U.S. Contract Research Organization (CRO) Services Market Size, Share & COVID-19 Impact Analysis, By Service Type (Early Phase Development Services (Chemistry, Manufacturing, and Controls (CMC), Preclinical Service, and Discovery), Clinical (Phase 1, Phase 2, Phase 3, and Phase 4), Laboratory Services, and Others), By Application (Oncology, Neurology, Cardiology, Infectious Disease, Metabolic Disorder, Renal/Nephrology, and Others), By End User (Pharmaceutical and Biotech Companies, Medical Device Companies, Academic and Research Institutes, and Others), and Country Forecast, 2023-2030

The U.S. Contract Research Organization (CRO) services market size was worth USD 32.99 billion in 2022 and is projected to grow at a CAGR of 11.5% during the forecast period.

Contract research organizations conduct clinical trials for pharmaceutical, biotechnological, and medical device companies and provide research-related support services. Contract research organizations help in conducting efficient and less time-consuming studies. Increasing outsourcing by pharmaceutical, biotechnological, and medical device companies to CROs are fueling market growth.

The increasing outsourcing of research studies is due to stringent regulatory approvals and high drug or device development costs. Moreover, the increasing prevalence of chronic diseases such as diabetes, cancer, Alzheimer’s, and infectious diseases has led to an increasing focus on R&D by market players. The above factors, combined with the emergence of regional, domestic, and global contract research organizations offering various services, including end-to-end research services, are leading to increased outsourcing of services to these organizations.

• For instance, in March 2022, IQVIA Inc. announced its agreement with Argenx SE to develop new indications for VYVGART.

During the COVID-19 outbreak, the U.S. Contract Research Organization services market experienced significant growth in 2020. The growth was due to the increased demand for research and development of vaccines and effective treatment options for COVID-19.

LATEST TRENDS

High Cost Associated with the R&D of Novel Drugs Fuels the Outsourcing of Clinical Trials

The entire cost for drug development, from preclinical studies to its commercialization, can be around USD 1.0 billion to USD 2.0 billion. However, the overall cost depends on the type of study being conducted, regulatory approvals, patient recruitment, and other factors. The estimated cost may increase if there are delays in the completion of the research study due to the above factors; consequently, the pharma and biotech companies’ spending on R&D increases. For instance, Bristol-Myers Squibb Company, one of the major players in the pharmaceutical industry, spent around USD 9.50 billion in 2022.

Contract research organizations help manufacturers to save time and money by reducing the time required to conduct a trial. The emergence of market players offering specific contract research organization services also assists in pharmacovigilance and regulatory approvals, thus speeding up the approval process.

To reduce their spending on R&D for novel treatment, many pharmaceutical and biotechnological companies have been outsourcing their research studies to the Contract Research Organization (CRO) services provider.

• For instance, in March 2023, ICON plc partnered with LEO Pharma for the execution of clinical trials to develop new effective medicines for dermatology patients. This fueled the growth in the company’s revenue generation.

Earlier, due to the limited availability of resources, small pharmaceutical and biotechnological companies were unable to conduct exhaustive research for new drug development. After the emergence of CROs, these companies started outsourcing their R&D activities to the CROs, positively impacting the U.S. Contract Research Organization (CRO) services market growth.

DRIVING FACTORS

Increased Outsourcing of Clinical Trials Fuels Market Expansion

Many academic institutes and pharmaceutical and biotechnological companies have increased their focus on developing effective treatments for a rising patient population suffering from chronic conditions. The increasing focus of life science companies in the R&D for new treatment or medical device development has been fueling the number of clinical trials in the country.

• For instance, around 9,901 clinical trials were registered in the U.S. in 2022, whereas in 2016, 9,221 clinical trials were registered in the U.S.

Drug development costs are quite high, and any failure in clinical trials can result in losing investments. Moreover, the duration of clinical trials is estimated before the trials are initiated, which determines the cost of the clinical trials. An extension in the estimated timeline results in increased expenditure on the trials.

A Contract Research Organization services providers help manufacturers by reducing the time required for conducting clinical research, resulting in significant cost savings. Early-stage clinical trials are increasingly being outsourced to cut costs and maximize revenues. Many pharmaceutical and medical device companies are inclined toward outsourcing their R&D process to CRO services. This trend is expected to propel the market growth during the forecast period.

