小児臨床試験市場- 世界の産業規模、シェア、動向、機会、予測、フェーズ別、試験デザイン別、治療分野別、地域別、競合市場別、2020-2030年

小児臨床試験の世界市場規模は、2024年に152億9,000万米ドル、2030年には236億7,000万米ドルに達し、予測期間中のCAGRは7.56%で成長すると予測されています。

小児臨床試験乳幼児、小児、青少年を対象とした医薬品、医療機器、治療法の安全性、有効性、適切な投与量の評価に重点が置かれています。これらの臨床試験は、小児集団に特有の病状に対処し、年齢に適した治療を確保するために不可欠です。倫理的配慮が最も重要であり、両親または保護者からのインフォームド・コンセントを含むプロトコールが用いられます。臨床試験は、症状の改善、疾患の進行、安全性などのアウトカムを測定するように構成されています。世界的に毎年10万人当たり1,400人以上の小児が罹患する肺炎など、小児疾患の罹患率が上昇していることから、標的治療薬の緊急の必要性が浮き彫りになっています。製薬会社は、特に南アジアやサハラ以南のアフリカのような負担の大きい地域で、治療ギャップを埋めるために小児科の研究を優先することで対応しています。小児専門医療に対する需要の高まりと規制当局の支援が、市場をさらに前進させています。

市場促進要因

希少疾患への注目の高まり

市場の課題

多様性と代表性

主要市場動向

小児用医薬品開発への注目の高まり

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の小児臨床試験市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • フェーズ別（フェーズI、フェーズII、フェーズIII、フェーズIV）
  • 研究デザイン（治療研究と観察研究）
  • 治療領域別（呼吸器疾患、感染症、腫瘍学、糖尿病、その他の治療領域）
  • 地域別
  • 企業別（2024）
• 市場マップ

第6章 アジア太平洋地域の小児臨床試験市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • オーストラリア
  • 日本
  • 韓国

第7章 欧州の小児臨床試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • スペイン
  • イタリア
  • 英国

第8章 北米の小児臨床試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第9章 南米の小児臨床試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの小児臨床試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 製品上市
• 合併と買収

第13章 世界の小児臨床試験市場：SWOT分析

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 PESTEL分析

第16章 競合情勢

• Bristol-Myers Squibb Company
• . SWOT Analysis
• Charles River Laboratories International Inc.
• Covance Inc.
• GlaxoSmithKline plc
• ICON plc
• IQVIA Inc.
• Novartis AG
• Pfizer, Inc.
• Pharmaceutical Product Development, LLC
• Syneos Health Inc.
• Paidion Research, Inc.
• The Emmes Company, LLC

第17章 戦略的提言

第18章 調査会社について・免責事項

The Global Pediatric Clinical Trials Market was valued at USD 15.29 billion in 2024 and is projected to reach USD 23.67 billion by 2030, growing at a CAGR of 7.56% during the forecast period. Pediatric clinical trials focus on assessing the safety, efficacy, and appropriate dosing of drugs, medical devices, and therapies for infants, children, and adolescents. These trials are vital for addressing medical conditions unique to the pediatric population and ensuring age-appropriate treatments. Ethical considerations are paramount, with protocols involving informed consent from parents or guardians. Trials are structured to measure outcomes such as symptom improvement, disease progression, and safety. Rising pediatric disease incidence, such as pneumonia, which affects over 1,400 children per 100,000 globally each year, underscores the urgent need for targeted therapies. Pharmaceutical companies are responding by prioritizing pediatric studies to close treatment gaps, especially in high-burden regions like South Asia and Sub-Saharan Africa. Growing demand for specialized pediatric care and regulatory support further propels the market forward.

Key Market Drivers

Growing Focus on Rare Diseases

The increasing emphasis on rare or orphan diseases-many of which primarily affect children-is a major driver of pediatric clinical trials. With limited treatment options available, pediatric trials play a crucial role in drug development for these underserved conditions. Regulatory bodies such as the FDA and EMA incentivize this research through extended exclusivity periods, tax credits, and application fee waivers. Orphan drug designations can also expedite development timelines and enhance funding opportunities. In addition, patient advocacy groups actively collaborate with stakeholders to promote awareness and facilitate research efforts, thus boosting clinical trial activity in pediatric rare disease populations.

