市场调查报告书
商品编码
1541621
2024-2032 年按服务(生物分析和 DMPK 研究、毒理学测试等)、最终用途(生物製药公司、政府和学术机构、医疗器材公司)和地区分類的临床前 CRO 市场报告Preclinical CRO Market Report by Service (Bioanalysis and DMPK Studies, Toxicology Testing, and Others), End Use (Biopharmaceutical Companies, Government and Academic Institutes, Medical Device Companies), and Region 2024-2032 |
2023年,全球临床前CROIMARC Group规模达到60亿美元。研发(R&D)活动支出不断增加、监管环境日益复杂、公司对核心能力的日益关注以及专业治疗的最新进展是推动市场的一些主要因素。
主要市场驱动因素:对个人化药物的日益关注是积极影响市场成长的关键因素之一。临床前 CRO 市场的一些关键最新发展包括技术进步,例如电脑模拟的高通量筛选和先进的成像技术。
主要市场趋势:生物技术、製药和医疗器材产业的发展以及监管支援正在推动临床前 CRO 市场的成长。此外,临床试验数量的不断增加增加了对具有全球影响力和应对国际监管环境专业知识的 CRO 的需求。这一趋势进一步推动了对临床前CRO服务的需求。
地理趋势:根据临床前CRO市场前景,北美正在占据整个市场的主导份额。这可以归因于领先的製药和生物技术公司的存在。此外,研发投资和临床前研究显着增加,这进一步成为该地区的另一个成长诱导因素。
竞争格局:全球临床前 CRO 市场的一些领导参与者包括 Charles River Laboratories Inc.、Covance Inc.(Laboratory Corporation of America Holdings)、Eurofins Scientific、ICON Plc、MD Biosciences Inc.(MLM Medical Labs)、Medpace、 Parexel International Corporation、PPD Inc. 和Wuxi AppTec 等。
挑战与机会:根据临床前CRO市场概况,不断提高的监管合规性、激烈的竞争和成本压力是市场面临的一些主要挑战。然而,临床前测试技术的不断进步为 CRO 提供新的机会来增强其服务产品和提高效率。
不断增加的研发活动
製药和生物技术行业不断升级的研发活动正在推动临床前 CRO 市场份额的成长。此外,药物开发过程变得越来越复杂,因此需要进行广泛的临床前测试以确保新药的安全性和有效性。根据美国食品药物管理局(FDA)的规定,研究人员必须使用医疗产品开发法规中定义的良好实验室规范(GLP)进行临床前研究。此外,对于製药公司来说,将临床前研发活动外包给 CRO 比内部进行这些研究更具成本效益。 CRO 通常拥有专业知识、基础设施和资源,可以简化药物开发流程并降低成本。例如,2024 年 1 月,国家转化科学促进中心与其他 NIH 机构和中心合作开发了临床前研究工具箱。这些资源包括检测指导手册、化合物管理、NCATS 药物集合、PubChem、探针、表型药物发现资源和 BioPlanet。
复杂的监管环境
製药和生物技术行业复杂的监管环境是增加临床前 CRO 市场份额的重要因素。美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构要求进行广泛的临床前测试,以证明新药的安全性和有效性。此外,例如,国家转化科学促进中心与学术界、工业界和患者倡导团体合作,使超过 45 种新药进入临床试验。据他们介绍,一种新药从实验室到药柜的旅程可能需要长达 15 年的时间。这导致对临床前 CRO 服务的需求增加,以确保符合监管要求。此外,临床试验的全球化使得製药公司必须应对多个国家复杂的监管环境。具有国际监管要求专业知识的临床前 CRO 可以帮助公司应对这些挑战。例如,根据美国疾病管制与预防中心的说法,疫苗的开发需要10到15年的实验室研究,研究人员需要向FDA提交研究性新药申请,其中包括有关疫苗的所有资讯。 FDA 的生物製品评估和研究中心负责监管美国疫苗的使用。
药物开发成本增加
药物开发成本的不断上升正在提振临床前 CRO 市场的收入。药物开发是一个复杂而漫长的过程,需要大量的研究和测试。这种复杂性可能会导致进行临床前研究的成本更高。此外,为了证明新药的安全性和有效性,欧洲药品管理局(EMA)和美国食品药物管理局(FDA)等组织要求进行全面的临床前测试。满足这些监管要求的成本可能很高。药物开发本质上是有风险的,儘管投入了大量资金,许多药物仍未能进入市场。根据美国生物化学与分子生物学学会会员杂誌报道,开发一种成功的药物需要10到15年的时间。研究人员发现,40% 到 50% 的药物无法对人类产生预期的影响。大约10%到15%是由于药物动力学特性不足所造成的。同时,约30%归因于无法控制的高毒性或不良反应。临床前 CRO 市场公司可以透过提供临床前研究专业知识来帮助减轻这些风险,从而帮助他们就考虑哪些药物做出明智的决定。
IMARC Group提供了全球临床前 CRO 市场报告各细分市场主要趋势的分析,以及 2024 年至 2032 年全球、区域和国家层面的预测。我们的报告根据服务和最终用途对市场进行了分类。
生物分析和 DMPK 研究
毒理学测试
其他的
毒理学测试主导市场
