Preclinical CRO Market Size
| 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 |
| Market Concentration | Low |
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 Market Trends
The Toxicology Testing Segment is Predicted to Witness Significant Growth Between 2024 and 2029
Toxicology testing involves the evaluation of the potential adverse effects of chemical substances or pharmaceutical compounds on living organisms. It encompasses a range of methodologies to assess these substances' safety profile, including their potential to cause harm or toxicity. In the dynamic landscape of pharmaceutical research and development, the demand for preclinical toxicology testing services offered by contract research organizations (CROs) is witnessing a significant upsurge. This surge can be attributed to various factors, including the increasing collaboration between pharmaceutical companies and CROs and technological advancements enhancing the efficiency and accuracy of toxicology testing processes.
The expanding partnership between pharmaceutical companies and CROs drives the demand for toxicology testing services. As pharmaceutical companies intensify their drug development efforts, they seek CROs' expertise and infrastructure to conduct essential preclinical toxicology studies. For instance, in May 2023, Immuter partnered with Charles River Laboratories to conduct a good laboratory practice (GLP) toxicology study for its proprietary candidate IMP761 to address autoimmune diseases. Similarly, in March 2024, Badvus Research forged a strategic alliance with Southern Research, focusing on preclinical toxicology testing and regulatory approval processes. These collaborations underscore the pivotal role of CROs in supporting drug development initiatives and ensuring regulatory compliance through comprehensive toxicology assessments.
Toxicology testing in preclinical CROs serves as a vital component of the drug development process, enabling pharmaceutical companies to evaluate the safety profiles of their candidates and make informed decisions regarding their progression in the development pipeline. Hence, increasing the vertical collaboration between pharma companies and CROs is likely to enhance the segmental growth of the market.
North America is Expected to Hold a Significant Share of the Market Between 2024 and 2029
The North American preclinical CRO market is expected to benefit from higher in-house drug development and discovery costs, rising prevalence of chronic diseases, increasing complexity in clinical trials, and a high number of investigational candidates in the development pipeline.
The higher prevalence of chronic diseases like cardiovascular diseases, diabetes, cancer, and neurological disorders necessitates the development of new therapies and treatments. Such a high and evolving burden of chronic diseases forces pharma companies to outsource preclinical trials to investigate promising candidates against those diseases, which is projected to foster the country’s market growth over the study period. For instance, according to the American Cancer Society, the prevalence of lung cancer is increasing in the country, and the country reported 238,340 lung cancer cases in 2023 compared to 236,740 in 2022. This data shows a rapid increase in the incidence of cancer cases in the country, and between 2024 and 2029, the incidence of cancer will further increase; thus, the escalating burden of cancer cases in the country is projected to spur the demand for advanced therapeutics and which is in turn projected to foster preclinical trial activities and is anticipated to support country’s market growth over the study period.
In addition, the higher in-house drug discovery and development costs facilitate pharmaceutical companies to outsource preclinical trial activities to reduce the cost burden and increased complexity associated with clinical trials. Thus, drug discovery and development costs are anticipated to foster demand for preclinical contract research organizations (CROs) to conduct clinical trials as they have all the required infrastructures. For instance, according to a study conducted by the World Health Organization (WHO) in 2022, the average cost to develop a new drug ranges from USD 43.4 million to USD 4.2 million. Thus, the significant cost associated with new drug development is expected to facilitate the demand for preclinical CROs to perform clinical trials and other research activities on behalf of pharmaceutical companies, as CROs have a better experience and infrastructure to conduct research services. Thus, the high demand for preclinical CROs to conduct research activities is projected to support the country’s market growth over the study period.
Hence, the high prevalence of chronic diseases and the higher in-house drug discovery and development costs are expected to drive the studied market in North America between 2024 and 2029.
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 compete against each other by expanding their range of solutions and services. There are a few companies that are currently dominating the market. 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.
Preclinical CRO Market Leaders
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Labcorp Drug Development
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Eurofins Scientific
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WuXi App Tec
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SGS SA
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Charles River Laboratories
*Disclaimer: Major Players sorted in no particular order
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 2023: CEBIS International expanded its preclinical and clinical trials services operations in the North American and Indian markets. With this, the company is committed to advancing its drug development and clinical trial capabilities in a much more efficient manner.
Preclinical CRO Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Research and Development (R&D) Expenditure Worldwide
4.2.2 Increase in Number of Drugs in Preclinical Trials
4.2.3 High Demand for Medicines Uptake by Chronically Ill Patients
4.3 Market Restraints
4.3.1 Lack of Standardization and Monitoring Issue
4.3.2 Stringent Regulatory Policies
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Service
5.1.1 Toxicology Testing
5.1.2 Bioanalysis and Drug Metabolism and Pharmacokinetics Studies
5.1.3 Safety Pharmacology
5.1.4 Other Services
5.2 By Mode Type
5.2.1 Patient Derived Organoid (PDO) Models
5.2.2 Patient Derived Xenograft (PDX) Models
5.3 By End Users
5.3.1 Biopharmaceutical Companies
5.3.2 Research Institutes and Universities
5.3.3 Other End Users
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Charles River Laboratories
6.1.2 Labcorp Drug Development
6.1.3 Thermo Fisher Scientific Inc. (Pharmaceutical Product Development (PPD))
6.1.4 NorthEast BioAnalytical Laboratories LLC
6.1.5 Parexel International Corporation
6.1.6 Medpace
6.1.7 Eurofins Scientific
6.1.8 WuXi App Tec
6.1.9 ICON PLC
6.1.10 SGS SA
6.1.11 PharmaLegacy Laboratories
6.1.12 Altasciences Company Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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 | ||||||||
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Preclinical CRO Market Research Faqs
How big is the Preclinical CRO Market?
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.
What is the current Preclinical CRO Market size?
In 2024, the Preclinical CRO Market size is expected to reach USD 7.10 billion.
Who are the key players in Preclinical CRO Market?
Labcorp Drug Development, Eurofins Scientific, WuXi App Tec, SGS SA and Charles River Laboratories are the major companies operating in the Preclinical CRO Market.
Which is the fastest growing region in Preclinical CRO Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Preclinical CRO Market?
In 2024, the North America accounts for the largest market share in Preclinical CRO Market.
What years does this Preclinical CRO Market cover, and what was the market size in 2023?
In 2023, the Preclinical CRO Market size was estimated at USD 6.57 billion. The report covers the Preclinical CRO Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Preclinical CRO Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Preclinical CRO Industry Report
The Preclinical CRO market report provides a comprehensive industry analysis, detailing the market share, market size, and global market trends. The industry reports cover various services such as toxicology testing, bioanalysis, drug metabolism, pharmacokinetics studies, and safety pharmacology. The market segmentation includes patient-derived organoid models and patient-derived xenograft models, catering to biopharmaceutical companies, research institutes, universities, and other end users.
The industry overview highlights the market forecast and market growth, emphasizing the market value and market outlook for the upcoming years. The industry research indicates significant growth rate and market predictions, driven by advancements in preclinical testing models and increasing demand from biopharmaceutical companies.
The market analysis includes detailed industry information and industry statistics, providing insights into market leaders and industry sales. The market review also covers geographical segmentation, with a focus on North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.
For a comprehensive understanding, the report includes a sample industry report PDF download, offering a detailed report example and industry trends. The market forecast outlook is based on historical data and future market predictions, ensuring that stakeholders have access to reliable market data and industry outlook.
In summary, the Preclinical CRO market report is an essential resource for research companies and industry stakeholders, providing a thorough market overview and industry research to support strategic decision-making.
