의료기기 RA 시장 : 시장 규모, 점유율, 동향 분석(유형별, 서비스 제공업체별, 서비스별, 지역별), 부문별 예측(2025-2030년)

Medical Device Regulatory Affairs Market Growth & Trends:

The global medical device regulatory affairs market size is estimated to reach USD 11.66 billion by 2030, registering to grow at a CAGR of 9.55% from 2025 to 2030 according to a new report by Grand View Research, Inc. Technological advancements in medical devices, such as AI and machine learning, increasing trends toward portable and smaller devices, and strict government regulations for medical devices are driving the market.

Medical equipment regulation is a vast and rapidly changing field that is often complicated by legal challenges. Even within one regulatory framework, legal terms and their definitions are not always consistent. As technology expands, software, machine learning, and algorithms become essential component of an increasing number of digital health resources. This presents new challenges as an increasing number of instruments fall under the regulatory framework.

Medical device companies have to deal with continuous changes in regulatory requirements, which can differ based on business activities and geographies. Noncompliance with the changing regulatory requirements can result in penalties and delays, which may lead to a loss of revenue. According to a survey sponsored by Genpact, 72.0% of executives from the life sciences industry consider regulatory compliance to be one of the top three challenges they face. Such factors are expected to support the demand for these services further.

Public organizations worldwide are providing funding to improve healthcare R&D. For instance, in March 2022, over USD 188.0 million was funded by the U.K. government to support NHS-led health research pertaining to diagnostics and treatments. Such investments in the future are expected to increase the number of new medical device launches, thus creating opportunities for medical device regulatory services. Such activities are expected to support the market in the forecasted period.

Medical Device Regulatory Affairs Market Report Highlights:

• The regulatory writing and publishing segment dominated the market with the largest revenue share of 36.4% in 2024. This is due to a rise in the number of clinical trials, government support, and an increasing need to launch the product quickly
• Based on type, the therapeutic segment accounted for the larger market share in 2024, due to increasing demand for equipment as a result of technological advancements in developed countries
• There is a huge demand for outsourcing these services. Hence, the segment contributed to 59.1% of the global market in 2024. This is largely owing to the lack of in-house capabilities and ever-changing regulations for medical devices across the globe
• Asia Pacific dominated the market and accounted for 38.03% of the revenue share in 2024. This is largely due to the expanding medical device market in India as a result of increased health awareness, a growing middle class, and government health initiatives.

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Services
  • 1.2.2. Type
  • 1.2.3. Service Provider
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information Or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Parent Market Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. Medical Device Regulatory Affairs 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. Changing regulatory landscape
    • 3.2.1.2. Entry of companies in the global market
    • 3.2.1.3. Life science companies focusing on their core competencies
    • 3.2.1.4. Economic and competitive pressures
    • 3.2.1.5. Demand for faster approval process for breakthrough drugs and devices
    • 3.2.1.6. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Risk associated with data security
    • 3.2.2.2. Monitoring issues and lack of standardization
• 3.3. Medical Device Regulatory Affairs Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Medical Device Regulatory Affairs Market: Services Estimates & Trend Analysis

• 4.1. Medical Device Regulatory Affairs Market, By Services: Segment Dashboard
• 4.2. Medical Device Regulatory Affairs Market, By Services: Movement Analysis
• 4.3. Medical Device Regulatory Affairs Market Estimates & Forecasts, By Services, 2018 - 2030
• 4.4. Regulatory Consulting
  • 4.4.1. Regulatory Consulting Market, 2018 to 2030 (USD Million)
• 4.5. Legal Representation
  • 4.5.1. Legal Representation Market, 2018 to 2030 (USD Million)
• 4.6. Regulatory Writing & Publishing
  • 4.6.1. Regulatory Writing & Publishing Market, 2018 to 2030 (USD Million)
• 4.7. Product Registration & Clinical Trial Applications
  • 4.7.1. Product Registration & Clinical Trial Applications Market, 2018 to 2030 (USD Million)
• 4.8. Other Services
  • 4.8.1. Other Services Market, 2018 to 2030 (USD Million)

Chapter 5. Medical Device Regulatory Affairs Market: Type Estimates & Trend Analysis

• 5.1. Medical Device Regulatory Affairs Market, By Type: Segment Dashboard
• 5.2. Medical Device Regulatory Affairs Market, By Type: Movement Analysis
• 5.3. Medical Device Regulatory Affairs Market Estimates & Forecasts, By Type, 2018 - 2030
• 5.4. Diagnostic
  • 5.4.1. Diagnostic Market, 2018 to 2030 (USD Million)
• 5.5. Therapeutic
  • 5.5.1. Therapeutic Market, 2018 to 2030 (USD Million)

Chapter 6. Medical Device Regulatory Affairs Market: Service Provider Estimates & Trend Analysis

• 6.1. Medical Device Regulatory Affairs Market, By Service Provider: Segment Dashboard
• 6.2. Medical Device Regulatory Affairs Market, By Service Provider: Movement Analysis
• 6.3. Medical Device Regulatory Affairs Market Estimates & Forecasts, By Service Provider, 2018 - 2030
• 6.4. In-house
  • 6.4.1. In-house Market, 2018 to 2030 (USD Million)
• 6.5. Outsource
  • 6.5.1. Outsource Market, 2018 to 2030 (USD Million)

Chapter 7. Medical Device Regulatory Affairs Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2030
• 7.2. Regional Market Dashboard
• 7.3. Global Regional Market Snapshot
• 7.4. North America
  • 7.4.1. North America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.2. U.S
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. UK Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Japan Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. China Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Australia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.6. Thailand
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.7. South Korea
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. South Korea Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.4. Colombia
    • 7.7.4.1. Key Country Dynamics
    • 7.7.4.2. Competitive Scenario
    • 7.7.4.3. Regulatory Framework
    • 7.7.4.4. Colombia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. MEA
  • 7.8.1. MEA Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Market Participant Categorization
• 8.2. Company Market Share Analysis, 2023/24
• 8.3. Company Profiles
  • 8.3.1. ICON, Plc
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Emergo
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Freyr
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Laboratory Corporation of America Holdings
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. IQVIA, Inc.
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Intertek Group plc
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. SGS Societe Generale de Surveillance SA
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Promedica International
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Integer Holdings Corporation
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Medpace
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives