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市场调查报告书
商品编码
1233111

罕见病临床试验市场规模、份额和趋势分析报告，按治疗领域（自身免疫/炎症、血液学）、阶段（第一阶段、第二阶段）、赞助商、地区、细分市场预测 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个工作天内

价格

罕见病临床试验市场的增长和趋势

Grand View Research, Inc. 的一份新报告显示，全球罕见病临床试验市场规模从 2023 年到 2030 年将以 9.7% 的复合年增长率增长，到 2030 年将达到 242 亿。预计达到5000万美元。

罕见病临床试验行业的一个主要驱动力是罕见病的全球高负担和不断增长的研究需求。 此外，断断续续的发布和大量正在筹备中的产品也在推动增长。 此外，政府鼓励产品开发的举措，如《孤儿药法》，预计也将促进行业增长。

根据美国国立卫生研究院 (NIH) 的数据，世界上有 7,000 多种罕见病。 这些疾病影响了大约 3000 万美国人，即十分之一。 据 Eurodis 称，72% 的罕见病是遗传性疾病，其余是由传染病、过敏和环境原因引起的。 提高公众对罕见疾病的认识以及对开发治疗罕见疾病的潜在疗法的兴趣日益浓厚，预计将支持市场的增长。

製药公司和非营利组织正在积极资助罕见病的临床研究。 例如，2022 年 2 月，卫生研究委员会拨款 110 万美元支持罕见病临床试验。 预计未来将继续进行类似的努力，以在预测期内支持市场。

孤儿药的销售额近年来稳步增长。 例如，根据 Evaluate Pharma 的数据，孤儿药销售额到 2020 年将达到 1380 亿美元，到 2022 年将达到 1720 亿美元。 预计2026年孤儿药销售额将达到2680亿美元。 预计孤儿药销量的增加将增加研究人员对开发罕见疾病领域新疗法的兴趣，并在大流行后时期支持市场。

罕见病临床试验市场报告重点。

  • 在预测期内，III 期部分预计将以 10.3% 的最快复合年增长率增长。 由于需要大量志愿者，III 期罕见病临床试验的高成本支持了这一细分市场的增长。
  • 到 2022 年，肿瘤学领域将占据最大的市场收入份额，达到 33.9%。 对开发治疗罕见癌症的新潜在疗法的研究兴趣不断增加，这支持了这一领域的发展。
  • 根据赞助商的数据，由于这些组织为支持罕见疾病的临床研究提供了大量资金，预计非营利部门在预测期内将以 9.9% 的复合年增长率增长。
  • 北美在市场中占据主导地位，在 2022 年占 49.3% 的收入份额。 市场占有率高主要是因为北美罕见病负担高，临床试验参与者多。

内容

第一章调查方法及范围

  • 市场细分和范围
    • 治疗领域
    • 阶段
    • 赞助商
    • 区域范围
  • 调查方法
  • 信息采购
    • 购买的数据库
    • GVR 内部数据库
    • 次要信息
    • 初步调查
    • 初步调查的内容
  • 信息或数据分析
    • 数据分析模型
  • 市场製定和验证
  • 模型详细信息
    • 商品流分析（模型 1）
      • 方法 1：商品流方法
    • 批量价格分析（模型 2）
      • 方法 2：体积分析
  • 二级信息列表
  • 主要信息列表
  • 目的

第 2 章执行摘要

  • 市场展望
  • 细分市场展望
  • 竞争考虑

第 3 章罕见病临床试验市场变量、趋势和范围

  • 市场系列展望
    • 母公司市场展望
    • 相关/子公司市场前景
  • 市场动态
    • 市场驱动因素分析
      • 为罕见病临床试验提供大量临床研究资金
      • 研究人员对罕见病临床试验领域的兴趣日益浓厚
      • 加强与製药公司的合作以开展罕见病临床试验
    • 市场製约因素分析
      • 罕见病临床试验的高成本和高周转率
  • 罕见病临床试验：市场分析工具
    • 行业分析 - 搬运工
    • PESTEL 分析
    • COVID-19 影响分析和改革战略

第 4 章罕见病临床试验市场：治疗领域的估计和趋势分析

  • 罕见病临床试验市场：定义和范围
  • 罕见病临床试验市场：治疗领域市场份额分析，2022 年和 2030 年
    • 肿瘤学
    • 心血管疾病
    • 神经系统疾病
    • 感染
    • 遗传病
    • 自身免疫和炎症
    • 血液病
    • 肌肉骨骼疾病
    • 其他

第 5 章罕见病临床试验市场：阶段估计和趋势分析

  • 罕见病临床试验市场：定义和范围
  • 罕见病临床试验市场：阶段市场份额分析，2022 年和 2030 年
    • 第一阶段
    • 第二阶段
    • 第三阶段
    • 第四阶段

第 6 章罕见病临床试验市场：赞助商估计和趋势分析

  • 罕见病临床试验市场：定义和范围
  • 罕见病临床试验市场：赞助商市场份额分析，2022 年和 2030 年
    • 製药和生物製药公司
    • 非营利组织
    • 其他

第 7 章罕见病临床试验市场：区域估计和趋势分析

  • 2022 年和 2030 年区域市场份额分析
  • 2018 年至 2030 年的市场规模、预测、收入和趋势分析：
  • 北美
    • 美国
    • 加拿大
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 意大利
    • 西班牙
    • 丹麦
    • 瑞典
    • 挪威
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳大利亚
    • 泰国
    • 韩国
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
  • 多边环境协定
    • 南非
    • 沙特阿拉伯
    • 阿拉伯联合酋长国
    • 科威特

第八章竞争格局

  • 市场份额分析
  • 参与公司
  • 近期发展和影响分析

第九章公司简介

  • 公司概况
  • 财务业绩
  • 战略举措
    • 分机
    • 伙伴关係和协作
    • 收购
      • 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)