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市场调查报告书

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1618418

全球临床前 CRO 市场规模：按服务、按应用、按最终用户、按地区、范围和预测

Global Preclinical CRO Market Size By Service, By Application, By End User, By Geographic Scope And Forecast

出版日期: 2024年10月29日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3个工作天内

价格

简介目录

临床前CRO市场规模及预测

2023年临床前CRO市场规模为54.4亿美元，预计2024年至2031年复合年增长率为8.03%，到2031年达到101亿美元。临床前合约组织 (CRO) 是製药和生物技术研究领域的专业服务提供商，他们在将新药物和治疗方法投入人体临床试验之前对其进行研究和试验。临床前 CRO 在药物开发的早期阶段发挥关键作用，专注于非人体测试以确定新化合物的安全性、有效性和潜在毒性。这些组织提供各种服务，包括体外和体内测试、药物动力学和毒理学研究。

此外，将临床前研究外包给 CRO 的製药和生技公司提供的服务包括：

临床前 CRO 市场动态

塑造临床前 CRO 市场的关键市场动态

主要市场驱动因子

药物开发的复杂性：

药物开发的复杂性日益增加：为了更好地瞭解复杂的疾病和治疗靶点，製药业正在专注于专业的临床前研究服务。因此，临床前 CRO 拥有先进的设备和专业团队，在解决药物开发的复杂性和提供加速早期研究的新颖解决方案方面发挥关键作用。因此，药物开发日益复杂已成为推动临床前CRO市场扩张的关键因素。

外包效率：

製药和生物技术公司越来越多地使用 CRO（合约研究组织）来简化药物开发流程。这种策略性外包使这些公司能够专注于自己的核心优势，同时利用临床前 CRO 的独特技能和成本效率。这种外包趋势表明，产业正在认识到 CRO 带来的价值，从而实现更有效率的资源配置和更快的周转。

调查工具的技术进步：

研究方法的不断发展，以及影像技术和分子生物学工具的进步，正在增强临床前 CRO 的能力，并推动临床前 CRO 市场的成长。尖端技术的使用使这些公司能够进行更准确、更有效率的临床前测试并改善药物开发流程。因此，研究仪器的技术发展是决定临床前 CRO 格局的关键因素。

主要挑战

漫长的监管审批时间表：

监管审批所需的额外时间阻碍了寻求快速进入临床前阶段的公司。批准延迟会减慢开发过程，增加製药公司的成本和不确定性，并严重限製药物开发时间表。

资料安全与保密问题：

临床前研究资料的敏感性是一个主要阻碍因素，因为对资料安全和保密性的担忧阻碍了公司外包药物开发的关键阶段。智慧财产权盗窃和未经授权存取敏感资讯的威胁是临床前 CRO 市场的主要障碍。

能力和资源有限：

无法满足製药业对临床前 CRO 服务不断增长的资源需求，预计将阻碍临床前 CRO 服务的采用。可用性限制和延迟也对製药业务产生重大影响。此外，某些专业 CRO 的稀缺性限制了合作机会，特别是在需要独特的专业知识时。

主要趋势

扩大治疗范围：

治疗领域的扩大可能会大幅增加对临床前CRO服务的需求。临床前 CRO 正在将其专业知识扩展到癌症等传统重点领域之外，扩展到神经病学和不太常见的疾病，这是一个主要的市场趋势。此外，临床前 CRO 正在适应不同的治疗领域并提高其专业化程度，加强其作为整体药物开发策略中策略合作伙伴的角色。

生物标记开发：

对生物标记开发的重视是一种变革趋势，它响应了人们对个人化患者治疗反应的日益认识。临床前 CRO 处于这场革命的最前沿，积极致力于识别和验证生物标记。这项策略策略能够实现更有针对性的药物研究，并将这些企业定位为未来个人化医疗保健的重要参与者，从而对临床前 CRO 产生更高的需求。

临床前 CRO 市场的区域分析

临床前 CRO 市场的详细区域分析如下：

北美

根据经过验证的市场研究，亚太地区预计将在预测期内主导临床前 CRO 市场。製药公司专注于药物和治疗的开发以及遵守严格监管结构的临床前 CRO 服务的实施，从而在北美实现了广泛的临床前应用。

该地区严格的药物开发法规对临床前 CRO 服务产生了巨大的需求。这些服务对于确保遵守严格的监管标准、展示对患者安全的奉献精神以及保持药物研究的最高功效至关重要。严格的监管框架使北美成为临床前研究的重要中心，吸引了寻求监管和透明的药物开发方法的公司。

