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市场调查报告书
商品编码
1820442
2025 年至 2033 年临床前 CRO 市场规模、份额、趋势及按服务、最终用途和地区分類的预测Preclinical CRO Market Size, Share, Trends, and Forecast by Service, End Use, and Region, 2025-2033 |
2024年,全球临床前CRO市场规模为64亿美元。展望未来, IMARC Group估计,到2033年,市场规模将达到113亿美元,2025年至2033年的复合年增长率为6.5%。北美目前占据市场主导地位,2024年的市占率将超过47.5%。研发支出不断增长、监管环境日益复杂、企业日益注重核心竞争力以及专科治疗领域的最新进展是推动该地区市场发展的主要因素。
临床前合约研究组织 (CRO) 市场成长的主要驱动力是对外包研发 (R&D) 的需求不断增长,以简化药物发现并节省成本。製药和生物技术公司已经开始相当程度地依赖 CRO 的专业知识、先进技术和更全面的临床前测试服务。除此之外,更广泛的生物製药研究、对创新疗法的更多投资以及需要满足的更严格的监管要求正在推动市场成长。此外,慢性病盛行率的上升和药物开发速度的加快导致对临床前 CRO 服务的需求增加。推动临床前 CRO 市场成长的另一个因素是持续的技术进步,例如人工智慧 (AI) 驱动的药物发现和更好的实验室工作,使与 CRO 的合作在全球范围内更加高效和有吸引力。
美国正在兴起一个巨大的市场,占据约93.7%的市场。製药和生物技术公司越来越多地将临床前研究的各个环节外包给合约研究组织(CRO),以节省成本并加快药物开发速度。越来越多的慢性病需要新的治疗方案来治疗,这也进一步刺激了市场对临床前合约研究组织(CRO)的需求。此外,药物开发的复杂性不断增加以及监管要求越来越严格,迫使公司寻求CRO的专业知识。根据美国疾病管制与预防中心(CDC)的统计数据,美国每十个成年人中就有六人患有癌症、心臟病或糖尿病等慢性疾病。慢性病是美国的头号杀手。心臟病和癌症合计占总死亡人数的近40%。慢性病发病率的上升对新疗法的需求日益迫切,这正在促进市场的成长。
研发活动不断增加
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,现代药物开发过程非常复杂,需要经过漫长的临床前测试过程以确保新药的安全性和有效性。研究人员必须遵循美国食品药物管理局 (FDA) 的良好实验室规范 (GLP) 来规范临床前研究的医疗产品开发。此外,据报道,印度的临床前 CRO 市场正在快速成长,2023 年的价值为 1.833 亿美元,到 2030 年的复合年增长率将达到 11.4%。随着研究活动的增加和基础设施的发达,包括全球外包需求,印度已成为临床前研究的主要目的地。 Syngene 和 Jubilant Biosys 是毒理学、安全药理学和生物分析服务的创新者。此外,对于製药公司来说,将临床前研发活动外包给 CRO 比自己进行更具成本效益。 CRO 拥有专业知识和基础设施,可以帮助简化药物开发流程并降低成本。例如,2024 年 1 月,美国国家转化科学促进中心 (NCATS) 与其他 NIH 研究所和中心合作开发了一个临床前研究工具箱。这些工具箱包括《检测指导手册》、《化合物管理》、《NCATS 药物库》、《PubChem》、《探针》、《表型药物发现资源》和《BioPlanet》。
复杂的监管环境
製药和生物技术产业复杂的监管环境是影响临床前 CRO 市场前景的重要因素。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,美国国家转化科学促进中心与学术界、工业界和患者权益团体合作,使 45 多种新药进入临床试验阶段。据他们介绍,一种新药从实验室到药柜的整个过程可能需要长达 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,临床试验的全球化要求製药公司了解各国复杂的监管环境。具有经验并熟悉国际监管要求的临床前 CRO 可以帮助公司克服这些困难。例如,美国疾病管制与预防中心 (CDC) 声称,实验室研究需要 10 到 15 年才能准备好疫苗,研究人员必须向 FDA 提交包含疫苗所有资讯的试验性新药申请。 FDA 的生物製品评估与研究中心负责监管美国疫苗的使用。
药物开发成本不断增加
药物开发成本的上升进一步推高了临床前CRO市场的收入。新药研发是一个非常复杂且耗时的过程。在药物开发过程中,大量的研究和测试至关重要。因此,这种复杂性导致了临床前研究的高成本。此外,为了确定新药的安全性和有效性,EMA和FDA都要求进行完整的临床前测试。满足这些监管规定成本高。药物开发本身就存在风险,儘管投入了大量资金,但仍有许多药物未能进入市场。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%的失败案例是因为药物无法对人体产生预期的效果。大约10%到15%的失败是由于药物动力学特性设计不当。同时,大约30%的失败是由于毒性/毒性/不良反应无法控制。根据临床前 CRO 市场预测,主要公司可以透过提供与临床前研究相关的专业知识来缓解这种危险,从而更好地指导他们选择要考虑的药物。
The global preclinical CRO market size was valued at USD 6.4 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 11.3 Billion by 2033, exhibiting a CAGR of 6.5% from 2025-2033. North America currently dominates the market, holding a market share of over 47.5% in 2024. 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 in the region.
