Preclinical CRO Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service (Bioanalysis and DMPK studies, Toxicology Testing, Compound Management, Chemistry, Safety Pharmacology, Others), By Model Type (Patient Derived Organoid (PDO) Model, Patient derived xenograft model), By End-Use Industry (Biopharmaceutical Companies, Government and Academic Institutes, Medical Device Companies), By Region and Competition, 2020-2030F

Market Overview

Global Preclinical CRO Market has valued at USD 6.24 billion in 2024 and is expected to reach USD 10.15 billion by 2030 with a CAGR of 8.45% during the forecast period. Preclinical CRO are colored substances that are applied in the form of an aqueous solution on various substrates. They serve as colorants in various industrial applications such as food processing, printing inks, wood stain, textile processing, and others. Preclinical CRO exhibit high selective absorptivity for liquids and substrates, making them superior to other color-imparting materials like pigments. Their exceptional absorption characteristics facilitate the modification of their physical and structural properties when applied on substrates. However, Preclinical CRO have low resistance to light and a relatively shorter shelf life. As a result, they are primarily used in surface coating, food, and printing applications that demand high levels of transparency in the manufacturing of finished products. Preclinical CRO can be categorized based on their solubility in a specific medium or substrate, including basic Preclinical CRO, fat-soluble Preclinical CRO, and metal complex Preclinical CRO. 

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 Key Market Drivers

Increasing Outsourcing Trends Drives the Market Growth

The increasing outsourcing trend is a significant driver behind the growth of the Global Preclinical Contract Research Organization (CRO) market. This trend involves pharmaceutical and biotechnology companies opting to delegate their preclinical research and development activities to specialized CROs rather than conducting them in-house. Outsourcing preclinical research allows pharmaceutical and biotechnology companies to save on various costs associated with maintaining in-house facilities, equipment, and personnel. CROs often have established infrastructure and expertise, enabling efficient and cost-effective execution of preclinical studies. By outsourcing preclinical research, companies can allocate their internal resources to core activities such as clinical trials, regulatory affairs, and commercialization. This streamlined focus enhances overall operational efficiency. Preclinical CROs are staffed with experts in various scientific disciplines, offering specialized knowledge and experience. Companies can tap into this expertise without having to build and maintain an extensive in-house team. CROs invest in state-of-the-art technologies and equipment for preclinical research. By outsourcing, companies gain access to these advanced tools without the need for significant capital investments. Outsourcing provides companies with flexibility to scale their preclinical activities up or down based on project needs. This adaptability is crucial for navigating the dynamic nature of drug development. Preclinical CROs often have established processes and workflows, which can lead to faster study execution and reduced development timelines. This acceleration is crucial for getting drugs to market more quickly.

Rising Number of Drugs In Preclinical Phases

The rising number of drugs in preclinical phases contributes to the growth of the Global Preclinical Contract Research Organization (CRO) market in several ways. 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 increases. As more drug candidates enter preclinical phases, there is a greater need for conducting various preclinical studies, such as safety assessments, efficacy testing, and pharmacokinetics studies. CROs offer the capacity and specialized expertise to handle multiple projects simultaneously. Different drug candidates require different types of preclinical testing, ranging from small molecules to biologics and novel therapies. CROs often possess a diverse range of expertise to accommodate these varying needs, leading to increased outsourcing. Companies may not have the internal resources, equipment, or facilities required to conduct multiple preclinical studies concurrently. Outsourcing to CROs enables efficient resource allocation and optimization. The increasing number of drug candidates underscores the need for streamlined and accelerated preclinical development processes. CROs' established workflows and expertise can help expedite studies, enabling quicker progression to clinical phases. Managing many preclinical programs can be challenging for companies. CROs offer specialized risk management strategies and tools to navigate the complexities of preclinical research, thereby reducing the potential for costly failures. According to the World Health Organization (WHO), approximately 5,596 phase 0 trials were registered in 2020, marking a 90.6% increase compared to the previous year.

Rising R&D Costs Drives the Market Growth

The rising costs of research and development (R&D) in the pharmaceutical and biotechnology industries are a significant driver behind the growth of the Global Preclinical Contract Research Organization (CRO) market. As R&D costs continue to escalate, companies are increasingly turning to preclinical CROs to optimize their drug development processes, improve cost-effectiveness, and enhance overall efficiency. The high costs associated with in-house preclinical research facilities, 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 expenses. By outsourcing preclinical studies to CROs, companies can leverage the CROs' established infrastructure, equipment, and experienced personnel, thereby minimizing the need for heavy capital investments and ongoing operational costs. Outsourcing preclinical work to CROs can help 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 expensive 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 can optimize study design, execution, and data interpretation. The complexity of regulatory requirements and the need for adherence to quality standards can contribute to R&D costs. 

Preclinical CROs are well-versed in navigating these regulatory landscapes, ensuring studies are conducted in compliance with guidelines. Efficient preclinical research conducted by CROs can accelerate 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. Companies can choose specific services based on their needs, optimizing resource allocation.  In January 2024, NIH institutions, in collaboration with the National Center for Advancing Translational Sciences (NCATS), developed a comprehensive preclinical research toolbox. This collection includes resources such as the Assay Guidance Manual, PubChem, and BioPlanet, designed to streamline drug discovery and translational research. The initiative aims to address gaps in preclinical research and foster the development of innovative therapies.

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Key Market Challenges

Regulatory Compliance and Quality Assurance

Regulatory compliance and quality assurance pose 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. Preclinical CROs working with clients from different geographic locations need 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. CROs must maintain a thorough understanding of evolving regulations to minimize the risk of non-compliance.

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. Interpreting this data requires a deep understanding of relevant scientific principles, statistical analyses, and biological context to draw accurate conclusions. Biological systems are inherently variable. CROs must account for biological variability in their data interpretation to differentiate true effects from background noise and to identify meaningful trends. Modern technologies generate vast amounts of data in preclinical studies. 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 scenarios can have serious consequences for drug development decisions.

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. If the client's goals and requirements are not clearly understood, it can result in deliverables that do not meet expectations. In an increasingly globalized industry, CROs and clients may come from different countries and cultures. Language barriers and cultural differences can hinder effective communication and collaboration. Preclinical studies often involve complex experimental designs and methodologies. Communicating these intricacies to clients and ensuring they understand 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. To address these challenges, CROs must prioritize clear, transparent, and proactive communication practices. They should establish robust communication channels, provide regular updates, and ensure that clients are well-informed about project progress.

Key Market Trends

Increase in the number of Virtual Trials

The increase in the number of virtual trials is a significant trend in the Global Contract Research Organization (CRO) market, transforming how clinical research is conducted. Virtual trials, also known as decentralized clinical trials, leverage technology to remotely collect data from participants, reducing the need for physical site visits. Virtual trials allow patients to participate from the comfort of their homes, increasing patient recruitment and retention rates. CROs are adapting their strategies to engage patients virtually through telehealth, wearables, and mobile apps. CROs are partnering with technology providers to integrate digital tools for remote data collection, patient monitoring, electronic informed consent, and telemedicine consultations. This requires expertise in selecting, implementing, and managing these technologies. CROs are implementing robust data management solutions to handle the large volumes of remote patient-generated data. This includes ensuring data integrity, security, and compliance with regulatory standards. Virtual trials reduce the dependence on physical trial sites, allowing CROs to conduct trials without traditional brick-and-mortar sites. This streamlines operations, enhances efficiency, and reduces costs associated with site infrastructure. Virtual trials enable access to a more diverse patient population, including those who may have been excluded due to geographic constraints. This expands the potential pool of participants and enhances the generalizability of trial results.

Segmental Insights

End User Insights

Based on the End User, Biopharmaceutical companies held the largest market share in the Preclinical CRO Market, driven by the increasing demand for drug discovery, development, and regulatory compliance support. With the rising prevalence of chronic diseases, rare disorders, and infectious diseases, biopharmaceutical firms are heavily investing in innovative therapies, including biologics, gene therapies, and personalized medicine. The growing complexity of drug development processes has led to an increased reliance on preclinical CROs to provide specialized expertise, advanced technologies, and cost-effective solutions. Additionally, stringent regulatory requirements and the need for efficient preclinical testing have further strengthened the role of CRO partnerships in streamlining research workflows. The integration of Patient-Derived Organoid (PDO) Models, AI-driven drug discovery, and high-throughput screening has also enhanced preclinical studies. With a strong focus on expediting drug pipelines and reducing time-to-market, biopharmaceutical companies will continue to dominate the Preclinical CRO Market, ensuring steady growth in the sector.

