Preclinical CRO Market Size, Share & Trends Analysis Report By Service (Toxicology Testing, Bioanalysis & DMPK Studies), By End Use (Biopharmaceutical Companies, Government & Academic Institutes), And Segment Forecasts, 2023 - 2030

Report Overview

The global preclinical CRO market size was valued at USD 5.28 billion in 2022 and is expected to grow at a CAGR of 7.9% from 2023 to 2030. Increased R&D budget for drug development is leading to rising demand for preclinical contract research organization (CRO) services, thus boosting the market growth during the forecast period. The surge in the number of preclinical trials involving large molecules and the growing need to curb R&D expense is expected to contribute to the growing demand for quality preclinical CRO. The ongoing COVID-19 pandemic initially disrupted preclinical research projects, especially during the first quarter of 2020. Nevertheless, lifesaving drugs are developing and are brought to market swiftly.

Over the years, there has been a significant change in the process of drug approval by the Food and Drug Administration (FDA). Recently, the 21st Century Cures bill was passed in the U.S., which fastened the approval process for the launch of breakthrough drugs and medical devices. These changes in approval processes are expected to drive innovation and are also anticipated to increase demand for preclinical services, thereby contributing to market growth.

With regards to the COVID-19 vaccine itself, preclinical studies have been performed at an exponential speed, indicative of the overwhelming role of CROs. Increasing spending on CRO services is expected to boost the market growth significantly during the forecast period. The growing demand for drugs for COVID-19 is further contributing to the market growth. Different organizations across the globe had made significant funding for developing therapeutics and medical devices for COVID-19. For instance, in April 2021, the WHO in the R&D Blueprint of COVID-19 reported that over USD 1,618.5 million was funded for COVID-19 vaccine research. Such initiatives are likely to profit from the market growth.

Service Insights

The toxicology testing segment accounted for the largest revenue share of 25.4% of the global preclinical CRO market in 2022, owing to a rise in outsourcing of noncore preclinical CRO studies and high adoption of toxicology tests. Toxicology is one of the key services, which is being outsourced to CROs owing to the improved capabilities of CROs to conduct toxicology tests. The growing rate of outsourcing noncore preclinical studies to the CROs and the growing capabilities of CROs to offer additional value-added services is expected to propel the growth of this segment during the forecast period.

The bioanalysis and DMPK studies segment is expected to register the fastest CAGR of 8.4% during the forecast period. The segment is expected to witness lucrative growth on account of a rise in the demand for pharmacokinetic services to support toxicology tests for IND-enabling studies. In addition, bioanalysis and DMPK studies are vital in the entire drug development process. They are performed in every stage of the drug development process and are not confined to the preclinical phase. These factors are further contributing to the segment growth.

Model Type Insights

The Patient Derived Organoid (PDO) Model segment held the largest share of 80.5% in 2022. The growing impact of the patient-derived organoid (PDO) model is due to the use of direct derived cells and tissues from the patient. This helps in personalized healthcare and the specimens can be cryopreserved. For these reasons, they are becoming an essential part of preclinical studies as they help in quicker diagnosis and prognosis of malignancy.

The Patient derived xenograft (PDX) model market has been analyzed to grow at a CAGR of 7.5% during the forecast period. This is attributed to the growing number of CROs maintaining an in-house inventory of immunodeficient mice with patient-derived xenografts (PDXs). Furthermore, this type of analysis allows for researchers to co-relate the laboratory research with humans, owing to the maintenance of the original genetic makeup of the tumor cells. Also, the responses observed in clinical trials among patients have been found to correlate with the responses in these patient-derived xenografts, which in turn allows for a better safety profile and thus expedites the approval of New Drug Investigation (NDA).

End-use Insights

The biopharmaceutical companies segment is expected to hold the largest market share of 80.9% in 2022. The increasing trend of outsourcing end-to-end services among biopharmaceutical companies, especially amongst the small- and mid-size companies that lack sufficient expertise in the preclinical phase of drug development, is expected to boost the demand for preclinical CRO services in the future.

The government and academic institutes segment is estimated to register the fastest growth of 8.2% during the forecast period. Academia and government bodies play a crucial role in the preclinical phase of discovery and development. In addition, an increasing number of academic organizations and government bodies outsourcing preclinical services to CROs will boost the segment growth. Academic institutes are one of the major sources of revenue for big CROs, such as Charles River Laboratories and LabCorp.

Regional Insights

North America accounts for the largest share of 47.4% in 2022 owing to the presence of established CROs specializing in early drug discovery, such as Charles River Laboratories and LabCorp. The U.S. is the biggest market for preclinical trial outsourcing, as several biopharmaceutical companies prefer outsourcing their preclinical trials to CROs based in the U.S., to seek benefit from the Investigational New Drug (IND) application, approved by the FDA.

Asia Pacific is also anticipated to grow with the fastest rate of 10.7% during the forecast period. The changing business model of MNC outsourcing and the rising cost of R&D is expected to increase preclinical outsourcing in the Asia Pacific, owing to the cost efficiency offered by CROs in countries such as India and China. Established companies located in Western Europe and the U.S. pursue analytical services, site research development, and clinical activities in the Asia Pacific region in order to reduce the cost associated with research.

Key Companies & Market Share Insights

The market players in the Preclinical CRO industry are competitive and are constantly implementing strategies for improving their share in the market. Various strategies adopted by the players are acquisitions, new trial launches, and collaborations, among others. For instance, in December 2021, Labcorp acquired Toxikon Corporation which is a contract research organization. This acquisition will help Labcorp with the development and expansion of CRO services in pharmaceuticals and medical devices. Similarly, in August 2021, Eurofins Scientific partnered with Fusion Antibodies; the partnership is to provide the best antibodies for a wide range of diseases. The agreement for this partnership is for two years and in this, advanced technology will be used. Some prominent players in the global Preclinical CRO market include:

• Eurofins Scientific

• 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

• Crown Bioscience

Preclinical CRO Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global Preclinical CRO market report on the basis of service, model type, end-use, and region:

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • 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 Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Patient Derived Organoid (PDO) Model

  • Patient derived xenograft model

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Biopharmaceutical Companies

  • Government and Academic Institutes

  • Medical Device Companies

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  •  Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Singapore

    • Philippines

    • Indonesia

    • Malaysia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait