Medical Device Affairs Outsourcing Market By Service, By Software, By End User : Global Opportunity Analysis and Industry Forecast, 2021-2031

List of Tables

The global medical device affairs outsourcing market was valued at $4,546.4 million in 2021, and is projected to reach $8,111.02 million by 2031, registering a CAGR of 6.0% from 2022 to 2031.

The medical affairs is a multi-faceted functional area with activities spread across regulatory affairs, pharmacovigilance, post-marketing studies, and brand sales & marketing. In all stages and at all aspects of a product's lifecycle and commercial processes, medical affairs foster significant value. It helps build a company's scientific & medical credibility, and even enhances their brand reputation. It originally emerged as a reaction to increasing pressures from regulators to separate product development and commercialization functions. Companies were experiencing increasing internal demands to focus the role of development on generating and developing new products rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure shifted a number of commercial activities to people with medical expertise, most often to medical affairs groups.

The global medical device affairs outsourcing market is anticipated to show significant market growth during the forecast period, owing to increase in number of on-going R&D activities, surge in number of clinical studies conducted, and rise in demand for outsourcing regulatory affairs services. Furthermore, the medical device regulatory affairs outsourcing helps to augment the volume of product registrations and clinical trial approvals, which contribute toward the market growth.

However, high cost of clinical trials & product development and change in the regulations regarding medical device in different regions negatively impact the market growth. Conversely, the economic growth in emerging market offers the lucrative opportunities for the growth of the market.

The medical device affairs outsourcing market is segmented on the basis of service, software, end user, and region. By service, the market is classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others. By software, the market is bifurcated into cloud-based software and on-premise software. By end user, the market is categorized into pharmaceutical companies, medical technology companies, and others. Furthermore, the pharmaceutical companies segment is subclassified into large and medium. The medical technology companies segment is further subsegmented into large and medium. Region wise, the market is studied across North America (U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).

The major companies profiled in the report include: Excelya, Icon plc, Indegene Private Limited, Inizio (UDG Healthcare plc.), IQVIA Holdings Inc., Parexel International Corporation, SGS SA, Syneos Health, Inc., Thermo Fisher Scientific, Inc. (PPD Inc.), and Wuxi AppTec.

Key Benefits For Stakeholders

This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the medical device affairs outsourcing market analysis from 2021 to 2031 to identify the prevailing medical device affairs outsourcing market opportunities.
The market research is offered along with information related to key drivers, restraints, and opportunities.
Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
In-depth analysis of the medical device affairs outsourcing market segmentation assists to determine the prevailing market opportunities.
Major countries in each region are mapped according to their revenue contribution to the global market.
Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
The report includes the analysis of the regional as well as global medical device affairs outsourcing market trends, key players, market segments, application areas, and market growth strategies.

Key Market Segments

By Service

Regulatory Writing and Submissions
Regulatory Registration Services
Regulatory Consulting
Others

By Software

Cloud Based Software
On Premise Software

By End User

Pharmaceutical Companies
- Company Size
- Large
- Medium
Medical Technology Companies
- Company Size
- Large
- Medium
Others

By Region

North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest Of Europe
Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest Of Asia-Pacific
LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest Of LAMEA
Key Market Players
- Charles River
- Inizio
- IQVIA Holdings Inc.
- Parexel International Corporation
- SGS SA
- Syneos Health, Inc.
- Thermo Fisher Scientific, Inc.
- Wuxi AppTec
- Excelya
- Icon plc
- Indegene Private Limited

Product Code: A17667

CHAPTER 1:INTRODUCTION

1.1.Report description
1.2.Key market segments
1.3.Key benefits to the stakeholders
1.4.Research Methodology
- 1.4.1.Secondary research
- 1.4.2.Primary research
- 1.4.3.Analyst tools and models

CHAPTER 2:EXECUTIVE SUMMARY

2.1.Key findings of the study
2.2.CXO Perspective

CHAPTER 3:MARKET OVERVIEW

3.1.Market definition and scope
3.2.Key findings
- 3.2.1.Top investment pockets
3.3.Porter's five forces analysis
3.4.Top player positioning
3.5.Market dynamics
- 3.5.1.Drivers
- 3.5.2.Restraints
- 3.5.3.Opportunities
3.6.COVID-19 Impact Analysis on the market

CHAPTER 4: MEDICAL DEVICE AFFAIRS OUTSOURCING MARKET, BY SERVICE

4.1 Overview
- 4.1.1 Market size and forecast
4.2 Regulatory Writing and Submissions
- 4.2.1 Key market trends, growth factors and opportunities
- 4.2.2 Market size and forecast, by region
- 4.2.3 Market analysis by country
4.3 Regulatory Registration Services
- 4.3.1 Key market trends, growth factors and opportunities
- 4.3.2 Market size and forecast, by region
- 4.3.3 Market analysis by country
4.4 Regulatory Consulting
- 4.4.1 Key market trends, growth factors and opportunities
- 4.4.2 Market size and forecast, by region
- 4.4.3 Market analysis by country
4.5 Others
- 4.5.1 Key market trends, growth factors and opportunities
- 4.5.2 Market size and forecast, by region
- 4.5.3 Market analysis by country

CHAPTER 5: MEDICAL DEVICE AFFAIRS OUTSOURCING MARKET, BY SOFTWARE

5.1 Overview
- 5.1.1 Market size and forecast
5.2 Cloud Based Software
- 5.2.1 Key market trends, growth factors and opportunities
- 5.2.2 Market size and forecast, by region
- 5.2.3 Market analysis by country
5.3 On Premise Software
- 5.3.1 Key market trends, growth factors and opportunities
- 5.3.2 Market size and forecast, by region
- 5.3.3 Market analysis by country

CHAPTER 6: MEDICAL DEVICE AFFAIRS OUTSOURCING MARKET, BY END USER

6.1 Overview
- 6.1.1 Market size and forecast
6.2 Pharmaceutical Companies
- 6.2.1 Key market trends, growth factors and opportunities
- 6.2.2 Market size and forecast, by region
- 6.2.3 Market analysis by country
- 6.2.4 Pharmaceutical Companies Medical Device Affairs Outsourcing Market by Company Size
  - 6.2.4.1 Large Market size and forecast, by region
  - 6.2.4.2 Medium Market size and forecast, by region
6.3 Medical Technology Companies
- 6.3.1 Key market trends, growth factors and opportunities
- 6.3.2 Market size and forecast, by region
- 6.3.3 Market analysis by country
- 6.3.4 Medical Technology Companies Medical Device Affairs Outsourcing Market by Company Size
  - 6.3.4.1 Large Market size and forecast, by region
  - 6.3.4.2 Medium Market size and forecast, by region
6.4 Others
- 6.4.1 Key market trends, growth factors and opportunities
- 6.4.2 Market size and forecast, by region
- 6.4.3 Market analysis by country

CHAPTER 7: MEDICAL DEVICE AFFAIRS OUTSOURCING MARKET, BY REGION

7.1 Overview
- 7.1.1 Market size and forecast
7.2 North America
- 7.2.1 Key trends and opportunities
- 7.2.2 North America Market size and forecast, by Service
- 7.2.3 North America Market size and forecast, by Software
- 7.2.4 North America Market size and forecast, by End User
  - 7.2.4.1 North America Pharmaceutical Companies Medical Device Affairs Outsourcing Market by Company Size
  - 7.2.4.2 North America Medical Technology Companies Medical Device Affairs Outsourcing Market by Company Size
- 7.2.5 North America Market size and forecast, by country
  - 7.2.5.1 U.S.
  - 7.2.5.1.1 Market size and forecast, by Service
  - 7.2.5.1.2 Market size and forecast, by Software
  - 7.2.5.1.3 Market size and forecast, by End User
  - 7.2.5.2 Canada
  - 7.2.5.2.1 Market size and forecast, by Service
  - 7.2.5.2.2 Market size and forecast, by Software
  - 7.2.5.2.3 Market size and forecast, by End User
  - 7.2.5.3 Mexico
  - 7.2.5.3.1 Market size and forecast, by Service
  - 7.2.5.3.2 Market size and forecast, by Software
  - 7.2.5.3.3 Market size and forecast, by End User
7.3 Europe
- 7.3.1 Key trends and opportunities
- 7.3.2 Europe Market size and forecast, by Service
- 7.3.3 Europe Market size and forecast, by Software
- 7.3.4 Europe Market size and forecast, by End User
  - 7.3.4.1 Europe Pharmaceutical Companies Medical Device Affairs Outsourcing Market by Company Size
  - 7.3.4.2 Europe Medical Technology Companies Medical Device Affairs Outsourcing Market by Company Size
- 7.3.5 Europe Market size and forecast, by country
  - 7.3.5.1 Germany
  - 7.3.5.1.1 Market size and forecast, by Service
  - 7.3.5.1.2 Market size and forecast, by Software
  - 7.3.5.1.3 Market size and forecast, by End User
  - 7.3.5.2 France
  - 7.3.5.2.1 Market size and forecast, by Service
  - 7.3.5.2.2 Market size and forecast, by Software
  - 7.3.5.2.3 Market size and forecast, by End User
  - 7.3.5.3 UK
  - 7.3.5.3.1 Market size and forecast, by Service
  - 7.3.5.3.2 Market size and forecast, by Software
  - 7.3.5.3.3 Market size and forecast, by End User
  - 7.3.5.4 Italy
  - 7.3.5.4.1 Market size and forecast, by Service
  - 7.3.5.4.2 Market size and forecast, by Software
  - 7.3.5.4.3 Market size and forecast, by End User
  - 7.3.5.5 Spain
  - 7.3.5.5.1 Market size and forecast, by Service
  - 7.3.5.5.2 Market size and forecast, by Software
  - 7.3.5.5.3 Market size and forecast, by End User
  - 7.3.5.6 Rest of Europe
  - 7.3.5.6.1 Market size and forecast, by Service
  - 7.3.5.6.2 Market size and forecast, by Software
  - 7.3.5.6.3 Market size and forecast, by End User
7.4 Asia-Pacific
- 7.4.1 Key trends and opportunities
- 7.4.2 Asia-Pacific Market size and forecast, by Service
- 7.4.3 Asia-Pacific Market size and forecast, by Software
- 7.4.4 Asia-Pacific Market size and forecast, by End User
  - 7.4.4.1 Asia-Pacific Pharmaceutical Companies Medical Device Affairs Outsourcing Market by Company Size
  - 7.4.4.2 Asia-Pacific Medical Technology Companies Medical Device Affairs Outsourcing Market by Company Size
- 7.4.5 Asia-Pacific Market size and forecast, by country
  - 7.4.5.1 China
  - 7.4.5.1.1 Market size and forecast, by Service
  - 7.4.5.1.2 Market size and forecast, by Software
  - 7.4.5.1.3 Market size and forecast, by End User
  - 7.4.5.2 Japan
  - 7.4.5.2.1 Market size and forecast, by Service
  - 7.4.5.2.2 Market size and forecast, by Software
  - 7.4.5.2.3 Market size and forecast, by End User
  - 7.4.5.3 India
  - 7.4.5.3.1 Market size and forecast, by Service
  - 7.4.5.3.2 Market size and forecast, by Software
  - 7.4.5.3.3 Market size and forecast, by End User
  - 7.4.5.4 Australia
  - 7.4.5.4.1 Market size and forecast, by Service
  - 7.4.5.4.2 Market size and forecast, by Software
  - 7.4.5.4.3 Market size and forecast, by End User
  - 7.4.5.5 South Korea
  - 7.4.5.5.1 Market size and forecast, by Service
  - 7.4.5.5.2 Market size and forecast, by Software
  - 7.4.5.5.3 Market size and forecast, by End User
  - 7.4.5.6 Rest of Asia-Pacific
  - 7.4.5.6.1 Market size and forecast, by Service
  - 7.4.5.6.2 Market size and forecast, by Software
  - 7.4.5.6.3 Market size and forecast, by End User
7.5 LAMEA
- 7.5.1 Key trends and opportunities
- 7.5.2 LAMEA Market size and forecast, by Service
- 7.5.3 LAMEA Market size and forecast, by Software
- 7.5.4 LAMEA Market size and forecast, by End User
  - 7.5.4.1 LAMEA Pharmaceutical Companies Medical Device Affairs Outsourcing Market by Company Size
  - 7.5.4.2 LAMEA Medical Technology Companies Medical Device Affairs Outsourcing Market by Company Size
- 7.5.5 LAMEA Market size and forecast, by country
  - 7.5.5.1 Brazil
  - 7.5.5.1.1 Market size and forecast, by Service
  - 7.5.5.1.2 Market size and forecast, by Software
  - 7.5.5.1.3 Market size and forecast, by End User
  - 7.5.5.2 Saudi Arabia
  - 7.5.5.2.1 Market size and forecast, by Service
  - 7.5.5.2.2 Market size and forecast, by Software
  - 7.5.5.2.3 Market size and forecast, by End User
  - 7.5.5.3 South Africa
  - 7.5.5.3.1 Market size and forecast, by Service
  - 7.5.5.3.2 Market size and forecast, by Software
  - 7.5.5.3.3 Market size and forecast, by End User
  - 7.5.5.4 Rest of LAMEA
  - 7.5.5.4.1 Market size and forecast, by Service
  - 7.5.5.4.2 Market size and forecast, by Software
  - 7.5.5.4.3 Market size and forecast, by End User

CHAPTER 8: COMPANY LANDSCAPE

8.1. Introduction
8.2. Top winning strategies
8.3. Product Mapping of Top 10 Player
8.4. Competitive Dashboard
8.5. Competitive Heatmap
8.6. Key developments

CHAPTER 9: COMPANY PROFILES

9.1 Charles River
- 9.1.1 Company overview
- 9.1.2 Company snapshot
- 9.1.3 Operating business segments
- 9.1.4 Product portfolio
- 9.1.5 Business performance
- 9.1.6 Key strategic moves and developments
9.2 Inizio
- 9.2.1 Company overview
- 9.2.2 Company snapshot
- 9.2.3 Operating business segments
- 9.2.4 Product portfolio
- 9.2.5 Business performance
- 9.2.6 Key strategic moves and developments
9.3 IQVIA Holdings Inc.
- 9.3.1 Company overview
- 9.3.2 Company snapshot
- 9.3.3 Operating business segments
- 9.3.4 Product portfolio
- 9.3.5 Business performance
- 9.3.6 Key strategic moves and developments
9.4 Parexel International Corporation
- 9.4.1 Company overview
- 9.4.2 Company snapshot
- 9.4.3 Operating business segments
- 9.4.4 Product portfolio
- 9.4.5 Business performance
- 9.4.6 Key strategic moves and developments
9.5 SGS SA
- 9.5.1 Company overview
- 9.5.2 Company snapshot
- 9.5.3 Operating business segments
- 9.5.4 Product portfolio
- 9.5.5 Business performance
- 9.5.6 Key strategic moves and developments
9.6 Syneos Health, Inc.
- 9.6.1 Company overview
- 9.6.2 Company snapshot
- 9.6.3 Operating business segments
- 9.6.4 Product portfolio
- 9.6.5 Business performance
- 9.6.6 Key strategic moves and developments
9.7 Thermo Fisher Scientific, Inc.
- 9.7.1 Company overview
- 9.7.2 Company snapshot
- 9.7.3 Operating business segments
- 9.7.4 Product portfolio
- 9.7.5 Business performance
- 9.7.6 Key strategic moves and developments
9.8 Wuxi AppTec
- 9.8.1 Company overview
- 9.8.2 Company snapshot
- 9.8.3 Operating business segments
- 9.8.4 Product portfolio
- 9.8.5 Business performance
- 9.8.6 Key strategic moves and developments
9.9 Excelya
- 9.9.1 Company overview
- 9.9.2 Company snapshot
- 9.9.3 Operating business segments
- 9.9.4 Product portfolio
- 9.9.5 Business performance
- 9.9.6 Key strategic moves and developments
9.10 Icon plc
- 9.10.1 Company overview
- 9.10.2 Company snapshot
- 9.10.3 Operating business segments
- 9.10.4 Product portfolio
- 9.10.5 Business performance
- 9.10.6 Key strategic moves and developments
9.11 Indegene Private Limited
- 9.11.1 Company overview
- 9.11.2 Company snapshot
- 9.11.3 Operating business segments
- 9.11.4 Product portfolio
- 9.11.5 Business performance
- 9.11.6 Key strategic moves and developments