Medical Device Regulatory Affairs Market - Global Industry Analysis

Medical Device Regulatory Affairs Market - By Service (Legal Representation and Regulatory Consulting), By Type (Diagnostics and Therapeutics), And By Region- Global Industry Perspective, Comprehensive Analysis, and Forecast, 2021 – 2028

Published Date: 08-Jul-2021 Category: Medical Device Report Format : PDF Pages: 130 Report Code: ZMR-6457 Status : Published

The global Medical Device Regulatory Affairs market accrued earnings worth approximately 5.1(USD Billion) in 2020 and is predicted to gain revenue of about 13.1(USD Billion) by 2028, is set to record a CAGR of nearly 8.7% over the period from 2021 to 2028.

Description

worth approximately 5.1(USD Billion) in 2020 and is predicted to gain revenue of about 13.1(USD Billion) by 2028, is set to record a CAGR of nearly 8.7% over the period from 2021 to 2028. The report offers assessment and analysis of the Medical Device Regulatory Affairs market on a global and regional level. The study offers a comprehensive assessment of the market competition, constraints, revenue estimates, opportunities, evolving trends, and industry-validated data. The report provides historical data from 2018 to 2020 along with a forecast from 2021 to 2028 based on revenue (USD Billion).

Report Scope :

Report Attribute Details
Base Year 2020
Historic Years 2016 - 2020
Forecast Years 2021 - 2028
Segments Covered By Product Type, By Application, and By End Use
Forecast Units Value (USD Billion), and Volume (Units)
Quantitative Units Revenue in USD million/billion and CAGR from 2021 to 2028
Regions Covered North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, and Rest of World
Countries Covered U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, China, India, Japan, South Korea, Brazil, Argentina, GCC Countries, and South Africa, among others
Number of Companies Covered 10 companies with scope for including additional 15 companies upon request
Report Coverage Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, market attractiveness analysis by segments and region, company market share analysis, and COVID-19 impact analysis.
Customization Scope Avail customized purchase options to meet your exact research needs.

Medical Device Regulatory Affairs Market: Overview

Medical device sector plays a core role in healthcare ecosystem by offering new solutions enhancing patient outcomes. Every firm needs to innovate by using iterative upgradation to current technology or developing new equipment that will provide proficient treatment to a particular ailment. With product developers trying to bring new idea or solution to reality, the regulatory affairs service providers play a key part by guiding team on particular legislations for ensuring that the medical device can be marketed legally. Moreover, regulatory affairs solution providers also advise product team as to how varied kinds of decisions impact kind of regulatory submissions along with their deadlines.  

Moreover, for products that are distributed globally, regulatory affairs co-ordinate with regional teams and ensure that the product possess global regulatory strategy. For maintaining effectiveness of medical device, it is necessary for regulatory affair professional for understanding global regulatory needs of medical equipment along with assuring that product development team takes into consideration global needs of product post testing & validation.

Medical Device Regulatory Affairs Market: Growth Drivers

Escalating demand for fast approval method, shifting regulations, and swiftly expanding domains like diagnostics & therapeutics will steer growth of medical device regulatory affairs market in the years ahead. Apart from this, favorable government schemes and growing complexity of medical equipment will embellish business space over the years to come. Growing cybersecurity threats and fiscal impact of data violations on sale of medical devices are making medical device producers accept strategies to safeguard their products, thereby driving market trends. Furthermore, occurrence of various kinds of chronic disorders like heart ailments, diabetes, cancer, and respiratory issues will open new vistas of growth for medical device regulatory affairs industry over the forthcoming years.

In addition to this, AI and machine learning tools help in extracting large amount of data at time of delivering healthcare services. With massive demand for personal protective equipment kits and ventilators due to large spread of COVID 19 pandemic, market for medical device regulatory affairs is anticipated to gain traction in the years ahead.

Global Medical Device Regulatory Affairs Market

Regional Landscape

Asia Pacific To Make Notable Contributions Towards Overall Market Size By 2028

The expansion of medical device regulatory affairs market in Asia Pacific over forecast timespan is due to massively evolved regulatory tools in countries such as Japan and Australia. Furthermore, supportive government policies for increasing FDAs and need for increasing approval of new products will steer regional market growth. In addition to this, necessity of relaxing laws related to procurement control will drive regional industry trends.

Competitive Landscape

Key players profiled in the study include Integer Holdings, ICON Plc, Medpace, Emergo, IQVIA Holdings, Intertek Plc, Covance, Promedica International, Freyr, and SGS SA.