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Regional Insights

Based on the region, North America held the largest market share in the Preclinical CRO Market, driven by the strong presence of leading biopharmaceutical companies, advanced research infrastructure, and a highly developed regulatory framework. The region benefits from significant R&D investments, government funding, and strategic collaborations aimed at accelerating drug discovery and development. The United States dominates the market, with a robust ecosystem of contract research organizations (CROs), pharmaceutical firms, and academic research institutions actively engaged in preclinical testing of novel therapeutics, including biologics, gene therapies, and small molecules. Additionally, technological advancements in AI-driven drug discovery, Patient-Derived Organoid (PDO) Models, and high-throughput screening have further strengthened North America's leadership position. With the increasing demand for outsourced preclinical services, a well-established regulatory environment, and rising clinical trial activities, North America is expected to maintain its market dominance, fueling continued growth in the Preclinical CRO sector. For instance, In September 2024, PharmaLegacy expanded its preclinical capabilities by acquiring BTS Research, a renowned preclinical CRO. This strategic move strengthens PharmaLegacy’s drug research and discovery efforts by extending its laboratory operations into North America. The acquisition aims to meet the rising demand for preclinical research by offering clients integrated solutions. It reflects PharmaLegacy’s commitment to global expansion and advancing innovation in life sciences.

Recent Developments

• In March 2024, Veeda Clinical Research Limited acquired Heads, a European CRO specializing in cancer clinical trials. This strategic acquisition strengthens Veeda's global presence in oncology research, expanding its service portfolio and enhancing its capacity to conduct complex cancer studies. The move underscores Veeda’s commitment to delivering comprehensive clinical research solutions.
• In September 2024, An article titled Navigating the Preclinical CRO Outsourcing Process was published, offering insights into selecting the right CRO partner. The piece emphasizes key factors such as regulatory compliance, effective communication, and capability alignment. It highlights the importance of understanding project-specific needs and fostering collaboration to achieve successful preclinical study outcomes.
• In April 2024, LabCorp expanded its precision oncology services to enhance cancer research and patient treatment on a global scale. This expansion focuses on leveraging advanced laboratory, diagnostic, and scientific technologies to drive innovation in oncology. By investing in state-of-the-art equipment, LabCorp aims to support the biotechnology, clinical research, and pharmaceutical industries, ultimately improving cancer therapies and patient outcomes worldwide.
• In March 2023, Apollo™ is a cloud-based, industry-leading platform for drug developers to save time and improve the client experience. Today, Charles River Laboratories International, LLC (CRL) announced the launch of Apollo™, the industry’s first cloud-based, secure platform for drug development. Apollo’s suite of features includes Access to study data Study milestones Documentation Cost estimates Program planning tools Current capabilities include: Safety assessment Toxicology studies.
• In November 2022, AppTec, a leading global provider of research, development and manufacturing services to the pharmaceutical, biotechnology and medical device industries for the advancement of discoveries and the delivery of innovative treatments to patients, today announced that it has been named a recipient of Frost & Sullivan’s 2022 Global Contract Research and Development and Manufacturing Company of the Year Awards. Frost & Sullivan is a global research and consulting firm that works with customers to help them drive growth. This is the 6th consecutive year that AppTec has received the award for leadership and innovative services.
• In February 2021, ICON Acquires PRA Health Sciences to Create a Global Leader in Healthcare Intelligence & Clinical Research. The consolidation combines two organizations that have a long-standing track record of strong growth and performance and are well-positioned to capitalize on this strength by leveraging the exceptional talent of both organizations to create greater value for patients, clients, staff and shareholders. The combination will meet the increasing demand for decentralised and hybrid trial services from a unique mix of mobile and connected healthcare platforms, a global network of sites, home health services, and wearables knowledge.

Key Market Players

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

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:

o   Bioanalysis and DMPK studies

o   Toxicology Testing

o   Compound Management

o   Chemistry

o   Safety Pharmacology

o   Others

• Preclinical CRO Market, By Model:

o   Patient Derived Organoid (PDO) Model

o   Patient derived xenograft model

• Preclinical CRO Market, By End User:

o   Biopharmaceutical Companies

o   Government and Academic Institutes

o   Medical Device Companies

• Global Preclinical CRO Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   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, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

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