May 27, 2024
Contract Research Organization

The Growing Landscape of U.S. Contract Research Organization

The U.S. Contract Research Organizations Market has experienced tremendous growth and transformation over the past few decades. Advancements in scientific understanding and technological capabilities have enabled the development of novel drug targets and innovative treatment approaches. As research and development has become more complex, specialized, and data-driven, pharmaceutical and biotechnology companies have increasingly relied on external partners to support various aspects of their drug development pipelines.

Outsourcing Non-Core Functions
One of the key trends fueling the expansion of the contract research organization (CRO) industry has been the biopharma sector’s focus on outsourcing non-core functions. As drug developers seek to streamline internal operations and contain costs, many have determined that drug discovery, clinical trials management, and regulatory consulting can be more efficiently and effectively handled by expert third-party providers. By outsourcing these specialized, yet non-essential capabilities, biopharma companies are able to devote more internal resources toward their core competencies of project leadership, portfolio strategy, and commercialization activities.

Growth of the CRO Industry
As a result, the U.S. Contract Research Organizations has experienced tremendous growth over the past two decades to help meet the extensive strategic and operational outsourcing needs of biopharmaceutical clients. According to industry reports, the global CRO market was worth an estimated $57 billion in 2021 and is projected to surpass $100 billion by 2026. Leaders in the fragmented CRO landscape provide a wide spectrum of drug development services, including target validation, compound screening, formulation development, clinical research, and regulatory support. The United States is home to many of the largest, most sophisticated CROs and accounts for approximately 40% of the worldwide CRO market.

Clinical Trial Support Remains Core Service
While the scope of CRO capabilities has expanded considerably, supporting clinical trials remains the cornerstone service for most organizations. As clinical research grows increasingly complex due to factors like multi-indication development programs and global study footprints, CRO expertise in trial design, patient recruitment, site management, and data management has become essential for sponsors. Leading U.S.-based CROs leverage extensive global infrastructure and therapeutic expertise to efficiently enroll thousands of patients across hundreds of clinical sites annually for Phase I-IV trials. Their integrated service offerings aim to minimize sponsors’ clinical development timelines and costs.

Data Management and Analytics Growth Area
One particularly fast-growing segment within the CRO sector has been data management and analytics services. As biopharma R&D becomes data-driven, the ability to capture, integrate, analyze and report on vast amounts of information from preclinical research through registrational studies has become invaluable. Leading CROs have substantially expanded their data and analytics capabilities in recent years through technology platforms, analytics firms, and partnerships. Many now offer services like real-world evidence generation, predictive modeling, outcome analysis, and personalized medicine support that help sponsors translate study data into actionable insights.

Partnering Across Drug Development Continuum
A defining characteristic of large U.S. CROs has been their ability to partner with clients across the entire drug development spectrum, from target identification and candidate selection through commercialization. By leveraging comprehensive therapeutic and technical expertise established through hundreds of completed projects, these CROs aim to form long-term strategic partnerships with biopharma sponsors. Their value propositions center on continuity of service, reduced overhead through consolidated relationships, multi-study/program discounts, and expert guidance on development programs from early research through commercialization.

Focus on Specialty Therapeutic Areas
While many large CROs provide solutions spanning major disease states, others have established specialized therapeutic expertise that addresses high-priority areas for biopharma R&D. For instance, some concentrate on oncology, others in areas like immunology/inflammation, neuroscience, or rare and orphan diseases. By deeply understanding disease pathways, endpoints, and the regulatory landscape, these therapeutic specialists can provide targeted guidance and operational support. Their focus also allows for dedicated project teams and technology platforms tailored for priority indications.

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