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U.S. Regulatory Affairs Market Size, Share & Trends Analysis Report by Services, Category, Indication, Product Stage, Service Provider, Company Size, End-use, Country, and Segment Forecasts, 2024-2030

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  • 80 Pages
  • June 2024
  • Region: United States
  • Grand View Research
  • ID: 5976504
Description Jump to:
The U.S. regulatory affairs market size is anticipated to reach USD 7.71 billion by 2030 and is anticipated to expand at a CAGR of 9.0% during the forecast period. The regulatory landscape constantly evolves and becomes more complex, with new laws and guidelines being introduced regularly. This complexity drives the demand for regulatory affairs professionals who can navigate these intricate requirements.

As the company expands its operations globally, regulatory compliance becomes more challenging due to varying regulations across different countries. Regulatory affairs professionals help organizations navigate international regulatory frameworks and ensure market access. For instance, as per Reuters update of Jan 2024, many U.S. law corporations are expected to enter into merger agreements in 2024. Stockton & Kilpatrick Townsend recently announced a merger with smaller companies. In addition, Fennemore Craig, a Phoenix-founded medium-sized company, announced its expansion into Seattle in the current year.

Regulatory bodies prioritize patient safety and product quality, leading to stringent regulations that companies must adhere to. Regulatory affairs professionals are vital in ensuring products meet these standards while expediting the approval process. As the healthcare industry expands and competition increases, companies must stay ahead by complying with regulations efficiently. Regulatory affairs expertise becomes a competitive advantage in launching products faster while meeting regulatory requirements.

U.S. Regulatory Affairs Market Report Highlights

  • Regulatory writing & publishing dominated the services segment with more than 16% share in 2023 owing to increasing outsources of these services by mid- and large size medical device and biopharmaceutical firms
  • The legal representation segment is expected to grow at the fastest CAGR over the forecast period
  • The medical devices segment held the largest market share in 2023. This is attributable to the rising outsource activities of medical devices by pharmaceutical firms allowing them to focus on their underlying competencies
  • Oncology accounted for the largest market revenue share in 2023.This can be attributed to the growing prevalence of cancer cases, encouraging a demand for effective and safe treatment selections
  • The immunology segment is expected to grow at the fastest CAGR of 10.4% during the forecast period owing to its capability to facilitate the treatment of several neurological, cardiovascular, inflammatory, and oncological diseases
  • Clinical studies accounted for the largest market revenue share in 2023 owing to the growing incidences of new diseases and the increasing occurrence of chronic illnesses.
  • Outsourced service provider accounted for the largest market revenue share in 2023 and is anticipated to grow at the fastest CAGR over the forecast period
  • The medium size companies accounted for the largest market revenue share in 2023 owing to the existence of several mid-sized recognized providers, specifically privately held, is anticipated to promote to the segment’s growth
  • The pharmaceutical companies segment dominated the market in 2023 and is anticipated to grow at the fastest CAGR over the forecast period attributing to the expansion in the number of authorized pharmaceutical products

Why should you buy this report?

  • Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
  • Competitive Landscape: Explore the market presence of key players worldwide.
  • Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
  • Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

  • Market intelligence to enable effective decision-making
  • Market estimates and forecasts from 2018 to 2030
  • Growth opportunities and trend analyses
  • Segment and regional revenue forecasts for market assessment
  • Competition strategy and market share analysis
  • Product innovation listing for you to stay ahead of the curve
  • COVID-19's impact and how to sustain in these fast-evolving markets


This product will be delivered within 1-3 business days.

