[195 Pages Report] 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.
Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects
Bioanalysis and DMPK studies are crucial for understanding potential therapeutic agents’ absorption, distribution, metabolism, and excretion (ADME) properties. This segment provides vital information on the drug’s behavior in a biological system, which is paramount for dosage determination and safety assessment. These studies are preferred in the early stages of drug development when detailed insight into the drug’s pharmacokinetic profile is required. Pharmaceutical companies and biotechnology firms often rely on external CROs with specialized expertise in bioanalytical methodologies and state-of-the-art technologies. Toxicology testing services are vital for evaluating the safety profile of drug candidates, ensuring they are safe for further development and human consumption. This segment encompasses a range of studies to assess the potential adverse effects of compounds on living organisms. These tests are critical before advancing to clinical trials, catering mainly to regulatory requirements that drugs must pass for approval. They are indispensable for all pharmaceutical and biotechnological companies needing to demonstrate the non-toxic nature of their products.
End-User: Evolving usage of preclinical CRO by biopharmaceutical companies
Biopharmaceutical companies are primary clients of preclinical CROs, leveraging their services for the development and testing of biologic drugs. These companies seek CRO partnerships to access specialized expertise in pharmacology, toxicology, and molecular biology. Services offered to biopharmaceutical companies often include drug efficacy and safety assessments, absorption, distribution, metabolism, excretion (ADME) studies, and regulatory support. Collaborating with preclinical CROs enables biopharmaceutical companies to accelerate their drug development process, manage costs effectively, and navigate complex regulatory requirements efficiently. Government and academic institutes often engage with preclinical CROs for research and development initiatives fundamental to public health objectives. These partnerships support projects, including new drug discoveries, vaccine development, and innovative medical treatments. Preclinical CROs provide these institutions with access to specialized resources and expertise that may not be available in-house. Additionally, CROs assist in conducting high-quality, regulatory-compliant research studies that can lead to groundbreaking medical advancements. Collaborations between government / academic institutes and CROs are pivotal in bridging the gap between basic research and clinical application. Medical device companies utilize preclinical CRO services to validate the security and efficacy of their products before proceeding to clinical trials. These companies benefit from CROs’ technical and regulatory expertise to conduct comprehensive biomedical testing, biomechanical evaluation, and risk assessment. Services tailored to medical device companies often encompass preclinical study design, prototype testing, and support in complying with international standards and regulations. By partnering with CROs, medical device companies can assure their products meet the highest quality and safety standards, facilitating smoother transitions into clinical phases.
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.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Preclinical CRO Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis 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: 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 examination of the current state of vendors in the Preclinical CRO Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. 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 this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
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
- Americas
The report offers valuable insights on the following aspects:
- Market Penetration: It presents comprehensive information on the market provided by key players.
- Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
- Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
- Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
- Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
The report addresses key questions such as:
- What is the market size and forecast of the Preclinical CRO Market?
- Which products, segments, applications, and areas should one consider investing in over the forecast period in the Preclinical CRO Market?
- What are the technology trends and regulatory frameworks in the Preclinical CRO Market?
- What is the market share of the leading vendors in the Preclinical CRO Market?
- Which modes and strategic moves are suitable for entering the Preclinical CRO Market?
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