The main driving force behind the growth of the preclinical contract research organization (CRO) market is the growing demand for outsourcing research and development (R&D) to streamline the discovery of drugs and save costs. Pharmaceutical and biotechnological companies have started taking considerable dependence on CRO's specialized expertise, advanced technology, and more inclusive preclinical testing services. Besides this, more extensive biopharmaceutical research, higher investments in innovative therapies, and stringent regulatory requirements that need to be fulfilled are impelling the market growth. Moreover, the escalating prevalence of chronic diseases and faster pace of drug development have led to the increased demand for preclinical CRO services. Another factor driving preclinical CRO market growth is the continuous technological progress such as artificial intelligence (AI)-driven drug discovery, and better laboratory work making the partnership with CRO more efficient and attractive worldwide.
A massive market is emerging in the United States, holding approximately 93.7% market share. Pharmaceutical and biotechnological companies are outsourcing all aspects of preclinical research increasingly to CROs just in order to save money on costs and accelerate the speed of drug development. A higher incidence of chronic diseases to be treated with new treatment options is also fueling further market demand for preclinical CROs. Along with this, the rising complexity of drug development and stricter regulatory requirements are forcing companies to seek specialized expertise from CROs. According to statistics from the Centers for Disease Control and Prevention (CDC), six in ten adults in the U.S. live with a chronic disease such as cancer, heart disease, or diabetes. Chronic diseases form the top killer in the United States. Heart disease and cancer combined take almost 40% of the total deaths. The growing rate of chronic diseases calls for a requirement of new therapies, which is strengthening the market growth.
Rising Research and Development Activities
The escalating R&D activities in the pharmaceutical and biotechnology industries are driving the preclinical CRO market share. Further, the modern drug development process is complex and demands a lengthy preclinical testing process for the safety and efficacy of new drugs. Researchers must use Good Laboratory Practice (GLP) defined in U.S. Food and Drug Administration (FDA) rules for regulation of medical product development for preclinical studies. Moreover, according to reports, India's preclinical CRO market, valued at USD 183.3 Million in 2023, is growing rapidly, driven by a CAGR of 11.4% through 2030. With increasing research activities and developed infrastructure, including global outsourcing demand, Indian is a prime destination in preclinical research. Innovators in toxicology, safety pharmacology, and bioanalytical services are Syngene and Jubilant Biosys. In addition, outsourcing preclinical R&D activities to CROs is more cost-effective for the pharmaceutical companies as compared to their in-house performance. CROs have specialized expertise and infrastructures that can assist in streamlining the process of drug development and making it less expensive. In January 2024, for example, the National Center of Advancing Translational Sciences developed a preclinical research toolbox in collaboration with other NIH institutes and centers. These include 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 outlook. 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. In addition, the globalization of clinical trials requires pharmaceutical companies to understand the intricate regulatory landscape in various countries. Preclinical CROs with experience and familiarity with international regulatory requirements can enable them to assist companies in conquering these difficulties. For example, the Centers for Disease Control and Prevention claim that laboratory research takes 10 to 15 years to get vaccines ready, and researchers have to apply to the FDA with an investigational new drug application that includes all information on the vaccine. The FDA's Center for Biologics Evaluation and Research regulates the use of vaccines in the United States.
Increasing Cost of Drug Development
The rising cost of drug development is further pushing the revenue of the preclinical CRO market. It is a very complex and time-consuming process to discover new drugs. Extensive research and testing are essential in drug development. Thus, such complexity contributes to the high cost that goes with the performance of preclinical studies. Additionally, with respect to establishing the safety and efficacy of new drugs, both the EMA and the FDA require complete preclinical testing. Meeting these regulatory provisions is 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% resulted from poorly designed pharmacokinetic characteristics. Meanwhile, about 30% resulted from being uncontrollably toxic/toxicity/adverse. According to preclinical CRO market forecast, key companies can ease such dangers by providing preclinical research-related expertise that can guide them better in choosing the drugs to consider.
Toxicology testing is the largest segment that commands around 51.6% of the market share in 2024, mainly due to the significant role that toxicology studies play in providing assurance regarding the safety of drugs and good compliance with high regulatory standards. The increasing demand for innovative therapies, as well as the complexity of drug formulations, has compelled pharmaceutical companies to conduct extensive toxicology testing. The in-vivo and in-vitro testing, genotoxicity studies, along with, carcinogenicity assessments are all popular services with respect to safety during early drug development. The increasing incidence of chronic diseases and increased investment in biopharmaceutical research form an underpinning driver for the demand for such services and emphasize toxicology testing as a core component of the preclinical CRO market.
Biopharmaceutical companies are the largest end-users of preclinical CRO services in 2024, taking about 81.0% of the market share. This is due to the biologics and targeted therapies, which come along with heavy preclinical research undertaken on them to ascertain efficacy and safety. These firms believe in the best use of available preclinical CRO services in meeting advanced testing capabilities, making the research more effective, and standing rigorous regulatory requirements. Another factor propelling investments in drug development from biopharmaceutical companies is the rising incidence of chronic diseases, combined with increased demand for personalized medicine. CRO outsourcing also enables such companies to decrease operational costs and speed up time-to-market for innovative therapies, making these companies the principal drivers of growth in the preclinical CRO market.
North America holds the largest chunk of the preclinical CRO market in 2024, with around 47.5% of the world's share. The reasons behind this can be attributed to the strength of the pharmaceutical and biotechnology industries, higher research grants, and an established regulatory framework within that region. With cutting-edge health infrastructure, significant chronic disease prevalence, and majorly research and innovation-based drug development within this region, the US contributes the most in bringing forward growth. In fact, biopharmaceutical firms are outsourcing more than before to save on operational cost and time while managing a research pipeline. Furthermore, higher penetration of more advanced technologies is in AI-driven drug discovery, laboratory automation, and the further strengthening of North America's presence as a major hub of preclinical CRO activity.
United States Preclinical CRO Market Analysis
The adoption of preclinical research services is significantly advancing the United States' biomedical and pharmaceutical sectors by allowing precise drug development and regulatory compliance. For example, the U.S. pharmaceutical industry, generating over USD 550 Billion in 2021 and employing 1.3 Million people, is driving the adoption of preclinical CRO through robust R&D investments and its dominant global market position. By utilizing cutting-edge technologies such as AI-driven drug modeling and advanced imaging systems, the U.S. is best positioned to lead in healthcare innovations. The research on personalized medicine in California and the breakthroughs in oncology in Massachusetts are examples of such leadership. States like Texas and North Carolina are also emerging as prominent hubs, benefiting from streamlined preclinical services that reduce development timelines and costs. These innovations bolster competitiveness on a global scale, attracting investments from countries including Germany and Japan. The U.S. stands out for its ability to integrate advancements with localized expertise, such as leveraging robust research facilities in academic centers. This strategic adoption enhances the country's role in addressing complex health challenges while maintaining its status as a global powerhouse in preclinical development.
Europe Preclinical CRO Market Analysis
Europe holds a prominent position in the preclinical Contract Research Organization (CRO) market, driven by its advanced healthcare infrastructure and a focus on biotechnological and pharmaceutical innovation. Countries such as Germany, the United Kingdom, and France are leading contributors, with a strong presence of global biopharma companies and research institutions. The region benefits from robust regulatory frameworks and streamlined drug approval processes, which make it an attractive destination for preclinical research. For instance, Germany's National Pharma Strategy aims to reverse its declining share in global clinical trials, down to 3.9% in 2021, by fostering faster approvals, reducing bureaucracy, and incentivizing local research. These reforms, including the Medical Research Act, are driving preclinical CRO adoption to support pharmaceutical innovation and competitiveness. Key advancements, such as the integration of AI in drug discovery and precision medicine studies, are transforming the preclinical landscape in Europe. For instance, Germany's thriving pharmaceutical sector supports extensive preclinical toxicology and pharmacokinetics research, while the UK fosters innovation through partnerships between CROs and academic centers. Locations such as Switzerland and Belgium further enhance the region's capabilities, offering specialized services like disease modeling and high-throughput screening. With significant investments in biopharma R&D, Europe is addressing critical unmet medical needs, reinforcing its role as a global hub for preclinical CRO services.
Asia Pacific Preclinical CRO Market Analysis
The Asia-Pacific region is emerging as a global leader in adopting preclinical Contract Research Organizations (CROs), driven by advancements in biotechnology, innovative drug discovery, and increasing demand for cost-effective research solutions. Countries like China, India, and South Korea, along with key locations such as Singapore, have positioned themselves as hubs for preclinical outsourcing due to their robust infrastructure, skilled workforce, and favorable regulatory frameworks. For instance, The Asia-Pacific (APAC) region, driving over 50% of global clinical trials from 2017 to 2021, is rapidly adopting preclinical CROs due to lower costs, robust site availability, and streamlined regulatory processes. Enhanced growth across therapeutic areas, coupled with APAC's pharmacogenomic advantages, positions it as a leader in clinical trial innovation. Notable advantages include reduced timelines for drug development, access to advanced technologies, and the ability to leverage expertise in diverse therapeutic areas. For instance, China's integration of AI in preclinical studies has accelerated precision medicine research, while India's cost-efficient services have attracted global pharmaceutical firms. South Korea's emphasis on immuno-oncology trials exemplifies the region's focus on innovative therapeutic areas. The Asia-Pacific's strategic location also enables seamless collaboration with Western markets, ensuring its prominence as a preferred destination for preclinical CRO partnerships.
Latin America Preclinical CRO Market Analysis
Latin America is emerging as a dynamic hub for preclinical CROs due to advancements in biomedical research and innovation. Countries like Brazil, Mexico, and Argentina are leveraging state-of-the-art facilities, competitive costs, and skilled professionals to attract global collaborations. For instance, Brazil recorded 625,000 new cancer cases in 2022, yet only 2.2% of global cancer clinical trials are conducted there, driving the need for preclinical CROs to address barriers such as limited trials, regulatory delays, and resource shortages. This highlights Brazil's growing role in advancing oncology research through increased CRO adoption. Strategic positioning near North American markets enhances its appeal. Preclinical CROs in Latin America specialize in drug safety and efficacy studies, with examples like Mexican CROs excelling in toxicology and Brazilian firms leading in pharmacokinetics. These developments are positioning the region as a critical player in the global preclinical research landscape.
Middle East and Africa Preclinical CRO Market Analysis
The adoption of preclinical CROs is significantly advancing the Middle East and Africa's position in global healthcare innovation. Countries such as the UAE, Saudi Arabia, and South Africa are leveraging CRO services to streamline drug development and boost research capabilities. For instance, the Middle East's pharmaceutical market, valued at USD 36 Billion in 2023, is fostering preclinical CRO adoption, driven by rising investments in drug development and regulatory demands. This growth highlights the region's increasing focus on advanced research services to meet expanding healthcare needs. These advancements reduce costs and accelerate timelines, fostering a competitive edge. Key hubs like Dubai and Cape Town are becoming research centers due to infrastructure investments and collaborations. This strategic approach is strengthening the region's role in global clinical research and pharmaceutical innovation.
The global preclinical CRO market is characterized by intense competition, driven by the growing demand for specialized services and the increasing trend of outsourcing drug development. Leading players dominate the market with comprehensive service portfolios, advanced technological capabilities, and global footprints. These companies invest heavily in research and development, strategic partnerships, and acquisitions to expand their offerings and stay ahead in the competitive landscape. Smaller and mid-sized CROs are also gaining traction by focusing on niche services, cost-effectiveness, and flexibility in client engagement. The market sees innovation as a key competitive factor, with companies adopting AI, predictive analytics, and automated platforms to improve efficiency and accuracy. Regional players are expanding their presence in emerging markets like Asia-Pacific, further intensifying the competition. The industry's growth potential continues to attract new entrants, adding to the dynamic and competitive nature of the market.