GVR Report cover Preclinical CRO Market Size, Share & Trends Report

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, 2021 - 2028

  • Published Date: Sep, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-2-68038-035-4
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 240

Report Overview

The global preclinical CRO market size was valued at USD 4.5 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 8.1% from 2021 to 2028. 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 ongoing COVID-19 pandemic has disrupted preclinical research projects, especially during the first quarter of 2020. Nevertheless, lifesaving drugs are to be developed and brought to market swiftly. Preclinical CROs are playing a vital role in bringing the concept to the commercialization stage for various biopharmaceutical organizations.

U.S. preclinical CRO market size, by service, 2016 - 2028 (USD Million)

With regards to the COVID-19 vaccine itself, the 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. As per a survey carried out by Servier Research Institute in 2017, around 50% of failure in the preclinical phase is due to toxicology testing, which is expected to propel the demand for preclinical CRO services in the coming years. Apart from this, recent regulatory changes in Europe relating to preclinical CRO services are also anticipated to increase the demand for toxicology testing, thus contributing to the regional market growth.

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.


COVID19 impact: Bioanalysis and DMPK studies witnessed the fastest growth rate of 8.6% in 2020

Pandemic Impact

Post COVID Outlook

As a wider industry, there were effects on the drug research and development pipeline, with companies having had to delay or even stop programs. This applies to the larger pharma companies, and also the smaller, virtual companies where funding may be an issue without clinical data to support the next steps.

Accelerated paths for antivirals, immunomodulators, anticoagulants, and other agents have been developed and can serve as ‘‘roadmaps’’ to support the prioritization of compounds for clinical testing.

Researchers with Cleveland Clinic’s Global Center for Pathogen Research & Human Health have developed a promising new COVID-19 vaccine candidate that uses nanotechnology and has shown strong efficacy in preclinical disease models.

The debate between efficiency and resilience will be paramount as companies think about R&D-for example, rebalancing research work by contract research organizations (CROs) across countries or reevaluating clinical supply chain diversification to minimize vulnerabilities, even if it comes at a greater cost.

As of 8 April 2020, the global COVID-19 vaccine R&D landscape includes 115 vaccine candidates, of which 78 are confirmed as active and 37 are unconfirmed. Of the 78 confirmed active projects, 73 are currently at exploratory or preclinical stages.

Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.


There is a lack of standardization as the preclinical CROs do not comply with international regulatory requirements, such as Good Laboratory Practice (GLP) standards, which may lead to several quality issues. Therefore, biopharmaceutical and medical device companies generally outsource only low-end functions of preclinical trials to CROs, whereas high-end tests, such as genotoxicity, are generally performed in-house. However, improvement in quality standards adopted by the CROs is expected to overcome the challenge of standardization, as outsourced vendors are currently trying to comply with the international standards set by regulatory authorities, such as the U.S. FDA and the European Medicines Agency (EMA).

Service Insights

Based on service, the market is categorized into bioanalysis and DMPK studies, toxicology testing, compound management, chemistry, safety pharmacology, and others. The toxicology testing segment accounted for the largest revenue share of more than 22% of the global market in 2020 owing to a rise in outsourcing of noncore preclinical CRO studies and high adoption in toxicology tests.

The bioanalysis and DMPK studies segment is expected to register the fastest CAGR of 8.4% over 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.

End-use Type Insights

The biopharmaceutical companies segment is expected to hold the largest market share of more than 80% in 2020. 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.

Global preclinical CRO market share, by end use, 2020 (%)

The government and academic institutes segment is estimated to register the fastest growth over 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 Insight

North America dominated the global market in 2020 accounting for the largest revenue share of more than 47%. The region is expected to remain dominant throughout the forecast period owing to the increasing R&D expenditure and high adoption of new technology. Increased availability of skilled human resources and low cost of devices are also the factors anticipated to drive the market growth over the forecast period.

The demand for preclinical CRO services is also rising owing to the increasing prevalence of chronic diseases in the region. Asia Pacific is expected to register the fastest CAGR over the forecast period due to the cost-efficiency of preclinical CROs in countries, such as India and China. Establishment of several CROs across the Asia Pacific region has also strengthened the preclinical trial outsourcing market in this region. For instance, Singapore has several CROs to support the growing needs of pharmaceutical and biopharmaceutical companies.

Key Companies & Market Share Insights

One of the key parameters boosting the competition in the market is the rapid adoption of advanced healthcare technologies for improved healthcare. Major players are undertaking mergers and acquisitions along with new product launches to retain market share and diversify the product portfolio. During the ongoing coronavirus pandemic, the key market players are working to provide various support and services to tackle the adverse conditions. For instance, in September 2020, Parexel collaborated with Innoplexus and launched the COVID-19 Clearinghouse, which is a comprehensive online resource for researchers, patients, and clinical trial sponsors to directly access datasets, publications, and links to current news and active global clinical trials related to COVID-19. Some of the key companies in the global preclinical CRO market are:

  • Envigo Corp.

  • MPI Research

  • Eurofins Scientific

  • PRA Health Sciences, Inc.

  • Wuxi AppTec

  • Medpace, Inc.

  • Pharmaceutical Product Development (PPD), LLC

  • PARAXEL International Corp.

  • ICON Plc

  • Laboratory Corporation of America, Inc.

Preclinical CRO Market Report Scope

Report Attribute


Market Size value in 2021

USD 4.9 billion

Revenue forecast in 2028

USD 8.4 billion

Growth rate

CAGR of 8.1% from 2021 to 2028

Base year for estimation


Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD million/billion and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Service, end use, and region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; U.K.; Germany; France; Italy; Spain; China; India; Japan; Australia; South Korea; Mexico; Brazil; Argentina; South Africa; Saudi Arabia; UAE

Key companies profiled

Envigo Corp.; MPI Research; Eurofins Scientific; PRA Health Sciences, Inc.; Wuxi AppTec; Medpace, Inc.; Pharmaceutical Product Development (PPD), LLC; PARAXEL International Corp.; ICON Plc; Laboratory Corporation of America, Inc.

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope

Pricing and purchase options

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global preclinical CRO market report on the basis of service, application, and region:

  • Service Outlook (Revenue, USD Million, 2016 - 2028)

    • 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

  • End-use Outlook (Revenue, USD Million, 2016 - 2028)

    • Biopharmaceutical Companies

    • Government and Academic Institutes

    • Medical Device Companies

  • Regional Outlook (Revenue, USD Million, 2016 - 2028)

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

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