The Preclinical CRO Market size was estimated at USD 6.25 billion in 2023 and expected to reach USD 6.85 billion in 2024, at a CAGR 9.68% to reach USD 11.95 billion by 2030.
A preclinical CRO is a support center providing expertise in research and development activities (R&D) essential for navigating a drug candidate through animal testing and forwarding it into the clinical phase. Preclinical research services encompass several studies critical to assessing drug efficacy & safety in animal models and complete Investigational New Drug (IND) filing studies. In a preclinical trial, CROs are hired by sponsors such as biopharma companies to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor’s behalf. A surge in the number of drugs in the preclinical phase and an increased research & development (R&D) budget for drug development are driving the usage of preclinical CRO services. The high cost and time-consuming process of preclinical CROS services hamper the market growth. Advances in technology, which include high-throughput screening and in silico modeling, enable more efficient and cost-effective preclinical research and are expected to create opportunities for market growth.
Regional Insights
The unprecedented rise in non-communicable diseases among the geriatric population and communicable diseases caused by changing environmental conditions, such as pollution, and insect infestation, create a demand for effective drug development in the healthcare sector, subsequently increasing the need for preclinical CRO services across the Americas, Asia-Pacific, and EMEA. The investments made by the governments of Asia-Pacific to push research and development (R&D) activities of medical devices and drug development are estimated to provide growth opportunities for the preclinical CRO market players. In August 2021, the Australian government invested USD 79 million in medical innovation and research projects. The developed economies in the European Union have established a supportive government framework to boost technological advancements by prioritizing research and innovation of new technologies and drug development. The government introduces several stringent regulations and standards to ensure that the medicines and devices developed are safe, reliable, and of high quality. In January 2022, the Clinical Trials Regulation (Regulation (EU) No 536/2014) was set to launch in the EU to modify the clinical trial processes. The government introduced a Clinical Trials Information System (CTIS) to harmonize the supervision and assessment processes. Thus, the ongoing government support for clinical trials for medical devices and drug development is expected to fuel the growth of the preclinical CRO market in EMEA.
Market Insights
Market Dynamics
The market dynamics represent an ever-changing landscape of the Preclinical CRO Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
Market Drivers
Increasing R&D activities by pharmaceutical and biopharmaceutical companies to develop new drugs & therapies
Rising trend of outsourcing drug development activities to CROs by pharmaceutical companies
Growing focus on the development of personalized medicines
Market Restraints
High cost and time-consuming constraints associated with preclinical CRO services
Market Opportunities
Growing advances in technologies to enable more efficient and cost-effective preclinical research
High potential for preclinical research for biologics, including monoclonal antibodies, vaccines, and cell therapies
Market Challenges
Stringent regulations and guidelines set by international regulatory authorities
Market Segmentation Analysis
Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects
End-User: Evolving usage of preclinical CRO by biopharmaceutical companies
Market Disruption Analysis
Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Preclinical CRO Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Preclinical CRO Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Recent Developments
CRO Company TriApex Completes Series C Financing Round Led by Legend Capital
Triapex, a Preclinical CRO and Contract Research Organization (CRO), recently completed a Series C round of financing led by Legend Capital. This investment further strengthens Triapex's place among the top players in the global preclinical CRO market. With this additional funding, Triapex is well-positioned to provide high-quality services to its clients and expand its presence worldwide. The success of this financing round is a testament to Triapex's commitment to providing quality services through innovative methods, making them a preferred partner for many organizations.
PsychoGenics Launches eCube, a New AI-Enabled Platform for Drug Discovery
PsychoGenics Inc., AI-enabled phenotypic drug discovery and preclinical CRO services provider, launched its advanced AI-Enabled Platform, eCube, to enable more efficient and effective preclinical drug discovery in the CRO market. eCube is the first data-driven platform that leverages Natural Language Processing (NLP) and Machine Learning algorithms to expedite the preclinical drug discovery process, which involves a large amount of manual labor. This revolutionary platform has been designed to streamline operations, reduce costs and optimize research timelines for various CROs in the preclinical market. With the help of eCube's comprehensive analytics system, CROs can generate meaningful insights from raw data for better decision-making. The launch of PsychoGenics' eCube marks a new era of innovation in the preclinical drug discovery process and promises to revolutionize the CRO market.
Proscia Announces Major Expansion in Preclinical R&D to Drive Faster Drug Safety Decisions
The preclinical CRO market rapidly expands due to increased demand for drug safety decisions. Proscia recently announced a significant expansion into the preclinical research space, with plans to significantly increase their capabilities and expand their services. This move allows Proscia to continue providing innovative solutions that enable pharmaceutical companies and research institutions to make faster and better decisions about drug safety. With its new technology, such as advanced digital pathology and AI-driven image analysis, Proscia can offer unprecedented scalability, accuracy, and speed in preclinical research. This expansion is an essential step in helping the industry move forward in developing safer drugs with more reliable data.
Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Preclinical CRO Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.
Key Company Profiles
The report delves into recent significant developments in the Preclinical CRO Market, highlighting leading vendors and their innovative profiles. These include 10x Genomics, Inc., AmplifyBio, Atuka Inc., BenchSci, Bioserve Biotechnologies (India) PVT Ltd. by REPROCELL Inc., Biotrofix, Inc., Celerion, Charles River Laboratories International, Inc., Crown Bioscience, Inc., CTI Clinical Trial and Consulting, Inc., Diag2Tec SAS, Eurofins Scientific SE, F. Hoffmann-La Roche Ltd., Gubra, Hera Biolabs, ICON PLC, Immusmol SAS, ImQuest BioSciences, Inotiv, Inc., Intertek Group PLC, Invivotek by Genesis Biotechnology Group, LLC, IQVIA Inc., Jubilant Biosys Ltd. byJubilant Pharmova Limited Company, Laboratory Corporation of America Holding, MCI Group Holding SA, MD Biosciences, Medpace Holdings, Inc., Novartis AG, Parexel International Corporation., PharmaCircle LLC, Phenos GmbH, PPD by Thermo Fisher Scientific Inc., PsychoGenics Inc., QPS Holdings, LLC, Sanofi S.A., SCiAN Services Inc., SGS SA, Shanghai Medicilon Inc., Syneos Health, Inc., Transpharmation, Veristat, LLC, Vimta Labs Limited, and WuXi AppTec Co., Ltd..
Market Segmentation & Coverage
This research report categorizes the Preclinical CRO Market to forecast the revenues and analyze trends in each of the following sub-markets:
Services
Bioanalysis & DMPK Studies
Toxicology Testing
Application
Cardiovascular Disease
Dermatology
Gastrointestinal
Genitourinary & Women’s Health
Hematology
Immunological Disorders
Infectious Diseases
Metabolic Disorders
Neurology
Oncology
Ophthalmology
Respiratory Disorders
End-User
Biopharmaceutical Companies
Government & Academic Institutes
Medical Device Companies
Region
Americas
Argentina
Brazil
Canada
Mexico
United States
California
Florida
Illinois
New York
Ohio
Pennsylvania
Texas
Asia-Pacific
Australia
China
India
Indonesia
Japan
Malaysia
Philippines
Singapore
South Korea
Taiwan
Thailand
Vietnam
Europe, Middle East & Africa
Denmark
Egypt
Finland
France
Germany
Israel
Italy
Netherlands
Nigeria
Norway
Poland
Qatar
Russia
Saudi Arabia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom
Please Note: PDF & Excel + Online Access - 1 Year
1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Increasing R&D activities by pharmaceutical and biopharmaceutical companies to develop new drugs & therapies
5.1.1.2. Rising trend of outsourcing drug development activities to CROs by pharmaceutical companies
5.1.1.3. Growing focus on the development of personalized medicines
5.1.2. Restraints
5.1.2.1. High cost and time-consuming constraints associated with preclinical CRO services
5.1.3. Opportunities
5.1.3.1. Growing advances in technologies to enable more efficient and cost-effective preclinical research
5.1.3.2. High potential for preclinical research for biologics, including monoclonal antibodies, vaccines, and cell therapies
5.1.4. Challenges
5.1.4.1. Stringent regulations and guidelines set by international regulatory authorities
5.2. Market Segmentation Analysis
5.2.1. Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects
5.2.2. End-User: Evolving usage of preclinical CRO by biopharmaceutical companies
5.3. Market Trend Analysis
5.3.1. Presence of well-established pharmaceutical & biopharmaceutical companies and the rising introduction of advanced preclinical CRO platforms in the Americas
5.3.2. Rising government support for expanding research & development activities into developing new drugs and medical devices in the Asia-Pacific region
5.3.3. Potential government funding in drug development activities expands the preclinical CRO business in the EMEA region.
5.4. Cumulative Impact of High Inflation
5.5. Porter’s Five Forces Analysis
5.5.1. Threat of New Entrants
5.5.2. Threat of Substitutes
5.5.3. Bargaining Power of Customers
5.5.4. Bargaining Power of Suppliers
5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis
5.8. Client Customization
6. Preclinical CRO Market, by Services
6.1. Introduction
6.2. Bioanalysis & DMPK Studies
6.3. Toxicology Testing
7. Preclinical CRO Market, by Application
7.1. Introduction
7.2. Cardiovascular Disease
7.3. Dermatology
7.4. Gastrointestinal
7.5. Genitourinary & Women’s Health
7.6. Hematology
7.7. Immunological Disorders
7.8. Infectious Diseases
7.9. Metabolic Disorders
7.10. Neurology
7.11. Oncology
7.12. Ophthalmology
7.13. Respiratory Disorders
8. Preclinical CRO Market, by End-User
8.1. Introduction
8.2. Biopharmaceutical Companies
8.3. Government & Academic Institutes
8.4. Medical Device Companies
9. Americas Preclinical CRO Market
9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States
10. Asia-Pacific Preclinical CRO Market
10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam
11. Europe, Middle East & Africa Preclinical CRO Market
11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom
12. Competitive Landscape
12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
12.3.1. CRO Company TriApex Completes Series C Financing Round Led by Legend Capital
12.3.2. PsychoGenics Launches eCube, a New AI-Enabled Platform for Drug Discovery
12.3.3. Proscia Announces Major Expansion in Preclinical R&D to Drive Faster Drug Safety Decisions
12.3.4. AmplifyBio Expands Cell Therapy Characterization, Fills Gap in Preclinical Development
12.3.5. Clinchoice Continues Expansion with CRO Acquisition
12.3.6. QPS opens an additional preclinical research facility in Taiwan
12.3.7. CRO Avania Acquires MAXIS
12.3.8. Apax Acquires a Majority Stake in Porsolt to Support its Growth Strategy and Become a Global Leader in Preclinical Services
12.3.9. Cryoport Announces Strategic Partnership with Syneos Health to Advance Cell & Gene Therapies
12.3.10. Crown Bioscience and ERS Genomics Announce Global CRISPR/Cas9 Licensing Agreement for Genome Editing Patents
12.3.11. Domain Therapeutics and Explicyte Enter Partnership Agreement in Immuno-Oncology
12.3.12. Celerion Expands Early Phase Clinical Pharmacology Units
12.3.13. ClinChoice Raises USD 150 Million in Series E Round
12.3.14. Hera BioLabs Announces Exclusive Global License With Charles River
12.3.15. IonsGate Preclinical Services and InSilicoTrials Form Partnership