Key Market Challenges

Diversity and Representation

A major challenge in pediatric clinical trials is ensuring demographic diversity and inclusive representation. Without adequate participation from diverse racial, ethnic, and socioeconomic groups, trial results risk being non-generalizable and potentially biased. This underrepresentation can exacerbate healthcare disparities, particularly in conditions that disproportionately impact specific populations. Factors such as cultural differences, language barriers, and socioeconomic status can hinder participation, while the need for parental consent introduces additional complexity. Regulatory authorities increasingly emphasize inclusivity in trial design, and engagement with local communities is essential to building trust and overcoming recruitment challenges. Culturally competent communication strategies are critical for improving representation across pediatric studies.

Key Market Trends

Increasing Emphasis on Pediatric Drug Development

There is a growing focus on developing pediatric-specific medications, driven by both commercial potential and public health need. Advances in genomics, targeted therapies, and precision medicine are creating new pathways for pediatric drug development. Collaborative networks like the Pediatric Trials Network and the International Neonatal Consortium are supporting these efforts by pooling resources and patient data. Patient advocacy groups and global health initiatives are further amplifying awareness and support for pediatric research. These developments are accelerating clinical trial activity and fostering innovation in pediatric therapeutics, especially in areas with historically limited treatment options.

Key Market Players

• Bristol-Myers Squibb Company
• Charles River Laboratories International Inc.
• Covance Inc.
• GlaxoSmithKline plc
• ICON plc
• IQVIA Inc.
• Novartis AG
• Pfizer, Inc.
• Pharmaceutical Product Development, LLC
• Syneos Health Inc.
• Paidion Research, Inc.
• The Emmes Company, LLC

Report Scope:

In this report, the Global Pediatric Clinical Trials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Pediatric Clinical Trials Market, By Phase:

• Phase I
• Phase II
• Phase III
• Phase IV

Pediatric Clinical Trials Market, By Study Design:

• Treatment Studies
• Observational Studies

Pediatric Clinical Trials Market, By Therapeutic Area:

• Respiratory Disease
• Infectious Diseases
• Oncology
• Diabetes
• Other Therapeutic Areas

Pediatric Clinical Trials Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Asia-Pacific
  • China
  • India
  • South Korea
  • Australia
  • Japan
• Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Pediatric Clinical Trials Market.

Available Customizations:

Global Pediatric Clinical Trials Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Pediatric Clinical Trials Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Phase (Phase I, Phase II, Phase III, and Phase IV)
  • 5.2.2. By Study Design (Treatment Studies and Observational Studies)
  • 5.2.3. By Therapeutic Area (Respiratory Diseases, Infectious Diseases, Oncology, Diabetes, and Other Therapeutic Areas)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. Asia Pacific Pediatric Clinical Trials Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Phase
  • 6.2.2. By Study Design
  • 6.2.3. By Therapeutic Design
  • 6.2.4. By Country
• 6.3. Asia Pacific: Country Analysis
  • 6.3.1. China Pediatric Clinical Trials Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Phase
      • 6.3.1.2.2. By Study Design
      • 6.3.1.2.3. By Therapeutic Design
  • 6.3.2. India Pediatric Clinical Trials Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Phase
      • 6.3.2.2.2. By Study Design
      • 6.3.2.2.3. By Therapeutic Design
  • 6.3.3. Australia Pediatric Clinical Trials Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Phase
      • 6.3.3.2.2. By Study Design
      • 6.3.3.2.3. By Therapeutic Design
  • 6.3.4. Japan Pediatric Clinical Trials Market Outlook
    • 6.3.4.1. Market Size & Forecast
      • 6.3.4.1.1. By Value
    • 6.3.4.2. Market Share & Forecast
      • 6.3.4.2.1. By Phase
      • 6.3.4.2.2. By Study Design
      • 6.3.4.2.3. By Therapeutic Design
  • 6.3.5. South Korea Pediatric Clinical Trials Market Outlook
    • 6.3.5.1. Market Size & Forecast
      • 6.3.5.1.1. By Value
    • 6.3.5.2. Market Share & Forecast
      • 6.3.5.2.1. By Phase
      • 6.3.5.2.2. By Study Design
      • 6.3.5.2.3. By Therapeutic Design

