医療機器向け薬事申請の世界市場：市場規模・シェア・動向分析 (種類別・サービスプロバイダー別・サービス別・地域別)、セグメント別予測 (2025年～2030年)

医療機器向け薬事申請市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、世界の医療機器向け薬事申請の市場規模は2030年までに116億6,000万米ドルに達し、2025年から2030年までのCAGRは9.55%で成長すると予測されています。

AIや機械学習などの医療機器の技術的進歩、携帯可能な小型機器への動向の増加、医療機器に対する政府の厳しい規制が市場を牽引しています。

医療機器の規制は広大で急速に変化する分野であり、しばしば法的課題によって複雑化します。1つの規制の枠組みの中でさえ、法律用語とその定義は必ずしも一貫していません。技術が拡大するにつれ、ソフトウェア、機械学習、アルゴリズムは、ますます多くのデジタル医療リソースに不可欠な要素となっています。このため、規制の枠組みに該当する機器の数が増え、新たな課題となっています。

医療機器企業は、事業活動や地域によって異なる規制要件の継続的な変更に対処しなければなりません。変化する規制要件へのコンプライアンス違反は、罰則や遅延を招き、収益の損失につながる可能性があります。Genpactが主催した調査によると、ライフサイエンス業界の経営幹部の72.0%が、法規制遵守を直面する課題の上位3つのうちの1つと考えています。このような要因により、これらのサービスに対する需要はさらに高まると予想されます。

世界中の公的機関が医療の研究開発を改善するために資金を提供しています。例えば、2022年3月には、診断や治療に関連するNHS主導の健康研究を支援するために、英国政府から1億8,800万米ドルを超える資金が提供されました。今後、このような投資により、新たな医療機器の発売が増加し、医療機器規制サービスの機会が創出されることが期待されます。このような活動は、予測期間中の市場を支えるものと期待されます。

医療機器向け薬事申請市場：分析概要

• 規制文書執筆・刊行セグメントが2024年に36.4%の最大収益シェアで市場を独占しました。この背景には、治験件数の増加、政府支援、製品の早期上市ニーズの高まりがあります。
• 種類別では、先進国の技術進歩に伴う機器需要の増加により、治療分野が2024年に大きな市場シェアを占めました。
• また、これらのサービスをアウトソーシングする需要も大きいです。したがって、このセグメントは2024年に世界市場の59.1%に寄与しました。これは、社内で対応できる能力が不足していることと、世界中で医療機器に関する規制が刻々と変化していることが主な要因です。
• アジア太平洋地域は市場を独占し、2024年の収益シェアの38.03%を占めました。これは、健康意識の高まり、中産階級の増加、政府の健康への取り組みの結果、インドの医療機器市場が拡大していることが主な原因です。

目次

第1章 分析方法・範囲

第2章 エグゼクティブサマリー

第3章 医療機器向け薬事申請市場：変動要因・傾向・範囲

• 市場連関の見通し
  • 親市場の見通し
  • 関連/付随市場の見通し
• 市場力学
  • 市場促進要因の分析
  • 市場抑制要因の分析
• 医療機器向け薬事申請市場：分析ツール
  • 業界分析：ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析

第4章 医療機器向け薬事申請市場：サービス別の推定と動向分析

• 医療機器向け薬事申請市場：サービス別のダッシュボード
• 医療機器向け薬事申請市場：サービス別の変動分析
• サービス別 (2018～2030年)
• 規制コンサルティング
  • 規制コンサルティング市場 (2018～2030年)
• 法的代理
  • 法務代理市場 (2018～2030年)
• 規制文書執筆・刊行
  • 規制文章執筆・刊行市場 (2018～2030年)
• 製品登録・治験申請
  • 製品登録・治験申請市場 (2018～2030年)
• その他のサービス
  • その他のサービス市場 (2018～2030年)

第5章 医療機器向け薬事申請市場：種類別の推定と動向分析

• 医療機器向け薬事申請市場：種類別のダッシュボード
• 医療機器向け薬事申請市場：種類別の変動分析
• 種類別 (2018～2030年)
• 診断
  • 診断市場 (2018～2030年)
• 治療
  • 治療市場 (2018～2030年)

第6章 医療機器向け薬事申請市場：サービスプロバイダー別の推定と動向分析

• 医療機器向け薬事申請市場：サービスプロバイダー別のダッシュボード
• 医療機器向け薬事申請市場：サービスプロバイダー別の変動分析
• サービスプロバイダー別 (2018～2030年)
• 社内
  • 社内市場 (2018～2030年)
• アウトソーシング
  • アウトソーシング市場 (2018～2030年)

第7章 医療機器向け薬事申請市場：地域別の推定と動向分析

• 市場シェア分析：地域別 (2024年・2030年)
• 市場のダッシュボード：地域別
• 世界市場のスナップショット：地域別
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー
• アジア太平洋
  • 日本
  • 中国
  • インド
  • オーストラリア
  • タイ
  • 韓国
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
  • コロンビア
• 中東・アフリカ
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート

第8章 競合情勢

• 市場参入企業の分類
• 企業市場シェア分析 (2023年/24年)
• 企業プロファイル
  • ICON, Plc
  • Emergo
  • Freyr
  • Laboratory Corporation of America Holdings
  • IQVIA, Inc.
  • Intertek Group plc
  • SGS Societe Generale de Surveillance SA
  • Promedica International
  • Integer Holdings Corporation
  • Medpace

