Healthcare Contract Research Outsourcing Market (Service: Clinical Trial Service, Regulatory Services, Clinical Data Management & Biometrics, Medical Writing, Pharmacovigilance, Site Management Protocol, and Others; Therapeutic Area: Oncology/Hematology, CNS, CV/Metabolic, Respiratory, Infectious Diseases, Immunology, Rare Diseases, Medical Devices, and Others; and End-user: Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, and Academic Institutes & Government Organizations) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2022-2030

The global healthcare contract research outsourcing market was surpassed at USD 39.24 billion in 2021 and is expected to hit around USD 65.39 billion by 2030, growing at a CAGR of 5.84% from 2022 to 2030.

Healthcare Contract Research Outsourcing Market: Overview

• Healthcare companies often outsource drug development functions to contract research organizations to efficiently and effectively use the development capabilities internationally
• The clinical, therapeutic, and regulatory expertise of CROs helps to improve the complete cost of development and accelerate time to market for a new product
• CROs have become larger and more diversified across various therapeutic areas and functions, expanding their penetration
• The global healthcare contract research outsourcing market has been segmented based on service, therapeutic area, and end-user
• The global healthcare contract research outsourcing market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global healthcare contract research outsourcing market in terms of revenue in 2020 and the trend is projected to continue during the forecast period.

The healthcare contract research outsourcing market is projected to witness strong growth during the forecast period driven by increase in funding for small to mid-sized pharmaceutical, biotechnology, and medical device companies, thus driving the companies to opt for CRO services with focus on niche markets. The global healthcare contract research outsourcing market is witnessing high growth, owing to globalization of clinical trials, increasing efforts for optimization of costs and development time for drug development, and rise in varied services and solutions offered by the CROs. Increased access to specialized technologies and therapeutics expertise is projected to fuel the adoption of clinical trial services in the North America during the forecast period.

Scope of The Report

Incremental Opportunities for Healthcare Contract Research Outsourcing Market Players

The global healthcare contract research outsourcing market is expected to expand on the back of several factors including surge in efforts intended for costs & drug development time optimization, increase in different services and solutions provided by the CROs, and globalization of clinical trials. Some of the important services available in the healthcare contract research outsourcing market include regulatory service, clinical trial service, pharmacovigilance, site management protocol, and medical writing. These services are mainly used by biotechnology companies, pharmaceutical companies, academic institutes & government organizations, and medical device companies across the globe.

Enterprises from the global healthcare contract research outsourcing market are estimated to observe increase in demand for regulatory services outsourcing. This increase can be attributed to rise in scrutiny by regulatory authorities, including the EMA and FDA at all stages of clinical trials. Moreover, changing regulatory needs in each region is expected to drive the demand opportunities for regulatory services outsourcing activities.

Expansion of Companies to Gain Potential Revenue Benefits Boosts Market Growth

Companies in the healthcare contract research outsourcing market are entering into collaboration and acquisition agreements in order to maintain their leading market position and expand their presence in newer regions. Some of the key players operating in the global healthcare contract research outsourcing market are focusing on offering quality services to gain attention from consumers. Outsourcing improves the global reach with respect to drug development with minimum maintenance cost, as CROs are well-versed with regulatory requirements of various regions to fueling the expansion of healthcare contract research outsourcing market. Healthcare companies often outsource drug development functions to contract research organizations to efficiently and effectively use the development capabilities internationally.

North America Dominates Global Healthcare Contract Research Outsourcing Market

North America is expected to offer lucrative opportunities due to factors such as presence of advanced infrastructure required for clinical researches and key government incentive programs in the region, specifically in the U.S. In addition, increase in availability of therapeutics expertise and specialized technologies is expected to result in rise in the number of clinical trial services in the U.S. in the upcoming years. The North America healthcare contract research outsourcing market is rising with increasing complex regulatory process & growing regulatory burden. The market in North America is primarily driven by advanced infrastructure of clinical research sites, and effective government incentive programs in United States. The Asia Pacific region is projected to be fastest growing region in the global healthcare contract research outsourcing market during the forecast period. In Asia Pacific, China and India are significant markets for healthcare CRO and India is estimated to grow at a rapid pace during the forecast period.