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Service
1.2.2. Category
1.2.3. Indication
1.2.4. Product Stage
1.2.5. Service Provider
1.2.6. Company Size
1.2.7. End-use
1.2.8. Estimates and forecasts timeline
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Volume price analysis (Model 2)
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Service outlook
2.2.2. Category outlook
2.2.3. Indication outlook
2.2.4. Product stage outlook
2.2.5. Service provider outlook
2.2.6. Company size outlook
2.2.7. End-use outlook
2.3. Competitive Insights
Chapter 3. U.S. Regulatory Affairs Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Market Dynamics
3.2.1. Market driver analysis
3.2.2. Market restraint analysis
3.3. U.S. Regulatory Affairs Market Analysis Tools
3.3.1. Industry Analysis - Porter’s
3.3.1.1. Supplier power
3.3.1.2. Buyer power
3.3.1.3. Substitution threat
3.3.1.4. Threat of new entrant
3.3.1.5. Competitive rivalry
3.3.2. PESTEL Analysis
3.3.2.1. Political landscape
3.3.2.2. Technological landscape
3.3.2.3. Economic landscape
Chapter 4. U.S. Regulatory Affairs Market: Service Estimates & Trend Analysis
4.1. Service Market Share, 2023 & 2030
4.2. Segment Dashboard
4.3. U.S. Regulatory Affairs Market by Service Outlook
4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
4.4.1. Regulatory Consulting
4.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.2. Legal Representation
4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.3. Regulatory Writing & Publishing
4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.3.1.1. Writing
4.4.3.1.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.3.1.2. Publishing
4.4.3.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.4. Product Registration & Clinical Trial Applications
4.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.5. Other Services
4.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 5. U.S. Regulatory Affairs Market: Category Estimates & Trend Analysis
5.1. Category Market Share, 2023 & 2030
5.2. Segment Dashboard
5.3. U.S. Regulatory Affairs Market by Category Outlook
5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
5.4.1. Drugs
5.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.2. Innovator
5.4.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.2.2. Preclinical
5.4.1.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.2.3. Clinical
5.4.1.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.2.4. Pre-Maker Approval (PMA)
5.4.1.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.3. Generics
5.4.1.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.3.2. Preclinical
5.4.1.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.3.3. Clinical
5.4.1.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.1.3.4. Pre-Maker Approval (PMA)
5.4.1.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2. Biologics
5.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.2. Biotech
5.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.2.2. Preclinical
5.4.2.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.2.3. Clinical
5.4.2.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.2.4. Pre-Maker Approval (PMA)
5.4.2.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.3. ATMP
5.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.3.2. Preclinical
5.4.2.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.3.3. Clinical
5.4.2.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.2.3.4. Pre-Maker Approval (PMA)
5.4.2.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.3. Biosimilars
5.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.3.2. Preclinical
5.4.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.3.3. Clinical
5.4.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.3.4. Pre-Maker Approval (PMA)
5.4.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4. Medical Devices
5.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.2. Diagnostics
5.4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.2.2. Preclinical
5.4.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.2.3. Clinical
5.4.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.2.4. Pre-Maker Approval (PMA)
5.4.4.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.3. Therapeutics
5.4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.3.2. Preclinical
5.4.4.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.3.3. Clinical
5.4.4.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.4.4.3.4. Pre-Maker Approval (PMA)
5.4.4.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 6. U.S. Regulatory Affairs Market: Indication Estimates & Trend Analysis
6.1. Indication Market Share, 2023 & 2030
6.2. Segment Dashboard
6.3. U.S. Regulatory Affairs Market by Indication Outlook
6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
6.4.1. Oncology
6.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
6.4.2. Neurology
6.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
6.4.3. Cardiology
6.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
6.4.4. Immunology
6.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
6.4.5. Others
6.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 7. U.S. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis
7.1. Product Stage Market Share, 2023 & 2030
7.2. Segment Dashboard
7.3. U.S. Regulatory Affairs Market by Product Stage Outlook
7.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
7.4.1. Preclinical
7.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
7.4.2. Clinical studies
7.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
7.4.3. PMA
7.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 8. U.S. Regulatory Affairs Market: Service Provider Estimates & Trend Analysis
8.1. Service Provider Market Share, 2023 & 2030
8.2. Segment Dashboard
8.3. U.S. Regulatory Affairs Market by Service Provider Outlook
8.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
8.4.1. In-house
8.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
