Regulatory Affairs Outsourcing Market
Regulatory Affairs Outsourcing Market Study by Regulatory Consulting, Legal Representation, and Regulatory Writing & Publishing for Oncology, Neurology, Radiology, and Immunology from 2024 to 2034
Analysis of Regulatory Affairs Outsourcing Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more
Regulatory Affairs Outsourcing Market Outlook (2024 to 2034)
Global revenue from regulatory affairs outsourcing is approximated at US$ 17.4 billion in 2024. The market has been projected by this recent report by Fact.MR to register 7.3% CAGR and reach a valuation of US$ 35.31 billion by 2034.
Increasing number of clinical trial applications and growing product registration are key factors boosting the regulatory affairs outsourcing market growth. The ongoing advancements in medicine manufacturing are set to boost the demand for pharmaceutical and biotechnology services outsourcing services. The integration of artificial intelligence, big data analytics, and machine learning in regulatory process are some of the emerging regulatory affairs outsourcing market trends.
Regulatory affairs outsourcing services are widely used to develop generic and orphan drugs. During the COVID-19 pandemic, the need for regulatory affairs outsourcing acquired high importance. Highly contagious and debilitating nature of the disease lead pharmaceutical research organizations and medical companies to come together for the development of anti-COVID drugs and vaccines. This required respective governments at a pan-global level to permit outsourcing of critical medical and pharmaceutical technology to global parties.
Aggressive geographical expansion initiatives by companies that aim for fast approvals in local markets is set to drive the demand for regulatory affairs outsourcing services over the next decade.
Report Attribute | Detail |
---|---|
Regulatory Affairs Outsourcing Market Size (2024E) | US$ 17.4 Billion |
Forecasted Market Value (2034F) | US$ 35.31 Billion |
Global Market Growth Rate (2024 to 2034) | 7.3% CAGR |
South Korea Market Value (2034F) | US$ 1.63 Billion |
East Asia Market Value (2034F) | US$ 6.29 Billion |
Regulatory Consulting Outsourcing Demand Growth (2024 to 2034) | 7.7% CAGR |
Key Companies Profiled |
|
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Which Market Dynamics are Increasing Popularity of Regulatory Affairs Outsourcing Services?
“Ongoing Research and Development Activities in Healthcare Sector Pushing Demand for Regulatory Affairs Outsourcing Services”
Increasing pressure on personal pockets and the growing measures taken by the governments of various countries to improve regulatory approval procedures are expected to boost demand for swift regulatory affairs outsourcing services. The ongoing developments in the healthcare sector along with extensive research and development (R&D) are other salient factors propelling the demand for regulatory affairs outsourcing services.
In addition, the rising need to reduce costs in the life-sciences industry is enhancing the demand for third-party services for regulatory affairs. Furthermore, the advent of efficient software that keeps the record of regulatory affairs is projected to provide a high boost to the market growth in the coming decade.
- The Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO) recently declared that they have decided to go cleaner and greener by diving into digitalization. The integration of advanced digital technologies is set to change the future of medicine production and the way regulatory process works.
Environmental concerns are further driving the need for sustainability practices and increasing the importance of circular manufacturing economy. The growing promise of precision medicine and integration of AI, ML and big data analytics is set to boost the overall market growth in the coming decade.
“Growing Focus on Development of Precision Medicine Driving Demand for Healthcare Contract Research Outsourcing Services”
Surge in the fixed costs of in-house regulatory affairs functions including technology, facilities, and training is set to boost the demand for reliable regulatory affairs outsourcing services. Big biopharma companies are focusing on the development of precision medicine due to the shift from recreation to prevention. The high expenses of trial and error are driving the popularity of precision medicine. To reduce the costs of drug development many small companies are outsourcing R&D to pre-clinical contract research outsourcing (CRO) services.
What’s Hampering Demand Growth for Regulatory Affairs Outsourcing Services?
“Threats Related to Outsourcing and Data Sharing”
Regulatory affairs outsourcing are highly vulnerable to cyber-attacks and privacy threats. The easy accessibility to several electronic digital solutions and digital documentations makes any organization vulnerable to cyber-attacks. The healthcare sector mainly moves around mergers, acquisitions, and collaborations. Various outsourcing partners have access to the sensitive data of pharmaceutical industries which is a threat to the security of companies. Thus sharing of critical data related patient information and contract increases the chances of cyber threat.
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How Can New Companies Stand Out in This Competitive Space?
“Focus of Advancing Safety Features Related to Data Exchange”
New companies eager to enter the regulatory affairs outsourcing market should focus on the development of secure and reliable services. Data theft and cyber-attack are major challenges faced by end users and to overcome these issues new companies should invest in advancing the safety steps and features controlling data exchange. They can also focus on integrating additional safety steps for verification.
Country-wise Analysis
What’s Influencing Demand for Regulatory Affairs Outsourcing Services in the United States?
“Strong Presence of Pharma and Medical Device Companies”
Attribute | United States |
---|---|
Market Value (2024E) | US$ 5.6 Billion |
Growth Rate (2024 to 2034) | 8.4% CAGR |
Projected Value (2034F) | US$ 12.57 Billion |
Presence of established pharmaceutical and medical devices companies is one of the key factors driving the demand for regulatory affairs outsourcing services in the United States. The contribution of the FDA (Food and Drug Administration) is a notable one since they regulate majority of the medical devices globally.
Will South Korea Be a Lucrative Market for Regulatory Affairs Service Providers?
“Market to Benefit from High Investments in Healthcare”
Attribute | South Korea |
---|---|
Market Value (2024E) | US$ 737.1 Million |
Growth Rate (2024 to 2034) | 8.3% CAGR |
Projected Value (2034F) | US$ 1.63 Billion |
Fact.MR, a market research and competitive intelligence provider reveals in its updated report that South Korea is projected to account for 26% of the East Asian market share by 2034. Aggressive investments in healthcare sector are set to create ample opportunities for regulatory affairs outsourcing service providers in the coming decade. The availability of skilled workforce and the rapid development of the life sciences sector are expected to increase the regulatory affairs outsourcing market growth in South Korea.
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Category-wise Analysis
Why Does Pre-clinical Outsourcing Hold a Leading Market Share?
“Strict Regulations Governing Pre-clinical Stage”
Attribute | Pre-clinical Stage |
---|---|
Segment Value (2024E) | US$ 10.42 Billion |
Growth Rate (2024 to 2034) | 7.4% CAGR |
Projected Value (2034F) | US$ 21.22 Billion |
- ClinicalTrials.gov estimates that at the start of year 2024 around 477,233 trials are registered and by the end of 2024 it is projected to reach 491,890.
The pre-clinical stage is expected to hold major position due to the rising need for effective therapies for contagious disease such as Zika virus, COVID-19, and Ebola and chronic disorders such as cancer, neurological, and cardiological diseases. Furthermore, strict regulations controlling pre-clinical trials is also driving need for effective regulatory affairs outsourcing services.
How are Pharmaceutical Companies Contributing to Increasing Demand for Regulatory Affairs Outsourcing Services?
“Rising Need for Biosimilars and Customized Medicines”
Attribute | Pharmaceutical Companies |
---|---|
Segment Value (2024E) | US$ 8.56 Billion |
Growth Rate (2024 to 2034) | 7.4% CAGR |
Projected Value (2034F) | US$ 17.44 Billion |
Increasing number of new drugs penetrating the pharmaceutical industry is expected to boost the regulatory affairs outsourcing service demand growth during the forecast period. The growing requirement for personalized orphan drugs & medicine, advanced medical technologies, and biologics is expected to offer lucrative opportunities for regulatory affairs outsourcing service providers.
Competitive Landscape
Key players in the global regulatory affairs outsourcing market are focusing on expanding their global influence. For that leading companies are adopting strategies such as partnerships, collaborations, mergers, and acquisitions.
- In August 2021, ProPharma Group, a portfolio company of Odyssey Investment Partners, announced the acquisition of iSafety Systems an Indian pharmacovigilance outsourcing service provider.
- In July 2021, ICON Plc. acquired a CRO, called PRA Health Sciences. The objective of the acquisition was to increase the services portfolio of ICON Plc. The company continued with its original name, ICON and brought together 38,000 employees across 47 countries to create the most developed clinical research organization and healthcare intelligence.
Key Segments of Regulatory Affairs Outsourcing Market Research
-
By Service :
- Regulatory Consulting Outsourcing
- Legal Representation Outsourcing
- Regulatory Writing & Publishing Outsourcing
- Others
-
By Company Size :
- Small-Sized Companies
- Medium-Sized Companies
- Large-Sized Companies
-
By Category :
- Drugs
- Biologics
- Medical Device
-
By Indication :
- Oncology
- Neurology
- Radiology
- Immunology
- Others
-
By Stage :
- Pre-Clinical
- Clinical
- Post Market Authorization
-
By End User :
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
-
By Region :
- North America
- Latin America
- Europe
- East Asia
- South Asia & Oceania
- Middle East & Africa
Table of Content
1. Executive Summary 1.1. Global Market Outlook 1.2. Summary of Statistics 1.3. Key Market Characteristics & Attributes 1.4. Fact.MR Analysis and Recommendations 2. Market Overview 2.1. Market Coverage / Taxonomy 2.2. Market Definition / Scope / Limitations 3. Market Risks and Trends Assessment 3.1. Risk Assessment 3.1.1. COVID-19 Crisis and Impact on Demand 3.1.2. COVID-19 Impact Benchmark with Previous Crisis 3.1.3. Impact on Market Value (US$ Mn) 3.1.4. Assessment by Key Countries 3.1.5. Assessment by Key Market Segments 3.1.6. Action Points and Recommendation for Suppliers 3.2. Key Trends Impacting the Market 3.3. Componentulation and Product Development Trends 4. Market Background 4.1. Market By Country, US$ Mn 4.2. Market Opportunity Assessment (US$ Mn) 4.2.1. Total Available Market 4.2.2. Serviceable Addressable Market 4.2.3. Serviceable Obtainable Market 4.3. Market Scenario Forecast 4.3.1. Demand in optimistic Scenario 4.3.2. Demand in Likely Scenario 4.3.3. Demand in Conservative Scenario 4.4. Investment Feasibility Analysis 4.4.1. Investment in Established Markets 4.4.1.1. In Short Term 4.4.1.2. In Long Term 4.4.2. Investment in Emerging Markets 4.4.2.1. In Short Term 4.4.2.2. In Long Term 4.5. Forecast Factors - Relevance & Impact 4.5.1. Top Companies Historical Growth 4.5.2. Global Market Growth 4.5.3. Adoption Rate, by Country 4.6. Market Dynamics 4.6.1. Market Driving Factors and Impact Assessment 4.6.2. Prominent Market Challenges and Impact Assessment 4.6.3. Market Opportunities 4.6.4. Prominent Trends in the Global Market & Their Impact Assessment 5. Key Success Factors 5.1. Manufacturers’ Focus on Low Penetration High Growth Markets 5.2. Banking on with Segments High Incremental Opportunity 5.3. Peer Benchmarking 6. Global Market Demand Analysis 2018-2023 and Forecast, 2024-2034 6.1. Historical