查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
医疗器械法规事务市场规模、份额和趋势分析报告：按服务（法规撰写和出版、法律代表）、类型、服务提供商、地区、细分市场预测，2023-2030 年
市场调查报告书
商品编码
1178599

医疗器械法规事务市场规模、份额和趋势分析报告：按服务（法规撰写和出版、法律代表）、类型、服务提供商、地区、细分市场预测，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个工作天内

价格

医疗器械监管事务市场增长和趋势

根据 Grand View Research, Inc. 的最新报告，到 2030 年，全球医疗器械法规事务市场预计将达到 121 亿美元。 从 2023 年到 2030 年，该市场预计将以 10.1% 的复合年增长率增长。 人工智能和机器学习等医疗设备的技术进步、小型便携式设备的增长趋势以及政府对医疗设备的严格监管推动了市场的发展。

医疗器械监管是一个广阔且瞬息万变的领域，通常因法律挑战而变得复杂。 即使在单一的监管框架内，法律术语及其定义也不总是一致的。 随着技术的发展，软件、机器学习和算法正在成为越来越多的数字健康资源的组成部分。 因此，更多的设备属于监管框架，带来了新的挑战。

医疗设备公司必须应对不断变化的监管要求，这些变化可能因业务活动和地理位置而异。 不遵守不断变化的监管要求可能会导致处罚、延误和收入损失。 根据 Genpact 赞助的一项调查，72.0% 的生命科学行业高管将合规性视为他们面临的三大挑战之一。 这些因素可能会进一步支持对这些服务的需求。

世界各地的公共机构提供资金以推进医疗保健研究和开发。 例如，2022 年 3 月，英国政府将提供超过 1.88 亿美元，用于支持 NHS 主导的诊断□□和治疗健康研究。 展望未来，随着新医疗器械的推出预计会增加，这些投资将为医疗器械监管服务创造机会。 预计此类活动将在预测期内支撑市场。

医疗器械监管事务市场报告要点

2022 年，监管写作和出版行业以 36.6% 的最大收入份额占据市场主导地位。 这是由于越来越多的临床试验、政府的支持以及对快速将产品推向市场的需求不断增长。

由于发达国家技术进步带来的设备需求增加，2022年处理领域将占据55.6%的较大市场份额

外包这些服务的需求很大。 因此，该细分市场将在 2022 年贡献全球市场的 57.0%。 这主要是由于内部产能短缺和世界各地不断变化的医疗器械法规。

亚太地区主导市场，占 2022 年收入份额的 37.5%。 这主要是由于印度的医疗器械市场不断扩大，原因是健康意识的提高、中产阶级的崛起、政府的卫生政策等。

内容

第1章调查方法及范围

  • 市场细分和范围
    • 服务
    • 类型
    • 服务提供商
    • 区域范围
  • 调查方法
  • 信息采购
    • 购买的数据库
    • GVR 内部数据库
    • 次要信息
    • 初步调查
  • 信息或数据分析
    • 数据分析模型
  • 市场製定和验证
  • 模型详细信息
    • 商品流分析（模型 1）
  • 二级信息列表
  • 主要信息列表
  • 目的

第 2 章执行摘要

  • 市场前景

第 3 章医疗器械监管事务市场变量、趋势和范围

  • 市场系列展望
    • 母公司市场展望
    • 相关/子公司市场前景
  • 描绘渗透率和增长前景
  • 市场动态
    • 市场驱动因素分析
      • 监管环境的变化
      • 公司进入全球市场
      • 专注于核心竞争力的生命科学公司
      • 经济和竞争压力
      • 要求加快突破性药物和器械的审批流程
      • 个性化医疗、生物仿製药和孤儿药等新兴领域的发展
    • 市场製约因素分析
      • 与数据安全相关的风险
      • 监控问题和缺乏标准化
    • 行业分析 - 波特五力模型
    • PESTLE 分析
    • COVID-19 的影响和恢復分析

第 4 章医疗器械监管事务市场：服务细分分析

  • 医疗器械监管事务市场：定义和范围
  • 医疗器械监管事务市场：服务市场份额分析，2022 年和 2030 年
  • 监管咨询
  • 法定代表人
  • 监管写作和出版
  • 产品註册和临床试验申请
  • 其他受监管的服务

第 5 章医疗器械监管事务市场：类型细分分析

  • 医疗器械监管事务市场：定义和范围
  • 医疗器械监管事务市场：类型市场份额分析，2022 年和 2030 年
  • 诊断
  • 治疗

第 6 章医疗器械监管事务市场：服务提供商细分分析

  • 医疗器械监管事务市场：定义和范围
  • 医疗器械监管事务市场：服务提供商市场份额分析，2022 年和 2030 年
  • 外包
  • 内部

第 7 章医疗器械监管事务市场：区域分析

  • 医疗器械监管事务：区域市场份额分析，2022 年和 2030 年
  • 北美
    • 美国
    • 加拿大
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 意大利
    • 西班牙
    • 丹麦
    • 瑞典
    • 挪威
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 韩国
    • 澳大利亚
    • 泰国
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
  • 多边环境协定
    • 南非
    • 沙特阿拉伯
    • 阿拉伯联合酋长国
    • 科威特

第8章竞争格局

  • 市场份额分析
  • 参与公司
  • 近期发展和影响分析

第9章公司简介

  • 公司简介
  • 财务业绩
  • 战略举措
    • 分机
    • 伙伴关係和协作
    • 收购
      • 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)