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Rare Disease Clinical Trials Global Market Report 2025

Publisher The Business Research Company
Published Oct 23, 2025
Length 250 Pages
SKU # BRC20492542

Description

Rare Disease Clinical Trials Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on rare disease clinical trials market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase
  • Gain a truly global perspective with the most comprehensive report available on this market covering 15 geographies.
  • Assess the impact of key macro factors such as geopolitical conflicts, trade policies and tariffs, post-pandemic supply chain realignment, inflation and interest rate fluctuations, and evolving regulatory landscapes.
  • Create regional and country strategies on the basis of local data and analysis.
  • Identify growth segments for investment.
  • Outperform competitors using forecast data and the drivers and trends shaping the market.
  • Understand customers based on the latest market shares.
  • Benchmark performance against key competitors.
  • Suitable for supporting your internal and external presentations with reliable high quality data and analysis
  • Report will be updated with the latest data and delivered to you within 2-3 working days of order along with an Excel data sheet for easy data extraction and analysis.
  • All data from the report will also be delivered in an excel dashboard format.
Description:

Where is the largest and fastest growing market for rare disease clinical trials ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The rare disease clinical trials market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
  • The market characteristics section of the report defines and explains the market.
  • The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
  • The forecasts are made after considering the major factors currently impacting the market. These include:
  • The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
  • Market segmentations break down the market into sub markets.
  • The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
  • The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
  • The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope

Markets Covered:1) By Phase: Phase I; Phase II; Phase III; Phase IV

2) By Therapeutic Area: Oncology; Cardiovascular Disorders; Neurological Disorders; Infectious Disease; Genetic Disorders; Autoimmune And Inflammation; Hematologic Disorders; Musculoskeletal Disorders; Other Therapeutic Areas

3) By Study Design: Interventional; Observational; Expanded Access

4) By End-User: Pharmaceutical Companies; Biotechnology Companies; Research Institutes; Other End-Users

Subsegments:

1) By Phase I: First In Human Trials; Dose Escalation Studies; Safety And Tolerability Studies

2) By Phase II: Proof Of Concept Studies; Dose Response Studies; Efficacy And Safety Studies

3) By Phase III: Randomized Controlled Trials; Comparative Effectiveness Studies; Large Scale Multicenter Trials

4) By Phase IV: Post Marketing Surveillance; Long Term Safety Studies; Real World Evidence Studies

Companies Mentioned: F. Hoffmann-La Roche AG; Pfizer Inc.; Novartis AG; AstraZeneca plc; Takeda Pharmaceutical Company Limited; IQVIA Holdings Inc.; Laboratory Corporation of America Holdings; ICON plc; Moderna Inc.; Charles River Laboratories International Inc.; Parexel International Corporation; Revvity Inc.; Sarepta Therapeutics Inc.; TFS HealthScience; Inventiva S.A.; Tonix Pharmaceuticals Holding Corp.; SpringWorks Therapeutics Inc.; OrphAI Therapeutics Inc.; BBCR Consulting LLC; Credevo Inc.

Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain

Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa

Time Series: Five years historic and ten years forecast.

Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,

Data Segmentations: country and regional historic and forecast data, market share of competitors, market segments.

Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.

Delivery Format: PDF, Word and Excel Data Dashboard.

Please Note: Report will be updated with the latest data and delivered to you within 3-5 working days of order.

