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. Internal database
1.4.3. Secondary Sources
1.4.4. Primary Research
1.5. Details of primary research
1.6. Market Formulation & Validation
1.7. Country-wise Market Calculation
1.7.1. Country Wise Market: Base Estimates
1.7.2. CAGR Calculation
1.7.3. Country Based Segment Share Calculation
1.8. Model Details
1.8.1. Commodity flow analysis (Model 1)
1.8.2. Value Chain-Based Sizing & Forecasting (Model 2)
1.8.3. QFD Model Sizing & Forecasting (Model 3)
1.8.4. Bottom-up Approach (Model 4)
1.9. Research Scope and Assumptions
1.10. List of Secondary Sources
1.11. List of Primary Sources
1.12. List of Abbreviations
1.13. Objectives
1.13.1. Objective 1
1.13.2. Objective 2
1.13.3. Objective 3
1.13.4. Objective 4
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. North America Biotechnology and Pharmaceutical Services Outsourcing Market Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Increasing Outsourcing of R&D Activities
3.2.1.2. Changing Regulatory Landscape
3.2.1.3. Increasing Focus on Core Competencies by Pharmaceutical and Biotechnology Companies
3.2.1.4. Growing Drug Development Costs Coupled With High Clinical Development Failure Rates
3.2.1.5. Increasing Mergers and Collaborations
3.2.2. Market Restraint Analysis
3.2.2.1. Monitoring Issues and Lack of Standardization
3.2.2.2. Loss of Control
3.2.2.3. Data Security Issues
3.3. Technology Landscape
3.4. Pricing Model Analysis
3.5. GxP Overview
3.5.1. Good Manufacturing Practices (GMP)
3.5.2. Current Good Manufacturing Practices (cGMP)
3.5.3. Good Laboratory Practices (GLP)
3.5.4. Good Clinical Practices (GCP)
3.5.5. Good Distribution Practices (GDP)
3.6. Clinical Trials Volume Analysis (2023)
3.6.1. Total Number of Clinical Trials, by Country
3.6.2. Total Number of Clinical Trials, by Phase
3.6.3. Total Number of Clinical Trials, by Study Design
3.6.4. Total Number of Clinical Trials, by Key Therapeutic Area
3.7. R&D Investment Analysis
3.8. North America Biotechnology and Pharmaceutical Services Outsourcing Market Analysis Tools
3.8.1. Porter’s Five Forces Analysis
3.8.2. PESTEL Analysis
3.9. COVID-19 Impact Analysis
Chapter 4. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Service Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Service Movement Analysis
4.3. North America Biotechnology and Pharmaceutical Services Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
4.4. Consulting
4.4.1. Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4.2. Regulatory Consulting
4.4.2.1. Regulatory Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4.3. Clinical Development Consulting
4.4.3.1. Clinical Development Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4.4. Strategic Planning & Business Development Consulting
4.4.4.1. Strategic Planning & Business Development Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4.5. Quality Management Systems Consulting
4.4.5.1. Quality Management Systems Consulting Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4.6. Others
4.4.6.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5. Regulatory Affairs
4.5.1. Regulatory Affairs Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.2. Legal Representation
4.5.2.1. Legal Representation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.3. Regulatory Writing & Publishing
4.5.3.1. Regulatory Writing & Publishing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.4. Product Registration & Clinical Trial Applications
4.5.4.1. Product Registration & Clinical Trial Applications Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.5. Regulatory Submissions
4.5.5.1. Regulatory Submissions Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.6. Regulatory Operations
4.5.6.1. Regulatory Operations Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5.7. Others
4.5.7.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6. Product Design & Development
4.6.1. Product Design & Development Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6.2. Research, Strategy, & Concept Generation
4.6.2.1. Research, Strategy, & Concept Generation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6.3. Concept & Requirements Development
4.6.3.1. Concept & Requirements Development Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6.4. Detailed Design & Process Development
4.6.4.1. Detailed Design & Process Development Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6.5. Design Verification & Validation
4.6.5.1. Design Verification & Validation Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6.6. Process Validation & Manufacturing Transfer
4.6.6.1. Process Validation & Manufacturing Transfer Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.6.7. Production & Commercial Support
4.6.7.1. Production & Commercial Support Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7. Auditing and Assessment
4.7.1. Auditing and Assessment Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7.2. General Auditing
4.7.2.1. General Auditing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7.3. Gap Assessments
4.7.3.1. Gap Assessments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7.4. Due Diligence Assessments
4.7.4.1. Due Diligence Assessments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7.5. Mock Audits/Inspections
4.7.5.1. Mock Audits/Inspections Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7.6. Inspection/Audit Management and Support
4.7.6.1. Inspection/Audit Management and Support Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.7.7. Others
4.7.7.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.8. Product Maintenance
4.8.1. Product Maintenance Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.9. Training & Education
4.9.1. Training & Education Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.10. Others
4.10.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 5. North America Biotechnology and Pharmaceutical Services Outsourcing Market: End-Use Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. North America Biotechnology and Pharmaceutical Services Outsourcing Market: End-Use Movement Analysis
5.3. North America Biotechnology and Pharmaceutical Services Outsourcing Market Size & Trend Analysis, by End-Use, 2018 to 2030 (USD Million)
5.4. Pharmaceutical Companies
5.4.1. Pharmaceutical Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.5. Biotech Companies
5.5.1. Biotech Companies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 6. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Country Estimates & Trend Analysis, by Service, by End-Use
6.1. Country Dashboard
6.2. North America Biotechnology and Pharmaceutical Services Outsourcing Market: Country Movement Analysis
6.3. U.S.
6.3.1. Key Country Dynamics
6.3.2. Competitive Scenario
6.3.3. Regulatory Framework
6.3.4. U.S. Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
6.4. Canada
6.4.1. Key Country Dynamics
6.4.2. Competitive Scenario
6.4.3. Regulatory Framework
6.4.4. Canada Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
6.5. Mexico
6.5.1. Key Country Dynamics
6.5.2. Competitive Scenario
6.5.3. Regulatory Framework
6.5.4. Mexico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
6.6. Puerto Rico
6.6.1. Key Country Dynamics
6.6.2. Competitive Scenario
6.6.3. Regulatory Framework
6.6.4. Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 7. Competitive Landscape
7.1. Company Categorization
7.1.1. Market Leaders
7.1.2. Emerging Players
7.2. Company Market Share/Assessment Analysis, 2023
7.3. Service Heat Map Analysis
7.4. Company Profiles
7.4.1. Parexel International Corporation
7.4.1.1. Company Overview
7.4.1.2. Financial Performance
7.4.1.3. Service Benchmarking
7.4.1.4. Strategic Initiatives
7.4.2. The Quantic Group
7.4.2.1. Company Overview
7.4.2.2. Financial Performance
7.4.2.3. Service Benchmarking
7.4.2.4. Strategic Initiatives
7.4.3. IQVIA
7.4.3.1. Company Overview
7.4.3.2. Financial Performance
7.4.3.3. Service Benchmarking
7.4.3.4. Strategic Initiatives
7.4.4. Lachman Consultant Services, Inc.
7.4.4.1. Company Overview
7.4.4.2. Financial Performance
7.4.4.3. Service Benchmarking
7.4.4.4. Strategic Initiatives
7.4.5. GMP Pharmaceuticals Pty Ltd.
7.4.5.1. Company Overview
7.4.5.2. Financial Performance
7.4.5.3. Service Benchmarking
7.4.5.4. Strategic Initiatives
7.4.6. LabCorp
7.4.6.1. Company Overview
7.4.6.2. Financial Performance
7.4.6.3. Service Benchmarking
7.4.6.4. Strategic Initiatives
7.4.7. Charles River Laboratories
7.4.7.1. Company Overview
7.4.7.2. Financial Performance
7.4.7.3. Service Benchmarking
7.4.7.4. Strategic Initiatives
7.4.8. ICON plc.
7.4.8.1. Company Overview
7.4.8.2. Financial Performance
7.4.8.3. Service Benchmarking
7.4.8.4. Strategic Initiatives
7.4.9. Syneos Health
7.4.9.1. Company Overview
7.4.9.2. Financial Performance
7.4.9.3. Service Benchmarking
7.4.9.4. Strategic Initiatives
7.4.10. Lonza
7.4.10.1. Company Overview
7.4.10.2. Financial Performance
7.4.10.3. Service Benchmarking
7.4.10.4. Strategic Initiatives
7.4.11. Catalent Inc.
7.4.11.1. Company Overview
7.4.11.2. Financial Performance
7.4.11.3. Service Benchmarking
7.4.11.4. Strategic Initiatives
7.4.12. Samsung Biologics
7.4.12.1. Company Overview
7.4.12.2. Financial Performance
7.4.12.3. Service Benchmarking
7.4.12.4. Strategic Initiatives
List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 North America Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
Table 4 North America Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
Table 5 North America Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
Table 6 North America Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
Table 7 North America Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
Table 8 North America Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
Table 9 North America Biotechnology and Pharmaceutical Services Outsourcing by Region, 2018 - 2030 (USD Million)
Table 10 North America Biotechnology and Pharmaceutical Services Outsourcing by Country, 2018 - 2030 (USD Million)
Table 11 North America Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
Table 12 North America Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
Table 13 North America Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
Table 14 North America Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
Table 15 North America Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
Table 16 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
Table 17 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
Table 18 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
Table 19 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
Table 20 U.S. Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
Table 21 U.S. Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
Table 22 Canada Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
Table 23 Canada Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
Table 24 Canada Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
Table 25 Canada Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
Table 26 Canada Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
Table 27 Canada Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
Table 28 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
Table 29 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
Table 30 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
Table 31 Mexico Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
Table 32 Mexico Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
Table 33 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Service, 2018 - 2030 (USD Million)
Table 34 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Consulting Services, 2018 - 2030 (USD Million)
Table 35 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Regulatory Affairs, 2018 - 2030 (USD Million)
Table 36 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Product Design and Development, 2018 - 2030 (USD Million)
Table 37 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by Auditing and Assessment, 2018 - 2030 (USD Million)
Table 38 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing by End-Use, 2018 - 2030 (USD Million)
List of Figures
Fig. 1 Information Procurement
Fig. 2 Primary Research Pattern
Fig. 3 Market Research Approaches
Fig. 4 Value Chain-Based Sizing & Forecasting
Fig. 5 Market Formulation & Validation
Fig. 6 North America Biotechnology and Pharmaceutical Services Outsourcing, Market Segmentation
Fig. 7 Market Driver Relevance Analysis (Current & Future Impact)
Fig. 8 Market Restraint Relevance Analysis (Current & Future Impact)
Fig. 9 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
Fig. 10 Porter’s Five Forces Analysis
Fig. 11 Regional Marketplace: Key Takeaways
Fig. 12 North America Biotechnology and Pharmaceutical Services Outsourcing, for Consulting, 2018 - 2030 (USD Million)
Fig. 13 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Consulting, 2018 - 2030 (USD Million)
Fig. 14 North America Biotechnology and Pharmaceutical Services Outsourcing, for Clinical Development Consulting, 2018 - 2030 (USD Million)
Fig. 15 North America Biotechnology and Pharmaceutical Services Outsourcing, for Strategic Planning & Business Development Consulting, 2018 - 2030 (USD Million)
Fig. 16 North America Biotechnology and Pharmaceutical Services Outsourcing, for Quality Management Systems Consulting, 2018 - 2030 (USD Million)
Fig. 17 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
Fig. 18 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Affairs, 2018 - 2030 (USD Million)
Fig. 19 North America Biotechnology and Pharmaceutical Services Outsourcing, for Legal Representation, 2018 - 2030 (USD Million)
Fig. 20 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
Fig. 21 North America Biotechnology and Pharmaceutical Services Outsourcing, for Product Registration & Clinical Trial Applications, 2018 - 2030 (USD Million)
Fig. 22 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Submissions, 2018 - 2030 (USD Million)
Fig. 23 North America Biotechnology and Pharmaceutical Services Outsourcing, for Regulatory Operations, 2018 - 2030 (USD Million)
Fig. 24 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
Fig. 25 North America Biotechnology and Pharmaceutical Services Outsourcing, for Product Design & Development, 2018 - 2030 (USD Million)
Fig. 26 North America Biotechnology and Pharmaceutical Services Outsourcing, for Research, Strategy, & Concept Generation, 2018 - 2030 (USD Million)
Fig. 27 North America Biotechnology and Pharmaceutical Services Outsourcing, for Concept & Requirements Development, 2018 - 2030 (USD Million)
Fig. 28 North America Biotechnology and Pharmaceutical Services Outsourcing, for Detailed Design & Process Development, 2018 - 2030 (USD Million)
Fig. 29 North America Biotechnology and Pharmaceutical Services Outsourcing, for Design Verification & Validation, 2018 - 2030 (USD Million)
Fig. 30 North America Biotechnology and Pharmaceutical Services Outsourcing, for Process Validation & Manufacturing Transfer, 2018 - 2030 (USD Million)
Fig. 31 North America Biotechnology and Pharmaceutical Services Outsourcing, for Production & Commercial Support, 2018 - 2030 (USD Million)
Fig. 32 North America Biotechnology and Pharmaceutical Services Outsourcing, for Auditing and Assessment, 2018 - 2030 (USD Million)
Fig. 33 North America Biotechnology and Pharmaceutical Services Outsourcing, for General Auditing, 2018 - 2030 (USD Million)
Fig. 34 North America Biotechnology and Pharmaceutical Services Outsourcing, for Gap Assessments, 2018 - 2030 (USD Million)
Fig. 35 North America Biotechnology and Pharmaceutical Services Outsourcing, for Due Diligence Assessments, 2018 - 2030 (USD Million)
Fig. 36 North America Biotechnology and Pharmaceutical Services Outsourcing, for Mock Audits/Inspections, 2018 - 2030 (USD Million)
Fig. 37 North America Biotechnology and Pharmaceutical Services Outsourcing, for Inspection/Audit Management and Support, 2018 - 2030 (USD Million)
Fig. 38 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
Fig. 39 North America Biotechnology and Pharmaceutical Services Outsourcing, for Product Maintenance, 2018 - 2030 (USD Million)
Fig. 40 North America Biotechnology and Pharmaceutical Services Outsourcing, for Training & Education, 2018 - 2030 (USD Million)
Fig. 41 North America Biotechnology and Pharmaceutical Services Outsourcing, for Others, 2018 - 2030 (USD Million)
Fig. 42 North America Biotechnology and Pharmaceutical Services Outsourcing, for Pharmaceutical Companies, 2018 - 2030 (USD Million)
Fig. 43 North America Biotechnology and Pharmaceutical Services Outsourcing, for Biotech Companies, 2018 - 2030 (USD Million)
Fig. 44 Country Outlook, 2023 & 2030
Fig. 45 U.S. Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Fig. 46 Canada Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Fig. 47 Mexico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Fig. 48 Puerto Rico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)