Preclinical CRO Market Size, Share & Trends Analysis Report By Services (Bioanalysis & DMPK Studies, Toxicology Testing), By End Use (Biopharmaceutical Companies, Medical Device Companies), And Segment Forecasts, 2020 - 2027

Industry Insights

The global preclinical CRO market size was estimated at USD 4.1 billion in 2019 and is anticipated to expand at a CAGR of 8.3% over the forecast period. R&D budget for drug development has increased in recent years, leading to rising demand for preclinical CRO (Contract Research Organization) services, thus boosting the market growth during the forecast period.

Increasing spending on CRO services is expected to boost the market growth significantly during the forecast period. As per survey carried out by Servier Research Institute in 2017, around 50% of failure in preclinical phase are due to toxicology testing, which is expected to propel the demand for preclinical CRO services in coming years. Apart from this, recent regulatory changes in Europe relating to preclinical CRO services is also anticipated to increase the demand for toxicology testing, thus contributing to the regional market growth.

The rise in competency of these CROs is also contributing to the growing demand for preclinical services by life science companies, as these clients are adopting strategic partnerships business model and outsourcing preclinical services to CROs. The pressure to contain R&D cost and decrease the overall cost of drug discovery and development is further contributing to the adoption of outsourcing model.

Over the years, there has been a significant change in the process of drug approval by the Food and Drug Administration (FDA). Recently, 21st Century Cures bill was passed in U.S., which fastened the approval process for 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

Based on service, the preclinical CRO market is categorized into bioanalysis and DMPK studies, toxicology testing, and others. Toxicology testing holds the largest share in the global market, since it is an important part of Investigational New Drug (IND)-enabling studies. Due to rise in outsourcing of noncore preclinical CRO studies, the market is expected to grow considerably during the forecast period.

The bioanalysis and DMPK studies segment held the largest market share of 22.8% in 2019 and is expected to dominate the market over the forecast period. The segment is expected to witness lucrative growth due to rise in demand for pharmacokinetic services to support toxicology tests for IND-enabling studies.

End-use Insights

On the basis of end use, the market is segmented into biopharmaceutical companies, government and academic institutes, and medical device companies. Government and academic institutes is estimated to be the fastest growing segment over the forecast period. The biopharmaceutical companies segment is expected to hold the largest market share in over the forecast period.

Increasing trend of outsourcing end to end services among biopharmaceutical companies, especially amongst the small- and mid-size companies that lack sufficient expertise in preclinical phase of drug development, is expected to boost the demand for preclinical CRO services in the future.

Regional Insights

North America dominated the market in 2019 and is expected to remain dominant throughout the forecast period owing to increasing R&D in and increasing adoption of new technology in medical devices. 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. Demand for preclinical CRO services is rising owing to increasing prevalence of chronic diseases, thus fueling the regional market growth. Asia Pacific is expected to show lucrative growth over the forecast period due to cost-efficiency of preclinical CROs in countries such as India and China.

Preclinical CRO Market Share Insights

Some of the players operating in the market are Envigo Corporation.; MPI research; Eurofins Scientific; PRA Health Sciences, Inc.; Wuxi AppTec; Medpace, Inc.; Pharmaceutical Product Development (PPD), LLC; PARAXEL International Corporation; ICON Plc; and Laboratory Corporation of America, Inc.

One of the key parameters affecting the competitive nature of the market is 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.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on the latest industry trends in each of the sub-segments from 2016 to 2027. 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 - 2027)

  • Bioanalysis and DMPK studies

  • Toxicology Testing

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2027)

  • Biopharmaceutical Companies

  • Government and Academic Institutes

  • Medical Device Companies

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

  • Asia Pacific

    • India

    • Japan

    • China

    • Australia

    • South Korea

    • Malaysia

    • Indonesia

    • Singapore

    • Philippines

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt