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

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    Report

  • 286 Pages
  • September 2022
  • Region: Global
  • Allied Market Research
  • ID: 5713160
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
Frequently Asked Questions about the Global Medical Device Affairs Outsourcing Market

What is the estimated value of the Global Medical Device Affairs Outsourcing Market?

The Global Medical Device Affairs Outsourcing Market was estimated to be valued at $4546.4 million in 2021.

What is the growth rate of the Global Medical Device Affairs Outsourcing Market?

The growth rate of the Global Medical Device Affairs Outsourcing Market is 6.0%, with an estimated value of $8111.02 million by 2031.

What is the forecasted size of the Global Medical Device Affairs Outsourcing Market?

The Global Medical Device Affairs Outsourcing Market is estimated to be worth $8111.02 million by 2031.

Who are the key companies in the Global Medical Device Affairs Outsourcing Market?

Key companies in the Global Medical Device Affairs Outsourcing Market include Charles River, Inizio, IQVIA Holdings Inc., Parexel International Corporation, SGS SA, Syneos Health, Inc., Thermo Fisher Scientific, Inc., Wuxi AppTec and Icon plc.

Table of Contents

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

List of Tables
Table 1. Global Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 2. Medical Device Affairs Outsourcing Market, for Regulatory Writing and Submissions, by Region, 2021-2031 ($Million)
Table 3. Medical Device Affairs Outsourcing Market for Regulatory Writing and Submissions, by Country, 2021-2031 ($Million)
Table 4. Medical Device Affairs Outsourcing Market, for Regulatory Registration Services, by Region, 2021-2031 ($Million)
Table 5. Medical Device Affairs Outsourcing Market for Regulatory Registration Services, by Country, 2021-2031 ($Million)
Table 6. Medical Device Affairs Outsourcing Market, for Regulatory Consulting, by Region, 2021-2031 ($Million)
Table 7. Medical Device Affairs Outsourcing Market for Regulatory Consulting, by Country, 2021-2031 ($Million)
Table 8. Medical Device Affairs Outsourcing Market, for Others, by Region, 2021-2031 ($Million)
Table 9. Medical Device Affairs Outsourcing Market for Others, by Country, 2021-2031 ($Million)
Table 10. Global Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 11. Medical Device Affairs Outsourcing Market, for Cloud Based Software, by Region, 2021-2031 ($Million)
Table 12. Medical Device Affairs Outsourcing Market for Cloud Based Software, by Country, 2021-2031 ($Million)
Table 13. Medical Device Affairs Outsourcing Market, for on Premise Software, by Region, 2021-2031 ($Million)
Table 14. Medical Device Affairs Outsourcing Market for on Premise Software, by Country, 2021-2031 ($Million)
Table 15. Global Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 16. Medical Device Affairs Outsourcing Market, for Pharmaceutical Companies, by Region, 2021-2031 ($Million)
Table 17. Medical Device Affairs Outsourcing Market for Pharmaceutical Companies, by Country, 2021-2031 ($Million)
Table 18. Global Pharmaceutical Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 19. Medical Device Affairs Outsourcing Market, for Large, by Region, 2021-2031 ($Million)
Table 20. Medical Device Affairs Outsourcing Market, for Medium, by Region, 2021-2031 ($Million)
Table 21. Medical Device Affairs Outsourcing Market, for Medical Technology Companies, by Region, 2021-2031 ($Million)
Table 22. Medical Device Affairs Outsourcing Market for Medical Technology Companies, by Country, 2021-2031 ($Million)
Table 23. Global Medical Technology Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 24. Medical Device Affairs Outsourcing Market, for Large, by Region, 2021-2031 ($Million)
Table 25. Medical Device Affairs Outsourcing Market, for Medium, by Region, 2021-2031 ($Million)
Table 26. Medical Device Affairs Outsourcing Market, for Others, by Region, 2021-2031 ($Million)
Table 27. Medical Device Affairs Outsourcing Market for Others, by Country, 2021-2031 ($Million)
Table 28. Medical Device Affairs Outsourcing Market, by Region, 2021-2031 ($Million)
Table 29. North America Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 30. North America Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 31. North America Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 32. North America Pharmaceutical Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 33. North America Medical Technology Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 34. North America Medical Device Affairs Outsourcing Market, by Country, 2021-2031 ($Million)
Table 35. U.S. Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 36. U.S. Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 37. U.S. Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 38. Canada Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 39. Canada Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 40. Canada Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 41. Mexico Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 42. Mexico Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 43. Mexico Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 44. Europe Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 45. Europe Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 46. Europe Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 47. Europe Pharmaceutical Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 48. Europe Medical Technology Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 49. Europe Medical Device Affairs Outsourcing Market, by Country, 2021-2031 ($Million)
Table 50. Germany Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 51. Germany Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 52. Germany Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 53. France Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 54. France Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 55. France Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 56. UK Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 57. UK Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 58. UK Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 59. Italy Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 60. Italy Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 61. Italy Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 62. Spain Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 63. Spain Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 64. Spain Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 65. Rest of Europe Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 66. Rest of Europe Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 67. Rest of Europe Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 68. Asia-Pacific Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 69. Asia-Pacific Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 70. Asia-Pacific Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 71. Asia-Pacific Pharmaceutical Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 72. Asia-Pacific Medical Technology Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 73. Asia-Pacific Medical Device Affairs Outsourcing Market, by Country, 2021-2031 ($Million)
Table 74. China Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 75. China Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 76. China Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 77. Japan Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 78. Japan Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 79. Japan Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 80. India Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 81. India Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 82. India Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 83. Australia Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 84. Australia Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 85. Australia Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 86. South Korea Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 87. South Korea Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 88. South Korea Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 89. Rest of Asia-Pacific Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 90. Rest of Asia-Pacific Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 91. Rest of Asia-Pacific Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 92. LAMEA Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 93. LAMEA Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 94. LAMEA Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 95. LAMEA Pharmaceutical Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 96. LAMEA Medical Technology Companies Medical Device Affairs Outsourcing Market, by Company Size, 2021-2031 ($Million)
Table 97. LAMEA Medical Device Affairs Outsourcing Market, by Country, 2021-2031 ($Million)
Table 98. Brazil Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 99. Brazil Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 100. Brazil Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 101. Saudi Arabia Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 102. Saudi Arabia Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 103. Saudi Arabia Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 104. South Africa Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 105. South Africa Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 106. South Africa Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 107. Rest of LAMEA Medical Device Affairs Outsourcing Market, by Service, 2021-2031 ($Million)
Table 108. Rest of LAMEA Medical Device Affairs Outsourcing Market, by Software, 2021-2031 ($Million)
Table 109. Rest of LAMEA Medical Device Affairs Outsourcing Market, by End-user, 2021-2031 ($Million)
Table 110. Charles River: Company Snapshot
Table 111. Charles River: Operating Segments
Table 112. Charles River: Product Portfolio
Table 113. Charles River: Net Sales
Table 114. Charles River: Key Strategies
Table 115. Inizio: Company Snapshot
Table 116. Inizio: Operating Segments
Table 117. Inizio: Product Portfolio
Table 118. Inizio: Net Sales
Table 119. Inizio: Key Strategies
Table 120. Iqvia Holdings Inc.: Company Snapshot
Table 121. Iqvia Holdings Inc.: Operating Segments
Table 122. Iqvia Holdings Inc.: Product Portfolio
Table 123. Iqvia Holdings Inc.: Net Sales
Table 124. Iqvia Holdings Inc.: Key Strategies
Table 125. Parexel International Corporation: Company Snapshot
Table 126. Parexel International Corporation: Operating Segments
Table 127. Parexel International Corporation: Product Portfolio
Table 128. Parexel International Corporation: Net Sales
Table 129. Parexel International Corporation: Key Strategies
Table 130. Sgs SA: Company Snapshot
Table 131. Sgs SA: Operating Segments
Table 132. Sgs SA: Product Portfolio
Table 133. Sgs SA: Net Sales
Table 134. Sgs SA: Key Strategies
Table 135. Syneos Health, Inc.: Company Snapshot
Table 136. Syneos Health, Inc.: Operating Segments
Table 137. Syneos Health, Inc.: Product Portfolio
Table 138. Syneos Health, Inc.: Net Sales
Table 139. Syneos Health, Inc.: Key Strategies
Table 140. Thermo Fisher Scientific, Inc.: Company Snapshot
Table 141. Thermo Fisher Scientific, Inc.: Operating Segments
Table 142. Thermo Fisher Scientific, Inc.: Product Portfolio
Table 143. Thermo Fisher Scientific, Inc.: Net Sales
Table 144. Thermo Fisher Scientific, Inc.: Key Strategies
Table 145. Wuxi Apptec: Company Snapshot
Table 146. Wuxi Apptec: Operating Segments
Table 147. Wuxi Apptec: Product Portfolio
Table 148. Wuxi Apptec: Net Sales
Table 149. Wuxi Apptec: Key Strategies
Table 150. Excelya: Company Snapshot
Table 151. Excelya: Operating Segments
Table 152. Excelya: Product Portfolio
Table 153. Excelya: Net Sales
Table 154. Excelya: Key Strategies
Table 155. Icon PLC: Company Snapshot
Table 156. Icon PLC: Operating Segments
Table 157. Icon PLC: Product Portfolio
Table 158. Icon PLC: Net Sales
Table 159. Icon PLC: Key Strategies
Table 160. Indegene Private Limited: Company Snapshot
Table 161. Indegene Private Limited: Operating Segments
Table 162. Indegene Private Limited: Product Portfolio
Table 163. Indegene Private Limited: Net Sales
Table 164. Indegene Private Limited: Key Strategies

List of Figures
Figure 1. Medical Device Affairs Outsourcing Market Segmentation
Figure 2. Medical Device Affairs Outsourcing Market, 2021-2031
Figure 3. Medical Device Affairs Outsourcing Market, 2021-2031
Figure 4. Top Investment Pockets, by Region
Figure 5. Porter Five-1
Figure 6. Porter Five-2
Figure 7. Porter Five-3
Figure 8. Porter Five-4
Figure 9. Porter Five-5
Figure 10. Top Player Positioning
Figure 11. Medical Device Affairs Outsourcing Mark.:Drivers, Restraints and Opportunities
Figure 12. Medical Device Affairs Outsourcing Market, By Service, 2021(%)
Figure 13. Comparative Share Analysis of Regulatory Writing and Submissions Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 14. Comparative Share Analysis of Regulatory Registration Services Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 15. Comparative Share Analysis of Regulatory Consulting Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 16. Comparative Share Analysis of Others Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 17. Medical Device Affairs Outsourcing Market, By Software, 2021(%)
Figure 18. Comparative Share Analysis of Cloud Based Software Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 19. Comparative Share Analysis of on Premise Software Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 20. Medical Device Affairs Outsourcing Market, By End-user, 2021(%)
Figure 21. Comparative Share Analysis of Pharmaceutical Companies Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 22. Comparative Share Analysis of Medical Technology Companies Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 23. Comparative Share Analysis of Others Medical Device Affairs Outsourcing Market, 2021-2031(%)
Figure 24. Medical Device Affairs Outsourcing Market by Region, 2021
Figure 25. U.S. Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 26. Canada Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 27. Mexico Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 28. Germany Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 29. France Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 30. Uk Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 31. Italy Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 32. Spain Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 33. Rest of Europe Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 34. China Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 35. Japan Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 36. India Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 37. Australia Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 38. South Korea Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 39. Rest of Asia-Pacific Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 40. Brazil Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 41. Saudi Arabia Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 42. South Africa Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 43. Rest of LAMEA Medical Device Affairs Outsourcing Market, 2021-2031($Million)
Figure 44. Top Winning Strategies, by Year
Figure 45. Top Winning Strategies, by Development
Figure 46. Top Winning Strategies, by Company
Figure 47. Product Mapping of Top 10 Players
Figure 48. Competitive Dashboard
Figure 49. Competitive Heatmap of Top 10 Key Players
Figure 50. Charles Rive.: Net Sales, ($Million)
Figure 51. Inizi.: Net Sales, ($Million)
Figure 52. Iqvia Holdings Inc.: Net Sales, ($Million)
Figure 53. Parexel International Corporatio.: Net Sales, ($Million)
Figure 54. Sgs S.: Net Sales, ($Million)
Figure 55. Syneos Health, Inc.: Net Sales, ($Million)
Figure 56. Thermo Fisher Scientific, Inc.: Net Sales, ($Million)
Figure 57. Wuxi Appte.: Net Sales, ($Million)
Figure 58. Excely.: Net Sales, ($Million)
Figure 59. Icon pl.: Net Sales, ($Million)
Figure 60. Indegene Private Limite.: Net Sales, ($Million)

Executive Summary

According to the report, “Medical Device Affairs Outsourcing Market," the medical device affairs outsourcing market was valued at $4.6 billion in 2021, and is estimated to reach $8.1 billion by 2031, growing at a CAGR of 6% from 2022 to 2031.

Many pharmaceutical companies are facing cost pressures and workforce spin. Recent trends show that it is much more challenging to obtain new marketing authorization approvals, maintain regulatory compliance, and ensure competitive staff operating costs. Hence, the key decision-makers of companies consider the possibility to obtain external regulatory affairs services from regulatory affairs service providers. The most often outsourced medical affairs activities in the group of regulatory services are clinical & nonclinical overviews & summaries, addendums to clinical overview, expert reports, scientific publications, preparation of clinical trials protocols, investigator’s brochure, PSURs, clinical study reports (CRSs). Some of the reasons to consider the outsourcing of the regulatory affairs services include reduction of excessive workload in pharmaceutical companies’ regulatory affairs department and cost effectiveness of the services. Medical affairs outsourcing services assist the original equipment manufacturing (OEM) companies with scalable and flexible solutions that support them to use healthcare personnel resources, resource components, and strategic management. The growth in the number of clinical trials being conducted is principally linked to the rising cases of many non-communicable and communicable diseases, which is boosting the demand for the development of medical devices or new drugs, which in turn increases the need for medical affairs outsourcing services. The major end users like medical technology companies those with established quality assurance/ regulatory affairs departments, often seek the assistance to supplement their in-house expertise, allowing them to overcome staffing shortages, accommodate a parental leave of absence, provide training, or obtain independent auditor assistance.

The impact of COVID-19 remains negative on medical device affairs outsourcing industry, as medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty. Medical device professionals have the unenviable task of asking for a pause amid the panic. For instance, the impact of COVID-19 on clinical trials has been hampered, due to challenges posed by travel bans, hospital/clinic visit restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity. IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology.

By service, the market is classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others. The others segment is anticipated to acquire the largest medical device affairs outsourcing market size. This is attributed to the increase in the use of regulatory affairs outsourcing services in the clinical research organization. Recent increase in the demand of the regulatory services have contributed to improve the preference for these services, thus driving the market growth.

On the other side, the regulatory writing and submissions segment is projected to exhibit the fastest market growth during the forecast period due to its increased number of benefits for the medical technology companies.

By software, the market is bifurcated into cloud-based software and on-premise software. The cloud based software segment acquired the largest medical device affairs outsourcing market size in 2021, and is anticipated to continue this trend during the forecast period, due to increase in the advantages of the cloud based software. In addition, the cloud based software segment is expected to exhibit the fastest market growth during the forecast period due to increase in R&D activities concerning medical devices.

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 acquired the largest medical device affairs outsourcing market share in 2021, and is anticipated to continue this trend during the forecast period. This is attributed to the increase in number of medical technology companies globally and increase in the number of product development. On the other side, the pharmaceutical companies segment is projected to exhibit the fastest market growth during the forecast period, owing to rise in preference of the market players for using the outsourcing services for the regulatory affairs compliance.

By region, 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). Europe accounted for the largest share of revenue in 2021, and is anticipated to maintain its dominance from 2022 to 2031, owing to presence of large number of clinical research organizations, strong presence of key players, increased healthcare expenditure, higher number of research, development, & innovation activities, and higher adoption of advanced technologies. Moreover, Asia-Pacific is expected to grow at the highest CAGR, owing to medical device affairs outsourcing market trends like increase in number of clinical trials conducted and rise in awareness related to regulatory affairs services outsourcing benefits.

KEY FINDINGS OF STUDY

  • By service, the others segment accounted for major share of the global medical device affairs outsourcing industry in 2021.
  • By software, the cloud based software segment is anticipated to grow with the highest CAGR during the medical device affairs outsourcing market forecast period.
  • By end user, the pharmaceutical companies segment is anticipated to grow with the highest CAGR during the forecast period.
  • Asia-Pacific is anticipated to grow at the highest rate during the medical device affairs outsourcing market analysis period.

Companies Mentioned

  • 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

Methodology

The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.

They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.

They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:

  • Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
  • Scientific and technical writings for product information and related preemptions
  • Regional government and statistical databases for macro analysis
  • Authentic news articles and other related releases for market evaluation
  • Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast

Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.

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