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Medical Device Regulatory Affairs Market by Services, Type, Service Provider, and by Region - Global Forecast to 2022-2033

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    Report

  • 200 Pages
  • January 2023
  • Region: Global
  • Quintana Research and Consulting
  • ID: 5717246
The medical device regulatory affairs market size is estimated to be USD 5,807.1 million in 2022 and is expected to witness a CAGR of 10.47% during the forecast period 2023-2033. Rise in demand for rapid approval procedures, changes in the regulatory environment, and expansion in newly developing industries including pharmaceuticals and diagnostics are some of the factors contributing to the market growth. Furthermore, increasing pre-market approvals and rising cybersecurity risks and the financial costs of data breaches are other factors supporting the market growth. However, surge in cyberattacks is expected to hinder the growth.

Rising cybersecurity risks and the financial costs of data breaches is expected to propel the market growth during the projected period. For instance, in order to address cybersecurity risks, such as less secure communication and the prevention of unauthorised access when it comes to data transfer to and from the device, the FDA collaborated with the U.S. Department of Homeland Security in October 2018 to improve information sharing and collaboration. Rising cybersecurity risks and the financial costs of data breaches are forcing medical device manufacturers to install security measures for their products.

Increasing pre-market approvals is predicted to fuel the market growth during the forecast period. Through the FDA's pre-market process, multiple pre-market approvals have recently been issued. The algorithm used in the Apple Watch's AF detection and diabetes management assistance systems, which offer personalized treatment programmes are two examples. The FDA has indicated a new approach that changes the focus for certification, particularly for AI-related technologies, away from a strict focus on the device or its performance and toward the company and its procedures.

Segmentation

By Services

The market is categorized into legal representation, regulatory consulting, product registration & clinical trial applications, regulatory writing & publishing, and other services. In 2022, the regulatory writing & publishing segment accounted for the highest revenue share due to the fact that these services are offered from the early stages of product development to premarket approval as high-quality documentation is crucial for regulatory affairs in order to prevent delays in the approval process. Given this, the market for medical device regulatory affairs is expected to grow as a result of the rising number of devices that are currently in development. The legal representation segment is expected to increase at the fastest rate over the projected period. This can be a result of the rising demand for legal representation worldwide brought on by the globalization of medical technology. The laws are quite complex and are often changing. The demand for local expertise for legal representation to get regulatory approvals and customs clearance is growing as a result of the shifting regulatory environment in regions including Latin America, the Middle East, and Asia-Pacific. These factors are increasing demand for legal services all around the world.

By Type

The market is categorized into therapeutic and diagnostic. In the global market, the therapeutic segment accounted for the largest revenue share in 2022 owing to rise in the incidence of chronic diseases including cancer, diabetes, cardiovascular problems, and respiratory issues. The growing demand for technologically improved products, such as auto-injectors or pen needles for the effective and efficient delivery of insulin to diabetic patients, is one factor driving segment expansion. In 2022, the diagnostics market maintained a 44.4% share. The high incidence of infectious and chronic diseases increases the need for diagnosis, which supports the market for advanced diagnostic equipment. Additionally, a sizable number of diagnostic devices were introduced in the last five years. For instance, Canon Medical introduced the Vantage Fortian MRI scanner in July 2022, which features improved scan and picture enhancement technology. All of these factors are predicted to increase demand for diagnostic device regulatory services.

By Service Provider

The market is segmented into in-house and outsource. In 2022, the outsource segment accounted for the largest revenue share owing to absence of an internal regulatory team. Additionally, the benefits of outsourcing these services, such as the cost and time savings, are driving industry expansion. Additionally, new regulatory barriers including regulating medical devices and in vitro diagnostic devices in Europe, and governmental cybersecurity inspection, hinder timelines for market introduction and recertification. Companies find it extremely difficult to handle regulatory obstacles with unskilled people, which fuels demand for outsourcing these services. It is anticipated that the in-house segment will grow at a fastest CAGR during the projection period. Large biotechnology and medical device companies have strong internal regulatory affairs teams due to their extensive product pipelines, diverse product portfolios, and the ability to recruit knowledgeable and experienced personnel. These are some of the primary drivers supporting the in-house segment. To concentrate on their core capabilities and deal with capacity challenges, some companies are also moving toward outsourcing. In the upcoming years, it is anticipated that this will decrease demand for in-house services.

