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Saudi Arabia Pediatric Medical Devices Market

The Saudi Arabia Pediatric Medical Devices Market, valued at USD 305 million, is growing due to increased awareness of pediatric health, chronic conditions, and innovations in IVD and respiratory devices.

Region:Middle East

Author(s):Rebecca

Product Code:KRAC1780

Pages:99

Published On:October 2025

About the Report

Base Year 2024

Saudi Arabia Pediatric Medical Devices Market Overview

  • The Saudi Arabia Pediatric Medical Devices Market is valued at USD 305 million, based on a five-year historical analysis. This growth is primarily driven by increasing healthcare expenditure, rising awareness of pediatric health issues, and advancements in medical technology. The demand for innovative and specialized medical devices tailored for children has surged, reflecting the growing focus on improving healthcare outcomes for the pediatric population. The market is further propelled by the rising prevalence of chronic pediatric conditions including respiratory disorders and asthma, alongside technological innovations in minimally invasive procedures specifically designed for young patients.
  • Key cities such as Riyadh, Jeddah, and Dammam dominate the market due to their advanced healthcare infrastructure and concentration of medical facilities. Riyadh, as the capital, hosts numerous hospitals and research institutions, while Jeddah serves as a major commercial hub with a high demand for pediatric healthcare services. Dammam's strategic location enhances access to healthcare resources, making these cities pivotal in the pediatric medical devices market.
  • The Saudi Food and Drug Authority (SFDA) Medical Devices Interim Regulation, 2021 issued by the Saudi Food and Drug Authority establishes comprehensive requirements for pediatric medical devices. This regulation mandates stringent approval processes for devices intended for children, ensuring compliance with specific safety standards and performance criteria through pre-market assessment procedures, post-market surveillance requirements, and quality management system certifications. Manufacturers must demonstrate device safety and efficacy through clinical data specific to pediatric populations, with separate approval pathways for different age groups including neonates, infants, and adolescents.
Saudi Arabia Pediatric Medical Devices Market Size

Saudi Arabia Pediatric Medical Devices Market Segmentation

By Type:The market is segmented into various types of pediatric medical devices, including In Vitro Diagnostic (IVD) Devices, Diagnostic Imaging Devices, Anesthesia and Respiratory Care Devices, Neonatal ICU Devices, Cardiology Devices, Monitoring Devices, Telemedicine Devices, and Others. Each of these sub-segments plays a crucial role in addressing the unique healthcare needs of children. In Vitro Diagnostic (IVD) Devices represent the largest segment, driven by increasing demand for early disease detection and routine pediatric screening procedures. Anesthesia and Respiratory Care Devices demonstrate significant growth momentum due to the rising incidence of respiratory conditions among children and advancements in ventilation technologies.

Saudi Arabia Pediatric Medical Devices Market segmentation by Type.

By End-User:The end-user segmentation includes Hospitals, Pediatric Clinics, Ambulatory Care Settings, and Research Institutes and Academic Medical Centers. Each of these segments utilizes pediatric medical devices to enhance patient care and treatment outcomes. Hospitals maintain the dominant position as primary end-users due to their comprehensive pediatric care facilities and availability of specialized pediatric departments. Pediatric Clinics demonstrate accelerating growth as standalone specialized facilities expand across major urban centers, offering focused care for child health conditions.

Saudi Arabia Pediatric Medical Devices Market segmentation by End-User.

Saudi Arabia Pediatric Medical Devices Market Competitive Landscape

The Saudi Arabia Pediatric Medical Devices Market is characterized by a dynamic mix of regional and international players. Leading participants such as Siemens Healthineers, Philips Healthcare, GE HealthCare Technologies Inc., Medtronic plc, Johnson & Johnson (including Ethicon and DePuy Synthes), Abbott Laboratories, Becton, Dickinson and Company (BD), Stryker Corporation, Boston Scientific Corporation, Baxter International Inc., Terumo Corporation, Smith & Nephew plc, 3M Health Care, Hologic, Inc., Fresenius Kabi AG, Hamilton Medical AG, Novonate Inc., Atom Medical Corporation, Phoenix Medical Systems Pvt. Ltd., Ningbo David Medical Device Co., Ltd. contribute to innovation, geographic expansion, and service delivery in this space.

Siemens Healthineers

1847

Erlangen, Germany

Philips Healthcare

1891

Amsterdam, Netherlands

GE HealthCare Technologies Inc.

