The U.S. biotechnology and pharmaceutical services outsourcing market size was exhibited at USD 10.18 billion in 2023 and is projected to hit around USD 16.68 billion by 2033, growing at a CAGR of 5.06% during the forecast period 2024 to 2033.
Report Coverage | Details |
Market Size in 2024 | USD 10.70 Billion |
Market Size by 2033 | USD 16.68 Billion |
Growth Rate From 2024 to 2033 | CAGR of 5.06% |
Base Year | 2023 |
Forecast Period | 2024-2033 |
Segments Covered | End-use, Service |
Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
Regional Scope | U.S. |
Key Companies Profiled | AbbVie Inc.; Lifecore Biomedical, Inc.; IQVIA Inc.; Parexel International (MA) Corp.; Lachman Consultant Services; Covance, Inc.; Charles River Laboratory; PRA Health Sciences; Simtra (Baxter); Alcami Corp. |
This market growth can be attributed to an increased inclination towards outsourcing certain business functions, such as research, drug development, and clinical trials among others. In addition, changing regulatory landscapes create the need for consulting for biotechnology and pharmaceutical companies. A rise in drug development costs and the availability of cost-effective services offered by outsourcing contractors from other regions are also among the key market growth drivers.
The U.S. biotechnology and pharmaceutical services outsourcing market held a share of over 22.3% of the global biotechnology and pharmaceutical services outsourcing market revenue in 2023. Several biotechnology and pharmaceutical companies in the U.S. are opting to outsource major business functions, such as design verification & validation, clinical development, product registration, and clinical trial applications. Furthermore, operational elements, such as quality management, strategy, & concept generation, product maintenance, auditing, and training, are also being outsourced to contractors.
This is mainly due to the cost-effective services offered by outsourcing contractors, which are equipped with technologies, know-how, resources, facilities, and expert professionals. The growing pressure of regulatory compliances, a rise in costs associated with drug development, and, an increase in failure rates have remarkably affected the market dynamics. Well-rooted contract research organizations (CROs), outsourcing service providers, manufacturers working on contracts, and management consulting firms are persistently taking care of the multifaceted demands of the biotechnological and pharmaceutical industry.
Based on the end-use, the pharmaceutical companies segment held the highest market share of 57.16% in 2023 mainly driven by factors, such as the changes in regulatory scenarios, developments and progress accomplished by competitors through outsourcing, improved product responses, and enhanced quality standards attained through expert assistance. Pharmaceuticals have also been outsourcing distribution to different service providers to leverage their robust networks in different regions.
A rise in expenses in areas, such as R&D, by pharmaceutical companies for the detection and development of potential exclusive products is estimated to fuel market growth in the coming years. The biotech companies segment is expected to register a CAGR of 5.4% from 2024 to 2033.
The consulting services segment dominated the market and accounted for a revenue share of 24.96% in 2023. Consulting companies offer several services to help pharmaceutical and biotechnology businesses adhere to regulatory compliances as well as accomplish better quality standards and reduce environmental footprint. For a pharmaceutical company, these companies deliver a greater level of proficiency and experience. A rise in fraudulent incidents and continuous growth in scientific innovations are two of the key challenges faced by pharmaceutical and biotechnological organizations. Therefore, such businesses prefer to outsource some of their business functions.
