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Medical Device Regulatory Affairs Market By Services, By Service Provider, By Types, By Indication: Global Opportunity Analysis and Industry Forecast, 2021-2031

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    Report

  • 356 Pages
  • May 2022
  • Region: Global
  • Allied Market Research
  • ID: 5640309
The global Medical Device Regulatory Affairs Market was valued at $6,969.7 million in 2021, and is projected to reach $12,247.7 million by 2031, registering a CAGR of 5.8% from 2022 to 2031.

Medical Device Regulatory Affairs are Regulatory affairs (RA), commonly known as government affairs, is a specialty in regulated industries such as pharmaceuticals, medical devices, and agrochemicals. Within the healthcare industry, regulatory affairs have a very specific connotation. The regulatory function in the healthcare industry is critical in ensuring the availability of safe and effective healthcare products around the world. Regulatory professionals include individuals who ensure regulatory compliance and prepare submissions, as well as those whose primary job function is clinical affairs or quality assurance. Medical Device Regulatory Affairs experts serve as a link between the medical device industry and regulatory bodies around the world, including the United States, the United Kingdom, Canada, the European Union, India, Japan, and Australia. As one of the most highly regulated industries, the healthcare industry needs more experts than ever before who are capable of resolving regulatory issues in a proficient way. Regulatory affairs experts are critical in ensuring that all medical devices comply with industry regulations. Industry regulatory specialists are involved with a wide range of medical devices manufactured in various nations. As regulatory processes become more sophisticated and broader, and as the area becomes more globalized, there will be a continued demand for personnel with a strong background in medical device regulatory affairs.

The advantages of medical device regulatory affairs are that it ensure that all GCP and ICH guidelines, as well as EU CTD and other applicable laws and regulations, are followed when conducting clinical trials for medical devices, it help in establishing, maintaining, and obtaining senior management approval for the Quality Management project and strategic audit programmed and also it help in setting up and maintaining clinical quality assurance papers, protocol deviations, investigations, and change management systems and tools wherever required for the approval of new medical device. With the rapid changes taking place in medical technologies the regulations and quality requirements also need to keep pace and address the specific needs across different geographies. For Medical Devices, the Quality and Regulatory affairs requirements kick in and play a crucial role from the product design phase and provide guidelines across the product lifecycle.

The market is expected to witness a moderate growth during the forecast period, owing to rise in adoption and development of advanced medical devices for the treatment of various disease such as cardiovascular, cancer, and other infectious diseases, along with various technological advancements and their increasing applications in the healthcare sector. Furthermore, surge in geriatric population along with various technological advancements in the market to meet the unmet needs of patients provides significant opportunities for existing players and new entrants.

However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks & concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period.

Impact of COVID-19 pandemic is expected to remain negative for the medical device regulatory affairs market, as the COVID-19 pandemic continues to unfold, medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty.

For instance, the impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation 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. IRB has been prioritizing the review of the numerous COVID-19 protocols received as well as amendments relating to changes in research conduct because of unforeseen circumstances. Clinical trial protocols are required to be changed to eliminate apparent immediate hazards to participants such as changing in-person visits to virtual visits, elimination of study visits/procedures that do not impact the integrity of the study or participant safety, incorporation of screening questions to identify potential COVID-19 exposure.

The global medical device regulatory affairs market is segmented on the basis of services, service provider, types, indication and region. On the basis of services, the market is divided into regulatory consulting /strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials and others. By service provider, it is classified into in-house and out-sourcing. By types it includes diagnostics and therapeutics. By indication the segment includes infectious diseases oncology & hematology, gynecology & obstetrics, musculoskeletal disorders, respiratory, cardiovascular and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Some of the key players operating in the global medical device regulatory affairs market include Amerisource Bergen, Charles River, Cliniexpert, Emergo, Icbio, Icon PLC, IQVIA, NKG, Parexel and Pepgra.

Key Benefits For Stakeholders

  • This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the medical device regulatory affairs market analysis from 2021 to 2031 to identify the prevailing medical device regulatory affairs market opportunity.
  • 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 regulatory affairs 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 regulatory affairs market trends, key players, market segments, application areas, and medical device regulatory affairs market growth strategies.

Key Market Segments


By Services

  • Regulatory consulting /Strategic Services
  • Regulatory writing and publishing
  • Legal representation
  • Product Registration and Clinical trials
  • Others

By Service Provider

  • In-House
  • Out sourcing

By Types

  • Diagnostic
  • Therapeutics

By Indication

  • Infectious Diseases
  • Oncology and Hematology
  • Gynaecology and Obstetrics
  • Muscusloskeletal Disorders
  • Respiratory
  • Cardiovascular
  • Others

By Region

  • North America
  • U.S.
  • Canada
  • Mexico
  • Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • Japan
  • China
  • India
  • South Korea
  • Malaysia
  • Rest of Asia-Pacific
  • LAMEA
  • Brazil
  • Israel
  • Saudi Arabia
  • South Africa
  • Rest of LAMEA

Key Market Players

  • Amerisource Bergen
  • Charles river
  • Clini expert
  • Emergo
  • icbio cro
  • icon plc
  • IQVIA Holdings Inc.
  • NKG
  • parexel
  • Pepgra
Frequently Asked Questions about the Global Medical Device Regulatory Affairs Market

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

The Global Medical Device Regulatory Affairs Market was estimated to be valued at $6969.7 million in 2021.

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

The growth rate of the Global Medical Device Regulatory Affairs Market is 5.8%, with an estimated value of $12247.7 million by 2031.

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

The Global Medical Device Regulatory Affairs Market is estimated to be worth $12247.7 million by 2031.

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

Key companies in the Global Medical Device Regulatory Affairs Market include Amerisource Bergen, Charles river, Clini expert, Emergo, icbio cro, icon plc, IQVIA Holdings Inc., NKG, parexel and Pepgra.

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 REGULATORY AFFAIRS MARKET, BY SERVICES
4.1 Overview
4.1.1 Market size and forecast
4.2 Regulatory consulting /Strategic Services
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 writing and publishing
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 Legal representation
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 Product Registration and Clinical trials
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
4.6 Others
4.6.1 Key market trends, growth factors and opportunities
4.6.2 Market size and forecast, by region
4.6.3 Market analysis by country
CHAPTER 5: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY SERVICE PROVIDER
5.1 Overview
5.1.1 Market size and forecast
5.2 In-House
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 Out sourcing
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 REGULATORY AFFAIRS MARKET, BY TYPES
6.1 Overview
6.1.1 Market size and forecast
6.2 Diagnostic
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
6.3 Therapeutics
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
CHAPTER 7: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY INDICATION
7.1 Overview
7.1.1 Market size and forecast
7.2 Infectious Diseases
7.2.1 Key market trends, growth factors and opportunities
7.2.2 Market size and forecast, by region
7.2.3 Market analysis by country
7.3 Oncology and Hematology
7.3.1 Key market trends, growth factors and opportunities
7.3.2 Market size and forecast, by region
7.3.3 Market analysis by country
7.4 Gynaecology and Obstetrics
7.4.1 Key market trends, growth factors and opportunities
7.4.2 Market size and forecast, by region
7.4.3 Market analysis by country
7.5 Muscusloskeletal Disorders
7.5.1 Key market trends, growth factors and opportunities
7.5.2 Market size and forecast, by region
7.5.3 Market analysis by country
7.6 Respiratory
7.6.1 Key market trends, growth factors and opportunities
7.6.2 Market size and forecast, by region
7.6.3 Market analysis by country
7.7 Cardiovascular
7.7.1 Key market trends, growth factors and opportunities
7.7.2 Market size and forecast, by region
7.7.3 Market analysis by country
7.8 Others
7.8.1 Key market trends, growth factors and opportunities
7.8.2 Market size and forecast, by region
7.8.3 Market analysis by country
CHAPTER 8: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY REGION
8.1 Overview
8.1.1 Market size and forecast
8.2 North America
8.2.1 Key trends and opportunities
8.2.2 North America Market size and forecast, by Services
8.2.3 North America Market size and forecast, by Service Provider
8.2.4 North America Market size and forecast, by Types
8.2.5 North America Market size and forecast, by Indication
8.2.6 North America Market size and forecast, by country
8.2.6.1 U.S.
8.2.6.1.1 Market size and forecast, by Services
8.2.6.1.2 Market size and forecast, by Service Provider
8.2.6.1.3 Market size and forecast, by Types
8.2.6.1.4 Market size and forecast, by Indication
8.2.6.2 Canada
8.2.6.2.1 Market size and forecast, by Services
8.2.6.2.2 Market size and forecast, by Service Provider
8.2.6.2.3 Market size and forecast, by Types
8.2.6.2.4 Market size and forecast, by Indication
8.2.6.3 Mexico
8.2.6.3.1 Market size and forecast, by Services
8.2.6.3.2 Market size and forecast, by Service Provider
8.2.6.3.3 Market size and forecast, by Types
8.2.6.3.4 Market size and forecast, by Indication
8.3 Europe
8.3.1 Key trends and opportunities
8.3.2 Europe Market size and forecast, by Services
8.3.3 Europe Market size and forecast, by Service Provider
8.3.4 Europe Market size and forecast, by Types
8.3.5 Europe Market size and forecast, by Indication
8.3.6 Europe Market size and forecast, by country
8.3.6.1 Germany
8.3.6.1.1 Market size and forecast, by Services
8.3.6.1.2 Market size and forecast, by Service Provider
8.3.6.1.3 Market size and forecast, by Types
8.3.6.1.4 Market size and forecast, by Indication
8.3.6.2 France
8.3.6.2.1 Market size and forecast, by Services
8.3.6.2.2 Market size and forecast, by Service Provider
8.3.6.2.3 Market size and forecast, by Types
8.3.6.2.4 Market size and forecast, by Indication
8.3.6.3 United Kingdom
8.3.6.3.1 Market size and forecast, by Services
8.3.6.3.2 Market size and forecast, by Service Provider
8.3.6.3.3 Market size and forecast, by Types
8.3.6.3.4 Market size and forecast, by Indication
8.3.6.4 Italy
8.3.6.4.1 Market size and forecast, by Services
8.3.6.4.2 Market size and forecast, by Service Provider
8.3.6.4.3 Market size and forecast, by Types
8.3.6.4.4 Market size and forecast, by Indication
8.3.6.5 Spain
8.3.6.5.1 Market size and forecast, by Services
8.3.6.5.2 Market size and forecast, by Service Provider
8.3.6.5.3 Market size and forecast, by Types
8.3.6.5.4 Market size and forecast, by Indication
8.3.6.6 Rest of Europe
8.3.6.6.1 Market size and forecast, by Services
8.3.6.6.2 Market size and forecast, by Service Provider
8.3.6.6.3 Market size and forecast, by Types
8.3.6.6.4 Market size and forecast, by Indication
8.4 Asia-Pacific
8.4.1 Key trends and opportunities
8.4.2 Asia-Pacific Market size and forecast, by Services
8.4.3 Asia-Pacific Market size and forecast, by Service Provider
8.4.4 Asia-Pacific Market size and forecast, by Types
8.4.5 Asia-Pacific Market size and forecast, by Indication
8.4.6 Asia-Pacific Market size and forecast, by country
8.4.6.1 Japan
8.4.6.1.1 Market size and forecast, by Services
8.4.6.1.2 Market size and forecast, by Service Provider
8.4.6.1.3 Market size and forecast, by Types
8.4.6.1.4 Market size and forecast, by Indication
8.4.6.2 China
8.4.6.2.1 Market size and forecast, by Services
8.4.6.2.2 Market size and forecast, by Service Provider
8.4.6.2.3 Market size and forecast, by Types
8.4.6.2.4 Market size and forecast, by Indication
8.4.6.3 India
8.4.6.3.1 Market size and forecast, by Services
8.4.6.3.2 Market size and forecast, by Service Provider
8.4.6.3.3 Market size and forecast, by Types
8.4.6.3.4 Market size and forecast, by Indication
8.4.6.4 South Korea
8.4.6.4.1 Market size and forecast, by Services
8.4.6.4.2 Market size and forecast, by Service Provider
8.4.6.4.3 Market size and forecast, by Types
8.4.6.4.4 Market size and forecast, by Indication
8.4.6.5 Malaysia
8.4.6.5.1 Market size and forecast, by Services
8.4.6.5.2 Market size and forecast, by Service Provider
8.4.6.5.3 Market size and forecast, by Types
8.4.6.5.4 Market size and forecast, by Indication
8.4.6.6 Rest of Asia-Pacific
8.4.6.6.1 Market size and forecast, by Services
8.4.6.6.2 Market size and forecast, by Service Provider
8.4.6.6.3 Market size and forecast, by Types
8.4.6.6.4 Market size and forecast, by Indication
8.5 LAMEA
8.5.1 Key trends and opportunities
8.5.2 LAMEA Market size and forecast, by Services
8.5.3 LAMEA Market size and forecast, by Service Provider
8.5.4 LAMEA Market size and forecast, by Types
8.5.5 LAMEA Market size and forecast, by Indication
8.5.6 LAMEA Market size and forecast, by country
8.5.6.1 Brazil
8.5.6.1.1 Market size and forecast, by Services
8.5.6.1.2 Market size and forecast, by Service Provider
8.5.6.1.3 Market size and forecast, by Types
8.5.6.1.4 Market size and forecast, by Indication
8.5.6.2 Israel
8.5.6.2.1 Market size and forecast, by Services
8.5.6.2.2 Market size and forecast, by Service Provider
8.5.6.2.3 Market size and forecast, by Types
8.5.6.2.4 Market size and forecast, by Indication
8.5.6.3 Saudi Arabia
8.5.6.3.1 Market size and forecast, by Services
8.5.6.3.2 Market size and forecast, by Service Provider
8.5.6.3.3 Market size and forecast, by Types
8.5.6.3.4 Market size and forecast, by Indication
8.5.6.4 South Africa
8.5.6.4.1 Market size and forecast, by Services
8.5.6.4.2 Market size and forecast, by Service Provider
8.5.6.4.3 Market size and forecast, by Types
8.5.6.4.4 Market size and forecast, by Indication
8.5.6.5 Rest of LAMEA
8.5.6.5.1 Market size and forecast, by Services
8.5.6.5.2 Market size and forecast, by Service Provider
8.5.6.5.3 Market size and forecast, by Types
8.5.6.5.4 Market size and forecast, by Indication
CHAPTER 9: COMPANY LANDSCAPE
9.1. Introduction
9.2. Top winning strategies
9.3. Product Mapping of Top 10 Player
9.4. Competitive Dashboard
9.5. Competitive Heatmap
9.6. Key developments
CHAPTER 10: COMPANY PROFILES
10.1 Amerisource Bergen
10.1.1 Company overview
10.1.2 Company snapshot
10.1.3 Operating business segments
10.1.4 Product portfolio
10.1.5 Business performance
10.1.6 Key strategic moves and developments
10.2 Charles river
10.2.1 Company overview
10.2.2 Company snapshot
10.2.3 Operating business segments
10.2.4 Product portfolio
10.2.5 Business performance
10.2.6 Key strategic moves and developments
10.3 Clini expert
10.3.1 Company overview
10.3.2 Company snapshot
10.3.3 Operating business segments
10.3.4 Product portfolio
10.3.5 Business performance
10.3.6 Key strategic moves and developments
10.4 Emergo
10.4.1 Company overview
10.4.2 Company snapshot
10.4.3 Operating business segments
10.4.4 Product portfolio
10.4.5 Business performance
10.4.6 Key strategic moves and developments
10.5 icbio cro
10.5.1 Company overview
10.5.2 Company snapshot
10.5.3 Operating business segments
10.5.4 Product portfolio
10.5.5 Business performance
10.5.6 Key strategic moves and developments
10.6 icon plc
10.6.1 Company overview
10.6.2 Company snapshot
10.6.3 Operating business segments
10.6.4 Product portfolio
10.6.5 Business performance
10.6.6 Key strategic moves and developments
10.7 IQVIA Holdings Inc.
10.7.1 Company overview
10.7.2 Company snapshot
10.7.3 Operating business segments
10.7.4 Product portfolio
10.7.5 Business performance
10.7.6 Key strategic moves and developments
10.8 NKG
10.8.1 Company overview
10.8.2 Company snapshot
10.8.3 Operating business segments
10.8.4 Product portfolio
10.8.5 Business performance
10.8.6 Key strategic moves and developments
10.9 parexel
10.9.1 Company overview
10.9.2 Company snapshot
10.9.3 Operating business segments
10.9.4 Product portfolio
10.9.5 Business performance
10.9.6 Key strategic moves and developments
10.10 Pepgra
10.10.1 Company overview
10.10.2 Company snapshot
10.10.3 Operating business segments
10.10.4 Product portfolio
10.10.5 Business performance
10.10.6 Key strategic moves and developments
LIST OF TABLES
Table 1. Global Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 2. Medical Device Regulatory Affairs Market Revenue, for Regulatory Consulting /Strategic Services, by Region, 2021-2031, ($Million)
Table 3. Medical Device Regulatory Affairs Market for Regulatory Consulting /Strategic Services by Country, 2021-2031, ($Million)
Table 4. Medical Device Regulatory Affairs Market Revenue, for Regulatory Writing and Publishing, by Region, 2021-2031, ($Million)
Table 5. Medical Device Regulatory Affairs Market for Regulatory Writing and Publishing by Country, 2021-2031, ($Million)
Table 6. Medical Device Regulatory Affairs Market Revenue, for Legal Representation, by Region, 2021-2031, ($Million)
Table 7. Medical Device Regulatory Affairs Market for Legal Representation by Country, 2021-2031, ($Million)
Table 8. Medical Device Regulatory Affairs Market Revenue, for Product Registration and Clinical Trials, by Region, 2021-2031, ($Million)
Table 9. Medical Device Regulatory Affairs Market for Product Registration and Clinical Trials by Country, 2021-2031, ($Million)
Table 10. Medical Device Regulatory Affairs Market Revenue, for Others, by Region, 2021-2031, ($Million)
Table 11. Medical Device Regulatory Affairs Market for Others by Country, 2021-2031, ($Million)
Table 12. Global Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 13. Medical Device Regulatory Affairs Market Revenue, for In-House, by Region, 2021-2031, ($Million)
Table 14. Medical Device Regulatory Affairs Market for In-House by Country, 2021-2031, ($Million)
Table 15. Medical Device Regulatory Affairs Market Revenue, for Out Sourcing, by Region, 2021-2031, ($Million)
Table 16. Medical Device Regulatory Affairs Market for Out Sourcing by Country, 2021-2031, ($Million)
Table 17. Global Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 18. Medical Device Regulatory Affairs Market Revenue, for Diagnostic, by Region, 2021-2031, ($Million)
Table 19. Medical Device Regulatory Affairs Market for Diagnostic by Country, 2021-2031, ($Million)
Table 20. Medical Device Regulatory Affairs Market Revenue, for Therapeutics, by Region, 2021-2031, ($Million)
Table 21. Medical Device Regulatory Affairs Market for Therapeutics by Country, 2021-2031, ($Million)
Table 22. Global Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 23. Medical Device Regulatory Affairs Market Revenue, for Infectious Diseases, by Region, 2021-2031, ($Million)
Table 24. Medical Device Regulatory Affairs Market for Infectious Diseases by Country, 2021-2031, ($Million)
Table 25. Medical Device Regulatory Affairs Market Revenue, for Oncology and Hematology, by Region, 2021-2031, ($Million)
Table 26. Medical Device Regulatory Affairs Market for Oncology and Hematology by Country, 2021-2031, ($Million)
Table 27. Medical Device Regulatory Affairs Market Revenue, for Gynaecology and Obstetrics, by Region, 2021-2031, ($Million)
Table 28. Medical Device Regulatory Affairs Market for Gynaecology and Obstetrics by Country, 2021-2031, ($Million)
Table 29. Medical Device Regulatory Affairs Market Revenue, for Muscusloskeletal Disorders, by Region, 2021-2031, ($Million)
Table 30. Medical Device Regulatory Affairs Market for Muscusloskeletal Disorders by Country, 2021-2031, ($Million)
Table 31. Medical Device Regulatory Affairs Market Revenue, for Respiratory, by Region, 2021-2031, ($Million)
Table 32. Medical Device Regulatory Affairs Market for Respiratory by Country, 2021-2031, ($Million)
Table 33. Medical Device Regulatory Affairs Market Revenue, for Cardiovascular, by Region, 2021-2031, ($Million)
Table 34. Medical Device Regulatory Affairs Market for Cardiovascular by Country, 2021-2031, ($Million)
Table 35. Medical Device Regulatory Affairs Market Revenue, for Others, by Region, 2021-2031, ($Million)
Table 36. Medical Device Regulatory Affairs Market for Others by Country, 2021-2031, ($Million)
Table 37. Medical Device Regulatory Affairs Market, by Region, 2021-2031, ($Million)
Table 38. North America Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 39. North America Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 40. North America Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 41. North America Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 42. North America Medical Device Regulatory Affairs Market, by Country, 2021-2031, ($Million)
Table 43. U.S. Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 44. U.S. Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 45. U.S. Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 46. U.S. Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 47. Canada Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 48. Canada Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 49. Canada Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 50. Canada Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 51. Mexico Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 52. Mexico Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 53. Mexico Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 54. Mexico Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 55. Europe Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 56. Europe Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 57. Europe Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 58. Europe Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 59. Europe Medical Device Regulatory Affairs Market, by Country, 2021-2031, ($Million)
Table 60. Germany Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 61. Germany Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 62. Germany Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 63. Germany Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 64. France Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 65. France Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 66. France Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 67. France Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 68. United Kingdom Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 69. United Kingdom Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 70. United Kingdom Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 71. United Kingdom Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 72. Italy Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 73. Italy Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 74. Italy Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 75. Italy Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 76. Spain Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 77. Spain Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 78. Spain Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 79. Spain Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 80. Rest of Europe Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 81. Rest of Europe Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 82. Rest of Europe Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 83. Rest of Europe Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 84. Asia-Pacific Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 85. Asia-Pacific Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 86. Asia-Pacific Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 87. Asia-Pacific Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 88. Asia-Pacific Medical Device Regulatory Affairs Market, by Country, 2021-2031, ($Million)
Table 89. Japan Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 90. Japan Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 91. Japan Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 92. Japan Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 93. China Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 94. China Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 95. China Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 96. China Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 97. India Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 98. India Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 99. India Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 100. India Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 101. South Korea Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 102. South Korea Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 103. South Korea Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 104. South Korea Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 105. Malaysia Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 106. Malaysia Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 107. Malaysia Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 108. Malaysia Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 109. Rest of Asia-Pacific Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 110. Rest of Asia-Pacific Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 111. Rest of Asia-Pacific Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 112. Rest of Asia-Pacific Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 113. LAMEA Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 114. LAMEA Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 115. LAMEA Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 116. LAMEA Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 117. LAMEA Medical Device Regulatory Affairs Market, by Country, 2021-2031, ($Million)
Table 118. Brazil Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 119. Brazil Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 120. Brazil Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 121. Brazil Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 122. Israel Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 123. Israel Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 124. Israel Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 125. Israel Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 126. Saudi Arabia Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 127. Saudi Arabia Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 128. Saudi Arabia Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 129. Saudi Arabia Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 130. South Africa Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 131. South Africa Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 132. South Africa Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 133. South Africa Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 134. Rest of LAMEA Medical Device Regulatory Affairs Market, by Services, 2021-2031, ($Million)
Table 135. Rest of LAMEA Medical Device Regulatory Affairs Market, by Service Provider, 2021-2031, ($Million)
Table 136. Rest of LAMEA Medical Device Regulatory Affairs Market, by Types, 2021-2031, ($Million)
Table 137. Rest of LAMEA Medical Device Regulatory Affairs Market, by Indication, 2021-2031, ($Million)
Table 138. Amerisource Bergen: Company Snapshot
Table 139. Amerisource Bergen: Operating Segments
Table 140. Amerisource Bergen: Product Portfolio
Table 141. Amerisource Bergen: Net Sales
Table 142. Amerisource Bergen: Key Stratergies
Table 143. Charles River: Company Snapshot
Table 144. Charles River: Operating Segments
Table 145. Charles River: Product Portfolio
Table 146. Charles River: Net Sales
Table 147. Charles River: Key Stratergies
Table 148. Clini Expert: Company Snapshot
Table 149. Clini Expert: Operating Segments
Table 150. Clini Expert: Product Portfolio
Table 151. Clini Expert: Net Sales
Table 152. Clini Expert: Key Stratergies
Table 153. Emergo: Company Snapshot
Table 154. Emergo: Operating Segments
Table 155. Emergo: Product Portfolio
Table 156. Emergo: Net Sales
Table 157. Emergo: Key Stratergies
Table 158. Icbio Cro: Company Snapshot
Table 159. Icbio Cro: Operating Segments
Table 160. Icbio Cro: Product Portfolio
Table 161. Icbio Cro: Net Sales
Table 162. Icbio Cro: Key Stratergies
Table 163. Icon plc: Company Snapshot
Table 164. Icon plc: Operating Segments
Table 165. Icon plc: Product Portfolio
Table 166. Icon plc: Net Sales
Table 167. Icon plc: Key Stratergies
Table 168. Iqvia Holdings Inc.: Company Snapshot
Table 169. Iqvia Holdings Inc.: Operating Segments
Table 170. Iqvia Holdings Inc.: Product Portfolio
Table 171. Iqvia Holdings Inc.: Net Sales
Table 172. Iqvia Holdings Inc.: Key Stratergies
Table 173. Nkg: Company Snapshot
Table 174. Nkg: Operating Segments
Table 175. Nkg: Product Portfolio
Table 176. Nkg: Net Sales
Table 177. Nkg: Key Stratergies
Table 178. Parexel: Company Snapshot
Table 179. Parexel: Operating Segments
Table 180. Parexel: Product Portfolio
Table 181. Parexel: Net Sales
Table 182. Parexel: Key Stratergies
Table 183. Pepgra: Company Snapshot
Table 184. Pepgra: Operating Segments
Table 185. Pepgra: Product Portfolio
Table 186. Pepgra: Net Sales
Table 187. Pepgra: Key Stratergies
LIST OF FIGURES
Figure 1. Medical Device Regulatory Affairs Market Segmentation
Figure 2. Medical Device Regulatory Affairs Market, 2021-2031
Figure 3. Medical Device Regulatory Affairs 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 Regulatory Affairs Market:Drivers, Restraints and Opportunities
Figure 12. Medical Device Regulatory Affairs Market, by Services, 2021 (%)
Figure 13. Comparative Share Analysis of Regulatory Consulting /Strategic Services Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 14. Comparative Share Analysis of Regulatory Writing and Publishing Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 15. Comparative Share Analysis of Legal Representation Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 16. Comparative Share Analysis of Product Registration and Clinical Trials Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 17. Comparative Share Analysis of Others Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 18. Medical Device Regulatory Affairs Market, by Service Provider, 2021 (%)
Figure 19. Comparative Share Analysis of In-House Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 20. Comparative Share Analysis of Out Sourcing Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 21. Medical Device Regulatory Affairs Market, by Types, 2021 (%)
Figure 22. Comparative Share Analysis of Diagnostic Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 23. Comparative Share Analysis of Therapeutics Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 24. Medical Device Regulatory Affairs Market, by Indication, 2021 (%)
Figure 25. Comparative Share Analysis of Infectious Diseases Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 26. Comparative Share Analysis of Oncology and Hematology Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 27. Comparative Share Analysis of Gynaecology and Obstetrics Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 28. Comparative Share Analysis of Muscusloskeletal Disorders Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 29. Comparative Share Analysis of Respiratory Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 30. Comparative Share Analysis of Cardiovascular Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 31. Comparative Share Analysis of Others Medical Device Regulatory Affairs Market, 2021-2031 (%)
Figure 32. Medical Device Regulatory Affairs Market by Region, 2021
Figure 33. U.S. Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 34. Canada Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 35. Mexico Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 36. Germany Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 37. France Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 38. United Kingdom Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 39. Italy Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 40. Spain Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 41. Rest of Europe Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 42. Japan Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 43. China Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 44. India Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 45. South Korea Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 46. Malaysia Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 47. Rest of Asia-Pacific Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 48. Brazil Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 49. Israel Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 50. Saudi Arabia Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 51. South Africa Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 52. Rest of LAMEA Medical Device Regulatory Affairs Market, 2021-2031 ($Million)
Figure 53. Top Winning Strategies, by Year
Figure 54. Top Winning Strategies, by Development
Figure 55. Top Winning Strategies, by Company
Figure 56. Product Mapping of Top 10 Players
Figure 57. Competitive Dashboard
Figure 58. Competitive Heatmap of Top 10 Key Players
Figure 59. Amerisource Bergen.: Net Sales, ($Million)
Figure 60. Charles River.: Net Sales, ($Million)
Figure 61. Clini Expert.: Net Sales, ($Million)
Figure 62. Emergo.: Net Sales, ($Million)
Figure 63. Icbio Cro.: Net Sales, ($Million)
Figure 64. Icon PLC.: Net Sales, ($Million)
Figure 65. Iqvia Holdings Inc. Net Sales, ($Million)
Figure 66. Nkg.: Net Sales, ($Million)
Figure 67. Parexel.: Net Sales, ($Million)
Figure 68. Pepgra.: Net Sales, ($Million)

Executive Summary

According to this report titled, 'Medical Device Regulatory Affairs Market,' the medical device regulatory affairs market size was valued at $7.0 billion in 2021, and is estimated to reach $12.2 billion by 2031, growing at a CAGR of 5.8% from 2022 to 2031. Regulatory affairs arose from the desire of governments to protect public health by regulating the safety and efficacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines.

The aim of companies is to be responsible for the discovery, testing, manufacture, and marketing of medical devices to ensure that the supplied products are safe and profitable. The various types of regulations followed in product life cycle of medical devices are regulatory strategy development, regulatory affairs consulting & support, regulatory outsourcing, and device classification determination.
Some other regulations which are required for the approval of medical devices include - pre-market, post-approval & post-market support, appraisal & evaluation of technical documentation, preliminary assessments, gap analyses & desktop audits, technical files, design dossiers and quality system support, European authorized representation services and UK responsible person services.
Ever changing law and regulation drive demand for regulatory affairs professionals who can help companies bring medical product to the market. The regulatory affairs for drugs, biologics, and medical devices require management of regulatory activities and to understand the current requirement for the development, design, and commercialization of new medical device.

Increase in demand for the approval of new device in the market or to conduct post market surveillance are major drivers of the market growth. Furthermore, surge in demand for premarketing regulatory strategy and to meet the regulatory requirement of international regulatory affairs such as Europe and South-Korea to launch the products/medical devices such as auto-injectors or pen needles for insulin, nebulizer, pulse oximeter, ventilator and many such devices globally drives the growth of the market. Moreover, medical technological companies are focused on undertaking key strategies such as product launch and product approval to strengthen their product portfolio, thereby enhancing opportunities in the fast-growing clinical areas in various regions. For instance, in August 2021, EMERGO by UL launched its Regulatory Affairs Management Suite (RAMS) digital platform for more efficient & cost-effective medical device and IVD regulatory affairs & quality assurance (RA/QA) operations.

However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks and concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period.
The global medical device regulatory affairs market is segmented based on services, service provider, types, indication and region. On the basis of services, the medical device regulatory affairs industry is divided into regulatory consulting /strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials & others. By service provider, it is classified into in-house and outsourcing. The types segment includes diagnostics and therapeutics. Depending on indication, the market is fragmented into infectious diseases, oncology & hematology, gynecology & obstetric, musculoskeletal disorder, respiratory, cardiovascular and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

By services segment, the medical device regulatory affairs industry is divided into regulatory consulting /strategic services, regulatory writing & publishing, legal representation, product registration & clinical trials, and others. The legal representation segment was the highest revenue contributor to the market owing to increase in demand for traditional and special 510(k), pre-market approval (PMA) preparation & submission, design dossier preparation & FDA notified body, and ISO 13485 registrar audit preparation & participation accessibility are expected to drive the market growth. The product registration and clinical trials segment is estimated to register a significant CAGR of 6.8% during the forecast period. Owing to rising demand for faster approval processes.

By service provider, the outsourcing segment was the highest revenue contributor to the market with a CAGR of 6.0%. The increase in number of clinical studies conducted and providing regulatory guidance for the approval of medical device to the small-scale industries act as a driver to boost the growth of the market.

The in-house segment is estimated to reach $at a significant CAGR of 5.5% during the forecast period due to the increasing complexity of medical devices and increase in demand for regulatory services required by small scale industries to get their product approval globally also because of the advantages such as cost and time saving.

By type, the therapeutics segment was the highest revenue contributor to the market, and is estimated to reach $a CAGR of 5.6%. This is owing to increase in prevalence of various chronic diseases such as cancer, diabetes, cardiovascular diseases, and respiratory disorders that create demand for advanced therapeutic products.
For instance, increasing demand for technologically advanced products such as auto-injectors or pen needles for effective and efficient delivery of insulin in diabetic patients is driving the segment.

The diagnostic segment registered a high CAGR of 6.2% during the forecast period. Due to a lack of supply, temporary approvals for expired therapeutic equipment such as respirators/ventilators and certification of similar equipment such as positive pressure breathing devices and anesthesia gas machines are permitted.

On the basis of indication, the musculoskeletal disorders segment was the highest revenue contributor to the market with a CAGR of 4.6%. This is primarily due to increase in demand of advanced medical devices for oncology & hematology, the demand for the regulatory service required also increases which drives the growth of the medical device regulatory affairs market trends.

The cardiovascular segment is estimated to a high growth rate of 6.5% during the forecast period. Owing to rise in prevalence of heart related disease which increase the demand of regulatory services for the approval of new medical devices.

Region wise, the medical device regulatory affairs market size is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America was the largest shareholder in the medical device regulatory affairs market in 2021. Increase in geriatric population, R&D investments, and supportive government initiatives directed toward use of advanced medical devices for chronic diseases are the major factors that drive growth of the medical device regulatory affairs market share.
Asia-Pacific is estimated to grow during the forecast period. Rise in number of product approval, increase in number of clinical trials procedures, surge in demand for regulatory services emphasis of prominent players in enhancing their presence and high demand for advanced medical devices in the region.

Some of the key players operating in the global medical device regulatory affairs market analysis include Amerisource Bergen, Charles River, Cliniexpert, Emergo, Icbio, Icon Plc, Iqvia, NKG, Parexel and Pepgra.

Key findings of the Study

  • By services type, the regulatory consulting/strategic services segment was the highest contributor to the market in 2021.
  • By service provider, the outsourcing was the highest contributor to the medical device regulatory affairs market forecast in 2021.
  • By types, the diagnostic segment is projected to grow at a significant CAGR of 6.2% from 2022 to 2031.
  • By indication, the oncology & hematology segment is projected to grow at a significant CAGR of 7.3% from 2022 to 2031.
  • By region, North America garnered largest revenue share of 2056.1.in 2021, whereas Asia-Pacific is anticipated to grow at the highest CAGR of 6.9% during the review period.

Companies Mentioned

  • Amerisource Bergen
  • Charles river
  • Clini expert
  • Emergo
  • icbio cro
  • icon plc
  • IQVIA Holdings Inc.
  • NKG
  • parexel
  • Pepgra

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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