세계 전임상 CRO(의약품 개발 업무 수탁기관) : 산업규모, 점유율, 동향, 기회 및 예측(2018년-2028년) - 서비스별, 모델 유형별(Patient Derived Organoid Model, Patient derived xenograft model), 최종 이용 산업별, 지역별 및 경쟁별

The Global Preclinical CRO Market reached a valuation of USD 5.89 Billion in 2022 and is poised for robust growth in the forecast period, with a projected Compound Annual Growth Rate (CAGR) of 8.53% and expected to reach USD 9.62 Billion through 2028.

Introduction:

Preclinical CROs (Contract Research Organizations) are specialized entities that provide aqueous-based colorants used in various industrial applications, including food processing, printing inks, wood stain, textile processing, and more. These colorants offer superior selective absorptivity for liquids and substrates, making them preferable to other color-imparting materials like pigments. Preclinical CROs possess exceptional absorption characteristics that allow for the modification of their physical and structural properties when applied to substrates. However, it's important to note that Preclinical CROs have limited resistance to light and a relatively shorter shelf life. As a result, they are primarily used in surface coating, food, and printing applications that require high levels of transparency in the manufacturing of finished products. Preclinical CROs can be categorized based on their solubility in a specific medium or substrate, including basic Preclinical CROs, fat-soluble Preclinical CROs, and metal complex Preclinical CROs.

Key Market Drivers:

1. Increasing Outsourcing Trends Drive Market Growth:

The growing trend of outsourcing is a significant driver behind the expansion of the Global Preclinical Contract Research Organization (CRO) market. Pharmaceutical and biotechnology companies are increasingly opting to delegate their preclinical research and development activities to specialized CROs rather than conducting them in-house. This strategic shift allows these companies to realize cost savings related to maintaining in-house facilities, equipment, and personnel. CROs often possess established infrastructure and expertise, which leads to the efficient and cost-effective execution of preclinical studies. Outsourcing preclinical research allows companies to allocate their internal resources to core activities such as clinical trials, regulatory affairs, and commercialization, thereby enhancing overall operational efficiency. Preclinical CROs are staffed with experts in various scientific disciplines, providing specialized knowledge and experience. This expertise can be leveraged by companies without the need to build and maintain extensive in-house teams. Moreover, CROs invest in state-of-the-art technologies and equipment for preclinical research, providing companies with access to advanced tools without substantial capital investments. Outsourcing also offers companies the flexibility to scale their preclinical activities based on project needs, which is crucial for navigating the dynamic nature of drug development. Preclinical CROs often have established processes and workflows, resulting in faster study execution and reduced development timelines, accelerating the drug development process.

2. Rising Number Of Drugs In Preclinical Phases:

The increasing number of drugs in preclinical phases contributes significantly to the growth of the Global Preclinical Contract Research Organization (CRO) market. As pharmaceutical and biotechnology companies continue to develop a larger pipeline of potential drug candidates, the demand for preclinical research and testing services provided by CROs grows. With more drug candidates entering preclinical phases, there is a greater need for conducting various preclinical studies, such as safety assessments, efficacy testing, and pharmacokinetics studies. CROs are equipped to handle multiple projects simultaneously and possess expertise in accommodating the diverse needs of different drug candidates, ranging from small molecules to biologics and novel therapies. Companies may not have the internal resources, equipment, or facilities required to conduct multiple preclinical studies concurrently. Therefore, outsourcing to CROs optimizes resource allocation. The increasing number of drug candidates underscores the importance of streamlined and accelerated preclinical development processes. CROs, with their established workflows and expertise, help expedite studies, enabling quicker progression to clinical phases. Managing a large number of preclinical programs can be challenging for companies. CROs provide specialized risk management strategies and tools to navigate the complexities of preclinical research, reducing the potential for costly failures.

3. Rising R&D Costs Drive Market Growth:

The escalating costs of research and development (R&D) in the pharmaceutical and biotechnology industries are a significant driver of the Global Preclinical Contract Research Organization (CRO) market. As R&D expenses continue to rise, companies increasingly turn to preclinical CROs to optimize their drug development processes, enhance cost-effectiveness, and improve overall efficiency. In-house preclinical research facilities, including infrastructure, equipment, staffing, and operational expenses, can strain a company's budget. Outsourcing to preclinical CROs offers a more cost-effective alternative, enabling companies to contain and manage their R&D expenditures. By outsourcing preclinical studies to CROs, companies can leverage the CROs' established infrastructure, equipment, and experienced personnel, minimizing the need for substantial capital investments and ongoing operational costs. Outsourcing preclinical work to CROs helps mitigate the financial risks associated with failed drug candidates. CROs conduct rigorous preclinical testing, identifying potential issues early in the development process and reducing the likelihood of costly clinical trial failures. CROs often employ specialists in various scientific and regulatory fields, providing access to a broad range of expertise without the need for extensive in-house teams. This expertise optimizes study design, execution, and data interpretation. Regulatory requirements and the need for adherence to quality standards can contribute to R&D costs. Preclinical CROs are experienced in navigating these regulatory landscapes, ensuring studies are conducted in compliance with guidelines. Efficient preclinical research conducted by CROs accelerates the drug development process, enabling companies to move promising candidates into clinical trials more quickly. This speed-to-market can result in significant cost savings and revenue generation. Preclinical CROs offer a variety of services, such as safety assessments, efficacy testing, pharmacokinetics, toxicology studies, and more, allowing companies to choose specific services based on their needs and optimizing resource allocation.

Key Market Challenges:

1. Regulatory Compliance and Quality Assurance:

Regulatory compliance and quality assurance present significant challenges to the Global Contract Research Organization (CRO) market, particularly in the context of preclinical research. The pharmaceutical and biotechnology industries are heavily regulated by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ensuring that preclinical studies are conducted in strict accordance with these regulations is essential for obtaining regulatory approvals and advancing to clinical trials. Regulatory requirements can vary between regions and countries, making it necessary for Preclinical CROs working with clients from different geographic locations to navigate and harmonize diverse regulatory frameworks, which can be complex and time-consuming. Failure to comply with regulatory guidelines can lead to delays, increased costs, or even the rejection of drug candidates in later development stages. Therefore, CROs must maintain a thorough understanding of evolving regulations to minimize the risk of non-compliance.

2. Data Interpretation and Reporting:

Data interpretation and reporting present significant challenges to the Global Contract Research Organization (CRO) market, particularly in the context of preclinical research. Accurate and meaningful data interpretation and reporting are essential for informed decision-making in drug development. Preclinical studies generate complex and multidimensional data that require a deep understanding of scientific principles, statistical analyses, and biological context to draw accurate conclusions. Biological systems are inherently variable, and CROs must account for this variability in data interpretation to differentiate true effects from background noise and identify meaningful trends. Modern technologies generate vast amounts of data in preclinical studies, and managing and analyzing this "big data" can be overwhelming, requiring sophisticated bioinformatics tools and expertise. Incorrect data interpretation can

lead to false positives (detecting effects that are not real) or false negatives (missing real effects), both of which can have serious consequences for drug development decisions.

3. Communication and Collaboration:

Communication and collaboration challenges can impact the Global Contract Research Organization (CRO) market, particularly in the context of preclinical research. Effective communication and collaboration between CROs and their clients are essential for successful project outcomes. Poor communication can lead to misaligned expectations between CROs and clients, potentially resulting in deliverables that do not meet expectations. In an increasingly globalized industry, CROs and clients may come from different countries and cultures, and language barriers and cultural differences can hinder effective communication and collaboration. Preclinical studies often involve complex experimental designs and methodologies, and communicating these intricacies to clients and ensuring their understanding of the technical aspects can be challenging. Delays in communication can lead to project disruptions, missed deadlines, and increased costs. Clear and timely communication is crucial to keep projects on track, and CROs must prioritize clear, transparent, and proactive communication practices.

Key Market Trends:

1. Increase in the Number of Virtual Trials:

A significant trend in the Global Contract Research Organization (CRO) market is the increase in the number of virtual trials, which is transforming how clinical research is conducted. Virtual trials, also known as decentralized clinical trials, utilize technology to remotely collect data from participants, reducing the need for physical site visits. These trials enable patients to participate from their homes, resulting in higher patient recruitment and retention rates. CROs are adapting their strategies to engage patients virtually through telehealth, wearables, and mobile apps, often partnering with technology providers to integrate digital tools for remote data collection, patient monitoring, electronic informed consent, and telemedicine consultations. This shift requires expertise in selecting, implementing, and managing these technologies, as well as robust data management solutions to handle large volumes of remote patient-generated data. Virtual trials reduce reliance on physical trial sites, streamlining operations, enhancing efficiency, and reducing costs associated with site infrastructure. Additionally, virtual trials expand access to a more diverse patient population, including those previously excluded due to geographic constraints, which broadens the potential pool of participants and enhances the generalizability of trial results.

Segmental Insights:

Service Insights:

In 2022, the Preclinical CRO market was dominated by Toxicology testing and is predicted to continue expanding over the coming years. Toxicology testing is a crucial and dominant segment within the Global Contract Research Organization (CRO) market, especially in the preclinical stage of drug development. It assesses the potential adverse effects of new compounds on living organisms, helping to determine their safety profiles before progressing to clinical trials. Ensuring the safety of potential drug candidates is a top priority for pharmaceutical and biotechnology companies. Toxicology studies provide critical data on the potential risks and hazards associated with new compounds, and this segment is projected to experience the highest compound annual growth rate (CAGR) from 2023 to 2030.

Model Type Insight:

In 2022, the Preclinical CRO market was dominated by the PDO (Patient-Derived Organoid) segment and is predicted to continue expanding over the coming years. PDO models are three-dimensional cell cultures derived from patient tissues, closely mimicking the complex architecture and functionality of organs compared to traditional cell lines. This high level of patient relevance makes PDOs valuable tools for studying disease mechanisms, drug responses, and personalized treatments. The move toward personalized medicine requires models that replicate patient-specific responses to treatments, and PDO models enable researchers to study how individual patients' cells respond to different therapies, facilitating the development of tailored treatment strategies.

End-Use Industry Insights:

In 2022, the Preclinical CRO market was dominated by biopharmaceutical companies, and this dominance is predicted to continue expanding over the coming years. Biopharmaceutical companies often prioritize their core competencies, such as research, innovation, and commercialization. Outsourcing certain functions, including preclinical and clinical research, to CROs allows these companies to concentrate their internal resources on critical areas. CROs offer a cost-effective solution for biopharmaceutical companies, eliminating the need for heavy investments in infrastructure, equipment, personnel, and operational costs associated with in-house research activities. CROs provide specialized expertise and experience in conducting various aspects of drug development, including preclinical testing, clinical trials, data analysis, regulatory submissions, and more. Biopharmaceutical companies benefit from accessing these specialized skills without maintaining an extensive in-house team.

Regional Insights:

The Asia Pacific region has established itself as the leader in the Global Preclinical CRO Market. The region is home to established CROs focused on early drug discovery, such as Charles River Laboratories or LabCorp. The United States also plays a significant role in the preclinical trial outsourcing market, as many biopharma companies prefer to outsource their preclinical trials to U.S.-based CROs to take advantage of the FDA-approved Investigational New Drug application process.

Key Market Players

• Eurofins Scientific SE
• PRA Health Sciences, Inc.
• Wuxi AppTec, Medpace, Inc.
• Charles River Laboratories International, Inc.
• PPD (Thermo Fisher Scientific, Inc.)
• SGA SA
• Intertek Group Plc (IGP)
• LABCORP Inc
• Crown Bioscience Inc

Report Scope:

In this report, the Global Preclinical CRO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Preclinical CRO Market, By Service:

• Bioanalysis and DMPK studies
• Toxicology Testing
• Compound Management
• Chemistry
• Safety Pharmacology
• Others

Preclinical CRO Market, By Model:

• Patient Derived Organoid (PDO) Model
• Patient derived xenograft model

Preclinical CRO Market, By End-User:

• Biopharmaceutical Companies
• Government and Academic Institutes
• Medical Device Companies

Global Preclinical CRO Market, By region:

• North America
• United States
• Canada
• Mexico
• Asia-Pacific
• China
• India
• South Korea
• Australia
• Japan
• Europe
• Germany
• France
• United Kingdom
• Spain
• Italy
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

• Company Profiles: Detailed analysis of the major companies present in the Global Preclinical CRO Market.

