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Saudi Arabia Clinical Trials Market, Ongoing Clinical Trials by Company, Indication, Phase & Regulations Insight 2025

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    Report

  • 250 Pages
  • February 2025
  • Region: Saudi Arabia
  • Kuick Research
  • ID: 6052928

Report Highlights

  • Saudi Arabia Clinical Trials Market Opportunity: US$ 200 Million
  • Comprehensive Insight on Clinical Trials Studies in Saudi Arabia: > 400 Studies
  • Clinical Trials Studies by Indication, Phase & Sponsor
  • Regulatory Framework & Clinical Trials Guidelines
  • Insight on Domestic CRO Operating in Saudi Arabia: 15 CRO
  • Overview on Existing Healthcare Infrastructure & Medical Professionals Like Doctors, Dentist, Nurses

Saudi Arabia is making significant strides in expanding its clinical research sector, aligning with the broader objectives of Vision 2030, which prioritizes scientific advancement and innovation. The Saudi government is actively enhancing research education and investing in clinical trials to improve healthcare outcomes. A key player in this transformation is the Saudi National Institute of Health (NIH), which has launched several initiatives to raise the quality and quantity of research conducted within the country. These efforts include establishing cutting-edge research facilities, fostering an environment where clinical trials can thrive, and setting new benchmarks for excellence.

By strengthening its focus on clinical trials, Saudi Arabia aims to develop medical treatments tailored to its population's specific genetic and health profiles. This is particularly important given the high prevalence of conditions such as diabetes and cardiovascular diseases, which require targeted treatment approaches. Addressing these health challenges through locally relevant clinical research ensures that therapies are better suited to the Saudi population, improving both patient outcomes and the overall healthcare system.

A closer look at the therapeutic areas of focus reveals that oncology, endocrinology, cardiology, and infectious diseases dominate Saudi Arabia's clinical trial landscape. These fields have attracted significant attention due to their widespread impact on public health. Pharmaceutical companies play a crucial role in this ecosystem, serving as the primary sponsors of most clinical trials, particularly multinational studies that require extensive resources and collaboration. Meanwhile, local researchers are actively involved in studies that focus specifically on the Saudi population, addressing region-specific health concerns.

Geographically, the majority of clinical trial sites are concentrated in urban centers, with Riyadh serving as the leading hub for research activities. The Makkah region and the Eastern Province also play significant roles, reflecting a broader trend where research efforts are primarily centered in areas with well-established medical infrastructure and access to specialized expertise. This concentration of research activity enables more efficient coordination of trials and facilitates collaborations between healthcare institutions, regulatory bodies, and industry stakeholders.

As Saudi Arabia's clinical research landscape continues to develop, there has been a noticeable rise in the number of clinical trial applications under review. The Saudi Food and Drug Authority (SFDA) is working diligently to strengthen its regulatory framework, ensuring that all studies meet stringent safety and efficacy standards. This regulatory progress is crucial as the country seeks to attract more international multicenter trials, allowing it to integrate into the global clinical research ecosystem.

The SFDA's efforts include refining approval processes, implementing robust monitoring systems, and ensuring compliance with international best practices. These improvements are particularly vital as Saudi Arabia moves toward more sophisticated trial designs, including precision medicine approaches and innovative drug development strategies.

Additionally, the country is placing greater emphasis on translational research, bridging the gap between laboratory discoveries and real-world clinical applications. By fostering a research-friendly environment and maintaining high regulatory standards, Saudi Arabia is positioning itself as a key player in the global clinical trials landscape, driving advancements that will shape the future of healthcare both regionally and beyond.

Table of Contents

1. Saudi Arabia Clinical Trials Market Outlook
1.1 Current Scenario
1.2 Future Growth Outlook

2. Saudi Arabia Pharmaceutical Market Analysis
2.1 Overview
2.2 Regulatory Framework
2.3 Branded v/s Generic Drugs Availability

3. Saudi Arabia Clinical Trials Overview
3.1 by Phase
3.2 by Sponsors

4. Saudi Arabia Clinical Trials Insight by Company, Indication & Phase
4.1 Phase I
4.2 Phase I/II
4.3 Phase I/IIIB
4.4 Phase II
4.5 Phase II/III
4.6 Phase III
4.7 Phase IV
4.8 Phase BE

5. Saudi Arabia Clinical Trials Regulatory Framework & Guidelines
5.1 Overview
5.2 Drug Safety Monitoring Initiatives
5.3 Regulations For Conducting Clinical Trials on Drugs
5.4 Regulation For Drugs Approval
5.5 Guidelines For Investigational New Drugs (IND)

6. Healthcare Infrastructure & Manpower in Saudi Arabia
7. Saudi Arabia Clinical Trials Market Dynamics
7.1 Drivers & Opportunities
7.2 Challenges & Restraints

8. Clinical Research Organizations Operating in Saudi Arabia
8.1 ArabMed CRO
8.2 Baahith
8.3 Balsam Clinical Research
8.4 CLINLIA
8.5 ClinServ International
8.6 CTI
8.7 KAU Med CRO
8.8 MCT CRO
8.9 Mesned
8.10 Monitoring Force Gulf Limited
8.11 PDC CRO
8.12 Phoenix Clinical Research
8.13 RAY CRO
8.14 SALA CRO
8.15 SGS

List of Figures
Figure 1-1: Saudi Arabia - Clinical Trials Market Opportunity Assessment (US$ Million), 2025 & 2030
Figure 2-1: Saudi Arabia - Drug Marketing Authorization Process
Figure 2-2: Saudi Arabia: Branded v/s Generic Drugs Market Share (%), 2024
Figure 3-1: Saudi Arabia - Clinical Pipeline by Phase (Number of Trials)
Figure 5 1: Saudi Arabia - Main Bodies Involved in Overseeing Clinical Trials
Figure 5 2: Saudi Arabia Clinical Trial Process
Figure 5 3: Saudi Arabia - Renewal Process of Marketing Authorization
Figure 6-1: Saudi Arabia - Total Hospitals in All Health Sectors, 2019-2023
Figure 6-2: Saudi Arabia - Total Beds in All Health Sectors, 2019-2023
Figure 6-3: Saudi Arabia - Hospitals Managed by Ministry of Health, 2019-2023
Figure 6-4: Saudi Arabia - Beds Managed by Ministry of Health, 2019-2023
Figure 6-5: Saudi Arabia - Hospitals Managed by Other Governmental Sectors, 2019-2023
Figure 6-6: Saudi Arabia - Beds Managed by Other Governmental Sectors, 2019-2023
Figure 6-7: Saudi Arabia - Hospitals Managed by Private Sector, 2019-2023
Figure 6-8: Saudi Arabia - Beds Managed y Private Sector, 2019-2023
Figure 7-1: Saudi Arabia Clinical Trials Market - Drivers & Opportunities
Figure 7-2: Saudi Arabia Clinical Trials Market - Challenges & Restraints

List of Tables
Table 3-1: Saudi Arabia - Clinical Trial Landscape by Sponsor (Number of Trials)
Table 4-1: Saudi Arabia - Ongoing Phase I Clinical Trials, 2025
Table 4-2: Saudi Arabia - Ongoing Phase I/II Clinical Trials, 2025
Table 4-3: Saudi Arabia - Ongoing Phase I/IIIB Clinical Trials, 2025
Table 4-4: Saudi Arabia - Ongoing Phase II Clinical Trials, 2025
Table 4-5: Saudi Arabia - Ongoing Phase II/III Clinical Trials, 2025
Table 4-6: Saudi Arabia - Ongoing Phase III Clinical Trials, 2025
Table 4-7: Saudi Arabia - Ongoing Phase IV Clinical Trials, 2025
Table 4-8: Saudi Arabia - Ongoing Phase BE Clinical Trials, 2025
Table 5-1: Clinical Trial Requirements
Table 5-2: Amendment, Adding Site & New Investigator Requirements (Phases I, II & III)
Table 6-1: Saudi Arabia - Hospitals & Beds by Health Region, 2023
Table 6-2: Saudi Arabia - Resident Physicians & Dentists by Specialty, 2023
Table 6-3: Saudi Arabia - Registrar Physicians & Dentists by Specialty, 2023
Table 6-4: Saudi Arabia - Consultant Physicians & Dentists by Specialty, 2023
Table 6-5: Saudi Arabia - Total Physicians & Dentists by Specialty, 2023
Table 6-6: Saudi Arabia - MoH Hospitals by Bed Capacity & Health Region, 2023
Table 6-7: Saudi Arabia - Intensive Care Beds at MoH Hospitals by Health Region, 2023
Table 6-8: Saudi Arabia - ER Beds at MoH Hospitals by Health Region, 2023
Table 6-9: Saudi Arabia - Primary Health Care Centers in MoH by Health Region, 2019-2023
Table 6-10 Saudi Arabia - Private Sector Hospitals, Medical Complexes, Beds & Other Medical Facilities by Health Region, 2023

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • ArabMed CRO
  • Baahith
  • Balsam Clinical Research
  • CLINLIA
  • ClinServ International
  • CTI
  • KAU Med CRO
  • MCT CRO
  • Mesned
  • Monitoring Force Gulf Limited
  • PDC CRO
  • Phoenix Clinical Research
  • RAY CRO
  • SALA CRO
  • SGS