8.4.2. Outsourced
8.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 9. U.S. Regulatory Affairs Market: Company Size Estimates & Trend Analysis
9.1. Company Size Market Share, 2023 & 2030
9.2. Segment Dashboard
9.3. U.S. Regulatory Affairs Market by Company Size Outlook
9.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
9.4.1. Small
9.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
9.4.2. Medium
9.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
9.4.3. Large
9.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 10. U.S. Regulatory Affairs Market: End-use Estimates & Trend Analysis
10.1. End-use Market Share, 2023 & 2030
10.2. Segment Dashboard
10.3. U.S. Regulatory Affairs Market by End-use Outlook
10.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
10.4.1. Medical Device Companies
10.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
10.4.2. Pharmaceutical Companies
10.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
10.4.3. Biotechnology Companies
10.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 11. U.S. Regulatory Affairs Market: Region Estimates & Trend Analysis
11.1. Regional Market Share, 2023 & 2030
11.2. U.S. Regulatory Affairs Market by Region Outlook
11.3. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
11.3.1. West
11.3.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
11.3.2. Midwest
11.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
11.3.3. Northeast
11.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
11.3.4. Southwest
11.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
11.3.5. Southeast
11.3.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 12. Competitive Landscape
12.1. Recent Developments & Impact Analysis, By Key Market Participants
12.2. Company/Competition Categorization
12.3. Vendor Landscape
12.3.1. List of key distributors and channel partners
12.3.2. Key customers
12.3.3. Key company market share analysis, 2023
12.4. Company Profiles
12.4.1. Accell Clinical Research, LLC
12.4.1.1. Company overview
12.4.1.2. Financial performance
12.4.1.3. Product benchmarking
12.4.1.4. Strategic initiatives
12.4.2. Genpact
12.4.2.1. Company overview
12.4.2.2. Financial performance
12.4.2.3. Product benchmarking
12.4.2.4. Strategic initiatives
12.4.3. CRITERIUM, INC.
12.4.3.1. Company overview
12.4.3.2. Financial performance
12.4.3.3. Product benchmarking
12.4.3.4. Strategic initiatives
12.4.4. ICON plc
12.4.4.1. Company overview
12.4.4.2. Financial performance
12.4.4.3. Product benchmarking
12.4.4.4. Strategic initiatives
12.4.5. Promedica International
12.4.5.1. Company overview
12.4.5.2. Financial performance
12.4.5.3. Product benchmarking
12.4.5.4. Strategic initiatives
12.4.6. WuXi AppTec
12.4.6.1. Company overview
12.4.6.2. Financial performance
12.4.6.3. Product benchmarking
12.4.6.4. Strategic initiatives
12.4.7. Medpace
12.4.7.1. Company overview
12.4.7.2. Financial performance
12.4.7.3. Product benchmarking
12.4.7.4. Strategic initiatives
12.4.8. Charles River Laboratories
12.4.8.1. Company overview
12.4.8.2. Financial performance
12.4.8.3. Product benchmarking
12.4.8.4. Strategic initiatives
12.4.9. Labcorp Drug Development
12.4.9.1. Company overview
12.4.9.2. Financial performance
12.4.9.3. Product benchmarking
12.4.9.4. Strategic initiatives
12.4.10. Parexel International (MA) Corporation
12.4.10.1. Company overview
12.4.10.2. Financial performance
12.4.10.3. Product benchmarking
12.4.10.4. Strategic initiatives
12.4.11. Freyr
12.4.11.1. Company overview
12.4.11.2. Financial performance
12.4.11.3. Product benchmarking
12.4.11.4. Strategic initiatives
12.4.12. Pharmalex GmbH
12.4.12.1. Company overview
12.4.12.2. Financial performance
12.4.12.3. Product benchmarking
12.4.12.4. Strategic initiatives
12.4.13. NDA Group AB
12.4.13.1. Company overview
12.4.13.2. Financial performance
12.4.13.3. Product benchmarking
12.4.13.4. Strategic initiatives
12.4.14. Qvigilance
12.4.14.1. Company overview
12.4.14.2. Financial performance
12.4.14.3. Product benchmarking
12.4.14.4. Strategic initiatives
12.4.15. BlueReg
12.4.15.1. Company overview
12.4.15.2. Financial performance
12.4.15.3. Product benchmarking
12.4.15.4. Strategic initiatives
12.4.16. Cambridge Regulatory Services
12.4.16.1. Company overview
12.4.16.2. Financial performance
12.4.16.3. Product benchmarking
12.4.16.4. Strategic initiatives
12.4.17. VCLS
12.4.17.1. Company overview
12.4.17.2. Financial performance
12.4.17.3. Product benchmarking
12.4.17.4. Strategic initiatives
List of Tables
Table 1 List of abbreviations
Table 2 U.S. regulatory affairs market, by services, 2018-2030 (USD Million)
Table 3 U.S. regulatory affairs market, by writing & publishing, 2018-2030 (USD Million)
Table 4 U.S. regulatory affairs market, by category, 2018-2030 (USD Million)
Table 5 U.S. regulatory affairs market, by drugs, 2018-2030 (USD Million)
Table 6 U.S. regulatory affairs market, by innovator, 2018-2030 (USD Million)
Table 7 U.S. regulatory affairs market, by generics, 2018-2030 (USD Million)
Table 8 U.S. regulatory affairs market, by biologics, 2018-2030 (USD Million)
Table 9 U.S. regulatory affairs market, by biotech, 2018-2030 (USD Million)
Table 10 U.S. regulatory affairs market, by ATMP, 2018-2030 (USD Million)
Table 11 U.S. regulatory affairs market, by biosimilars, 2018-2030 (USD Million)
Table 12 U.S. regulatory affairs market, by medical devices, 2018-2030 (USD Million)
Table 13 U.S. regulatory affairs market, by diagnostics, 2018-2030 (USD Million)
Table 14 U.S. regulatory affairs market, by therapeutics, 2018-2030 (USD Million)
Table 15 U.S. regulatory affairs market, by indication, 2018-2030 (USD Million)
Table 16 U.S. regulatory affairs market, by product stage, 2018-2030 (USD Million)
Table 17 U.S. regulatory affairs market, by service provider, 2018-2030 (USD Million)
Table 18 U.S. regulatory affairs market, by company size, 2018-2030 (USD Million)
Table 19 U.S. regulatory affairs market, by end - use, 2018-2030 (USD Million)
