Global Clinical Trials Support Services Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Service;
Clinical Trial Site Management, Data Management, Patient Recruitment Management, Administrative Staff, IRB, and Others.By Phase;
Phase I, Phase II, Phase III, and Phase IV.By Sponsor;
Pharmaceutical & Biopharmaceutical, Medical Devices, and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa, and Latin America - Report Timeline (2021 - 2031).Introduction
Global Clinical Trials Support Services Market (USD Million), 2021 - 2031
In the year 2024, the Global Clinical Trials Support Services Market was valued at USD 24,573.61 million. The size of this market is expected to increase to USD 41,302.73 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 7.7%.
Clinical trial support services encompass a diverse array of essential functions provided by pharmaceutical companies throughout the various stages of clinical trials. These services are indispensable for ensuring the successful development and eventual approval of new drug molecules, as well as facilitating the market introduction of generics and biosimilars. From initial assay design to clinical testing and beyond, these support services play a pivotal role in every aspect of the trial process.
One of the fundamental aspects of clinical trial support services is patient recruitment. This involves identifying and enrolling suitable participants who meet the specific criteria outlined for the trial. Effective patient recruitment strategies are crucial for ensuring that the study progresses smoothly and meets its enrollment targets within the designated timeframe.
Clinical trial site support is another critical component of these services. This involves establishing and maintaining relationships with clinical trial sites, providing them with the necessary resources and support to conduct the study effectively. This may include training site staff, supplying study materials and medications, and addressing any issues or concerns that arise during the course of the trial. Procuring and storing study medications is essential to ensure the integrity and efficacy of the trial. This includes acquiring the necessary medications from approved suppliers, ensuring their proper storage and handling according to regulatory guidelines, and maintaining accurate inventory records throughout the duration of the study.
Blinding of study drugs is a common practice in clinical trials to minimize bias and ensure the validity of the results. This involves concealing the identity of the study drug from both participants and investigators, typically through the use of placebo controls or double-blind protocols. Coordination and reconciliation of returned medications are important for tracking the usage of study drugs and ensuring compliance with the trial protocol. This may involve collecting unused medications from study participants, reconciling discrepancies in medication usage, and documenting any adverse events or side effects reported by participants.
Calculation of specific dosing regimens is essential for ensuring the safety and efficacy of the study drugs. This involves determining the appropriate dosage for each participant based on factors such as age, weight, and medical history, and providing clear instructions for administration. Lab kit handling involves the procurement, distribution, and tracking of laboratory kits used for collecting and analyzing biological samples during the trial. This ensures that samples are handled and processed according to standard protocols to maintain the integrity of the data.
Global Clinical Trials Support Services Market Recent Developments
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In Nov 2022, End-of-treatment data from Amgen's Phase 2 OCEAN(a)-DOSE study of investigational olpasiran (formerly AMG 890) in adults were presented. Olpasiran reduced lipoprotein(a) levels in patients with established atherosclerotic cardiovascular disease by more than 95%. (ASCVD).
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In April 2022, As part of its continued expansion into Europe, Advanced Clinical announced the opening a new office in Zug, Switzerland, in April 2022.
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In Jan 2022, By combining self-assembled monolayers and MALDI MS, Charles River Laboratories International, Inc expanded its collaboration with SAMDI Tech Inc in January 2022 to address the throughput and sample preparation limitations of traditional MS screening methods.
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In 2022, the Advarra Cloud solution will provide end-to-end integration and automated, seamless research document exchange between sites, sponsors, and CROs due to collaboration with Advarra's Site-Sponsor Consortium.
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In 2021, ERT, the international leader in clinical endpoint data solutions, merged with Bioclinica and the combined company was renamed Clario. Bioclinica's expertise in imaging, eClinical software, and drug safety solutions will be combined with ERT's expertise in eCOA, cardiac, respiratory, and wearable safety. The development aims to combine both companies' technical aspects to provide better service to a more extensive customer base.
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In March 2021, Advarra, a leading research company that provides solutions to make clinical trials safer, smarter, and faster, announced the completion of its acquisition of Bio-Optronics, the creator of CCTrialSuite and a provider of clinical trial matching system (CTMS) solutions for the healthcare system and clinical research. The company expanded its product portfolio and customer base with this acquisition strategy.
Segment Analysis
Clinical trial site management encompasses activities such as site selection, training, and monitoring to ensure compliance with protocol requirements. Data management involves the collection, storage, and analysis of clinical trial data to ensure accuracy and regulatory compliance. Patient recruitment management focuses on strategies to identify and enroll suitable participants in clinical trials, crucial for meeting study objectives and timelines. Administrative staff support includes personnel responsible for coordinating logistics, scheduling, and administrative tasks essential for trial operations.
