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Global Medical Device Regulatory Affairs Market Size study, by Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services) Type (Diagnostic, and Therapeutic) Service Provider (Outsource, and In-house) and Regional Forecasts 2021-2027

  • BIZ4599919
  • 200 Pages
  • July 2021
  • Healthcare
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The Global Medical Device Regulatory Affairs Market is valued approximately USD 4.5 billion in 2020 and is anticipated to grow with a healthy growth rate of more than 8.6% over the forecast period 2021-2027. The global medical device regulatory affairs market is gaining from the changing regulatory landscape and increased need for faster approval processes. The demand for the medical device regulatory affairs is being boosted by the rise of developing industries such as diagnostics and pharmaceuticals. The global market is progressing thanks to favorable government initiatives and the increasing complexity of medical equipment. Manufacturers of medical devices are adopting ways to safeguard their products in response to increased cybersecurity threats and the financial implications of data breaches. When it comes to data transfer to and from the device, the government is supporting these security enhancements to address these dangers and prevent unauthorized access. Market launch and recertification timescales are becoming more challenging due to increased regulatory issues such as medical device regulation and in vitro diagnostic device regulation, as well as regulatory cybersecurity monitoring. Due to the increased need for businesses to address regulatory challenges, the global medical device regulatory affairs market is expanding in demand. For instance, Emergo released 510(k) Builder in February 2020, a new subscription-based software tool that simplifies and streamlines the U.S. drug approval process. The FDA's submissions for medical device manufacturers allow for quicker market access. 510(k) Builder has comprehensive integration with FDA databases, assisting users in discovering required data such as product codes and predicate devices, as well as automating documentation formatting to FDA standards. Furthermore, expected modifications in the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Devices Regulation (IVDR) from regulators will make meeting market launch and recertification timeframes much more challenging. As a result, the demand for regulatory outsourcing has grown in order to manage and improve current and ongoing regulatory requirements. As a result, the market is expected to grow.

The main regions of Asia Pacific, North America, Europe, Latin America, and the Rest of the World are included in the geographical analysis of the worldwide Medical Device Regulatory Affairs Market. Currently, the Asia Pacific region is predicted to lead the global medical device regulatory affairs market. The government's initiatives to simplify the regulatory system for foreign investigators, fast approval for innovative products, and simplified procurement restrictions are supporting the global market's growth. Due to the presence of two main international regulatory bodies in each area, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), North America and Europe are expected to contribute considerably to the development of the global market. More than half of all medical devices are regulated by these authorities, and the US FDA publishes various guidelines for medical device producers to help with the process.

Major market player included in this report are:

Integer Holdings

ICON Plc

SGS SA

Emergo

Intertek Plc

Covance

IQVIA Holdings

Freyr

Medpace

Promedica International

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed inRoute of Administration about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Type:

Diagnostic

Therapeutics

By Service:

Regulatory Consulting

Legal Representation

Regulatory Writing & Publishing

Product Registration & Clinical Trial Applications

Other Services

By Service Provider:

Outsource

In-house

By Region:

North America

U.S.

Canada

Europe

UK

Germany

France

Spain

Italy

ROE

Asia Pacific

China

India

Japan

Australia

South Korea

RoAPAC

Latin America

Brazil

Mexico

Rest of the World

Furthermore, years considered for the study are as follows:

Historical year – 2018, 2019

Base year – 2020

Forecast period – 2021 to 2027

Target Audience of the Global Medical Device Regulatory Affairs Market in Market Study:

Key Consulting Companies & Advisors

Large, medium-sized, and small enterprises

Venture capitalists

Value-Added Resellers (VARs)

Third-party knowledge providers

Investment bankers

Investors

Chapter 1. Executive Summary

1.1. Market Snapshot

1.2. Global & Segmental Market Estimates & Forecasts, 2019-2027 (USD Billion)

1.2.1. Medical Device Regulatory Affairs Market, by Region, 2019-2027 (USD Billion)

1.2.2. Medical Device Regulatory Affairs Market, by Type, 2019-2027 (USD Billion)

1.2.3. Medical Device Regulatory Affairs Market, by Service Provider, 2019-2027 (USD Billion)

1.2.4. Medical Device Regulatory Affairs Market, by Services, 2019-2027 (USD Billion)

1.3. Key Trends

1.4. Estimation Methodology

1.5. Research Assumption

Chapter 2. Global Medical Device Regulatory Affairs Market Definition and Scope

2.1. Objective of the Study

2.2. Market Definition & Scope

2.2.1. Scope of the Study

2.2.2. Industry Evolution

2.3. Years Considered for the Study

2.4. Currency Conversion Rates

Chapter 3. Global Medical Device Regulatory Affairs Market Dynamics

3.1. Medical Device Regulatory Affairs Market Impact Analysis (2019-2027)

3.1.1. Market Drivers

3.1.1.1. Changing regulations and policies.

3.1.1.2. Entry of new market players

3.1.2. Market Restraints

3.1.2.1. Issues with monitoring and a lack of consistency.

3.1.3. Market Opportunities

3.1.3.1. New innovations and developments in the areas of property rights, monetization, and techniques.

Chapter 4. Global Medical Device Regulatory Affairs Market Industry Analysis

4.1. Porter’s 5 Force Model

4.1.1. Bargaining Power of Suppliers

4.1.2. Bargaining Power of Buyers

4.1.3. Threat of New Entrants

4.1.4. Threat of Substitutes

4.1.5. Competitive Rivalry

4.1.6. Futuristic Approach to Porter’s 5 Force Model (2018-2027)

4.2. PEST Analysis

4.2.1. Political

4.2.2. Economical

4.2.3. Social

4.2.4. Technological

4.3. Investment Adoption Model

4.4. Analyst Recommendation & Conclusion

Chapter 5. Global Medical Device Regulatory Affairs Market, by Type

1.1. Market Snapshot

1.2. Global Medical Device Regulatory Affairs Market by Type, Performance - Potential Analysis

1.3. Global Medical Device Regulatory Affairs Market Estimates & Forecasts by Type 2018-2027 (USD Billion)

1.4. Medical Device Regulatory Affairs Market, Sub Segment Analysis

1.4.1. Diagnostic

1.4.2. Therapeutic

Chapter 2. Global Medical Device Regulatory Affairs Market, by Service

2.1. Market Snapshot

2.2. Global Medical Device Regulatory Affairs Market by Service Provider, Performance - Potential Analysis

2.3. Global Medical Device Regulatory Affairs Market Estimates & Forecasts by Service Provider 2018-2027 (USD Billion)

2.4. Medical Device Regulatory Affairs Market, Sub Segment Analysis

2.4.1. Regulatory Consulting

2.4.2. Legal Representation

2.4.3. Regulatory Writing & Publishing

2.4.4. Product Registration & Clinical Trial Applications

2.4.5. Other Services

Chapter 3. Global Medical Device Regulatory Affairs Market, by Service Provider

3.1. Market Snapshot

3.2. Global Medical Device Regulatory Affairs Market by Services, Performance - Potential Analysis

3.3. Global Medical Device Regulatory Affairs Market Estimates & Forecasts by Services 2018-2027 (USD Billion)

3.4. Medical Device Regulatory Affairs Market, Sub Segment Analysis

3.4.1. Outsource

3.4.2. In-house

Chapter 4. Global Medical Device Regulatory Affairs Market, Regional Analysis

4.1. Medical Device Regulatory Affairs Market, Regional Market Snapshot

4.2. North America Medical Device Regulatory Affairs Market

4.2.1. U.S. Medical Device Regulatory Affairs Market

4.2.1.1. Type breakdown estimates & forecasts, 2018-2027

4.2.1.2. Service Provider breakdown estimates & forecasts, 2018-2027

4.2.1.3. Services breakdown estimates & forecasts, 2018-2027

4.2.2. Canada Medical Device Regulatory Affairs Market

4.3. Europe Medical Device Regulatory Affairs Market Snapshot

4.3.1. U.K. Medical Device Regulatory Affairs Market

4.3.2. Germany Medical Device Regulatory Affairs Market

4.3.3. France Medical Device Regulatory Affairs Market

4.3.4. Spain Medical Device Regulatory Affairs Market

4.3.5. Italy Medical Device Regulatory Affairs Market

4.3.6. Rest of Europe Medical Device Regulatory Affairs Market

4.4. Asia-Pacific Medical Device Regulatory Affairs Market Snapshot

4.4.1. China Medical Device Regulatory Affairs Market

4.4.2. India Medical Device Regulatory Affairs Market

4.4.3. Japan Medical Device Regulatory Affairs Market

4.4.4. Australia Medical Device Regulatory Affairs Market

4.4.5. South Korea Medical Device Regulatory Affairs Market

4.4.6. Rest of Asia Pacific Medical Device Regulatory Affairs Market

4.5. Latin America Medical Device Regulatory Affairs Market Snapshot

4.5.1. Brazil Medical Device Regulatory Affairs Market

4.5.2. Mexico Medical Device Regulatory Affairs Market

4.6. Rest of The World Medical Device Regulatory Affairs Market

Chapter 5. Competitive Intelligence

5.1. Top Market Strategies

5.2. Company Profiles

5.2.1. Integer Plc

5.2.1.1. Key Information

