Global Regulatory Affairs Outsourcing Market- Industry Analysis and forecast 2026: By Service and Region

Global Regulatory Affairs Outsourcing Market- Industry Analysis and forecast 2026: By Service and Region

Market Scenario

Global Regulatory Affairs Outsourcing Market was valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at CAGR of 12.8% during forecast period of 2019 to 2026.  Drivers and Restrains: Regulatory outsourcing has now become a norm as various companies are looking for partners to manage operational tasks containing report publishing and submission publishing. Regulatory affairs outsourcing are the services used by the pharmaceutical, medical and biotech devices manufacturing companies for gaining fast regulatory approvals from several organizations. The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis. Increasing R&D activities especially in the life science industry across the world for the reduction in overall approval process by reducing delays in regulatory filings and rise in cost efficiency, and the development in the return on investment (ROI) are expected to drive the regulatory affairs outsourcing market growth. Moreover, Changing regulatory mandates are anticipated to drive the market growth globally. e.g., ICH E17 guidance on multi-regional clinical trials are published by the U.S Food and Drug Administration (FDA). This initiative is expected to bring global clinical trials under a single protocol, submitted by numerous authorities in different regions. The global regulatory affairs outsourcing market is driven by economic and competitive pressures, growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. However, the risk associated with data security, technological advancement, which is leading to rapid pricing fluctuations, monitoring issues and lack of standardization are hampering the market growth at the global level. Emerging economies are likely to create lucrative opportunities in the global regulatory affairs outsourcing market. This is evidence, as the revenue from emerging economies are estimated to reach approximately US$ XX million by 2026. An implementation of changing rules are the key challenges for the global regulatory affairs outsourcing market during the forecast period. Global Regulatory Affairs Outsourcing Market Segmentation Analysis: Based on the service, the regulatory writing and publishing segment held the XX% market share of the regulatory affairs outsourcing market in 2018 and is expected to continue its leading position over the forecast period. The Legal representation and Regulatory consulting segments are expected to grow at the highest CAGR of 14%, over the upcoming period, owing to regulatory reforms in the developing countries. Rising adoption of legal representatives in industrialized regions such as North America and Europe are gaining traction for the insights regarding market authorization for companies who want to set up a base in the respective country. Globalization of clinical trials particularly in regions such as the Asia Pacific and Latin America are estimated to gain demand for clinical trial application and product registration services, thereby contributing to the market growth. Global Regulatory Affairs Outsourcing Market Regional Analysis: Geographically, the regulatory affairs outsourcing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America was valued US$ XX Mn in 2018 for regulatory affairs outsourcing market and is estimated to reach US$ Mn end of 2026, with a CAGR of XX%. Due to the existence of life sciences and pharmaceutical companies, implementation of well-structured regulatory policies such as FDA and the availability of talent pool will contribute to the overall market growth. But, high service cost than developing economies such as Latin America and Asia Pacific are a major challenge affecting the regional market growth. Asia Pacific is projected to be the fastest-growing region in the near future. The region is expected to hold the XX% of market share in the upcoming period. Rising cases of regulatory filings and the availability of low-cost labor are the factors impelling the regional growth. The development of multinational pharmaceutical and life science companies are also projected to boost the regional demand. The objective of the report is to present a comprehensive analysis of global regulatory affairs outsourcing market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants by region. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the market are presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers. The report also helps in understanding global regulatory affairs outsourcing market dynamics, structure by analyzing the market segments and project the global regulatory affairs outsourcing market size. Clear representation of competitive analysis of key players By Type, Price, Financial position, Product portfolio, Growth strategies, and regional presence in the global regulatory affairs outsourcing market make the report investor’s guide.