Table 20 U.S. regulatory affairs market, by region, 2018-2030 (USD Million)
List of Figures
Figure 1 Market research process
Figure 2 Data triangulation techniques
Figure 3 Primary research pattern
Figure 4 Market research approaches
Figure 5 Value-chain-based sizing & forecasting
Figure 6 QFD modeling for market share assessment
Figure 7 Market formulation & validation
Figure 8 U.S. regulatory affairs market: market outlook
Figure 9 U.S. regulatory affairs competitive insights
Figure 10 Parent market outlook
Figure 11 Related/ancillary market outlook
Figure 12 Penetration and growth prospect mapping
Figure 13 U.S. regulatory affairs market driver impact
Figure 14 U.S. regulatory affairs market restraint impact
Figure 15 U.S. regulatory affairs market: Services movement analysis
Figure 16 U.S. regulatory affairs market: Services outlook and key takeaways
Figure 17 Regulatory consulting market estimates and forecast, 2018-2030 (USD Million)
Figure 18 Legal representation estimates and forecast, 2018-2030 (USD Million)
Figure 19 Regulatory writing & publishing market estimates and forecast, 2018-2030 (USD Million)
Figure 20 Writing estimates and forecast, 2018-2030 (USD Million)
Figure 21 Publishing market estimates and forecast, 2018-2030 (USD Million)
Figure 22 Product Registration & Clinical Trial Applications market estimates and forecast, 2018-2030 (USD Million)
Figure 23 Others services estimates and forecast, 2018-2030 (USD Million)
Figure 24 U.S. regulatory affairs market: Category movement Analysis
Figure 25 U.S. regulatory affairs market: Category outlook and key takeaways
Figure 26 Drugs market estimates and forecasts, 2018-2030 (USD Million)
Figure 27 Innovator market estimates and forecasts, 2018-2030 (USD Million)
Figure 28 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 29 Generics market estimates and forecasts, 2018-2030 (USD Million)
Figure 30 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 31 Clinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 32 Pre-Market Approval (PMA) market estimates and forecasts, 2018-2030 (USD Million)
Figure 33 Biologics market estimates and forecasts, 2018-2030 (USD Million)
Figure 34 Biotech market estimates and forecasts, 2018-2030 (USD Million)
Figure 35 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 36 Clinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 37 Pre-Market Approval (PMA) market estimates and forecasts, 2018-2030 (USD Million)
Figure 38 ATMP market estimates and forecasts, 2018-2030 (USD Million)
Figure 39 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 40 Clinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 41 Pre-Market Approval (PMA) market estimates and forecasts, 2018-2030 (USD Million)
Figure 42 Biosimilars market estimates and forecasts, 2018-2030 (USD Million)
Figure 43 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 44 Clinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 45 Pre-Market Approval (PMA) market estimates and forecasts, 2018-2030 (USD Million)
Figure 46 Medical Devices market estimates and forecasts, 2018-2030 (USD Million)
Figure 47 Diagnostics market estimates and forecasts, 2018-2030 (USD Million)
Figure 48 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 49 Clinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 50 Pre-Market Approval (PMA) market estimates and forecasts, 2018-2030 (USD Million)
Figure 51 Therapeutics market estimates and forecasts, 2018-2030 (USD Million)
Figure 52 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 53 Clinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 54 Pre-Market Approval (PMA) market estimates and forecasts, 2018-2030 (USD Million)
Figure 55 U.S. regulatory affairs market: indication movement analysis
Figure 56 U.S. regulatory affairs market: indication outlook and key takeaways
Figure 57 Oncology market estimates and forecasts, 2018-2030 (USD Million)
Figure 58 Neurology market estimates and forecasts, 2018-2030 (USD Million)
Figure 59 Cardiology market estimates and forecasts, 2018-2030 (USD Million)
Figure 60 Immunology market estimates and forecasts, 2018-2030 (USD Million)
Figure 61 Others market estimates and forecasts, 2018-2030 (USD Million)
Figure 62 U.S. regulatory affairs market: product stage outlook and key takeaways
Figure 63 Preclinical market estimates and forecasts, 2018-2030 (USD Million)
Figure 64 Clinical studies market estimates and forecasts, 2018-2030 (USD Million)
Figure 65 PMA market estimates and forecasts, 2018-2030 (USD Million)
Figure 66 U.S. regulatory affairs market: service provider outlook and key takeaways
Figure 67 In-house market estimates and forecasts, 2018-2030 (USD Million)
Figure 68 Outsourced market estimates and forecasts, 2018-2030 (USD Million)
Figure 69 U.S. regulatory affairs market: company size outlook and key takeaways
Figure 70 Small market estimates and forecasts, 2018-2030 (USD Million)
Figure 71 Medium market estimates and forecasts, 2018-2030 (USD Million)
Figure 72 Large market estimates and forecasts, 2018-2030 (USD Million)
Figure 73 U.S. regulatory affairs market: end-use outlook and key takeaways
Figure 74 Medical device companies market estimates and forecasts, 2018-2030 (USD Million)
Figure 75 Pharmaceutical companies market estimates and forecasts, 2018-2030 (USD Million)
Figure 76 Biotechnology companies market estimates and forecasts, 2018-2030 (USD Million)
Figure 77 U.S. regulatory affairs market: Regional movement analysis
Figure 78 U.S. regulatory affairs market: Regional outlook and key takeaways
Figure 79 West market estimates and forecasts, 2018-2030 (USD Million)
Figure 80 Midwest market estimates and forecasts, 2018-2030 (USD Million)
Figure 81 Northeast market estimates and forecasts, 2018-2030 (USD Million)
Figure 82 Southwest market estimates and forecasts, 2018-2030 (USD Million)
Figure 83 Southeast market estimates and forecasts, 2018-2030 (USD Million)