Market Analysis, 2018-2023 6.2. Current and Future Market Projections, 2024-2034 6.3. Y-o-Y Growth Trend Analysis 7. Global Market Value Analysis 2018-2023 and Forecast, 2024-2034 7.1. Historical Market Value (US$ Mn) Analysis, 2018-2023 7.2. Current and Future Market Value (US$ Mn) Projections, 2024-2034 7.2.1. Y-o-Y Growth Trend Analysis 7.2.2. Absolute $ Opportunity Analysis 8. Global Market Analysis 2018-2023 and Forecast 2024-2034, By Services 8.1. Introduction / Key Findings 8.2. Historical Market Value (US$ Mn) and Analysis By Services, 2018-2023 8.3. Current and Future Market Value (US$ Mn) and Analysis and Forecast By Services, 2024-2034 8.3.1. Regulatory Consulting 8.3.2. Legal Representation 8.3.3. Regulatory Writing & Publishing 8.3.4. Product Registration & Clinical Trial Applications 8.3.5. Other Services 8.4. Market Attractiveness Analysis By Services 9. Global Market Analysis 2018-2023 and Forecast 2024-2034, By Company Size 9.1. Introduction / Key Findings 9.2. Historical Market Value (US$ Mn) and Analysis By Company Size, 2018-2023 9.3. Current and Future Market Value (US$ Mn) and Analysis and Forecast By Company Size, 2024-2034 9.3.1. Small Sized Companies 9.3.2. Medium Sized Companies 9.3.3. Large Sized Companies 9.4. Market Attractiveness Analysis By Company Size 10. Global Market Analysis 2018-2023 and Forecast 2024-2034, By Category 10.1. Introduction / Key Findings 10.2. Historical Market Value (US$ Mn) and Analysis By Category, 2018-2023 10.3. Current and Future Market Value (US$ Mn) and Analysis and Forecast By Category, 2024-2034 10.3.1. Drugs 10.3.1.1. Generics 10.3.1.2. Innovators 10.3.2. Biologics 10.3.2.1. Biotech 10.3.2.2. ATMPs 10.3.2.3. Biosimilars 10.3.3. Medical Devices 10.3.3.1. Therapeutic 10.3.3.2. Diagnostic 10.4. Market Attractiveness Analysis By Category 11. Global Market Analysis 2018-2023 and Forecast 2024-2034, By Indication 11.1. Introduction / Key Findings 11.2. Historical Market Value (US$ Mn) and Analysis By Indication, 2018-2023 11.3. Current and Future Market Value (US$ Mn) and Analysis and Forecast By Indication, 2024-2034 11.3.1. Oncology 11.3.2. Neurology 11.3.3. Cardiology 11.3.4. Immunology 11.3.5. Others 11.4. Market Attractiveness Analysis By Indication 12. Global Market Analysis 2018-2023 and Forecast 2024-2034, By Stage 12.1. Introduction / Key Findings 12.2. Historical Market Value (US$ Mn) and Analysis By Stage, 2018-2023 12.3. Current and Future Market Value (US$ Mn) and Analysis and Forecast By Stage, 2024-2034 12.3.1. Preclinical 12.3.2. Clinical 12.3.3. PMA (Post Market Authorization) 12.4. Market Attractiveness Analysis By Stage 13. Global Market Analysis 2018-2023 and Forecast 2024-2034, By End-use 13.1. Introduction 13.2. Historical Market Value (US$ Mn) and Analysis By End-use, 2018-2023 13.3. Current Market Size (US$ Mn) & Analysis and Forecast By End-use, 2024-2034 13.3.1. Medical Device Companies 13.3.2. Pharmaceutical Companies 13.3.3. Biotechnology Companies 13.4. Market Attractiveness Analysis By End-use 14. Global Market Analysis 2018-2023 and Forecast 2024-2034, By Region 14.1. Introduction 14.2. Historical Market Value (US$ Mn) and Analysis By Region, 2018-2023 14.3. Current Market Size (US$ Mn) & Analysis and Forecast By Region, 2024-2034 14.3.1. North America 14.3.2. Latin America 14.3.3. Europe 14.3.4. Asia Pacific 14.3.5. Middle East and Africa (MEA) 14.4. Market Attractiveness Analysis By Region 15. North America Market Analysis 2018-2023 and Forecast 2024-2034 15.1. Introduction 15.2. Pricing Analysis 15.3. Historical Market Value (US$ Mn) and Trend Analysis By Market Taxonomy, 2018-2023 15.4. Market Value (US$ Mn) & Forecast By Market Taxonomy, 2024-2034 15.4.1. By Country 15.4.1.1. U.S. 15.4.1.2. Canada 15.4.2. By Category 15.4.3. By Services 15.4.4. By Company Size 15.4.5. By Indication 15.4.6. By Stage 15.4.7. By End-use 15.5. Market Attractiveness Analysis 15.5.1. By Country 15.5.2. By Category 15.5.3. By Services 15.5.4. By Company Size 15.5.5. By Indication 15.5.6. By Stage 15.5.7. By End-use 16. Latin America Market Analysis 2018-2023 and Forecast 2024-2034 16.1. Introduction 16.2. Pricing Analysis 16.3. Historical Market Value (US$ Mn) and Trend Analysis By Market Taxonomy, 2018-2023 16.4. Market Value (US$ Mn) & Forecast By Market Taxonomy, 2024-2034 16.4.1. By Country 16.4.1.1. Brazil 16.4.1.2. Mexico 16.4.1.3. Rest of Latin America 16.4.2. By Category 16.4.3. By Services 16.4.4. By Company Size 16.4.5. By Indication 16.4.6. By Stage 16.4.7. By End-use 16.5. Market Attractiveness Analysis 16.5.1. By Country 16.5.2. By Category 16.5.3. By Services 16.5.4. By Company Size 16.5.5. By Indication 16.5.6. By Stage 16.5.7. By End-use 17. Europe Market Analysis 2018-2023 and Forecast 2024-2034 17.1. Introduction 17.2. Pricing Analysis 17.3. Historical Market Value (US$ Mn) and Trend Analysis By Market Taxonomy, 2018-2023 17.4. Market Value (US$ Mn) & Forecast By Market Taxonomy, 2024-2034 