此外，众多製药和生物技术公司的存在也有助于该地区的临床前研究优势。这些行业参与者的接近创造了一个动态的生态系统，其中临床前研究活动集中。这种集聚效应促进了製药公司与已建立的临床前 CRO 之间的互动。

欧洲

欧洲的临床前 CRO 市场处于药物发现和治疗领域创新的前沿，从而推动了药物研究的进步。由于生物技术产业的蓬勃发展、积极的政府举措以及临床前 CRO 市场不断增长的外包趋势，欧洲已成为决定临床前研究轨蹟的关键参与者。

该地区对新药和生物製药的日益关注正在推动对临床前专业服务的需求。随着欧洲公司专注于尖端生物技术的进步，对全面的临床前研究的需求不断增加。因此，欧洲的治疗方法有望取得进展。

此外，製药公司对临床前CRO外包的需求不断增长，为开拓欧洲市场创造了机会。欧洲製药公司认识到药物开发早期阶段专业知识和成本效益的好处，越来越多地与临床前 CRO 合作。这项策略性举措使公司能够专注于核心能力并简化运营，同时利用 CRO 提供的专业服务。

亚太地区

预计在预测期内，亚太地区的临床前 CRO 市场复合年增长率最高。由于慢性病的高盛行率，亚太地区的临床前CRO市场正在迅速扩大，促使对高效治疗和生物製药的需求激增。除此之外，随着生物製药公司的发展，医疗保健支出不断增加，吸引了多样化的患者群体，扩大了临床前CRO服务的采用范围。

亚太地区的医疗保健支出大幅增加，尤其是在中国和印度等人口大国。这种投资的增加正在推动製药和生物技术行业的崛起。随着这些产业在该地区的扩张，对临床前 CRO 服务的需求也不断增加。

此外，亚太国家多样化的种族和人口结构为临床前研究提供了宝贵的资源。与该地区临床前 CRO 合作的製药公司受益于测试跨种族药物反应的能力，从而更深入地瞭解新候选药物的功效和安全性。因此，亚太地区因其多样化的患者群体而成为扩大临床前 CRO 市场的沃土，并可能影响全球药物开发方法。

Preclinical CRO Market size was valued at USD 5.44 Billion in 2023 and is projected to reach USD 10.1 Billion by 2031, growing at a CAGR of 8.03% from 2024 to 2031. A preclinical Contract Research Organization (CRO) is a specialist service provider in pharmaceutical and biotechnological research that conducts investigations and experiments before moving a new medicine or medical treatment into human clinical trials. Preclinical CROs serve an important role in the early stages of drug development, focusing on non-human testing to determine the safety, effectiveness, and possible toxicity of novel compounds. These organizations offer a variety of services, including in vitro and in vivo testing, pharmacokinetics, and toxicological research.

Furthermore, pharmaceutical and biotech companies that outsource preclinical research to CROs

Preclinical CRO Market Dynamics

The key market dynamics that are shaping the Preclinical CRO Market include:

Key Market Drivers

Increasing Complexity in Drug Development:

To gain a better understanding of complex diseases and treatment targets, the pharmaceutical industries are focusing on specialized preclinical research services. Thus, preclinical CROs, equipped with advanced equipment and professional teams, play a critical role in resolving the complexity of drug development, providing novel solutions to speed up the early stages of research. As a result, the increasing complexity of drug development is a significant driver fueling the expansion of the Preclinical CRO Market.

Outsourcing Efficiency:

Pharmaceutical and biotech companies are increasingly using contract research organizations (CROs) to streamline the drug development process. This strategic outsourcing enables these businesses to focus on their core strengths while taking advantage of preclinical CROs' specific skills and cost-effectiveness. This inclination toward outsourcing demonstrates the industry's recognition of the value that CROs bring to the table, allowing for more efficient resource allocation and faster turnaround.

Technological Advancements in Research Tools:

The constant evolution of research methodology, together with advances in imaging techniques and molecular biology tools is enhancing the capabilities of preclinical CROs, propelling the growth of the Preclinical CRO Market. The use of cutting-edge technologies enables these firms to undertake more precise and efficient preclinical examinations to improve their drug development processes. Thus, technological developments in research instruments are an important factor defining the preclinical CRO landscape.

