Biotechnology And Pharmaceutical Services Outsourcing Market Size, Share & Trends Report

Biotechnology And Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report By Services (Consulting, Auditing and Assessment, Regulatory Affairs), By End-use (Pharma, Biotech), By Region, And Segment Forecasts, 2024 - 2030

Report ID: GVR-1-68038-326-3
Number of Pages: 133
Format: Electronic (PDF)

Historical Range: 2018 - 2023
Industry: Healthcare

Market Segmentation

Biotechnology & Pharmaceutical Services Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)
- Consulting
  - Regulatory Compliance
  - Remediation
  - Quality Management Systems Consulting
  - Others
- Auditing & Assessment
- Regulatory Affairs
  - Clinical Trial Applications & Product Registration
  - Regulatory Writing & Publishing
  - Legal Representation
  - Others
- Product Maintenance
- Product Design & Development
- Product Testing & Validation
- Training & Education
- Others
Biotechnology & Pharmaceutical Services Outsourcing End-Use Outlook (Revenue, USD Million, 2018 - 2030)
- Pharma
- Biotech
Biotechnology & Pharmaceutical Services Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)
- North America
  - North America Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
    - Consulting
      - Regulatory compliance
      - Remediation
      - Quality management systems consulting
      - Others
    - Auditing and assessment
    - Regulatory affairs
      - Clinical trial applications & product registration
      - Regulatory writing & publishing
      - Legal representation
      - Others
    - Product maintenance
    - Product design & development
    - Product testing & validation
    - Training & education
    - Others
  - North America Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
    - Pharma
    - Biotech
  - U.S.
    - U.S. Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - U.S. Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Canada
    - Canada Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Canada Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
- Europe
  - Europe Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
    - Consulting
      - Regulatory compliance
      - Remediation
      - Quality management systems consulting
      - Others
    - Auditing and assessment
    - Regulatory affairs
      - Clinical trial applications & product registration
      - Regulatory writing & publishing
      - Legal representation
      - Others
    - Product maintenance
    - Product design & development
    - Product testing & validation
    - Training & education
    - Others
  - Europe Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
    - Pharma
    - Biotech
  - UK
    - UK Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - UK Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Germany
    - Germany Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Germany Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - France
    - France Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - France Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Italy
    - Italy Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Italy Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Spain
    - Spain Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Spain Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Denmark
    - Denmark Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Denmark Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Sweden
    - Sweden Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Sweden Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Norway
    - Norway Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Norway Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
- Asia Pacific
- Latin America
  - Latin America Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
    - Consulting
      - Regulatory compliance
      - Remediation
      - Quality management systems consulting
      - Others
    - Auditing and assessment
    - Regulatory affairs
      - Clinical trial applications & product registration
      - Regulatory writing & publishing
      - Legal representation
      - Others
    - Product maintenance
    - Product design & development
    - Product testing & validation
    - Training & education
    - Others
  - Latin America Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
    - Pharma
    - Biotech
  - Brazil
    - Brazil Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Brazil Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Mexico
    - Mexico Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Mexico Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Argentina
    - Argentina Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Argentina Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
- MEA
  - MEA Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
    - Consulting
      - Regulatory compliance
      - Remediation
      - Quality management systems consulting
      - Others
    - Auditing and assessment
    - Regulatory affairs
      - Clinical trial applications & product registration
      - Regulatory writing & publishing
      - Legal representation
      - Others
    - Product maintenance
    - Product design & development
    - Product testing & validation
    - Training & education
    - Others
  - MEA Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
    - Pharma
    - Biotech
  - South Africa
    - South Africa Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - South Africa Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Saudi Arabia
  - UAE
    - UAE Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - UAE Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech
  - Kuwait
    - Kuwait Biotechnology and Pharmaceutical Services Outsourcing Market, By Service
      - Consulting
        
        Regulatory compliance
        
        Remediation
        
        Quality management systems consulting
        
        Others
      - Auditing and assessment
      - Regulatory affairs
        
        Clinical trial applications & product registration
        
        Regulatory writing & publishing
        
        Legal representation
        
        Others
      - Product maintenance
      - Product design & development
      - Product testing & validation
      - Training & education
      - Others
    - Kuwait Biotechnology and Pharmaceutical Services Outsourcing Market, By End Use
      - Pharma
      - Biotech

Biotechnology And Pharmaceutical Services Outsourcing Market Dynamics

Drivers: Increasing Outsourcing Of R&D Activities

Industry is witnessing outsourcing; many patents of many drugs are expected to expire soon, which is anticipated to drive the biosimilar market. This, in turn, is expected to boost R&D activities of companies for commercializing generic versions of drugs. Launching generics in the market in a feasible timeline and cost is anticipated to drive the demand for global Contract Research Organizations (CROs). In 2015, the top 30 sponsor companies had allied with at least one CRO. It has been observed that significant players have three alliances on average to maintain their product portfolios. A pharmaceutical company engages multiple CROs, each providing a unique service. Companies invest in R&D to gain a competitive advantage; pharmaceutical and biotechnology companies allocate a significant portion of their revenue to R&D activities.

Changing Regulatory Landscape

The regulatory approval process is becoming more stringent and time-consuming, and to gain a more significant market share, market players are striving to receive product approvals at the first attempt. Pharmaceutical and biotechnology companies must have an in-house regulatory department or outsource their regulatory affairs functions due to stringent regulatory requirements in developed countries and changing regulations in developing countries. Companies are outsourcing biotech/pharmaceutical services based on project size and priority due to the difficulty of establishing in-house regulatory affairs departments in offshore countries.

Pharmaceutical companies must manage continuous changes in regulatory requirements, spanning different business activities and multiple geographies. Noncompliance with changing regulatory requirements may result in penalties and delays, which may lead to loss of revenue. Medical device companies' geographic expansion aimed at speedy approvals in global markets is expected to further contribute to an increase in the adoption of outsourcing models for regulatory affairs and consulting services.

Restraints: Monitoring Issues And Lack Of Standardization

Managing and controlling outsourced services performed by Contract Research Organizations (CROs) is complex. There is a lack of standardization as not all CROs comply with international regulatory requirements, which may adversely affect the quality of services. Therefore, pharmaceutical and biotechnology companies are now outsourcing only lower-end functions and prefer performing high-end functions in-house. Standardization and authenticity of documented data are significant issues, as many small-scale companies need digital documentation capabilities. However, service providers are trying to comply with international standards of regulatory authorities such as the U.S. FDA to overcome this difficult challenge.

What Does This Report Include?

This section will provide insights into the contents included in this biotechnology and pharmaceutical services outsourcing market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

Biotechnology and pharmaceutical services outsourcing market qualitative analysis

Industry overview
Industry trends
Market drivers and restraints
Market size
Growth prospects
Porter’s analysis
PESTEL analysis
Key market opportunities prioritized
Competitive landscape
- Company overview
- Financial performance
- Product benchmarking
- Latest strategic developments

Biotechnology and pharmaceutical services outsourcing market quantitative analysis

Market size, estimates, and forecast from 2018 to 2030
Market estimates and forecast for product segments up to 2030
Regional market size and forecast for product segments up to 2030
Market estimates and forecast for application segments up to 2030
Regional market size and forecast for application segments up to 2030
Company financial performance

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