US Clinical Trial Market Analysis


  • Type: Service area
  • Published : October 2021
  • Region: North America
  • Country: US
  • Report ID : 4980

  • Format: PPT, PDF

US Clinical Trial Market: Segmented by Phase, Design and Application – Growth, Market Size, Future Prospects & Competitive Analysis, 2020 – 2028

SKU: 4980 Categories: ,

Report Description of the US Clinical Trial

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 US Clinical Trial
• 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 US Clinical Trial
• 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

US Clinical Trial Executive Summary
The Clinical Trials Industry growth rate is attributed to the rising number of biologics, the need for personalized medicines and orphan drugs, and the demand for advanced technologies such as Electronic Data Capture (EDC) aid market participants in managing patient data that ultimately reduce monitoring cost coupled with the rising demand for CROs to conduct clinical trials and is anticipated bringing new opportunities. Clinical trials are time-consuming endeavours that necessitate the integration of various roles and processes. In every clinical trial, a pharmaceutical manufacturer’s primary aim is to maximize clinical trial supplies such that packed investigational materials are delivered to patients enrolled on time.

Market Size and Key Findings
The US Clinical Trial size stood at around USD 3.82 billion in 2020 and is projected to reach USD xx billion by 2028, exhibiting a CAGR of xx% during the forecast period.
US Clinical Trial market, will be growing at faster pace of xx% during the forecasted period till 2028. The major factors propelling the growth of the market include the high demand for clinical trials in emerging markets, high R&D spending of the pharmaceutical industry, an increasing prevalence of diseases, and the focus on rare diseases and multiple orphan drugs in the pipeline.Market Dynamics
Market Growth Drivers Analysis
The major factors propelling the growth of the market include the high demand for clinical trials in emerging markets, high R&D spending of the pharmaceutical industry, an increasing prevalence of diseases. Aging is also found to be the major factor driving the burden of diseases and demand in the market. With the increasing burden of diseases, there has been a rising focus of the market players on developing new therapeutics for rare or genetic disorders that need specialization and focused clinical trials, which is expected to boost the market growth.

Market Restraints
Some of the factors hindering the growth of the market includes Stringent regulatory policies for patient enrollment in US and Lack of skilled workforce in clinical research is becoming the main challenge in the growth of the market.

COVID-19 impact on “US Clinical Trial”
The COVID-19 pandemic has tremendously impacted the market for clinical trials, as there has been a rising focus on the development of new therapeutics or vaccines to curb or treat the disease. Also, COVID-19 has brought a slight shift in terms of the way clinical trials were performed. In the clinical trial space, usually, there has been an increased interest in virtual/decentralized trials and those have been featured on conference agendas and in magazine articles for a long time. Despite that, most companies are still opting for the same processes. However, COVID-19 has essentially forced some of the trials to move to a virtual model to keep the trials on track during this pandemic situation.

Competitive Landscape

Key Players
The “US Clinical Trial” study report will provide valuable insights with an emphasis on the US market including some of the key market players such as Clinipace, Pfizer Inc., Eli Lilly and company, PRA Health Sciences, Parexel, IQVAI and PRA Health Sciences.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight to the financial statements of all the major players, along with its product benchmarking and revenue analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players.

Notable Recent Deals
In July 2020, UC San Diego Health and the Altman Clinical and Translational Research Institute, part of UC San Diego School of Medicine, will be sites for accelerated national clinical trials to assess the efficacy and immunogenicity of a vaccine intended to protect against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Healthcare Policies and Regulatory Landscape
Policy changes and Reimbursement scenario
This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric post market surveillances of a device product to, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric post market surveillances of a device product that are ordered by FDA.

1. Report Description of the US Clinical Trial……………
1.1 Research Scope and Assumption
1.2 Objective of the study
1.3 Research Methodology
1.4 Reason to buy the report
2. US Clinical Trial Executive Summary………………………
2.1 US Clinical Trial – Industry Snapshot & key buying criteria, 2020-2028
2.2 Market Size, Growth Prospects and Key findings
3. Market Dynamics of US Clinical Trial……………………
3.1 Market Growth Drivers Analysis
3.1.1 High demand for clinical trials
3.1.2 High R&D spending of the pharmaceutical industry
3.1.3 Increasing prevalence of diseases
3.1.4 Developing new therapeutics
3.2 Market Restraints Analysis
3.2.1 Stringent regulatory policies for patient enrollment
3.2.2 Lack of skilled professionals in the market
3.3 Covid-19 Market Impact Analysis
4. US Clinical Trial Market Segmentation………………………………………
4.1 By Phase Analysis:
4.1.1 Phase I
4.1.2 Phase II
4.1.3 Phase III
4.2 By Design Analysis:
4.2.1 Interventional Trials
4.2.2 Observational Trials
4.2.3 Expanded Access Trials
4.3 By Application Analysis:
4.3.1 Autoimmune
4.3.2 Blood disorders
4.3.3 Cancer
4.3.4 Circulatory
4.3.5 Congenita
4.3.6 Others
5. US Clinical Trial Market Share………………………………………
5.1 Market Analysis, Insights and Forecast – By Revenue
6. Competitive Landscape…………………………………………………………………
6.1 Major Top Market Players
6.2 R&D Initiatives 5. US Clinical Trial Market
6.3 Notable recent deals in US Clinical Trial Market
6.3.1 Joint Ventures
6.3.2 Partnerships
6.3.3 Mergers & Acquisitions
6.3.4 Strategic divestments
7. Key Company Profiles………………………………………………………………….
7.1 Clinipace Company overview
Product & Services, Strategies & Financials
7.2 Pfizer Inc., Company overview
Product & Services, Strategies & Financials
7.3 Eli Lilly and Company overview
Product & Services, Strategies & Financials
7.4 PRA Health Sciences Company overview
Product & Services, Strategies & Financials
7.5 Parexel Company overview
Product & Services, Strategies & Financials
7.6 IQVAI Company overview
Product & Services, Strategies & Financials
7.7 PRA Health Sciences 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 US Clinical Trial market
9.2 Future Opportunities
10. Strategic Recommendations

US Clinical Trial Market Segmentation
By Phase:
• Phase I
• Phase II
• Phase III
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:
• Interventional Trials
• Observational Trials
• Expanded Access Trials

By Application:
• Autoimmune
• Blood disorders
• Cancer
• Circulatory
• Congenita
• Others

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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