Preclinical CRO Market Size & Share Analysis - Growth Trends & Forecasts (2023 - 2028)

The Preclinical CRO Market is segmented by Service (Toxicology Testing, Bioanalysis and Drug Metabolism and Pharmacokinetics Studies, Safety Pharmacology, and Other Services), Mode Type (Patient-Derived Organoid (PDOs) Models and Patient-Derived Xenograft (PDX) Models), End Users (Biopharmaceutical Companies, Research Institutes and Universities, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America).

Preclinical CRO Market Size

Preclinical CRO Market Summary
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Study Period 2018-2028
Base Year For Estimation 2022
CAGR 7.86 %
Fastest Growing Market Asia-Pacific
Largest Market North America
Market Concentration Low

Major Players

Preclinical CRO Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Preclinical CRO Market Analysis

The preclinical CRO market is expected to register a CAGR of more than 7.86% during the forecast period.

The onset of the COVID-19 pandemic garnered preclinical studies for pharmaceutical products such as vaccines, drugs, and other medical products. Thus, several laboratories and companies were engaged in conducting clinical trials for effective vaccines and drugs for COVID-19. According to a research article published in NCBI in August 2021, even though the clinical studies for drug development of diseases such as Alzheimer's Disease (AD) were hampered by the pandemic in the early stages, the demand for clinical trials increased for various other diseases along with the COVID-19. Thus, these increasing clinical trials for pharmaceutical products increased and impacted the studied market during the later phases of the pandemic. Additionally, in the current times, the production of pharmaceutical products has increased, with an increase in research and development (R&D). This creates a demand for contract research organizations (CROs) engaged in preclinical services and anticipated to fuel market growth. Hence, owing to the above-mentioned factors, the market witnessed considerable growth during the pandemic and is expected to continue its growth trend over the analysis period.

The studied market growth is largely attributed to the factors such as an increase in increasing research and development (r&d) expenditure worldwide, an increase in the number of drugs in preclinical trials, and high demand for medicines uptake by chronically ill patients during the forecast period.

Outsourcing assists organizations in the pharmaceutical sector to reduce both their operational and manufacturing costs and thereby minimize financial risk. Thus, pharmaceutical companies are increasingly outsourcing R&D activities to private contract research organizations (CROs) as a strategy for conducting research and development activities. For instance, in September 2022, Emyria Limited, a clinical-stage biotechnology company, collaborated with PsychoGenics, a neuroscience preclinical drug discovery and contract research organization (CRO). Under this collaboration, Emyria will use PsychoGenic's drug discovery platform, SmartCube, a next-generation automated testing platform. Such instances are expected to increase the demand for the preclinical services the major market players offer. Hence, it is anticipated to contribute to the market's growth.

Moreover, according to the IFPMA's 2021 report, the annual R&D spending by the international biopharmaceutical industry is 7.3 times higher than that of the aerospace and defense industries, 6.5 times more than the chemicals industry, and 1.5 times more than the software and computer services industry. The source above also mentioned that the global biopharmaceutical industry spent USD 196,000 million in 2021, and it is expected to increase to USD 213,000 million by 2024. Thus, with the increasing R&D in the biopharmaceutical industry for pharmaceutical product development worldwide, the adoption of the CRO services and approach is increasing among the market players. This is expected to garner market growth over the forecast period.

However, a lack of standardization, monitoring issues, and stringent regulatory policies are expected to hamper the market's growth.

Preclinical CRO Market Trends

Toxicology Testing Segment is Predicted to Witness Significant Growth Over the Forecast Period

The harmful effects of an investigational substance are identified via species-, organ-, and dose-specific preclinical toxicity testing on several biological systems. Most of the preclinical CROs provide toxicology testing solutions that include Investigational New Drug Application (IND)-enabling and New Drug Application (NDA)-enabling toxicology services that meet global regulatory requirements, for both small and large molecules. Thus, with the increasing demand for drug and vaccine development, the demand for toxicology testing is also increasing and is anticipated to create opportunities for the availability of toxicity testing services in the preclinical stage. Hence, driving the segment growth.

Consumers' buying behavior of pharmaceutical products such as medicines, vaccines, and medical devices has increased significantly due to the increased burden of chronic diseases. This is anticipated to persist over the coming years. Therefore, several CROs are focusing on the toxicology testing of cosmetic products. For instance, as per a press release by Altogen Labs in January 2022, the company's preclinical CRO services include a full spectrum of pharmacological toxicity safety assays along with other preclinical services.

In addition, as per Charles River in January 2023, to assess the potential safety and toxicity of a drug candidate before it is put to the test in human clinical trials, preclinical toxicology studies are a crucial step in the drug development process. These studies are crucial in determining a drug candidate's dosage range and can reveal information about possible side effects and adverse responses. Thus, Charles River offers a wide range of preclinical toxicology services. Thus, the availability of such service providers creates a competitive environment and creates opportunities for several new entrants. This is further expected to drive the segment growth over the forecast period.

Preclinical CRO Market - Number of FDA-Registered Facilities (in Thousands), United States, 2021

North America is Expected to Hold a Significant Share of the Market Over the Forecast Period

North America is expected to hold a significant share of the market studied throughout the forecast period. Factors such as increasing R&D and increasing demand for medicines among the target population in the region are predicted to drive market growth.

The pharmaceutical industry in North America is concentrated, and companies are focusing more on outsourcing activities with CROs for drug development. In addition, governments across the region also invest heavily in contract development and manufacturing organization (CDMO) drug substance and drug product manufacturing capacity. This is creating opportunities for preclinical CRO services among end users. For instance, in February 2022, Canadian CRO IonsGatePreclinical Services Inc (IonsGate), a company focused on preclinical research services, and European life sciences company InSilicoTrials partnered to leverage innovative technology like Modeling and Simulation. These two companies will work together to optimize preclinical studies relying on innovation and digitalization, as recommended by FDA and EMA. Such activities by major players are anticipated to fuel the segment growth in the region.

Furthermore, according to the February 2022 update by FDA, access to the safest and cutting-edge pharmaceutical system benefits American consumers, and CDER, a division of the FDA, assures that safe and effective drugs are available to the American people. Thus, effective pharmaceutical product development is increasing in the region. In addition, as per data published by the Government of Canada in June 2022, several organizations in Canada are providing preclinical CRO services that include preclinical programs supporting Investigational New Drug (IND) and New Drug Application (NDA) enabling studies. This creates competition in the market, creating opportunities for emerging new entrants. Thus, the competitiveness in pharmaceutical product development creates opportunities for preclinical testing services and is expected to fuel the overall market growth in the region.

Preclinical CRO Market - Growth Rate by Region

Preclinical CRO Industry Overview

The preclinical CRO market is highly competitive and fragmented in nature, with the presence of various well-known service providers globally. Major market players are competing against each other by expanding their range f solutions and services. There are a few companies that are currently dominating the market. The key players have been involved in various strategic alliances such as acquisitions, collaborations, and the launch of advanced services to secure their position in the global market. These companies include Eurofins Scientific, Charles River Laboratories, WuXi Apptec, Labcorp Drug Development, and SGS SA, among others.

Preclinical CRO Market Leaders

  1. Labcorp Drug Development

  2. Eurofins Scientific

  3. WuXi App Tec

  4. SGS SA

  5. Charles River Laboratories

*Disclaimer: Major Players sorted in no particular order

Preclinical CRO Market Concentration

Preclinical CRO Market News

  • March 2023: GTP Bioways, a contract development and manufacturing organization (CDMO) dedicated to biotherapeutics manufacturing, and Texcell, a contract research organization (CRO) specialized in viral safety, assay development, and GMP banking, partnered to provide comprehensive pre-clinical to clinal phases services to biopharmaceutical companies.
  • November 2022: AmplifyBio, a contract research organization that is building an ecosystem for the advancement of advanced therapies, reported the completion of initiatives to expand capacity and reduce timelines for the execution of pre-clinical studies. The projects, which took a little over a year to complete, involved talent recruitment, vivarium modifications, supply chain management, and data technology solutions to remove the obstacles that commonly delay pre-clinical research.
  • February 2022: Canadian CRO IonsGatePreclinical Services Inc (IonsGate), a company focused on pre-clinical research services, and European life sciences company InSilicoTrials partnered to leverage innovative technology like Modeling and Simulation. These two companies will work together to optimize pre-clinical studies relying on innovation and digitalization, as recommended by FDA and EMA.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Research and Development (R&D) Expenditure Worldwide

      2. 4.2.2 Increase in Number of Drugs in Preclinical Trials

      3. 4.2.3 High Demand for Medicines Uptake by Chronically Ill Patients

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Standardization and Monitoring Issue

      2. 4.3.2 Stringent Regulatory Policies

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Service

      1. 5.1.1 Toxicology Testing

      2. 5.1.2 Bioanalysis and Drug Metabolism and Pharmacokinetics Studies

      3. 5.1.3 Safety Pharmacology

      4. 5.1.4 Other Services

    2. 5.2 By Mode Type

      1. 5.2.1 Patient Derived Organoid (PDOs) Models

      2. 5.2.2 Patient Derived Xenograft (PDX) Models

    3. 5.3 By End Users

      1. 5.3.1 Biopharmaceutical Companies

      2. 5.3.2 Research Institutes and Universities

      3. 5.3.3 Other End Users

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Charles River Laboratories

      2. 6.1.2 Labcorp Drug Development

      3. 6.1.3 Thermo Fisher Scientific Inc (Pharmaceutical Product Development (PPD))

      4. 6.1.4 NorthEast BioAnalytical Laboratories LLC

      5. 6.1.5 Parexel International Corporation

      6. 6.1.6 Medpace

      7. 6.1.7 Eurofins Scientific

      8. 6.1.8 WuXi App Tec

      9. 6.1.9 ICON plc

      10. 6.1.10 SGS SA

      11. 6.1.11 PharmaLegacy Laboratories

      12. 6.1.12 Altasciences Company, Inc.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

Preclinical CRO Industry Segmentation

As per the scope of the report, preclinical Contract Research Organizations (CROs) specialize in ensuring a seamless procedure with reliable results for each test. Prior to entering clinical trials (or receiving other approvals like 510Ks) or being used for human care, preclinical CROs assist new medical product developers in demonstrating their products' safety and efficacy in live models that the FDA considers approximate as closely as possible the human anatomy.

The Preclinical CRO Market is segmented by Service (Toxicology Testing, Bioanalysis and Drug Metabolism and Pharmacokinetics Studies, Safety Pharmacology, and Other Services), Mode Type (Patient-Derived Organoid (PDOs) Models and Patient-Derived Xenograft (PDX) Models), End Users (Biopharmaceutical Companies, Research Institutes and Universities, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Service
Toxicology Testing
Bioanalysis and Drug Metabolism and Pharmacokinetics Studies
Safety Pharmacology
Other Services
By Mode Type
Patient Derived Organoid (PDOs) Models
Patient Derived Xenograft (PDX) Models
By End Users
Biopharmaceutical Companies
Research Institutes and Universities
Other End Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America

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Frequently Asked Questions

The Preclinical CRO Market is projected to register a CAGR of 7.86% during the forecast period (2023-2028).

Labcorp Drug Development, Eurofins Scientific, WuXi App Tec, SGS SA and Charles River Laboratories are the major companies operating in the Preclinical CRO Market.

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2023-2028).

In 2023, the North America accounts for the largest market share in the Preclinical CRO Market.

Preclinical CRO Industry Report

Statistics for the 2023 Preclinical CRO market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Preclinical CRO analysis includes a market forecast outlook to for 2023 to 2028 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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