U.S. Contract Research Organization (CROs) Market, by Service Type (Drug Discovery, Preclinical studies, Early Phase I – IIa, Phase IIa – III, Phase IIIb – IV, Drug Development, Medical Coding and Writing, Monitoring, Clinical Data Management, Bio-statistics, Site Management, Protocol Development, and Biomarker Discovery), by Therapeutic Application (Oncology, Cardiovascular Diseases, Central Nervous System Diseases, Infectious Diseases, Metabolic Disorders, Immunological Disorders, Respiratory Disorders, and Others), and by Size of CRO (Small Size, Medium Size, and Large Size)- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The U.S. contract research organization (CROs) market size was estimated at USD 16.85 billion in 2022 and is expected to surpass around USD 42.14 billion by 2032 and poised to grow at a compound annual growth rate (CAGR) of 9.6% during the forecast period 2023 to 2032.

Key Takeaways:

• The U.S. contract research organization (CROs) market is expected to exhibit a CAGR of 4.8% during the forecast period (2023-2032), increasing initiatives by key players to innovative services and products for managing the processes ranging from drug development to commercialization. For instance, in March, Parexel International Corporation launched PAREXEL's Medical Writing Solutions for offering communication services throughout the process of drug development and commercialization.
• Among size of CRO, large size segment is expected to hold significant share in the U.S. contract research organization (CROs) market over the forecast period, owing to increasing mergers & acquisitions by key players. These large-sized players have acquired numerous small and mid-sized CROs, in order to expand their service offering in different therapeutic areas and service modules such as full service, hybrid, and functional service along with expansion into newer markets. For instance, in May 2017, inVentiv Health and INC Research announced US$ 7.9 billion merger to form Syneos Health, one of the largest outsourcing providers. The merger has led to increase client base for Syneos Health.

U.S. Contract Research Organization (CROs) Market Report Scope

In order to increase success rate of drug discovery programs and decrease R&D costs, pharmaceutical companies seek to accelerate every stage of drug discovery process, starting from target identification to preclinical drug candidate. Increasing research and development expenditure has led to an increase in number of drug approvals in the recent past. For instance, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), 2018, the overall research and development spending of pharmaceutical and biotechnology companies was around US$ 63.2 billion in 2018 compared to US$ 56.8 billion in 2017, which was majority of all biopharmaceutical R&D spending in the U.S.

Increasing adoption of inorganic growth strategies such as acquisition to strengthen service portfolio by major players operating in the market is expected to drive the market growth during the forecast period. For instance, in August 2018, Syneos Health, Inc. acquired Kinapse, a leading advisory and operational solutions provider. This acquisition would help Syneos Health to expand regulatory, safety, and pharmacovigilance consulting and operations. Moreover, In May 2018, Ritter Pharmaceuticals, Inc. collaborated with Medpace: a clinical research organization (CRO), to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).

Furthermore, increase in strategic collaboration for development of innovative therapies for treatment of various health conditions such as immunological disorder is expected to drive the growth during the forecast period. For instance, in August 2019, Pharmaceutical Product Development, LLC entered into a collaborative agreement with Harbour BioMed (HBM), a global clinical-stage biopharmaceutical company, to conduct clinical studies for its research pipeline on anti-cancer immunotherapy

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.

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.

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.

Some of the prominent players 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
• Clinipace

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Contract Research Organization (CROs) market.

By Service Type:

• Drug Discovery
• Preclinical studies
• Early Phase I - IIa
• Phase IIa - III
• Phase IIIb – IV
• Drug Development
• Medical Coding and Writing
• Monitoring
• Clinical Data Management
• Bio-statistics
• Site Management
• Protocol Development
• Biomarker Discovery

By Therapeutic Application:

• Oncology
• Cardiovascular Diseases
• Central Nervous System Diseases
• Infectious Diseases
• Metabolic Disorders
• Immunological Disorders
• Respiratory Disorders
• Others

By Size of CRO

• Small size
• Medium size
• Large size