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The US Clinical Trials Market size is estimated to grow by USD 5.9 billion at a CAGR of 5.3% between 2022 and 2027.
The US has experienced a significant rise in clinical trials for drugs in recent years. This increase can be attributed to several factors, including advancements in medical research, the growing need for new and improved treatments, and regulatory changes that have made the process more accessible. Moreover, with the prevalence of cancer becoming more prominent, there has been a surge in the development of new drugs aimed at combating this disease. The FDA has implemented measures to streamline the approval process, allowing for more efficient and timely evaluation of drugs. For instance, the FDA's Fast Track program is designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions.
This initiative has paved the way for more trials to be conducted, as researchers are provided with a clearer and faster pathway to bring their drugs to market resulting in market expansion. Thus, a rise in the number of drug trials is expected to drive the growth of the market during the forecast period. This market analysis and report also includes an in-depth analysis of drivers, trends, and challenges. Our report examines historic data from 2017 to 2021, besides analyzing the current market scenario.
The market is propelled by the collaboration between pharmaceutical, biopharmaceutical, and medical device companies, leveraging R&D efficiencies and biotechnology advancements. With a focus on innovative drug candidates and testing approaches, the market anticipates a favorable outlook, particularly in cancer research. The utilization of monoclonal antibodies and the involvement of skilled professionals and clinical research organizations (CROs) underscore the nation's leadership in driving clinical trial innovation and excellence.
In the market, the type segment encompasses a diverse array of components and services vital for research and development. This segment includes small-molecule drugs and large-molecule drugs, reflecting the broad spectrum of pharmaceuticals under investigation. Raw material suppliers and consumables play crucial roles in facilitating trial operations, and providing essential resources such as assays, kits, and accessories. With a focus on patient safety and efficacy, clinical trials leverage robust technologies offered by service providers to streamline processes. Recent advancements, including Electronic Data Capture (EDC) and Clinical Outcome Assessment (e-COA), supported by AI and big data analytics, have revolutionized data management and analysis. Notable trials like the Solidarity trial, featuring Interferon-beta (IFN-beta), underscore the importance of collaborative efforts in advancing medical research within the US.
The market share growth by the phase III segment will be significant during the forecast period. The phase III segment in the market plays a significant role in testing the safety and efficacy of new drugs or medical treatments before they can be approved for public use. This phase is the final step in the process of drug development and involves testing the investigational treatment on a larger population to gather more data and assess the potential benefits and risks.
Phase III was the largest and was valued at USD 8.87 billion in 2017. Phase III segment often involves hundreds or even thousands of participants spread across multiple trial sites across the country. The trials are carefully monitored by medical professionals, including doctors and researchers, who closely follow the progress of each participant and collect data on various parameters such as survival rates, progression-free survival, quality of life, and adverse events. For instance, during phase III trials, the participants receive the investigational treatment and follow a specific treatment regimen. Researchers actively track their progress and document any improvements or adverse reactions they observe. Additionally, medical professionals regularly engage with the participants, providing guidance and monitoring their overall health throughout the trial duration.
The Clinical Trials Market in the US is witnessing significant growth, driven by pharmaceutical, biopharmaceutical, and medical device companies aiming to enhance R&D efficiencies. Biotechnology advancements are facilitating the development of innovative drug candidates, including monoclonal antibodies, addressing pressing healthcare challenges like cancer. Skilled professionals and clinical research organizations (CROs) play pivotal roles in conducting trials for both small and large-molecule drugs. With a diverse patient population, safety, and efficacy remain paramount. Robust technologies, including AI and big data analytics, along with tools like Electronic Data Capture (EDC) and Clinical Outcome Assessment (e-COA), are revolutionizing testing approaches, promising a favorable outlook for the future. The market dynamics are influenced by factors such as the availability of funding, regulatory policies, and the increasing competition among players. There are multiple factors influencing market growth and trends. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges.