The number of clinical trials registered in the U.S. in 2022 was 9,901, experiencing a growth of 7.4% from 2016.

RESTRAINING FACTORS

Limited Availability of Experienced Workforce is Expected to Restrict Market Growth

Industrialization has been increasing significantly. With the growing industrialization, the demand for advanced skills has increased. Market players are facing issues in hiring skilled workforce, including scientists. The limited availability of skilled workforce, with their experience in the pharmaceutical, biotechnological, and medical devices industry, is restricting the market growth in the country.

• For instance, Bio-Rad Laboratories, Inc., in its article published in 2022, mentioned that the U.S. states with emerging biotechnological industries, such as St. Louis, are in increasing need for an experienced workforce to fill the biotech job vacancies in the state.

The limited availability of skilled workforce restricts the penetration of contract research organizations in the country, negatively impacting the market during the forecast period.

SEGMENTATION

By Service Type Analysis

Based on service type, the market is fragmented into early phase development services, clinical, laboratory services, and others. The early phase development services segment is further sub-segmented into Chemistry, Manufacturing, and Controls (CMC), preclinical service, and discovery. Similarly, the clinical segment is sub-segmented into phase 1, phase 2, phase 3, and phase 4.

The clinical segment dominated the market in 2022. The segment’s dominance is attributed to the increased focus of the pharmaceutical industry on the R&D of novel treatments.

• For instance, according to NCBI, in 2021, the overall pharmaceutical expenditure in the U.S. grew by 7.7% from the prior year.

By Application Analysis

On the basis of application, the market is segmented into oncology, neurology, cardiology, infectious disease, metabolic disorder, renal/nephrology, and others.

The oncology segment dominated the market in 2022 due to the companies’ increasing focus on R&D in oncology.  

• In December 2022, Phastar joined Lean Life Sciences Oncology Development Programme (ODP2). The objective was to identify and boost novel oncology innovations for academics and early-stage companies.

By End-user Analysis

Based on end-user, the market is segmented into pharmaceutical and biotech companies, medical device companies, academic and research institutes, and others.

The pharmaceutical and biotech companies segment is expected to grow at a significant CAGR during the forecast period. The segment's growth is majorly due to the increased outsourcing of early-phase development services.

KEY INDUSTRY PLAYERS

The market comprises significant players such as IQVIA Inc., Icon plc, Syneos Health, Laboratory Corporation of America Holdings, and PRA Health. IQVIA Inc. accounted for a significant U.S. Contract Research Organization services market share in 2022, owing to its strong focus on R&D to enhance its services.

• In November 2021, IQVIA announced its product IQVIA RIM Smart Labeling. It is a purpose-built next-generation label information management solution to manage pharmaceutical labeling. This enhanced the company’s services portfolio.

Other companies in the market include Parexel (MA) Corporation, Charles River Laboratories, PSI, and Medpace. These companies have been focusing on partnership and collaboration to strengthen their position in the market.

LIST OF KEY COMPANIES PROFILED:

• IQVIA Inc. (U.S.)


• Parexel International (MA) Corporation (U.S.)


• ICON plc (Ireland)


• Laboratory Corporation of American Holdings (U.S.)


• Charles River Laboratories (U.S.)


• PHASTAR (U.K.)


• PSI (Switzerland)


• Medpace (U.S.)


• Worldwide Clinical Trials (U.S.)


• ProRelix Services LLP (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• June 2023 – Laboratory Corporation of America Holdings announced the formation of a new company Fortrea after the spinning-off of Labcorp's Clinical Development and Commercialization Services business.


• May 2023 – Laboratory Corporation of America Holdings, BML Research Institute, and General Laboratory announced the expansion of clinical laboratory testing capabilities in Japan.


• October 2021 – Parexel International (MA) Corporation and Kyoto University Hospital partnered to provide opportunities for clinical research and to produce effective ways to support clinical studies.

REPORT COVERAGE

The market research report provides a detailed market analysis with market segmentation, key points such as an overview of technological advancements, and services provided by CROs. Additionally, it includes penetration of Contract Research Organization services in the U.S., new service launches, key industry developments such as mergers, collaborations, & acquisitions, and the impact of COVID-19 on the market. Furthermore, the report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that contributed to the growth of this market in recent years.

Report Scope & Segmentation