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市場調查報告書

商品編碼

1871415

2021-2031年北美臨床試驗市場報告：範圍、細分、動態和競爭分析

North America Clinical Trials Market Report 2021-2031 by Scope, Segmentation, Dynamics, and Competitive Analysis

出版日期: 2025年09月01日 | 出版商:

The Insight Partners | 英文 125 Pages | 訂單完成後即時交付

價格

簡介目錄圖表

預計北美臨床試驗市場將大幅成長，到 2031 年將達到約 324.4582 億美元，高於 2023 年的 190.4218 億美元，在此期間的年複合成長率(CAGR) 為 6.9%。

執行摘要和市場分析

北美臨床試驗市場以其先進的基礎設施、雄厚的研究經費和龐大的患者群體為特徵。技術創新和個人化醫療的興起推動了該行業的發展，提升了試驗的設計和執行效率。製藥公司與合約研究組織（CRO）之間的合作提高了營運效率。然而，該市場也面臨著許多挑戰，例如嚴格的監管要求和不斷上漲的成本，因此需要持續調整以維持成長並最佳化藥物研發流程。

市場區隔分析

北美臨床試驗市場可根據研究設計、適應症和階段類型進行細分：

研究設計：市場分為干涉性試驗和擴大准入試驗，到 2023 年，干預性試驗將佔據市場佔有率的主導地位。
適應症：主要領域包括自體免疫/發炎、疼痛管理、腫瘤、神經系統疾病、糖尿病、肥胖、代謝性疾病、心血管疾病等。 2023年，腫瘤領域佔最大佔有率。
階段類型：市場分為 I 期、II 期和 III 期試驗，其中 II 期在 2023 年佔據最大的市場佔有率。

市場展望

研究在製藥、生物製藥和醫療器材領域發揮著至關重要的作用，它能夠開發出具有巨大醫療和商業潛力的新型治療方案。製藥業尤其注重研發投入，致力於提高藥物的療效和效率，以滿足患者的需求。藥品成本的不斷上漲仍然是主要問題，促使企業利用研發來實現成本目標。過去十年，新藥的年度核准率持續成長，光是2022年，美國食品藥物管理局（FDA）就批准了37種新藥。美國在全球研發投入方面處於領先地位，過去十年中，其新藥分子數量佔全球總數的50%以上。根據歐洲製藥工業協會聯合會（EFPIA）的數據，2021年北美佔全球藥品銷售額的49.1%，而美國在2016年至2021年期間的新藥銷售額佔全球新藥銷售額的64.4%。

主要製藥公司的研發投資

下表列出了主要製藥公司的研發支出：

| 公司 | 2022年（十億美元） | 2023（十億美元） |

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

| 武田藥品工業株式會社 | 4.2 | 5.08 |

| 輝瑞公司 | 11.4 | 10.6 |

|格里福斯公司 | 427.05 | 427.05 432.71 | 432.71

註：貨幣顯示採用當前匯率。 *

資料來源：年度報告與The Insight Partners分析

研發投入對於企業發現、開發和生產新產品、改進現有產品以及確保合規至關重要。臨床試驗的相關成本包括材料、耗材、員工薪資和品質控制開發。根據美國藥品研究與製造商協會（PhRMA）2021年會員公司報告，前15名的製藥公司在研發方面共投入1,330億美元，其中約44%用於臨床試驗。與醫院的合作也在不斷增加，以開發治療包括免疫系統疾病在內的各種疾病的方法。例如，武田製藥於2021年6月宣布啟動ADVANCE-1試驗，以評估HYQVIA治療慢性發炎性脫髓鞘性多發性神經根神經病變（CIDP）的療效。

國家概況

北美臨床試驗市場涵蓋美國、加拿大和墨西哥，其中美國在2023年佔據最大的市場佔有率。美國是臨床研究的首選目的地，幾乎一半的臨床試驗都在美國進行。製藥公司青睞美國，是因為其完善的醫療基礎設施、快速的批准流程和良好的監管環境。世界衛生組織的報告顯示，美國擁有最多的臨床試驗，2021年總計達157,618項。美國臨床試驗市場的成長得益於創新產品和服務，例如Medical Metrics公司的“Assessa”，該工具可輔助神經系統疾病的藥物研發。

公司簡介

臨床試驗市場的主要參與者包括QVIA Holdings Inc、Parexel International Corp、IXICO Plc、Charles River Laboratories International Inc、ICON Plc、藥明康德股份有限公司、SGS SA、Syneos Health Inc、Thermo Fisher Scientific Inc、Laboratory Corp of America Holdings、CliniRx Research Private Limited、Caidyaal.這些公司正在推行擴張、產品創新以及併購等策略，以增強其市場佔有率並提供創新解決方案。

市場促進因素
- 臨床研究外包實務與試驗數量大幅成長
- 蓬勃發展的製藥業，研發活動激增
市場限制
- 昂貴且耗時的過程
市場機遇
- 採用分散式臨床試驗及混合式臨床試驗
未來趨勢
- 人工智慧驅動的臨床試驗
駕駛員和安全帶的影響：

第6章：臨床試驗市場—北美分析

2021-2031年北美臨床試驗市場收入
北美臨床試驗市場預測分析

第7章：北美臨床試驗市場分析－依研究設計分類

干預性試驗
擴大使用試驗

第8章：北美臨床試驗市場分析－依適應症分類

自體免疫/炎症
疼痛管理
腫瘤學
神經系統疾病
糖尿病
肥胖
代謝紊亂
心血管
其他

第9章：北美臨床試驗市場分析－以階段類型分類

第一階段
第二階段
第三階段

第10章：北美臨床試驗市場—國家分析

北美洲
- 美國
- 加拿大
- 墨西哥

第11章：行業概況

概述
臨床試驗市場成長策略
有機成長策略
- 概述
無機成長策略
- 概述

第12章：公司簡介

QVIA Holdings Inc
Parexel International Corp
IXICO Plc
Charles River Laboratories International Inc
ICON Plc
WuXi AppTec Co Ltd
SGS SA
Syneos Health Inc
SIRO Clinpharm Pvt Ltd
Thermo Fisher Scientific Inc
Laboratory Corp of America Holdings
CliniRx Research Private Limited
Caidya
Oracle Corp
Medpace Holdings Inc

第13章：附錄

簡介目錄圖表

Product Code: BMIRE00029014

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.

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

簡介目錄圖表

List Of Tables

Table 1. North America Clinical Trials Market Segmentation
Table 2. R&D Investments by Major Pharmaceutical Companies
Table 3. North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Table 4. North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Study Design
Table 5. North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Indications
Table 6. North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Phase Type
Table 7. North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Country
Table 8. United States: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Study Design
Table 9. United States: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Indications
Table 10. United States: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Phase Type
Table 11. Canada: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Study Design
Table 12. Canada: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Indications
Table 13. Canada: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Phase Type
Table 14. Mexico: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Study Design
Table 15. Mexico: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Indications
Table 16. Mexico: North America Clinical Trials Market - Revenue and Forecast, 2021 - 2031(US$ Million) - by Phase Type
Table 17. Recent Organic Growth Strategies in Clinical Trials Market
Table 18. Recent Inorganic Growth Strategies in the Clinical Trials Market
Table 19. List of Abbreviations

List Of Figures

Figure 1. North America Clinical Trials Market Segmentation - Country
Figure 2. PEST Analysis
Figure 3. North America Clinical Trials Market - Key Market Dynamics
Figure 4. Impact Analysis of Drivers and Restraints
Figure 5. North America Clinical Trials Market Revenue (US$ Million), 2021-2031
Figure 6. North America Clinical Trials Market Share (%) - by Study Design (2023 and 2031)
Figure 7. Interventional Trials: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 8. Expanded Access Trials: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 9. North America Clinical Trials Market Share (%) - by Indications (2023 and 2031)
Figure 10. Autoimmune/Inflammation: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 11. Pain Management: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 12. Oncology: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 13. Neurological Disorders: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 14. Diabetes: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 15. Obesity: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 16. Metabolic Disorders: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 17. Cardiovascular: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 18. Others: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 19. North America Clinical Trials Market Share (%) - by Phase Type (2023 and 2031)
Figure 20. Phase I: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 21. Phase II: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 22. Phase III: North America Clinical Trials Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 23. North America Clinical Trials Market Breakdown, by Key Countries, 2023 and 2031 (%)
Figure 24. United States: North America Clinical Trials Market - Revenue and Forecast, 2021- 2031 (US$ Million)
Figure 25. Canada: North America Clinical Trials Market - Revenue and Forecast, 2021- 2031 (US$ Million)
Figure 26. Mexico: North America Clinical Trials Market - Revenue and Forecast, 2021- 2031 (US$ Million)
Figure 27. Growth Strategies in Clinical Trials Market