Companies Mentioned

  • Accell Clinical Research, LLC
  • Genpact
  • CRITERIUM, INC.
  • ICON plc
  • Promedica International
  • WuXi AppTec
  • Medpace
  • Charles River Laboratories
  • Labcorp Drug Development
  • Parexel International (MA) Corporation
  • Freyr
  • Pharmalex GmbH
  • NDA Group AB
  • Qvigilance
  • BlueReg
  • Cambridge Regulatory Services
  • VCLS

Methodology

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Table Information

Report AttributeDetails
No. of Pages80
PublishedJune 2024
Forecast Period2023 - 2030
Estimated Market Value ( USD ) in 2023 $ 4.23 Billion
Forecasted Market Value ( USD ) by 2030 $ 7.71 Billion
Compound Annual Growth Rate9.0%
Regions CoveredUnited States
No. of Companies Mentioned17

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  • Global
From
Biotechnology & Pharmaceutical Services Outsourcing Market by Services, End-User - Global Forecast 2025-2030 - Product Image

Biotechnology & Pharmaceutical Services Outsourcing Market by Services, End-User - Global Forecast 2025-2030

  • Report
  • 180 Pages
  • Global
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About the Regulatory Affairs Market

Regulatory Affairs in the biotechnology industry is the process of obtaining and maintaining approval from regulatory authorities for the development, manufacture, and marketing of biotechnology products. This includes the submission of applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). Regulatory Affairs professionals are responsible for ensuring that biotechnology products comply with applicable laws and regulations. Regulatory Affairs professionals must have a thorough understanding of the regulatory environment and the ability to interpret and apply regulations to the development and marketing of biotechnology products. They must also be able to effectively communicate with regulatory authorities and other stakeholders. Companies in the Regulatory Affairs market in the biotechnology industry include Parexel, Quintiles, Covance, PRA Health Sciences, and Charles River Laboratories. Show Less Read more

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