7. Europe Pediatric Clinical Trials Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Phase
  • 7.2.2. By Study Design
  • 7.2.3. By Therapeutic Design
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Pediatric Clinical Trials Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Phase
      • 7.3.1.2.2. By Study Design
      • 7.3.1.2.3. By Therapeutic Design
  • 7.3.2. Germany Pediatric Clinical Trials Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Phase
      • 7.3.2.2.2. By Study Design
      • 7.3.2.2.3. By Therapeutic Design
  • 7.3.3. Spain Pediatric Clinical Trials Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Phase
      • 7.3.3.2.2. By Study Design
      • 7.3.3.2.3. By Therapeutic Design
  • 7.3.4. Italy Pediatric Clinical Trials Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Phase
      • 7.3.4.2.2. By Study Design
      • 7.3.4.2.3. By Therapeutic Design
  • 7.3.5. United Kingdom Pediatric Clinical Trials Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Phase
      • 7.3.5.2.2. By Study Design
      • 7.3.5.2.3. By Therapeutic Design

8. North America Pediatric Clinical Trials Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Phase
  • 8.2.2. By Study Design
  • 8.2.3. By Therapeutic Design
  • 8.2.4. By Country
• 8.3. North America: Country Analysis
  • 8.3.1. United States Pediatric Clinical Trials Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Phase
      • 8.3.1.2.2. By Study Design
      • 8.3.1.2.3. By Therapeutic Design
  • 8.3.2. Mexico Pediatric Clinical Trials Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Phase
      • 8.3.2.2.2. By Study Design
      • 8.3.2.2.3. By Therapeutic Design
  • 8.3.3. Canada Pediatric Clinical Trials Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Phase
      • 8.3.3.2.2. By Study Design
      • 8.3.3.2.3. By Therapeutic Design

9. South America Pediatric Clinical Trials Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Phase
  • 9.2.2. By Study Design
  • 9.2.3. By Therapeutic Design
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Pediatric Clinical Trials Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Phase
      • 9.3.1.2.2. By Study Design
      • 9.3.1.2.3. By Therapeutic Design
  • 9.3.2. Argentina Pediatric Clinical Trials Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Phase
      • 9.3.2.2.2. By Study Design
      • 9.3.2.2.3. By Therapeutic Design
  • 9.3.3. Colombia Pediatric Clinical Trials Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Phase
      • 9.3.3.2.2. By Study Design
      • 9.3.3.2.3. By Therapeutic Design

10. Middle East and Africa Pediatric Clinical Trials Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Phase
  • 10.2.2. By Study Design
  • 10.2.3. By Therapeutic Design
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Pediatric Clinical Trials Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Phase
      • 10.3.1.2.2. By Study Design
      • 10.3.1.2.3. By Therapeutic Design
  • 10.3.2. Saudi Arabia Pediatric Clinical Trials Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Phase
      • 10.3.2.2.2. By Study Design
      • 10.3.2.2.3. By Therapeutic Design
  • 10.3.3. UAE Pediatric Clinical Trials Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Phase
      • 10.3.3.2.2. By Study Design
      • 10.3.3.2.3. By Therapeutic Design

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Product Launches
• 12.3. Mergers & Acquisitions

13. Global Pediatric Clinical Trials Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

• 16.1. Bristol-Myers Squibb Company
  • 16.1.1. Business Overview
  • 16.1.2. Company Snapshot
  • 16.1.3. Products & Services
  • 16.1.4. Financials (In case of listed companies)
  • 16.1.5. Recent Developments
  • 16.1.6. Key Personnel Details
• 16.1.. SWOT Analysis
• 16.2. Charles River Laboratories International Inc.
• 16.3. Covance Inc.
• 16.4. GlaxoSmithKline plc
• 16.5. ICON plc
• 16.6. IQVIA Inc.
• 16.7. Novartis AG
• 16.8. Pfizer, Inc.
• 16.9. Pharmaceutical Product Development, LLC
• 16.10.Syneos Health Inc.
• 16.11.Paidion Research, Inc.
• 16.12.The Emmes Company, LLC

17. Strategic Recommendations

18. About Us & Disclaimer