북미의 임상시험 시장 보고서 : 범위, 부문, 역학, 경쟁 분석(2021-2031년)

The North American clinical trials market is projected to grow significantly, reaching approximately USD 32,445.82 million by 2031, up from USD 19,042.18 million in 2023, reflecting a compound annual growth rate (CAGR) of 6.9% during this period.

Executive Summary and Market Analysis

The clinical trials market in North America is characterized by its advanced infrastructure, substantial research funding, and a large patient population. The sector is driven by technological innovations and the rise of personalized medicine, which enhance trial design and execution. Collaborations between pharmaceutical companies and contract research organizations (CROs) are improving operational efficiency. However, the market faces challenges such as stringent regulatory requirements and increasing costs, necessitating ongoing adjustments to sustain growth and optimize drug development processes.

Market Segmentation Analysis

The North American clinical trials market can be segmented based on study design, indications, and phase type:

• Study Design: The market is divided into interventional trials and expanded access trials, with interventional trials dominating the market share in 2023.
• Indications: Key segments include autoimmune/inflammation, pain management, oncology, neurological disorders, diabetes, obesity, metabolic disorders, cardiovascular issues, and others. Oncology represented the largest segment in 2023.
• Phase Type: The market is categorized into phase I, phase II, and phase III trials, with phase II holding the largest market share in 2023.

Market Outlook

Research plays a crucial role in the pharmaceutical, biopharmaceutical, and medical device sectors, enabling the development of new therapeutic solutions with significant medical and commercial potential. The pharmaceutical industry is notably R&D-intensive, focusing on enhancing effectiveness and efficiency to meet patient needs. The rising costs of medications remain a primary concern, prompting companies to leverage R&D to achieve cost targets. Over the past decade, the annual approval rate of new drugs has increased, with the FDA approving 37 new drugs in 2022 alone. The United States leads globally in R&D investments, contributing over 50% of new drug molecules in the last decade. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), North America accounted for 49.1% of global pharmaceutical sales in 2021, with the US responsible for 64.4% of new medicine sales from 2016 to 2021.

R&D Investments by Major Pharmaceutical Companies

The following table outlines R&D expenditures by major pharmaceutical companies:

| Company | 2022 (USD Billion) | 2023 (USD Billion) |

|----------------------------------|--------------------|--------------------|

| Takeda Pharmaceutical Co Ltd | 4.2 | 5.08 |

| Pfizer Inc | 11.4 | 10.6 |

| Grifols SA | 427.05 | 432.71 |

Note: Current conversion rates are applied for currency presentation.*

Source: Annual Reports and The Insight Partners Analysis

R&D spending is vital for companies to discover, develop, and produce new products, improve existing outcomes, and ensure regulatory compliance. The costs associated with clinical trials include materials, supplies, employee salaries, and quality control development. According to the PhRMA Member Companies 2021 report, the top 15 pharmaceutical companies invested a total of USD 133 billion in R&D, with approximately 44% allocated to clinical trials. Collaborations with hospitals are also increasing to develop treatments for various diseases, including immunological disorders. For instance, in June 2021, Takeda announced the ADVANCE-1 trial to evaluate HYQVIA for treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Country Insights

The North American clinical trials market includes the US, Canada, and Mexico, with the US holding the largest market share in 2023. The US is a premier destination for clinical research, hosting nearly half of all clinical trials. Pharmaceutical companies favor the US for its established medical infrastructure, rapid approval processes, and favorable regulatory environment. A WHO report indicated that the US had the highest number of clinical trials, totaling 157,618 in 2021. The growth of the clinical trials market in the US is driven by innovative products and services, such as Medical Metrics' "Assessa," which aids in drug discovery for neurological disorders.

Company Profiles

Key players in the clinical trials market include QVIA Holdings Inc, Parexel International Corp, IXICO Plc, Charles River Laboratories International Inc, ICON Plc, WuXi AppTec Co Ltd, SGS SA, Syneos Health Inc, Thermo Fisher Scientific Inc, Laboratory Corp of America Holdings, CliniRx Research Private Limited, Caidya, Oracle Corp, Medpace Holdings Inc, and SIRO Clinpharm Pvt Ltd. These companies are pursuing strategies such as expansion, product innovation, and mergers and acquisitions to enhance their market presence and offer innovative solutions.

Table Of Contents

1. Introduction

• 1.1 Report Guidance
• 1.2 Market Segmentation

2. Executive Summary

• 2.1 Key Insights

3. Research Methodology

• 3.1 Secondary Research
• 3.2 Primary Research
  • 3.2.1 Hypothesis formulation:
  • 3.2.2 Macroeconomic factor analysis:
  • 3.2.3 Developing base number:
  • 3.2.4 Data Triangulation:
  • 3.2.5 Country-level data:

4. North America Clinical Trials Market Landscape

• 4.1 Overview
• 4.2 PEST Analysis

5. North America Clinical Trials Market - Key Market Dynamics

• 5.1 Market Drivers
  • 5.1.1 Practice of Outsourcing Clinical Studies with Massive Rise in Number of Trials
  • 5.1.2 Flourishing Pharmaceutical Industry with Surge in R&D Activities
• 5.2 Market Restraints
  • 5.2.1 Expensive and Time-Consuming Process
• 5.3 Market Opportunities
  • 5.3.1 Adoption of Decentralized Clinical Trials and Hybrid Clinical Trials
• 5.4 Future Trends
  • 5.4.1 AI-Driven Clinical Trials
• 5.5 Impact of Drivers and Restraints:

6. Clinical Trials Market - North America Analysis

• 6.1 North America Clinical Trials Market Revenue (US$ Million), 2021-2031
• 6.2 North America Clinical Trials Market Forecast Analysis

7. North America Clinical Trials Market Analysis - by Study Design

• 7.1 Interventional Trials
  • 7.1.1 Overview
  • 7.1.2 Interventional Trials: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 7.2 Expanded Access Trials
  • 7.2.1 Overview
  • 7.2.2 Expanded Access Trials: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)

8. North America Clinical Trials Market Analysis - by Indications

• 8.1 Autoimmune/Inflammation
  • 8.1.1 Overview
  • 8.1.2 Autoimmune/Inflammation: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.2 Pain Management
  • 8.2.1 Overview
  • 8.2.2 Pain Management: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.3 Oncology
  • 8.3.1 Overview
  • 8.3.2 Oncology: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.4 Neurological Disorders
  • 8.4.1 Overview
  • 8.4.2 Neurological Disorders: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.5 Diabetes
  • 8.5.1 Overview
  • 8.5.2 Diabetes: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.6 Obesity
  • 8.6.1 Overview
  • 8.6.2 Obesity: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.7 Metabolic Disorders
  • 8.7.1 Overview
  • 8.7.2 Metabolic Disorders: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.8 Cardiovascular
  • 8.8.1 Overview
  • 8.8.2 Cardiovascular: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 8.9 Others
  • 8.9.1 Overview
  • 8.9.2 Others: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)

9. North America Clinical Trials Market Analysis - by Phase Type

• 9.1 Phase I
  • 9.1.1 Overview
  • 9.1.2 Phase I: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 9.2 Phase II
  • 9.2.1 Overview
  • 9.2.2 Phase II: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
• 9.3 Phase III
  • 9.3.1 Overview
  • 9.3.2 Phase III: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)

10. North America Clinical Trials Market - Country Analysis

• 10.1 North America
  • 10.1.1 North America Clinical Trials Market - Revenue and Forecast Analysis - by Country
    • 10.1.1.1 North America Clinical Trials Market - Revenue and Forecast Analysis - by Country
    • 10.1.1.2 United States: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
      • 10.1.1.2.1 United States: North America Clinical Trials Market Share - by Study Design
      • 10.1.1.2.2 United States: North America Clinical Trials Market Share - by Indications
      • 10.1.1.2.3 United States: North America Clinical Trials Market Share - by Phase Type
    • 10.1.1.3 Canada: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
      • 10.1.1.3.1 Canada: North America Clinical Trials Market Share - by Study Design
      • 10.1.1.3.2 Canada: North America Clinical Trials Market Share - by Indications
      • 10.1.1.3.3 Canada: North America Clinical Trials Market Share - by Phase Type
    • 10.1.1.4 Mexico: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
      • 10.1.1.4.1 Mexico: North America Clinical Trials Market Share - by Study Design
      • 10.1.1.4.2 Mexico: North America Clinical Trials Market Share - by Indications
      • 10.1.1.4.3 Mexico: North America Clinical Trials Market Share - by Phase Type

11. Industry Landscape

• 11.1 Overview
• 11.2 Growth Strategies in Clinical Trials Market
• 11.3 Organic Growth Strategies
  • 11.3.1 Overview
• 11.4 Inorganic Growth Strategies
  • 11.4.1 Overview

12. Company Profiles

• 12.1 QVIA Holdings Inc
  • 12.1.1 Key Facts
  • 12.1.2 Business Description
  • 12.1.3 Products and Services
  • 12.1.4 Financial Overview
  • 12.1.5 SWOT Analysis
  • 12.1.6 Key Developments
• 12.2 Parexel International Corp
  • 12.2.1 Key Facts
  • 12.2.2 Business Description
  • 12.2.3 Products and Services
  • 12.2.4 Financial Overview
  • 12.2.5 SWOT Analysis
  • 12.2.6 Key Developments
• 12.3 IXICO Plc
  • 12.3.1 Key Facts
  • 12.3.2 Business Description
  • 12.3.3 Products and Services
  • 12.3.4 Financial Overview
  • 12.3.5 SWOT Analysis
  • 12.3.6 Key Developments
• 12.4 Charles River Laboratories International Inc
  • 12.4.1 Key Facts
  • 12.4.2 Business Description
  • 12.4.3 Products and Services
  • 12.4.4 Financial Overview
  • 12.4.5 SWOT Analysis
  • 12.4.6 Key Developments
• 12.5 ICON Plc
  • 12.5.1 Key Facts
  • 12.5.2 Business Description
  • 12.5.3 Products and Services
  • 12.5.4 Financial Overview
  • 12.5.5 SWOT Analysis
  • 12.5.6 Key Developments
• 12.6 WuXi AppTec Co Ltd
  • 12.6.1 Key Facts
  • 12.6.2 Business Description
  • 12.6.3 Products and Services
  • 12.6.4 Financial Overview
  • 12.6.5 SWOT Analysis
  • 12.6.6 Key Developments
• 12.7 SGS SA
  • 12.7.1 Key Facts
  • 12.7.2 Business Description
  • 12.7.3 Products and Services
  • 12.7.4 Financial Overview
  • 12.7.5 SWOT Analysis
  • 12.7.6 Key Developments
• 12.8 Syneos Health Inc
  • 12.8.1 Key Facts
  • 12.8.2 Business Description
  • 12.8.3 Products and Services
  • 12.8.4 Financial Overview
  • 12.8.5 SWOT Analysis
  • 12.8.6 Key Developments
• 12.9 SIRO Clinpharm Pvt Ltd
  • 12.9.1 Key Facts
  • 12.9.2 Business Description
  • 12.9.3 Products and Services
  • 12.9.4 Financial Overview
  • 12.9.5 SWOT Analysis
  • 12.9.6 Key Developments
• 12.10 Thermo Fisher Scientific Inc
  • 12.10.1 Key Facts
  • 12.10.2 Business Description
  • 12.10.3 Products and Services
  • 12.10.4 Financial Overview
  • 12.10.5 SWOT Analysis
  • 12.10.6 Key Developments
• 12.11 Laboratory Corp of America Holdings
  • 12.11.1 Key Facts
  • 12.11.2 Business Description
  • 12.11.3 Products and Services
  • 12.11.4 Financial Overview
  • 12.11.5 SWOT Analysis
  • 12.11.6 Key Developments
• 12.12 CliniRx Research Private Limited
  • 12.12.1 Key Facts
  • 12.12.2 Business Description
  • 12.12.3 Products and Services
  • 12.12.4 Financial Overview
  • 12.12.5 SWOT Analysis
  • 12.12.6 Key Developments
• 12.13 Caidya
  • 12.13.1 Key Facts
  • 12.13.2 Business Description
  • 12.13.3 Products and Services
  • 12.13.4 Financial Overview
  • 12.13.5 SWOT Analysis
  • 12.13.6 Key Developments
• 12.14 Oracle Corp
  • 12.14.1 Key Facts
  • 12.14.2 Business Description
  • 12.14.3 Products and Services
  • 12.14.4 Financial Overview
  • 12.14.5 SWOT Analysis
  • 12.14.6 Key Developments
• 12.15 Medpace Holdings Inc
  • 12.15.1 Key Facts
  • 12.15.2 Business Description
  • 12.15.3 Products and Services
  • 12.15.4 Financial Overview
  • 12.15.5 SWOT Analysis
  • 12.15.6 Key Developments

13. Appendix

• 13.1 About Us
• 13.2 List of Abbreviations