Scope of the Global Regulatory Affairs Outsourcing Market:

Global Regulatory Affairs Outsourcing Market, by Service:

• Regulatory consulting • Legal representation • Regulatory writing and publishing • Product registration and clinical trial application • Other regulatory services

Global Regulatory Affairs Outsourcing Market, by Region:

• Asia Pacific • North America • Europe • Latin America • Middle East Africa

Global Regulatory Affairs Outsourcing Market, Major Players:

• Accell Clinical Research • PRA International • PAREXEL International Corporation • Quintiles Transnational Holdings • Charles River Laboratories International Inc. • Clinilabs Inc. • Criterium Inc. • Wuxi AppTec • Medpace Inc. • IQVIA Holdings Inc. • Pharmaceutical Product Development, (PPD) LLC • Promedica International • ICON plc. • BlueReg Group • Covance, Inc., • Dr.Regenold GmbH • FMD K&L • Genpact Limited • ProductLife Group S.A. • Intertek Group plc • Kinapse Ltd • Medpace, Inc. • Navitas Life Sciences • PharmaLex GmbH • PRA Health Sciences, Inc. • Syneos Health, Inc. • Verisk 3E. Global Meningococcal Vaccines Market

Table of Contents

Global Regulatory Affairs Outsourcing Market 1. Preface 1.1. Report Scope and Market Segmentation 1.2. Research Highlights 1.3. Research Objectives 2. Assumptions and Research Methodology 2.1. Report Assumptions 2.2. Abbreviations 2.3. Research Methodology 2.3.1. Secondary Research 2.3.1.1. Secondary data 2.3.1.2. Secondary Sources 2.3.2. Primary Research 2.3.2.1. Data from Primary Sources 2.3.2.2. Breakdown of Primary Sources 3. Executive Summary: Global Regulatory Affairs Outsourcing Market Size, by Market Value (US$ Mn) 4. Market Overview 4.1. Introduction 4.2. Market Indicator 4.2.1. Drivers 4.2.2. Restraints 4.2.3. Opportunities 4.2.4. Challenges 4.3. Porter’s Analysis 4.4. Value Chain Analysis 4.5. Market Risk Analysis 4.6. SWOT Analysis 4.7. Industry Trends and Emerging Technologies 5. Supply Side and Demand Side Indicators 6. Global Regulatory Affairs Outsourcing Market Analysis and Forecast 6.1. Global Regulatory Affairs Outsourcing Market Size & Y-o-Y Growth Analysis 6.1.1. North America 6.1.2. Europe 6.1.3. Asia Pacific 6.1.4. Middle East & Africa 6.1.5. South America 7. Global Regulatory Affairs Outsourcing Market Analysis and Forecast, by Service 7.1. Introduction and Definition 7.2. Key Findings 7.3. Global Regulatory Affairs Outsourcing Market Value Share Analysis, by Service 7.4. Global Regulatory Affairs Outsourcing Market Size (US$ Mn) Forecast, by Service 7.5. Global Regulatory Affairs Outsourcing Market Analysis, by Service 7.6. Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Service 8. Global Regulatory Affairs Outsourcing Market Analysis, by Region 8.1. Global Regulatory Affairs Outsourcing Market Value Share Analysis, by Region 8.2. Global Regulatory Affairs Outsourcing Market Size (US$ Mn) Forecast, by Region 8.3. Global Regulatory Affairs Outsourcing Market Attractiveness Analysis, by Region 9. North America Regulatory Affairs Outsourcing Market Analysis 9.1. Key Findings 9.2. North America Regulatory Affairs Outsourcing Market Overview 9.3. North America Regulatory Affairs Outsourcing Market Value Share Analysis, by Service 9.4. North America Regulatory Affairs Outsourcing Market Forecast, by Service 9.4.1. Regulatory consulting 9.4.2. Legal representation 9.4.3. Regulatory writing and publishing 9.4.4. Product registration and clinical trial application 9.4.5. Other regulatory service 9.5. North America Regulatory Affairs Outsourcing Market Value Share Analysis, by Country 9.6. North America Regulatory Affairs Outsourcing