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レポートナンバー 0000033796

医療機器薬事申請市場規模、シェア、動向分析レポート、予測2023-2030

Grand View Research Inc.

Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report, And Segment Forecasts, 2023 - 2030

発刊日 2022/12

言語英語

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ライセンス/価格100ページ

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レポート概要

医療機器薬事申請市場の規模、シェア、動向分析レポートサービス別(Regulatory Writing & Publishing, Legal Representation)、タイプ別、サービスプロバイダー別、地域別、および2023年から2030年までのセグメント予測

レポートの概要
世界の医療機器薬事申請市場は、2022 年に 56 億ドルと評価され、2023 年から 2030 年までに 10.1% のCAGRで拡大すると予想されます。この成長を促す要因としては、承認プロセスの迅速化に対する需要の高まり、規制環境の変化、治療や診断などの新興分野の拡大などがあります。さらに、医療機器の複雑化と政府の好意的な取組みも、医療機器薬事申請市場の成長を支えています。医療機器のパイプラインは、近年着実に増加しています。たとえば、GlobalData によると、2021 年の第 2 四半期には 1,103 の医療機器がパイプラインにありましたが、第 3 四半期にはパイプラインが 20% 増加しました。新しい技術に対する需要の高まりと、デバイスを使い易いものにするニーズの高まりによって、予測期間中、医療機器パイプラインの改善が期待されます。その結果、医療機器規制サービスの需要が生まれ、パンデミック後の市場の成長を促すでしょう。

レポート詳細

目次

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. GVR’s 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)

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