The product design & development segment is expected to witness a CAGR of 4.19% from 2024 to 2033 due to the dynamic nature of the industry. Companies provide services, such as formulation for analyzing & optimizing chemical & physical properties of API; formulation development studies determining the optimal dosage form, composition, & manufacturing route of pharmaceutical products; analytical solutions for complex research needs; and stability studies. It also includes pharmaceutical product development strategies, such as nonclinical studies, management of changing CMC issues, and timing & requirements for regulatory submissions to support ongoing development activities.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. biotechnology and pharmaceutical services outsourcing market
End-use
Service
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. Region-wise Market Calculation
1.7.1. Region-Wise Market: Base Estimates
1.7.2. Global Market: CAGR Calculation
1.7.3. Region Based Segment Share Calculation
1.8. Model Details
1.8.1. Commodity flow analysis (Model 1)
1.8.1.1. Approach 1: Commodity flow approach
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. 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. Clinical Trials Volume Analysis
3.6. R&D Investment Analysis
3.7. Biotechnology and Pharmaceutical Services Outsourcing Market Analysis Tools
3.7.1. Porter’s Five Forces Analysis
3.7.2. PESTEL Analysis
3.8. COVID-19 Impact Analysis
Chapter 4. Biotechnology and Pharmaceutical Services Outsourcing Market: Service Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Biotechnology and Pharmaceutical Services Outsourcing Market: Service Movement Analysis
4.3. Global Biotechnology and Pharmaceutical Services Outsourcing Market Size & Trend Analysis, by Service, 2021 to 2033
4.4. Consulting
4.4.1. Consulting Market Revenue Estimates and Forecasts, 2021 - 2033
4.4.2. Regulatory Consulting
4.4.2.1. Regulatory Consulting Market Revenue Estimates and Forecasts, 2021 - 2033
4.4.3. Clinical Development Consulting
4.4.3.1. Clinical Development Consulting Market Revenue Estimates and Forecasts, 2021 - 2033
4.4.4. Strategic Planning & Business Development Consulting
4.4.4.1. Strategic Planning & Business Development Consulting Market Revenue Estimates and Forecasts, 2021 - 2033
4.4.5. Quality Management Systems Consulting
4.4.5.1. Quality Management Systems Consulting Market Revenue Estimates and Forecasts, 2021 - 2033
4.4.6. Others
4.4.6.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033
4.5. Regulatory Affairs
4.5.1. Regulatory Affairs Market Revenue Estimates and Forecasts, 2021 - 2033
4.5.2. Legal Representation
4.5.2.1. Legal Representation Market Revenue Estimates and Forecasts, 2021 - 2033
4.5.3. Regulatory Writing & Publishing
4.5.3.1. Regulatory Writing & Publishing Market Revenue Estimates and Forecasts, 2021 - 2033
4.5.4. Product Registration & Clinical Trial Applications
4.5.4.1. Product Registration & Clinical Trial Applications Market Revenue Estimates and Forecasts, 2021 - 2033
4.5.5. Regulatory Submissions
4.5.5.1. Regulatory Submissions Market Revenue Estimates and Forecasts, 2021 - 2033
4.5.6. Regulatory Operations
4.5.6.1. Regulatory Operations Market Revenue Estimates and Forecasts, 2021 - 2033
4.5.7. Others
4.5.7.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033
4.6. Product Design & Development
4.6.1. Product Design & Development Market Revenue Estimates and Forecasts, 2021 - 2033
4.7. Auditing and Assessment
4.7.1. Auditing and Assessment Market Revenue Estimates and Forecasts, 2021 - 2033
4.8. Product Maintenance
4.8.1. Product Maintenance Market Revenue Estimates and Forecasts, 2021 - 2033
4.9. Training & Education
4.9.1. Training & Education Market Revenue Estimates and Forecasts, 2021 - 2033
4.10. Others
4.10.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033
Chapter 5. Biotechnology and Pharmaceutical Services Outsourcing Market: End-Use Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Biotechnology and Pharmaceutical Services Outsourcing Market: End-Use Movement Analysis
5.3. Global Biotechnology and Pharmaceutical Services Outsourcing Market Size & Trend Analysis, by End-Use, 2021 to 2033
5.4. Pharmaceutical Companies
5.4.1. Pharmaceutical Companies Market Revenue Estimates and Forecasts, 2021 - 2033
5.5. Biotech Companies
5.5.1. Biotech Companies Market Revenue Estimates and Forecasts, 2021 - 2033
Chapter 6. Biotechnology and Pharmaceutical Services Outsourcing Market: Regional Estimates & Trend Analysis, by Service, by End-Use
