1.
Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2.
Research Methodology
2.1.
Objective of the Study
2.2.
Baseline Methodology
2.3.
Key Industry Partners
2.4.
Major Association and Secondary Sources
2.5.
Forecasting Methodology
2.6.
Data Triangulation & Validation
2.7.
Assumptions and Limitations
3.
Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market
Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key
Regions/Countries
3.5. Overview of Market Drivers,
Challenges, Trends
4.
Voice of Customer
5. Global Regulatory Affairs Outsourcing Market Outlook
5.1.
Market Size & Forecast
5.1.1. By Value
5.2.
Market Share & Forecast
5.2.1. By Service
(Regulatory Consulting, Legal Representation, Regulatory Writing &
Publishing, Product registration & clinical trial applications, Regulatory
Submissions, Regulatory Operations, Other services)
5.2.2. By Category (Pharmaceutical, Medical Device)
5.2.3. By Company Size (Small Companies, Medium Companies, Large
Companies)
5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies,
Biotechnology Companies)
5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle
East & Africa)
5.2.8. By Company (2022)
5.3.
Market Map
5.3.1 By Service
5.3.2 By Category
5.3.3 By Company
Size
5.3.4 By Indication
5.3.5 By Product
Stage
5.3.6 By End Use
6.
North America Regulatory Affairs Outsourcing
Market Outlook
6.1.
Market Size & Forecast
6.1.1. By Value
6.2.
Market Share & Forecast
6.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory
Writing & Publishing, Product registration & clinical trial
applications, Regulatory Submissions, Regulatory Operations, Other services)
6.2.2. By Category (Pharmaceutical, Medical Device)
6.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
6.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
6.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
6.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies,
Biotechnology Companies)
6.2.7. By Country
6.3.
North America: Country Analysis
6.3.1. United States
Regulatory Affairs Outsourcing Market Outlook
6.3.1.1.
Market Size & Forecast
6.3.1.1.1.
By Value
6.3.1.2.
Market Share & Forecast
6.3.1.2.1.
By Service
6.3.1.2.2.
By Category
6.3.1.2.3.
By Company Size
6.3.1.2.4.
By Indication
6.3.1.2.5.
By Product Stage
6.3.1.2.6.
By End Use
6.3.2. Canada Regulatory
Affairs Outsourcing Market Outlook
6.3.2.1.
Market Size & Forecast
6.3.2.1.1.
By Value
6.3.2.2.
Market Share & Forecast
6.3.2.2.1.
By Service
6.3.2.2.2.
By Category
6.3.2.2.3.
By Company Size
6.3.2.2.4.
By Indication
6.3.2.2.5.
By Product Stage
6.3.2.2.6.
By End Use
6.3.3. Mexico Regulatory
Affairs Outsourcing Market Outlook
6.3.3.1.
Market Size & Forecast
6.3.3.1.1.
By Value
6.3.3.2.
Market Share & Forecast
6.3.3.2.1.
By Service
6.3.3.2.2.
By Category
6.3.3.2.3.
By Company Size
6.3.3.2.4.
By Indication
6.3.3.2.5.
By Product Stage
6.3.3.2.6.
By End Use
7. Europe Regulatory
Affairs Outsourcing Market Outlook
7.1.
Market Size & Forecast
7.1.1. By Value
7.2.
Market Share & Forecast
7.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory
Writing & Publishing, Product registration & clinical trial
applications, Regulatory Submissions, Regulatory Operations, Other services)
7.2.2. By Category (Pharmaceutical, Medical Device)
7.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
7.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
7.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
7.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies,
Biotechnology Companies)
7.2.7. By Country
7.3.
Europe: Country Analysis
7.3.1. France Regulatory
Affairs Outsourcing Market Outlook
7.3.1.1.
Market Size & Forecast
7.3.1.1.1.
By Value
7.3.1.2.
Market Share & Forecast
7.3.1.2.1.
By Service
7.3.1.2.2.
By Category
7.3.1.2.3.
By Company Size
7.3.1.2.4.
By Indication
7.3.1.2.5.
By Product Stage
7.3.1.2.6.
By End Use
7.3.2. Germany Regulatory
Affairs Outsourcing Market Outlook
7.3.2.1.
Market Size & Forecast
7.3.2.1.1.
By Value
7.3.2.2.
Market Share & Forecast
7.3.2.2.1.
By Service
7.3.2.2.2.
By Category
7.3.2.2.3.
By Company Size
7.3.2.2.4.
By Indication
7.3.2.2.5.
By Product Stage
7.3.2.2.6.
By End Use
7.3.3. United Kingdom
Regulatory Affairs Outsourcing Market Outlook
7.3.3.1.