5.2.1.2. Overview

5.2.1.3. Financial (Subject to Data Availability)

5.2.1.4. Product Summary

5.2.1.5. Recent Developments

5.2.2. ICON Plc

5.2.3. SGS SA

5.2.4. Emergo

5.2.5. Intertek Plc

5.2.6. Covance

5.2.7. IQVIA Holdings

5.2.8. Freyr

5.2.9. Medpace

5.2.10. Promedica International

Chapter 6. Research Process

6.1. Research Process

6.1.1. Data Mining

6.1.2. Analysis

6.1.3. Market Estimation

6.1.4. Validation

6.1.5. Publishing

6.2. Research Attributes

6.3. Research Assumption

List of Tables

TABLE 1. Global Medical Device Regulatory Affairs Market, report scope

TABLE 2. Global Medical Device Regulatory Affairs Market estimates & forecasts by Services 2018-2027 (USD Billion)

TABLE 3. Global Medical Device Regulatory Affairs Market estimates & forecasts by Type 2018-2027 (USD Billion)

TABLE 4. Global Medical Device Regulatory Affairs Market estimates & forecasts by Service Provider 2018-2027 (USD Billion)

TABLE 5. Global Medical Device Regulatory Affairs Market estimates & forecasts by Services 2018-2027 (USD Billion)

TABLE 6. Global Medical Device Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 7. Global Medical Device Regulatory Affairs Market by Services, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 8. Global Medical Device Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 9. Global Medical Device Regulatory Affairs Market by Services, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 10. Global Medical Device Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 11. Global Medical Device Regulatory Affairs Market by Services, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 12. Global Medical Device Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 13. Global Medical Device Regulatory Affairs Market by Services, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 14. Global Medical Device Regulatory Affairs Market by segment, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 15. Global Medical Device Regulatory Affairs Market by Services, estimates & forecasts, 2018-2027 (USD Billion)

TABLE 16. U.S. Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 17. U.S. Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 18. U.S. Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 19. Canada Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 20. Canada Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 21. Canada Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 22. UK Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 23. UK Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 24. UK Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 25. Germany Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 26. Germany Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 27. Germany Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 28. RoE Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 29. RoE Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 30. RoE Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 31. China Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 32. China Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 33. China Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 34. India Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 35. India Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 36. India Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 37. Japan Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 38. Japan Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 39. Japan Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 40. RoAPAC Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 41. RoAPAC Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 42. RoAPAC Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 43. Brazil Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 44. Brazil Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 45. Brazil Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 46. Mexico Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 47. Mexico Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 48. Mexico Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 49. RoLA Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 50. RoLA Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 51. RoLA Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 52. Row Medical Device Regulatory Affairs Market estimates & forecasts, 2018-2027 (USD Billion)

TABLE 53. Row Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 54. Row Medical Device Regulatory Affairs Market estimates & forecasts by segment 2018-2027 (USD Billion)

TABLE 55. List of secondary sources, used in the study of Global Medical Device Regulatory Affairs Market

TABLE 56. List of primary sources, used in the study of Global Medical Device Regulatory Affairs Market

TABLE 57. Years considered for the study

TABLE 58. Exchange rates considered

 
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