Global Medical Device Regulatory Affairs Outsourcing Market to 2032

Overview

The Global Medical Device Regulatory Affairs Outsourcing Market is expected to reach a 19,332.64 USD Billion by 2032 and is projected to grow at a CAGR of 12.81% from 2025 to 2032.

Revenue, 2024 (USD Billion)
7,275.33
Forecast, 2032 (USD Billion)
19,332.64
CAGR, 2024 - 2032
12.81%
Report Coverage
Global

Global Medical Device Regulatory Affairs Outsourcing Market 2018-2032 USD Billion

Global Medical Device Regulatory Affairs Outsourcing Market, Key Findings (2025-2032)

Market Growth and Projections:

  • Market Size (2024): 7,275.33 USD Billion
  • Projected Market Size (2032): 19,332.64 USD Billion
  • CAGR (2025-2032): 12.81%

Key Findings of Global Medical Device Regulatory Affairs Outsourcing Market

  • The Global Medical Device Regulatory Affairs Outsourcing Market was valued at 19,332.64 USD Billion in 2024.
  • The Global Medical Device Regulatory Affairs Outsourcing Market is likely to grow at a CAGR of 12.81% during the forecast period of 2024 to 2032.
  • In 2024, the Largest segment Regulatory Affairs Services in Services Segment accounted for the largest share of the market with a revenue of 4,635.77 USD Billion
  • The fastest growing segment Cardiology in Application Segment grew Fastest with a CAGR of 17.50% during the forecast period from 2024 to 2032.

Global Medical Device Regulatory Affairs Outsourcing Market Scope

Global Medical Device Regulatory Affairs Outsourcing Market Segmentation & Scope
Application
  • Diabetes Care
  • Endoscopy
  • Dental
  • Drug Delivery
  • Others
  • Opthalmic
  • Diagnostic Imaging
  • General and Plastic Surgery
  • Orthopedic
  • IVD
  • Cardiology
Device Type
  • Class III
  • Class II
  • Class I
Services
  • Medical Writing
  • Quality Consulting
  • Regulatory Affairs Services
Product
  • Raw Materials
  • Electronics
  • Finished Goods
End User
  • Large Medical Device Company
  • Small Medical Device Company
  • Medium Medical Device Company

Global Medical Device Regulatory Affairs Outsourcing Market Data Coverage Insights

Study Period 2024-2032
Base Year 2020
Unit Revenue in USD Billion
Market Value in 2024 7,275.33 USD Billion
Market Value in 2032 19,332.64 USD Billion
CAGR (2025-2032) 12.81%
Historic Data 2016-2023
Market Segments Covered Application,Device Type,Services,Product,End User

Regional Insights:

  • Leading Market (2024-2032): Global, leading in terms of revenue 7,275.33 USD Billion in 2024
    • Key Country: U.S., leading in terms of revenue with value of 2,155.21 USD Billion in 2024.

Segments and Scope

  • Global Medical Device Regulatory Affairs Outsourcing Market to 2032, By Application
    • Cardiology is the largest segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a revenue of 1,730.33 USD Billion in the year 2024.
    • Cardiology is the Fastest growing segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 17.50 % in forecast period 2025-2032.
  • Global Medical Device Regulatory Affairs Outsourcing Market to 2032, By Device Type
    • Class I is the largest segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a revenue of 3,244.76 USD Billion in the year 2024.
    • Class I is the Fastest growing segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 15.29 % in forecast period 2025-2032.
  • Global Medical Device Regulatory Affairs Outsourcing Market to 2032, By Services
    • Regulatory Affairs Services is the largest segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a revenue of 4,635.77 USD Billion in the year 2024.
    • Regulatory Affairs Services is the Fastest growing segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 13.69 % in forecast period 2025-2032.
  • Global Medical Device Regulatory Affairs Outsourcing Market to 2032, By Product
    • Finished Goods is the largest segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a revenue of 3,456.38 USD Billion in the year 2024.
    • Finished Goods is the Fastest growing segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 15.01 % in forecast period 2025-2032.
  • Global Medical Device Regulatory Affairs Outsourcing Market to 2032, By End User
    • Medium Medical Device Company is the largest segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a revenue of 3,629.86 USD Billion in the year 2024.
    • Medium Medical Device Company is the Fastest growing segment in Global Medical Device Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 14.75 % in forecast period 2025-2032.

Global Medical Device Regulatory Affairs Outsourcing Market Company Share Analysis

 
Company Name Company Share Analysis
Parexel International Corporation
North American Science Associates, LLC
Integer Holdings Corporation
Labcorp Drug Development
TÜV SÜD
Global Medical Device Regulatory Affairs Outsourcing Market Company Share Analysis

Global Medical Device Regulatory Affairs Outsourcing Market Geographical Sales Distribution, 2018-2032 USD Billion

Global Medical Device Regulatory Affairs Outsourcing Market Geographical Sales Distribution, 2018-2032 USD Billion

Global Medical Device Regulatory Affairs Outsourcing Market Company Profiling

Global Medical Device Regulatory Affairs Outsourcing Market Company Profiling
Frequently Asked Questions
The Global Medical Device Regulatory Affairs Outsourcing Market is segmented based on Segmentation Application,Device Type,Services,Product,End User.
Global Medical Device Regulatory Affairs Outsourcing Market was valued at USD 7,275.33(Revenue in USD Billion) in 2020.
Global Medical Device Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of 12.81% during the forecast period of 2024 to 2032.
The Regulatory Affairs Services segment is expected to dominate the Global Medical Device Regulatory Affairs Outsourcing Market, holding a largest market share of 4,635.77 USD Billion in 2024

Global Medical Device Regulatory Affairs Outsourcing Market Scope

Global Medical Device Regulatory Affairs Outsourcing Market Segmentation & Scope
Application
  • Diabetes Care
  • Endoscopy
  • Dental
  • Drug Delivery
  • Others
  • Opthalmic
  • Diagnostic Imaging
  • General and Plastic Surgery
  • Orthopedic
  • IVD
  • Cardiology
Device Type
  • Class III
  • Class II
  • Class I
Services
  • Medical Writing
  • Quality Consulting
  • Regulatory Affairs Services
Product
  • Raw Materials
  • Electronics
  • Finished Goods
End User
  • Large Medical Device Company
  • Small Medical Device Company
  • Medium Medical Device Company
Frequently Asked Questions
The Global Medical Device Regulatory Affairs Outsourcing Market is segmented based on Segmentation Application,Device Type,Services,Product,End User.
Global Medical Device Regulatory Affairs Outsourcing Market was valued at USD 7,275.33(Revenue in USD Billion) in 2020.
Global Medical Device Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of 12.81% during the forecast period of 2024 to 2032.
The estimated market value of the Global Medical Device Regulatory Affairs Outsourcing Market for final year is USD 19,332.64 (USD Billion).

Global Medical Device Regulatory Affairs Outsourcing Market Company Profiling

Global Medical Device Regulatory Affairs Outsourcing Market Company Profiling
Frequently Asked Questions
The Global Medical Device Regulatory Affairs Outsourcing Market is segmented based on Segmentation Application,Device Type,Services,Product,End User.
Global Medical Device Regulatory Affairs Outsourcing Market was valued at USD 7,275.33(Revenue in USD Billion) in 2020.
Global Medical Device Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of 12.81% during the forecast period of 2024 to 2032.
The estimated market value of the Global Medical Device Regulatory Affairs Outsourcing Market for final year is USD 19,332.64 (USD Billion).

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