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NEW YORK, Dec. 5, 2024 /PRNewswire/ — Report with market evolution powered by AI – The clinical trials market in US  size is estimated to grow by USD 5 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of  4.38%  during the forecast period. Rise in number of clinical trials of drugs is driving market growth, with a trend towards advancement in technology and scientific research. However, rise in cost of clinic trials  poses a challenge. Key market players include Accell Clinical Research LLC, Apex Medical Research Inc., Caidya, Charles River Laboratories International Inc., Clinipace Inc., CTI Clinical Trial and Consulting Inc., Eli Lilly and Co., eResearchTechnology GmbH, ICON plc, IQVIA Holdings Inc., Laboratory Corp. Of America Holdings, Medpace Holdings Inc., Novartis AG, Novo Nordisk AS, Parexel International Corp., Pfizer Inc., Sanofi SA, Syneos Health Inc., Thermo Fisher Scientific Inc., and WuXi AppTec Co. Ltd..

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Forecast period

2024-2028

Base Year

2023

Historic Data

2017 – 2021

Segment Covered

Type (Phase III, Phase I, Phase II, and Phase IV), Service Type (Interventional studies, Observational studies, and Expanded access studies), Indication (Oncology, CNS, Autoimmune/inflammation, and Others), and Geography (North America)

Region Covered

US

Key companies profiled

Accell Clinical Research LLC, Apex Medical Research Inc., Caidya, Charles River Laboratories International Inc., Clinipace Inc., CTI Clinical Trial and Consulting Inc., Eli Lilly and Co., eResearchTechnology GmbH, ICON plc, IQVIA Holdings Inc., Laboratory Corp. Of America Holdings, Medpace Holdings Inc., Novartis AG, Novo Nordisk AS, Parexel International Corp., Pfizer Inc., Sanofi SA, Syneos Health Inc., Thermo Fisher Scientific Inc., and WuXi AppTec Co. Ltd.

Key Market Trends Fueling Growth

The Clinical Trials Market in the US is experiencing significant growth, driven by biopharmaceutical and medical device companies seeking to bring new drug candidates to market. Contract Research Organizations (CROs) play a crucial role in this process, providing essential services to pharmaceutical companies during all phases of clinical research, from Phase I to IV. This includes working with healthcare workers to conduct studies on various diseases such as cardiology, autoimmune, inflammation, pain management, oncology, CNS conditions, diabetes, obesity, and cardiovascular conditions. Technological evolution is a key trend in the market, with the use of AI, IoT, real-world data, patient-centric trials, virtual trials, and home healthcare services driving digitalization. The demand for CROs is high, with companies like Parexel and Syneos Health leading the way in providing CRO services. Small-molecule drugs, biologics, biosimilars, and large-molecule drugs are all under development, with raw material suppliers and laboratory services supporting research activities. The industry is at a growth stage, with R&D programs and outsourcing activities expanding. The European Medicines Agency and other regulatory bodies are also playing a role in the market, with an increased focus on personalized medicine and advanced therapies. Patent expiration is leading to an increased focus on post-marketing surveillance. The degree of innovation is high, with big data analytics, remote monitoring, and electronic data capture driving progress. End-users include hospitals and clinics, with virtual clinical trials, interventional studies, expanded access trials, and compassionate use trials also playing a role. Industries like Thermo Fisher Scientific and CorEvitas, LLC are contributing to the market with their expertise in various areas. 

The clinical trials market in the US has experienced substantial progress due to technological and scientific advancements. Notable developments include the implementation of electronic data capture (EDC) systems. EDC platforms streamline and enhance clinical trial data management. Researchers can now electronically record data from study participants, eliminating the need for paper-based systems and manual data entry. This leads to time savings, reduced errors, and improved data quality. EDC systems play a crucial role in the efficient and effective testing and approval of new medications and therapies. 

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Market Challenges

  • The Clinical Trials Market in the US is a significant sector, involving biopharmaceutical and medical device companies, Contract Research Organizations (CROs), and various end-users like hospitals and clinics. Challenges include bringing new drug candidates, including small-molecule drugs, biologics, biosimilars, and large-molecule drugs, through Phase I, II, III, and IV trials for indications like autoimmune, inflammation, pain management, oncology, CNS conditions, diabetes, obesity, and cardiovascular diseases. Healthcare workers collaborate with CROs to conduct research activities, while raw material suppliers and laboratory services support the process. Technological evolution, including genomics, AI, IoT, real-world data, patient-centric trials, virtual trials, home healthcare services, and digitalization, is transforming the industry. End-users, including people with diseases, seek personalized medicine and innovative treatments, driving the demand for CROs and R&D programs. The industry’s growth stage is influenced by outsourcing activities, patent expiration, and regulatory requirements from the European Medicines Agency and FDA. Companies like Parexel, Syneos Health, Thermo Fisher Scientific, and CorEvitas LLC contribute to the degree of innovation with electronic data capture, decentralized trials, telemedicine, and advanced therapies.
  • The cost of clinical trials in the US has emerged as a major concern for the healthcare sector. Complexity in research protocols, stringent regulatory requirements, and the high cost of acquiring and maintaining technology and equipment are primary reasons for this increase. The demand for large-scale, multicenter trials further adds to the expenses. The intricacy of research protocols has grown as the medical field advances, necessitating extensive and detailed protocols to ensure precise data collection and analysis.