Market Size & Forecast
7.3.3.1.1.
By Value
7.3.3.2.
Market Share & Forecast
7.3.3.2.1.
By Service
7.3.3.2.2.
By Category
7.3.3.2.3.
By Company Size
7.3.3.2.4.
By Indication
7.3.3.2.5.
By Product Stage
7.3.3.2.6.
By End Use
7.3.4. Italy Regulatory
Affairs Outsourcing Market Outlook
7.3.4.1.
Market Size & Forecast
7.3.4.1.1.
By Value
7.3.4.2.
Market Share & Forecast
7.3.4.2.1.
By Service
7.3.4.2.2.
By Category
7.3.4.2.3.
By Company Size
7.3.4.2.4.
By Indication
7.3.4.2.5.
By Product Stage
7.3.4.2.6.
By End Use
7.3.5. Spain Regulatory
Affairs Outsourcing Market Outlook
7.3.5.1.
Market Size & Forecast
7.3.5.1.1.
By Value
7.3.5.2.
Market Share & Forecast
7.3.5.2.1.
By Service
7.3.5.2.2.
By Category
7.3.5.2.3.
By Company Size
7.3.5.2.4.
By Indication
7.3.5.2.5.
By Product Stage
7.3.5.2.6.
By End Use
8. Asia-Pacific
Regulatory Affairs Outsourcing Market Outlook
8.1.
Market Size & Forecast
8.1.1. By Value
8.2.
Market Share & Forecast
8.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory
Writing & Publishing, Product registration & clinical trial applications,
Regulatory Submissions, Regulatory Operations, Other services)
8.2.2. By Category (Pharmaceutical, Medical Device)
8.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
8.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
8.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
8.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies,
Biotechnology Companies)
8.2.7.
By Country
8.3.
Asia-Pacific: Country Analysis
8.3.1. China Regulatory
Affairs Outsourcing Market Outlook
8.3.1.1.
Market Size & Forecast
8.3.1.1.1.
By Value
8.3.1.2.
Market Share & Forecast
8.3.1.2.1.
By Service
8.3.1.2.2.
By Category
8.3.1.2.3.
By Company Size
8.3.1.2.4.
By Indication
8.3.1.2.5.
By Product Stage
8.3.1.2.6.
By End Use
8.3.2. India Regulatory
Affairs Outsourcing Market Outlook
8.3.2.1.
Market Size & Forecast
8.3.2.1.1.
By Value
8.3.2.2.
Market Share & Forecast
8.3.2.2.1.
By Service
8.3.2.2.2.
By Category
8.3.2.2.3.
By Company Size
8.3.2.2.4.
By Indication
8.3.2.2.5.
By Product Stage
8.3.2.2.6.
By End Use
8.3.3. Japan Regulatory
Affairs Outsourcing Market Outlook
8.3.3.1.
Market Size & Forecast
8.3.3.1.1.
By Value
8.3.3.2.
Market Share & Forecast
8.3.3.2.1.
By Service
8.3.3.2.2.
By Category
8.3.3.2.3.
By Company Size
8.3.3.2.4.
By Indication
8.3.3.2.5.
By Product Stage
8.3.3.2.6.
By End Use
8.3.4. South Korea
Regulatory Affairs Outsourcing Market Outlook
8.3.4.1.
Market Size & Forecast
8.3.4.1.1.
By Value
8.3.4.2.
Market Share & Forecast
8.3.4.2.1.
By Service
8.3.4.2.2.
By Category
8.3.4.2.3.
By Company Size
8.3.4.2.4.
By Indication
8.3.4.2.5.
By Product Stage
8.3.4.2.6.
By End Use
8.3.5. Australia Regulatory
Affairs Outsourcing Market Outlook
8.3.5.1.
Market Size & Forecast
8.3.5.1.1.
By Value
8.3.5.2.
Market Share & Forecast
8.3.5.2.1.
By Service
8.3.5.2.2.
By Category
8.3.5.2.3.
By Company Size
8.3.5.2.4.
By Indication
8.3.5.2.5.
By Product Stage
8.3.5.2.6.
By End Use
9. South America
Regulatory Affairs Outsourcing Market Outlook
9.1.
Market Size & Forecast
9.1.1. By Value
9.2.
Market Share & Forecast
9.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory
Writing & Publishing, Product registration & clinical trial
applications, Regulatory Submissions, Regulatory Operations, Other services)
9.2.2. By Category (Pharmaceutical, Medical Device)
9.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
9.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
9.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
9.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies,
Biotechnology Companies)
9.2.7.
By Country
9.3.