Table of Contents

250 Pages
1. Executive Summary
2. Rare Disease Clinical Trials Market Characteristics
3. Rare Disease Clinical Trials Market Trends And Strategies
4. Rare Disease Clinical Trials Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market
4.1. Supply Chain Impact from Tariff War & Trade Protectionism
5. Global Rare Disease Clinical Trials Growth Analysis And Strategic Analysis Framework
5.1. Global Rare Disease Clinical Trials PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors, Drivers and Restraints)
5.2. Analysis Of End Use Industries
5.3. Global Rare Disease Clinical Trials Market Growth Rate Analysis
5.4. Global Rare Disease Clinical Trials Historic Market Size and Growth, 2019 - 2024, Value ($ Billion)
5.5. Global Rare Disease Clinical Trials Forecast Market Size and Growth, 2024 - 2029, 2034F, Value ($ Billion)
5.6. Global Rare Disease Clinical Trials Total Addressable Market (TAM)
6. Rare Disease Clinical Trials Market Segmentation
6.1. Global Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Phase I
Phase II
Phase III
Phase IV
6.2. Global Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Oncology
Cardiovascular Disorders
Neurological Disorders
Infectious Disease
Genetic Disorders
Autoimmune And Inflammation
Hematologic Disorders
Musculoskeletal Disorders
Other Therapeutic Areas
6.3. Global Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Interventional
Observational
Expanded Access
6.4. Global Rare Disease Clinical Trials Market, Segmentation By End-User, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Pharmaceutical Companies
Biotechnology Companies
Research Institutes
Other End-Users
6.5. Global Rare Disease Clinical Trials Market, Sub-Segmentation Of Phase I, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
First In Human Trials
Dose Escalation Studies
Safety And Tolerability Studies
6.6. Global Rare Disease Clinical Trials Market, Sub-Segmentation Of Phase II, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Proof Of Concept Studies
Dose Response Studies
Efficacy And Safety Studies
6.7. Global Rare Disease Clinical Trials Market, Sub-Segmentation Of Phase III, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Randomized Controlled Trials
Comparative Effectiveness Studies
Large Scale Multicenter Trials
6.8. Global Rare Disease Clinical Trials Market, Sub-Segmentation Of Phase IV, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Post Marketing Surveillance
Long Term Safety Studies
Real World Evidence Studies
7. Rare Disease Clinical Trials Market Regional And Country Analysis
7.1. Global Rare Disease Clinical Trials Market, Split By Region, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
7.2. Global Rare Disease Clinical Trials Market, Split By Country, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
8. Asia-Pacific Rare Disease Clinical Trials Market
8.1. Asia-Pacific Rare Disease Clinical Trials Market Overview
Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments, Major Companies
8.2. Asia-Pacific Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
8.3. Asia-Pacific Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
8.4. Asia-Pacific Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
9. China Rare Disease Clinical Trials Market
9.1. China Rare Disease Clinical Trials Market Overview
9.2. China Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F,$ Billion
9.3. China Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F,$ Billion
9.4. China Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F,$ Billion
10. India Rare Disease Clinical Trials Market
10.1. India Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
10.2. India Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
10.3. India Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
11. Japan Rare Disease Clinical Trials Market
11.1. Japan Rare Disease Clinical Trials Market Overview
11.2. Japan Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
11.3. Japan Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
11.4. Japan Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
12. Australia Rare Disease Clinical Trials Market
12.1. Australia Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
12.2. Australia Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
12.3. Australia Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
13. Indonesia Rare Disease Clinical Trials Market
13.1. Indonesia Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
13.2. Indonesia Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
13.3. Indonesia Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
14. South Korea Rare Disease Clinical Trials Market
14.1. South Korea Rare Disease Clinical Trials Market Overview
14.2. South Korea Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
14.3. South Korea Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
14.4. South Korea Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
15. Western Europe Rare Disease Clinical Trials Market
15.1. Western Europe Rare Disease Clinical Trials Market Overview
15.2. Western Europe Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
15.3. Western Europe Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
15.4. Western Europe Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
16. UK Rare Disease Clinical Trials Market
16.1. UK Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
16.2. UK Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
16.3. UK Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
17. Germany Rare Disease Clinical Trials Market
17.1. Germany Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
17.2. Germany Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
17.3. Germany Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
18. France Rare Disease Clinical Trials Market
18.1. France Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
18.2. France Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
18.3. France Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
19. Italy Rare Disease Clinical Trials Market
19.1. Italy Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
19.2. Italy Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
19.3. Italy Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
20. Spain Rare Disease Clinical Trials Market
20.1. Spain Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
20.2. Spain Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
20.3. Spain Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
21. Eastern Europe Rare Disease Clinical Trials Market
21.1. Eastern Europe Rare Disease Clinical Trials Market Overview
21.2. Eastern Europe Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
21.3. Eastern Europe Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
21.4. Eastern Europe Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
22. Russia Rare Disease Clinical Trials Market
22.1. Russia Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
22.2. Russia Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
22.3. Russia Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
23. North America Rare Disease Clinical Trials Market
23.1. North America Rare Disease Clinical Trials Market Overview
23.2. North America Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
23.3. North America Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
23.4. North America Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
24. USA Rare Disease Clinical Trials Market
24.1. USA Rare Disease Clinical Trials Market Overview
24.2. USA Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
24.3. USA Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
24.4. USA Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
25. Canada Rare Disease Clinical Trials Market
25.1. Canada Rare Disease Clinical Trials Market Overview
25.2. Canada Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
25.3. Canada Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
25.4. Canada Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
26. South America Rare Disease Clinical Trials Market
26.1. South America Rare Disease Clinical Trials Market Overview
26.2. South America Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
26.3. South America Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
26.4. South America Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
27. Brazil Rare Disease Clinical Trials Market
27.1. Brazil Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
27.2. Brazil Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
27.3. Brazil Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
28. Middle East Rare Disease Clinical Trials Market
28.1. Middle East Rare Disease Clinical Trials Market Overview
28.2. Middle East Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
28.3. Middle East Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
28.4. Middle East Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
29. Africa Rare Disease Clinical Trials Market
29.1. Africa Rare Disease Clinical Trials Market Overview
29.2. Africa Rare Disease Clinical Trials Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
29.3. Africa Rare Disease Clinical Trials Market, Segmentation By Therapeutic Area, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
29.4. Africa Rare Disease Clinical Trials Market, Segmentation By Study Design, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
30. Rare Disease Clinical Trials Market Competitive Landscape And Company Profiles
30.1. Rare Disease Clinical Trials Market Competitive Landscape
30.2. Rare Disease Clinical Trials Market Company Profiles
30.2.1. F. Hoffmann-La Roche AG Overview, Products and Services, Strategy and Financial Analysis
30.2.2. Pfizer Inc. Overview, Products and Services, Strategy and Financial Analysis
30.2.3. Novartis AG Overview, Products and Services, Strategy and Financial Analysis
30.2.4. AstraZeneca plc Overview, Products and Services, Strategy and Financial Analysis
30.2.5. Takeda Pharmaceutical Company Limited Overview, Products and Services, Strategy and Financial Analysis
31. Rare Disease Clinical Trials Market Other Major And Innovative Companies
31.1. IQVIA Holdings Inc.
31.2. Laboratory Corporation of America Holdings
31.3. ICON plc
31.4. Moderna Inc.
31.5. Charles River Laboratories International Inc.
31.6. Parexel International Corporation
31.7. Revvity Inc.
31.8. Sarepta Therapeutics Inc.
31.9. TFS HealthScience
31.10. Inventiva S.A.
31.11. Tonix Pharmaceuticals Holding Corp.
31.12. SpringWorks Therapeutics Inc.
31.13. OrphAI Therapeutics Inc.
31.14. BBCR Consulting LLC
31.15. Credevo Inc.
32. Global Rare Disease Clinical Trials Market Competitive Benchmarking And Dashboard
33. Key Mergers And Acquisitions In The Rare Disease Clinical Trials Market
34. Recent Developments In The Rare Disease Clinical Trials Market
35. Rare Disease Clinical Trials Market High Potential Countries, Segments and Strategies
35.1 Rare Disease Clinical Trials Market In 2029 - Countries Offering Most New Opportunities
35.2 Rare Disease Clinical Trials Market In 2029 - Segments Offering Most New Opportunities
35.3 Rare Disease Clinical Trials Market In 2029 - Growth Strategies
35.3.1 Market Trend Based Strategies
35.3.2 Competitor Strategies
36. Appendix
36.1. Abbreviations
36.2. Currencies
36.3. Historic And Forecast Inflation Rates
36.4. Research Inquiries
36.5. The Business Research Company
36.6. Copyright And Disclaimer

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