Key Challenges

Long Regulatory Approval Timelines:

The additional period required for regulatory clearance hampers companies looking to move fast through the preclinical phase. Delays in approvals delay the development process and also increase pharmaceutical companies' costs and uncertainties, posing a significant constraint on the total drug development timetable.

Data Security and Confidentiality Issues:

The delicate nature of preclinical research data creates a significant constraint as concerns regarding data security and confidentiality discourage corporations from outsourcing vital stages of drug development. This threat of intellectual property theft or illegal access to confidential information poses a significant impediment in the Preclinical CRO Market.

Limited Capacity and Resources:

The inability to meet the rising demand for resources for preclinical CRO services in the pharmaceutical industry is projected to inhibit the adoption of preclinical CRO services. Also, the limited availability or delays further have a huge impact on the pharmaceutical businesses. Furthermore, the scarcity of certain specialized CROs limits collaboration opportunities, particularly when unique expertise is required.

Key Trends

Expansion of Therapeutic Areas:

The growth of therapeutic domains is likely to surge the demand for preclinical CRO services. Preclinical CROs are expanding their expertise beyond conventional emphasis areas like cancer and into neurology and uncommon disorders representing a significant trend in the market. Also, preclinical CROs' ability to adapt to and increase their expertise in a variety of therapeutic areas strengthens their role as strategic partners in overall drug development strategy.

Biomarker Development:

The emphasis on biomarker development is a transformative trend that corresponds to the growing awareness of personalized patient responses to therapies. Preclinical CROs are at the vanguard of this revolution, actively identifying and validating biomarkers. This strategic strategy allows for more targeted and successful medication research and also places these businesses as essential actors in the future of customized healthcare, creating higher demand for preclinical CRO.

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Preclinical CRO Market Regional Analysis

Here is a more detailed regional analysis of the Preclinical CRO Market:

North America

According to Verified Market Research, Asia Pacific is estimated to dominate in Preclinical CRO Market over the forecast period. The focus of pharmaceutical companies on developing drugs, treatments, and implementing preclinical CRO services compliant with strict regulatory structure is enabling in creating vast application of preclinical in North America..

The region is experiencing significant demand for preclinical CRO services due to the strict regulations governing drug development. These services are critical in guaranteeing compliance with stringent regulatory standards, demonstrating dedication to patient safety and maintaining the highest levels of efficacy in pharmaceutical research. The tight regulatory framework distinguishes North America as a prominent hub for preclinical research, attracting companies seeking a regulatory-compliant and transparent approach for drug development.

Furthermore, the concentration of a large number of pharmaceutical and biotech companies contributes to the region's preclinical research dominance. The proximity of these industry participants has resulted in a dynamic ecosystem, with a high concentration of preclinical research activity. This clustering effect allows for easy interactions between pharmaceutical corporations and established preclinical CROs.

Europe

Europe's Preclinical CRO Market is at the forefront of generating innovation in the field of drug discovery and treatment, thereby leading to the progression of pharmaceutical research. Europe has emerged as an important player in defining the trajectory of preclinical research, owing to a thriving biotechnology sector, favorable government efforts, and an expanding tendency of outsourcing in the Preclinical CRO Market.

The region's increased focus on novel medicines and biopharmaceuticals has increased demand for specialist preclinical services. As European corporations focus more on cutting-edge biotechnological advancements, the need for comprehensive preclinical research grows. This is likely to result in the advancements of therapeutics in Europe.

Furthermore, the growing demand for outsourcing of preclinical CRO in pharmaceutical companies is creating development opportunities for the market in Europe. Recognizing the benefits of specialized expertise and cost-effectiveness in the early stages of drug development, European pharmaceutical companies are actively collaborating with preclinical CROs. This strategic move enables businesses to streamline their operations, focusing on core capabilities while leveraging the specialized services provided by CRO.

Asia Pacific

Asia Pacific is estimated to grow at the highest CAGR in the Preclinical CRO Market during the forecast period. The Preclinical CRO Market in Asia Pacific is expanding rapidly owing to the high prevalence of chronic illnesses, which is surging the demand for efficient treatment and biopharmaceuticals. In addition to this, the increasing healthcare spending along with the development of biopharmaceutical companies is attracting diverse patient population, creating a wider scope of adoption for the preclinical CRO services.

Healthcare expenditure in Asia-Pacific is increasing significantly, particularly in populous countries like China and India. This increasing investment has fueled the rise of the pharmaceutical and biotech industries. This demand for preclinical CRO services increases in parallel with the expansion of these sectors in this region.

Furthermore, the diverse ethnicities and demographics that exist in Asia Pacific countries provide an invaluable resource for preclinical research. Pharmaceutical companies that work with preclinical CROs in this region benefit from the capacity to test medication reactions across ethnicities, resulting in a more thorough understanding of a drug candidate's efficacy and safety profile. Because of the diversity of patient populations, Thus, Asia Pacific is turning into a fertile ground for the expansion of the Preclinical CRO Market that is likely to influence worldwide drug development methods.

Global Preclinical CRO Market Segmentation Analysis

The Global Preclinical CRO Market is segmented on the basis of Service, Application, End-User, And Geography.

Preclinical CRO Market, By Service

Bioanalysis and Drug Metabolism and Pharmacokinetics (DMPK) Studies
Toxicology Testing

Based on Service, the market is segmented into Bioanalysis & DMPK Studies and Toxicology Testing. The Toxicology Testing segment is estimated to dominate the Preclinical CRO Market due to its critical role in assessing the safety and potential toxicity of new drug candidates. Toxicology testing is an essential part of the preclinical review process, providing critical information on the negative effects a substance may have on biological systems. As regulatory authorities prioritize comprehensive safety assessments before clinical trials, pharmaceutical and biotech businesses are increasingly relying on CROs for specialist toxicology testing services. These services cover a wide range of investigations, including acute, sub-chronic, and chronic toxicity assessments, as well as reproductive and developmental toxicology research. The importance of toxicological testing reflects its critical role in guaranteeing the overall safety profile of drug candidates, reducing risks and increasing the possibility of achieving regulatory approval in later clinical phases.

Preclinical CRO Market, By Application

Oncology
Central Nervous System (CNS) Disorders
Cardiovascular Diseases
Immunological Disorders
Respiratory Diseases
Infectious Diseases
Diabetes
Others

Based on Application, the market is segmented into Oncology, Central Nervous System (CNS) Disorders, Cardiovascular Diseases, Immunological Disorders, Respiratory Diseases, Infectious Diseases, Diabetes, and Others. The Oncology segment is estimated to dominate the Preclinical CRO Market. Oncology has seen an increase in demand for preclinical CRO services because of the complexities and obstacles of finding effective cancer medicines is increasing the application of preclinical CRO in oncology.

Preclinical CROs that specialize in oncology conduct critical research such as efficacy assessments, toxicity evaluations, and biomarker discovery to help create innovative and tailored medicines. The complexities of cancer biology require specialized expertise, cutting-edge technologies, and a thorough understanding of regulatory regulations, all of which is likely to be provided by preclinical CROs. Their ability to manage the complexities of oncology research, combined with the rising worldwide cancer incidence and the ongoing hunt for novel treatments, positions the oncology application segment as the primary driver driving the growth and significance of the entire Preclinical CRO Market.

Preclinical CRO Market, By End-User

Pharmaceutical and Biopharmaceutical Industries
Medical Device Companies
Academic Institutes

Based on End-User, the market is segmented into Pharmaceutical & Biopharmaceutical Industries, Medical Device Companies, and Academic Institutes. The pharmaceutical and biopharmaceutical industries end-user segment is estimated to dominate the market over the forecast period. Pharmaceutical and biopharmaceutical companies are depending more and more on the specialized services provided by preclinical CROs to help them negotiate the challenging early stages of drug development as the market for innovative and focused therapeutics grows. These sectors necessitate extensive preclinical testing, including efficacy, safety, and toxicity investigations, to guarantee that new drug candidates meet tight regulatory requirements. Outsourcing preclinical research efforts to CROs enables pharmaceutical and biopharmaceutical companies to benefit from external knowledge, cutting-edge technologies, and cost-effective solutions, accelerating the drug development process.

