A contract research organization (CRO) is a service provider organization that offers various drug developmental and clinical data management services supporting pharmaceutical and biotechnology industries engaged in clinical trials, in the form of outsourced pharmaceutical research services (for both drugs and medical devices). CROs range from large, medium to small, and niche specialty groups.
Increasing adoption of regulatory outsourcing services by pharmaceutical and other industries, in order to gain various grants from U.S. FDA such as fast track designation and orphan drug designation for their products to gain faster approvals in market are expected to propel the market growth over the forecast period. For instance, in 2018, according to the Center for Drug Evaluation and Research, a division of the U.S. Food and Drug Administration (FDA), 34 out of 59 novel drugs were approved for treating orphan diseases in the U.S.
U.S. Contract Research Organization (CROs) market is estimated to be valued at US$ 15,918.6 million in 2022 and is expected to exhibit a CAGR of 9.6% during the forecast period (2022-2030).
Figure 1. U.S. Contract Research Organization (CROs) Market Share (%), by Therapeutic Application, 2022
-market-figure-1.png "U.S. Contract Research Organization (CROs) | CMI")
Increasing technological advancements such as use of artificial intelligence and machine learning in the field of clinical research are expected to drive growth of the U.S. contract research organization (CROs) market during the forecast period.
Increasing use of artificial intelligence and machine learning along with big data is expected to improve the efficiency of clinical trial process and help speed up drug approval process. Artificial intelligence can help in identifying potential hazards in the clinical development process at an early stage, thereby allowing researchers to reduce the cost and time required for research. Artificial Intelligence can also be used in combination with wearable devices for processing and analyzing multiple real-time data. For instance, in June 2018, BioClinica, a global life science service provider, expanded and enhanced SMART technology suite equipped with medical imaging, electronic data capture (EDC), and interactive response technology (IRT) technologies for efficient analysis of clinical trial data.
| Report Coverage | Details | ||
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| Base Year: | 2021 | Market Size in 2022: | US$ 15,918.6 Mn |
| Historical Data for: | 2017 to 2020 | Forecast Period: | 2022 to 2030 |
| Forecast Period 2022 to 2030 CAGR: | 9.6% | 2030 Value Projection: | US$ 33,203.1 Mn |
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| Companies covered: |
Laboratory Corporation of America Holdings (Covance), IQVIA, Paraxel International Corporation, Syneos Health, PRA Health Sciences, Charles River Laboratoires International Inc. (CRL), Pharmaceutical Product Development (PPD), ICON Public Limited Corporation, Wuxi Apptec, Medpace Holdings, Inc, Medidata Solutions, Inc., Theorem Clinical Research, Pharmaron, Envigo, and Clinipace. |
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Figure 2. U.S. Contract Research Organization (CROs) Market Share (%), by Size of CRO, 2022
-market-figure-2.png "U.S. Contract Research Organization (CROs) | CMI")
Increasing merger and acquisition activities by various market players is expected to drive market growth during the forecast period.
Key market players are focusing on inorganic growth strategies such mergers and acquisition in order to increase their market presence.
For instance, on July 5, 2022, Eurofins Discovery, a U.S based drug discovery company acquired contract research organization DiscoveryBioMed, a life sciences and biotechnology company. This acquisition contributed to Eurofins Discovery's aim of offering array of drug discovery services and products.
U.S. Contract Research Organization (CROs) Market– Impact of Coronavirus (COVID-19) Pandemic
Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.
COVID-19 has affected the economy in three main ways: by directly affecting production and demand of drugs and vaccines, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, UAE, Egypt, and others, faced problems with regard to the transportation of drugs and vaccines from one place to another.
However, the COVID-19 pandemic had a positive impact on the U.S. Contract Research Organization (CROs) market. The impact of the COVID-19 pandemic on the contract research organization market has been significant due to the ongoing clinical trials to develop effective therapeutics and vaccines against the SARS-CoV2 virus.
U.S. Contract Research Organization (CROs) Market: Key Developments
On June 16, 2022, Medidata, a Dassault Systèmes company, announced that they expanded their partnership with Novotech, a contract research organization (CRO), to continue scaling clinical studies in various therapeutic areas from 2022.
Leveraging Rave EDC, Rave RTSM, eCOA and eConsent technology from Medidata, Novotech is equipped with flexible, configurable tools that can address clinical research needs at scale and facilitate accelerated drug and device development in Asia Pacific and the U.S.
U.S. Contract Research Organization (CROs) Market: Restraint
Fluctuation in prices and hidden cost of clinical research services are the major factors that are expected to hinder the market growth over the forecast period. Moreover, other costs are involved in the services with increasing use of technological platforms, which includes software for clinical data management, database, document management, and others. Usage of such advanced technology enhances the overall process and provides quality data, however, it increases the cost of outsourcing services, which in turn is expected to hamper growth of the U.S. contract research organization (CROs) market during the forecast period.
Key Players
Major players operating in the U.S. Contract Research Organization (CROs) market include Laboratory Corporation of America Holdings (Covance), IQVIA, Paraxel International Corporation, Syneos Health, PRA Health Sciences, Charles River Laboratoires International Inc. (CRL), Pharmaceutical Product Development (PPD), ICON Public Limited Corporation, Wuxi Apptec, Medpace Holdings, Inc, Medidata Solutions, Inc., Theorem Clinical Research, Pharmaron, Envigo, and Clinipace.
A contract research organization (CRO) offers effective services to pharmaceutical and biotechnology organizations by reducing cost and time period required to conduct clinical trials. The U.S. continues to be one of the largest market for pharmaceutical research and development, thereby providing growth opportunities for contract research organizations (CROs). CROs offer drug discovery services such as drug target identification, drug discovery screening, library screening, fragment-based drug design, ligand-based drug design, ligand protein binding, drug profiling, lead identification, lead compound identification, and lead optimization. CROs conduct clinical trial studies (from phase I to phase IV). They are also engaged in medical coding, monitoring, clinical data management, protocol development, and other services which are included in clinical development of any drug molecules.
Market Dynamics
Rising number of U.S. Food and Drug Administration (FDA) approvals and clinical trials are supporting growth of biopharmaceutical industry and are expected to fuel growth of the U.S. contract research organization (CROs) market. The U.S. is expected to hold dominant position in the contract research organization market over the forecast period due to rising demand for generic drugs, increasing clinical research and development activities, and government support. The U.S. is one of the biggest market for contract research organization due increasing pharmaceutical research and development activities in the country, thereby providing growth opportunities for contract research organizations (CROs). For instance, according to the clinicaltrials.gov, as of September 12, 2022, the total number of registered clinical studies were 427,488 out of which 134,895 (32%) of the studies were performed in the U.S. alone.
Key features of the study:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
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