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Segment Overview 

This clinical trials market in US report extensively covers market segmentation by

  1. Type 
    • 1.1 Phase III
    • 1.2 Phase I
    • 1.3 Phase II
    • 1.4 Phase IV
  2. Service Type
    • 2.1 Interventional studies
    • 2.2 Observational studies
    • 2.3 Expanded access studies
  3. Indication 
    • 3.1 Oncology
    • 3.2 CNS
    • 3.3 Autoimmune/inflammation
    • 3.4 Others
  4. Geography 
    • 4.1 North America

1.1 Phase III-  The Phase III segment of clinical trials in the US plays a crucial role in testing the safety and efficacy of new drugs or medical treatments before they are approved for public use. This phase is the final step in the drug development process and involves testing the investigational treatment on a larger population to gather more data and assess potential benefits and risks. For instance, a new cancer drug that has already undergone rigorous testing in Phase I and II trials will enter Phase III trials, where it is administered to a larger group of cancer patients. The trial aims to gather more evidence on the drug’s safety profile, dosage, side effects, and long-term outcomes. Phase III trials involve hundreds or even thousands of participants spread across multiple trial sites in the country. These trials are meticulously planned, ethically conducted, and require data management systems. Regulatory authorities, such as the US Food and Drug Administration (FDA), rely on the data from Phase III trials to evaluate the safety and effectiveness of new treatments and make informed decisions about their approval. The growing demand for new treatments and the increasing focus on personalized medicine are expected to drive the growth of the Phase III clinical trials market in the US during the forecast period.

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Research Analysis

The Clinical Trials Market in the US is experiencing significant growth due to the increasing number of biopharmaceutical and medical device companies investing heavily in Research & Development (R&D) for new drug candidates and medical devices. Clinical research organizations (CROs) and laboratories play a crucial role in conducting clinical trials for these companies. The focus on patient-centric trials, virtual trials, and real-world data is transforming the clinical trials landscape. Technological advancements such as genomics, Artificial Intelligence (AI), Internet of Things (IoT), and digital health are revolutionizing the way trials are conducted. Small-molecule drugs and biologics continue to dominate the market, with Interferon-beta treatment being a notable example. The technological evolution of clinical trials is enabling faster and more efficient trial processes, benefiting both healthcare workers and patients alike. Traditional clinical trials are being supplemented with innovative approaches to address the challenges of recruiting and retaining patients, ensuring data accuracy, and reducing trial costs.

Market Research Overview

The Clinical Trials Market in the US is a dynamic and evolving industry, driven by the research and development (R&D) activities of biopharmaceutical companies and medical device manufacturers. The market encompasses various stakeholders including clinical research organizations (CROs), healthcare workers, and end-users such as hospitals and clinics. The pipeline includes drug candidates ranging from small-molecule drugs to biologics and biosimilars, with a focus on indications like autoimmune, inflammation, pain management, oncology, CNS conditions, diabetes, obesity, and cardiovascular diseases. Technological advancements, such as genomics, AI, IoT, real-world data, patient-centric trials, virtual trials, home healthcare services, digitalization, and electronic data capture, are transforming the landscape. The industry is in a growth stage, with a high demand for CRO services, decentralized trials, telemedicine, and advanced therapies. The European Medicines Agency and regulatory bodies play a crucial role in post-marketing surveillance. The degree of innovation is high, with a focus on personalized medicine, R&D programs, outsourcing activities, and patent expiration. Key trends include the use of interventional studies, expanded access trials, compassionate use trials, and the evolution of traditional clinical trials towards more decentralized and virtual models. Companies like Parexel, Syneos Health, Thermo Fisher Scientific, and CorEvitas, LLC are at the forefront of these developments.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

  • Type
  • Phase III
  • Phase I
  • Phase II
  • Phase IV
  • Service Type
    • Interventional Studies
    • Observational Studies
    • Expanded Access Studies
  • Indication
    • Oncology
    • CNS
    • Autoimmune/inflammation
    • Others
  • Geography
    • North America


    7 Customer Landscape
    8 Geographic Landscape
    9 Drivers, Challenges, and Trends
    10 Company Landscape
    11 Company Analysis
    12 Appendix

    About Technavio

    Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

    With over 500 specialized analysts, Technavio’s report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio’s comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

    Contacts

    Technavio Research
    Jesse Maida
    Media & Marketing Executive
    US: +1 844 364 1100
    UK: +44 203 893 3200
    Email: [email protected]
    Website: www.technavio.com/

    SOURCE Technavio

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