희귀질환 임상시험 시장 규모, 점유율, 동향 분석 보고서 : Phase별, 치료 영역별, 스폰서별, 지역별, 부문별 예측(2025-2030년)

Rare Disease Clinical Trials Market Size, Share, & Trends Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Therapeutic Area (Oncology, Cardiovascular), By Sponsor, By Region, And Segment Forecasts, 2025 - 2030

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한글목차

희귀질환 임상시험 시장 성장과 동향

Grand View Research, Inc.의 최신 보고서에 따르면 세계의 희귀질환 임상시험 시장 규모는 2025-2030년에 걸쳐 CAGR 6.8%를 나타내 2030년에는 190억 2,000만 달러에 이를 것으로 전망됩니다.

희귀질환 임상시험 산업의 주요 촉진요인은 세계적으로 희소질환의 부담이 크고 조사 수요가 높아지고 있는 것입니다. 또한 간헐적인 상시와 파이프라인에 있는 다수의 제품도 성장을 뒷받침하고 있습니다.

미국 국립위생실험실(NIH)에 따르면 세계에는 7,000개가 넘는 희귀질환이 존재합니다.

제약회사와 비영리단체는 희소질환 임상연구에 적극적으로 자금을 제공합니다.

희귀의약품의 판매는 최근 꾸준히 증가하고 있습니다. Pharma에 따르면 희귀의약품의 매출은 2020년에는 1,380억 달러를 차지했고, 2022년에는 1,720억 달러에 이르렀습니다. 희귀질환 치료의 매출 증가는 희귀질환 영역에서 새로운 치료 개발에 대한 연구자의 관심을 환기하고 유행 후 시장을 지원할 것으로 기대됩니다.

희귀질환 임상시험 시장 보고서 하이라이트

• phase III는 2024년 매출액 점유율 54.2%로 시장을 독점했습니다.
• 2024년에는 암 영역이 최대의 매출 점유율을 차지했습니다.
• 비영리 단체 부문은 이들 단체가 희귀질환 임상 연구를 지원하기 위해 다액의 자금을 제공하고 있기 때문에 예측 기간 중에 높은 CAGR로 성장할 것으로 예측되고 있습니다.
• 북미가 시장을 독점해 2024년의 매출 점유율은 42.6%였습니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 희귀질환 임상시험 시장 변수, 동향, 범위

• 시장 계통의 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
• 비즈니스 환경 분석
  • 산업 분석 - Porter's Five Forces 분석
  • PESTLE 분석

제4장 희귀질환 임상시험 시장 : Phase 비즈니스 분석

• 위상 시장 점유율(2024년, 2030년)
• 위상 부문 대시보드
• 시장 규모, 예측, 동향 분석(Phase별, 2018-2030년)
• Phase I
• Phase II
• Phase III
• Phase IV

제5장 희귀질환 임상시험 시장 : 치료 영역 비즈니스 분석

• 치료 영역 시장 점유율(2024년, 2030년)
• 치료 영역 부문 대시보드
• 시장 규모, 예측, 동향 분석(치료 영역별, 2018-2030년)
• 종양학
• 심혈관 질환
• 신경 장애
• 전염병
• 유전 질환
• 자가면역 및 염증
• 혈액 질환
• 근골격계 장애
• 기타

제6장 희귀질환 임상시험 시장 : 스폰서 비즈니스 분석

• 스폰서 시장 점유율(2024년, 2030년)
• 스폰서 부문 대시보드
• 시장 규모, 예측, 동향 분석(스폰서별, 2018-2030년)
• 제약 및 바이오 제약 기업
• 비영리 단체
• 기타

제7장 희귀질환 임상시험 시장 : 지역별, 추정·동향 분석

• 지역별 시장 점유율 분석(2024년, 2030년)
• 지역별 시장 대시보드
• 시장 규모와 예측 동향 분석(2018-2030년)
• 북미
  • 국가별(2018-2030년)
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 국가별(2018-2030년)
  • 영국
  • 독일
  • 프랑스
  • 이탈리아
  • 스페인
  • 덴마크
  • 스웨덴
  • 노르웨이
• 아시아태평양
  • 일본
  • 중국
  • 인도
  • 한국
  • 호주
  • 태국
• 라틴아메리카
  • 국가별(2018-2030년)
  • 브라질
  • 아르헨티나
• 중동 및 아프리카
  • 국가별(2018-2030년)
  • 남아프리카
  • 사우디아라비아
  • 아랍에미리트(UAE)
  • 쿠웨이트

제8장 경쟁 구도

• 참가자 개요
• 기업의 시장 포지셔닝 분석
• 기업 분류
• 전략 매핑
• 기업 프로파일/상장 기업
  • Takeda Pharmaceutical Company Limited
  • F. Hoffmann-La Roche Ltd
  • Pfizer Inc
  • AstraZeneca
  • Novartis AG
  • Laboratory Corporation of America Holdings(LabCorp)
  • IQVIA
  • Charles River Laboratories
  • ICON plc
  • Parexel International(MA) Corporation

KTH

영문 목차

영문목차

Rare Disease Clinical Trials Market Growth & Trends:

The global rare disease clinical trials market size is expected to reach USD 19.02 billion by 2030, expanding at 6.8% CAGR from 2025 to 2030, according to a new report by Grand View Research, Inc. The main driving factors of the rare disease clinical trial industry are the high burden of rare diseases worldwide, which has led to rising demand for research. Furthermore, intermittent launches and a large number of products in the pipeline also propel growth. Government initiatives that encourage product development, such as the Orphan Drug Act, are further expected to assist industry growth.

