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Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report By Services (Regulatory Writing & Publishing, Legal Representation), By Type, By Service Provider, By Region, And Segment Forecasts, 2023 - 2030

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    Report

  • 100 Pages
  • December 2022
  • Region: Global
  • Grand View Research
  • ID: 5415527
The global medical device regulatory affairs market size is expected to reach USD 12.1 billion by 2030. The market is expected to expand at a CAGR of 10.1% from 2023 to 2030. 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 36.6% in 2022. 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 of 55.6% in 2022, 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 57.0% of the global market in 2022. 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 37.5% of the revenue share in 2022. 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. Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Services
1.1.2. Type
1.1.3. Service Provider
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. internal database
1.3.3. Secondary sources
1.3.4. 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)
1.7. List of Secondary Sources
1.8. List of Primary Sources
1.9. Objectives
1.9.1. Objective 1
1.9.2. Objective 2
1.9.3. Objective 3
1.9.4. Objective 4
Chapter 2. Executive Summary
2.1. Market Outlook
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. Penetration & Growth Prospect Mapping
3.3. Market Dynamics
3.3.1. Market driver analysis
3.3.1.1. Changing regulatory landscape
3.3.1.2. Entry of companies in the global market
3.3.1.3. Life science companies focusing on their core competencies
3.3.1.4. Economic and competitive pressures
3.3.1.5. Demand for faster approval process for breakthrough drugs and devices
3.3.1.6. Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
3.3.2. Market restraint analysis
3.3.2.1. Risk associated with data security
3.3.2.2. Monitoring issues and lack of standardization
3.3.3. Industry Analysis - Porter’s Five Forces
3.3.4. PESTLE Analysis
3.3.5. Covid-19 Impact & Recovery Analysis
Chapter 4. Medical Device Regulatory Affairs Market: Services Segment Analysis
4.1. Medical Device Regulatory Affairs Market: Definition & Scope
4.2. Medical Device Regulatory Affairs Market: Service Market Share Analysis, 2022 & 2030
4.3. Regulatory Consulting
4.3.1. Regulatory Consulting Market, 2018 - 2030 (USD Billion)
4.4. Legal Representation
4.4.1. Legal Representation Market, 2018 - 2030 (USD Billion)
4.5. Regulatory Writing and Publishing
4.5.1. Regulatory Writing and Publishing Market, 2018 - 2030 (USD Billion)
4.6. Product Registration and Clinical Trial Application
4.6.1. Product Registration and Clinical Trial Application Market, 2018 - 2030 (USD Billion)
4.7. Others Regulatory Services
4.7.1. Others Regulatory Services Market, 2018 - 2030 (USD Billion)
Chapter 5. Medical Device Regulatory Affairs Market: Type Segment Analysis
5.1. Medical Device Regulatory Affairs Market: Definition & Scope
5.2. Medical Device Regulatory Affairs Market: Type Market Share Analysis, 2022 & 2030
5.3. Diagnostics
5.3.1. Diagnostics Market, 2018 - 2030 (USD Billion)
5.4. Therapeutics
5.4.1. Therapeutics Market, 2018 - 2030 (USD Billion)
Chapter 6. Medical Device Regulatory Affairs Market: Service Provider Segment Analysis
6.1. Medical Device Regulatory Affairs Market: Definition & Scope
6.2. Medical Device Regulatory Affairs Market: Service Provider Market Share Analysis, 2022 & 2030
6.3. Outsource
6.3.1. Outsource Market, 2018 - 2030 (USD Billion)
6.4. In-house
6.4.1. In-house Market, 2018 - 2030 (USD Billion)
Chapter 7. Medical Device Regulatory Affairs Market: Regional Analysis
7.1. Medical Device Regulatory Affairs: Regional market share analysis, 2022 & 2030
7.2. North America
7.2.1. North America Market estimates and forecast, 2018 - 2030
7.2.2. U.S.
7.2.2.1. U.S. Market estimates and forecast, 2018 - 2030
7.2.3. Canada
7.2.3.1. Canada Market estimates and forecast, 2018 - 2030
7.3. Europe
7.3.1. Europe Market estimates and forecast, 2018 - 2030
7.3.2. U.K.
7.3.2.1. U.K. Market estimates and forecast, 2018 - 2030
7.3.3. Germany
7.3.3.1. Germany Market estimates and forecast, 2018 - 2030
7.3.4. France
7.3.4.1. France Market estimates and forecast, 2018 - 2030
7.3.5. Italy
7.3.5.1. Italy Market estimates and forecast, 2018 - 2030
7.3.6. Spain
7.3.6.1. Spain Market estimates and forecast, 2018 - 2030
7.3.7. Denmark
7.3.7.1. Denmark Market estimates and forecast, 2018 - 2030
7.3.8. Sweden
7.3.8.1. Sweden Market estimates and forecast, 2018 - 2030
7.3.9. Norway
7.3.9.1. Norway Market estimates and forecast, 2018 - 2030
7.4. Asia Pacific
7.4.1. Asia Pacific Market estimates and forecast, 2018 - 2030
7.4.2. Japan
