本レポートは、世界の医療機器規制関連業務産業を、2020年から2023年の過去期間、2024年の推定期間、2025年から2030年の予測期間について、タイプ別(診断、治療)、サービス別(規制コンサルティング、法的代理、規制作成&公開、その他のサービス)、サービスプロバイダー別(アウトソース、社内)の市場セグメンテーションの観点から詳細な分析を提供しています。
この調査レポートは、医療機器規制関連業務市場を地域別(南北アメリカ、ヨーロッパ、アジア太平洋地域、中東・アフリカ)、10カ国別(アメリカ、カナダ、イギリス、ドイツ、フランス、イタリア、中国、日本、インド、韓国)に分析しています。世界の医療機器規制関連業務市場は2020年から2023年にCAGR 12.98%の成長を見せました。2023年の市場規模は68億6,000万米ドルで、2030年には275億8,000万米ドルに達すると予測されています。医療機器規制関連業務市場は、規制要件の進化、医療機器開発における技術進歩、市場のグローバル化、患者の安全性と製品品質への関心の高まりなどの要因の影響を受けています。
世界保健機関(WHO)によると、非感染性疾患(NCD)により毎年4,100万人が死亡しており、これは世界全体の死亡者数の74%に相当します。冠動脈疾患、末梢動脈疾患、不整脈などの心血管疾患は、引き続き世界的に罹患率と死亡率の主な原因となっています。肥満、糖尿病、高血圧などの危険因子の有病率が増加するにつれて、心血管疾患の発生率も増加します。非感染性疾患は多くの場合、合併症を予防し、患者の転帰を改善するために継続的なモニタリングと管理を必要とします。NCD の有病率が高まるにつれて、これらの症状の診断、監視、管理のための医療機器の需要が高まっています。規制関連の専門家は、これらの機器が市販され、臨床現場で使用される前に、安全性、有効性、性能に関する規制要件を満たしていることを確認する上で重要な役割を果たします。
国際貿易を促進し、規制要件を調和させる必要性を認識し、世界中の規制当局は医療機器の基準と規制を調整することに取り組んでいます。国際医療機器規制者フォーラム (IMDRF) などの取り組みは、規制要件の統一と相互承認を促進し、取り組みの重複を減らし、複数の管轄区域にわたる医療機器の市場アクセスを促進することを目的としています。
ゲノミクス、バイオマーカー、診断技術の進歩により、治療介入における個別化された精密医療アプローチの出現が促進されています。薬事関連の専門家は、遺伝子検査やコンパニオン診断などの個別化医療機器の開発者と協力して、法規制の順守と臨床上の有用性と有効性の証拠に基づく検証を保証します。
自動オーサリングおよびパブリッシングツールは、文書の書式設定、テンプレートの作成、提出用文書の生成など、規制当局の文書作成および公開における反復作業を自動化します。これらのツールは、薬事文書作成の生産性、正確性、一貫性を向上させ、手作業によるミスを減らし、医療機器の市場投入までの時間を短縮します。薬事担当者はコンテンツ作成と薬事戦略に集中でき、自動化されたツールは書式設定と出版作業を効率的に処理します。
クラウドベースのコラボレーションプラットフォームは、医療機器企業とアウトソーシングサービスプロバイダー間のシームレスなコミュニケーション、文書共有、プロジェクト管理を容易にします。これらのプラットフォームは、地理的な場所に関係なく、薬事プロジェクトにおけるリアルタイムのコラボレーションを可能にします。クラウドベースのコラボレーションプラットフォームは、アウトソーシング関係の透明性、効率性、説明責任を高めます。医療機器企業は、ドキュメントを安全に共有し、プロジェクトの進捗状況を追跡し、アウトソーシングサービスプロバイダーとコミュニケーションをとることができ、効果的なコラボレーションとプロジェクト管理を促進します。
目次
Table of Content
1. Market Background
1.1 Scope and Product Outlook
1.2 Executive Summary
1.3 Research Methodology
2. Strategic Recommendations
2.1 Introduce niche offering for different end-use sectors
2.2 Focus on deploying different subscription models
3. Global Medical Device Regulatory Affairs Market: Historic and Forecast
3.1 Impact Analysis of Macro Economic Factors on Global Medical Device Regulatory Affairs Market
3.2 Recall Status by Device and Recall Characteristics
3.3 Duration from Recall initiation to termination
3.4 Global Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
3.5 Degree of Impact of Covid-19 on Medical Device Regulatory Affairs Market
3.6 Global Medical Device Regulatory Affairs Market Segmentation: By Type
3.6.1 Global Medical Device Regulatory Affairs Market, By Type Overview
3.6.2 Global Medical Device Regulatory Affairs Market Attractiveness Index, By Type Overview
3.6.3 Global Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
3.6.4 Global Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
3.7 Global Medical Device Regulatory Affairs Market Segmentation: By Services
3.7.1 Global Medical Device Regulatory Affairs Market, By Services Overview
3.7.2 Global Medical Device Regulatory Affairs Market Attractiveness Index, By Services Overview
3.7.3 Global Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
3.7.4 Global Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
3.7.5 Global Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
3.7.6 Global Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
3.8 Global Medical Device Regulatory Affairs Market Segmentation: By Service Provider
3.8.1 Global Medical Device Regulatory Affairs Market, By Service Provider Overview
3.8.2 Global Medical Device Regulatory Affairs Market Attractiveness Index, By Service Provider Overview
3.8.3 Global Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
3.8.4 Global Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
4. Global Medical Device Regulatory Affairs Market, Region Analysis
4.1 Regional Coverage of the Study
4.2 Regional Snapshot
5. Americas Medical Device Regulatory Affairs Market: Historic and Forecast
5.1 Americas Medical Device Regulatory Affairs Market: Snapshot
5.2 Americas Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.3 Americas Medical Device Regulatory Affairs Market: Key Factors
5.4 Americas Medical Device Regulatory Affairs Market: Segment Analysis
5.5 Americas Medical Device Regulatory Affairs Market Segmentation: By Type
5.5.1 Americas Medical Device Regulatory Affairs Market, By Type Overview
5.5.2 Americas Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
5.5.3 Americas Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
5.6 Americas Medical Device Regulatory Affairs Market Segmentation: By Services
5.6.1 Americas Medical Device Regulatory Affairs Market, By Services Overview
5.6.2 Americas Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
5.6.3 Americas Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
5.6.4 Americas Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
5.6.5 Americas Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
5.7 Americas Medical Device Regulatory Affairs Market Segmentation: By Service Provider
5.7.1 Americas Medical Device Regulatory Affairs Market, By Service Provider Overview
5.7.2 Americas Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
5.7.3 Americas Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
5.8 Americas Medical Device Regulatory Affairs Market Segmentation: By Country
5.8.1 Europe Medical Device Regulatory Affairs Market, By Country Overview
5.8.2 United States Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.8.2.1 United States Medical Device Regulatory Affairs Market, By Type
5.8.2.2 United States Medical Device Regulatory Affairs Market, By Services
5.8.2.3 United States Medical Device Regulatory Affairs Market, By Service Provider
5.8.3 Canada Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.8.3.1 Canada Medical Device Regulatory Affairs Market, By Type
5.8.3.2 Canada Medical Device Regulatory Affairs Market, By Services
5.8.3.3 Canada Medical Device Regulatory Affairs Market, By Service Provider
5.8.4 Rest of Americas Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.8.4.1 Rest of Americas Medical Device Regulatory Affairs Market, By Type
5.8.4.2 Rest of Americas Medical Device Regulatory Affairs Market, By Services
5.8.4.3 Rest of Americas Medical Device Regulatory Affairs Market, By Service Provider
6. Europe Medical Device Regulatory Affairs Market: Historic and Forecast
6.1 Europe Medical Device Regulatory Affairs Market: Snapshot
6.2 Europe Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.3 Europe Medical Device Regulatory Affairs Market: Key Factors
6.4 Europe Medical Device Regulatory Affairs Market: Segment Analysis
6.5 Europe Medical Device Regulatory Affairs Market Segmentation: By Type
6.5.1 Europe Medical Device Regulatory Affairs Market, By Type Overview
6.5.2 Europe Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
6.5.3 Europe Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
6.6 Europe Medical Device Regulatory Affairs Market Segmentation: By Services
6.6.1 Europe Medical Device Regulatory Affairs Market, By Services Overview
6.6.2 Europe Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
6.6.3 Europe Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
6.6.4 Europe Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
6.6.5 Europe Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
6.7 Europe Medical Device Regulatory Affairs Market Segmentation: By Service Provider
6.7.1 Europe Medical Device Regulatory Affairs Market, By Service Provider Overview
6.7.2 Europe Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
6.7.3 Europe Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
6.8 Europe Medical Device Regulatory Affairs Market Segmentation: By Country
6.8.1 Europe Medical Device Regulatory Affairs Market, By Country Overview
6.8.2 United Kingdom Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.2.1 United Kingdom Medical Device Regulatory Affairs Market, By Type
6.8.2.2 United Kingdom Medical Device Regulatory Affairs Market, By Services
6.8.2.3 United Kingdom Medical Device Regulatory Affairs Market, By Service Provider
6.8.3 Germany Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.3.1 Germany Medical Device Regulatory Affairs Market, By Type
6.8.3.2 Germany Medical Device Regulatory Affairs Market, By Services
6.8.3.3 Germany Medical Device Regulatory Affairs Market, By Service Provider
6.8.4 France Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.4.1 France Medical Device Regulatory Affairs Market, By Type
6.8.4.2 France Medical Device Regulatory Affairs Market, By Services
6.8.4.3 France Medical Device Regulatory Affairs Market, By Service Provider
6.8.5 Italy Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.5.1 Italy Medical Device Regulatory Affairs Market, By Type
6.8.5.2 Italy Medical Device Regulatory Affairs Market, By Services
6.8.5.3 Italy Medical Device Regulatory Affairs Market, By Service Provider
6.8.6 Rest of Europe Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.6.1 Rest of Europe Medical Device Regulatory Affairs Market, By Type
6.8.6.2 Rest of Europe Medical Device Regulatory Affairs Market, By Services
6.8.6.3 Rest of Europe Medical Device Regulatory Affairs Market, By Service Provider
7. Asia Pacific Medical Device Regulatory Affairs Market: Historic and Forecast
7.1 Asia Pacific Medical Device Regulatory Affairs Market: Snapshot
7.2 Asia Pacific Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.3 Asia Pacific Medical Device Regulatory Affairs Market: Key Factors
7.4 Asia Pacific Medical Device Regulatory Affairs Market: Segment Analysis
7.5 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Type
7.5.1 Asia Pacific Medical Device Regulatory Affairs Market, By Type Overview
7.5.2 Asia Pacific Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
7.5.3 Asia Pacific Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
7.6 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Services
7.6.1 Asia Pacific Medical Device Regulatory Affairs Market, By Services Overview
7.6.2 Asia Pacific Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
7.6.3 Asia Pacific Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
7.6.4 Asia Pacific Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
7.6.5 Asia Pacific Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
7.7 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Service Provider
7.7.1 Asia Pacific Medical Device Regulatory Affairs Market, By Service Provider Overview
7.7.2 Asia Pacific Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
7.7.3 Asia Pacific Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
7.8 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Country
7.8.1 Asia Pacific Medical Device Regulatory Affairs Market, By Country Overview
7.8.2 China Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.2.1 China Medical Device Regulatory Affairs Market, By Type
7.8.2.2 China Medical Device Regulatory Affairs Market, By Services
