세계의 규제 컨설팅 아웃소싱 서비스 시장 규모, 점유율 및 동향 분석 보고서 : 카테고리별, 적응증별, 최종 용도별, 기업 규모별, 지역별, 부문별 예측(2024-2030년)

Regulatory Consulting Outsourcing Services Market Growth & Trends:

The global regulatory consulting outsourcing services market size is expected to reach USD 1.90 billion by 2030, registering at a CAGR of 8.36%, according to a new report by Grand View Research, Inc. Rising number of outsourcing players to curb costs associated with clinical trials and stringent regulatory compliance are key drivers for this market. Healthcare regulatory compliance is complex and constantly evolving. Outsourcing allows organizations to access specialized expertise in regulatory affairs, compliance, and quality assurance without having to maintain an in-house team.

The regulatory consulting firms provide clinical trial regulatory services globally, assisting them through faster trial start-ups by combining centralized data administration with the capacity to manage various regulatory submissions simultaneously. For instance, in June 2023, FDA Announces Further Measures to Modernize Clinical Trials. The Agency Seeks Input on the Proposed Guidelines and Their Applicability Across a Range of Trial Varieties and Data Resources. As regulatory frameworks evolve and clinical trial processes modernize, healthcare companies encounter greater complexity in navigating compliance requirements. This complexity is expected to drive demand for regulatory consultancy services to ensure adherence to changing regulations.

Globalization of biopharmaceuticals and medical device companies is likely to be one of the major market drivers. Biopharmaceutical and medical device companies expanded their operations globally to tap into new markets. Emerging economies like China, India, Brazil, and others offer significant growth opportunities due to rising healthcare expenditures, increasing demand for advanced medical treatments, and improving regulatory environments. Regulatory consulting firms are crucial in facilitating market entry by providing strategic advice on regulatory pathways, product registration, and compliance strategies tailored to specific markets.

Regulatory Consulting Outsourcing Services Market Report Highlights:

• By Category, the drugs segment held the largest share in 2023. This is attributed to the complex and evolving regulatory landscape of the pharmaceutical industry
• Oncology held a substantial market share in 2023. This can be attributed to the high prevalence of cancer, prompting a need for safe and effective treatment options
• Pharmaceutical companies held a major share in regulatory consulting outsourcing services with a revenue share of over 40.24% in 2023. The patent expiry of several branded drugs is anticipated to boost regulatory services for generic applications and related services, thereby facilitating market growth
• The mid-size companies segment holds a major revenue share in 2023. Mid-size companies in such industries frequently encounter shortages in resources and technology, leading them to engage with suppliers on a project-by-project basis and commonly delegate application and submission management to consultants through outsourcing arrangements
• North America held the largest share of over 30% in the regulatory consulting outsourcing services market in 2023. The presence of established consulting firms with deep expertise in regulatory compliance and a strong track record of delivering effective solutions attracts businesses seeking regulatory support to drive regional market growth

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
• 1.5. Details of primary research
  • 1.5.1. Data for primary interviews in North America
  • 1.5.2. Data for primary interviews in Europe
  • 1.5.3. Data for primary interviews in Asia Pacific
  • 1.5.4. Data for primary interviews in Latin America
  • 1.5.5. Data for Primary interviews in MEA
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.1.1. Approach 1: Commodity flow approach
  • 1.7.2. Volume price analysis (Model 2)
    • 1.7.2.1. Approach 2: Volume price analysis
• 1.8. Research Scope and Assumptions
  • 1.8.1. List of Secondary Sources
  • 1.8.2. List of Primary Sources
  • 1.8.3. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Regulatory Consulting Outsourcing Services Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Increasing Regulatory Complexity
    • 3.2.1.2. Technological Advancements
    • 3.2.1.3. Rising Cost of Compliance
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Data Security and Confidentiality Concerns
• 3.3. Regulatory Consulting Outsourcing Services Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Bargaining power of the suppliers
    • 3.3.1.2. Bargaining power of the buyers
    • 3.3.1.3. Threats of substitution
    • 3.3.1.4. Threats from new entrants
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Economic and Social Landscape
    • 3.3.2.3. Technological landscape

Chapter 4. Regulatory Consulting Outsourcing Services Market: Category Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Regulatory Consulting Outsourcing Services Market: Category Movement Analysis
• 4.3. Global Regulatory Consulting Outsourcing Services Market Size & Trend Analysis, by Category, 2018 to 2030 (USD Million)
• 4.4. Drugs
  • 4.4.1. Drugs Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Biologics
  • 4.5.1. Biologics Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Medical Devices
  • 4.6.1. Medical Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Regulatory Consulting Outsourcing Services Market: Indication Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Regulatory Consulting Outsourcing Services Market: Indication Movement Analysis
• 5.3. Global Regulatory Consulting Outsourcing Services Market Size & Trend Analysis, by Indication, 2018 to 2030 (USD Million)
• 5.4. Oncology
  • 5.4.1. Oncology Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Neurology
  • 5.5.1. Neurology Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Cardiology
  • 5.6.1. Cardiology Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.7. Immunology
  • 5.7.1. Immunology Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.8. Others
  • 5.8.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Regulatory Consulting Outsourcing Services Market: End Use Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Regulatory Consulting Outsourcing Services Market: End Use Movement Analysis, 2022 & 2030 (USD Million)
• 6.3. Global Regulatory Consulting Outsourcing Services Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 6.4. Biotechnology Companies
  • 6.4.1. Biotechnology Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Pharmaceutical Companies
  • 6.5.1. Pharmaceutical Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Medical Device Companies
  • 6.6.1. Medical Device Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Regulatory Consulting Outsourcing Services Market: Company Size Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Regulatory Consulting Outsourcing Services Market: Company Size Movement Analysis, 2022 & 2030 (USD Million)
• 7.3. Global Regulatory Consulting Outsourcing Services Market Size & Trend Analysis, by Company Size, 2018 to 2030 (USD Million)
• 7.4. Small
  • 7.4.1. Small Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Medium
  • 7.5.1. Medium Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Large
  • 7.6.1. Large Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Regulatory Consulting Outsourcing Services: Regional Estimates & Trend Analysis, by Services, by Area, by Demographic

• 8.1. Regulatory Consulting Outsourcing Services: Regional Movement Analysis, 2022 & 2030
• 8.2. North America
  • 8.2.1. North America Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.2.2. U.S.
    • 8.2.2.1. Key Country Dynamics
    • 8.2.2.2. Competitive Scenario
    • 8.2.2.3. Prevalence Insights
    • 8.2.2.4. Regulatory Framework
    • 8.2.2.5. Reimbursement Structure
    • 8.2.2.6. U.S. Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.2.3. Canada
    • 8.2.3.1. Key Country Dynamics
    • 8.2.3.2. Competitive Scenario
    • 8.2.3.3. Prevalence Insights
    • 8.2.3.4. Regulatory Framework
    • 8.2.3.5. Reimbursement Structure
    • 8.2.3.6. Canada Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.3. Europe
  • 8.3.1. Europe Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.2. UK
    • 8.3.2.1. Key Country Dynamics
    • 8.3.2.2. Competitive Scenario
    • 8.3.2.3. Prevalence Insights
    • 8.3.2.4. Regulatory Framework
    • 8.3.2.5. Reimbursement Structure
    • 8.3.2.6. UK Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.3. Germany
    • 8.3.3.1. Key Country Dynamics
    • 8.3.3.2. Competitive Scenario
    • 8.3.3.3. Prevalence Insights
    • 8.3.3.4. Regulatory Framework
    • 8.3.3.5. Reimbursement Structure
    • 8.3.3.6. Germany Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.4. France
    • 8.3.4.1. Key Country Dynamics
    • 8.3.4.2. Competitive Scenario
    • 8.3.4.3. Prevalence Insights
    • 8.3.4.4. Regulatory Framework
    • 8.3.4.5. Reimbursement Structure
    • 8.3.4.6. France Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.5. Italy
    • 8.3.5.1. Key Country Dynamics
    • 8.3.5.2. Competitive Scenario
    • 8.3.5.3. Prevalence Insights
    • 8.3.5.4. Regulatory Framework
    • 8.3.5.5. Reimbursement Structure
    • 8.3.5.6. Italy Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.6. Spain
    • 8.3.6.1. Key Country Dynamics
    • 8.3.6.2. Competitive Scenario
    • 8.3.6.3. Prevalence Insights
    • 8.3.6.4. Regulatory Framework
    • 8.3.6.5. Reimbursement Structure
    • 8.3.6.6. Spain Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.7. Denmark
    • 8.3.7.1. Key Country Dynamics
    • 8.3.7.2. Competitive Scenario
    • 8.3.7.3. Prevalence Insights
    • 8.3.7.4. Regulatory Framework
    • 8.3.7.5. Reimbursement Structure
    • 8.3.7.6. Denmark Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.8. Sweden
    • 8.3.8.1. Key Country Dynamics
    • 8.3.8.2. Competitive Scenario
    • 8.3.8.3. Prevalence Insights
    • 8.3.8.4. Regulatory Framework
    • 8.3.8.5. Reimbursement Structure
    • 8.3.8.6. Sweden Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.9. Norway
    • 8.3.9.1. Key Country Dynamics
    • 8.3.9.2. Competitive Scenario
    • 8.3.9.3. Prevalence Insights
    • 8.3.9.4. Regulatory Framework
    • 8.3.9.5. Reimbursement Structure
    • 8.3.9.6. Norway Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.4. Asia Pacific
  • 8.4.1. Asia Pacific Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.2. Japan
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Competitive Scenario
    • 8.4.2.3. Prevalence Insights
    • 8.4.2.4. Regulatory Framework
    • 8.4.2.5. Reimbursement Structure
    • 8.4.2.6. Japan Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. China
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Competitive Scenario
    • 8.4.3.3. Prevalence Insights
    • 8.4.3.4. Regulatory Framework
    • 8.4.3.5. Reimbursement Structure
    • 8.4.3.6. China Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. India
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Competitive Scenario
    • 8.4.4.3. Prevalence Insights
    • 8.4.4.4. Regulatory Framework
    • 8.4.4.5. Reimbursement Structure
    • 8.4.4.6. India Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.5. Australia
    • 8.4.5.1. Key Country Dynamics
    • 8.4.5.2. Competitive Scenario
    • 8.4.5.3. Prevalence Insights
    • 8.4.5.4. Regulatory Framework
    • 8.4.5.5. Reimbursement Structure
    • 8.4.5.6. Australia Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.6. Thailand
    • 8.4.6.1. Key Country Dynamics
    • 8.4.6.2. Competitive Scenario
    • 8.4.6.3. Prevalence Insights
    • 8.4.6.4. Regulatory Framework