7.4.2.1. Japan Market estimates and forecast, 2018 - 2030
7.4.3. China
7.4.3.1. China Market estimates and forecast, 2018 - 2030
7.4.4. India
7.4.4.1. India Market estimates and forecast, 2018 - 2030
7.4.5. South Korea
7.4.5.1. South Korea Market estimates and forecast, 2018 - 2030
7.4.6. Australia
7.4.6.1. Australia Market estimates and forecast, 2018 - 2030
7.4.7. Thailand
7.4.7.1. Thailand Market estimates and forecast, 2018 - 2030
7.5. Latin America
7.5.1. Latin America Market estimates and forecast, 2018 - 2030
7.5.2. Brazil
7.5.2.1. Brazil Market estimates and forecast, 2018 - 2030
7.5.3. Mexico
7.5.3.1. Mexico Market estimates and forecast, 2018 - 2030
7.5.4. Argentina
7.5.4.1. Argentina Market estimates and forecast, 2018 - 2030
7.6. MEA
7.6.1. MEA Market estimates and forecast, 2018 - 2030
7.6.2. South Africa
7.6.2.1. South Africa Market estimates and forecast, 2018 - 2030
7.6.3. Saudi Arabia
7.6.3.1. Saudi Arabia Market estimates and forecast, 2018 - 2030
7.6.4. UAE
7.6.4.1. UAE Market estimates and forecast, 2018 - 2030
7.6.5. Kuwait
7.6.5.1. Kuwait Market estimates and forecast, 2018 - 2030
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. ICON, Plc
9.3.3.2. Emergo
9.3.3.3. Freyr
9.3.3.4. Laboratory Corporation of America Holdings
9.3.3.5. IQVIA, Inc.
9.3.3.6. Intertek Group plc
9.3.3.7. SGS Société Générale de Surveillance SA
9.3.3.8. Promedica International
9.3.3.9. Integer Holdings Corporation
9.3.3.10. Medpace
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 Medical Device Regulatory Affairs 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 Global Medical Device Regulatory Affairs market: Service outlook key takeaways
Fig. 15 Global Medical Device Regulatory Affairs market: Service movement analysis
Fig. 16 Global Regulatory Consulting market, 2018 - 2030 (USD Billion)
Fig. 17 Global Legal Representation market, 2018 - 2030 (USD Billion)
Fig. 18 Global Regulatory Writing & Publishing market, 2018 - 2030 (USD Billion)
Fig. 19 Global Product Registration & Clinical Trial Applications market, 2018 - 2030
Fig. 20 Global Other Services market, 2018 - 2030 (USD Billion)
Fig. 21 Global Medical Device Regulatory Affairs market: Type movement analysis
Fig. 22 Global Diagnostics market, 2018 - 2030 (USD Billion)
Fig. 23 Global Therapeutics market, 2018 - 2030 (USD Billion)
Fig. 24 Global Medical Device Regulatory Affairs market: Service Provider movement analysis
Fig. 25 Global Outsource market, 2018 - 2030 (USD Billion)
Fig. 26 Global In-house market, 2018 - 2030 (USD Billion)
Fig. 27 Regional marketplace: Key takeaway
Fig. 28 Medical Device Regulatory Affairs regional outlook, 2022 & 2030
Fig. 29 North America Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 30 U.S. Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 31 Canada Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 32 Europe Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 33 Germany Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 34 France Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 35 UK Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 36 Spain Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 37 Italy Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 38 Denmark Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 39 Sweden Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 40 Norway Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 41 Asia Pacific Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 42 China Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 43 Japan Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 44 India Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 45 Australia Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 46 Thailand Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 47 South Korea Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 48 Latin America Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 49 Brazil Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 50 Mexico Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 51 Argentina Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 51 Middle East & Africa Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 52 South Africa Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 53 Saudi Arabia Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 54 UAE Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)
Fig. 55 Kuwait Medical Device Regulatory Affairs market, 2018 - 2030 (USD Billion)

Companies Mentioned

  • ICON, Plc
  • Emergo
  • Freyr
  • Laboratory Corporation of America Holdings
  • IQVIA, Inc.
  • Intertek Group plc
  • SGS Société Générale de Surveillance SA
  • Promedica International
  • Integer Holdings Corporation
  • Medpace

Methodology

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Table Information