South America: Country Analysis
9.3.1. Brazil Regulatory
Affairs Outsourcing Market Outlook
9.3.1.1.
Market Size & Forecast
9.3.1.1.1.
By Value
9.3.1.2.
Market Share & Forecast
9.3.1.2.1.
By Service
9.3.1.2.2.
By Category
9.3.1.2.3.
By Company Size
9.3.1.2.4.
By Indication
9.3.1.2.5.
By Product Stage
9.3.1.2.6.
By End Use
9.3.2. Argentina Regulatory
Affairs Outsourcing Market Outlook
9.3.2.1.
Market Size & Forecast
9.3.2.1.1.
By Value
9.3.2.2.
Market Share & Forecast
9.3.2.2.1.
By Service
9.3.2.2.2.
By Category
9.3.2.2.3.
By Company Size
9.3.2.2.4.
By Indication
9.3.2.2.5.
By Product Stage
9.3.2.2.6.
By End Use
9.3.3. Colombia Regulatory
Affairs Outsourcing Market Outlook
9.3.3.1.
Market Size & Forecast
9.3.3.1.1.
By Value
9.3.3.2.
Market Share & Forecast
9.3.3.2.1.
By Service
9.3.3.2.2.
By Category
9.3.3.2.3.
By Company Size
9.3.3.2.4.
By Indication
9.3.3.2.5.
By Product Stage
9.3.3.2.6.
By End Use
10. Middle East and
Africa Regulatory Affairs Outsourcing Market Outlook
10.1.
Market Size & Forecast
10.1.1. By Value
10.2.
Market Share & Forecast
10.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory
Writing & Publishing, Product registration & clinical trial
applications, Regulatory Submissions, Regulatory Operations, Other services)
10.2.2. By Category (Pharmaceutical, Medical Device)
10.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
10.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
10.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
10.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies,
Biotechnology Companies)
10.2.7.
By Country
10.3.
MEA: Country Analysis
10.3.1. South Africa
Regulatory Affairs Outsourcing Market Outlook
10.3.1.1. Market Size &
Forecast
10.3.1.1.1.
By Value
10.3.1.2. Market Share &
Forecast
10.3.1.2.1.
By Service
10.3.1.2.2.
By Category
10.3.1.2.3.
By Company Size
10.3.1.2.4.
By Indication
10.3.1.2.5.
By Product Stage
10.3.1.2.6.
By End Use
10.3.2. Saudi Arabia
Regulatory Affairs Outsourcing Market Outlook
10.3.2.1. Market Size &
Forecast
10.3.2.1.1.
By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1.
By Service
10.3.2.2.2.
By Category
10.3.2.2.3.
By Company Size
10.3.2.2.4.
By Indication
10.3.2.2.5.
By Product Stage
10.3.2.2.6.
By End Use
10.3.3. UAE Regulatory
Affairs Outsourcing Market Outlook
10.3.3.1. Market Size &
Forecast
10.3.3.1.1.
By Value
10.3.3.2. Market Share &
Forecast
10.3.3.2.1.
By Service
10.3.3.2.2.
By Category
10.3.3.2.3.
By Company Size
10.3.3.2.4.
By Indication
10.3.3.2.5.
By Product Stage
10.3.3.2.6.
By End Use
11.
Market Dynamics
11.1.
Drivers
11.2.
Challenges
12.
Market Trends & Developments
12.1.
Recent Development
12.2.
Mergers & Acquisitions
12.3.
Product Launches
13. Global Regulatory Affairs Outsourcing Market: SWOT Analysis
14. Porter’s Five Forces Analysis
14.1.
Competition in the Industry
14.2.
Potential of New Entrants
14.3.
Power of Suppliers
14.4.
Power of Customers
14.5.
Threat of Substitute Products
15.
Competitive Landscape
15.1.
Business Overview
15.2.
Product Offerings
15.3.
Recent Developments
15.4.
Financials (As Reported)
15.5.
Key Personnel
15.6.
SWOT Analysis
15.6.1 Accell Clinical Research, LLC.
15.6.2 Genpact Ltd.
15.6.3 CRITERIUM, INC.
15.6.4 Promedica International.
15.6.5 WuXi AppTec Co Ltd.
15.6.6 Medpace Inc.
15.6.7 Charles River Laboratories.
15.6.8 ICON plc.
15.6.9 Covance, Inc.
15.6.10
Parexel International Corporation.
15.6.11
Freyr AS
15.6.12
PHARMALEX GMBH
15.6.13
NDA Group AB
15.6.14
Pharmexon Consulting.
15.6.15
Qvigilance
15.6.16
BlueReg Group.
16. Strategic Recommendations