Preclinical CRO Market Report 2025

The preclinical CRO market size has grown strongly in recent years. It will grow from $5.7 billion in 2024 to $6.26 billion in 2025 at a compound annual growth rate (CAGR) of 9.9%. The growth in the historic period can be attributed to demand for faster drug development, cost containment strategies, focus on core competencies, regulatory compliance requirements, globalization of clinical trials.

The preclinical CRO market size is expected to see strong growth in the next few years. It will grow to $9.06 billion in 2029 at a compound annual growth rate (CAGR) of 9.7%. The growth in the forecast period can be attributed to rise in personalized medicine, focus on rare diseases and orphan drugs, increased outsourcing in biopharmaceuticals, emphasis on biomarker research, demand for real-world evidence generation. Major trends in the forecast period include integration of artificial intelligence (AI), expansion of oncology research, advances in omics technologies, advanced in vitro and in vivo models, collaboration for translational research.

The growing demand for preclinical trials is projected to drive the expansion of the preclinical contract research organization (CRO) market in the future. Preclinical trials involve studies conducted on medicines or treatments for a condition before human volunteers are involved as test subjects. These studies often encompass innovative medical devices, prescription medications, and diagnostics, primarily aiming to determine a safe initial dose for first-in-human research and assess any potential toxicity of the product. Preclinical trials are essential to drug development, and their significance is heightened by the increasing focus on the safety and efficacy of new drugs. For instance, in February 2024, IQVIA, a U.S.-based company serving the healthcare technology and clinical research sectors, reported that clinical development productivity improved in 2023, with a total of 69 novel active substances (NASs) launched globally, which is six more than the previous year, including 24 first-in-class launches in the U.S. Consequently, the rising demand for preclinical trials is fueling the growth of the preclinical CRO market.

The increasing need for outsourcing services is poised to be a driving force behind the growth of the preclinical CRO market in the coming years. Outsourcing services involve contracting with third-party vendors to manage specific business tasks or operations. The complexity of preclinical research is on the rise, requiring specialized skills and expertise not always available in-house for pharmaceutical and biotechnology companies. Outsourcing to preclinical CROs allows companies to access the necessary expertise without the burden of building internal capabilities, enabling them to focus on core business activities while ensuring the completion of preclinical research. In April 2023, a survey by BioPlan Associates Inc. revealed that 84.6% of biomanufacturers are outsourcing analytical testing, and 74.5% are outsourcing toxicity testing in 2023. This underscores the increasing reliance on outsourcing services, contributing to the upward trajectory of the preclinical CRO market.

Technological advancements are a prominent trend gaining momentum in the preclinical Contract Research Organization (CRO) market, with significant companies in the sector adopting innovative technologies to strengthen their market positions. In February 2023, BenchSci, a Canada-based AI solutions company specializing in preclinical Research and Development (R&D), introduced ASCEND, an end-to-end Software as a Service (SaaS) platform for preclinical drug discovery. Leveraging artificial intelligence, ASCEND accelerates the preclinical phase of drug development pipelines by deriving biological insights into the foundational aspects of diseases. BenchSci's machine learning technology is employed to extract experimental data from both internal and external sources, enabling a comparison of results using curated ontology datasets. This approach facilitates the creation of evidence-based maps illustrating the biological processes underlying various diseases.

Key players in the preclinical CRO landscape are actively engaging in collaborations and partnerships to enhance their service offerings. Strategic partnerships, characterized by structured affiliations through business agreements or contracts, are a focal point in this context. In February 2022, IonsGate Preclinical Services Inc., a Canada-based CRO specializing in preclinical research services, announced a partnership with Insilicotrials Technologies Srl, an Italy-based provider of specialized consultancy for clinical trial solutions. This collaborative effort aims to leverage innovative technologies to expedite drug discovery processes, enabling more comprehensive preclinical testing capable of identifying potential safety risks at earlier stages of development.

In June 2022, Asahi Kasei Medical Co. Ltd., a Japan-based chemical company, successfully completed the acquisition of Bionova Scientific, LLC, in an undisclosed transaction. This strategic acquisition enhances Asahi Kasei Medical's bioprocess business by integrating a biopharmaceutical Contract Development and Manufacturing Organization (CDMO). The move broadens their customer base, particularly among those engaged in the development of cutting-edge next-generation biopharmaceuticals. Bionova Scientific LLC, a US-based company, specializes in offering contract process development services and Good Manufacturing Practice (GMP)-compliant contract manufacturing services for biopharmaceutical firms.

Major companies operating in the preclinical CRO market include Eurofins Scientific SE, PRA Health Sciences Inc., Wuxi AppTec Co. Ltd., Medpace Holdings Inc., Charles River Laboratories International Inc., Laboratory Corporation of America Holdings, SGA SA, Intertek Group plc, Crown Bioscience International, Cynbiose, AmplifyBio LLC, Vivotecnia SL, Simavita Ltd., BioEmission Technology Solutions, Altasciences Company Inc., Global Center For Medical Innovation, Pharmaceutical Product Development LLC, Parexel International Corporation, Envigo RMS Holding Corporation, Veeda Clinical Research Ltd., ICON plc, Kunming Biomed International Ltd., PharmaLegacy Laboratories, NorthEast BioAnalytical Laboratories LLC, MDS Pharma Services, MPI Research, Toxikon Corporation, BioReliance Corporation, Covance Inc., Syngene International Limited.

North America was the largest region in the preclinical CRO market in 2024. Asia-Pacific is expected to be the fastest-growing region in the global preclinical CRO market during the forecast period. The regions covered in the preclinical cro market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the preclinical cro market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Preclinical Contract Research Organizations (CROs) play a crucial role as indispensable support entities, providing essential expertise in research and development to guide drug candidates through the animal testing phase and advance them toward the clinical stage. Their significance lies in aiding medical product producers in demonstrating the safety and efficacy of their products in animals that closely mimic human anatomy, adhering to FDA standards. This process is a prerequisite before initiating clinical trials or human applications.

The services offered by preclinical CROs cover a wide spectrum, including bioanalysis and DMPK studies, toxicology testing, compound management, chemistry, safety pharmacology, and more. A notable advancement in this domain is the adoption of patient-derived organoids (PDOs), which are small three-dimensional cell cultures created from a patient's cancer cells. Substantial investments and experimental validation efforts have been dedicated to PDOs, presenting promising therapeutic alternatives for diagnosing complex diseases. The repertoire of preclinical CRO services encompasses various models, such as the patient-derived organoid (PDO) model and patient-derived xenograft model, applicable to both small and large animal models. These model systems, spanning In Vivo and In Vitro approaches, find applications among biopharmaceutical companies, government and academic institutes, medical device companies, and other stakeholders.

The preclinical CRO market research report is one of a series of new reports that provides preclinical CRO market statistics, including preclinical CRO industry global market size, regional shares, competitors with an preclinical CRO market share, detailed preclinical CRO market segments, market trends and opportunities, and any further data you may need to thrive in the preclinical CRO industry. This preclinical CRO market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The preclinical CRO market includes revenues earned by entities through project management, information gathering, medical evaluations, maximum dose research, adherence to regulations, efficacy and safety reporting, and quality analysis. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

This product will be delivered within 3-5 business days.