1892

Chicago, USA

Medtronic plc

1949

Dublin, Ireland

Johnson & Johnson

1886

New Brunswick, USA

Company

Establishment Year

Headquarters

Company Size (Large, Medium, Small)

Revenue from Pediatric Medical Devices (USD, % of total revenue)

Market Share in Saudi Arabia Pediatric Segment (%)

Product Portfolio Breadth (Number of Pediatric Device Categories)

R&D Investment in Pediatric Devices (USD, % of revenue)

Regulatory Approvals (Number of SFDA/CE/FDA-approved pediatric devices)

Saudi Arabia Pediatric Medical Devices Market Industry Analysis

Growth Drivers

  • Increasing Prevalence of Pediatric Diseases:The rise in pediatric diseases in Saudi Arabia is a significant growth driver for the medical devices market. According to the Saudi Ministry of Health, approximately 1.5 million children are diagnosed with chronic conditions annually, including asthma and diabetes. This increasing prevalence necessitates advanced medical devices for effective management and treatment, thereby driving demand. The growing awareness of pediatric health issues further supports the need for innovative solutions tailored to children’s healthcare requirements.
  • Advancements in Medical Technology:The rapid advancements in medical technology are transforming the pediatric medical devices landscape in Saudi Arabia. In future, the country is expected to invest over SAR 5.5 billion in healthcare technology, focusing on developing devices that enhance diagnostic accuracy and treatment efficacy. Innovations such as wearable health monitors and telehealth solutions are gaining traction, enabling healthcare providers to deliver better care. These technological advancements are crucial in addressing the unique healthcare needs of pediatric patients.
  • Government Initiatives for Healthcare Improvement:The Saudi government is actively promoting healthcare improvements through various initiatives, including Vision 2030, which aims to enhance healthcare services. In future, the government plans to allocate SAR 12 billion towards pediatric healthcare infrastructure. This funding will support the development of specialized pediatric facilities and the procurement of advanced medical devices. Such initiatives are expected to significantly boost the pediatric medical devices market by ensuring better access to quality healthcare for children across the nation.

Market Challenges

  • Regulatory Hurdles:Navigating the regulatory landscape in Saudi Arabia poses significant challenges for pediatric medical device manufacturers. The Saudi Food and Drug Authority (SFDA) has stringent regulations that require extensive clinical trials and documentation before product approval. In future, the average time for regulatory approval is projected to exceed 20 months, which can delay market entry for innovative devices. These regulatory hurdles can hinder the growth of the pediatric medical devices market, limiting the availability of new technologies.
  • High Cost of Advanced Medical Devices:The high cost associated with advanced pediatric medical devices remains a critical challenge in Saudi Arabia. Many innovative devices, such as advanced imaging systems and specialized surgical instruments, can cost upwards of SAR 1.2 million. This high price point can restrict access for healthcare facilities, particularly in rural areas where budgets are limited. Consequently, the financial burden on hospitals and clinics can impede the adoption of essential medical technologies needed for pediatric care.

Saudi Arabia Pediatric Medical Devices Market Future Outlook

The future of the pediatric medical devices market in Saudi Arabia appears promising, driven by ongoing technological advancements and government support. As healthcare facilities expand and invest in modern equipment, the demand for innovative pediatric devices is expected to rise. Additionally, the integration of digital health technologies and telemedicine services will enhance patient care. These trends indicate a shift towards more personalized and accessible healthcare solutions for children, ultimately improving health outcomes across the nation.

Market Opportunities

  • Growing Demand for Home Healthcare Devices:The increasing preference for home healthcare solutions presents a significant opportunity in the pediatric medical devices market. In future, the home healthcare market in Saudi Arabia is projected to reach SAR 2.5 billion, driven by the need for continuous monitoring and management of chronic pediatric conditions. This trend encourages manufacturers to develop user-friendly devices that cater to home use, enhancing patient comfort and convenience.
  • Expansion of Pediatric Healthcare Facilities:The expansion of pediatric healthcare facilities across Saudi Arabia is another promising opportunity. With the government’s commitment to improving healthcare infrastructure, over 35 new pediatric hospitals are expected to be established in future. This expansion will create a higher demand for specialized medical devices, providing manufacturers with a lucrative market to supply innovative solutions tailored to pediatric care.

