或取消临床前研究,影响CRO收益和成长前景,进一步阻碍该市场。
预计预测期内毒理学测试领域规模最大
预计毒理学检测领域将占据最大份额。专门从事毒理学的 CRO 透过彻底评估潜在药物以满足严格的监管标准,为生物技术和製药公司提供关键服务。这些测试透过评估化学物质如何影响各种生物系统来帮助发现不良反应和给药。因此,我们透过最大限度地降低开发风险、加快监管核准和确保药物安全来保护公共卫生和药物开发倡议的成功,从而推动该领域的成长。
患者来源的异质骨移植(PDX)领域预计在预测期内复合年增长率最高
患者来源的异质骨移植(PDX)领域预计在预测期内复合年增长率最高。这是由于 PDX 模型,将患者的肿瘤组织移植到免疫力缺乏小鼠体内,以重建患者的肿瘤环境。如果候选药物在更临床相关的环境中进行评估,这些模型更有可能在人体试验中取得成功。此外,PDX CRO 还提供个体化医疗见解,为特定患者提供治疗。由于精准医疗的重要性日益增加,PDX 市场对于进一步开发高效、有针对性的癌症治疗至关重要,推动了这一领域的扩张。
由于促进製药公司和 CRO 之间顺利资料交换和协作的整合平台的成长,亚太地区在预测期内获得了最大的市场占有率。 Covance Inc.、Medpace Holdings, Inc.、MPI Research 和 Eurofins Scientific 等主要企业为国际合作提供了有吸引力的环境,并为全球製药和生物技术行业的发展做出了贡献。此外,政府支持的增加、监管的协调以及高通量筛检、机器学习和资料处理人工智慧等技术进步正在推动该地区的扩张。
鑑于北美在药物开发临床前阶段对支持製药和生物技术公司的关键作用,预计在预测期内复合年增长率最高。美国、加拿大和墨西哥地区的特点是强大的基础设施、最尖端科技和高技能的劳动力。这些领域包括药理学、毒理学、生物分析以及对监管核准至关重要的各种其他临床前研究。此外,该地区的 CRO 受益于有利的法规环境以及与学术机构的合作,促进创新和专业知识,并支持该地区的成长。
According to Stratistics MRC, the Global Preclinical Contract Research Organization (CRO) Market is accounted for $4.99 billion in 2023 and is expected to reach $9.42 billion by 2030 growing at a CAGR of 9.5% during the forecast period. A Preclinical Contract Research Organization (CRO) is a specialized service provider in the pharmaceutical and biotechnology industry that conducts research and testing on experimental drugs and therapies before they enter clinical trials. To evaluate the safety, efficacy, and possible dangers associated with novel compounds, preclinical CROs provide a broad range of services. Furthermore, their knowledge and resources aid pharmaceutical businesses in optimizing drug development by offering vital information and regulatory support and by providing adherence to regulatory and industry norms.
According to the IFPMA's 2021 report, the annual R&D spending by the international biopharmaceutical industry is 7.3 times higher than that of the aerospace and defense industries, 6.5 times more than the chemicals industry, and 1.5 times more than the software and computer services industry.
CROs are international businesses that provide pharmaceutical and biotech firms with access to a wide range of resources, knowledge, and regulatory routes in several jurisdictions. By taking advantage of regulatory benefits, diversified patient populations, and developing markets, corporations can optimize their drug development strategy through globalization. Additionally, it improves healthcare outcomes and public access to cutting-edge therapeutics by encouraging cooperation and innovation and accelerating the time and efficiency of bringing new drugs to market.
The need to adhere to stringent regulatory regulations and uphold quality standards increases expenditures. To properly undertake preclinical research, CROs must invest a significant amount of money in cutting-edge facilities, machinery, and highly qualified staff. Intense competition is a common occurrence for CROs, which raises the price of marketing and business development initiatives. In addition, smaller or newly established CROs may find it difficult to enter the market due to these exorbitant costs, which thereby hinder market growth.
Pharmaceutical and biotech businesses may make well-informed judgments on drug development with the help of their advanced technologies, which enables them to provide reliable and efficient preclinical testing and data analysis. CROs use this specific knowledge to lower development risks, speed up the identification of promising drug candidates, and improve the general quality and safety of novel treatments. Furthermore, because of their specialization and experience, CROs are advantageous collaborators for promoting drug development and innovation in a tough, government-regulated setting thereby driving this market size.