Advancement in technology and scientific research is an emerging trend shaping the market growth. The clinical trials market in the US has experienced substantial technological evolution, leading to enhanced data management and efficiency. Notable advancements include the integration of Artificial Intelligence (AI) and Machine Learning (ML) in data analysis. Developing countries are also adopting these technologies to boost their drug development activities. EDC systems, such as those utilizing AI and ML, enable online data collection, management, and analysis, significantly reducing the need for manual data entry and paper-based systems. This not only improves data quality but also expedites patient recruitment rates for chronic diseases and novel therapies. Laboratories and researchers are leveraging these advancements to navigate stringent regulatory procedures and bring personalized medicine to the forefront of genomics-based treatments. The prevalence of diseases and the demand for patient-centric trials continue to drive the need for advanced data management solutions.
The rise in the cost of clinic trials is a significant challenge shaping the market growth. The clinical trials market in the US has experienced a notable increase in costs, driven by several factors. One significant contributor is the intricacy of research protocols, necessitating advanced data management systems and technologies such as Artificial Intelligence (AI) and Machine Learning (ML) for accurate data analysis. The prevalence of chronic diseases and the demand for novel therapies, particularly in developing countries, have led to an increase in drug development activities and the need for large-scale, multicenter trials. Stringent regulatory procedures and the high cost of acquiring and maintaining technology and equipment in laboratories further add to the expenses. Technological evolution, including the use of online resources for patient recruitment and patient-centric trials, aims to mitigate these costs. The focus on personalized medicine and genomics also requires extensive protocols and resources. Despite these challenges, the clinical trials market continues to evolve, offering opportunities for innovation and advancements in healthcare.
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The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth and forecasting strategies.
US Clinical Trials Market Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
Medpace Holdings Inc. - The company offers clinical trial management services from Phase I to IV in Russia, CIS and Eastern Europe.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The Global clinical trials market thrives with collaboration between pharmaceutical companies, medical device companies, and clinical research organizations (CROs), driven by R&D efficiencies and biotechnology advancements. These partnerships aim to develop innovative drug candidates and testing approaches, including monoclonal antibodies and novel molecules, fostering a favorable outlook for the industry. With a skilled workforce and robust technologies, the sector explores both small-molecule and large-molecule drugs, supported by raw material suppliers providing essential consumables, assays, and kits. Moreover, patient populations are engaged in trials, facilitated by clinical trial service providers utilizing electronic data capture (EDC) and clinical outcome assessment (e-COA) tools. Notably, recent initiatives like the Solidarity trial have spotlighted promising therapies like Interferon-beta (IFN-beta), highlighting the significance of collaborative efforts in advancing healthcare.
The market is propelled by the collective efforts of biopharmaceutical companies, leveraging their expertise in developing innovative molecules such as biologics and biosimilars. However, challenges persist due to the shortage of skilled professionals, hindering the advancement of trials for both small-molecule drugs and biologics. Despite this, the sector continues to flourish, with various accessories and reliable clinical research entities supporting the process. Engaging the patient population remains pivotal, driving the demand for global clinical trials. As the industry evolves, collaboration among stakeholders is vital to address workforce shortages and ensure the availability of reliable clinical resources for groundbreaking medical advancements.
This market report forecasts market growth by revenue and provides an analysis of the latest trends and growth opportunities from 2017 to 2027.
US Clinical Trials Market Scope |
|
Report Coverage |
Details |
Page number |
148 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 5.3% |
Market growth 2023-2027 |
USD 5.9 billion |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
4.7 |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks |
Key companies profiled |
Medpace Holdings Inc., Laboratory Corp. of America Holdings, Sanofi, CTI Clinical Trial and Consulting Inc., ICON plc, Syneos Health Inc., IQVIA Holdings Inc., Charles River Laboratories International Inc., Parexel International Corp., Pfizer Inc., Thermo Fisher Scientific Inc., Caidya, Accell Clinical Research LLC, Clinipace Inc., eResearchTechnology GmbH, Apex Medical Research Inc., WuXi AppTec Co. Ltd., Novartis AG, Novo Nordisk AS, and Eli Lilly and Co. |
Market dynamics |
Market trends and analysis, Market research and growth, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Type
7 Market Segmentation by Service Type
8 Market Segmentation by Indication
9 Customer Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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