Scope of the Report

SegmentSub-Segments
By Type

In Vitro Diagnostic (IVD) Devices

Diagnostic Imaging Devices

Anesthesia and Respiratory Care Devices

Neonatal ICU Devices

Cardiology Devices

Monitoring Devices

Telemedicine Devices

Others

By End-User

Hospitals

Pediatric Clinics

Ambulatory Care Settings

Research Institutes and Academic Medical Centers

By Application

Cardiology

Neurology

Orthopedics

Respiratory

Neonatology

By Distribution Channel

Direct Sales

Distributors

Online Sales

By Price Range

Low Range

Mid Range

High Range

By Region

Central Region

Eastern Region

Western Region

Southern Region

By Technology

Digital Health Technologies

Traditional Medical Devices

Hybrid Devices

Key Target Audience

Investors and Venture Capitalist Firms

Government and Regulatory Bodies (e.g., Saudi Food and Drug Authority, Ministry of Health)

Manufacturers and Producers

Distributors and Retailers

Healthcare Providers and Hospitals

Medical Device Wholesalers

Industry Associations (e.g., Saudi Medical Devices Association)

Health Insurance Companies

Players Mentioned in the Report:

Siemens Healthineers

Philips Healthcare

GE HealthCare Technologies Inc.

Medtronic plc

Johnson & Johnson (including Ethicon and DePuy Synthes)

Abbott Laboratories

Becton, Dickinson and Company (BD)

Stryker Corporation

Boston Scientific Corporation

Baxter International Inc.

Terumo Corporation

Smith & Nephew plc

3M Health Care

Hologic, Inc.

Fresenius Kabi AG

Hamilton Medical AG

Novonate Inc.

Atom Medical Corporation

Phoenix Medical Systems Pvt. Ltd.

Ningbo David Medical Device Co., Ltd.

Table of Contents

Market Assessment Phase

1. Executive Summary and Approach


2. Saudi Arabia Pediatric Medical Devices Market Overview

2.1 Key Insights and Strategic Recommendations

2.2 Saudi Arabia Pediatric Medical Devices Market Overview

2.3 Definition and Scope

2.4 Evolution of Market Ecosystem

2.5 Timeline of Key Regulatory Milestones

2.6 Value Chain & Stakeholder Mapping

2.7 Business Cycle Analysis

2.8 Policy & Incentive Landscape


3. Saudi Arabia Pediatric Medical Devices Market Analysis

3.1 Growth Drivers

3.1.1 Increasing prevalence of pediatric diseases
3.1.2 Advancements in medical technology
3.1.3 Government initiatives for healthcare improvement
3.1.4 Rising healthcare expenditure

3.2 Market Challenges

3.2.1 Regulatory hurdles
3.2.2 High cost of advanced medical devices
3.2.3 Limited awareness among healthcare providers
3.2.4 Supply chain disruptions

3.3 Market Opportunities

3.3.1 Growing demand for home healthcare devices
3.3.2 Expansion of pediatric healthcare facilities
3.3.3 Increasing investment in healthcare infrastructure
3.3.4 Collaborations with international medical device companies

3.4 Market Trends

3.4.1 Shift towards minimally invasive devices
3.4.2 Integration of digital health technologies
3.4.3 Focus on personalized medicine
3.4.4 Rise in telemedicine services

3.5 Government Regulation

3.5.1 Implementation of stricter quality standards
3.5.2 Introduction of new licensing requirements
3.5.3 Enhanced monitoring of medical device safety
3.5.4 Support for local manufacturing initiatives

4. SWOT Analysis


5. Stakeholder Analysis


6. Porter's Five Forces Analysis


7. Saudi Arabia Pediatric Medical Devices Market Market Size, 2019-2024

7.1 By Value

7.2 By Volume

7.3 By Average Selling Price


8. Saudi Arabia Pediatric Medical Devices Market Segmentation

8.1 By Type

8.1.1 In Vitro Diagnostic (IVD) Devices
8.1.2 Diagnostic Imaging Devices
8.1.3 Anesthesia and Respiratory Care Devices
8.1.4 Neonatal ICU Devices
8.1.5 Cardiology Devices
8.1.6 Monitoring Devices
8.1.7 Telemedicine Devices
8.1.8 Others

8.2 By End-User

8.2.1 Hospitals
8.2.2 Pediatric Clinics
8.2.3 Ambulatory Care Settings
8.2.4 Research Institutes and Academic Medical Centers

