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醫療器械法規事務市場規模、份額和趨勢分析報告：按服務（法規撰寫和出版、法律代表）、類型、服務提供商、地區、細分市場預測，2023-2030 年
市場調查報告書
商品編碼
1178599

醫療器械法規事務市場規模、份額和趨勢分析報告：按服務（法規撰寫和出版、法律代表）、類型、服務提供商、地區、細分市場預測，2023-2030 年

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
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10個工作天內

價格

醫療器械監管事務市場增長和趨勢

根據 Grand View Research, Inc. 的最新報告，到 2030 年，全球醫療器械法規事務市場預計將達到 121 億美元。 從 2023 年到 2030 年，該市場預計將以 10.1% 的複合年增長率增長。 人工智能和機器學習等醫療設備的技術進步、小型便攜式設備的增長趨勢以及政府對醫療設備的嚴格監管推動了市場的發展。

醫療器械監管是一個廣闊且瞬息萬變的領域，通常因法律挑戰而變得複雜。 即使在單一的監管框架內，法律術語及其定義也不總是一致的。 隨著技術的發展，軟件、機器學習和算法正在成為越來越多的數字健康資源的組成部分。 因此，更多的設備屬於監管框架，帶來了新的挑戰。

醫療設備公司必須應對不斷變化的監管要求，這些變化可能因業務活動和地理位置而異。 不遵守不斷變化的監管要求可能會導致處罰、延誤和收入損失。 根據 Genpact 贊助的一項調查，72.0% 的生命科學行業高管將合規性視為他們面臨的三大挑戰之一。 這些因素可能會進一步支持對這些服務的需求。

世界各地的公共機構提供資金以推進醫療保健研究和開發。 例如，2022 年 3 月，英國政府將提供超過 1.88 億美元，用於支持 NHS 主導的診斷□□和治療健康研究。 展望未來，隨著新醫療器械的推出預計會增加，這些投資將為醫療器械監管服務創造機會。 預計此類活動將在預測期內支撐市場。

醫療器械監管事務市場報告要點

2022 年，監管寫作和出版行業以 36.6% 的最大收入份額佔據市場主導地位。 這是由於越來越多的臨床試驗、政府的支持以及對快速將產品推向市場的需求不斷增長。

由於發達國家技術進步帶來的設備需求增加，2022年處理領域將佔據55.6%的較大市場份額

外包這些服務的需求很大。 因此，該細分市場將在 2022 年貢獻全球市場的 57.0%。 這主要是由於內部產能短缺和世界各地不斷變化的醫療器械法規。

亞太地區主導市場，佔 2022 年收入份額的 37.5%。 這主要是由於印度的醫療器械市場不斷擴大，原因是健康意識的提高、中產階級的崛起、政府的衛生政策等。

內容

第1章調查方法及範圍

  • 市場細分和範圍
    • 服務
    • 類型
    • 服務提供商
    • 區域範圍
  • 調查方法
  • 信息採購
    • 購買的數據庫
    • GVR 內部數據庫
    • 次要信息
    • 初步調查
  • 信息或數據分析
    • 數據分析模型
  • 市場製定和驗證
  • 模型詳細信息
    • 商品流分析（模型 1）
  • 二級信息列表
  • 主要信息列表
  • 目的

第 2 章執行摘要

  • 市場前景

第 3 章醫療器械監管事務市場變量、趨勢和範圍

  • 市場系列展望
    • 母公司市場展望
    • 相關/子公司市場前景
  • 描繪滲透率和增長前景
  • 市場動態
    • 市場驅動因素分析
      • 監管環境的變化
      • 公司進入全球市場
      • 專注於核心競爭力的生命科學公司
      • 經濟和競爭壓力
      • 要求加快突破性藥物和器械的審批流程
      • 個性化醫療、生物仿製藥和孤兒藥等新興領域的發展
    • 市場製約因素分析
      • 與數據安全相關的風險
      • 監控問題和缺乏標準化
    • 行業分析 - 波特五力模型
    • PESTLE 分析
    • COVID-19 的影響和恢復分析

第 4 章醫療器械監管事務市場：服務細分分析

  • 醫療器械監管事務市場：定義和範圍
  • 醫療器械監管事務市場：服務市場份額分析，2022 年和 2030 年
  • 監管諮詢
  • 法定代表人
  • 監管寫作和出版
  • 產品註冊和臨床試驗申請
  • 其他受監管的服務

第 5 章醫療器械監管事務市場：類型細分分析

  • 醫療器械監管事務市場：定義和範圍
  • 醫療器械監管事務市場：類型市場份額分析，2022 年和 2030 年
  • 診斷
  • 治療

第 6 章醫療器械監管事務市場：服務提供商細分分析

  • 醫療器械監管事務市場：定義和範圍
  • 醫療器械監管事務市場：服務提供商市場份額分析，2022 年和 2030 年
  • 外包
  • 內部

第 7 章醫療器械監管事務市場：區域分析

  • 醫療器械監管事務：區域市場份額分析，2022 年和 2030 年
  • 北美
    • 美國
    • 加拿大
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 意大利
    • 西班牙
    • 丹麥
    • 瑞典
    • 挪威
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 韓國
    • 澳大利亞
    • 泰國
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
  • 多邊環境協定
    • 南非
    • 沙特阿拉伯
    • 阿拉伯聯合酋長國
    • 科威特

第8章競爭格局

  • 市場份額分析
  • 參與公司
  • 近期發展和影響分析

第9章公司簡介

  • 公司簡介
  • 財務業績
  • 戰略舉措
    • 分機
    • 夥伴關係和協作
    • 收購
      • 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
Product Code: GVR-4-68039-360-4

Medical Device Regulatory Affairs Market Growth & Trends:

The global medical device regulatory affairs market size is expected to reach USD 12.1 billion by 2030, according to a new report by Grand View Research, Inc. 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. 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 Societe Generale 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)