7.8.2.3 China Medical Device Regulatory Affairs Market, By Service Provider
7.8.3 Japan Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.3.1 Japan Medical Device Regulatory Affairs Market, By Type
7.8.3.2 Japan Medical Device Regulatory Affairs Market, By Services
7.8.3.3 Japan Medical Device Regulatory Affairs Market, By Service Provider
7.8.4 India Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.4.1 India Medical Device Regulatory Affairs Market, By Type
7.8.4.2 India Medical Device Regulatory Affairs Market, By Services
7.8.4.3 India Medical Device Regulatory Affairs Market, By Service Provider
7.8.5 South Korea Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.5.1 South Korea Medical Device Regulatory Affairs Market, By Type
7.8.5.2 South Korea Medical Device Regulatory Affairs Market, By Services
7.8.5.3 South Korea Medical Device Regulatory Affairs Market, By Service Provider
7.8.6 Rest of Asia Pacific Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.6.1 Rest of Asia Pacific Medical Device Regulatory Affairs Market, By Type
7.8.6.2 Rest of Asia Pacific Medical Device Regulatory Affairs Market, By Services
7.8.6.3 Rest of Asia Pacific Medical Device Regulatory Affairs Market, By Service Provider
8. Middle East and Africa Medical Device Regulatory Affairs Market: Historic and Forecast
8.1 Middle East and Africa Medical Device Regulatory Affairs Market: Snapshot
8.2 Middle East and Africa Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
8.3 Middle East and Africa Medical Device Regulatory Affairs Market: Key Factors
8.4 Middle East and Africa Medical Device Regulatory Affairs Market: Segment Analysis
8.5 Middle East and Africa Medical Device Regulatory Affairs Market Segmentation: By Type
8.5.1 Middle East and Africa Medical Device Regulatory Affairs Market, By Type Overview
8.5.2 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
8.5.3 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
8.6 Middle East and Africa Medical Device Regulatory Affairs Market Segmentation: By Services
8.6.1 Middle East and Africa Medical Device Regulatory Affairs Market, By Services Overview
8.6.2 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
8.6.3 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
8.6.4 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
8.6.5 Middle East and Africa Medical Device Regulatory Affairs Market, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
8.7 Middle East and Africa Medical Device Regulatory Affairs Market Segmentation: By Service Provider
8.7.1 Middle East and Africa Medical Device Regulatory Affairs Market, By Service Provider Overview
8.7.2 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
8.7.3 Middle East and Africa Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
9. Market Dynamics
9.1 Impact assessment of Market Dynamics on Global Medical Device Regulatory Affairs Market
9.2 Drivers
9.3 Restraints
9.4 Trends
10. Industry Ecosystem Analysis
10.1 Porter Analysis
11. Competitive Positioning
11.1 Companies’ Product Positioning
11.2 Market Share of Leading Companies
11.3 Company Profiling
11.3.1 ICON Plc
11.3.2 Labcorp
11.4.3 IQVIA
11.3.4 Intertek Group Plc
11.3.5 SGS SA
11.3.6 Integer Holdings Corp
11.3.7 Medpace Holdings
11.3.8 Emergo
11.3.9 Freyr Solutions
11.3.10 Promedica International
12. About Us and Disclaimer
List of Figures
Figure 1: Recall Status Class I of Medical Device Recalls from 2018 to 2022 (%)
Figure 2: Global Medical Device Regulatory Affairs Market Size, By Value, 2020-2023 (USD Million)
Figure 3: Global Medical Device Regulatory Affairs Market Size, By Value, 2024-2030 (USD Million)
Figure 4: Global Medical Device Regulatory Affairs Market Share, By Services, 2023 (%)
Figure 5: Market Attractiveness Analysis of Global Medical Device Regulatory Affairs Market, By Type (2025-2030)
Figure 6: Global Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 7: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Diagnostic, 2020H-2030F (USD Million)
Figure 8: Global Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 9: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Therapeutic, 2020H-2030F (USD Million)
Figure 10: Market Attractiveness Analysis of Global Medical Device Regulatory Affairs Market, By Services (2025-2030)
Figure 11: Global Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
Figure 12: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Regulatory Consulting, 2020H-2030F (USD Million)
Figure 13: Global Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
Figure 14: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Legal Representation, 2020H-2030F (USD Million)
Figure 15: Global Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
Figure 16: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Regulatory Writing & Publishing, 2020H-2030F (USD Million)
Figure 17: Global Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
Figure 18: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Other Services, 2020H-2030F (USD Million)
Figure 19: Market Attractiveness Analysis of Global Medical Device Regulatory Affairs Market, By Service Provider (2025-2030)
Figure 20: Global Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
Figure 21: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By Outsource, 2020H-2030F (USD Million)
Figure 22: Global Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
Figure 23: Global Medical Device Regulatory Affairs Market Absolute Opportunity, By In-house, 2020H-2030F (USD Million)
Figure 24: Americas Medical Device Regulatory Affairs Market Size, By Value, 2020H-2030F (USD Million)
Figure 25: Americas Medical Device Regulatory Affairs Market Share, By Services, 2023 (%)
Figure 26: Americas Medical Device Regulatory Affairs Market, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 27: Americas Medical Device Regulatory Affairs Market, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 28: Americas Medical Device Regulatory Affairs Market, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
Figure 29: Americas Medical Device Regulatory Affairs Market, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
Figure 30: Americas Medical Device Regulatory Affairs Market, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
Figure 31: Americas Medical Device Regulatory Affairs Market, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
Figure 32: Americas Medical Device Regulatory Affairs Market, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
Figure 33: Americas Medical Device Regulatory Affairs Market, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
Figure 34: United States Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 35: United States Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 36: United States Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 37: United States Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 38: United States Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 39: Canada Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 40: Canada Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 41: Canada Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 42: Canada Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 43: Canada Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 44: Rest of Americas Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 45: Rest of Americas Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 46: Rest of Americas Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 47: Rest of Americas Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 48: Rest of Americas Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 49: Europe Medical Device Regulatory Affairs Market Size, By Value, 2020H-2030F (USD Million)
Figure 50: Europe Medical Device Regulatory Affairs Market Share, By Services, 2023 (%)
Figure 51: Europe Medical Device Regulatory Affairs Market, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 52: Europe Medical Device Regulatory Affairs Market, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 53: Europe Medical Device Regulatory Affairs Market, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
Figure 54: Europe Medical Device Regulatory Affairs Market, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
Figure 55: Europe Medical Device Regulatory Affairs Market, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
Figure 56: Europe Medical Device Regulatory Affairs Market, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
Figure 57: Europe Medical Device Regulatory Affairs Market, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
Figure 58: Europe Medical Device Regulatory Affairs Market, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
Figure 59: United Kingdom Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 60: United Kingdom Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 61: United Kingdom Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 62: United Kingdom Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 63: United Kingdom Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 64: Germany Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 65: Germany Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 66: Germany Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 67: Germany Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 68: Germany Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 69: France Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 70: France Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 71: France Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 72: France Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 73: France Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 74: Italy Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 75: Italy Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 76: Italy Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 77: Italy Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 78: Italy Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 79: Rest of Europe Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 80: Rest of Europe Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 81: Rest of Europe Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 82: Rest of Europe Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 83: Rest of Europe Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 84: Asia-Pacific Medical Device Regulatory Affairs Market Size, By Value, 2020H-2030F (USD Million)
Figure 85: Asia-Pacific Medical Device Regulatory Affairs Market Share, By Services, 2023 (%)
