North America Biotechnology And Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report By Service (Consulting, Regulatory Affairs), By End Use, By Country, And Segment Forecasts, 2024 - 2030

North America Biotechnology And Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report By Service (Consulting, Regulatory Affairs), By End Use, By Country, And Segment Forecasts, 2024 - 2030


North America Biotechnology and Pharmaceutical Services Outsourcing Market Growth & Trends

The North America biotechnology and pharmaceutical services outsourcing market size is expected to reach USD 16.81 billion by 2030, according to a new report by Grand View Research, Inc., growing at a CAGR of 5.13% from 2024 to 2030.

Increasing competition to launch novel molecules with better RoI is expected to heighten the demand for CRO service providers across the globe. Pharmaceutical companies face complexity in regulations along with increased research costs, creating a need for expertise in numerous portfolios and driving the need for outsourcing in the market. With increasing clinical trial privatization, there has been an increase in outsourcing functions to CROs and CDMOs to focus on core capabilities. Pharmaceutical and biotechnology companies have started outsourcing R&D activities, which are complex and need a strict timeline to follow up. A CRO’s function is to bring new products to the market as per the timeline given by the client. CROs have the required infrastructure and skilled expertise, which provides several advantages associated with cost, time, and efficiency. The cost saved helps in offering the best savings for sponsors and patients.

Drug discovery and development is an integral strategy adopted by pharmaceutical and biotechnology companies. An increase in the prevalence of chronic and long-term diseases led to a rise in the demand for extensive R&D investments in the drug development process. Growing clinical trial failure rates coupled with increasing drug development costs lead to huge losses in revenue for manufacturers. Setbacks faced in clinical studies have led smaller pharmaceutical companies to go bankrupt. Many private investors have been observed to withdraw venture capital support from startup drug companies, considering their investments would suffer if there were a disruption in the drug development process. To circumvent these situations and gain a substantial return on investment, pharmaceutical companies are now adopting computational biology-based predictive models over traditional methods of clinical trials, which are expected to drive market growth during the forecast period. Insights gained from subject-matter experts, R&D executives, and clinical professionals help a company save a large amount, which can be spent on R&D, thereby boosting demand for consulting services.

The healthcare outsourcing industry has recently witnessed a surge in mergers and acquisitions. The sector's rapid growth and promising potential have attracted significant investment from pharmaceutical companies, biotech firms, & venture capitalists. As a result, companies seek to expand their portfolios and capabilities through strategic acquisitions to capitalize on emerging opportunities and strengthen their competitive position in the market. For instance, in May 2024, Sartorius AG announced a collaboration with NVIDIA to help the development of new therapies, leveraging NVIDIA’s AI-powered computing software and platform. Moreover, the complexity and high costs associated with developing therapeutics are leading to increased collaboration & consolidation within the industry. Mergers & acquisitions offer companies complementary technologies, expertise, and resources, enabling them to overcome development challenges, accelerate product development timelines, and enhance manufacturing capabilities.

North America Biotechnology And Pharmaceutical Services Outsourcing Market Report highlights
  • Based on service, the consulting segment held the largest revenue share in 2023. The large segment growth is owing to the growing adoption of consulting services to meet regulatory compliance, quality assurance, remediation challenges, and strategic consulting requirements by sponsors. Furthermore, regulatory consulting services are widely used owing to increasing fraud cases, discrepancies in Intellectual Property Rights (IPR), and rising technological innovation, which are some of the major challenges faced by pharmaceutical and biotechnology companies. Another factor driving the demand for consulting services is the consolidated nature of the market, which leads to an increase in the number of joint ventures, takeovers, acquisitions, and mergers. Such factors are anticipated to drive the market growth.
  • Based on end use, the pharmaceutical companies segment held the largest revenue share of over 57.79% in 2023. The segment growth is owing to an increasing preference for outsourcing non-core activities such as clinical trials, data management, regulatory compliance, and manufacturing to CROs and CMOs among pharmaceutical companies is anticipated to boost segment revenue growth. Outsourcing to CROs and CMOs provides pharmaceutical companies with cost-effective solutions compared to maintaining extensive in-house capabilities.
  • The U.S. dominated the biotechnology and pharmaceutical services outsourcing market with a share of 87.37% in 2023. The country’s revenue growth is owing to high R&D spending on clinical trials, which is another major factor expected to fuel market growth. For instance, in October 2021, the U.S. FDA approved 11 new clinical trial research, resulting in over USD 25 million in funding over the next four years. These grants aim to support the development of new medical products specifically for treating rare diseases. The growing presence of these companies expanding their manufacturing capabilities to cater to the rising demand for pharmaceuticals is anticipated to propel market growth.
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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
1.4.3. 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

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