IRB services involve ethical review and oversight to protect the rights and welfare of study participants. Additionally, various other services such as laboratory services, regulatory consulting, and pharmacovigilance contribute to the comprehensive support ecosystem for clinical trials. Regarding the phase of clinical trials, segmentation includes Phase I, Phase II, Phase III, and Phase IV trials, each presenting distinct challenges and requirements. Finally, the market can be segmented by sponsor type, with pharmaceutical and biopharmaceutical companies being the primary sponsors, followed by medical device manufacturers and other organizations involved in clinical research. Understanding these segmentation factors is essential for stakeholders in the clinical trials support services market to tailor their offerings and strategies effectively to meet the diverse needs of sponsors and optimize trial outcomes.
Global Clinical Trials Support Services Segment Analysis
In this report, the Global Clinical Trials Support Services Market has been segmented by Service, Phase, Sponsor, and Geography.
Global Clinical Trials Support Services Market, Segmentation by Service
The Global Clinical Trials Support Services Market has been segmented by Service into Clinical Trial Site Management, Data Management, Patient Recruitment Management, Administrative Staff, IRB, and Others.
Clinical Trial Site Management constitutes a pivotal segment involving the coordination and oversight of clinical trial sites. This includes tasks such as site selection, initiation, monitoring, and close-out visits to ensure that sites adhere to protocol requirements, Good Clinical Practice (GCP) guidelines, and regulatory standards. Data Management is another vital segment focused on the collection, processing, and analysis of clinical trial data. This involves designing data collection forms, implementing data capture systems, ensuring data quality and integrity, and generating statistical analyses to support decision-making throughout the trial. Patient Recruitment Management addresses the challenge of identifying and enrolling suitable participants for clinical trials. This segment encompasses various strategies and tactics to effectively reach target populations, engage potential participants, and facilitate informed consent processes while maintaining ethical standards.
Administrative Staff support forms a critical segment that encompasses various administrative tasks essential for the smooth operation of clinical trials. This includes logistical support, scheduling, coordination of study-related activities, documentation management, and communication facilitation among stakeholders. Institutional Review Board (IRB) services represent a segment dedicated to ethical oversight and regulatory compliance. IRBs play a crucial role in reviewing and approving study protocols, ensuring the protection of participants' rights, safety, and welfare throughout the trial process.
Global Clinical Trials Support Services Market, Segmentation by Phase
The Global Clinical Trials Support Services Market has been segmented by Phase into Phase I, Phase II, Phase III, and Phase IV.
Based on the phase segment, the global clinical trial support services market is segmented into phases I, II, III, and IV. In 2022, the phase III segment accounted for the highest market share. This segment's growth is due to the fact that phase III clinical trials are more costly and involve many subjects. Given the small sample size, the failure rate in this phase is the highest, and the study design usually requires complex dosing at the optimal level. Failure causes both human and financial loss, and most failures are caused by noncompliance with safety and efficacy standards.
The primary goal of Phase III trials is to prove and confirm the initial data from former trials that the drug is a safe, functional, and efficient treatment for the particular indication. These phase III clinical trials are performed to confirm and develop safety or efficacy results from phase I and II trials or to evaluate the comparative effect of the new medication over the previous medications available. According to the National Clinical Trial (NCT) record, updated on clinical trial.gov in November 2022, there are approximately 12,136 clinical trials in the phase III stage for several indications worldwide. Many current phase III clinical trials are expected to influence the segment’s growth during the forecast period.
Global Clinical Trials Support Services Market, Segmentation by Sponsor
The Global Clinical Trials Support Services Market has been segmented by Sponsor into Pharmaceutical & Biopharmaceutical, Medical Devices, and Others.
Pharmaceutical & Biopharmaceutical: This segment comprises the largest share of sponsors in the clinical trials support services market. Pharmaceutical and biopharmaceutical companies conduct a wide range of clinical trials to develop and bring new drugs and biologics to market. These trials may involve testing the safety, efficacy, and dosage of investigational drugs across various therapeutic areas such as oncology, cardiovascular diseases, infectious diseases, and neurological disorders. Clinical trial support services for pharmaceutical and biopharmaceutical sponsors encompass a comprehensive range of activities, including protocol development, site selection, patient recruitment, data management, regulatory compliance, and post-market surveillance. These sponsors often work with contract research organizations (CROs) and other service providers to outsource certain aspects of clinical trial management and leverage specialized expertise.
Medical Devices: The medical device industry also plays a significant role in clinical research, conducting trials to evaluate the safety and effectiveness of new medical devices, diagnostics, and combination products. Clinical trials for medical devices may involve assessing the performance of devices such as implants, prosthetics, diagnostic imaging equipment, and surgical instruments across diverse therapeutic areas. Clinical trial support services for medical device sponsors encompass unique challenges related to device design, regulatory approval, usability testing, and post-market surveillance. These sponsors require specialized expertise in navigating regulatory requirements, conducting clinical investigations, and collecting clinical evidence to support device clearance or approval.
Global Clinical Trials Support Services Market, Segmentation by Geography
In this report, the Global Clinical Trials Support Services Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Global Clinical Trials Support Services Market Share (%), by Geographical Region, 2024
In 2022, North America dominated the clinical trial support services market and is estimated to grow faster during the forecast period. The region's growth is owing to the fact that most pharmaceutical firms are located in the United States, where they conduct most of their business and clinical trials, as well as rising R&D spending and the need for drug advancement. Increased clinical studies in the region, owing to the occurrence of key market participants, are also driving the market growth. Walgreens, for instance, launched a clinical trial service in June 2022 to deliver pharmaceutical companies' patient registration and enrollment services.
Collaborations, partnerships, and mergers among crucial market players propel the region's market growth. Pfizer, MorphoSys, and Incyte, for instance, entered a clinical trial collaboration and supply agreement in June 2022 to investigate the immunotherapeutic combination of Pfizer's TTI-622, a novel SIRP-Fc fusion protein, and Monjuvi (tafasitamab-cxix) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). As a result, such collaborations are propelling the region's market growth.
The incidence of diseases such as osteoarthritis has improved considerably in Canada, driving the region's market growth. For instance, according to a report allocated by the Arthritis Community Research and Evaluation Unit (ACREU) in Canada, approximately 15% of Canadians aged 20 and up had osteoarthritis. According to the report, more than four million Canadians, or roughly one in every seven adults, have osteoarthritis. As a result, the high frequency of orthopedic disorders is expected to boost demand for the availability and development of therapeutics or medical devices, resulting in clinical trials, which may fuel the overall market's growth.
The rising prevalence of infectious diseases is causing a significant healthcare burden in Mexico, driving market growth. For instance, the article published in May 2021 reported that the overall prevalence of anti-DENV (dengue virus) IgG at enrolment was 19.4%, with the fully-grown group in Mexico having the highest seroprevalence rate. Such cases demonstrate the country's high incidence of dengue, which raises the requirement for developing dengue vaccines following clinical trials. Thus, rising chronic and infectious disease cases, improved need for clinical trials and partnerships among the region's key market players are expected to significantly enhance the growth of the North American clinical trials support services market during the forecast period.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Clinical Trials Support Services Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Growing Complexity of Clinical Trials
- Expansion of the Biopharmaceutical Industry
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Emphasis on Patient-Centric Trials- Patient-centricity recognizes the pivotal role of patients as partners in research and seeks to enhance their engagement, satisfaction, and overall experience in clinical trials. This approach is driven by various factors, including evolving regulatory expectations, advances in technology, and growing recognition of the importance of patient input in drug development and healthcare decision-making.
Patient-centric trials involve designing and conducting clinical trials with a focus on meeting the needs and preferences of patients. This includes considerations such as minimizing the burden of participation, improving accessibility and convenience, enhancing communication and transparency, and ensuring that trial protocols align with patient priorities and goals. Clinical trial support services play a critical role in facilitating patient-centric trials by providing tailored solutions and support mechanisms that address the unique needs and challenges faced by patients.
One key aspect of patient-centric trials is patient recruitment and retention. Traditional recruitment methods often fail to engage diverse patient populations effectively, leading to recruitment challenges and delays in trial timelines. Clinical trial support services employ innovative strategies to enhance patient recruitment, such as leveraging digital technologies, community outreach programs, patient advocacy groups, and patient-centered advertising campaigns. These approaches aim to reach a broader and more representative pool of potential participants and create a positive experience from the outset. Additionally, patient-centric trials focus on improving patient engagement and retention throughout the trial duration. This involves providing adequate support, education, and resources to empower patients to actively participate in their care and adhere to trial protocols. Clinical trial support services may offer patient-centric solutions such as patient portals, mobile applications, remote monitoring devices, and personalized communication channels to facilitate ongoing engagement and communication between patients, investigators, and study coordinators.
Restraints
- Stringent Regulatory Environment
- Intellectual Property Concerns
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High Cost of Clinical Trials- Regulatory Requirements: Regulatory agencies such as the FDA and EMA impose stringent requirements on clinical trials to ensure the safety, efficacy, and quality of investigational products. Meeting these regulatory standards necessitates comprehensive documentation, extensive testing, and rigorous compliance measures, all of which incur substantial costs in terms of personnel, resources, and time.
