Pre Clinical CROs Market Share Report - Growth Outlook 2027

Pre Clinical CROs Market to 2027 - Global Analysis and Forecasts By Service (Bio-Analysis and DMPK Studies, Toxicology, and Other Services), End User (Biopharmaceutical Companies, Government & Academic Institutes, and Medical Device Companies), and Geography

  • Report Code : TIPRE00003316
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 155
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The pre-clinical CROs market size is expected to grow from US$ 4,282.2 million in 2018 to US$ 8,412.9 million by 2027; it is estimated to grow at a CAGR of 8.1% from 2019 to 2027.


Analyst’s ViewPoint

The pre-clinical CROs market aims to support compliance regulations across geographies. Once adopted, it provides a comprehensive knowledge-rich environment that enables early investigational new drug (IND). The pre-clinical CROs market analysis include driving factors such as rising prevalence of rare diseases and rising number of outsourcing activities by the pharmaceutical companies to CROs for drug development acting as the most impacting factors responsible for influential growth of pre-clinical CROs market. Further, technological advancements in the clinical research acts as a future trend for the market to grow during 2023-2028. According to the segmentation profiled in the report, based on service segment, toxicology segment accounts the highest share and based on end user, biopharmaceutical companies dominate the market recording maximum share.

Pre-clinical CRO is a support center that offers expertise in research & development intended for navigating a drug candidate through animal testing and advancing it into the clinical phase. Also, preclinical research services involve several studies related to assessing drug efficacy and safety in animal models and complete Investigational New Drug (IND) filing studies. Furthermore, the main objective of the pharmaceutical organization using a preclinical CRO is to achieve fast and effective delivery to the market.

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Pre Clinical CROs Market: Strategic Insights

Market Size Value inUS$ 4,282.2 Million in 2018
Market Size Value byUS$ 8,412.9 Million by 2027
Growth rateCAGR of 8.1% from 2019-2027
Forecast Period2019-2027
Base Year2018
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The main services under pre-clinical CROs involve:

  • Project Management
  • Medical Testing
  • Toxicology
  • Maximum Dosage Studies
  • Regulatory Compliance
  • Safety And Efficacy Reporting
  • Quality Analysis
  • Species Expertise

Furthermore, improvements in pre-clinical development result in reduced costs as well as timelines. For example, pharma companies reduce the time they take to reach FIH application by 40% or more, with drugs progressing from candidate nomination to the start of clinical trials in little as 12 to 15 months. Such timelines not only provide patients with rapid access to innovative medicines but also provides pharma companies to account for high revenue targets with a longer period of drug exclusivity in the market.

Market Insights

Rising Number of Outsourcing Activities by the Pharmaceutical Companies to CROs For Drug Development

Outsourcing of pharmaceutical services started in areas such as clinical development and manufacturing. Also, rapidly evolving market dynamics have encouraged pharmaceutical companies to broaden the scope of outsourcing activities across commercial activities. For example, pharmaceutical companies heavily invest in R&D to discover and develop new drugs, which can be time-consuming and expensive. Therefore, by outsourcing R&D to CDMO services, pharmaceutical companies can reduce capital expenditure and conserve cash. Furthermore, CDMOs can invest in specialized equipment and facilities that will support R&D resulting in pharmaceutical companies avoiding the need to make large capital investments.

Additionally, by reducing capital expenditures, outsourcing can help pharmaceutical companies to limit their financial risks. CDMOs can provide the necessary manufacturing capacity and expertise, allowing pharmaceutical companies to focus their resources on other business areas. Such aforementioned factors are responsible for the significant growth of the global pre-clinical CROs market during the forecast period.