Figure 86: Asia-Pacific Medical Device Regulatory Affairs Market, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 87: Asia-Pacific Medical Device Regulatory Affairs Market, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 88: Asia-Pacific Medical Device Regulatory Affairs Market, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
Figure 89: Asia-Pacific Medical Device Regulatory Affairs Market, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
Figure 90: Asia-Pacific Medical Device Regulatory Affairs Market, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
Figure 91: Asia-Pacific Medical Device Regulatory Affairs Market, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
Figure 92: Asia-Pacific Medical Device Regulatory Affairs Market, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
Figure 93: Asia-Pacific Medical Device Regulatory Affairs Market, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
Figure 94: China Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 95: China Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 96: China Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 97: China Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 98: China Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 99: Japan Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 100: Japan Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 101: Japan Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 102: Japan Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 103: Japan Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 104: India Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 105: India Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 106: India Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 107: India Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 108: India Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 109: South Korea Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 110: South Korea Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 111: South Korea Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 112: South Korea Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 113: South Korea Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 114: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Value, 2020H-2030F (USD Million & CAGR)
Figure 115: Rest of Asia-Pacific Medical Device Regulatory Affairs Market Value, By Type, 2023 (USD Million)
Figure 116: Rest of Asia-Pacific Medical Device Regulatory Affairs Market Share, By Type, By Value, 2023 (%)
Figure 117: Rest of Asia-Pacific Medical Device Regulatory Affairs Market Share, By Services, By Value, 2023 (%)
Figure 118: Rest of Asia-Pacific Medical Device Regulatory Affairs Market Share, By Service Provider, By Value, 2023 (%)
Figure 119: Middle East and Africa Medical Device Regulatory Affairs Market Size, By Value, 2020H-2030F (USD Million)
Figure 120: Middle East and Africa Medical Device Regulatory Affairs Market Share, By Services, 2023 (%)
Figure 121: Middle East and Africa Medical Device Regulatory Affairs Market, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 122: Middle East and Africa Medical Device Regulatory Affairs Market, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
Figure 123: Middle East and Africa Medical Device Regulatory Affairs Market, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
Figure 124: Middle East and Africa Medical Device Regulatory Affairs Market, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
Figure 125: Middle East and Africa Medical Device Regulatory Affairs Market, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
Figure 126: Middle East and Africa Medical Device Regulatory Affairs Market, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
Figure 127: Middle East and Africa Medical Device Regulatory Affairs Market, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
Figure 128: Middle East and Africa Medical Device Regulatory Affairs Market, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
Figure 129: Global Impact of Drivers and Restraints
Figure 130: Market Share of Prominent Companies of Medical Device Regulatory Affairs, 2023 (%)
Figure 131: ICON Revenues, 2021-2023 (USD Million)
Figure 132: ICON Revenue , By Geographic Segments, 2023 (%)
Figure 133: Labcorp Revenues, 2021-2023 (USD Million)
Figure 134: Labcorp Revenue, By Business Segments, 2023 (%)
Figure 135: Labcorp Revenue, By Geographical Segments, 2023 (%)
Figure 136: IQVIA Revenues, 2021-2023 (USD Million)
Figure 137: IQVIA Revenue, By Business Segments, 2023 (%)
Figure 138: IQVIA Revenue, By Geographical Segments, 2023 (%)
Figure 139: Intertek Revenues, 2021-2023 (USD Million)
Figure 140: Intertek Revenue, By Geographical Segments, 2023 (%)
Figure 141: SGS Revenues, 2021-2023 (USD Million)
Figure 142: SGS Revenue, By Business Segments, 2023 (%)
Figure 143: SGS Revenue, By Geographical Segments, 2023 (%)
Figure 144: Integer Revenues, 2021-2023 (USD Million)
Figure 145: Integer Revenue, By Business Segments, 2023 (%)
Figure 146: Integer Revenue, By Geographical Segments, 2023 (%)
Figure 147: Medpace Revenues, 2021-2023 (USD Million)
Figure 148: Medpace Revenue, By Business Segments, 2023 (%)
Figure 149: Medpace Revenue, By Geographical Segments, 2023 (%)
List of Tables
Table A1: Global Impact of Macro Economic Factors, By Region
Table A2: Recall Status of Medical Device Recalls from 2018 to 2022
