Growth in Outsourcing and Enhanced Pre-Clinical CRO Capabilities Drive Market Expansion

The global pre-clinical Contract Research Organization (CRO) market size was USD 5.72 Billion in 2022 and is expected to register a revenue CAGR of 8.3% during the forecast period. The pre-clinical Contract Research Organization (CRO) market is experiencing strong growth, propelled by a shift towards outsourcing non-core functions in the pharmaceutical and biopharmaceutical sectors, alongside enhanced services offered by CROs. The demand for pre-clinical CRO services is largely driven by the increased number of drugs entering the pre-clinical phase, economies of production, and a rising focus on cost efficiencies. These factors have created a mutually beneficial environment for both contractors and clients. Additionally, the rise in research and development (R&D) budgets is playing a critical role in supporting this growth.

As the demand for R&D services grows, pre-clinical CROs are increasingly relied upon to support the safety and reliability testing of new pharmaceuticals. These services include in vitro and in vivo lab testing, which are critical steps before a drug can be used in human trials. With a specialized focus on testing and safety, CROs have become indispensable partners in the pharmaceutical industry's drug development pipeline. This focus on outsourcing R&D services also allows pharmaceutical companies to streamline operations and focus on core business activities.

The outsourcing of non-core functions is expected to remain a significant driver for market growth, particularly as many pharmaceutical and medical device companies are turning to CROs for services such as clinical trial management, drug testing, and compound synthesis. CROs bring expert guidance to the drug development process, helping to accelerate the journey of drugs from conception to market, while also reducing overall costs. This trend is especially beneficial for smaller companies, which often face resource limitations and thus increasingly rely on CROs for end-to-end drug development services.

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Despite its growth, the pre-clinical CRO market does face some challenges. Scarcity of skilled labor and high labor costs are prominent issues, as are strict regulatory requirements that demand adherence to Good Laboratory Practice (GLP) standards. Furthermore, competition within the market remains intense, with both large multinational CROs and specialized smaller firms vying for market share.

In terms of service segments, the pre-clinical CRO market is diversified, with segments such as bioanalysis, drug metabolism and pharmacokinetics (DMPK) studies, toxicology testing, and safety pharmacology. Among these, toxicology testing has emerged as a dominant segment due to the increasing demand for outsourcing these services. This trend is supported by the advanced toxicology capabilities of CROs, which offer specialized testing services that align with the needs of pharmaceutical companies. Companies like Labcorp have expanded their toxicology services through acquisitions, such as the purchase of Toxikon Corporation in 2021, to meet growing market demands.

Another rapidly growing segment is bioanalysis and DMPK studies, which are essential for drug testing, particularly in the early stages of development. Demand for these services has been on the rise, driven by the need for accurate pharmacokinetic data in investigational drug studies. Recent expansions, such as Frontage Laboratories' acquisition of Accelera's bioanalytical and DMPK divisions in Italy, reflect this trend and are helping to support CRO capabilities across Europe.

Pre-clinical CRO services are also categorized by model types, notably patient-derived organoid models and patient-derived xenograft (PDX) models. Patient-derived organoid models have become highly popular due to their ability to use patient-derived cells, which supports precision medicine by enabling the preservation of patient specimens for future testing. This model type plays a key role in personalized healthcare by allowing researchers to better understand and treat specific diseases, particularly in oncology. The PDX model segment, which uses patient tumors to create more accurate models for drug testing, is also experiencing significant growth, as it helps researchers capture patient-specific responses and improve the accuracy of drug development.

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In terms of end-users, biopharmaceutical companies currently dominate the market due to their high demand for outsourced pre-clinical services, especially smaller firms that benefit from the expertise and cost-efficiency provided by CROs. Government and academic institutions also play a major role, contributing significantly to market demand by outsourcing pre-clinical research activities and investing in drug and device development. Increased collaboration between CROs and academic institutions, alongside rising government investments, is expected to continue driving demand within this segment.

The future of the pre-clinical CRO market looks promising, with continued growth expected as the demand for outsourced R&D services rises and CROs expand their capabilities to meet evolving industry needs.

Pre-clinical CRO Top Companies and Competitive Landscape

The global pre-clinical Contract Research Organization (CRO) market is fragmented with many large and medium-sized players accounting for majority of market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective pre-clinical CRO solutions.

Some major players included in the global pre-clinical Contract Research Organization (CRO) market report are:

Crown Bioscience.

Thermo Fisher Scientific Inc.

ICON plc

SGA

Intertek Group plc

Charles River Laboratories

Medpace

Eurofins Scientific

WuXi AppTec

IQVIA Inc

Parexel International (MA) Corporation

Syneos Health

PSI

Labcorp Drug Development

Olon Ricerca

Noble Lifesciences

GenScript ProBio

InnoVentiv

Altasciences

Pre-clinical CRO Latest Industry Updates

In January 2024, Altasciences, an integrated CRO/CDMO that provides pharmaceutical and biotechnology companies with a comprehensive solution for early-stage drug development, from lead candidate selection to clinical proof of concept, announced the successful acquisition of Sinclair Research, a pre-clinical CRO in the Midwest. The new center will provide access to Altasciences' pre-clinical services across the United States, complementing current offices on the East and West Coasts.

In March 2021, NAMSA announced the purchase of Minneapolis-based American Pre-clinical Services (APS), a full-service pre-clinical CRO. With the addition of APS's portfolio of services, NAMSA will strengthen its already robust pre-clinical solutions by providing Sponsors with a broader range of laboratory models and analysis tools, including innovative surgical instrumentation and several cutting-edge catheterization labs, imaging capabilities, and surgical suites.

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Pre-clinical CRO Market Segmentation Analysis

For the purpose of this report, Emergen Research has segmented the global pre-clinical Contract Research Organization (CRO) market on the business function, organization size, deployment mode, and region:

Service Type Outlook (Revenue, USD Billion; 2019-2032)

Bioanalysis and DMPK studies

In vitro ADME

In-vivo PK

Toxicology Testing

GLP

Non-GLP

Compound Management

Process R&D

Custom Synthesis

Others

Chemistry

Medicinal Chemistry

Computation Chemistry

Safety Pharmacology

Others

Model Outlook (Revenue, USD Billion; 2019-2032)

Patient derived organoid models

Patient Derived Xenograft (PDX) Models

End use Outlook (Revenue, USD Billion; 2019-2032)

Biopharmaceutical Companies

Government and Academic Institutes

Medical Device Companies

Regional Outlook (Revenue, USD Billion; 2019-2032)

North America

U.S.

Canada

Europe

Germany

France

U.K.

Italy

Spain

Benelux

Russia

Rest of Europe

Asia Pacific

China

Japan

South Korea

India

ASEAN Countries

Oceania

Rest of APAC

Latin America

Brazil

Mexico

Rest of LATAM

Middle East & Africa

GCC Countries

Israel

Turkey

South Africa

Rest of MEA

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