According to the National Institutes of Health (NIH), there are more than 7,000 rare diseases worldwide. These diseases affect nearly 30 million Americans, or 1 in every 10 people. Eurodis states that 72% of rare diseases are genetic, while others are caused by infections, allergies, and environmental causes. The growing awareness among people regarding rare diseases and growing interest in developing potential treatments for treating rare diseases are expected to support market growth.

Pharmaceutical companies and non-profit organizations are actively providing funding for rare disease clinical research. For instance, in February 2022, the Health Research Board funded USD 1.1 million to support rare disease clinical trials. Similar initiatives in the future are expected to support the market during the forecast period.

Orphan drug sales have been steadily increasing in recent years. For instance, according to Evaluate Pharma, orphan drug sales accounted for USD 138 billion in 2020, and by 2022, they accounted for USD 172 billion. It is estimated that orphan drug sales will reach USD 268 billion by 2026. The rise in the sales of orphan drugs is expected to generate interest among researchers in developing new treatments in the area of rare diseases and thus support the market in the post-pandemic period.

Rare Disease Clinical Trials Market Report Highlights:

• The phase III segment dominated the market with the largest revenue share of 54.2% in 2024. The segment's growth is supported by the high cost of phase III rare disease clinical trials due to the requirement for a large number of volunteers
• The oncology segment dominated the market with the largest revenue share in 2024. The growing interest of researchers in the development of new potential treatments for treating rare cancers is supporting the growth of the segment
• The non-profit organizations segment is projected to grow at a significant CAGR over the forecast period owing to the significant funding offered by these organizations to support rare disease clinical research
• North America dominated the market and accounted for a revenue share of 42.6% in 2024. The high burden of rare diseases in North America and the presence of a large number of players in clinical trials are some of the key reasons for its high market share

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Phase
  • 1.2.2. Therapeutic Area
  • 1.2.3. Sponsor
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Rare Disease Clinical Trials Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis

Chapter 4. Rare Disease Clinical Trials Market: Phase Business Analysis

• 4.1. Phase Market Share, 2024 & 2030
• 4.2. Phase Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Phase, 2018 to 2030 (USD Billion)
• 4.4. Phase I
  • 4.4.1. Phase I Market, 2018 - 2030 (USD Billion)
• 4.5. Phase II
  • 4.5.1. Phase II Market, 2018 - 2030 (USD Billion)
• 4.6. Phase III
  • 4.6.1. Phase II Market, 2018 - 2030 (USD Billion)
• 4.7. Phase IV
  • 4.7.1. Phase IV Market, 2018 - 2030 (USD Billion)

Chapter 5. Rare Disease Clinical Trials Market: Therapeutic Area Business Analysis

• 5.1. Therapeutic Area Market Share, 2024 & 2030
• 5.2. Therapeutic Area Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Therapeutic Area, 2018 to 2030 (USD Billion)
• 5.4. Oncology
  • 5.4.1. Oncology Market, 2018 - 2030 (USD Billion)
• 5.5. Cardiovascular Disorders
  • 5.5.1. Cardiovascular Disorders Market, 2018 - 2030 (USD Billion)
• 5.6. Neurological Disorders
  • 5.6.1. Neurological Disorders Market, 2018 - 2030 (USD Billion)
• 5.7. Infectious Disease
  • 5.7.1. Infectious Disease Market, 2018 - 2030 (USD Billion)
• 5.8. Genetic Disorders
  • 5.8.1. Genetic Disorders Market, 2018 - 2030 (USD Billion)
• 5.9. Autoimmune and Inflammation
  • 5.9.1. Autoimmune and Inflammation Market, 2018 - 2030 (USD Billion)
• 5.10. Hematologic Disorders
  • 5.10.1. Hematologic Disorders Market, 2018 - 2030 (USD Billion)
• 5.11. Musculoskeletal Disorders
  • 5.11.1. Musculoskeletal Disorders Market, 2018 - 2030 (USD Billion)
• 5.12. Others
  • 5.12.1. Others Market, 2018 - 2030 (USD Billion)

Chapter 6. Rare Disease Clinical Trials Market: Sponsor Business Analysis

• 6.1. Sponsor Market Share, 2024 & 2030
• 6.2. Sponsor Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Sponsor, 2018 to 2030 (USD Billion)
• 6.4. Pharmaceutical & Biopharmaceutical Companies
  • 6.4.1. Pharmaceutical & Biopharmaceutical Companies Market, 2018 - 2030 (USD Billion)
• 6.5. Non-Profit Organizations
  • 6.5.1. Non-Profit Organizations Market, 2018 - 2030 (USD Billion)
• 6.6. Other
  • 6.6.1. Other Market, 2018 - 2030 (USD Billion)

Chapter 7. Rare Disease Clinical Trials Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2030
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 7.4. North America
  • 7.4.1. North America Rare Disease Clinical Trials Market Estimates and Forecasts, by Country, 2018 - 2030 (USD Billion)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Regulatory Framework
    • 7.4.2.3. Competitive Insights
    • 7.4.2.4. U.S. Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Regulatory Framework
    • 7.4.3.3. Competitive Insights
    • 7.4.3.4. Canada Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Regulatory Framework
    • 7.4.4.3. Competitive Insights
    • 7.4.4.4. Mexico Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
• 7.5. Europe
  • 7.5.1. Europe Rare Disease Clinical Trials Market Estimates and Forecasts, by Country, 2018 - 2030 (USD Billion)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Regulatory Framework
    • 7.5.2.3. Competitive Insights
    • 7.5.2.4. UK Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Regulatory Framework
    • 7.5.3.3. Competitive Insights
    • 7.5.3.4. Germany Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Regulatory Framework
    • 7.5.4.3. Competitive Insights
    • 7.5.4.4. France Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Regulatory Framework
    • 7.5.5.3. Competitive Insights
    • 7.5.5.4. Italy Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Regulatory Framework
    • 7.5.6.3. Competitive Insights
    • 7.5.6.4. Spain Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Regulatory Framework
    • 7.5.7.3. Competitive Insights
    • 7.5.7.4. Denmark Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Regulatory Framework
    • 7.5.8.3. Competitive Insights
    • 7.5.8.4. Sweden Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Regulatory Framework
    • 7.5.9.3. Competitive Insights
    • 7.5.9.4. Norway Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Regulatory Framework
    • 7.6.2.3. Competitive Insights
    • 7.6.2.4. Japan Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Regulatory Framework
    • 7.6.3.3. Competitive Insights
    • 7.6.3.4. China Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Regulatory Framework
    • 7.6.4.3. Competitive Insights
    • 7.6.4.4. India Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.6.5. South Korea
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Regulatory Framework
    • 7.6.5.3. Competitive Insights
    • 7.6.5.4. South Korea Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.6.6. Australia
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Regulatory Framework
    • 7.6.6.3. Competitive Insights
    • 7.6.6.4. Australia Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Regulatory Framework
    • 7.6.7.3. Competitive Insights
    • 7.6.7.4. Thailand Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
• 7.7. Latin America
  • 7.7.1. Latin America Rare Disease Clinical Trials Market Estimates and Forecasts, by Country, 2018 - 2030 (USD Billion)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Regulatory Framework
    • 7.7.2.3. Competitive Insights
    • 7.7.2.4. Brazil Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Regulatory Framework
    • 7.7.3.3. Competitive Insights
    • 7.7.3.4. Argentina Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
• 7.8. MEA
  • 7.8.1. MEA Rare Disease Clinical Trials Market Estimates and Forecasts, by Country, 2018 - 2030 (USD Billion)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Regulatory Framework
    • 7.8.2.3. Competitive Insights
    • 7.8.2.4. South Africa Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Regulatory Framework
    • 7.8.3.3. Competitive Insights
    • 7.8.3.4. Saudi Arabia Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Regulatory Framework
    • 7.8.4.3. Competitive Insights
    • 7.8.4.4. UAE Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Regulatory Framework
    • 7.8.5.3. Competitive Insights
    • 7.8.5.4. Kuwait Rare Disease Clinical Trials Market Estimates and Forecasts, 2018 - 2030 (USD Billion)

Chapter 8. Competitive Landscape

• 8.1. Participant Overview
• 8.2. Company Market Position Analysis
• 8.3. Company Categorization
• 8.4. Strategy Mapping
• 8.5. Company Profiles/Listing
  • 8.5.1. Takeda Pharmaceutical Company Limited
    • 8.5.1.1. Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. F. Hoffmann-La Roche Ltd
    • 8.5.2.1. Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. Pfizer Inc
    • 8.5.3.1. Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. AstraZeneca
    • 8.5.4.1. Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Novartis AG
    • 8.5.5.1. Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. Laboratory Corporation of America Holdings (LabCorp)
    • 8.5.6.1. Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. IQVIA
    • 8.5.7.1. Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. Charles River Laboratories
    • 8.5.8.1. Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. ICON plc
    • 8.5.9.1. Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. Parexel International (MA) Corporation
    • 8.5.10.1. Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives

관련자료