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

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


U.S. Regulatory Affairs Market Growth & Trends

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, according to a new report by Grand View Research, Inc. 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
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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

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