17.4.1. By Country 17.4.1.1. Germany 17.4.1.2. France 17.4.1.3. U.K. 17.4.1.4. Italy 17.4.1.5. Benelux 17.4.1.6. Russia 17.4.1.7. Rest of Europe 17.4.2. By Category 17.4.3. By Services 17.4.4. By Company Size 17.4.5. By Indication 17.4.6. By Stage 17.4.7. By End-use 17.5. Market Attractiveness Analysis 17.5.1. By Country 17.5.2. By Category 17.5.3. By Services 17.5.4. By Company Size 17.5.5. By Indication 17.5.6. By Stage 17.5.7. By End-use 18. Asia Pacific Market Analysis 2018-2023 and Forecast 2024-2034 18.1. Introduction 18.2. Pricing Analysis 18.3. Historical Market Value (US$ Mn) and Trend Analysis By Market Taxonomy, 2018-2023 18.4. Market Value (US$ Mn) & Forecast By Market Taxonomy, 2024-2034 18.4.1. By Country 18.4.1.1. China 18.4.1.2. Japan 18.4.1.3. South Korea 18.4.1.4. Rest of Asia Pacific 18.4.2. By Category 18.4.3. By Services 18.4.4. By Company Size 18.4.5. By Indication 18.4.6. By Stage 18.4.7. By End-use 18.5. Market Attractiveness Analysis 18.5.1. By Country 18.5.2. By Category 18.5.3. By Services 18.5.4. By Company Size 18.5.5. By Indication 18.5.6. By Stage 18.5.7. By End-use 19. Middle East and Africa Market Analysis 2018-2023 and Forecast 2024-2034 19.1. Introduction 19.2. Pricing Analysis 19.3. Historical Market Value (US$ Mn) and Trend Analysis By Market Taxonomy, 2018-2023 19.4. Market Value (US$ Mn) & Forecast By Market Taxonomy, 2024-2034 19.4.1. By Country 19.4.1.1. GCC Countries 19.4.1.2. South Africa 19.4.1.3. Turkey 19.4.1.4. Rest of Middle East and Africa 19.4.2. By Category 19.4.3. By Services 19.4.4. By Company Size 19.4.5. By Indication 19.4.6. By Stage 19.4.7. By End-use 19.5. Market Attractiveness Analysis 19.5.1. By Country 19.5.2. By Category 19.5.3. By Services 19.5.4. By Company Size 19.5.5. By Indication 19.5.6. By Stage 19.5.7. By End-use 20. Key Countries Market Analysis 2018-2023 and Forecast 2024-2034 20.1. Introduction 20.1.1. Market Value Proportion Analysis, By Key Countries 20.1.2. Global Vs. Country Growth Comparison 20.2. US Market Analysis 20.2.1. Value Proportion Analysis by Market Taxonomy 20.2.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.2.2.1. By Category 20.2.2.2. By Services 20.2.2.3. By Company Size 20.2.2.4. By Indication 20.2.2.5. By Stage 20.2.2.6. By End-use 20.3. Canada Market Analysis 20.3.1. Value Proportion Analysis by Market Taxonomy 20.3.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.3.2.1. By Category 20.3.2.2. By Services 20.3.2.3. By Company Size 20.3.2.4. By Indication 20.3.2.5. By Stage 20.3.2.6. By End-use 20.4. Mexico Market Analysis 20.4.1. Value Proportion Analysis by Market Taxonomy 20.4.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.4.2.1. By Category 20.4.2.2. By Services 20.4.2.3. By Company Size 20.4.2.4. By Indication 20.4.2.5. By Stage 20.4.2.6. By End-use 20.5. Brazil Market Analysis 20.5.1. Value Proportion Analysis by Market Taxonomy 20.5.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.5.2.1. By Category 20.5.2.2. By Services 20.5.2.3. By Company Size 20.5.2.4. By Indication 20.5.2.5. By Stage 20.5.2.6. By End-use 20.6. Germany Market Analysis 20.6.1. Value Proportion Analysis by Market Taxonomy 20.6.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.6.2.1. By Category 20.6.2.2. By Services 20.6.2.3. By Company Size 20.6.2.4. By Indication 20.6.2.5. By Stage 20.6.2.6. By End-use 20.7. France Market Analysis 20.7.1. Value Proportion Analysis by Market Taxonomy 20.7.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.7.2.1. By Category 20.7.2.2. By Services 20.7.2.3. By Company Size 20.7.2.4. By Indication 20.7.2.5. By Stage 20.7.2.6. By End-use 20.8. Italy Market Analysis 20.8.1. Value Proportion Analysis by Market Taxonomy 20.8.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.8.2.1. By Category 20.8.2.2. By Services 20.8.2.3. By Company Size 20.8.2.4. By Indication 20.8.2.5. By Stage 20.8.2.6. By End-use 20.9. Russia Market Analysis 20.9.1. Value Proportion Analysis by Market Taxonomy 20.9.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.9.2.1. By Category 20.9.2.2. By Services 20.9.2.3. By Company Size 20.9.2.4. By Indication 20.9.2.5. By Stage 20.9.2.6. By End-use 20.10. UK Market Analysis 20.10.1. Value Proportion Analysis by Market Taxonomy 20.10.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.10.2.1. By Category 20.10.2.2. By Services 20.10.2.3. By Company Size 20.10.2.4. By Indication 20.10.2.5. By Stage 20.10.2.6. By End-use 20.11. Benelux Market Analysis 20.11.1. Value Proportion Analysis by Market Taxonomy 20.11.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.11.2.1. By Category 20.11.2.2. By Services 20.11.2.3. By Company Size 20.11.2.4. By Indication 20.11.2.5. By Stage 20.11.2.6. By End-use 20.12. China Market Analysis 20.12.1. Value Proportion Analysis by Market Taxonomy 20.12.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.12.2.1. By Category 20.12.2.2. By Services 20.12.2.3. By Company Size 20.12.2.4. By Indication 20.12.2.5. By Stage 20.12.2.6. By End-use 20.13. Japan Market Analysis 20.13.1. Value Proportion Analysis by Market Taxonomy 20.13.