May 23, 2024
U.S. Contract Research Organization (CROs)

The Growing Role of U.S. Contract Research Organizations in Pharmaceutical Sector

Overview of CRO Industry in the United States

The contract research organization or CRO industry has experienced significant growth in the United States over the past few decades. CROs provide outsourced services to the pharmaceutical, biotechnology and medical device industries, helping them with drug discovery, clinical trial design and management, and regulatory affairs. As R&D costs in the pharmaceutical industry continue to skyrocket and product development timelines remain long, more pharmaceutical companies are turning to CROs to share risks and reduce costs.

Some key factors that have driven the growth of U.S. Contract Research Organization (CROs) include the need for pharmaceutical companies to reduce fixed costs and focus on their core competencies. By outsourcing non-core activities like clinical trials to CROs, drug developers hope to streamline operations and boost efficiency. In addition, CROs offer therapeutic and region-specific expertise that pharmaceutical companies may lack. Their specialized services and resources help sponsors meet regulatory requirements more easily. The biopharmaceutical industry’s increasing R&D expenditures, paired with pressure to quickly develop new drugs, have further boosted demand for high-quality outsourcing partners like CROs.

Services Offered by Leading CROs

CROs offer a wide range of clinical and non-clinical research services over the course of drug development. On the clinical side, some of their major service areas include:

– Clinical Trial Design – CROs help translate the scientific hypothesis into well-designed clinical protocols suitable for regulatory approval.

Site Identification and Management – They utilize their global site networks to recruit patients, set up sites, and oversee site activities and document flow.

– Patient Recruitment – With an in-depth understanding of regional healthcare landscapes, CROs tap their resources and relationships to enroll appropriate patients fast.

– Data Management – They ensure accurate capturing, validation and reporting of clinical data using electronic data capture systems.

– Biostatistics – CRO statisticians offer planning, analysis and programming expertise for experimental data.

– Medical Monitoring – Their clinicians monitor trial conduct and patient safety on an ongoing basis.

On the non-clinical front, key CRO services span preclinical research, laboratory testing, molecular imaging, biopharmaceutical characterization and more. Regulatory services include preparing documentation for global filings. CROs provide integrated solutions across the value chain to meet sponsors’ research objectives.

Top U.S. Contract Research Organizations

A few leading CROs that have built a strong presence in the competitive U.S include:

– IQVIA: Formed in 2018 via merger of IMS Health and Quintiles, it is the world’s largest CRO with headquarters in North Carolina.

– PRA Health Sciences: This Raleigh, NC-based full-service CRO trades on NASDAQ and has expertise in Phase I-IV trials.

– PAREXEL International: Specializing in biopharma services and drug development, it is headquartered in Massachusetts.

Laboratory Corporation of America (Covance): Following acquisition of Covance in 2015, it is a frontrunner in preclinical and clinical research.

– Charles River Laboratories: Originating in Massachusetts, it offers comprehensive outsourcing for non-clinical and clinical phases.

– Syneos Health: A product of merger between INC Research and inVentiv Health, it has capabilities across clinical development spectrum.

– ICON plc
: The Dublin, Ireland-based company executes clinical research through its network of sites internationally.

Impact of COVID-19 and Future Growth Prospects

The sudden outbreak of the COVID-19 pandemic posed unique challenges as well as opportunities for CROs in the United States. Strict lockdowns initially disrupted on-site trials but CROs quickly adapted through remote and virtual trial strategies. They helped transfer resources to high-priority COVID-19 vaccine and drug development programs on an emergency basis.

Looking ahead, the U.S. Contract Research Organizations is expected to grow at a healthy pace. Pharmaceutical R&D spending will remain robust as the focus shifts to complex therapies in areas like oncology and rare diseases. Outsourcing trends indicate sponsors preferring strategically managed partnerships over owning trial infrastructure. Digital technologies are revolutionizing trials too, opening up new streams for tech-focused CROs. Markets like Asia-Pacific also promise future expansion as regional drug development activity rises. Overall, the increasing R&D workload could fuel sustainable growth of established large CRO franchises in the U.S over the coming years.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it