세계의 바이오테크놀러지 및 제약 서비스 아웃소싱 시장 - 규모, 점유율, 동향 분석 보고서 : 서비스별, 최종 용도별, 지역별 부문 예측(2024-2030년)

Biotechnology And Pharmaceutical Services Outsourcing Market Growth & Trends:

The global biotechnology and pharmaceutical services outsourcing market size is expected to reach USD 66.95 billion by 2030, registering a CAGR of 5.67% from 2024 to 2030, according to a new report by Grand View Research, Inc.

The growing R&D investment for innovative therapeutics by pharmaceutical and biotechnology companies, which are complex and require strict timeline follow-up, is driving outsourcing trend in the industry. Moreover, high costs associated with the new drug development in the biotechnology and pharmaceutical industries lead to customer's preference for cost-effective outsourcing solutions. CROs have the required expertise and infrastructure that provide the benefit of cost, time, and efficiency. Moreover, emerging economies, such as Japan, India, and China are mostly preferred countries for outsourcing activities, owing to strong availability of experts, R&D infrastructure, and affordability.

In addition, regulatory framework for drug discovery and development is complex in several countries. Thus, increasing need for expertise in different areas of drug development is driving the demand for outsourcing services. Drug companies are not only outsourcing production of medicines but also clinical trials. Moreover, the outsourcing of manufacturing activities to developing countries such as China, India, and Latin America is growing due to expanding privatization of clinical trials. Additionally, the globalization of clinical trials has increased the demand for outsourcing services, particularly in emerging markets such as Latin America and MEA owing to large patient pool and lower costs

Regulatory approval procedures are becoming more stringent & time-consuming, and business players aim to receive product approvals at the first attempt to gain a higher market share. Pharmaceutical and biotechnology companies are required to 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. Establishing an in-house regulatory affairs department in offshore countries is not feasible, thus companies are adopting different outsourcing models depending upon size and priority of projects, thereby contributing to the growth of global biotechnology/pharmaceutical services outsourcing market.

Pharmaceutical and biotechnology companies are now focusing on their core competencies and outsourcing non-core functions to increase their productivity & operational efficiency. These companies commonly outsource R&D functions to emerging regions, such as Asia Pacific, and have now started outsourcing product design & development to CROs to reduce cost & increase focus on core functions. Small- or mid-sized companies, which do not have in-house capabilities, have to outsource their product design and development, auditing, and regulatory affairs to enter into new markets. Small or specialty companies are hiring CRO consultants to assist in regulatory affairs and legal representation functions in international markets.

Biotechnology And Pharmaceutical Services Outsourcing Market Report Highlights:

• Based on services, the consulting segment dominated the market in 2023. The high segment growth is driven by increasing changes in regulations by several regulatory authorities such as U.S. FDA and EMA creating the need for regulatory compliance for pharmaceutical & biotech companies. Pharmaceutical and biotech products may face withdrawals, recalls, repacking, or relabeling if products are not compliant with the regulatory standards, thereby preferring consulting services from third party organizations to ensure compliance with evolving regulations
• Based on end-use, the pharmaceutical companies segment held majority revenue share, accounting of over 58.44% in 2023. Growth in the segment can be attributed to factors such as increase in outsourcing of regulatory services and product design & development services by pharmaceutical companies to avoid high capital expenditure and increase profit margins
• Asia Pacific dominated the market with a share of 42.41% in 2023. The regional growth is owing to surge in R&D investments by developed countries and numerous regulatory reforms in clinical trial assessment to align with regulatory guidelines of various countries investing in the region

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
  • 1.4.3. 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, 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)
• 4.7. Auditing and Assessment
  • 4.7.1. Auditing and Assessment 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. 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, 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. 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
• 6.4. Europe
  • 6.4.1. Europe Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
• 6.5. Asia Pacific
  • 6.5.1. Asia Pacific Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
• 6.6. Latin America
  • 6.6.1. Latin America Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
• 6.7. Middle East & Africa
  • 6.7.1. Middle East & Africa Biotechnology and Pharmaceutical Services Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 2018 - 2030 (USD Million)
  • 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, 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. 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