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.13.2.1. By Category 20.13.2.2. By Services 20.13.2.3. By Company Size 20.13.2.4. By Indication 20.13.2.5. By Stage 20.13.2.6. By End-use 20.14. South Korea Market Analysis 20.14.1. Value Proportion Analysis by Market Taxonomy 20.14.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.14.2.1. By Category 20.14.2.2. By Services 20.14.2.3. By Company Size 20.14.2.4. By Indication 20.14.2.5. By Stage 20.14.2.6. By End-use 20.15. GCC Countries Market Analysis 20.15.1. Value Proportion Analysis by Market Taxonomy 20.15.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.15.2.1. By Category 20.15.2.2. By Services 20.15.2.3. By Company Size 20.15.2.4. By Indication 20.15.2.5. By Stage 20.15.2.6. By End-use 20.16. South Africa Market Analysis 20.16.1. Value Proportion Analysis by Market Taxonomy 20.16.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.16.2.1. By Category 20.16.2.2. By Services 20.16.2.3. By Company Size 20.16.2.4. By Indication 20.16.2.5. By Stage 20.16.2.6. By End-use 20.17. Turkey Market Analysis 20.17.1. Value Proportion Analysis by Market Taxonomy 20.17.2. Value & Analysis and Forecast by Market Taxonomy, 2018-2034 20.17.2.1. By Category 20.17.2.2. By Services 20.17.2.3. By Company Size 20.17.2.4. By Indication 20.17.2.5. By Stage 20.17.2.6. By End-use 20.17.3. Competition Landscape and Player Concentration in the Country 21. Market Structure Analysis 21.1. Market Analysis by Tier of Companies 21.2. Market Concentration 21.3. Market Share Analysis of Top Players 21.4. Market Presence Analysis 21.4.1. By Regional footprint of Players 21.4.2. Product footprint by Players 22. Competition Analysis 22.1. Competition Dashboard 22.2. Competition Benchmarking 22.3. Competition Deep Dive 22.3.1. Accell Clinical Research LLC. 22.3.1.1. Overview 22.3.1.2. Product Portfolio 22.3.1.3. Sales Footprint 22.3.1.4. Strategy Overview 22.3.2. GenPact Ltd. 22.3.2.1. Overview 22.3.2.2. Product Portfolio 22.3.2.3. Sales Footprint 22.3.2.4. Strategy Overview 22.3.3. Criterium Inc. 22.3.3.1. Overview 22.3.3.2. Product Portfolio 22.3.3.3. Sales Footprint 22.3.3.4. Strategy Overview 22.3.4. PRA Health Sciences 22.3.4.1. Overview 22.3.4.2. Product Portfolio 22.3.4.3. Sales Footprint 22.3.4.4. Strategy Overview 22.3.5. Promedica International 22.3.5.1. Overview 22.3.5.2. Product Portfolio 22.3.5.3. Sales Footprint 22.3.5.4. Strategy Overview 22.3.6. WuXi AppTec Inc. 22.3.6.1. Overview 22.3.6.2. Product Portfolio 22.3.6.3. Sales Footprint 22.3.6.4. Strategy Overview 22.3.7. Medpace 22.3.7.1. Overview 22.3.7.2. Product Portfolio 22.3.7.3. Sales Footprint 22.3.7.4. Strategy Overview 22.3.8. Charles River Laboratories International Inc. 22.3.8.1. Overview 22.3.8.2. Product Portfolio 22.3.8.3. Sales Footprint 22.3.8.4. Strategy Overview 22.3.9. ICON plc 22.3.9.1. Overview 22.3.9.2. Product Portfolio 22.3.9.3. Sales Footprint 22.3.9.4. Strategy Overview 22.3.10. Labcorp 22.3.10.1. Overview 22.3.10.2. Product Portfolio 22.3.10.3. Sales Footprint 22.3.10.4. Strategy Overview 23. Assumptions and Acronyms Used 24. Research Methodology
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List Of Table
Table 01: Global Market Value (US$ Mn),By End-use, 2018-2023
Table 02: Global Market Value (US$ Mn),By End-use, 2024-2034
Table 03: Global Market Value (US$ Mn), By Services, 2018-2023
Table 04: Global Market Value (US$ Mn), By Services, 2024-2034
Table 05: Global Market Value (US$ Mn), By Category, 2018-2023
Table 06: Global Market Value (US$ Mn), By Category, 2024-2034
Table 07: Global Market Value (US$ Mn), By Company Size, 2018-2023
Table 08: Global Market Value (US$ Mn), By Company Size, 2024-2034
Table 09: Global Market Value (US$ Mn), By Indication, 2018-2023
Table 10: Global Market Value (US$ Mn), By Indication, 2024-2034
Table 11: Global Market Value (US$ Mn), By Stage, 2018-2023
Table 12: Global Market Value (US$ Mn), By Stage, 2024-2034
Table 13: Global Market, By Region, 2018-2023
Table 14: Global Market, By Region, 2024-2034
Table 15: North America Market Value (US$ Mn),By End-use, 2018-2023
Table 16: North America Market Value (US$ Mn),By End-use, 2024-2034
Table 17: North America Market Value (US$ Mn), By Services, 2018-2023
Table 18: North America Market Value (US$ Mn), By Services, 2024-2034
Table 19: North America Market Value (US$ Mn), By Category, 2018-2023
Table 20: North America Market Value (US$ Mn), By Category, 2024-2034
Table 21: North America Market Value (US$ Mn), By Company Size, 2018-2023
Table 22: North America Market Value (US$ Mn), By Company Size, 2024-2034
Table 23: North America Market Value (US$ Mn), By Indication, 2018-2023
Table 24: North America Market Value (US$ Mn), By Indication, 2024-2034
Table 25: North America Market Value (US$ Mn), By Stage, 2018-2023
Table 26: North America Market Value (US$ Mn), By Stage, 2024-2034
Table 27: North America Market, By Country, 2018-2023
Table 28: North America Market, By Country, 2024-2034
Table 29: Latin America Market Value (US$ Mn),By End-use, 2018-2023
Table 30: Latin America Market Value (US$ Mn),By End-use, 2024-2034
Table 31: Latin America Market Value (US$ Mn), By Services, 2018-2023
Table 32: Latin America Market Value (US$ Mn), By Services, 2024-2034
Table 33: Latin America Market Value (US$ Mn), By Category, 2018-2023
Table 34: Latin America Market Value (US$ Mn), By Category, 2024-2034
Table 35: Latin America Market Value (US$ Mn), By Company Size, 2018-2023
Table 36: Latin America Market Value (US$ Mn), By Company Size, 2024-2034
Table 37: Latin America Market Value (US$ Mn), By Indication, 2018-2023
Table 38: Latin America Market Value (US$ Mn), By Indication, 2024-2034
Table 39: Latin America Market Value (US$ Mn), By Stage, 2018-2023
Table 40: Latin America Market Value (US$ Mn), By Stage, 2024-2034
Table 41: Latin America Market, By Country, 2018-2023
Table 42: Latin America Market, By Country, 2024-2034
Table 43: Europe Market Value (US$ Mn),By End-use, 2018-2023
Table 44: Europe Market Value (US$ Mn),By End-use, 2024-2034
Table 45: Europe Market Value (US$ Mn), By Services, 2018-2023
Table 46: Europe Market Value (US$ Mn), By Services, 2024-2034
Table 47: Europe Market Value (US$ Mn), By Category, 2018-2023
Table 48: Europe Market Value (US$ Mn), By Category, 2024-2034
Table 49: Europe Market Value (US$ Mn), By Company Size, 2018-2023
Table 50: Europe Market Value (US$ Mn), By Company Size, 2024-2034
Table 51: Europe Market Value (US$ Mn), By Indication, 2018-2023
Table 52: Europe Market Value (US$ Mn), By Indication, 2024-2034
Table 53: Europe Market Value (US$ Mn), By Stage, 2018-2023
Table 54: Europe Market Value (US$ Mn), By Stage, 2024-2034
Table 55: Europe Market, By Country, 2018-2023
Table 56: Europe Market, By Country, 2024-2034
Table 57: Asia Pacific Market Value (US$ Mn),By End-use, 2018-2023
Table 58: Asia Pacific Market Value (US$ Mn),By End-use, 2024-2034
Table 59: Asia Pacific Market Value (US$ Mn), By Services, 2018-2023
Table 60: Asia Pacific Market Value (US$ Mn), By Services, 2024-2034
Table 61: Asia Pacific Market Value (US$ Mn), By Category, 2018-2023
Table 62: Asia Pacific Market Value (US$ Mn), By Category, 2024-2034
Table 63: Asia Pacific Market Value (US$ Mn), By Company Size, 2018-2023
Table 64: Asia Pacific Market Value (US$ Mn), By Company Size, 2024-2034
Table 65: Asia Pacific Market Value (US$ Mn), By Indication, 2018-2023
Table 66: Asia Pacific Market Value (US$ Mn), By Indication, 2024-2034
Table 67: Asia Pacific Market Value (US$ Mn), By Stage, 2018-2023
Table 68: Asia Pacific Market Value (US$ Mn), By Stage, 2024-2034
Table 69: Asia Pacific Market, By Country, 2018-2023
Table 70: Asia Pacific Market, By Country, 2024-2034
Table 71: MEA Market Value (US$ Mn),By End-use, 2018-2023
Table 72: MEA Market Value (US$ Mn),By End-use, 2024-2034
Table 73: MEA Market Value (US$ Mn), By Services, 2018-2023
Table 74: MEA Market Value (US$ Mn), By Services, 2024-2034
Table 75: MEA Market Value (US$ Mn), By Category, 2018-2023
Table 76: MEA Market Value (US$ Mn), By Category, 2024-2034
Table 77: MEA Market Value (US$ Mn), By Company Size, 2018-2023
Table 78: MEA Market Value (US$ Mn), By Company Size, 2024-2034
Table 79: MEA Market Value (US$ Mn), By Indication, 2018-2023
Table 80: MEA Market Value (US$ Mn), By Indication, 2024-2034
Table 81: MEA Market Value (US$ Mn), By Stage, 2018-2023
Table 82: MEA Market Value (US$ Mn), By Stage, 2024-2034
Table 83: MEA Market, By Country, 2018-2023
Table 84: MEA Market, By Country, 2024-2034
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List Of Figures
Figure 01: Global Market Value (US$ Mn) and Year-on-Year Growth, 2018-2034
Figure 02: Global Market Absolute $ Historical Gain (2018-2023) and Opportunity (2024-2034), US$ Mn
Figure 03: Global Market Share, By End-use, 2024 & 2034
Figure 04: Global Market Y-o-Y Growth Projections, By End-use – 2024-2034
Figure 05: Global Market Attractiveness Index, By End-use – 2024-2034
Figure 06: Global Market Share, By Services, 2024 & 2034
Figure 07: Global Market Y-o-Y Growth Projections, By Services – 2024-2034
Figure 08: Global Market Attractiveness Index, By Services – 2024-2034
Figure 09: Global Market Share, By Company Size, 2024 & 2034
Figure 10: Global Market Y-o-Y Growth Projections, By Company Size – 2024-2034
Figure 11: Global Market Attractiveness Index, By Company Size – 2024-2034
Figure 12: Global Market Share, By Stage, 2024 & 2034
Figure 13: Global Market Y-o-Y Growth Projections, By Stage – 2024-2034
Figure 14: Global Market Attractiveness Index, By Stage – 2024-2034
Figure 15: Global Market Share, By Category, 2024 & 2034
Figure 16: Global Market Y-o-Y Growth Projections, By Category – 2024-2034
Figure 17: Global Market Attractiveness Index, By Category – 2024-2034
