North America Clinical Trials Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The North America Clinical Trials Market is segmented By Phase (Phase I, Phase II, Phase III, and Phase IV), By Design (Treatment Studies and Observational Studies), and Geography (United States, Canada, and Mexico). The report offers the value in USD (US Dollar) million for the above segments.

Market Snapshot

North America Clinical Trials Market Forecast
Study Period: 2019-2027
Base Year: 2021
CAGR: 8.1 %

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Market Overview

The North America clinical trials market is expected to register a CAGR of 8.1% during the forecast period.

The emergence of the COVID-19 pandemic had an adverse effect on the world economy and the healthcare system. The lockdown all over the globe has affected the supply chain of pharmaceuticals, medical devices, and biotechnological products. On the other hand, research and development have come into focus. All government agencies and healthcare players all over the world have increased their focus to support the development of prevention, diagnostics, and treatment methods for COVID-19.​ This led to an increase in the number of clinical trials focusing on COVID-19 medication, which majorly benefitted the market growth.

The market will show rapid growth due to the increasing number of clinical trials in the North American region, the high R&D expenditure of the pharmaceutical industry, and the rising prevalence of diseases.

The rising population in the North American region is found to have has varied disease profiles which are 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.

According to the United States National Library of Medicine, as of September 2022, there are approximately 13,323 active clinical trials across different phases for cancer indication in the United States. 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, many pharmaceutical companies 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, henceforth increasing the overall market.

Scope of the Report

As per the scope of the report, clinical trials are experiments that are conducted under clinical research and follow a regulated protocol. These experiments are primarily performed to obtain data regarding the safety and efficacy of newly developed drugs. Clinical trial data is mandatory for drug approval, as well as for it to be introduced in the market. These trials are performed under three phases (I, II, III, and IV), which depend upon various factors. This process is not only expensive, but also time-consuming, and requires expertise at all stages. The North America Clinical Trials Market is segmented By Phase (Phase I, Phase II, Phase III, and Phase IV), By Design (Treatment Studies and Observational Studies), and Geography (United States, Canada, and Mexico). The report offers the value in USD (US Dollar) million for the above segments.

By Phase
Phase I
Phase II
Phase III
Phase IV
By Design
Treatment Studies
Randomized Control Trial
Double Blind Trial Randomized Trial
Single Blind Trial Randomized Trial
Non-blind Randomized Trial
Adaptive Clinical Trial
Non-randomized Control Trial
Observational Studies
Cohort Study
Case Control Study
Cross Sectional Study
Ecological Study
Geography
United States
Canada
Mexico

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Key Market Trends

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 in 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. Government initiatives in North American countries for the promotion of drug discovery and continuous technological innovations are expected to propel market growth.

According to the National Clinical Trials Registry (NCT), as of September 2022, there were about 3,300 active clinical trials under phase III development for various diseases in the United States. Around 1,478 active phase III, clinical trials were being investigated in Canada. Thus, owing to the above factors the segment is expected to show growth in the coming years.

The results of phase III clinical trials help in the determination of the safety and efficacy of the treatment in a large population. Such study aid in the approval process that ultimately results in the commercialization of the treatment. Thus, the phase III trials play a significant role in the growthof the studied market over the forecast period.

Number of Clinical Trials (in Thousands), by Country, North America, as of September 2022

United States is Expected to Hold a Significant Share in the Market over the Forecast Period

The United States is leading the market, due to factors such as a rise in the number of research activities pertaining to new therapies, an increase in the budget for the pharmaceutical sector, and growing awareness about clinical studies. The growing healthcare concern, increasing healthcare expenditure, and presence of well-established healthcare infrastructure are the primary drivers for the United States.

The United States has the largest number of clinical trials performed in the region. According to the United States National Library of Medicine, as of September 28, 2022, there were over 156,478 clinical trials registered in the United States. The large number of clinical studies carried out in the nation is expected to have a positive impact on the market growth over the forecast period.

Also, the clinical trials by the key market players in the United States are likely to boost the growth of the market. As per the United States National Library of Medicine, as of September 28, 2022, Eli Lilly has sponsored over 1,093 clinical studies as a lead sponsor in the United States. Similarly, Novartis has sponsored around 1,449 clinical trials as the lead sponsor. Pfizer acted as a lead sponsor for around 1,927 clinical trials, and Hoffmann-La Roche has over 816 clinical trials in the nation. The large interest of the key players in the country is expected to propel the growth of the studied market over the forecast period.

The rising demand for novel therapeutics in various prominent diseases or disorders has also increased the number of clinical trials in the United States. For instance, in September 2022, over 42,122 clinical trials for cancer studies were registered in the nation. Around 6,375 clinical studies were registered for cardiac diseases, and over 1,950 studies were registered for respiratory disorders. A large number of clinical studies in the nation is expected to have a positive impact n the market growth over the forecast period.

Thus, owing to the above-mentioned factors, the United States is expected to hold a significant market share in the region over the forecast period.

Number of Clinical Trials (in Thousands), by Phase, United States, as of September 2022

Competitive Landscape

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.

Recent Development

  • In September 2022, IVERIC bio, Inc. started an Open-label Extension (OLE) phase 3 trial to assess the safety of intravitreal administration of avacincaptad pegol (complement C5 inhibitor) in patients with geographic atrophy who previously completed phase 3 study ISEE2008 (GATHER2).
  • In September 2022, the University of Illinois at Chicago conducted a clinical trial to investigate the blood flow and blood pressure in down syndrome or Trisomy 21: FBI21.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definitio

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Demand for Clinical Trials

      2. 4.2.2 High R&D Expenditure of the Pharmaceutical Industry

      3. 4.2.3 Rising Prevalence of Diseases

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Skilled Workforce for Clinical Research

      2. 4.3.2 Stringent Regulations

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Phase

      1. 5.1.1 Phase I

      2. 5.1.2 Phase II

      3. 5.1.3 Phase III

      4. 5.1.4 Phase IV

    2. 5.2 By Design

      1. 5.2.1 Treatment Studies

        1. 5.2.1.1 Randomized Control Trial

          1. 5.2.1.1.1 Double Blind Trial Randomized Trial

          2. 5.2.1.1.2 Single Blind Trial Randomized Trial

          3. 5.2.1.1.3 Non-blind Randomized Trial

        2. 5.2.1.2 Adaptive Clinical Trial

        3. 5.2.1.3 Non-randomized Control Trial

      2. 5.2.2 Observational Studies

        1. 5.2.2.1 Cohort Study

        2. 5.2.2.2 Case Control Study

        3. 5.2.2.3 Cross Sectional Study

        4. 5.2.2.4 Ecological Study

    3. 5.3 Geography

      1. 5.3.1 United States

      2. 5.3.2 Canada

      3. 5.3.3 Mexico

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Clinipace

      2. 6.1.2 Eli Lilly and Company

      3. 6.1.3 F. Hoffmann-La Roche Ltd

      4. 6.1.4 ICON PLC

      5. 6.1.5 IQVIA

      6. 6.1.6 Laboratory Corporation of America

      7. 6.1.7 Novo Nordisk AS

      8. 6.1.8 PAREXEL International Corporation

      9. 6.1.9 Pfizer Inc.

      10. 6.1.10 Pharmaceutical Product Development LLC

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The North America Clinical Trials Market market is studied from 2019 - 2027.

The North America Clinical Trials Market is growing at a CAGR of 8.1% over the next 5 years.

Novo Nordisk AS, ICON Plc, Eli Lilly and Company, IQVIA, Clinipace are the major companies operating in North America Clinical Trials Market.

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