Table A3: United States Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A4: United States Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A5: United States Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A6: United States Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A7: United States Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A8: United States Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A9: Canada Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A10: Canada Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A11: Canada Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A12: Canada Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A13: Canada Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A14: Canada Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A15: Rest of Americas Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A16: Rest of Americas Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A17: Rest of Americas Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A18: Rest of Americas Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A19: Rest of Americas Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A20: Rest of Americas Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A21: United Kingdom Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A22: United Kingdom Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A23: United Kingdom Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A24: United Kingdom Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A25: United Kingdom Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A26: United Kingdom Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A27: Germany Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A28: Germany Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A29: Germany Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A30: Germany Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A31: Germany Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A32: Germany Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A33: France Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A34: France Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A35: France Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A36: France Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A37: France Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A38: France Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A39: Italy Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A40: Italy Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A41: Italy Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A42: Italy Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A43: Italy Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A44: Italy Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A45: Rest of Europe Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A46: Rest of Europe Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A47: Rest of Europe Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A48: Rest of Europe Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A49: Rest of Europe Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A50: Rest of Europe Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A51: China Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A52: China Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A53: China Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A54: China Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A55: China Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A56: China Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A57: Japan Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A58: Japan Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A59: Japan Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A60: Japan Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A61: Japan Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A62: Japan Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A63: India Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A64: India Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A65: India Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A66: India Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A67: India Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A68: India Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A69: South Korea Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A70: South Korea Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A71: South Korea Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A72: South Korea Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A73: South Korea Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A74: South Korea Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A75: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A76: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A77: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A78: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A79: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A80: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A81: ICON Key Company Financials, 2021-2023
Table A82: Labcorp Key Company Financials, 2021-2023
Table A83: IQVIA Key Company Financials, 2021-2023
Table A84: Intertek Key Company Financials, 2021-2023
Table A85: SGS Key Company Financials, 2021-2023
Table A86: Integer Key Company Financials, 2021-2023
Table A87: Medpace Key Company Financials, 2021-2023