Key Players

The "Global Preclinical CRO Market" study report will provide valuable insight with an emphasis on the global market including some of the major players such as
Charles River Laboratories, Syneos Health, WuXi AppTec, Eurofins Scientific, Envigo, Covance, Parexel, Labcorp Drug Development, Emmes Corporation, Albany Molecular Research Inc., Aptuit LLC, Bio-Bridge Laboratories Inc., Stelis Biopharma, ToxStrategies Inc., Epredia, Marshall BioResources, Taconic Biosciences, Xenotech and Evotec.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

In January 2024, WuXi AppTec, a renowned Chinese CRO, collaborated with Personalis, a genomics data business, to develop AI-powered drug discovery solutions. The collaboration hopes to use Personalis' AI technology to scan massive amounts of genomic data and find new therapeutic targets.
In January 2024, Charles River Laboratories, a global leader in preclinical CRO services, announced an expansion of its bioanalytical capabilities in Europe. The company bought a bioanalytical laboratory in the United Kingdom, expanding its drug development support services.
In January 2024, Syneos Health, a well-known clinical CRO, partnered with Huma Therapeutics, a digital health business, to create digital biomarkers for Parkinson's disease. This cooperation intends to use wearable technologies and artificial intelligence to monitor illness development and improve clinical trial design.
In January 2024, Eurofins Scientific, a prominent provider of analytical testing services, acquired Bio-Alternatives, a preclinical drug discovery CRO. This acquisition broadens Eurofins' expertise in fields such as in vitro toxicity and ADME investigations.

1 INTRODUCTION OF GLOBAL PRECLINICAL CRO MARKET

1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL PRECLINICAL CRO MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis

5 GLOBAL PRECLINICAL CRO MARKET, BY SERVICE

5.1 Overview
5.2 Bioanalysis and Drug Metabolism and Pharmacokinetics (DMPK) Studies
5.3 Toxicology Testing

6 GLOBAL PRECLINICAL CRO MARKET, BY END-USER

6.1 Overview
6.2 Pharmaceutical and Biopharmaceutical Industries
6.3 Medical Device Companies
6.4 Academic Institutes

7 GLOBAL PRECLINICAL CRO MARKET, BY APPLICATION

7.1 Overview
7.2 Oncology
7.3 Central Nervous System (CNS) Disorders
7.4 Cardiovascular Diseases
7.5 Immunological Disorders
7.6 Respiratory Diseases
7.7 Infectious Diseases
7.8 Diabetes
7.9 Others

8 GLOBAL PRECLINICAL CRO MARKET, BY GEOGRAPHY

8.1 Overview
8.2 North America
- 8.2.1 U.S.
- 8.2.2 Canada
- 8.2.3 Mexico
8.3 Europe
- 8.3.1 Germany
- 8.3.2 U.K.
- 8.3.3 France
- 8.3.4 Rest of Europe
8.4 Asia Pacific
- 8.4.1 China
- 8.4.2 Japan
- 8.4.3 India
- 8.4.4 Rest of Asia Pacific
8.5 Rest of the World
- 8.5.1 Latin America
- 8.5.2 Middle East & Africa

9 GLOBAL PRECLINICAL CRO MARKET COMPETITIVE LANDSCAPE

9.1 Overview
9.2 Company Market Ranking
9.3 Key Development Strategies

10 COMPANY PROFILES

10.1 Charles River Laboratories
- 10.1.1 Overview
- 10.1.2 Financial Performance
- 10.1.3 Product Outlook
- 10.1.4 Key Developments
10.2 Syneos Health
- 10.2.1 Overview
- 10.2.2 Financial Performance
- 10.2.3 Product Outlook
- 10.2.4 Key Developments
10.3 WuXi AppTec
- 10.3.1 Overview
- 10.3.2 Financial Performance
- 10.3.3 Product Outlook
- 10.3.4 Key Developments
10.4 Eurofins Scientific
- 10.4.1 Overview
- 10.4.2 Financial Performance
- 10.4.3 Product Outlook
- 10.4.4 Key Developments
10.5 Envigo
- 10.5.1 Overview
- 10.5.2 Financial Performance
- 10.5.3 Product Outlook
- 10.5.4 Key Developments
10.6 Covance
- 10.6.1 Overview
- 10.6.2 Financial Performance
- 10.6.3 Product Outlook
- 10.6.4 Key Developments
10.7 Parexel
- 10.7.1 Overview
- 10.7.2 Financial Performance
- 10.7.3 Product Outlook
- 10.7.4 Key Developments
10.8 Labcorp Drug Development
- 10.8.1 Overview
- 10.8.2 Financial Performance
- 10.8.3 Product Outlook
- 10.8.4 Key Developments
10.9 Emmes Corporation
- 10.9.1 Overview
- 10.9.2 Financial Performance
- 10.9.3 Product Outlook
- 10.9.4 Key Developments