Figure 18: Global Market Share, By Indication, 2024 & 2034
Figure 19: Global Market Y-o-Y Growth Projections, By Indication – 2024-2034
Figure 20: Global Market Attractiveness Index, By Indication – 2024-2034
Figure 21: Global Market Share, By Region, 2024 & 2034
Figure 22: Global Market Y-o-Y Growth Projections, By Region – 2024-2034
Figure 23: Global Market Attractiveness Index, By Region – 2024-2034
Figure 24: North America Market Value (US$ Mn) and Year-on-Year Growth, 2018-2034
Figure 25: North America Market Absolute $ Historical Gain (2018-2023) and Opportunity (2024-2034), US$ Mn
Figure 26: North America Market Share, By End-use, 2024 & 2034
Figure 27: North America Market Y-o-Y Growth Projections, By End-use – 2024-2034
Figure 28: North America Market Attractiveness Index, By End-use – 2024-2034
Figure 29: North America Market Share, By Services, 2024 & 2034
Figure 30: North America Market Y-o-Y Growth Projections, By Services – 2024-2034
Figure 31: North America Market Attractiveness Index, By Services – 2024-2034
Figure 32: North America Market Share, By Company Size, 2024 & 2034
Figure 33: North America Market Y-o-Y Growth Projections, By Company Size – 2024-2034
Figure 34: North America Market Attractiveness Index, By Company Size – 2024-2034
Figure 35: North America Market Share, By Category, 2024 & 2034
Figure 36: North America Market Y-o-Y Growth Projections, By Category – 2024-2034
Figure 37: North America Market Attractiveness Index, By Category – 2024-2034
Figure 38: North America Market Share, By Indication, 2024 & 2034
Figure 39: North America Market Y-o-Y Growth Projections, By Indication – 2024-2034
Figure 40: North America Market Attractiveness Index, By Indication – 2024-2034
Figure 41: North America Market Share, By Stage, 2024 & 2034
Figure 42: North America Market Y-o-Y Growth Projections, By Stage – 2024-2034
Figure 43: North America Market Attractiveness Index, By Stage – 2024-2034
Figure 44: North America Market Share, By Country, 2024 & 2034
Figure 45: North America Market Y-o-Y Growth Projections, By Country – 2024-2034
Figure 46: North America Market Attractiveness Index, By Country – 2024-2034
Figure 47: Latin America Market Value (US$ Mn) and Year-on-Year Growth, 2018-2034
Figure 48: Latin America Market Absolute $ Historical Gain (2018-2023) and Opportunity (2024-2034), US$ Mn
Figure 49: Latin America Market Share, By End-use, 2024 & 2034
Figure 50: Latin America Market Y-o-Y Growth Projections, By End-use – 2024-2034
Figure 51: Latin America Market Attractiveness Index, By End-use – 2024-2034
Figure 52: Latin America Market Share, By Services, 2024 & 2034
Figure 53: Latin America Market Y-o-Y Growth Projections, By Services – 2024-2034
Figure 54: Latin America Market Attractiveness Index, By Services – 2024-2034
Figure 55: Latin America Market Share, By Company Size, 2024 & 2034
Figure 56: Latin America Market Y-o-Y Growth Projections, By Company Size – 2024-2034
Figure 57: Latin America Market Attractiveness Index, By Company Size – 2024-2034
Figure 58: Latin America Market Share, By Category, 2024 & 2034
Figure 59: Latin America Market Y-o-Y Growth Projections, By Category – 2024-2034
Figure 60: Latin America Market Attractiveness Index, By Category – 2024-2034
Figure 61: Latin America Market Share, By Indication, 2024 & 2034
Figure 62: Latin America Market Y-o-Y Growth Projections, By Indication – 2024-2034
Figure 63: Latin America Market Attractiveness Index, By Indication – 2024-2034
Figure 64: Latin America Market Share, By Stage, 2024 & 2034
Figure 65: Latin America Market Y-o-Y Growth Projections, By Stage – 2024-2034
Figure 66: Latin America Market Attractiveness Index, By Stage – 2024-2034
Figure 67: Latin America Market Share, By Country, 2024 & 2034
Figure 68: Latin America Market Y-o-Y Growth Projections, By Country – 2024-2034
Figure 69: Latin America Market Attractiveness Index, By Country – 2024-2034
Figure 70: Europe Market Value (US$ Mn) and Year-on-Year Growth, 2018-2034
Figure 71: Europe Market Absolute $ Historical Gain (2018-2023) and Opportunity (2024-2034), US$ Mn
Figure 72: Europe Market Share, By End-use, 2024 & 2034
Figure 73: Europe Market Y-o-Y Growth Projections, By End-use – 2024-2034
Figure 74: Europe Market Attractiveness Index, By End-use – 2024-2034
Figure 75: Europe Market Share, By Services, 2024 & 2034
Figure 76: Europe Market Y-o-Y Growth Projections, By Services – 2024-2034
Figure 77: Europe Market Attractiveness Index, By Services – 2024-2034
Figure 78: Europe Market Share, By Company Size, 2024 & 2034
Figure 79: Europe Market Y-o-Y Growth Projections, By Company Size – 2024-2034
Figure 80: Europe Market Attractiveness Index, By Company Size – 2024-2034
Figure 81: Europe Market Share, By Category, 2024 & 2034
Figure 82: Europe Market Y-o-Y Growth Projections, By Category – 2024-2034
Figure 83: Europe Market Attractiveness Index, By Category – 2024-2034
Figure 84: Europe Market Share, By Indication, 2024 & 2034