Market Forecast, by Country 9.6.1. U.S. 9.6.2. Canada 9.7. North America Regulatory Affairs Outsourcing Market Analysis, by Country 9.8. U.S. Regulatory Affairs Outsourcing Market Forecast, by Service 9.8.1. Regulatory consulting 9.8.2. Legal representation 9.8.3. Regulatory writing and publishing 9.8.4. Product registration and clinical trial application 9.8.5. Other regulatory service 9.9. Canada Regulatory Affairs Outsourcing Market Forecast, by Service 9.9.1. Regulatory consulting 9.9.2. Legal representation 9.9.3. Regulatory writing and publishing 9.9.4. Product registration and clinical trial application 9.9.5. Other regulatory service 9.10. North America Regulatory Affairs Outsourcing Market Attractiveness Analysis 9.10.1. By Service 9.11. PEST Analysis 9.12. Key Trends 9.13. Key Developments 10. Europe Regulatory Affairs Outsourcing Market Analysis 10.1. Key Findings 10.2. Europe Regulatory Affairs Outsourcing Market Overview 10.3. Europe Regulatory Affairs Outsourcing Market Value Share Analysis, by Service 10.4. Europe Regulatory Affairs Outsourcing Market Forecast, by Service 10.4.1. Regulatory consulting 10.4.2. Legal representation 10.4.3. Regulatory writing and publishing 10.4.4. Product registration and clinical trial application 10.4.5. Other regulatory service 10.5. Europe Regulatory Affairs Outsourcing Market Value Share Analysis, by Country 10.6. Europe Regulatory Affairs Outsourcing Market Forecast, by Country 10.6.1. Germany 10.6.2. U.K. 10.6.3. France 10.6.4. Italy 10.6.5. Spain 10.6.6. Rest of Europe 10.7. Europe Regulatory Affairs Outsourcing Market Analysis, by Country 10.8. Germany Regulatory Affairs Outsourcing Market Forecast, by Service 10.8.1. Regulatory consulting 10.8.2. Legal representation 10.8.3. Regulatory writing and publishing 10.8.4. Product registration and clinical trial application 10.8.5. Other regulatory service 10.9. U.K. Regulatory Affairs Outsourcing Market Forecast, by Service 10.9.1. Regulatory consulting 10.9.2. Legal representation 10.9.3. Regulatory writing and publishing 10.9.4. Product registration and clinical trial application 10.9.5. Other regulatory service 10.10. France Regulatory Affairs Outsourcing Market Forecast, by Service 10.10.1. Regulatory consulting 10.10.2. Legal representation 10.10.3. Regulatory writing and publishing 10.10.4. Product registration and clinical trial application 10.10.5. Other regulatory service 10.11. Italy Regulatory Affairs Outsourcing Market Forecast, by Service 10.11.1. Regulatory consulting 10.11.2. Legal representation 10.11.3. Regulatory writing and publishing 10.11.4. Product registration and clinical trial application 10.11.5. Other regulatory service 10.12. Spain Regulatory Affairs Outsourcing Market Forecast, by Service 10.12.1. Regulatory consulting 10.12.2. Legal representation 10.12.3. Regulatory writing and publishing 10.12.4. Product registration and clinical trial application 10.12.5. Other regulatory service 10.13. Rest of Europe Regulatory Affairs Outsourcing Market Forecast, by Service 10.13.1. Regulatory consulting 10.13.2. Legal representation 10.13.3. Regulatory writing and publishing 10.13.4. Product registration and clinical trial application 10.13.5. Other regulatory service 10.14. Europe Regulatory Affairs Outsourcing Market Attractiveness Analysis 10.14.1. By Service 10.15. PEST Analysis 10.16. Key Trends 10.17. Key Developments 11. Asia Pacific Regulatory Affairs Outsourcing Market Analysis 11.1. Key Findings 11.2. Asia Pacific Regulatory Affairs Outsourcing Market Overview 11.3. Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, by Service 11.4. Asia Pacific Regulatory Affairs Outsourcing Market Forecast, by Service 11.4.1. Regulatory consulting 11.4.2. Legal representation 11.4.3. Regulatory writing and publishing 11.4.4. Product registration and clinical trial application 11.4.5. Other regulatory service 11.5. Asia Pacific Regulatory Affairs Outsourcing Market Value Share Analysis, by Country 11.6. Asia Pacific Regulatory Affairs Outsourcing Market Forecast, by Country 11.6.1. China 11.6.2. India 11.6.3. Japan 11.6.4. ASEAN 11.6.5. Rest of Asia Pacific 11.7. Asia Pacific Regulatory Affairs Outsourcing Market Analysis, by Country 11.8. China Regulatory Affairs Outsourcing Market Forecast, by Service 11.8.1. Regulatory consulting 11.8.2. Legal representation 11.8.3. Regulatory writing and publishing 11.8.4. Product registration and clinical trial application 11.8.5. Other regulatory service 11.9. India Regulatory Affairs Outsourcing Market Forecast, by Service 11.9.1. Regulatory consulting 11.9.2. Legal representation 11.9.3. Regulatory writing and publishing 11.9.4. Product registration and clinical trial application 11.9.5. Other regulatory service 11.10. Japan Regulatory Affairs Outsourcing Market Forecast, by Service 11.10.1. Regulatory consulting 11.10.2. Legal representation 11.10.3. Regulatory writing and publishing 11.10.4. Product registration and clinical trial application 11.10.5. Other regulatory service 11.11. ASEAN Regulatory Affairs Outsourcing Market Forecast, by Service 11.11.1. Regulatory consulting 11.11.2. Legal representation 11.11.3. Regulatory writing and publishing 11.11.4. Product registration and clinical trial application 11.11.5. Other regulatory service 11.12. Rest of Asia Pacific Regulatory Affairs Outsourcing Market Forecast, by Service 11.12.1. Regulatory consulting 11.12.2. Legal representation 11.12.3. Regulatory writing and publishing 11.12.4. Product registration and clinical trial application 11.12.5. Other regulatory service 11.13. Asia Pacific Regulatory Affairs Outsourcing Market Attractiveness Analysis 11.13.1. By Service 11.14. PEST Analysis 11.15. Key Trends 11.16. Key Developments 12. Middle East & Africa Regulatory Affairs Outsourcing Market Analysis 12.1. Key Findings 12.2. Middle East & Africa Regulatory Affairs Outsourcing Market Overview 12.3. Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, by Service 12.4. Middle East & Africa Regulatory Affairs Outsourcing Market Forecast, by Service 12.4.1. Regulatory consulting 12.4.2. Legal representation 12.4.3. Regulatory writing and publishing 12.4.4. Product registration and clinical trial application 12.4.5. Other regulatory service 12.5. Middle East & Africa Regulatory Affairs Outsourcing Market Value Share Analysis, by Country 12.6. Middle East & Africa Regulatory Affairs Outsourcing Market Forecast, by Country 12.6.1. GCC 12.6.2. South Africa 12.6.3. Rest of Middle East & Africa 12.7. Middle East & Africa Regulatory Affairs Outsourcing Market Analysis, by Country 12.8. GCC Regulatory Affairs Outsourcing Market Forecast, by Service 12.8.1. Regulatory consulting 12.8.2. Legal representation 12.8.3. Regulatory writing and publishing 12.8.4. Product registration and clinical trial application 12.8.5. Other regulatory service 12.9. South Africa Regulatory Affairs Outsourcing Market Forecast, by Service 12.9.1. Regulatory consulting 12.9.2. Legal representation 12.9.3. Regulatory writing and publishing 12.9.4. Product registration and clinical trial application 12.9.5. Other regulatory service 12.10. Rest of Middle East & Africa Regulatory Affairs Outsourcing Market Forecast, by Service 12.10.1. Regulatory consulting 