6.1. Regional Dashboard
6.2. Biotechnology and Pharmaceutical Services Outsourcing Market: Regional Movement Analysis
6.3. North America
6.3.1. North America Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.3.2. U.S.
6.3.2.1. Key Country Dynamics
6.3.2.2. Competitive Scenario
6.3.2.3. Regulatory Framework
6.3.2.4. U.S. Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.3.3. Canada
6.3.3.1. Key Country Dynamics
6.3.3.2. Competitive Scenario
6.3.3.3. Regulatory Framework
6.3.3.4. Canada Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4. Europe
6.4.1. Europe Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.2. UK
6.4.2.1. Key Country Dynamics
6.4.2.2. Competitive Scenario
6.4.2.3. Regulatory Framework
6.4.2.4. UK Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.3. Germany
6.4.3.1. Key Country Dynamics
6.4.3.2. Competitive Scenario
6.4.3.3. Regulatory Framework
6.4.3.4. Germany Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.4. France
6.4.4.1. Key Country Dynamics
6.4.4.2. Competitive Scenario
6.4.4.3. Regulatory Framework
6.4.4.4. France Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.5. Italy
6.4.5.1. Key Country Dynamics
6.4.5.2. Competitive Scenario
6.4.5.3. Regulatory Framework
6.4.5.4. Italy Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.6. Spain
6.4.6.1. Key Country Dynamics
6.4.6.2. Competitive Scenario
6.4.6.3. Regulatory Framework
6.4.6.4. Spain Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.7. Denmark
6.4.7.1. Key Country Dynamics
6.4.7.2. Competitive Scenario
6.4.7.3. Regulatory Framework
6.4.7.4. Denmark Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.8. Sweden
6.4.8.1. Key Country Dynamics
6.4.8.2. Competitive Scenario
6.4.8.3. Regulatory Framework
6.4.8.4. Sweden Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.4.9. Norway
6.4.9.1. Key Country Dynamics
6.4.9.2. Competitive Scenario
6.4.9.3. Regulatory Framework
6.4.9.4. Norway Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5. Asia Pacific
6.5.1. Asia Pacific Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5.2. Japan
6.5.2.1. Key Country Dynamics
6.5.2.2. Competitive Scenario
6.5.2.3. Regulatory Framework
6.5.2.4. Japan Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5.3. China
6.5.3.1. Key Country Dynamics
6.5.3.2. Competitive Scenario
6.5.3.3. Regulatory Framework
6.5.3.4. China Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5.4. India
6.5.4.1. Key Country Dynamics
6.5.4.2. Competitive Scenario
6.5.4.3. Regulatory Framework
6.5.4.4. India Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5.5. Australia
6.5.5.1. Key Country Dynamics
6.5.5.2. Competitive Scenario
6.5.5.3. Regulatory Framework
6.5.5.4. Australia Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5.6. Thailand
6.5.6.1. Key Country Dynamics
6.5.6.2. Competitive Scenario
6.5.6.3. Regulatory Framework
6.5.6.4. Thailand Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.5.7. South Korea
6.5.7.1. Key Country Dynamics
6.5.7.2. Competitive Scenario
6.5.7.3. Regulatory Framework
6.5.7.4. South Korea Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.6. Latin America
6.6.1. Latin America Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.6.2. Brazil
6.6.2.1. Key Country Dynamics
6.6.2.2. Competitive Scenario
6.6.2.3. Regulatory Framework
6.6.2.4. Brazil Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.6.3. Mexico
6.6.3.1. Key Country Dynamics
6.6.3.2. Competitive Scenario
6.6.3.3. Regulatory Framework
6.6.3.4. Mexico Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.6.4. Argentina
6.6.4.1. Key Country Dynamics
6.6.4.2. Competitive Scenario
6.6.4.3. Regulatory Framework
6.6.4.4. Argentina Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.7. Middle East & Africa
6.7.1. Middle East & Africa Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.7.2. South Africa
6.7.2.1. Key Country Dynamics
6.7.2.2. Competitive Scenario
6.7.2.3. Regulatory Framework
6.7.2.4. South Africa Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.7.3. Saudi Arabia
6.7.3.1. Key Country Dynamics
6.7.3.2. Competitive Scenario
6.7.3.3. Regulatory Framework
6.7.3.4. Saudi Arabia Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.7.4. UAE
6.7.4.1. Key Country Dynamics
6.7.4.2. Competitive Scenario
6.7.4.3. Regulatory Framework
6.7.4.4. UAE Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
6.7.5. Kuwait
6.7.5.1. Key Country Dynamics
6.7.5.2. Competitive Scenario
6.7.5.3. Regulatory Framework
6.7.5.4. Kuwait Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2021 - 2033
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, 2024
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. Concept Heidelberg GmbH
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. LabCorp
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. Charles River Laboratories
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. ICON plc.
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. Syneos Health
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. Lonza
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. Catalent Inc.
7.4.12.1. Company Overview
7.4.12.2. Financial Performance
7.4.12.3. Service Benchmarking
7.4.12.4. Strategic Initiatives
7.4.13. Samsung Biologics
7.4.13.1. Company Overview
7.4.13.2. Financial Performance
7.4.13.3. Service Benchmarking
7.4.13.4. Strategic Initiatives