该报告根据服务提供了详细的市场细分和分析。这包括生物分析和 DMPK 研究、毒理学测试等。根据该报告,毒理学测试代表了最大的市场领域。
根据临床前 CRO 市场的最新发展,毒理学测试的成长是由全球医疗机构制定的严格监管要求所推动的,以确定对人类健康的潜在不利影响。此外,随着药物变得越来越复杂,了解与生物系统潜在的毒性交互作用变得更加重要。临床前阶段的毒理学测试可以防止不合适候选者的发展,从而帮助公司节省大量时间和财务资源。例如,美国食品药物管理局表示,筛选新分子的药理活性和潜在毒性至关重要。
生物製药公司
政府和学术机构
医疗器材公司
生物製药公司主导市场
该报告根据最终用途提供了详细的市场细分和分析。这包括生物製药公司、政府和学术机构以及医疗器材公司。报告称,生物製药公司代表了最大的细分市场。
根据临床前CRO市场统计数据,由于生物製剂(包括单株抗体、重组蛋白和基因疗法)的持续发展,生物製药公司正在主导市场,这些生物製剂需要彻底的临床前评估,通常需要CRO提供的专业知识。此外,生物製药实体正在大力投资临床前活动,其中许多活动外包给 CRO 以提高效率和专业知识。
北美洲
美国
加拿大
亚太
中国
日本
印度
韩国
澳洲
印尼
其他的
欧洲
德国
法国
英国
义大利
西班牙
俄罗斯
其他的
拉丁美洲
巴西
墨西哥
其他的
中东和非洲
北美市场占据明显主导地位,占据最大的临床前CRO市场份额
该报告还对所有主要区域市场进行了全面分析,其中包括北美(美国和加拿大);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);欧洲(德国、法国、英国、义大利、西班牙等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告称,北美是最大的细分市场。
由于许多领先的製药和生物技术公司的存在,北美在临床前 CRO 市场占据主导地位,这与该地区临床前研究服务需求的增加直接相关。此外,北美公司在研发活动方面的投资始终处于领先地位。此外,这种对创新的承诺推动了对临床前研究和专业 CRO 服务的巨大需求。这反过来又对区域市场产生正面影响。例如,2022 年 2 月,欧洲生命科学公司 InSilicoTrials 和专门从事临床前研究服务的加拿大 CRO IonsGatePreclinical Services Inc. (IonsGate) 合作,利用模拟等尖端技术。除此之外,北美政府机构关于药物安全的监管要求的实施正在不断增加对临床前 CRO 的需求,以满足要求并应对复杂的审批流程。此外,LabCorp 和 Charles River Laboratories 等专门从事早期药物发现的成熟 CRO 的广泛存在预计将在预测期内促进北美市场的成长。
临床前 CRO 市场的顶尖公司正在扩大其产品组合,以提供端到端解决方案,涵盖从早期发现到临床前开发的所有内容,这确保客户可以在同一屋檐下获得全套服务。此外,该公司正在投资体外毒理学、高通量筛选和计算建模等技术,以增强其临床前研究能力。此外,他们还透过建立新设施、升级现有设施或收购区域参与者来扩大全球业务。除此之外,一些市场参与者正在吸引顶尖人才并专注于持续培训,以确保他们的团队随时了解最新的科学进展和监管变化。此外,他们正在与製药公司建立长期合作,以简化药物开发流程、减少冗余并促进各方之间更深入的了解。
查尔斯河实验室公司
科文斯公司(美国实验室控股公司)
欧陆科技
图示公司
MD Biosciences Inc.(传销医学实验室)
医疗空间
精锐国际公司
PPD公司
无锡药明康德
(请注意,这只是关键参与者的部分列表,报告中提供了完整列表。)
2024 年 4 月:创新和综合实验室服务领域的领导企业 Labcorp 扩大了其精准肿瘤学产品组合,以改善全球患者护理和癌症研究。 Labcorp 正在投资科学、诊断和实验室创新,以支持其製药、生物技术和临床研究,从而带来尖端疗法。
2024 年 3 月:全方位服务的合约研究组织 Veeda Clinical Research Limited 收购了专门从事肿瘤学临床试验的欧洲 CRO Heads。
2024 年 1 月:国家转化科学促进中心与其他 NIH 机构和中心合作开发了临床前研究工具箱。这些资源包括检测指导手册、化合物管理、NCATS 药物集合、PubChem、探针、表型药物发现资源和 BioPlanet。
The global preclinical CRO market size reached US$ 6.0 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 11.0 Billion by 2032, exhibiting a growth rate (CAGR) of 6.8% during 2024-2032. The growing expenditure on research and development (R&D) activities, the rising complexity of the regulatory environment, the increasing focus on core competencies among companies, and recent advancements in specialized treatments are some of the major factors propelling the market.