12.10.2. Legal representation 12.10.3. Regulatory writing and publishing 12.10.4. Product registration and clinical trial application 12.10.5. Other regulatory service 12.11. Middle East & Africa Regulatory Affairs Outsourcing Market Attractiveness Analysis 12.11.1. By Service 12.12. PEST Analysis 12.13. Key Trends 12.14. Key Developments 13. South America Regulatory Affairs Outsourcing Market Analysis 13.1. Key Findings 13.2. South America Regulatory Affairs Outsourcing Market Overview 13.3. South America Regulatory Affairs Outsourcing Market Value Share Analysis, by Service 13.4. South America Regulatory Affairs Outsourcing Market Forecast, by Service 13.4.1. Regulatory consulting 13.4.2. Legal representation 13.4.3. Regulatory writing and publishing 13.4.4. Product registration and clinical trial application 13.4.5. Other regulatory service 13.5. South America Regulatory Affairs Outsourcing Market Value Share Analysis, by Country 13.6. South America Regulatory Affairs Outsourcing Market Forecast, by Country 13.6.1. Brazil 13.6.2. Mexico 13.6.3. Rest of South America 13.7. South America Regulatory Affairs Outsourcing Market Analysis, by Country 13.8. Brazil Regulatory Affairs Outsourcing Market Forecast, by Service 13.8.1. Regulatory consulting 13.8.2. Legal representation 13.8.3. Regulatory writing and publishing 13.8.4. Product registration and clinical trial application 13.8.5. Other regulatory service 13.9. Mexico Regulatory Affairs Outsourcing Market Forecast, by Service 13.9.1. Regulatory consulting 13.9.2. Legal representation 13.9.3. Regulatory writing and publishing 13.9.4. Product registration and clinical trial application 13.9.5. Other regulatory service 13.10. Rest of South America Regulatory Affairs Outsourcing Market Forecast, by Service 13.10.1. Regulatory consulting 13.10.2. Legal representation 13.10.3. Regulatory writing and publishing 13.10.4. Product registration and clinical trial application 13.10.5. Other regulatory service 13.11. South America Regulatory Affairs Outsourcing Market Attractiveness Analysis 13.11.1. By Service 13.12. PEST Analysis 13.13. Key Trends 13.14. Key Developments 14. Company Profiles 14.1. Market Share Analysis, by Company 14.2. Competition Matrix 14.2.1. Competitive Benchmarking of key players by price, presence, market share, Applications and R&D investment 14.2.2. Market Consolidation 14.2.2.1. M&A by Regions, Investment and Applications 14.2.2.2. M&A Key Players, Forward Integration and Backward Integration 14.3. Company Profiles: Key Players 14.3.1. Accell Clinical Research 14.3.1.1. Company Overview 14.3.1.2. Financial Overview 14.3.1.3. Product Portfolio 14.3.1.4. Business Strategy 14.3.1.5. Recent Developments 14.3.1.6. Development Footprint 14.3.2. PRA International 14.3.3. PAREXEL International Corporation 14.3.4. Quintiles Transnational Holdings 14.3.5. Charles River Laboratories International Inc. 14.3.6. Clinilabs Inc. 14.3.7. Criterium Inc. 14.3.8. Wuxi AppTec 14.3.9. Medpace Inc. 14.3.10. IQVIA Holdings Inc. 14.3.11. Pharmaceutical Product Development, (PPD) LLC 14.3.12. Promedica International 14.3.13. ICON plc. 14.3.14. BlueReg Group 14.3.15. Covance, Inc., 14.3.16. Dr.Regenold GmbH 14.3.17. FMD K&L 14.3.18. Genpact Limited 14.3.19. ProductLife Group S.A. 14.3.20. Intertek Group plc 14.3.21. Kinapse Ltd 14.3.22. Medpace, Inc. 14.3.23. Navitas Life Sciences 14.3.24. PharmaLex GmbH 14.3.25. PRA Health Sciences, Inc. 14.3.26. Syneos Health, Inc. 14.3.27. Verisk 3E. 15. Primary Key Insights

About This Report

Report ID44332
Category Medical Devices
Published DateJan 2020
No of Pages302
Contact Us
Call Now