CROs to Contribute to Success of Pharmaceutical Industry

The clinical, therapeutic, and regulatory expertise of CROs help to improve the complete cost of development and accelerate time to market a new product. CROs have become larger and enormously more diversified across various therapeutic areas and functions, expanding their penetration. Small pharmaceutical companies are also looking for advancements in product development through CRO services due to rise in demand for innovative products and patent expiration. CROs are anticipated to expand geographically and add competencies in emerging therapeutic areas, while boosting their current services beyond traditional clinical capabilities, including post-approval, commercial, informatics, etc. where low - outsourced penetration observed, further enhancing the demand for CROs, driving greater outsourcing demand. The regulatory services outsourcing is anticipated to increase due to increased scrutiny by regulatory bodies such as the FDA and EMA at every stage of clinical trial and changing regulatory requirements as per the region.

Late Stage Drug Development Outsourcing: Key Driver

• Transit of a drug from the laboratory to market is a time consuming process, with regulatory authorities demanding for more trial data evidences. Late stage development process demands large number of patient recruitment and longer trials. Hence, most of the development activities are outsourced to CROs.
• For instance, in June 2018, Laboratory Corporation of America Holdings acquired Sciformix Corporation (a U.S.-based scientific process outsourcing firm that lays emphasis on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices companies) in order to strengthen its position in the later phases of drug and device development, especially for post-marketing pharmacovigilance and market access solutions. Sciformix is a part of Covance (LabCorp’s drug development business), which will support Covance’s work in transforming drug development through innovation and high efficiency.
• Healthcare companies are seeking approvals of multiple regions simultaneously. Global CROs are well-positioned to provide late-stage development services with an added expertise of regulatory knowledge of various geographies, which drives the demand for their services.

Oncology/Hematology Segment to Dominate Global Market

• A robust pipeline of more than 600 molecules for oncology is undergoing late-stage development. Hence, the oncology/hematology segment is anticipated to capture the largest market share by the end of the forecast period.
• In 2021, the Food and Drug Administration (FDA) approved 50 new drugs for 22 indications, but there are still a lot more incurable cancer types
• This increases the need of development of new drug products, driving the drug development. Moreover, competition in the oncology segment is high, as no single therapy is sufficient for the treatment of cancer. This calls for continuous development of better treatment options, which fuels the oncology segment.

North America to Dominate Healthcare Contract Research Outsourcing Market

• In terms of region, the global healthcare contract research outsourcing market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
• North America is projected to account for the largest share of 44.98% of the global market by 2028. The market in the region is likely to reach US$ 29.69 Bn by 2030, expanding at a CAGR of 7.6% from 2021 to 2030

Key Players

• Syneos Health
• PAREXEL International
• ICON plc
• PRA Health Sciences, Inc.
• Charles River
• Laboratory Corporation of America Holdings (Covance)
• IQVIA
• Medpace
• Pharmaceutical Product Development, LLC.

Market Segmentation

• By Service
• Clinical Trial Service
• Preclinical
• Clinical
• Regulatory Service
• Clinical Data Management & Biometrics
• Electronic Data Capture
• Electronic Patient Recorded Outcomes
• Others
• Medical Writing
• Pharmacovigilance
• Site Management Protocol
• Others
• By Therapeutic Area
• Oncology / Hematology
• CNS
• CV / Metabolic
• Respiratory
• Infectious Diseases
• Immunology
• Rare Diseases
• Medical Devices
• Others
• By End-user
• Pharmaceutical Companies
• Biotechnology Companies
• Medical Device Companies
• Academic Institutes & Government Organizations
• By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa