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市場調查報告書
商品編碼
1233111

罕見病臨床試驗市場規模、份額和趨勢分析報告，按治療領域（自身免疫/炎症、血液學）、階段（第一階段、第二階段）、贊助商、地區、細分市場預測 2023-2030 年

Rare Disease Clinical Trials Market Size, Share & Trends Analysis Report By Therapeutic Area (Autoimmune & Inflammation, Hematologic Disorders), By Phase (Phase I, Phase II), By Sponsor, By Region, And Segment Forecasts, 2023 - 2030
出版日期: | 出版商: Grand View Research | 英文 225 Pages | 商品交期: 2-10個工作天內

價格

罕見病臨床試驗市場的增長和趨勢

Grand View Research, Inc. 的一份新報告顯示，全球罕見病臨床試驗市場規模從 2023 年到 2030 年將以 9.7% 的複合年增長率增長，到 2030 年將達到 242 億。預計達到5000萬美元。

罕見病臨床試驗行業的一個主要驅動力是罕見病的全球高負擔和不斷增長的研究需求。 此外，斷斷續續的發布和大量正在籌備中的產品也在推動增長。 此外，政府鼓勵產品開發的舉措，如《孤兒藥法》，預計也將促進行業增長。

根據美國國立衛生研究院 (NIH) 的數據，世界上有 7,000 多種罕見病。 這些疾病影響了大約 3000 萬美國人，即十分之一。 據 Eurodis 稱，72% 的罕見病是遺傳性疾病，其餘是由傳染病、過敏和環境原因引起的。 提高公眾對罕見疾病的認識以及對開發治療罕見疾病的潛在療法的興趣日益濃厚，預計將支持市場的增長。

製藥公司和非營利組織正在積極資助罕見病的臨床研究。 例如，2022 年 2 月，衛生研究委員會撥款 110 萬美元支持罕見病臨床試驗。 預計未來將繼續進行類似的努力，以在預測期內支持市場。

孤兒藥的銷售額近年來穩步增長。 例如，根據 Evaluate Pharma 的數據，孤兒藥銷售額到 2020 年將達到 1380 億美元，到 2022 年將達到 1720 億美元。 預計2026年孤兒藥銷售額將達到2680億美元。 預計孤兒藥銷量的增加將增加研究人員對開發罕見疾病領域新療法的興趣，並在大流行後時期支持市場。

罕見病臨床試驗市場報告重點。

  • 在預測期內，III 期部分預計將以 10.3% 的最快複合年增長率增長。 由於需要大量志願者，III 期罕見病臨床試驗的高成本支持了這一細分市場的增長。
  • 到 2022 年，腫瘤學領域將佔據最大的市場收入份額，達到 33.9%。 對開發治療罕見癌症的新潛在療法的研究興趣不斷增加，這支持了這一領域的發展。
  • 根據贊助商的數據，由於這些組織為支持罕見疾病的臨床研究提供了大量資金，預計非營利部門在預測期內將以 9.9% 的複合年增長率增長。
  • 北美在市場中佔據主導地位，在 2022 年佔 49.3% 的收入份額。 市場佔有率高主要是因為北美罕見病負擔高，臨床試驗參與者多。

內容

第一章調查方法及範圍

  • 市場細分和範圍
    • 治療領域
    • 階段
    • 贊助商
    • 區域範圍
  • 調查方法
  • 信息採購
    • 購買的數據庫
    • GVR 內部數據庫
    • 次要信息
    • 初步調查
    • 初步調查的內容
  • 信息或數據分析
    • 數據分析模型
  • 市場製定和驗證
  • 模型詳細信息
    • 商品流分析（模型 1）
      • 方法 1：商品流方法
    • 批量價格分析（模型 2）
      • 方法 2：體積分析
  • 二級信息列表
  • 主要信息列表
  • 目的

第 2 章執行摘要

  • 市場展望
  • 細分市場展望
  • 競爭考慮

第 3 章罕見病臨床試驗市場變量、趨勢和範圍

  • 市場系列展望
    • 母公司市場展望
    • 相關/子公司市場前景
  • 市場動態
    • 市場驅動因素分析
      • 為罕見病臨床試驗提供大量臨床研究資金
      • 研究人員對罕見病臨床試驗領域的興趣日益濃厚
      • 加強與製藥公司的合作以開展罕見病臨床試驗
    • 市場製約因素分析
      • 罕見病臨床試驗的高成本和高周轉率
  • 罕見病臨床試驗：市場分析工具
    • 行業分析 - 搬運工
    • PESTEL 分析
    • COVID-19 影響分析和改革戰略

第 4 章罕見病臨床試驗市場：治療領域的估計和趨勢分析

  • 罕見病臨床試驗市場：定義和範圍
  • 罕見病臨床試驗市場：治療領域市場份額分析，2022 年和 2030 年
    • 腫瘤學
    • 心血管疾病
    • 神經系統疾病
    • 感染
    • 遺傳病
    • 自身免疫和炎症
    • 血液病
    • 肌肉骨骼疾病
    • 其他

第 5 章罕見病臨床試驗市場：階段估計和趨勢分析

  • 罕見病臨床試驗市場：定義和範圍
  • 罕見病臨床試驗市場：階段市場份額分析，2022 年和 2030 年
    • 第一階段
    • 第二階段
    • 第三階段
    • 第四階段

第 6 章罕見病臨床試驗市場：贊助商估計和趨勢分析

  • 罕見病臨床試驗市場：定義和範圍
  • 罕見病臨床試驗市場：贊助商市場份額分析，2022 年和 2030 年
    • 製藥和生物製藥公司
    • 非營利組織
    • 其他

第 7 章罕見病臨床試驗市場：區域估計和趨勢分析

  • 2022 年和 2030 年區域市場份額分析
  • 2018 年至 2030 年的市場規模、預測、收入和趨勢分析：
  • 北美
    • 美國
    • 加拿大
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 意大利
    • 西班牙
    • 丹麥
    • 瑞典
    • 挪威
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳大利亞
    • 泰國
    • 韓國
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
  • 多邊環境協定
    • 南非
    • 沙特阿拉伯
    • 阿拉伯聯合酋長國
    • 科威特

第八章競爭格局

  • 市場份額分析
  • 參與公司
  • 近期發展和影響分析

第九章公司簡介

  • 公司概況
  • 財務業績
  • 戰略舉措
    • 分機
    • 夥伴關係和協作
    • 收購
      • Takeda Pharmaceutical Company
      • F. Hoffmann-La Roche Ltd.
      • Pfizer, Inc.
      • AstraZeneca
      • Novartis AG
      • Labcorp Drug Development
      • IQVIA, Inc.
      • Charles River Laboratories
      • Icon Plc
      • Parexel International Corporation
Product Code: GVR-4-68040-031-1

Rare Disease Clinical Trials Market Growth & Trends:

The global rare disease clinical trials market size is expected to reach USD 24.25 billion by 2030, expanding at 9.7% CAGR from 2023 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 is expected to grow at the fastest CAGR of 10.3% during the forecast period. 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 held the largest market revenue share of 33.9% in 2022. The growing interest of researchers in the development of new potential treatments for treating rare cancers is supporting the growth of the segment
  • Based on the sponsor, the nonprofit organization segment is expected to grow at a CAGR of 9.9% 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 49.3% in 2022. 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
    • 1.1.1. Therapeutic Area
    • 1.1.2. Phase
    • 1.1.3. Sponsors
    • 1.1.4. Regional scope
    • 1.1.5. Estimates and forecast timeline.
  • 1.2. Research Methodology
  • 1.3. Information Procurement
    • 1.3.1. Purchased database
    • 1.3.2. GVR's internal database
    • 1.3.3. Secondary sources
    • 1.3.4. Primary research
    • 1.3.5. Details of primary research
  • 1.4. Information or Data Analysis
    • 1.4.1. Data analysis models
  • 1.5. Market Formulation & Validation
  • 1.6. Model Details
    • 1.6.1. Commodity flow analysis (Model 1)
      • 1.6.1.1. Approach 1: Commodity flow approach
    • 1.6.2. Volume price analysis (Model 2)
      • 1.6.2.1. Approach 2: Volume price analysis
  • 1.7. List of Secondary Sources
  • 1.8. List of Primary Sources
  • 1.9. Objectives
    • 1.9.1. Objective 1
    • 1.9.2. Objective 2

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

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

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
    • 3.1.2. Related/ancillary market outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market driver analysis
      • 3.2.1.1. Significant number of clinical research fundings for rare diseases clinical trials
      • 3.2.1.2. Growing interest of researchers in the area of rare disease clinical trials
      • 3.2.1.3. Increase in the number of collaborations by pharmaceutical companies to conduct rare disease clinical trials.
    • 3.2.2. Market restraint analysis
      • 3.2.2.1. High cost of rare diseases clinical trials and high attrition rate
  • 3.3. Rare Disease Clinical Trials: Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
    • 3.3.2. PESTEL Analysis
    • 3.3.3. COVID-19 Impact Analysis and Reformation Strategies

Chapter 4. Rare Disease Clinical Trials Market: Therapeutic Area Estimates & Trend Analysis

  • 4.1. Rare Disease Clinical Trials Market: Definitions and Scope
  • 4.2. Rare Disease Clinical Trials Market: Therapeutic Area Market Share Analysis, 2022 & 2030
    • 4.2.1. Oncology
      • 4.2.1.1. Oncology market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.2. Cardiovascular Disorders
      • 4.2.2.1. Cardiovascular Disorders Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.3. Neurological Disorders
      • 4.2.3.1. Neurological Disorders Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.4. Infectious Disease
      • 4.2.4.1. Infectious Disease Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.5. Genetic Disorders
      • 4.2.5.1. Metabolic Disorders Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.6. Autoimmune and Inflammation
      • 4.2.6.1. Autoimmune and Inflammation Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.7. Hematologic Disorders
      • 4.2.7.1. Hematologic Disorders Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.8. Musculoskeletal Disorders
      • 4.2.8.1. Musculoskeletal Disorders Market estimates and forecast 2018 to 2030 (USD Million)
    • 4.2.9. Others
      • 4.2.9.1. Others Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 5. Rare Disease Clinical Trials Market: Phase Estimates & Trend Analysis

  • 5.1. Rare Disease Clinical Trials Market: Definitions and Scope
  • 5.2. Rare Disease Clinical Trials Market: Phase Market Share Analysis, 2022 & 2030
    • 5.2.1. Phase I
      • 5.2.1.1. Phase I Market estimates and forecast 2018 to 2030 (USD Million)
    • 5.2.2. Phase II
      • 5.2.2.1. Phase II Market estimates and forecast 2018 to 2030 (USD Million)
    • 5.2.3. Phase III
      • 5.2.3.1. Phase III Market estimates and forecast 2018 to 2030 (USD Million)
    • 5.2.4. Phase IV
      • 5.2.4.1. Phase IV Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 6. Rare Disease Clinical Trials Market: Sponsor Estimates & Trend Analysis

  • 6.1. Rare Disease Clinical Trials Market: Definitions and Scope
  • 6.2. Rare Disease Clinical Trials Market: Sponsor Market Share Analysis, 2022 & 2030
    • 6.2.1. Pharmaceutical & Biopharmaceutical Companies
      • 6.2.1.1. Pharmaceutical & Biopharmaceutical Companies Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.2. Non-Profit Organizations
      • 6.2.2.1. Non-Profit Organizations Market estimates and forecast 2018 to 2030 (USD Million)
    • 6.2.3. Others
      • 6.2.3.1. Others Market estimates and forecast 2018 to 2030 (USD Million)

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

  • 7.1. Regional market share analysis, 2022 & 2030
  • 7.2. Market Size, & Forecasts, Revenue and Trend Analysis, 2018 to 2030:
  • 7.3. North America
    • 7.3.1. Market estimates and forecast, 2018 - 2030 (Value)
    • 7.3.2. U.S.
      • 7.3.2.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.3.3. Canada
      • 7.3.3.1. Market estimates and forecast, 2018 - 2030 (USD Million)
  • 7.4. Europe
    • 7.4.1. U.K.
      • 7.4.1.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.2. Germany
      • 7.4.2.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.3. France
      • 7.4.3.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.4. Italy
      • 7.4.4.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.5. Spain
      • 7.4.5.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.6. Denmark
      • 7.4.6.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.7. Sweden
      • 7.4.7.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.4.8. Norway
      • 7.4.8.1. Market estimates and forecast, 2018 - 2030 (USD Million)
  • 7.5. Asia Pacific
    • 7.5.1. Japan
      • 7.5.1.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.5.2. China
      • 7.5.2.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.5.3. India
      • 7.5.3.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.5.4. Australia
      • 7.5.4.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.5.5. Thailand
      • 7.5.5.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.5.6. South Korea
      • 7.5.6.1. Market estimates and forecast, 2018 - 2030 (USD Million)
  • 7.6. Latin America
    • 7.6.1. Brazil
      • 7.6.1.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.6.2. Mexico
      • 7.6.2.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.6.3. Argentina
      • 7.6.3.1. Market estimates and forecast, 2018 - 2030 (USD Million)
  • 7.7. MEA
    • 7.7.1. South Africa
      • 7.7.1.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.7.2. Saudi Arabia
      • 7.7.2.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.7.3. UAE
      • 7.7.3.1. Market estimates and forecast, 2018 - 2030 (USD Million)
    • 7.7.4. Kuwait
      • 7.7.4.1. Market estimates and forecast, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Market Share Analysis
  • 8.2. Participant Categorization
  • 8.3. Recent Development and Impact Analysis

Chapter 9. Company Profiles

  • 9.1. Company Overview
  • 9.2. Financial Performance
  • 9.3. Strategic Initiatives
    • 9.3.1. Expansions
    • 9.3.2. Partnerships and Collaborations
    • 9.3.3. Acquisitions
      • 9.3.3.1. Takeda Pharmaceutical Company
      • 9.3.3.2. F. Hoffmann-La Roche Ltd.
      • 9.3.3.3. Pfizer, Inc.
      • 9.3.3.4. AstraZeneca
      • 9.3.3.5. Novartis AG
      • 9.3.3.6. Labcorp Drug Development
      • 9.3.3.7. IQVIA, Inc.
      • 9.3.3.8. Charles River Laboratories
      • 9.3.3.9. Icon Plc
      • 9.3.3.10. Parexel International Corporation

List of Tables

  • TABLE 1 List of secondary sources
  • TABLE 2 List of Abbreviations

List of Figures

  • FIG. 1 Market research process
  • FIG. 2 Information Procurement
  • FIG. 3 Primary research pattern
  • FIG. 4 Market research approaches
  • FIG. 5 Value chain-based sizing & forecasting
  • FIG. 6 QFD modeling for market share assessment
  • FIG. 7 Market segmentation & scope
  • FIG. 8 Rare disease clinical trials market outlook, 2018 - 2030
  • FIG. 9 Market trends & outlook
  • FIG. 10 Market driver relevance analysis (Current & future impact)
  • FIG. 11 Market restraint relevance analysis (Current & future impact)
  • FIG. 12 SWOT Analysis, By Factor (political & legal, economic and technological)
  • FIG. 13 Porter's Five Forces Analysis
  • FIG. 14 Rare disease clinical trials market: Therapeutic area outlook key takeaways
  • FIG. 15 Rare disease clinical trials market: Therapeutic area movement analysis
  • FIG. 16 Oncology market, 2018 - 2030 (USD Million)
  • FIG. 17 Cardiovascular disorders market, 2018 - 2030 (USD Million)
  • FIG. 18 Neurological disorders market, 2018 - 2030 (USD Million)
  • FIG. 19 Infectious disease market, 2018 - 2030 (USD Million)
  • FIG. 20 Genetic disorders market, 2018 - 2030 (USD Million)
  • FIG. 21 Autoimmune and inflammation market, 2018 - 2030 (USD Million)
  • FIG. 22 Hematologic disorders market, 2018 - 2030 (USD Million)
  • FIG. 23 Musculoskeletal disorders market, 2018 - 2030 (USD Million)
  • FIG. 24 Others market, 2018 - 2030 (USD Million)
  • FIG. 25 Rare disease clinical trials market: Phase outlook key takeaways
  • FIG. 26 Rare disease clinical trials market: Phase movement analysis
  • FIG. 27 Phase I market, 2018 - 2030 (USD Million)
  • FIG. 28 Phase II market, 2018 - 2030 (USD Million)
  • FIG. 29 Phase III market, 2018 - 2030
  • FIG. 30 Phase IV market, 2018 - 2030 (USD Million)
  • FIG. 31 Rare disease clinical trials market: Sponsor outlook key takeaways
  • FIG. 32 Rare disease clinical trials market: Sponsor movement analysis
  • FIG. 33 Pharmaceutical & biopharmaceutical companies market, 2018 - 2030
  • FIG. 34 Nonprofit organizations market, 2018-2031
  • FIG. 35 Others market, 2018-2032
  • FIG. 36 Regional marketplace: Key takeaway
  • FIG. 37 Rare disease clinical trials regional outlook, 2020 & 2028
  • FIG. 38 North America rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 39 U.S. rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 40 Canada rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 41 Europe rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 42 Germany rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 43 France rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 44 U.K. rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 45 Spain rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 46 Sweden rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 47 Norway rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 48 Asia Pacific rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 49 Japan rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 50 India rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 51 China rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 52 South Korea rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 53 Australia rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 54 Thailand rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 55 Latin America rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 56 Brazil rare disease clinical trials market,2018 - 2030 (USD Million)
  • FIG. 57 Mexico rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 58 Argentina rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 59 Middle East & Africa rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 60 South rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 61 Saudi Arabia rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 62 UAE rare disease clinical trials market, 2018 - 2030 (USD Million)
  • FIG. 63 Kuwait rare disease clinical trials market, 2018 - 2030 (USD Million)