8.3 By Application

8.3.1 Cardiology
8.3.2 Neurology
8.3.3 Orthopedics
8.3.4 Respiratory
8.3.5 Neonatology

8.4 By Distribution Channel

8.4.1 Direct Sales
8.4.2 Distributors
8.4.3 Online Sales

8.5 By Price Range

8.5.1 Low Range
8.5.2 Mid Range
8.5.3 High Range

8.6 By Region

8.6.1 Central Region
8.6.2 Eastern Region
8.6.3 Western Region
8.6.4 Southern Region

8.7 By Technology

8.7.1 Digital Health Technologies
8.7.2 Traditional Medical Devices
8.7.3 Hybrid Devices

9. Saudi Arabia Pediatric Medical Devices Market Competitive Analysis

9.1 Market Share of Key Players

9.2 KPIs for Cross Comparison of Key Players

9.2.1 Company Name
9.2.2 Company Size (Large, Medium, Small)
9.2.3 Revenue from Pediatric Medical Devices (USD, % of total revenue)
9.2.4 Market Share in Saudi Arabia Pediatric Segment (%)
9.2.5 Product Portfolio Breadth (Number of Pediatric Device Categories)
9.2.6 R&D Investment in Pediatric Devices (USD, % of revenue)
9.2.7 Regulatory Approvals (Number of SFDA/CE/FDA-approved pediatric devices)
9.2.8 Distribution Network Coverage (Number of Saudi cities/regions served)
9.2.9 Local Partnerships/Joint Ventures (Number, type)
9.2.10 Customer Satisfaction/Net Promoter Score (NPS)

9.3 SWOT Analysis of Top Players

9.4 Pricing Analysis

9.5 Detailed Profile of Major Companies

9.5.1 Siemens Healthineers
9.5.2 Philips Healthcare
9.5.3 GE HealthCare Technologies Inc.
9.5.4 Medtronic plc
9.5.5 Johnson & Johnson (including Ethicon and DePuy Synthes)
9.5.6 Abbott Laboratories
9.5.7 Becton, Dickinson and Company (BD)
9.5.8 Stryker Corporation
9.5.9 Boston Scientific Corporation
9.5.10 Baxter International Inc.
9.5.11 Terumo Corporation
9.5.12 Smith & Nephew plc
9.5.13 3M Health Care
9.5.14 Hologic, Inc.
9.5.15 Fresenius Kabi AG
9.5.16 Hamilton Medical AG
9.5.17 Novonate Inc.
9.5.18 Atom Medical Corporation
9.5.19 Phoenix Medical Systems Pvt. Ltd.
9.5.20 Ningbo David Medical Device Co., Ltd.

10. Saudi Arabia Pediatric Medical Devices Market End-User Analysis

10.1 Procurement Behavior of Key Ministries

10.1.1 Ministry of Health
10.1.2 Ministry of Education
10.1.3 Ministry of Finance

10.2 Corporate Spend on Infrastructure & Energy

10.2.1 Investment in Pediatric Healthcare Facilities
10.2.2 Funding for Medical Research
10.2.3 Budget Allocation for Medical Devices