    • 8.4.6.5. Reimbursement Structure
    • 8.4.6.6. Thailand Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.7. South Korea
    • 8.4.7.1. Key Country Dynamics
    • 8.4.7.2. Competitive Scenario
    • 8.4.7.3. Prevalence Insights
    • 8.4.7.4. Regulatory Framework
    • 8.4.7.5. Reimbursement Structure
    • 8.4.7.6. South Korea Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.5. Latin America
  • 8.5.1. Latin America Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.2. Brazil
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Competitive Scenario
    • 8.5.2.3. Prevalence Insights
    • 8.5.2.4. Regulatory Framework
    • 8.5.2.5. Reimbursement Structure
    • 8.5.2.6. Brazil Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. Mexico
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Competitive Scenario
    • 8.5.3.3. Prevalence Insights
    • 8.5.3.4. Regulatory Framework
    • 8.5.3.5. Reimbursement Structure
    • 8.5.3.6. Mexico Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. Argentina
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Competitive Scenario
    • 8.5.4.3. Prevalence Insights
    • 8.5.4.4. Regulatory Framework
    • 8.5.4.5. Reimbursement Structure
    • 8.5.4.6. Argentina Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.6. Middle East & Africa
  • 8.6.1. Middle East & Africa Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.2. South Africa
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Competitive Scenario
    • 8.6.2.3. Prevalence Insights
    • 8.6.2.4. Regulatory Framework
    • 8.6.2.5. Reimbursement Structure
    • 8.6.2.6. South Africa Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. Saudi Arabia
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Competitive Scenario
    • 8.6.3.3. Prevalence Insights
    • 8.6.3.4. Regulatory Framework
    • 8.6.3.5. Reimbursement Structure
    • 8.6.3.6. Saudi Arabia Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.4. UAE
    • 8.6.4.1. Key Country Dynamics
    • 8.6.4.2. Competitive Scenario
    • 8.6.4.3. Prevalence Insights
    • 8.6.4.4. Regulatory Framework
    • 8.6.4.5. Reimbursement Structure
    • 8.6.4.6. UAE Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.5. Kuwait
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Competitive Scenario
    • 8.6.5.3. Prevalence Insights
    • 8.6.5.4. Regulatory Framework
    • 8.6.5.5. Reimbursement Structure
    • 8.6.5.6. Kuwait Regulatory Consulting Outsourcing Services Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Categorization
• 9.2. Company Market Share Analysis, 2023
• 9.3. Strategy Mapping
• 9.4. Company Profiles/Listing
  • 9.4.1. Parexel International Corporation
    • 9.4.1.1. Overview
    • 9.4.1.2. Financial Performance
    • 9.4.1.3. Product Benchmarking
    • 9.4.1.4. Strategic Initiatives
  • 9.4.2. ICON plc
    • 9.4.2.1. Overview
    • 9.4.2.2. Financial Performance
    • 9.4.2.3. Product Benchmarking
    • 9.4.2.4. Strategic Initiatives
  • 9.4.3. IQVIA
    • 9.4.3.1. Overview
    • 9.4.3.2. Financial Performance
    • 9.4.3.3. Product Benchmarking
    • 9.4.3.4. Strategic Initiatives
  • 9.4.4. Syneos Health
    • 9.4.4.1. Overview
    • 9.4.4.2. Financial Performance
    • 9.4.4.3. Product Benchmarking
    • 9.4.4.4. Strategic Initiatives
  • 9.4.5. Navigant Consulting, Inc.
    • 9.4.5.1. Overview
    • 9.4.5.2. Financial Performance
    • 9.4.5.3. Product Benchmarking
    • 9.4.5.4. Strategic Initiatives
  • 9.4.6. Premier Research
    • 9.4.6.1. Overview
    • 9.4.6.2. Financial Performance
    • 9.4.6.3. Product Benchmarking
    • 9.4.6.4. Strategic Initiatives
  • 9.4.7. Weinberg Group
    • 9.4.7.1. Overview
    • 9.4.7.2. Financial Performance
    • 9.4.7.3. Product Benchmarking
    • 9.4.7.4. Strategic Initiatives
  • 9.4.8. ProPharma
    • 9.4.8.1. Overview
    • 9.4.8.2. Financial Performance
    • 9.4.8.3. Product Benchmarking
    • 9.4.8.4. Strategic Initiatives
  • 9.4.9. PharmaLex GmbH
    • 9.4.9.1. Overview
    • 9.4.9.2. Financial Performance
    • 9.4.9.3. Product Benchmarking
    • 9.4.9.4. Strategic Initiatives
  • 9.4.10. LabCorp
    • 9.4.10.1. Overview
    • 9.4.10.2. Financial Performance
    • 9.4.10.3. Product Benchmarking
    • 9.4.10.4. Strategic Initiatives