The global Medical Device Regulatory Affairs Market is segmented as follows:

By Service

  • Legal Representation
  • Regulatory Consulting

By Type

  • Diagnostics
  • Therapeutics

By Region

  • North America
    • The U.S.
    • Canada
  • Europe
    • France
    • The UK
    • Spain
    • Germany
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Southeast Asia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa

Table Of Content

  • Chapter 1. Preface
    • 1.1. Report Description and Scope
    • 1.2. Research Scope
    • 1.3. Research Methodology
      • 1.3.1. Market Research Type
      • 1.3.2. Market Research Methodology
  • Chapter 2. Executive Summary
    • 2.1. Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
    • 2.2. Medical Device Regulatory Affairs Market: Snapshot
  • Chapter 3. Global Medical Device Regulatory Affairs Market– Industry Analysis
    • 3.1. Medical Device Regulatory Affairs Market: Market Dynamics
    • 3.2. Market Drivers
      • 3.2.1. Burgeoning demand for fast approval method, shifting laws, and rapidly expanding domains like diagnostics & therapeutics will prop up growth of medical device regulatory affairs market in the years ahead.
      • 3.2.2. Supportive government schemes and growing complexity of medical instrument will foster business growth in the years to come.
    • 3.3. Porter’s Five Forces Analysis
    • 3.4. Market Attractiveness Analysis
      • 3.4.1. Market attractiveness analysis By Service
      • 3.4.2. Market attractiveness analysis By Type
  • Chapter 4. Global Medical Device Regulatory Affairs Market– Competitive Landscape
    • 4.1. Company market share analysis
      • 4.1.1. Global Medical Device Regulatory Affairs Market: company market share, 2019
    • 4.2. Strategic development
      • 4.2.1. Acquisitions & mergers
      • 4.2.2. New Service launches
      • 4.2.3. Agreements, partnerships, cullaborations, and joint ventures
      • 4.2.4. Research and development and Regional expansion
    • 4.3. Price trend analysis
  • Chapter 5. Global Medical Device Regulatory Affairs Market– Service Analysis
    • 5.1. Global Medical Device Regulatory Affairs Market overview: By Service
      • 5.1.1. Global Medical Device Regulatory Affairs Market share, By Service, 2020 and 2028
    • 5.2. Legal Representation
      • 5.2.1. Global Medical Device Regulatory Affairs Market by Legal Representation, 2018–2028(USD Billion)
    • 5.3. Regulatory Consulting
      • 5.3.1. Global Medical Device Regulatory Affairs Market by Regulatory Consulting, 2018–2028(USD Billion)
  • Chapter 6. Global Medical Device Regulatory Affairs Market– Type Analysis
    • 6.1. Global Medical Device Regulatory Affairs Market overview: By Type
      • 6.1.1. Global Medical Device Regulatory Affairs Market share, By Type, 2020 and 2028
    • 6.2. Diagnostics
      • 6.2.1. Global Medical Device Regulatory Affairs Market by Diagnostics, 2018–2028(USD Billion)
    • 6.3. Therapeutics
      • 6.3.1. Global Medical Device Regulatory Affairs Market by Therapeutics, 2018–2028(USD Billion)
  • Chapter 7. Company Profiles
    • 7.1. Integer Huldings
      • 7.1.1. Overview
      • 7.1.2. Financials
      • 7.1.3. Service Portfolio
      • 7.1.4. Business Strategy
      • 7.1.5. Recent Developments
    • 7.2. ICON Plc
      • 7.2.1. Overview
      • 7.2.2. Financials
      • 7.2.3. Service Portfolio
      • 7.2.4. Business Strategy
      • 7.2.5. Recent Developments
    • 7.3. Medpace
      • 7.3.1. Overview
      • 7.3.2. Financials
      • 7.3.3. Service Portfolio
      • 7.3.4. Business Strategy
      • 7.3.5. Recent Development
    • 7.4. Emergo
      • 7.4.1. Overview
      • 7.4.2. Financials
      • 7.4.3. Service Portfolio
      • 7.4.4. Business Strategy
      • 7.4.5. Recent Development
    • 7.5. IQVIA Huldings
      • 7.5.1. Overview
      • 7.5.2. Financials
      • 7.5.3. Service Portfolio
      • 7.5.4. Business Strategy
      • 7.5.5. Recent Development
    • 7.6. Intertek Plc
      • 7.6.1. Overview
      • 7.6.2. Financials
      • 7.6.3. Service Portfolio
      • 7.6.4. Business Strategy
      • 7.6.5. Recent Development
    • 7.7. Covance
      • 7.7.1. Overview
      • 7.7.2. Financials
      • 7.7.3. Service Portfolio
      • 7.7.4. Business Strategy
      • 7.7.5. Recent Development
    • 7.8. Promedica International
      • 7.8.1. Overview
      • 7.8.2. Financials
      • 7.8.3. Service Portfolio
      • 7.8.4. Business Strategy
      • 7.8.5. Recent Development
    • 7.9. Freyr
      • 7.9.1. Overview
      • 7.9.2. Financials
      • 7.9.3. Service Portfolio
      • 7.9.4. Business Strategy
      • 7.9.5. Recent Development
    • 7.10. SGS SA
      • 7.10.1. Overview
      • 7.10.2. Financials
      • 7.10.3. Service Portfolio
      • 7.10.4. Business Strategy
      • 7.10.5. Recent Development

Table Of Figures

List of Figures

1. Market research Type
2. Market research methodology
3. Global Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
4. Porter’s Five Forces Analysis
5. Global Medical Device Regulatory Affairs Marketattractiveness, By Service
6. Global Medical Device Regulatory Affairs Marketattractiveness, By Type
7. Global Medical Device Regulatory Affairs Marketshare by Service ,2020 and 2028 (USD Billion)
8. Global Medical Device Regulatory Affairs Marketby Legal Representation, 2018–2028(USD Billion)
9. Global Medical Device Regulatory Affairs Marketby Regulatory Consulting, 2018–2028(USD Billion)
10. Global Medical Device Regulatory Affairs Marketshare by Type ,2020 and 2028 (USD Billion)
11. Global Medical Device Regulatory Affairs Marketby Diagnostics, 2018–2028(USD Billion)
12. Global Medical Device Regulatory Affairs Marketby Therapeutics, 2018–2028(USD Billion)
13. Global Medical Device Regulatory Affairs Marketshare, by Region, 2020 and 2028
14. North America Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
15. Europe Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
16. Asia Pacific Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
17. Latin America Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
18. The Middle East and Africa Medical Device Regulatory Affairs Market, 2018–2028(USD Billion)
 


Table Of Tables

List of Tables

1. Global Medical Device Regulatory Affairs Market: snapshot
2. Drivers of the Medical Device Regulatory Affairs Market: impact analysis
3. North America Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
4. North America Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
5. The U.S. Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
6. The U.S. Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
7. Rest of North America Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
8. Rest of North America Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
9. Europe Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
10. Europe Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
11. UK Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
12. UK Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
13. France Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
14. France Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
15. Germany Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
16. Germany Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
17. Rest of Europe Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
18. Rest of Europe Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
19. Asia Pacific Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
20. Asia Pacific Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
21. China Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
22. China Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
23. Japan Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
24. Japan Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
25. India Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
26. India Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
27. Rest of Asia Pacific Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
28. Rest of Asia Pacific Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
29. Latin America Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
30. Latin America Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
31. Brazil Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
32. Brazil Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
33. Rest of Latin America Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
34. Rest of Latin  America Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
35. The Middle East and Africa Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
36. The Middle East and Africa Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
37. Saudi Arabia Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
38. Saudi Arabia Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
39. South Africa Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
40. South Africa Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)
41. Rest of the Middle East & Africa Medical Device Regulatory Affairs Market revenue, By Service  ,2018–2028(USD Billion)
42. Rest of the Middle East & Africa Medical Device Regulatory Affairs Market revenue, By Type  ,2018–2028(USD Billion)


 
 

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FrequentlyAsked Questions

Escalating demand for fast approval method, shifting regulations, and swiftly expanding domains like diagnostics & therapeutics will steer growth of medical device regulatory affairs market in the years ahead. Apart from this, favorable government schemes and growing complexity of medical equipment will embellish business space over the years to come. Growing cybersecurity threats and fiscal impact of data violations on sale of medical devices are making medical device producers accept strategies to safeguard their products, thereby driving market trends. Furthermore, occurrence of various kinds of chronic disorders like heart ailments, diabetes, cancer, and respiratory issues will open new vistas of growth for medical device regulatory affairs industry over the forthcoming years.

In addition to this, AI and machine learning tools help in extracting large amount of data at time of delivering healthcare services. With massive demand for personal protective equipment kits and ventilators due to large spread of COVID 19 pandemic, market for medical device regulatory affairs is anticipated to gain traction in the years ahead.

 

According to Zion market research report, the global Medical Device Regulatory Affairs market accrued earnings worth approximately 5.1(USD Billion) in 2020 and is predicted to gain revenue of about 13.1(USD Billion) by 2028, is set to record a CAGR of nearly 8.7% over the period from 2021 to 2028.

Asia Pacific will contribute lucratively towards the global market size over the estimated timeline. The regional market surge is due to massively evolved regulatory tools in countries such as Japan and Australia. Furthermore, supportive government policies for increasing FDAs and need for increasing approval of new products will steer regional market growth. In addition to this, necessity of relaxing laws related to procurement control will drive regional industry trends.

The key market participants include Integer Holdings, ICON Plc, Medpace, Emergo, IQVIA Holdings, Intertek Plc, Covance, Promedica International, Freyr, and SGS SA.

 

 

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