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Global Regulatory Affairs Outsourcing Market Size study, by Services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services) by Company Size (Small, Medium, Large) by Category (Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Biosimilars, Medical devices, Therapeutic, Diagnostic) by Indication (Oncology, Neurology, Cardiology, Immunology, Others) by Stage (Preclinical, Clinical, PMA (Post Authorization)) by End-use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies) and Regional Forecasts 2022-2028

  • BIZ4983039
  • 200 Pages
  • June 2022
  • Medical Devices
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Global Regulatory Affairs Outsourcing Market is valued approximately USD 5.72 billion in 2021 and is anticipated to grow with a healthy growth rate of more than 8.90 % over the forecast period 2022-2028. Regulatory affairs outsourcing is becoming more common in the healthcare industry. The adoption of regulatory outsourcing models is projected to be aided by an increase in geographical expansion activities by corporations seeking quick approvals in local markets. The regulatory affairs outsourcing market is quickly growing as a result of increased R&D activity, which is increasing the number of clinical trial applications and product registrations. Outsourcing of regulatory affairs duties is being driven by a significant increase in the fixed expenses of in-house resources for regulatory affairs and operations activities such as training, technology, specialist knowledge, and facilities. For example, ProPharma Group bought iSafety Systems, an Indian pharmacovigilance service provider, in August 2021 to boost its pharmacovigilance market position. Similarly, in July 2021, ICON plc purchased PRA Health Sciences, contract research organization that specializes in medication development and regulatory consultation. The goal of this acquisition was to expand ICON plc's service portfolio. The demand for these services is being driven by local legal challenges and frequent changes in the rules of major markets such as the United States, Europe, and Asia.. Amendments to current regulations are likely to make the regulatory process easier for the business, but they will also make it more difficult for healthcare product manufacturers to operate. As a result, regulatory affairs are being outsourced to service providers. This is due to an increase in the number of clinical trial registrations in recent years. ClinicalTrials.gov reports that about 401,716 studies were registered in January 2022, up from around 325,834 by the end of 2019. Furthermore, an increase in the number of biologics, a high demand for innovative technologies, and a need for individualized orphan pharmaceuticals and medicine are all expected to drive segment growth throughout the projection period. However, over the projection period of 2022-2028, rigorous government regulations governing various medical items would stifle market growth.

The key regions considered for the global Regulatory Affairs Outsourcing Market study includes Asia Pacific, North America, Europe, Latin America, and Rest of the World. The Asia Pacific area had the largest share. Over the forecast period, the area is also expected to have the quickest CAGR. This can be linked to an increase in clinical trials as well as a rise in the number of enterprises attempting to penetrate developing markets such as India and China. Another element projected to drive regional market expansion is the availability of a competent labour in the region at cheaper costs than in the United States.

Major market player included in this report are:

Accell Clinical Research, LLC

GenPact Ltd.

Criterium, Inc.

PRA Health Sciences

Promedica International

Dr. Regenold GmbH

BioMapas

Zeincro Group

Parexel International Corp.

Charles River Laboratories International, Inc.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to 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 information 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 Services

Regulatory Consulting

Legal Representation

Regulatory Writing & Publishing

Product Registration & Clinical Trial Applications

Other Services

By Company Size

Small

Medium

Large

By Category

Drugs

Generics

Innovators

Biologics

Biotech

ATMPs

Biosimilars

Medical devices

Therapeutic

Diagnostic

By Indication

Oncology

Neurology

Cardiology

Immunology

Others

By Stage

Preclinical

Clinical

PMA (Post Market Authorization)

By End-use

Medical Device Companies

Pharmaceutical Companies

Biotechnology Companies

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, 2020

Base year – 2021

Forecast period – 2022 to 2028

Target Audience of the Global Regulatory Affairs Outsourcing 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, 2020-2028 (USD Billion)

1.2.1. Regulatory Affairs Outsourcing Market, by Region, 2020-2028 (USD Billion)

1.2.2. Regulatory Affairs Outsourcing Market, by Services, 2020-2028 (USD Billion)

1.2.3. Regulatory Affairs Outsourcing Market, by Company Size, 2020-2028 (USD Billion)

1.2.4. Regulatory Affairs Outsourcing Market, by Category, 2020-2028 (USD Billion)

1.2.5. Regulatory Affairs Outsourcing Market, by Indication, 2020-2028 (USD Billion)

1.2.6. Regulatory Affairs Outsourcing Market, by Stage, 2020-2028 (USD Billion)

1.2.7. Regulatory Affairs Outsourcing Market, by End-use, 2020-2028 (USD Billion)

1.3. Key Trends

1.4. Estimation Methodology

1.5. Research Assumption

Chapter 2. Global Regulatory Affairs Outsourcing 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 Regulatory Affairs Outsourcing Market Dynamics

3.1. Regulatory Affairs Outsourcing Market Impact Analysis (2020-2028)

3.1.1. Market Drivers

3.1.1.1. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities

3.1.1.2. Augmenting the volume of clinical trial applications and product registration

3.1.2. Market Challenges

3.1.2.1. Strict government regulations regarding the various medical products

3.1.3. Market Opportunities

3.1.3.1. Increase in geographical expansion activities by companies

3.1.3.2. Increase in R&D activities

Chapter 4. Global Regulatory Affairs Outsourcing 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 (2018-2028)

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

4.5. Top investment opportunity

4.6. Top winning strategies

Chapter 5. Risk Assessment: COVID-19 Impact

5.1.1. Assessment of the overall impact of COVID-19 on the industry

5.1.2. Pre COVID-19 and post COVID-19 Market scenario

Chapter 6. Global Regulatory Affairs Outsourcing Market, by Services

6.1. Market Snapshot

6.2. Global Regulatory Affairs Outsourcing Market by Services, Performance - Potential Analysis

6.3. Global Regulatory Affairs Outsourcing Market Estimates & Forecasts by Services 2018-2028 (USD Billion)

6.4. Regulatory Affairs Outsourcing Market, Sub Segment Analysis

6.4.1. Regulatory Consulting

6.4.2. Legal Representation

6.4.3. Regulatory Writing & Publishing

6.4.4. Product Registration & Clinical Trial Applications

6.4.5. Other Services

Chapter 7. Global Regulatory Affairs Outsourcing Market, by Company Size

7.1. Market Snapshot

7.2. Global Regulatory Affairs Outsourcing Market by Company Size, Performance - Potential Analysis

7.3. Global Regulatory Affairs Outsourcing Market Estimates & Forecasts by Company Size 2018-2028 (USD Billion)

7.4. Regulatory Affairs Outsourcing Market, Sub Segment Analysis

7.4.1. Small

7.4.2. Medium

7.4.3. Large

Chapter 8. Global Regulatory Affairs Outsourcing Market, by Category

8.1. Market Snapshot

8.2. Global Regulatory Affairs Outsourcing Market by Category, Performance - Potential Analysis

8.3. Global Regulatory Affairs Outsourcing Market Estimates & Forecasts by Category 2018-2028 (USD Billion)

8.4. Regulatory Affairs Outsourcing Market, Sub Segment Analysis

8.4.1. Drugs

8.4.2. Generics

8.4.3. Innovators

8.4.4. Biologics

8.4.5. Biotech

8.4.6. ATMPs

8.4.7. Biosimilars

8.4.8. Medical devices

8.4.9. Therapeutic

8.4.10. Diagnostic

Chapter 9. Global Regulatory Affairs Outsourcing Market, by Indication

9.1. Market Snapshot

9.2. Global Regulatory Affairs Outsourcing Market by Indication, Performance - Potential Analysis

9.3. Global Regulatory Affairs Outsourcing Market Estimates & Forecasts by Indication 2018-2028 (USD Billion)

9.4. Regulatory Affairs Outsourcing Market, Sub Segment Analysis

9.4.1. Oncology

9.4.2. Neurology

9.4.3. Cardiology

9.4.4. Immunology

9.4.5. Others

Chapter 10. Global Regulatory Affairs Outsourcing Market, by Stage

10.1. Market Snapshot

10.2. Global Regulatory Affairs Outsourcing Market by Stage, Performance - Potential Analysis

10.3. Global Regulatory Affairs Outsourcing Market Estimates & Forecasts by Stage 2018-2028 (USD Billion)

10.4. Regulatory Affairs Outsourcing Market, Sub Segment Analysis

10.4.1. Preclinical

10.4.2. Clinical

10.4.3. PMA (Post Market Authorization)

Chapter 11. Global Regulatory Affairs Outsourcing Market, by End-use

11.1. Market Snapshot

11.2. Global Regulatory Affairs Outsourcing Market by End-use, Performance - Potential Analysis

11.3. Global Regulatory Affairs Outsourcing Market Estimates & Forecasts by End-use 2018-2028 (USD Billion)

11.4. Regulatory Affairs Outsourcing Market, Sub Segment Analysis

11.4.1. Medical Device Companies

11.4.2. Pharmaceutical Companies

11.4.3. Biotechnology Companies

Chapter 12. Global Regulatory Affairs Outsourcing Market, Regional Analysis

12.1. Regulatory Affairs Outsourcing Market, Regional Market Snapshot

12.2. North America Regulatory Affairs Outsourcing Market

12.2.1. U.S. Regulatory Affairs Outsourcing Market

12.2.1.1. Services breakdown estimates & forecasts, 2018-2028

12.2.1.2. Company Size breakdown estimates & forecasts, 2018-2028

12.2.1.3. Category breakdown estimates & forecasts, 2018-2028

12.2.1.4. Indication breakdown estimates & forecasts, 2018-2028

12.2.1.5. Stage breakdown estimates & forecasts, 2018-2028

12.2.1.6. End-use breakdown estimates & forecasts, 2018-2028

12.2.2. Canada Regulatory Affairs Outsourcing Market

12.3. Europe Regulatory Affairs Outsourcing Market Snapshot

12.3.1. U.K. Regulatory Affairs Outsourcing Market

12.3.2. Germany Regulatory Affairs Outsourcing Market

12.3.3. France Regulatory Affairs Outsourcing Market

12.3.4. Spain Regulatory Affairs Outsourcing Market

12.3.5. Italy Regulatory Affairs Outsourcing Market

12.3.6. Rest of Europe Regulatory Affairs Outsourcing Market

12.4. Asia-Pacific Regulatory Affairs Outsourcing Market Snapshot

12.4.1. China Regulatory Affairs Outsourcing Market

12.4.2. India Regulatory Affairs Outsourcing Market

12.4.3. Japan Regulatory Affairs Outsourcing Market

12.4.4. Australia Regulatory Affairs Outsourcing Market

12.4.5. South Korea Regulatory Affairs Outsourcing Market

12.4.6. Rest of Asia Pacific Regulatory Affairs Outsourcing Market

12.5. Latin America Regulatory Affairs Outsourcing Market Snapshot

12.5.1. Brazil Regulatory Affairs Outsourcing Market

12.5.2. Mexico Regulatory Affairs Outsourcing Market

12.6. Rest of The World Regulatory Affairs Outsourcing Market

Chapter 13. Competitive Intelligence

13.1. Top Market Strategies

13.2. Company Profiles

13.2.1. Accell Clinical Research, LLC

13.2.1.1. Key Information

13.2.1.2. Overview

13.2.1.3. Financial (Subject to Data Availability)

13.2.1.4. Company Size Summary

13.2.1.5. Recent Developments

13.2.2. GenPact Ltd.

13.2.3. Criterium, Inc.

13.2.4. PRA Health Sciences

13.2.5. Promedica International

13.2.6. Dr. Regenold GmbH

13.2.7. BioMapas

13.2.8. Zeincro Group

13.2.9. Parexel International Corp.

13.2.10. Charles River Laboratories International, Inc.

Chapter 14. Research Process

14.1. Research Process

14.1.1. Data Mining

14.1.2. Analysis

14.1.3. Market Estimation

14.1.4. Validation

14.1.5. Publishing

14.2. Research Attributes

14.3. Research Assumption

List of Tables

TABLE 1. Global Regulatory Affairs Outsourcing Market, report scope

TABLE 2. Global Regulatory Affairs Outsourcing Market estimates & forecasts by Region 2018-2028 (USD Billion)

TABLE 3. Global Regulatory Affairs Outsourcing Market estimates & forecasts by Services 2018-2028 (USD Billion)

TABLE 4. Global Regulatory Affairs Outsourcing Market estimates & forecasts by Company Size 2018-2028 (USD Billion)

TABLE 5. Global Regulatory Affairs Outsourcing Market estimates & forecasts by Category 2018-2028 (USD Billion)

TABLE 6. Global Regulatory Affairs Outsourcing Market estimates & forecasts by Indication 2018-2028 (USD Billion)

TABLE 7. Global Regulatory Affairs Outsourcing Market estimates & forecasts by Stage 2018-2028 (USD Billion)

TABLE 8. Global Regulatory Affairs Outsourcing Market estimates & forecasts by End-use 2018-2028 (USD Billion)

TABLE 9. Global Regulatory Affairs Outsourcing Market by segment, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 10. Global Regulatory Affairs Outsourcing Market by region, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 11. Global Regulatory Affairs Outsourcing Market by segment, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 12. Global Regulatory Affairs Outsourcing Market by region, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 13. Global Regulatory Affairs Outsourcing Market by segment, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 14. Global Regulatory Affairs Outsourcing Market by region, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 15. Global Regulatory Affairs Outsourcing Market by segment, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 16. Global Regulatory Affairs Outsourcing Market by region, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 17. Global Regulatory Affairs Outsourcing Market by segment, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 18. Global Regulatory Affairs Outsourcing Market by region, estimates & forecasts, 2018-2028 (USD Billion)

TABLE 19. U.S. Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 20. U.S. Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 21. U.S. Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 22. Canada Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 23. Canada Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 24. Canada Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 25. UK Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 26. UK Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 27. UK Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 28. Germany Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 29. Germany Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 30. Germany Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 31. RoE Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 32. RoE Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 33. RoE Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 34. China Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 35. China Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 36. China Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 37. India Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 38. India Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 39. India Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 40. Japan Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 41. Japan Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 42. Japan Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 43. RoAPAC Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 44. RoAPAC Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 45. RoAPAC Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 46. Brazil Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 47. Brazil Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 48. Brazil Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 49. Mexico Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 50. Mexico Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 51. Mexico Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 52. RoLA Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 53. RoLA Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 54. RoLA Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 55. Row Regulatory Affairs Outsourcing Market estimates & forecasts, 2018-2028 (USD Billion)

TABLE 56. Row Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 57. Row Regulatory Affairs Outsourcing Market estimates & forecasts by segment 2018-2028 (USD Billion)

TABLE 58. List of secondary sources, used in the study of global Regulatory Affairs Outsourcing Market

TABLE 59. List of primary sources, used in the study of global Regulatory Affairs Outsourcing Market

TABLE 60. Years considered for the study

TABLE 61. Exchange rates considered

 
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