Service Insights

Based on service, the pre-clinical CROs market is segmented as bio-analysis and DMPK studies, toxicology, and other services. The toxicology segment held the largest market share of 45.7% in 2019. Toxicology studies are used to characterize the toxicity profile of a drug by identifying its impact on organ structure and/or functionality. The toxicology studies reveal an assessment of the severity and reversibility of toxicity, as well as dose ranges and exposure. Also, pharmacological studies such as in-vivo preclinical toxicology studies are intended to assess the onset, severity, and duration of toxic effects, dose-dependency, and degree of reversibility (or irreversibility). Also, top companies like IITRI is a high-quality provider of preclinical toxicology and drug safety evaluation services in accordance with GLP standards. Also, the company provides a full range of in-vivo toxicology testing services that support submissions to the Food and Drug Administration (FDA) and other regulatory agencies involving complete IND-enabling programs and chemical toxicity assessments. Such aforementioned factors are responsible for influential segmental growth thereby dominating the overall market growth during the forecast period.

End User Insights

Based on end user, the global pre-clinical CROs market is segregated as biopharmaceutical companies, government & academic institutes, and medical device companies. The biopharmaceutical companies segment accounted largest market share of 50.25% in 2019. Pre-clinical development benefits from advancing new drug application (NDA) resulting in accelerating innovation, value, and improve quality of innovative products by the biopharmaceutical companies. Such untapped potential will increase the exposure of preclinical development. Furthermore, with pre-clinical research progressing from target identification early discovery of new drugs, experiments generating data, modulation of targets, manufacturing, improves resulting in investigational new drug (IND). Therefore, leading biopharmaceutical companies are searching for new ways to streamline processes and practices in pre-clinical development for new drug discoveries. Such aforementioned factors are responsible for influential segmental growth thereby dominating the overall market growth during the forecast period.

Pre-clinical CROs Market, by Service – 2019 and 2027

Regional Analysis

North America dominated the pre-clinical CROs market accounting maximum share. The market growth in this region is attributed due to presence of large players launching innovative product launches particularly pre-clinical CROs and continuous product introduction in the region. Among North America region, the US records maximum share of 60% for the pre-clinical CROs solution. As per the American Association for the Advancement of Science (AAAS) report, US$28 billion is spent in the US annually on pre-clinical research. With such high expenditure on pre-clinical research, US pharma companies extract useful information about treatment for specific or rare diseases. With promising pre-clinical research studies, the US FDA permits testing the treatment among the infected patient population.

Likewise, Asia Pacific is expected to account highest CAGR of 12.0% for the global pre-clinical CROs market during the forecast period. Among Asia Pacific region, China will account maximum CAGR for the global pre-clinical CROs market during the forecast period. The attributing factors involve investigational new drug (IND) applications and new drug applications (NDAs) intended for innovative drugs (that were applied for and approved in China between January 2010 and December 2020). The aforementioned factor is a standalone factor responsible for growth of pre-clinical CROs market in Asia Pacific region during the forecast period.

The report comprises leading players operating in the global pre-clinical CROs market. These involve LabCorp, Charles River Laboratories, Eurofins Scientific, PRA Health Sciences, WuXi AppTec, Medspace, Inc., Pharmaceutical Product Development, LLC., Paraxel International Corporation, ICON Plc, and MD Biosciences.

In July 2022, Biogen, Inc. announced that USFDA has accepted a new drug application (NDA) for "Tofersen", an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). ALS is a rare, progressive and fatal neurodegenerative disease that results in the loss of motor neurons in the brain and spinal cord that are responsible for controlling voluntary muscle movement.

Company Profiles

  • LabCorp
  • Charles River Laboratories
  • Eurofins Scientific
  • PRA Health Sciences
  • WuXi AppTec
  • Medspace, Inc.
  • Pharmaceutical Product Development, LLC.
  • Paraxel International Corporation
  • ICON Plc
  • MD Biosciences.
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Service, End User, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

The List of Companies

  1. Covance, Inc.
  2. Charles River
  3. Eurofins Scientific
  4. PRA Health Sciences
  5. WuXi AppTec
  6. Medpace, Inc.
  7. Pharmaceutical Product Development, LLC
  8. Parexel International Corporation
  9. ICON Plc
  10. MD Biosciences

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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