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 a 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 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 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.
The rise in the 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 models and outsourcing preclinical services to CROs. The pressure to contain R&D costs 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 the 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).
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 a rise in demand for pharmacokinetic services to support toxicology tests for IND-enabling studies.
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 are estimated to be the fastest growing segment over the forecast period. The biopharmaceutical companies segment is expected to hold the largest market share 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.
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.
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.
Base year for estimation
Actual estimates/ Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million and CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Russia, Sweden, China, India, Japan, Australia, South Korea, Malaysia, Indonesia, Singapore, Philippines, Thailand, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Saudi Arabia, UAE, Israel, Egypt
Revenue forecast, company share, competitive landscape, growth factors and trends
15% free customization scope (equivalent to 5 analysts working days)
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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
End-use Outlook (Revenue, USD Million, 2016 - 2027)
Government and Academic Institutes
Medical Device Companies
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East & Africa
b. The global preclinical CRO market size was estimated at USD 4.1 billion in 2019 and is expected to reach USD 4.8 billion in 2020.
b. The global preclinical CRO market is expected to grow at a compound annual growth rate of 8.3% from 2020 to 2027 to reach USD 7.8 billion by 2027.
b. North America dominated the preclinical CRO market with a share of 47.3% in 2019. This is attributable to increasing R&D and the adoption of new technology in medical devices along with increased availability of skilled human resources.
b. Some key players operating in the 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; and Laboratory Corporation of America, Inc.
b. Key factors that are driving the market growth include an increasing number of drugs in preclinical phases, economies of production and scale, increasing R&D expenditure.
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