CROs operating in this space encounter challenges in navigating the intricate regulatory frameworks, leading to increased compliance costs and potential delays in project timelines. The stringent regulatory environment also influences the decision-making process of pharmaceutical and biotechnology companies when selecting CRO partners. Furthermore, the regulatory load results in longer approval processes and more inspection, affects the general effectiveness and pace of preclinical research carried out by CROs. This unfavourable environment inhibits innovation, lowers the availability of preclinical research services, and thereby impedes this market expansion.
The COVID-19 pandemic has had a notable negative impact on the preclinical contract research organization (CRO) market. The number of preclinical studies that were postponed or cancelled resulted in a decline in the need for CRO services. The pandemic's financial insecurity has resulted in decreased investment in research and development, which has an effect on the money set aside for preclinical study outsourcing. Furthermore, the pandemic-induced economic downturn and uncertainty prompted some clients to postpone or cancel preclinical projects, impacting the revenue and growth prospects of CRO and further impeding this market.
The toxicology testing segment is estimated to hold the largest share. Toxicology-focused CROs offer vital services to biotech and pharmaceutical firms by thoroughly assessing potential drugs in order to satisfy strict regulatory standards. These tests help discover harmful reactions and dosage levels by assessing how chemicals affect different biological systems. Therefore, it protects public health and the success of drug development initiatives by minimizing development risks, expediting regulatory approvals, and guaranteeing the safety of pharmaceutical goods, which thereby boosts this segment's growth.
The patient derived xenograft (PDX) segment is anticipated to have highest CAGR during the forecast period due to the tumor tissues from patients being transplanted into immunodeficient mice in PDX models to replicate the tumor environment of the patient. These models show a greater chance of success in human trials when drug candidates are evaluated in a more clinically appropriate setting. Furthermore, customized medicine insights are provided by PDX CROs, enabling treatmentsfor specific patients. The PDX market is essential for further developing efficient and targeted cancer treatments because of the growing significance of precision medicine, thereby driving this segment's expansion.
Asia Pacific commanded the largest market share during the extrapolated period due to the growth of integrated platforms that facilitate smooth data exchange and cooperation between pharmaceutical corporations and CROs. Key players such as Covance Inc., Medpace Holdings, Inc., MPI Research, and Eurofins Scientific offer a compelling environment for international collaborations and are establishing themselves in advancing the global pharmaceutical and biotechnology industries. Additionally, growing government support, regulatory harmonization, and technological advancements such as high-throughput screening, machine learning, and artificial intelligence for data processing drive this region's expansion.
North America is expected to witness highest CAGR over the projection period, owing to its pivotal role in supporting pharmaceutical and biotechnology companies in the preclinical phase of drug development. The United States, Canada, and Mexico regions are characterized by a robust infrastructure, cutting-edge technology, and a highly skilled workforce. They include pharmacology, toxicology, bioanalysis, and various other preclinical studies essential for regulatory approval. Furthermore, the region's CROs benefit from a favorable regulatory environment and collaboration with academic institutions, fostering innovation and expertise that are propelling this region's growth.
Some of the key players in the Preclinical Contract Research Organization (CRO) Market include Crown Bioscience, Eurofins Scientific, Laboratory Corporation of America, Inc., PRA Health Sciences, Inc., Intertek Group Plc (IGP), Wuxi AppTec, SGS SA (SGS), Medpace, Inc., Pharmaceutical Product Development (PPD), LLC, Charles River Laboratories International, Inc., PPD (Thermo Fisher Scientific, Inc.) and WuXi AppTec, Inc. (WAI).
In November 2023, Intertek, announced the launch of iCare in Turkiye, one of its most successful markets. iCare is an innovative one-stop digital portal providing textile manufacturers with a pioneering solution that enables seamless management and monitoring of their testing processes from start to finish.
In October 2023, SGS is signed an agreement to divest its US powertrain testing operations as part of its strategic portfolio evolution to Columbia River Partners, a private equity firm focused on the industrials, business services and IT services sectors, headquartered in California.
In September 2023, Intertek, proudly announced the integration of advanced PhotonAssay technology into its Minerals laboratory facility in Tarkwa, Ghana. With a legacy of excellence and a commitment to innovation, Intertek Minerals aims to revolutionise gold industry support in West Africa through the implementation of this groundbreaking technology.