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 Global Medical Device Regulatory Affairs market, by region, 2018 - 2030 (USD Million)
• Table 4 Global Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 5 Global Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 6 Global Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 7 North America Device Regulatory Affairs market, by country, 2018 - 2030 (USD Million)
• Table 8 North America Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 9 North America Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 10 North America Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 11 U.S. Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 12 U.S. Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 13 U.S. Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 14 Canada Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 15 Canada Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 16 Canada Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 17 Mexico Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 18 Mexico Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 19 Mexico Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 20 Europe Medical Device Regulatory Affairs market, by country, 2018 - 2030 (USD Million)
• Table 21 Europe Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 22 Europe Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 23 Europe Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 24 UK Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 25 UK Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 26 UK Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 27 Germany Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 28 Germany Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 29 Germany Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 30 France Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 31 France Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 32 France Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 33 Italy Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 34 Italy Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 35 Italy Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 36 Spain Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 37 Spain Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 38 Spain Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 39 Denmark Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 40 Denmark Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 41 Denmark Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 42 Sweden Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 43 Sweden Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 44 Sweden Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 45 Norway Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 46 Norway Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 47 Norway Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 48 Asia Pacific Medical Device Regulatory Affairs market, by country, 2018 - 2030 (USD Million)
• Table 49 Asia Pacific Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 50 Asia Pacific Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 51 Asia Pacific Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 52 Japan Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 53 Japan Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 54 Japan Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 55 China Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 56 China Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 57 China Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 58 India Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 59 India Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 60 India Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 61 Australia Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 62 Australia Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 63 Australia Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 64 Thailand Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 65 Thailand Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 66 Thailand Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 67 South Korea Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 68 South Korea Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 69 South Korea Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 70 Latin America Medical Device Regulatory Affairs market, by country, 2018 - 2030 (USD Million)
• Table 71 Latin America Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 72 Latin America Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 73 Latin America Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 74 Brazil Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 75 Brazil Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 76 Brazil Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 77 Mexico Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 78 Mexico Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 79 Mexico Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 80 Argentina Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 81 Argentina Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 82 Argentina Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 83 Colombia Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 84 Colombia Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 85 Colombia Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 86 Middle East & Africa Medical Device Regulatory Affairs market, by country, 2018 - 2030 (USD Million)
• Table 87 Middle East & Africa Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 88 Middle East & Africa Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 89 Middle East & Africa Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 90 South Africa Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 91 South Africa Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 92 South Africa Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 93 Saudi Arabia Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 94 Saudi Arabia Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 95 Saudi Arabia Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 96 UAE Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 97 UAE Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 98 UAE Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)
• Table 99 Kuwait Medical Device Regulatory Affairs market, by services, 2018 - 2030 (USD Million)
• Table 100 Kuwait Medical Device Regulatory Affairs market, by type, 2018 - 2030 (USD Million)
• Table 101 Kuwait Medical Device Regulatory Affairs market, by service provider, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Medical Device Regulatory Affairs market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Market formulation & validation
• Fig. 7 Commodity flow analysis
• Fig. 8 Value-chain-based sizing & forecasting
• Fig. 9 QFD model sizing & forecasting
• Fig. 10 Bottom-up approach
• Fig. 11 Market snapshot
• Fig. 12 Segment snapshot 1
• Fig. 13 Segment snapshot 2
• Fig. 14 Competitive landscape snapshot
• Fig. 15 Parent market outlook, 2023 (USD Billion)
• Fig. 16 Ancillary market outlook, 2023 (USD Billion)
• Fig. 17 Medical Device Regulatory Affairs market dynamics
• Fig. 18 Porter's five forces analysis
• Fig. 19 PESTEL analysis
• Fig. 20 Medical Device Regulatory Affairs market: Service outlook and key takeaways
• Fig. 21 Medical Device Regulatory Affairs market: Service movement analysis
• Fig. 22 Regulatory consulting market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 23 Legal representation market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 24 Regulatory writing & publishing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 25 Product registration & clinical trial applications market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 26 Other services market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 27 Medical Device Regulatory Affairs market: Type outlook and key takeaways
• Fig. 28 Medical Device Regulatory Affairs market: Type movement analysis
• Fig. 29 Diagnostics market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 30 Therapeutics market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 31 Medical Device Regulatory Affairs market: Service provider outlook and key takeaways
• Fig. 32 Medical Device Regulatory Affairs market: Service provider movement analysis
• Fig. 33 Inhouse market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 34 Outsource market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 35 Regional Marketplace: Key Takeaways
• Fig. 36 North America Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 37 Key country dynamics
• Fig. 38 U.S. Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 39 Key country dynamics
• Fig. 40 Canada Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 41 Mexico Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 42 Europe Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 43 Key country dynamics
• Fig. 44 UK Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 45 Key country dynamics
• Fig. 46 Germany Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 47 Key country dynamics
• Fig. 48 France Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 49 Key country dynamics
• Fig. 50 Italy Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 51 Key country dynamics
• Fig. 52 Spain Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 53 Key country dynamics
• Fig. 54 Denmark Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 55 Key country dynamics
• Fig. 56 Sweden Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 57 Key country dynamics
• Fig. 58 Norway Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 59 Asia Pacific Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 60 Key country dynamics
• Fig. 61 Japan Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 62 Key country dynamics
• Fig. 63 China Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 64 Key country dynamics
• Fig. 65 India Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 66 Key country dynamics
• Fig. 67 Australia Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 68 Key country dynamics
• Fig. 69 Thailand Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 70 Key country dynamics
• Fig. 71 South Korea Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 72 Latin America Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 73 Key country dynamics
• Fig. 74 Brazil Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 75 Key country dynamics
• Fig. 76 Argentina Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 77 Key country dynamics
• Fig. 78 Colombia Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 79 MEA Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 80 Key country dynamics
• Fig. 81 South Africa Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 82 Fig. Key country dynamics
• Fig. 83 Saudi Arabia Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 84 Key country dynamics
• Fig. 85 UAE Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 86 Key country dynamics
• Fig. 87 Kuwait Medical Device Regulatory Affairs market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 88 Key company categorization
• Fig. 89 Service heat map analysis
• Fig. 90 Strategic framework

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