小児臨床試験市場：フェーズ別、研究設計別、治療領域別、地域別

世界の小児臨床試験市場は2025年に192億6,000万米ドルと推定され、2032年には370億8,000万米ドルに達すると予測され、2025～2032年にかけてCAGR9.8％で成長すると予測されています。

図.小児臨床試験市場の地域別シェア（%）（2025年）

小児臨床試験市場は近年著しい成長を遂げています。小児における慢性疾患の有病率の増加と新たな治療オプションに対する需要の高まりが、小児臨床試験産業を後押ししています。さらに、同市場では、小児を対象とした医薬品開発のために製薬企業からの投資が増加しています。希少疾患に対する意識の高まりや、小児用医薬品の臨床評価を義務付ける規制当局によるさまざまな取り組みが、市場機会を拡大しています。しかし、小児用医薬品の臨床試験の実施は、倫理的な懸念、年齢特有の薬剤代謝、募集の難しさ、代替エンドポイントに関するコンセンサスの欠如などの理由から、成人用試験よりも複雑で困難です。新たな治療法の出現や、小児に優しい医薬品の開発に対する各社の継続的な努力により、小児臨床試験市場は今後数年間で力強い成長を遂げるものと考えられます。

市場力学

世界の小児臨床試験市場の成長は、小児の慢性疾患罹患率の上昇、新たな治療法に対する需要の高まり、医薬品開発プロセスの合理化を目的とした規制当局の取り組みによってもたらされます。WHOの推定によると、2021年には世界中で2億人以上の小児が様々な非伝染性疾患に罹患しています。アンメットニーズが高いことから、製薬企業は小児に特化した治療法の開発に向けた投資を強化しています。米国食品医薬品局（FDA）の2012年改正法などの好意的な規制により、小児用医薬品の市販前臨床評価が義務付けられ、市場機会が拡大しています。しかし、小児臨床研究に伴う複雑さや十分な代替エンドポイントの不足は、引き続き市場成長に悪影響を及ぼしています。また、臨床試験に伴う高いコストや経験豊富な治験責任医師の不足も、より広範な市場導入の妨げとなっています。斬新なアプローチで問題に対処しようとする産業関係者と研究機関の継続的な協力関係は、今後の拡大を後押しすると考えられます。

本調査の主要特徴

本レポートでは、世界の小児臨床試験市場を詳細に分析し、2024年を基準年とした予測期間（2025～2032年）の市場規模とCAGRを掲載しています。

また、さまざまなセグメントにわたる潜在的な収益機会を明らかにし、この市場の魅力的な投資提案マトリクスについて解説しています。

また、市場促進要因、抑制要因、機会、新製品の上市や承認、市場動向、地域による展望、主要企業が採用する競争戦略などに関する主要考察も提供しています。

世界の小児臨床試験市場における主要企業プロファイルを、企業ハイライト、製品ポートフォリオ、主要ハイライト、業績、戦略などのパラメータに基づいて掲載しています。

主要企業は、CSL Behring、Sanofi、Takeda Pharmaceutical Company Limited、Orchard Therapeutics plc.、Pharming Group N.V.、BioCryst Pharmaceuticals, Inc.、Ionis Pharmaceuticals, Inc.、Attune Pharmaceuticals、Arrowhead Pharmaceuticals, Inc.、Adverum BIoTechnologies, Inc.、KalVista Pharmaceuticals、CENTOGENE N.V.などがあります。

本レポートから洞察により、マーケティング担当者や企業の経営陣は、将来の製品上市、タイプアップ、市場拡大、マーケティング戦術に関する情報に基づいた意思決定を行うことができます。

世界の小児臨床試験市場レポートは、投資家、サプライヤー、製品メーカー、流通業者、新規参入者、財務アナリストなど、この産業の様々な利害関係者を対象としています。

利害関係者は、世界の小児臨床試験市場分析に使用される様々な戦略マトリックスを通じて、意思決定が容易になります。

目次

第1章 調査の目的と前提条件

• 調査目的
• 前提条件
• 略語

第2章 市場展望

• レポートの説明
  • 市場の定義と範囲
• エグゼクティブサマリー

第3章 市場力学、規制、動向の分析

• 市場力学
• 影響分析
• 規制シナリオ
• 製品の発売/承認
• PEST分析
• ポーター分析
• 合併と買収のシナリオ
• 疫学

第4章 世界の小児臨床試験市場、フェーズ別、2020～2032年（10億米ドル）

• イントロダクション
• フェーズI
• フェーズII
• フェーズIII
• フェーズIV

第5章 世界の小児臨床試験市場、研究設計別、2020～2032年（10億米ドル）

• イントロダクション
• 治療研究
• 観察研究

第6章 小児臨床試験市場、治療領域別、2020～2032年（10億米ドル）

• イントロダクション
• 呼吸器疾患
• 心血管疾患
• 神経精神疾患
• 腫瘍学
• 糖尿病
• その他（神経精神疾患など）

第7章 世界の小児臨床試験市場、地域別、2020～2032年、金額（10億米ドル）

• イントロダクション
• 北米
• ラテンアメリカ
• 欧州
• アジア太平洋
• 中東
• アフリカ

第8章 競合情勢

• CSL Behring
• Sanofi
• Takeda Pharmaceutical Company Limited
• Orchard Therapeutics plc.
• Pharming Group N.V.
• BioCryst Pharmaceuticals, Inc.
• Ionis Pharmaceuticals, Inc.
• Attune Pharmaceuticals
• Arrowhead Pharmaceuticals, Inc.
• Adverum BIoTechnologies, Inc.
• KalVista Pharmaceuticals
• CENTOGENE N.V.

第9章 アナリストの推奨事項

• 隆盛と衰退
• 一貫型機会マップ

第10章 参考文献と調査手法

• 参考文献
• 調査手法
• 出版社について

Global Pediatric Clinical Trials Market is estimated to be valued at USD 19.26 Bn in 2025 and is expected to reach USD 37.08 Bn by 2032, growing at a compound annual growth rate (CAGR) of 9.8% from 2025 to 2032.

Figure. Pediatric Clinical Trials Market Share (%), By Region 2025

The pediatric clinical trials market is witnessing significant growth in recent times. Growing prevalence of chronic diseases among children and rising demand for new treatment options have boosted the pediatric clinical trials industry. Further, the market has witnessed rising investment from pharmaceutical companies for drug development targeting pediatric population. Growing awareness about rare diseases and various initiatives undertaken by regulatory bodies mandating clinical evaluation of drugs for pediatric use have augmented market opportunities. However, conducting clinical trials for pediatric drugs is more complex and challenging than adult trials due to ethical concerns, age specific drug metabolism, difficulty in recruitment, and lack of consensus over surrogate endpoints. Nevertheless, with emerging novel medical therapies and continuous efforts by players towards developing child-friendly drugs, the pediatric clinical trials market is poised to experience strong growth over the forthcoming years.

Market Dynamics:

The global pediatric clinical trials market growth is driven by the rising incidence of chronic diseases among children, growing demand for new treatment modalities, and initiatives undertaken by regulatory bodies to streamline drug development process. In 2021, as per WHO estimates, over 200 million children suffer from various non-communicable illnesses worldwide. High unmet clinical needs have encouraged pharmaceutical companies to boost investments towards developing specialized treatments for pediatric population. Favorable regulations such as the U.S. Food and Drug Administration's amendments Act 2012 have mandated pre-marketing clinical evaluation of drugs for pediatric use, thereby augmenting market opportunities. However, complexities involved in pediatric clinical research and lack of sufficient surrogate endpoints continue to negatively impact market growth. High costs associated with trials and inadequate number of experienced clinical investigators also impede broader market adoption. Nevertheless, continual collaborations between industry players and research organizations to address issues through novel approaches will support future expansion.

Key Features of the Study:

This report provides in-depth analysis of the global pediatric clinical trials market, and provides market size (US$ Bn) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approvals, market trends, regional outlook, and competitive strategies adopted by key players

It profiles key players in the global pediatric clinical trials market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies

Key companies covered as a part of this study include CSL Behring, Sanofi, Takeda Pharmaceutical Company Limited, Orchard Therapeutics plc., Pharming Group N.V., BioCryst Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Attune Pharmaceuticals, Arrowhead Pharmaceuticals, Inc., Adverum Biotechnologies, Inc., KalVista Pharmaceuticals, and CENTOGENE N.V.

Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics

The global pediatric clinical trials market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts

Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global pediatric clinical trials market

Market Segmentation

• Phase Insights (Revenue, USD Bn, 2019-2032)
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• Study Design Insights (Revenue, USD Bn, 2019-2032)
  • Treatment Studies
  • Observational Studies
• Therapeutic Area Insights (Revenue, USD Bn, 2019-2032)
  • Respiratory Diseases
  • Cardiovascular Diseases
  • Neuropsychiatric Conditions
  • Oncology
  • Diabetes
  • Others (Neuropsychiatric Conditions, etc.)
• Regional Insights (Revenue, USD Bn, 2019-2032)
  • North America
  • U.S.
  • Canada
  • Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
  • Europe
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
  • Africa
  • South Africa
  • North Africa
  • Central Africa
• Key Players Insights
  • CSL Behring
  • Sanofi
  • Takeda Pharmaceutical Company Limited
  • Orchard Therapeutics plc.
  • Pharming Group N.V.
  • BioCryst Pharmaceuticals, Inc.
  • Ionis Pharmaceuticals, Inc.
  • Attune Pharmaceuticals
  • Arrowhead Pharmaceuticals, Inc.
  • Adverum Biotechnologies, Inc.
  • KalVista Pharmaceuticals
  • CENTOGENE N.V.

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Pediatric Clinical Trials Market, By Phase
  • Pediatric Clinical Trials Market, By Study Design
  • Pediatric Clinical Trials Market, By Therapeutic Area
  • Pediatric Clinical Trials Market, By Region

3. Market Dynamics, Regulations, And Trends Analysis

• Market Dynamics
• Impact Analysis
• Key Highlights
• Regulatory Scenario
• Product Launches/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario
• Epidemiology

4. Global Pediatric Clinical Trials Market, By Phase, 2020-2032, (USD Bn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Phase I
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Phase II
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Phase III
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Phase IV
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)

5. Global Pediatric Clinical Trials Market, By Study Design, 2020-2032, (USD Bn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Treatment Studies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Observational Studies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)

6. Pediatric Clinical Trials Market, By Therapeutic Area, 2020-2032, (USD Bn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Respiratory Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Cardiovascular Diseases
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Neuropsychiatric Conditions
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Oncology
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Diabetes
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)
• Others (Neuropsychiatric Conditions, etc.)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Bn)

7. Global Pediatric Clinical Trials Market, By Region, 2020 - 2032, Value (USD Bn)

• Introduction
  • Market Share (%) Analysis, 2025,2028 & 2032, Value (USD Bn)
  • Market Y-o-Y Growth Analysis (%), 2021 - 2032, Value (USD Bn)
  • Regional Trends
• North America
  • Introduction
  • Market Size and Forecast, By Phase, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Study Design, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Therapeutic Area, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Country, 2020 - 2032, Value (USD Bn)
  • U.S.
  • Canada
• Latin America
  • Introduction
  • Market Size and Forecast, By Phase, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Study Design, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Therapeutic Area, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Country, 2020 - 2032, Value (USD Bn)
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Europe
  • Introduction
  • Market Size and Forecast, By Phase, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Study Design, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Therapeutic Area, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Country, 2020 - 2032, Value (USD Bn)
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, By Phase, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Study Design, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Therapeutic Area, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Country, 2020 - 2032, Value (USD Bn)
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • Introduction
  • Market Size and Forecast, By Phase, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Study Design, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Therapeutic Area, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Country, 2020 - 2032, Value (USD Bn)
  • GCC Countries
  • Israel
  • Rest of Middle East
• Africa
  • Introduction
  • Market Size and Forecast, By Phase, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Study Design, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Therapeutic Area, 2020 - 2032, Value (USD Bn)
  • Market Size and Forecast, By Country/Sub-region, 2020 - 2032, Value (USD Bn)
  • South Africa
  • North Africa
  • Central Africa

8. Competitive Landscape

• CSL Behring
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Sanofi
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Takeda Pharmaceutical Company Limited
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Orchard Therapeutics plc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Pharming Group N.V.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• BioCryst Pharmaceuticals, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Ionis Pharmaceuticals, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Attune Pharmaceuticals
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Arrowhead Pharmaceuticals, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Adverum Biotechnologies, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• KalVista Pharmaceuticals
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• CENTOGENE N.V.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies

9. Analyst Recommendations

• Wheel of Fortune
• Analyst View
• Coherent Opportunity Map

10. References and Research Methodology

• References
• Research Methodology
• About us