Global preclinical CRO market was valued at USD4.5 billion in 2020. It is projected to grow at 8.1% compound annual growth rate (CAGR), between 2021 and 2028. The market growth is expected to be boosted by an increase in R&D budgets for drug development. Preclinical research projects have been disrupted by the ongoing COVID-19 pandemic, particularly in the first quarter 2020. However, lifesaving drugs will be quickly developed and put on the market. The preclinical CROs play a crucial role in the commercialization of the idea for different biopharmaceutical companies.
The preclinical trials for the COVID-19 vaccine have been completed at an incredible pace, a sign of the immense role played by CROs. The market is expected to grow significantly if CRO services are more widely used. Servier Research Institute's 2017 survey found that around half of all preclinical failures are due to toxicology testing. This will increase the demand for CRO services in the future. Recent regulatory changes in Europe regarding preclinical CRO service are expected to also increase demand for toxicology testing and contribute to regional market growth.
The process for drug approval by FDA has seen significant changes over the years. The 21st Century Cures Act was recently passed in the United States. This bill accelerated the approval process for medical devices and breakthrough drugs. These changes to approval procedures are expected to spur innovation and increase demand for preclinical services. This will contribute to market growth.
Pandemic Impact |
Outlook after COVID |
The wider industry had an impact on drug research and development, with many companies having to stop or delay programs. This is true for both the larger pharma companies and smaller virtual companies that don't have clinical data. |
It has been possible to develop accelerated paths for antivirals and immunomodulators and anticoagulants. These can be used as ''roadmaps" to help prioritize compounds for clinical testing. |
The new COVID-19 vaccine candidate has been developed by researchers at the Cleveland Clinic's Global Center for Pathogen Research & Human Health. It uses nanotechnology and has proven to be highly effective in preclinical models of disease. |
As companies consider R&D, the debate between efficiency and resilience will be key. For example, rebalancing research work across countries by contract research organisations (CROs), or evaluating clinical supply chain diversification in order to minimize vulnerabilities. |
The global COVID-19 vaccine research and development landscape currently includes 115 vaccine candidates. 78 of these vaccine candidates have been confirmed active, while 37 remain unconfirmed. Out of the 78 active projects, 73 remain in exploratory or preclinical stage. |
Preclinical trials are ongoing. They will continue for the next few months to determine if MRT5500 and additional mRNA vaccine candidate candidates will induce neutralizing antibodies to the emerging SARS CoV-2 variants. This could inform future clinical development. |
Preclinical CROs are not compliant with international regulations, such as Good Laboratory Practice standards (GLP), which can lead to quality problems. Biopharmaceutical companies and medical device firms generally outsource low-end preclinical trial functions to CROs. High-end tests such as genotoxicity are usually performed in-house. The CROs are expected to improve their quality standards. Outsourced vendors currently try to adhere to the international standards established by regulatory authorities such as the U.S. FDA (US) and the European Medicines Agency, (EMA).
The market can be divided into several service segments: bioanalysis and DMPK, toxicology testing and compound management. Safety pharmacology and chemistry are also included. In 2020, the toxicology testing segment was the most lucrative with a more than 22% revenue share. This is due to increased outsourcing of preclinical CRO studies as well as high adoption of toxicology tests.
The segment of bioanalysis and DMPK analyses is expected to grow at 8.4% CAGR over the forecast period. This segment will experience lucrative growth due to a rising demand for pharmacokinetic support for toxicology tests for IND-enabling research. Bioanalysis and DMPK are essential in drug development. These studies are done at every stage of drug development and not just in the preclinical phase.
In 2020, the market share for biopharmaceutical businesses will exceed 80%. Preclinical CRO services will be in demand due to the increasing trend in outsourcing services from biopharmaceutical firms, particularly among small and medium-sized companies lacking sufficient expertise in drug development.
According to forecasts, the fastest growth will be seen in the government and academic institutions segment. Preclinical discovery and development is a critical phase in which government and academia play an important role. The segment will also grow as more academic institutions and government agencies outsource preclinical services for CROs. For large CROs like Charles River Laboratories or LabCorp, academic institutes are a major source of revenue.
North America was the dominant market place in 2020, accounting for more than 47% of the total revenue. Due to increased R&D spending and the high adoption of new technology, the region will continue to be dominant over the forecast period. Market growth will also be driven by the availability of skilled workers and the low cost of devices.
Due to increasing rates of chronic diseases, the demand for preclinical services in CRO is also growing. Asia Pacific will experience the fastest CAGR during the forecast period. This is due to the cost-efficiency and efficiency of preclinical CROs located in countries such as India or China. The preclinical outsourcing market for Asia Pacific has been strengthened by the establishment of multiple CROs. Singapore, for example, has many CROs that can support growing pharmaceutical and biopharmaceutical company needs.
The rapid adoption of new healthcare technologies is one of the key factors driving market competition. To retain market share and diversify their product portfolio, major players are launching new products and completing mergers and acquisitions. The market leaders are providing support and services in the face of the coronavirus pandemic. Parexel and Innoplexus collaborated to launch the COVID-19 Clearinghouse in September 2020. This online resource allows researchers, patients, and sponsors of clinical trials to access data, publications, current news, and links to active clinical trials. These are some of the major companies that make up the preclinical CRO market:
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.
Up Market Research published a new report titled “Preclinical CRO Market research report which is segmented by Service (Bioanalysis & DMPK Studies, Toxicology Testing), by End Use (Government & Academic Institutes, Biopharmaceutical Companies), By Players/Companies LLC; PARAXEL International Corporation; ICON Plc; and Laboratory Corporation of America, Inc; Pharmaceutical Product Development (PPD), Inc; Wuxi AppTec; Medpace, Inc, Envigo Corporation; MPI research; Eurofins Scientific; PRA Health Sciences”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.
Report Attributes | Report Details |
Report Title | Preclinical CRO Market Research Report |
By Service | Bioanalysis & DMPK Studies, Toxicology Testing |
By End Use | Government & Academic Institutes, Biopharmaceutical Companies |
By Companies | LLC; PARAXEL International Corporation; ICON Plc; and Laboratory Corporation of America, Inc; Pharmaceutical Product Development (PPD), Inc; Wuxi AppTec; Medpace, Inc, Envigo Corporation; MPI research; Eurofins Scientific; PRA Health Sciences |
Regions Covered | North America, Europe, APAC, Latin America, MEA |
Base Year | 2020 |
Historical Year | 2018 to 2019 (Data from 2010 can be provided as per availability) |
Forecast Year | 2028 |
Number of Pages | 209 |
Number of Tables & Figures | 147 |
Customization Available | Yes, the report can be customized as per your need. |
The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.
The market is segmented by Service (Bioanalysis & DMPK Studies, Toxicology Testing), by End Use (Government & Academic Institutes, Biopharmaceutical Companies).
Preclinical CRO Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.
Key Benefits for Industry Participants & Stakeholders:
Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.
We have studied the Preclinical CRO Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.
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