Available Customizations:

• Global Preclinical CRO Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Preclinical CRO Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Bioanalysis and DMPK Studies, Toxicology Testing, Compound Management, Chemistry, Safety Pharmacology, Others)
  • 5.2.2. By Model Type (Patient Derived Organoid (PDO) Model, Patient derived xenograft model)
  • 5.2.3. By End-Use Industry (Biopharmaceutical Companies, Government and Academic Institutes, Medical Device Companies)
  • 5.2.4. By Company (2022)
  • 5.2.5. By Region
• 5.3. Market Map

6. North America Preclinical CRO Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service
  • 6.2.2. By Model Type
  • 6.2.3. By End-Use Industry
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Preclinical CRO Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Service
      • 6.3.1.2.2. By Model Type
      • 6.3.1.2.3. By End-Use Industry
  • 6.3.2. Mexico Preclinical CRO Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Service
      • 6.3.2.2.2. By Model Type
      • 6.3.2.2.3. By End-Use Industry
  • 6.3.3. Canada Preclinical CRO Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Service
      • 6.3.3.2.2. By Model Type
      • 6.3.3.2.3. By End-Use Industry

7. Europe Preclinical CRO Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service
  • 7.2.2. By Model Type
  • 7.2.3. By End-Use Industry
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Preclinical CRO Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Service
      • 7.3.1.2.2. By Model Type
      • 7.3.1.2.3. By End-Use Industry
  • 7.3.2. Germany Preclinical CRO Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Service
      • 7.3.2.2.2. By Model Type
      • 7.3.2.2.3. By End-Use Industry
  • 7.3.3. United Kingdom Preclinical CRO Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Service
      • 7.3.3.2.2. By Model Type
      • 7.3.3.2.3. By End-Use Industry
  • 7.3.4. Italy Preclinical CRO Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Service
      • 7.3.4.2.2. By Model Type
      • 7.3.4.2.3. By End-Use Industry
  • 7.3.5. Spain Preclinical CRO Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Service
      • 7.3.5.2.2. By Model Type
      • 7.3.5.2.3. By End-Use Industry

8. Asia-Pacific Preclinical CRO Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service
  • 8.2.2. By Model Type
  • 8.2.3. By End-Use Industry
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Preclinical CRO Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Service
      • 8.3.1.2.2. By Model Type
      • 8.3.1.2.3. By End-Use Industry
  • 8.3.2. India Preclinical CRO Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Service
      • 8.3.2.2.2. By Model Type
      • 8.3.2.2.3. By End-Use Industry
  • 8.3.3. South Korea Preclinical CRO Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Service
      • 8.3.3.2.2. By Model Type
      • 8.3.3.2.3. By End-Use Industry
  • 8.3.4. Japan Preclinical CRO Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Service
      • 8.3.4.2.2. By Model Type
      • 8.3.4.2.3. By End-Use Industry
  • 8.3.5. Australia Preclinical CRO Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Service
      • 8.3.5.2.2. By Model Type
      • 8.3.5.2.3. By End-Use Industry

9. South America Preclinical CRO Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service
  • 9.2.2. By Model Type
  • 9.2.3. By End-Use Industry
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Preclinical CRO Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Service
      • 9.3.1.2.2. By Model Type
      • 9.3.1.2.3. By End-Use Industry
  • 9.3.2. Argentina Preclinical CRO Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Service
      • 9.3.2.2.2. By Model Type
      • 9.3.2.2.3. By End-Use Industry
  • 9.3.3. Colombia Preclinical CRO Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Service
      • 9.3.3.2.2. By Model Type
      • 9.3.3.2.3. By End-Use Industry

10. Middle East and Africa Preclinical CRO Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service
  • 10.2.2. By Model Type
  • 10.2.3. By End-Use Industry
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Preclinical CRO Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Service
      • 10.3.1.2.2. By Model Type
      • 10.3.1.2.3. By End-Use Industry
  • 10.3.2. Saudi Arabia Preclinical CRO Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Service
      • 10.3.2.2.2. By Model Type
      • 10.3.2.2.3. By End-Use Industry
  • 10.3.3. UAE Preclinical CRO Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Service
      • 10.3.3.2.2. By Model Type
      • 10.3.3.2.3. By End-Use Industry

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Product Launches
• 12.3. Mergers & Acquisitions

13. PESTLE Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. Competitive Landscape

• 15.1. Business Overview
• 15.2. Company Snapshot
• 15.3. Products & Services
• 15.4. Financials (In case of listed companies)
• 15.5. Recent Developments
• 15.6. SWOT Analysis
  • 15.6.1. Eurofins Scientific SE
  • 15.6.2. PRA Health Sciences, Inc.
  • 15.6.3. Wuxi AppTec
  • 15.6.4. Medpace, Inc.
  • 15.6.5. Charles River Laboratories International, Inc.
  • 15.6.6. PPD (Thermo Fisher Scientific, Inc.)
  • 15.6.7. SGA SA
  • 15.6.8. Intertek Group Plc (IGP)
  • 15.6.9. LABCORP Inc
  • 15.6.10. Crown Bioscience Inc

16. Strategic Recommendations