Figure 85: Europe Market Y-o-Y Growth Projections, By Indication – 2024-2034
Figure 86: Europe Market Attractiveness Index, By Indication – 2024-2034
Figure 87: Europe Market Share, By Stage, 2024 & 2034
Figure 88: Europe Market Y-o-Y Growth Projections, By Stage – 2024-2034
Figure 89: Europe Market Attractiveness Index, By Stage – 2024-2034
Figure 90: Europe Market Share, By Country, 2024 & 2034
Figure 91: Europe Market Y-o-Y Growth Projections, By Country – 2024-2034
Figure 92: Europe Market Attractiveness Index, By Country – 2024-2034
Figure 93: Asia Pacific Market Value (US$ Mn) and Year-on-Year Growth, 2018-2034
Figure 94: Asia Pacific Market Absolute $ Historical Gain (2018-2023) and Opportunity (2024-2034), US$ Mn
Figure 95: Asia Pacific Market Share, By End-use, 2024 & 2034
Figure 96: Asia Pacific Market Y-o-Y Growth Projections, By End-use – 2024-2034
Figure 97: Asia Pacific Market Attractiveness Index, By End-use – 2024-2034
Figure 98: Asia Pacific Market Share, By Services, 2024 & 2034
Figure 99: Asia Pacific Market Y-o-Y Growth Projections, By Services – 2024-2034
Figure 100: Asia Pacific Market Attractiveness Index, By Services – 2024-2034
Figure 101: Asia Pacific Market Share, By Company Size, 2024 & 2034
Figure 102: Asia Pacific Market Y-o-Y Growth Projections, By Company Size – 2024-2034
Figure 103: Asia Pacific Market Attractiveness Index, By Company Size – 2024-2034
Figure 104: Asia Pacific Market Share, By Category, 2024 & 2034
Figure 105: Asia Pacific Market Y-o-Y Growth Projections, By Category – 2024-2034
Figure 106: Asia Pacific Market Attractiveness Index, By Category – 2024-2034
Figure 107: Asia Pacific Market Share, By Indication, 2024 & 2034
Figure 108: Asia Pacific Market Y-o-Y Growth Projections, By Indication – 2024-2034
Figure 109: Asia Pacific Market Attractiveness Index, By Indication – 2024-2034
Figure 110: Asia Pacific Market Share, By Stage, 2024 & 2034
Figure 111: Asia Pacific Market Y-o-Y Growth Projections, By Stage – 2024-2034
Figure 112: Asia Pacific Market Attractiveness Index, By Stage – 2024-2034
Figure 113: Asia Pacific Market Share, By Country, 2024 & 2034
Figure 114: Asia Pacific Market Y-o-Y Growth Projections, By Country – 2024-2034
Figure 115: Asia Pacific Market Attractiveness Index, By Country – 2024-2034
Figure 116: MEA Market Value (US$ Mn) and Year-on-Year Growth, 2018-2034
Figure 117: MEA Market Absolute $ Historical Gain (2018-2023) and Opportunity (2024-2034), US$ Mn
Figure 118: MEA Market Share, By End-use, 2024 & 2034
Figure 119: MEA Market Y-o-Y Growth Projections, By End-use – 2024-2034
Figure 120: MEA Market Attractiveness Index, By End-use – 2024-2034
Figure 121: MEA Market Share, By Services, 2024 & 2034
Figure 122: MEA Market Y-o-Y Growth Projections, By Services – 2024-2034
Figure 123: MEA Market Attractiveness Index, By Services – 2024-2034
Figure 124: MEA Market Share, By Company Size, 2024 & 2034
Figure 125: MEA Market Y-o-Y Growth Projections, By Company Size – 2024-2034
Figure 126: MEA Market Attractiveness Index, By Company Size – 2024-2034
Figure 127: MEA Market Share, By Category, 2024 & 2034
Figure 128: MEA Market Y-o-Y Growth Projections, By Category – 2024-2034
Figure 129: MEA Market Attractiveness Index, By Category – 2024-2034
Figure 130: MEA Market Share, By Indication, 2024 & 2034
Figure 131: MEA Market Y-o-Y Growth Projections, By Indication – 2024-2034
Figure 132: MEA Market Attractiveness Index, By Indication – 2024-2034
Figure 133: MEA Market Share, By Stage, 2024 & 2034
Figure 134: MEA Market Y-o-Y Growth Projections, By Stage – 2024-2034
Figure 135: MEA Market Attractiveness Index, By Stage – 2024-2034
Figure 136: MEA Market Share, By Country, 2024 & 2034
Figure 137: MEA Market Y-o-Y Growth Projections, By Country – 2024-2034
Figure 138: MEA Market Attractiveness Index, By Country – 2024-2034
Know thy Competitors
Competitive landscape highlights only certain players
Complete list available upon request
- FAQs -
How big is the regulatory affairs outsourcing market size in 2024?
The global regulatory affairs outsourcing market is evaluated at US$ 17.4 billion in 2024.
What is the estimated demand growth for regulatory affairs outsourcing services?
Demand for regulatory affairs outsourcing services is projected to increase at a CAGR of 7.3% during the next 10 years.
What is the forecasted value of the global market for 2034?
The market for regulatory affairs outsourcing is projected to reach US$ 35.31 billion by 2034.
What are the estimated sales of regulatory affairs outsourcing services in South Korea?
The South Korea market is approximated at US$ 737.1 million in 2024.
What are the industry trends in regulatory affairs?
A key market trend is the integration of digital technologies such as AI, ML, and big data analytics in regulatory affairs.
What are the challenges in regulatory affairs?
Shifting policies and strict compliance guidelines are some of the challenges for market growth.