Major Market Drivers: The rising focus on personalized medicines is one of the key factors positively influencing the market growth. Some of the key preclinical CRO market recent developments include technological advancements, such as high-throughput screening in silico modeling and advanced imaging techniques.
Key Market Trends: The development in biotechnology, pharmaceutical, and medical device industries, along with regulatory support, are bolstering the preclinical CRO market growth. Moreover, the rising number of clinical trials has increased the need for CROs with a global presence and expertise in navigating international regulatory environments. This trend is further propelling the demand for preclinical CRO services.
Geographical Trends: According to the preclinical CRO market outlook, North America is acquiring a dominant share of the overall market. This can be attributed to the presence of leading pharmaceutical and biotech companies. Moreover, there has been a significant increase in R&D investments and preclinical studies, which is further acting as another growth-inducing factor across the region.
Competitive Landscape: Some of the leading players in the global preclinical CRO market include Charles River Laboratories Inc., Covance Inc. (Laboratory Corporation of America Holdings), Eurofins Scientific, ICON Plc, MD Biosciences Inc. (MLM Medical Labs), Medpace, Parexel International Corporation, PPD Inc., and Wuxi AppTec, among many others.
Challenges and Opportunities: According to the preclinical CRO market overview, rising regulatory compliance, surging competition, and cost pressures are some of the major challenges that the market is facing. However, continuous advances in preclinical testing technology are opening new opportunities for CROs to enhance their service offerings and improve efficiency.
Rising Research and Development Activities
The escalating R&D activities in the pharmaceutical and biotechnology industries are driving the preclinical CRO market share. Additionally, the drug development process is becoming more complex, thereby requiring extensive preclinical testing to ensure the safety and efficacy of new drugs. According to the U.S. Food and Drug Administration (FDA), researchers are required to use Good Laboratory Practice (GLP) defined in regulations of medical product development for preclinical studies. Moreover, outsourcing preclinical R&D activities to CROs can be more cost-effective for pharmaceutical companies than conducting these studies in-house. CROs often have specialized expertise, infrastructures, and resources that can streamline the drug development process and reduce costs. For instance, in January 2024, the National Center of Advancing Translational Sciences developed a preclinical research toolbox in collaboration with other NIH institutes and centers. The resources include the Assay Guidance Manual, Compound Management, NCATS Pharmaceutical Collection, PubChem, Probes, Phenotypic Drug Discovery Resource, and BioPlanet.
Complex Regulatory Environment
The complex regulatory environment in the pharmaceutical and biotechnology industries is a significant factor adding to the preclinical CRO market share. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require extensive preclinical testing to demonstrate the safety and efficacy of new drugs. Moreover, for instance, the National Center for Advancing Translational Sciences partnered with academia, industry, and patient advocacy groups to enable more than 45 novel drugs to move into clinical trials. According to them, a new drug's journey from the lab to the medicine cabinet can take up to 15 years. This has led to an increased demand for preclinical CRO services to ensure compliance with regulatory requirements. Moreover, the globalization of clinical trials has made it necessary for pharmaceutical companies to navigate complex regulatory environments in multiple countries. Preclinical CROs with expertise in international regulatory requirements can help companies navigate these challenges. For instance, according to the Centers for Disease Control and Prevention, the development of a vaccine takes 10 to 15 years of laboratory research, and researchers need to submit an investigational new drug application to the FDA, which includes all the information about the vaccine. The FDA's Center for Biologics Evaluation and Research regulates the usage of vaccines in the United States.
Increasing Cost of Drug Development
The escalating cost of drug development is bolstering the preclinical CRO market revenue. Drug development is a complex and lengthy process that requires extensive research and testing. This complexity can lead to higher costs associated with conducting preclinical studies. Furthermore, to prove the safety and effectiveness of new medications, organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) demand comprehensive preclinical testing. Meeting these regulatory requirements can be costly. Drug development is inherently risky, with many drugs failing to reach the market despite significant investments. According to Member Magazine of the American Society for Biochemistry and Molecular Biology, it takes 10 to 15 years to develop one successful drug. Researchers discovered that the drug's inability to have the desired impact in humans was between 40% and 50% of failures. About 10% to 15% were caused by inadequate pharmacokinetic properties. At the same time, around 30% were attributed to uncontrollably high toxicity or adverse effects. Preclinical CRO market companies can help to mitigate these risks by providing expertise in preclinical research, thereby aiding them in making informed decisions about which drugs to consider.
IMARC Group provides an analysis of the key trends in each segment of the global preclinical CRO market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on the service and end use.
Bioanalysis and DMPK Studies
Toxicology Testing
Others
Toxicology testing dominates the market
The report has provided a detailed breakup and analysis of the market based on the service. This includes bioanalysis and DMPK studies, toxicology testing, and others. According to the report, toxicology testing represented the largest market segment.
According to the preclinical CRO market recent developments, the growth of toxicology testing is driven by stringent regulatory requirements set by healthcare authorities worldwide to identify the potential adverse effects on human health. Moreover, as pharmaceuticals become more complex, understanding potential toxic interactions with biological systems becomes even more critical. Toxicology testing in the preclinical stage helps in saving companies significant time and financial resources by preventing the progression of unsuitable candidates. For instance, the U.S. Food and Drug Administration states that it is crucial to screen new molecules for pharmacological activity and toxicity potential.
Biopharmaceutical Companies
Government and Academic Institutes
Medical Device Companies
Biopharmaceutical companies dominate the market
The report has provided a detailed breakup and analysis of the market based on the end use. This includes biopharmaceutical companies, government and academic institutes, and medical device companies. According to the report, biopharmaceutical companies represented the largest market segment.
According to the preclinical CRO market statistics, biopharmaceutical companies are dominating the market due to the increasing development of biologics, including monoclonal antibodies, recombinant proteins, and gene therapies, which require thorough preclinical evaluation, often necessitating specialized expertise that CROs provide. Furthermore, biopharmaceutical entities are investing heavily in preclinical activities, many of which are outsourced to CROs for efficiency and expertise.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance in the market, accounting for the largest preclinical CRO market share
The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represented the largest market segment.
North America is dominating the preclinical CRO market, owing to the presence of many leading pharmaceutical and biotech companies, which directly correlates with heightened demand for preclinical research services across the region. Additionally, firms in North America consistently lead in investments in terms of R&D activities. Moreover, this commitment to innovation drives a considerable need for preclinical studies and specialized CRO services. This, in turn, is positively influencing the regional market. For instance, in February 2022, the European life sciences company InSilicoTrials and the Canadian CRO IonsGatePreclinical Services Inc. (IonsGate), which specialize in preclinical research services, collaborated to take advantage of cutting-edge technologies like simulation. Besides this, the implementation of regulatory requirements by government bodies in North America regarding drug safety is escalating the demand for preclinical CROs to meet requirements and navigate the intricate approval process. Furthermore, the wide presence of established CROs specializing in early drug discovery, such as LabCorp and Charles River Laboratories, is expected to augment the market growth in North America over the forecasted period.
The top companies in the preclinical CRO market are broadening their portfolio to provide end-to-end solutions, encompassing everything from early-stage discovery to preclinical development, which ensures clients can access a full suite of services under one roof. Additionally, companies are investing in technologies, such as in vitro toxicology, high-throughput screening, and computational modeling, to enhance their preclinical study capabilities. Furthermore, they are expanding their operations globally by setting up new facilities, upgrading existing ones, or acquiring regional players. Apart from this, several market players are attracting top talent and focusing on ongoing training to ensure their teams stay updated on the latest scientific advances and regulatory changes. Moreover, they are entering into long-term collaborations with pharmaceutical companies to streamline the drug development process, reduce redundancies, and foster deeper understanding between parties.
Charles River Laboratories Inc.
Covance Inc. (Laboratory Corporation of America Holdings)
Eurofins Scientific
ICON Plc
MD Biosciences Inc. (MLM Medical Labs)
Medpace
Parexel International Corporation
PPD Inc.
Wuxi AppTec
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
April 2024: Labcorp, a leading player in innovative and comprehensive laboratory services, expanded its precision oncology portfolio to improve patient care and cancer research globally. Labcorp is investing in scientific, diagnostic, and laboratory innovations to support its pharmaceutical, biotechnology, and clinical research to bring cutting-edge therapies.
March 2024: Veeda Clinical Research Limited, a full-service contract research organization acquired Heads, a European CRO that specializes in clinical trials in oncology.
January 2024: The National Center of Advancing Translational Sciences developed a preclinical research toolbox in collaboration with other NIH institutes and centers. The resources include the Assay Guidance Manual, Compound Management, NCATS Pharmaceutical Collection, PubChem, Probes, Phenotypic Drug Discovery Resource, and BioPlanet.