Patient Recruitment and Retention: Patient recruitment is a critical aspect of clinical trial success, yet it often proves to be a costly and time-consuming endeavor. Identifying and enrolling eligible participants who meet the specific criteria outlined for the trial can be challenging, particularly for studies targeting rare diseases or niche patient populations. Additionally, retaining participants throughout the duration of the trial requires ongoing engagement, monitoring, and support services, all of which contribute to the overall cost burden.
Data Management: Effective data management is essential for ensuring the accuracy, integrity, and regulatory compliance of clinical trial data. Implementing robust data management systems and processes, including electronic data capture (EDC) systems, centralized monitoring, and quality assurance measures, requires significant investments in technology infrastructure, personnel training, and quality control procedures. Infrastructure Expenses: Conducting clinical trials requires access to specialized facilities, equipment, and expertise, all of which incur substantial infrastructure expenses. This includes costs associated with establishing and maintaining clinical trial sites, laboratory facilities, imaging centers, and other essential resources. Additionally, overhead expenses such as utilities, insurance, and administrative support further contribute to the overall cost burden.
Opportunities
- Technological Advancements
- Focus on Patient-Centric Trials
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Expansion of Biosimilar and Generic Drug Development- Biosimilars and generic drugs offer cost-effective alternatives to brand-name biologics and pharmaceuticals, making healthcare more accessible and affordable for patients worldwide. As the demand for these products continues to grow, pharmaceutical companies are increasingly investing in the development and commercialization of biosimilars and generics.
Clinical trials are a crucial component of the biosimilar and generic drug development process, providing essential evidence of safety, efficacy, and bioequivalence compared to reference products. Clinical trials for biosimilars and generics often involve demonstrating similarity or interchangeability with the reference product through comparative studies in healthy volunteers or patients with the target disease. These trials require rigorous study design, robust data management, and regulatory compliance to meet stringent regulatory requirements imposed by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Clinical trial support services play a vital role in facilitating the development and regulatory approval of biosimilars and generics by providing specialized expertise and infrastructure to pharmaceutical companies. These services encompass a wide range of activities tailored to the unique needs of biosimilar and generic drug trials, including protocol development, site selection, patient recruitment, data management, statistical analysis, and regulatory affairs support. Clinical trial support service providers work closely with pharmaceutical sponsors to design and execute efficient and cost-effective clinical trials, ensuring compliance with regulatory standards and timelines.
Competitive Landscape Analysis
Key players in Global Clinical Trials Support Services Market include:
- IQVIA Holding Inc
- Icon PLC
- WuXi AppTec
- LapCorp
- Alcura
- Parexel International
- Charles River Laboratories
- Eurofins Scientific SE
- F.Hoffmann-La Roche Ltd
- Novo Nordisk A/S
- Eli Lilly and Company
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Service
- Market Snapshot, By Phase
- Market Snapshot, By Sponsor
- Market Snapshot, By Region
- Global Clinical Trials Support Services Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
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Growing Complexity of Clinical Trials
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Expansion of the Biopharmaceutical Industry
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Emphasis on Patient-Centric Trials
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- Restraints
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Stringent Regulatory Environment
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Intellectual Property Concerns
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High Cost of Clinical Trials
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- Opportunities
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Technological Advancements
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Focus on Patient-Centric Trials
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Expansion of Biosimilar and Generic Drug Development
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- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Clinical Trials Support Services Market, By Service, 2021 - 2031 (USD Million)
- Clinical Trial Site Management
- Data Management
- Patient Recruitment Management
- Administrative Staff
- IRB
- Others
- Global Clinical Trials Support Services Market, By Phase, 2021 - 2031 (USD Million)
- Phase I
- Phase II
- Phase III
- Phase IV
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Global Clinical Trials Support Services Market, By Sponsor, 2021 - 2031 (USD Million)
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Pharmaceutical & Biopharmaceutical
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Medical Devices
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Others
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- Global Clinical Trials Support Services Market, By Geography, 2021 - 2031 (USD Million)
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North America
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United States
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Canada
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Europe
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Germany
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United Kingdom
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France
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Italy
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Spain
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Nordic
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Benelux
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Rest of Europe
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Asia Pacific
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Japan
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China
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India
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Australia & New Zealand
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South Korea
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ASEAN (Association of South East Asian Countries)
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Rest of Asia Pacific
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Middle East & Africa
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GCC
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Israel
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South Africa
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Rest of Middle East & Africa
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Latin America
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Brazil
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Mexico
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Argentina
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Rest of Latin America
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- Global Clinical Trials Support Services Market, By Service, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
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IQVIA Holding Inc
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Icon PLC
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WuXi AppTec
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LapCorp
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Alcura
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Parexel International
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Charles River Laboratories
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Eurofins Scientific SE
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F.Hoffmann-La Roche Ltd
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Novo Nordisk A/S
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Eli Lilly and Company
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- Company Profiles
- Analyst Views
- Future Outlook of the Market