Preclinical CRO Market Size (2024 - 2029)

The Preclinical CRO Market is projected to experience significant growth over the forecast period, driven by increasing global research and development expenditure and a rising number of drugs in preclinical trials. This expansion is expected to enhance the adoption of preclinical CRO services, as organizations seek to reduce drug development costs and improve approval chances. However, challenges such as a lack of standardization, monitoring issues, and stringent regulatory policies may impede market growth.

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Market Size of Preclinical CRO Industry

Preclinical CRO Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 7.10 Billion
Market Size (2029) USD 10.10 Billion
CAGR (2024 - 2029) 7.44 %
Fastest Growing Market Asia-Pacific
Largest Market North America

Major Players

Preclinical CRO Market Major Players

*Disclaimer: Major Players sorted in no particular order

Preclinical CRO Market Analysis

The Preclinical CRO Market size is estimated at USD 7.10 billion in 2024, and is expected to reach USD 10.10 billion by 2029, growing at a CAGR of 7.44% during the forecast period (2024-2029).

The studied market growth is primarily attributed to increasing research and development (R&D) expenditure worldwide, increasing the number of drugs in preclinical trials, and high demand for medicines uptake by chronically ill patients between 2024 and 2029.

The increasing research and development expenditure in life sciences and substantial public and private funding spending in the sector boosts market growth. For instance, the Indian Ministry of Science and Technology allocated a budget of INR 40 billion (USD 427.20 million) for the Department of Biotechnology (DBT) of India in the Union Budget for the year 2023-2024. The significant increase in funding is primarily due to the increasing R&D expenditure in the country. Hence, the rising research and development expenditure is expected to increase the adoption of preclinical CRO services to decrease the overall cost of the drug development process.

Similarly, the European Federation of Pharmaceutical Industries and Association (EFPIA) pharmaceutical research and development expenditure in 2022 reached USD 44 billion, which grew by 4.6% compared to the 2021 expenditure. Hence, the increasing R&D expenditure in Europe is expected to increase the demand for preclinical CRO services to reduce the expenditure from 2024 to 2029.

Additionally, the increasing number of drugs in preclinical stages is also expected to increase the demand for outsourcing preclinical services to reduce the cost of development and increase the chances of drug approval for conducting clinical trials. For instance, according to the ClinicalTrials.gov 2024 updated data, as of January 2024, nearly 479 thousand clinical studies were registered globally. This significant increase in clinical trials reflects the number of therapeutics and medical devices that have undergone preclinical trials and received New Drug Application Approval (NDA). Hence, the increasing number of drugs in the preclinical trials is expected to drive the studied market between 2024 and 2029.

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

Preclinical CRO Industry Segmentation

As per the scope of this 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, mode type, end users, and geography. By service, the market is segmented into toxicology testing, bioanalysis and drug metabolism and pharmacokinetics studies, safety pharmacology, and other services. By mode type, the market is segmented into patient-derived organoid (PDO) models and patient-derived xenograft (PDX) models. By end user, the market is segmented into biopharmaceutical companies, research institutes and universities, and other end users. By geography, the market is segmented into 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 countries across major regions globally. The report offers the value in USD 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 (PDO) 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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Preclinical CRO Market Size Summary

The preclinical CRO market is poised for significant growth over the forecast period, driven by increasing global research and development expenditures and a rising number of drugs entering preclinical trials. The demand for preclinical contract research organization services is bolstered by the need to streamline drug development processes and enhance the likelihood of drug approval, particularly as pharmaceutical companies face escalating costs and complexities in clinical trials. The market is further supported by substantial public and private funding in life sciences, with regions like Europe and India witnessing notable increases in R&D budgets. This financial backing is expected to propel the adoption of preclinical CRO services, as companies seek to mitigate development costs and expedite the drug approval process.

In North America, the preclinical CRO market is expected to thrive due to the high prevalence of chronic diseases and the substantial costs associated with in-house drug discovery and development. The increasing incidence of conditions such as cancer necessitates the development of new therapies, driving pharmaceutical companies to outsource preclinical trials to leverage the expertise and infrastructure of CROs. The market is characterized by intense competition and fragmentation, with major players like Eurofins Scientific, Charles River Laboratories, and WuXi Apptec leading the charge through strategic alliances and service expansions. These companies are actively enhancing their offerings to maintain a competitive edge in the global market, underscoring the critical role of preclinical CROs in supporting pharmaceutical research and development initiatives.

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Preclinical CRO Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Research and Development (R&D) Expenditure Worldwide

      2. 1.2.2 Increase in Number of Drugs in Preclinical Trials

      3. 1.2.3 High Demand for Medicines Uptake by Chronically Ill Patients

    3. 1.3 Market Restraints

      1. 1.3.1 Lack of Standardization and Monitoring Issue

      2. 1.3.2 Stringent Regulatory Policies

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD)

    1. 2.1 By Service

      1. 2.1.1 Toxicology Testing

      2. 2.1.2 Bioanalysis and Drug Metabolism and Pharmacokinetics Studies

      3. 2.1.3 Safety Pharmacology

      4. 2.1.4 Other Services

    2. 2.2 By Mode Type

      1. 2.2.1 Patient Derived Organoid (PDO) Models

      2. 2.2.2 Patient Derived Xenograft (PDX) Models

    3. 2.3 By End Users

      1. 2.3.1 Biopharmaceutical Companies

      2. 2.3.2 Research Institutes and Universities

      3. 2.3.3 Other End Users

    4. 2.4 Geography

      1. 2.4.1 North America

        1. 2.4.1.1 United States

        2. 2.4.1.2 Canada

        3. 2.4.1.3 Mexico

      2. 2.4.2 Europe

        1. 2.4.2.1 Germany

        2. 2.4.2.2 United Kingdom

        3. 2.4.2.3 France

        4. 2.4.2.4 Italy

        5. 2.4.2.5 Spain

        6. 2.4.2.6 Rest of Europe

      3. 2.4.3 Asia-Pacific

        1. 2.4.3.1 China

        2. 2.4.3.2 Japan

        3. 2.4.3.3 India

        4. 2.4.3.4 Australia

        5. 2.4.3.5 South Korea

        6. 2.4.3.6 Rest of Asia-Pacific

      4. 2.4.4 Middle East and Africa

        1. 2.4.4.1 GCC

        2. 2.4.4.2 South Africa

        3. 2.4.4.3 Rest of Middle East and Africa

      5. 2.4.5 South America

        1. 2.4.5.1 Brazil

        2. 2.4.5.2 Argentina

        3. 2.4.5.3 Rest of South America

Preclinical CRO Market Size FAQs

The Preclinical CRO Market size is expected to reach USD 7.10 billion in 2024 and grow at a CAGR of 7.44% to reach USD 10.10 billion by 2029.

In 2024, the Preclinical CRO Market size is expected to reach USD 7.10 billion.

Preclinical CRO Market Report Snapshots

Preclinical CRO Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)