Regional Markets

In 2022, Asia Pacific region accounted for the highest revenue in the medical device regulatory affairs market and is expected to maintain its dominance during the forecast period. This is attributed to the better regulatory environment, cost savings, rising number of clinical trials conducted in the region, and soaring number of medical device companies venturing in the region. Another factor that is anticipated to spur expansion is the region's access to skilled personnel at a lower cost than in the United States. North America and Europe are also anticipated to be key markets for medical device regulatory affairs owing to existence of two large international regulatory organizations, the European Medicines Agency (EMA) and the U.S. FDA, which manage more than half of all medical devices globally. Additionally, a large number of medical device companies are based in North America, and they outsource some of their regulatory functions to regulatory service providers, helping the regional industry to expand.

Competitor Insights

Some of the key players operating in the medical device regulatory affairs market are Intertek Group plc, Freyr, Laboratory Corporation of America Holdings, IQVIA, Inc., SGS Société Générale de Surveillance SA, Emergo, Promedica International, ICON, Plc, Integer Holdings Corporation, and Medpace.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

For instance, as per the terms of the partnership agreement, Freyr supplied regulatory device registration and legal representation services to a Korean manufacturer of orthopedic implants in October 2022.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including services, type, and service provider from 2023 to 2033.

Segmentation: Medical Device Regulatory Affairs Market Report 2022 - 2033

Services (Revenue, USD Million), 2022 - 2033

  • Legal Representation
  • Regulatory Consulting
  • Product Registration & Clinical Trial Applications
  • Regulatory Writing & Publishing
  • Other Services

Type (Revenue, USD Million), 2022 - 2033

  • Therapeutic
  • Diagnostic

Service Provider (Revenue, USD Million), 2022 - 2033

  • In-house
  • Outsource

By Region (Revenue, USD Million), 2022 - 2033

North America

  • U.S.
  • Canada

Europe

  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC

Latin America

  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM

Middle East & Africa

  • South Africa
  • GCC
  • Rest of MEA

Table of Contents

1. Research Methodology
1.1. Study Objectives
1.2. Study Scope
1.3. Research Framework
1.3.1. Research Models
1.3.1.1. Bottom-up Approach
1.3.1.2. Top-down Approach
1.3.1.3. Data Triangulation
1.3.2. Data Analysis
1.3.2.1. Data Validation
1.3.2.2. Market Size Estimation
1.3.2.3. Market Forecast Model

2. Introduction: Medical Device Regulatory Affairs

3. Executive Summary

4. Market Dynamics
4.1. Market Drivers
4.1.1. Driver 1
4.1.2. Driver 2
4.1.3. Driver 3
4.1.4. Driver 4
4.2. Market Restraint
4.2.1. Restraint 1
4.2.2. Restraint 2
4.2.3. Restraint 3
4.3. Market Opportunities
4.3.1. Opportunity 1
4.3.2. Opportunity 2
4.3.3. Opportunity 3
4.4. Market Trends
4.4.1. Trend 1
4.4.2. Trend 2
4.4.3. Trend 3
4.5. Market Challenges
4.5.1. Challenge 1
4.5.2. Challenge 2
4.5.3. Challenge 3

5. Market Environment Analysis
5.1. Porter’s 5 Forces Analysis
5.2. PESTEL Analysis
5.3. SWOT Analysis

6. COVID-19 Impact Analysis: Medical Device Regulatory Affairs Market

7. Market Analysis by Services
7.1. Legal Representation
7.1.1. Legal Representation Market Forecast, 2022-2033 (USD Million)
7.2. Regulatory Consulting
7.2.1. Regulatory Consulting Market Forecast, 2022-2033 (USD Million)
7.3. Product Registration & Clinical Trial Applications
7.3.1. Product Registration & Clinical Trial Applications Market Forecast, 2022-2033 (USD Million)
7.4. Regulatory Writing & Publishing
7.4.1. Regulatory Writing & Publishing Market Forecast, 2022-2033 (USD Million)
7.5. Other Services
7.5.1. Other Services Market Forecast, 2022-2033 (USD Million)

8. Market Analysis by Test
8.1. Therapeutic
8.1.1. Therapeutic Market Forecast, 2022-2033 (USD Million)
8.2. Diagnostic
8.2.1. Diagnostic Market Forecast, 2022-2033 (USD Million)

9. Market Analysis by End User
9.1. In-house
9.1.1. In-house Market Forecast, 2022-2033 (USD Million)
9.2. Outsource
9.2.1. Outsource Market Forecast, 2022-2033 (USD Million)

8. Regional Market Analysis
8.1. Regional Market Trends Analysis

9. North America Medical Device Regulatory Affairs Market
9.1. North America Medical Device Regulatory Affairs Market
9.1.1. North America Market Size and Forecast, 2022-2033 (USD Million)
9.1.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
9.1.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
9.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
9.2. U.S. Medical Device Regulatory Affairs Market
9.2.1. U.S. Market Size and Forecast, 2022-2033 (USD Million)
9.2.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
9.2.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
9.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
9.3. Canada Medical Device Regulatory Affairs Market
9.3.1. Canada Market Size and Forecast, 2022-2033 (USD Million)
9.3.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
9.3.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
9.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

10. Europe Medical Device Regulatory Affairs Market
10.1. Europe Medical Device Regulatory Affairs Market
10.1.1. Europe Market Size and Forecast, 2022-2033 (USD Million)
10.1.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.1.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.2. Germany Medical Device Regulatory Affairs Market
10.2.1. Germany Market Size and Forecast, 2022-2033 (USD Million)
10.2.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.2.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.3. UK Medical Device Regulatory Affairs Market
10.3.1. UK Market Size and Forecast, 2022-2033 (USD Million)
10.3.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.3.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.4. France Medical Device Regulatory Affairs Market
10.4.1. France Market Size and Forecast, 2022-2033 (USD Million)
10.4.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.4.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.5. Spain Medical Device Regulatory Affairs Market
10.5.1. Spain Market Size and Forecast, 2022-2033 (USD Million)
10.5.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.5.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.5.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.6. Italy Medical Device Regulatory Affairs Market
10.6.1. Italy Market Size and Forecast, 2022-2033 (USD Million)
10.6.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.6.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.6.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
10.7. Rest of Europe Medical Device Regulatory Affairs Market
10.7.1. Rest of Europe Market Size and Forecast, 2022-2033 (USD Million)
10.7.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
10.7.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
10.7.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

11. Asia Pacific Medical Device Regulatory Affairs Market
11.1. Asia Pacific Medical Device Regulatory Affairs Market
11.1.1. Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
11.1.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.1.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.2. Japan Medical Device Regulatory Affairs Market
11.2.1. Japan Market Size and Forecast, 2022-2033 (USD Million)
11.2.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.2.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.3. China Medical Device Regulatory Affairs Market
11.3.1. China Market Size and Forecast, 2022-2033 (USD Million)
11.3.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.3.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.4. India Medical Device Regulatory Affairs Market
11.4.1. India Market Size and Forecast, 2022-2033 (USD Million)
11.4.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.4.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.5. South Korea Medical Device Regulatory Affairs Market
11.5.1. South Korea Market Size and Forecast, 2022-2033 (USD Million)
11.5.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.5.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.5.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.6. Australia Medical Device Regulatory Affairs Market
11.6.1. Australia Market Size and Forecast, 2022-2033 (USD Million)
11.6.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.6.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.6.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
11.7. Rest of Asia Pacific Medical Device Regulatory Affairs Market
11.7.1. Rest of Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
11.7.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
11.7.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
11.7.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

12. Latin America Medical Device Regulatory Affairs Market
12.1. Latin America Medical Device Regulatory Affairs Market
12.1.1. Latin America Market Size and Forecast, 2022-2033 (USD Million)
12.1.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
12.1.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
12.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.2. Brazil Medical Device Regulatory Affairs Market
12.2.1. Brazil Market Size and Forecast, 2022-2033 (USD Million)
12.2.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
12.2.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
12.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.3. Mexico Medical Device Regulatory Affairs Market
12.3.1. Mexico Market Size and Forecast, 2022-2033 (USD Million)
12.3.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
12.3.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
12.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.4. Argentina Medical Device Regulatory Affairs Market
12.4.1. Argentina Market Size and Forecast, 2022-2033 (USD Million)
12.4.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
12.4.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
12.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
12.5. Rest of Latin America Medical Device Regulatory Affairs Market
12.5.1. Rest of Latin America Market Size and Forecast, 2022-2033 (USD Million)
12.5.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
12.5.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
12.5.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

13. MEA Medical Device Regulatory Affairs Market
13.1. MEA Medical Device Regulatory Affairs Market
13.1.1. MEA Market Size and Forecast, 2022-2033 (USD Million)
13.1.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
13.1.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
13.1.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
13.2. GCC Medical Device Regulatory Affairs Market
13.2.1. GCC Market Size and Forecast, 2022-2033 (USD Million)
13.2.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
13.2.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
13.2.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
13.3. South Africa Medical Device Regulatory Affairs Market
13.3.1. South Africa Market Size and Forecast, 2022-2033 (USD Million)
13.3.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
13.3.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
13.3.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)
13.4. Rest of MEA Medical Device Regulatory Affairs Market
13.4.1. Rest of MEA Market Size and Forecast, 2022-2033 (USD Million)
13.4.1.1. Market Size and Forecast by Services, 2022-2033 (USD Million)
13.4.1.2. Market Size and Forecast by Test, 2022-2033 (USD Million)
13.4.1.3. Market Size and Forecast by End User, 2022-2033 (USD Million)

14. Competitor Analysis
14.1. Market Share Analysis, 2022
14.2. Major Recent Developments, 2019-2022

15. Company Profiles
15.1. Intertek Group plc
15.1.1. Company Snapshot
15.1.2. Company Overview
15.1.3. Financial Analysis
15.1.4. Product Benchmarking
15.1.5. Recent Developments
15.2. Freyr
15.2.1. Company Snapshot
15.2.2. Company Overview
15.2.3. Financial Analysis
15.2.4. Product Benchmarking
15.2.5. Recent Developments
15.3. Laboratory Corporation of America Holdings
15.3.1. Company Snapshot
15.3.2. Company Overview
15.3.3. Financial Analysis
15.3.4. Product Benchmarking
15.3.5. Recent Developments
15.4. IQVIA, Inc.
15.4.1. Company Snapshot
15.4.2. Company Overview
15.4.3. Financial Analysis
15.4.4. Product Benchmarking
15.4.5. Recent Developments
15.5. SGS Société Générale de Surveillance SA
15.5.1. Company Snapshot
15.5.2. Company Overview
15.5.3. Financial Analysis
15.5.4. Product Benchmarking
15.5.5. Recent Developments
15.6. Emergo
15.6.1. Company Snapshot
15.6.2. Company Overview
15.6.3. Financial Analysis
15.6.4. Product Benchmarking
15.6.5. Recent Developments
15.7. Promedica International
15.7.1. Company Snapshot
15.7.2. Company Overview
15.7.3. Financial Analysis
15.7.4. Product Benchmarking
15.7.5. Recent Developments
15.8. ICON, Plc
15.8.1. Company Snapshot
15.8.2. Company Overview
15.8.3. Financial Analysis
15.8.4. Product Benchmarking
15.8.5. Recent Developments
15.9. Integer Holdings Corporation
15.9.1. Company Snapshot
15.9.2. Company Overview
15.9.3. Financial Analysis
15.9.4. Product Benchmarking
15.9.5. Recent Developments
15.10. Medpace
15.10.1. Company Snapshot
15.10.2. Company Overview
15.10.3. Financial Analysis
15.10.4. Product Benchmarking
15.10.5. Recent Developments
15.11. Company 11
15.11.1. Company Snapshot
15.11.2. Company Overview
15.11.3. Financial Analysis
15.11.4. Product Benchmarking
15.11.5. Recent Developments
15.12. Company 12
15.12.1. Company Snapshot
15.12.2. Company Overview
15.12.3. Financial Analysis
15.12.4. Product Benchmarking
15.12.5. Recent Developments
15.13. Company 13
15.13.1. Company Snapshot
15.13.2. Company Overview
15.13.3. Financial Analysis
15.13.4. Product Benchmarking
15.13.5. Recent Developments
15.14. Company 14
15.14.1. Company Snapshot
15.14.2. Company Overview
15.14.3. Financial Analysis
15.14.4. Product Benchmarking
15.14.5. Recent Developments
15.15. Company 15
15.15.1. Company Snapshot
15.15.2. Company Overview
15.15.3. Financial Analysis
15.15.4. Product Benchmarking
15.15.5. Recent Developments

16. Conclusion

17. Recommendations

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Intertek Group plc
  • Freyr
  • Laboratory Corporation of America Holdings
  • IQVIA Inc.
  • SGS Société Générale de Surveillance SA
  • Emergo
  • Promedica International
  • ICON PLC
  • Integer Holdings Corporation
  • Medpace.