세계의 소아 임상시험 시장 : 산업 규모, 점유율, 동향, 기회, 예측, 단계별, 시험 디자인별, 치료 분야별, 지역별, 경쟁별(2020-2030년)

Pediatric Clinical Trials Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Phase, By Study Design, By Therapeutic Area, By Region and Competition, 2020-2030F

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한글목차

세계의 소아 임상시험 시장 규모는 2024년에 152억 9,000만 달러로 평가되었고, 2030년에는 236억 7,000만 달러에 이를것으로 예측되며, 예측 기간 동안 CAGR은 7.56%를 보일 것으로 전망됩니다.

소아 임상시험은 영유아, 어린이, 청소년을 위한 약물, 의료 기기, 치료법의 안전성, 효능, 적절한 투여량을 평가하는 데 중점을 둡니다. 이러한 임상시험은 소아 특유의 의학적 문제를 해결하고 연령에 적합한 치료를 보장하는 데 필수적입니다. 윤리적 고려 사항이 가장 중요하며, 부모 또는 보호자의 사전 동의를 포함하는 프로토콜이 필요합니다. 임상시험은 증상 개선, 질병 진행, 안전성과 같은 결과를 측정하도록 구성되어 있습니다. 매년 전 세계적으로 10만 명당 1,400명 이상의 소아에게 영향을 미치는 폐렴과 같은 소아 질환의 발병률이 증가함에 따라 표적 치료제가 시급히 필요함을 강조하고 있습니다. 제약 회사들은 특히 남아시아 및 사하라 사막 이남의 아프리카처럼 치료비 부담이 큰 지역에서 치료 격차를 줄이기 위해 소아과 연구에 우선순위를 두며 이에 대응하고 있습니다. 소아 전문 치료 및 규제 지원에 대한 수요 증가는 시장을 더욱 발전시키고 있습니다.

시장 개요
예측 기간	2026-2030년
시장 규모(2024년)	152억 9,000만 달러
시장 규모(2030년)	236억 7,000만 달러
CAGR(2025-2030년)	7.56%
급성장 부문	관찰 연구
최대 시장	북미

시장 성장 촉진요인

희귀질환에 대한 관심 증가

시장의 과제

다양성 및 대표성

주요 시장 동향

소아용 의약품 개발에 대한 중요성 증대

목차

제1장 개요

제2장 조사 방법

제3장 주요 요약

제4장 고객의 목소리

제5장 세계의 소아 임상시험 시장 전망

• 시장 규모와 예측
  • 금액별
• 시장 점유율 및 예측
  • 단계별(1상, 2상, 3상, 4상)
  • 시험 디자인별(치료 연구, 관찰 연구)
  • 치료 분야별(호흡기 질환, 감염증, 종양학, 당뇨병, 기타)
  • 지역별
  • 기업별(2024년)
• 시장 맵

제6장 아시아태평양의 소아 임상시험 시장 전망

• 시장 규모와 예측
• 시장 점유율 및 예측
• 아시아태평양 : 국가별 분석
  • 중국
  • 인도
  • 호주
  • 일본
  • 한국

제7장 유럽 소아 임상시험 시장 전망

• 시장 규모와 예측
• 시장 점유율 및 예측
• 유럽 : 국가별 분석
  • 프랑스
  • 독일
  • 스페인
  • 이탈리아
  • 영국

제8장 북미의 소아 임상시험 시장 전망

• 시장 규모와 예측
• 시장 점유율 및 예측
• 북미 : 국가별 분석
  • 미국
  • 멕시코
  • 캐나다

제9장 남미의 소아 임상시험 시장 전망

• 시장 규모와 예측
• 시장 점유율 및 예측
• 남미 : 국가별 분석
  • 브라질
  • 아르헨티나
  • 콜롬비아

제10장 중동 및 아프리카의 소아 임상시험 시장 전망

• 시장 규모와 예측
• 시장 점유율 및 예측
• 중동 및 아프리카 : 국가별 분석
  • 남아프리카
  • 사우디아라비아
  • 아랍에미리트(UAE)

제11장 시장 역학

• 성장 촉진요인
• 과제

제12장 시장 동향과 발전

• 최근 동향
• 제품 출시
• 합병과 인수

제13장 세계의 소아 임상시험 시장 : SWOT 분석

제14장 Porter's Five Forces 분석

• 업계 내 경쟁
• 신규 진입의 가능성
• 공급자의 힘
• 고객의 힘
• 대체품의 위협

제15장 PESTEL 분석

제16장 경쟁 구도

• 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

제17장 전략적 제안

제18장 기업 소개와 면책사항

HBR

영문 목차

영문목차

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.

Market Overview
Forecast Period	2026-2030
Market Size 2024	USD 15.29 Billion
Market Size 2030	USD 23.67 Billion
CAGR 2025-2030	7.56%
Fastest Growing Segment	Observational Studies
Largest Market	North America

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

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