10.3 Pain Point Analysis by End-User Category

10.3.1 Hospitals
10.3.2 Clinics
10.3.3 Home Care Providers

10.4 User Readiness for Adoption

10.4.1 Training and Support Needs
10.4.2 Technology Acceptance Levels
10.4.3 Infrastructure Readiness

10.5 Post-Deployment ROI and Use Case Expansion

10.5.1 Evaluation of Device Performance
10.5.2 Cost-Benefit Analysis
10.5.3 Opportunities for Device Upgrades

11. Saudi Arabia Pediatric Medical Devices Market Future Size, 2025-2030

11.1 By Value

11.2 By Volume

11.3 By Average Selling Price


Go-To-Market Strategy Phase

1. Whitespace Analysis + Business Model Canvas

1.1 Identification of Market Gaps

1.2 Business Model Framework

1.3 Value Proposition Development

1.4 Revenue Streams Analysis

1.5 Cost Structure Evaluation

1.6 Key Partnerships

1.7 Customer Segmentation


2. Marketing and Positioning Recommendations

2.1 Branding Strategies

2.2 Product USPs

2.3 Target Audience Identification

2.4 Communication Strategy

2.5 Digital Marketing Approaches


3. Distribution Plan

3.1 Urban Retail Strategies

3.2 Rural NGO Tie-ups

3.3 E-commerce Integration

3.4 Logistics and Supply Chain Management


4. Channel & Pricing Gaps

4.1 Underserved Routes

4.2 Pricing Bands Analysis

4.3 Competitor Pricing Strategies


5. Unmet Demand & Latent Needs

5.1 Category Gaps

5.2 Consumer Segments Analysis

5.3 Emerging Trends Identification


6. Customer Relationship

6.1 Loyalty Programs

6.2 After-sales Service

6.3 Customer Feedback Mechanisms


7. Value Proposition

7.1 Sustainability Initiatives

7.2 Integrated Supply Chains

7.3 Competitive Advantages


8. Key Activities

8.1 Regulatory Compliance

8.2 Branding Efforts

8.3 Distribution Setup


9. Entry Strategy Evaluation

9.1 Domestic Market Entry Strategy

9.1.1 Product Mix Considerations
9.1.2 Pricing Band Strategy
9.1.3 Packaging Solutions

9.2 Export Entry Strategy

9.2.1 Target Countries
9.2.2 Compliance Roadmap

10. Entry Mode Assessment

10.1 Joint Ventures

10.2 Greenfield Investments

10.3 Mergers & Acquisitions

10.4 Distributor Model


11. Capital and Timeline Estimation

11.1 Capital Requirements

11.2 Timelines for Implementation


12. Control vs Risk Trade-Off

12.1 Ownership vs Partnerships


13. Profitability Outlook

13.1 Breakeven Analysis

13.2 Long-term Sustainability


14. Potential Partner List

14.1 Distributors

14.2 Joint Ventures

14.3 Acquisition Targets


15. Execution Roadmap

15.1 Phased Plan for Market Entry

15.1.1 Market Setup
15.1.2 Market Entry
15.1.3 Growth Acceleration
15.1.4 Scale & Stabilize

15.2 Key Activities and Milestones

15.2.1 Milestone Planning
15.2.2 Activity Tracking

Research Methodology

ApproachModellingSample

Phase 1: Approach1

Desk Research

  • Analysis of market reports from healthcare authorities in Saudi Arabia
  • Review of published studies on pediatric health trends and device usage
  • Examination of regulatory frameworks and compliance guidelines from the Saudi Food and Drug Authority (SFDA)

Primary Research

  • Interviews with pediatricians and healthcare professionals specializing in child health
  • Surveys conducted with hospital procurement departments regarding pediatric device needs
  • Focus groups with parents and caregivers to understand device acceptance and usage

Validation & Triangulation

  • Cross-validation of findings through multiple expert interviews and surveys
  • Triangulation of data from healthcare providers, manufacturers, and regulatory bodies
  • Sanity checks through feedback from a panel of pediatric healthcare experts

Phase 2: Market Size Estimation1

Top-down Assessment

  • Estimation of total healthcare expenditure in Saudi Arabia allocated to pediatric care
  • Segmentation of the market by device type, including diagnostic, therapeutic, and monitoring devices
  • Incorporation of demographic data on the pediatric population and healthcare access

Bottom-up Modeling

  • Collection of sales data from leading pediatric medical device manufacturers
  • Estimation of device usage rates based on hospital admission statistics and pediatric health reports
  • Analysis of pricing strategies and market penetration rates of existing products

Forecasting & Scenario Analysis

  • Multi-variable forecasting using growth rates in pediatric healthcare and technological advancements
  • Scenario analysis based on potential regulatory changes and healthcare policy shifts
  • Development of baseline, optimistic, and pessimistic market growth projections through 2030

Phase 3: CATI Sample Composition1

Scope Item/SegmentSample SizeTarget Respondent Profiles
Pediatric Device Usage in Hospitals80Pediatricians, Hospital Administrators
Home Care Device Adoption60Parents, Caregivers, Home Health Providers
Market Trends in Pediatric Diagnostics50Medical Device Distributors, Healthcare Analysts
Feedback on Pediatric Therapeutic Devices40Child Health Specialists, Rehabilitation Experts
Regulatory Compliance Insights40Regulatory Affairs Managers, Compliance Officers

Frequently Asked Questions

What is the current value of the Saudi Arabia Pediatric Medical Devices Market?

The Saudi Arabia Pediatric Medical Devices Market is valued at approximately USD 305 million, reflecting a significant growth driven by increased healthcare expenditure, awareness of pediatric health issues, and advancements in medical technology tailored for children.

What are the key growth drivers for the pediatric medical devices market in Saudi Arabia?

Which cities are the primary markets for pediatric medical devices in Saudi Arabia?

What types of pediatric medical devices are most in demand in Saudi Arabia?

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