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

Report Overview

The global preclinical CRO market size was valued at USD 4.5 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.1% from 2021 to 2028. The R&D budget for drug development has increased in recent years, 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 crisis 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. With regards to the COVID 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 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 the market growth.

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

Toxicology testing held the largest revenue share of 61.1% in 2020 due to a rise in the outsourcing of noncore preclinical CRO studies and high adoption in toxicology tests. Based on service, the market for preclinical CRO is categorized into bioanalysis and DMPK studies, toxicology testing, and others.

The bioanalysis and DMPK studies segment is expected to expand at the fastest CAGR of 8.6% over the forecast period. This lucrative growth is attributed to a rise in demand for pharmacokinetic services to support toxicology tests for IND-enabling studies.

End-use Insights

The biopharmaceutical companies segment held the largest share of 81.1% in 2020. The growing 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.

Government and academic institutes are estimated to witness the fastest growth over the forecast period. On the basis of end-use, the market is segmented into biopharmaceutical companies, government and academic institutes, and medical device companies.

Regional Insights

North America dominated the market in 2020 with a share of 47.7%. The region is expected to maintain its lead throughout the forecast period owing to increasing R&D expenditure and increasing adoption of new technology. Increased availability of skilled human resources and low cost of devices are also the key factors anticipated to drive the market over the forecast period. Demand for preclinical CRO services is rising owing to the increasing prevalence of chronic diseases, thus fueling the regional market growth. Asia Pacific is expected to witness the fastest growth over the forecast period due to the cost-efficiency of preclinical CROs in countries, such as India and China.

Key Companies & Market Share Insights

One of the key parameters affecting the competitive nature of the market is the rapid adoption of advanced healthcare technology for improved healthcare. Major players are undertaking mergers and acquisitions, along with new product launches, in order to retain market share and diversify the product portfolio.

During the ongoing coronavirus pandemic, the key market players are working to provide various support services in order to tackle the current 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 prominent players in the global preclinical CRO market include:

• Envigo Corporation

•  MPI research

•  Eurofins Scientific

•  PRA Health Sciences, Inc.

•  Wuxi AppTec

•  Medpace, Inc.

•  Pharmaceutical Product Development (PPD), LLC

•  PARAXEL International Corporation

•  ICON Plc

• Laboratory Corporation of America, Inc.

Preclinical CRO Market Report Scope 

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities 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, end-use, and region:

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

  • Bioanalysis and DMPK Studies

  • Toxicology Testing

  • 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

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Malaysia

    • Indonesia

    • Singapore

    • Philippines

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Columbia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt