U.S. Clinical Trials Market Analysis


  • Type: Service area
  • Published : January 2022
  • Region: North America
  • Country: US
  • Report ID : 5018

  • Format: PPT, PDF

U.S. Clinical Trials Market Analysis: Segmented by Phase, Design, Geography – Growth, Market Size, Future Prospects & Competitive Analysis, 2020 – 2028

SKU: 5018 Categories: ,

Report Description of the U.S. Clinical Trials Market Analysis

Research Scope and Assumption

  • The report provides the market value for the base year 2020 and a yearly forecast up to 2028 in terms of revenue (USD billion)
  • The key industry dynamics, regulatory scenario, reimbursement scenario, major market trends, and drug markets are evaluated to understand their impacts on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis
  • We have used the combination of top-down and bottom-up approach for market sizing, analyzing key regional markets, dynamics, and trends for various solutions, services, and end uses
  • All market estimates and forecasts have been validated through primary interviews with the Key Industry Players (KIPs) and secondary analysis
  • Inflation has not been accounted for in order to estimate and forecast the market
  • Numbers may not add up due to rounding off

Reason to buy the report:

  • Facilitate decision-making based on strong current and forecast data for U.S. Clinical Trials Market Analysis
  • Develop strategies based on the latest regulatory framework
  • Strategically analyze micro-markets with respect to individual growth trends, future prospects, and their contribution to the market
  • Analyze competitive developments such as expansions, investments, mergers & acquisitions, new product developments, and research & developments in the U.S. Clinical Trials Market Analysis
  • Analyze the opportunities in the market for stakeholders and draw a competitive landscape for market leaders
  • To strategically profile key players and comprehensively analyze their market shares and core competencies
  • We have technically sound team which do a deep dive research and also provide strategy based consulting analysis

U.S. Clinical Trials Market Analysis Executive Summary

The North America clinical trials market is expected to register a CAGR of 8.1% during the forecast period. The market will show rapid growth due to the demand for clinical trials in the emerging markets, high R&D expenditure of the pharmaceutical industry and the rising prevalence of diseases.

Market Size and Key Findings

The U.S. Clinical Trials Market Analysis size stood at around USD 6.07 billion in 2020 and is projected to reach USD xx billion by 2028, exhibiting a CAGR of 8.1% during the forecast period.

The North American Clinical Trials Market size has been estimated at USD 6.07 billion in 2021 and is projected to reach USD 8.67 billion by 2028 at CAGR of 7.40% during the forecast period from 2021 to 2028. North America market is accredited with increasing R&D and also increasing the new technologies in clinical research. These factors are anticipated to boost the regional market growth. Within North America, The United States Clinical Trials Market Size is expected to grow at a healthy rate in the coming years.

Market Dynamics

Market Growth Drivers Analysis

In emerging countries, there are numerous unmet needs of clinical trials for novel drugs, due to the increasing prevalence of infectious and tropical diseases in the region. The population is found to have has varied disease profile which is increasing with the span of time and this is expected to boost the clinical trials of new or rare diseases. Therefore the number of patients having a specific disease would act as a stimulus for biopharmaceutical companies to invest more in clinical trials for a disease segment.

The research and development (R&D) spending of pharmaceutical companies has also been steadily increasing over the past few years. This was mainly due to numerous patent expiries, and as a result of the patent expiration, there are many pharmaceutical companies that will have no other option but to develop new drugs. Therefore, the companies are spending more on R&D to accelerate the development of drugs through clinical trials, and henceforth increasing the overall market.

Market Restraints

Factors like lack of skilled clinical research in the workforce, poor reimbursement for health care in developing nations, and strict patient enrolment regulations, however, hamper the market growth. Many companies outsource their recently developed drug clinical trials to different contract research organizations as it could save them from the research and development process the hassles of regulatory issues and the expense of patient recruitment.

COVID-19 impact on “U.S. Clinical Trials Market Analysis”  

Strength through adversity is a commonly used aphorism and one which is true of people and industries alike. When confronted with challenges, human inventiveness knows no limits and COVID-19 has been both the mother of innovation but also the catalyst for the widespread adoption of current technologies. Thus, it is of little surprise that the clinical trial market has swiftly adjusted to the new paradigm circumscribed by restrictions on social interaction, by looking to leverage technological solutions.

Competitive Landscape

Key Players

The North America Clinical Trials Market is fragmented competitive and consists of several major players. The major pharmaceutical companies are found making enormous investments in R&D, especially in the emerging nations, in order to gain opportunities for market growth in the major regions. The strategic partnerships among pharmaceutical companies and the CROs are expected to have a significant impact on the market’s growth.

Notable Recent Deals

  • The COVID-19 pandemic has brought significant changes in the clinical trials industry and shifted the focus of many research and commercial organizations to focus on the development of new therapies and vaccines for COVID-19. For instance, in August 2020, China-based Sinopharm commenced a Phase III clinical trial of its COVID-19 vaccine candidate at the Bahrain International Exhibition and Convention Centre (BIECC).

Healthcare Policies and Regulatory Landscape

Policy changes and Reimbursement scenario

There are also favorable government initiatives regarding clinical trials in the United States that are anticipated to boost the market growth. For instance, in March 2020, the FDA launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to speed up the development of treatment for the global disease caused by the coronavirus. In the United States, pharmaceutical companies are found spending more money, time, and energy on R&D than most organizations. According to the National Institute of Health data, in the fiscal year 2017, clinical research funding by the NIH was around USD 12.7 billion, and it increased to USD 15 billion in 2019. Also, the R&D budgets of the pharmaceutical companies have increased in the past few years, owing to the rising burden of diseases, complex molecules, and therapy segments.



1. Report Description of the U.S. Clinical Trials Market Analysis
1.1 Research Scope and Assumption
1.2 Objective of the study
1.3 Research Methodology
1.4 Reason to buy the report
2. U.S. Clinical Trials Market Analysis Executive Summary
2.1 U.S. Clinical Trials Market Analysis – Industry Snapshot & key buying criteria, 2020-2028
2.2 Market Size, Growth Prospects and Key findings
3. Market Dynamics of U.S. Clinical Trials Market Analysis
3.1 Market Growth Drivers Analysis
3.1.1 Demand for Clinical Trials
3.1.2 High R&D Expenditure of the Pharmaceutical Industry
3.1.3 Rising Prevalence of Diseases
3.2 Market Restraints Analysis
3.2.1 Lack of Skilled Workforce for Clinical Research
3.2.2 Stringent Regulations
3.3 Covid-19 Market Impact Analysis
4. U.S. Clinical Trials Market Segmentation
4.1 By Phase:
4.1.1 Phase I
4.1.2 Phase II
4.1.3 Phase III
4.1.4 Phase IV
4.2 By Design:
4.2.1 Treatment Studies
4.2.2 Observational Studies
4.3 By Geography:
4.3.1 USA
4.3.2 Canada
4.3.3 Mexico
5. US Clinical Trials Market Share
5.1 Market Analysis, Insights and Forecast – By Revenue
6. Competitive Landscape
6.1 Major Top Market Players
6.2 Products in Pipeline
6.3 R&D Initiatives in Clinical Trials Market
6.4 Notable recent deals in Clinical Trials Market
6.4.1 Joint Ventures
6.4.2 Partnerships
6.4.3 Mergers & Acquisitions
6.4.4 Strategic divestments
7. Key Company Profiles
7.1 Clinipace Company overview
Product & Services, Strategies & Financials
7.2 Eli Lilly and Company overview
Product & Services, Strategies & Financials
7.3 F. Hoffmann-La Roche Ltd Company overview
Product & Services, Strategies & Financials
Product & Services, Strategies & Financials
7.5 ICON PLC Company overview
Product & Services, Strategies & Financials
7.6 IQVIA Company overview
Product & Services, Strategies & Financials
7.7 Laboratory Corporation of America Company overview
Product & Services, Strategies & Financials
8. Healthcare Policies and Regulatory Landscape
8.1 Policy changes and Reimbursement scenario
8.2 Government Initiatives / Intervention programs
9. Factors Driving Future Growth
9.1 New Trends and Development of Clinical Trials market
9.2 Future Opportunities
10. Strategic Recommendations

U.S. Clinical Trials market Analysis Segmentation

By Phase

Phase III is the Largest Segment under Phases that is Expected to grow during the Forecast Period. The market is expected to be dominated by Phase III, with Phase I expected to witness the fastest growth. Phase III is one of the most critical phases assessing the effectiveness of the new intervention, as well as its value in clinical practice. The Phase I trial in the market studied is also expected to grow at a steady rate, due to the increasing number of investigative new drug (IND) applications filed. The government initiatives in the North American countries for the promotion of drug discovery and continuous technological innovations are expected to propel the market growth. According to the National Clinical Trials Registry (NCT), currently there are about 309 active clinical trials under phase III development for cardiovascular diseases in the United States. Thus, owing to above factors the segment is expected to show growth in coming years.

By Design:

Treatment Studies

  • Randomized Control Trial
    1. Double Blind Trial Randomized Trial
    2. Single Blind Trial Randomized Trial
    3. Non-blind Randomized Trial
  • Adaptive Clinical Trial
  • Non-randomized Control Trial

Observational Studies

  • Cohort Study
  • Case Control Study
  • Cross Sectional Study
  • Ecological Study

By Geography:

Geographically, North America is the biggest market in terms of market share across the globe. Ample availability of funds to outsource clinical trials serves as the major growth driver for North America.

North America is the leading market in 2019 and also expected to lead in the future. The U.S. Clinical Trials Market is holding the largest shares of the market. Adoption of technological developments is levelling up the demand of the market. North America conducts a number of clinical trials spend the highest funds with USD 753.7 million given by the National Institute of Health in 2018 which was the highest healthcare per capita. Canada Clinical trials Market size is expected to grow more in Phase-III by 2027.

Research Methodology

Insights10 will provide you reports within 10 key parameters which are:

  1. Market overview
  2. Market growth drivers & restraints
  3. Epidemiology or disease type
  4. Market segmentation
  5. Market share
  6. Competitive landscape
  7. Key company profiles
  8. Healthcare policies & regulatory framework
  9. Reimbursement scenario
  10. Factors driving future growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision making for business stakeholders. Our focused approach to develop reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

Our analysis methodology involves three critical stages:

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers and researchers across countries through which we engage with local experts to gather key data points and assumptions around each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

Secondary Data Collection: We have developed strong expertise and experience in secondary data collection methods for developing unique data sets and research material. We gather data from multiple reliable sources to maintain the high level of accuracy and consistency. The market data is analysed and forecasted using appropriate statistical and coherent models. The report offers an overall analysis of the market size, growth, market share as well as segment-level analysis of the specific market. Our report includes precise, to the point information related to the overall market, competition, growth drivers, challenges, regulatory updates, and competition.

Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

  • Statistical Databases
  • Company Websites/Annual Reports
  • Trade Publications
  • Online Databases
  • Published Research Reports
  • Whitepapers
  • Press Releases of Key Market Players

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameter and micro indicators. The macro parameters includes changes in government policies, demand and supply of the market, government intervention programs and major market share. The micro indicators GDP growth, market size, market volume etc. We also understand nuances specific to each country like US, Canada, India, Germany, etc. and have worked across 60+ countries and hence no only understand global trends, but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. start with large overall market and segment different areas and bottom-up approach i.e. start with population and epidemiology and roll up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach mainly used for new product forecasting and bottom-up approach is used for demand estimation of any product for different countries summed up to form total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and Africa for the period of 2020 to 2028. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape and policy and regulatory scenario and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases and the company level averages etc.

We make sure to finalize the numbers in alignment to the market research. Firstly, our internal experts ensure thorough validation and checking to ensure the accurate and precise analysis and then validation is also done using multiple data analysis model.  Two level validation is done and entails finalization of report scope and to way of representation pattern.

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analysed and synthesized. A second series of interviews are done if necessary to check and validate. The future opportunities are analysed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results are then, interpreted by considering following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue / volume
  • Analyzing current needs and determining penetration to estimate market

Insights: Our reports deliver actionable insights backed with supporting facts and figures to assist you in achieving exemplary growth. Our in-depth analyses are interspersed with relevant insights and statistics to offer an executive-level view of a given market. The description helps in correlating many minor factors affecting the market and its impact to the different segments within the market.
Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumptions.
The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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