바이오테크놀러지 및 제약 서비스 아웃소싱 시장 : 서비스별, 최종사용자별 - 세계 예측(2025-2030년)

The Biotechnology & Pharmaceutical Services Outsourcing Market was valued at USD 150.82 billion in 2023, expected to reach USD 167.95 billion in 2024, and is projected to grow at a CAGR of 11.84%, to USD 330.17 billion by 2030.

The Biotechnology & Pharmaceutical Services Outsourcing market encompasses a wide array of services including clinical research, manufacturing, and supply chain management, all intended to enhance efficiency and cost-effectiveness in the biotech and pharmaceutical industries. The necessity of outsourcing arises from the growing complexity of drug development and the need for companies to focus on their core competencies while leveraging external expertise for specialized tasks. Applications of outsourcing range from drug discovery, clinical trial management, and regulatory compliance, to commercialization and pharmacovigilance. End-users typically include large pharmaceutical companies, biotech firms, and generics manufacturers. Key growth factors influencing this market include the rising demand for specialized drugs, increasing R&D investments, and the pressure to reduce operational costs. Opportunities abound in the adoption of digital health technologies, expansion into emerging markets, and the integration of AI and big data for enhanced decision-making and precision medicine. Companies are recommended to form strategic alliances and invest in technology that can streamline operations and offer a competitive edge.

However, market growth faces limitations such as regulatory uncertainties, intellectual property concerns, and challenges in maintaining quality control across outsourced functions. Additionally, geopolitical tensions and fluctuations in currency exchange rates can impact operations and profitability. To overcome these hurdles, firms should innovate in areas like sustainable development and personalized medicine, ensuring adherence to stringent regulatory standards, while continuously enhancing their technological capabilities. Research and innovation in biologics, gene therapy, and biosimilars represent promising growth trajectories. Insights into the market's nature reveal it to be highly competitive and fragmented, necessitating agility and strategic foresight to thrive. In conclusion, businesses must carefully navigate this landscape, leveraging growth opportunities while mitigating potential risks to sustain and enhance their market positions.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biotechnology & Pharmaceutical Services Outsourcing Market

The Biotechnology & Pharmaceutical Services Outsourcing Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Increasing R&D expenditure of pharmaceutical and biopharmaceutical industry
  • Rising demand for outsourcing services in drug development
  • Growing regulatory support activities including labeling and documentation
• Market Restraints
  • Issues associated with monitoring and lack of standardization
• Market Opportunities
  • Rising outsourcing of generics and biosimilar manufacturing
  • Outsourcing of clinical trial activity
• Market Challenges
  • Issues associated with data security and increasing lead time and logistics costs

Porter's Five Forces: A Strategic Tool for Navigating the Biotechnology & Pharmaceutical Services Outsourcing Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biotechnology & Pharmaceutical Services Outsourcing Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Biotechnology & Pharmaceutical Services Outsourcing Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biotechnology & Pharmaceutical Services Outsourcing Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Biotechnology & Pharmaceutical Services Outsourcing Market

A detailed market share analysis in the Biotechnology & Pharmaceutical Services Outsourcing Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Biotechnology & Pharmaceutical Services Outsourcing Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biotechnology & Pharmaceutical Services Outsourcing Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Biotechnology & Pharmaceutical Services Outsourcing Market

A strategic analysis of the Biotechnology & Pharmaceutical Services Outsourcing Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Biotechnology & Pharmaceutical Services Outsourcing Market, highlighting leading vendors and their innovative profiles. These include AmerisourceBergen Corporation, CEVA Logistics AG, Charles River Laboratories, Inc., Concept Heidelberg GmbH, Curia Global, Inc., Dalton Pharma Services by Seikagaku Corporation, DHL International GmbH, Eurofins Scientific (Ireland) Limited, Evotec SE, GenScript Biotech Corporation, Hitachi Ltd., Icon PLC, IQVIA HOLDINGS, INC., Laboratory Corporation of America Holdings, Lachman Consultant Services, Inc., McKesson Corporation by Aurelius Group, Parexel International Corporation, The Quantic Group, and WuXi AppTec Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Biotechnology & Pharmaceutical Services Outsourcing Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Services, market is studied across Auditing & Assessment, Consulting, Product Design & Development, Product Maintenance, Product Testing & Validation, Regulatory Affairs, and Training & Education. The Consulting is further studied across Quality Management Systems Consulting, Regulatory Compliance, and Remediation. The Regulatory Affairs is further studied across Clinical Trial Applications & Product Registration, Legal Representation, and Regulatory Writing & Publishing.
• Based on End-User, market is studied across Biotech Companies and Pharmaceutical Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Increasing R&D expenditure of pharmaceutical and biopharmaceutical industry
    • 5.1.1.2. Rising demand for outsourcing services in drug development
    • 5.1.1.3. Growing regulatory support activities including labeling and documentation
  • 5.1.2. Restraints
    • 5.1.2.1. Issues associated with monitoring and lack of standardization
  • 5.1.3. Opportunities
    • 5.1.3.1. Rising outsourcing of generics and biosimilar manufacturing
    • 5.1.3.2. Outsourcing of clinical trial activity
  • 5.1.4. Challenges
    • 5.1.4.1. Issues associated with data security and increasing lead time and logistics costs
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Biotechnology & Pharmaceutical Services Outsourcing Market, by Services

• 6.1. Introduction
• 6.2. Auditing & Assessment
• 6.3. Consulting
  • 6.3.1. Quality Management Systems Consulting
  • 6.3.2. Regulatory Compliance
  • 6.3.3. Remediation
• 6.4. Product Design & Development
• 6.5. Product Maintenance
• 6.6. Product Testing & Validation
• 6.7. Regulatory Affairs
  • 6.7.1. Clinical Trial Applications & Product Registration
  • 6.7.2. Legal Representation
  • 6.7.3. Regulatory Writing & Publishing
• 6.8. Training & Education

7. Biotechnology & Pharmaceutical Services Outsourcing Market, by End-User

• 7.1. Introduction
• 7.2. Biotech Companies
• 7.3. Pharmaceutical Companies

8. Americas Biotechnology & Pharmaceutical Services Outsourcing Market

• 8.1. Introduction
• 8.2. Argentina
• 8.3. Brazil
• 8.4. Canada
• 8.5. Mexico
• 8.6. United States

9. Asia-Pacific Biotechnology & Pharmaceutical Services Outsourcing Market

• 9.1. Introduction
• 9.2. Australia
• 9.3. China
• 9.4. India
• 9.5. Indonesia
• 9.6. Japan
• 9.7. Malaysia
• 9.8. Philippines
• 9.9. Singapore
• 9.10. South Korea
• 9.11. Taiwan
• 9.12. Thailand
• 9.13. Vietnam

10. Europe, Middle East & Africa Biotechnology & Pharmaceutical Services Outsourcing Market

• 10.1. Introduction
• 10.2. Denmark
• 10.3. Egypt
• 10.4. Finland
• 10.5. France
• 10.6. Germany
• 10.7. Israel
• 10.8. Italy
• 10.9. Netherlands
• 10.10. Nigeria
• 10.11. Norway
• 10.12. Poland
• 10.13. Qatar
• 10.14. Russia
• 10.15. Saudi Arabia
• 10.16. South Africa
• 10.17. Spain
• 10.18. Sweden
• 10.19. Switzerland
• 10.20. Turkey
• 10.21. United Arab Emirates
• 10.22. United Kingdom

11. Competitive Landscape

• 11.1. Market Share Analysis, 2023
• 11.2. FPNV Positioning Matrix, 2023
• 11.3. Competitive Scenario Analysis
• 11.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. AmerisourceBergen Corporation
• 2. CEVA Logistics AG
• 3. Charles River Laboratories, Inc.
• 4. Concept Heidelberg GmbH
• 5. Curia Global, Inc.
• 6. Dalton Pharma Services by Seikagaku Corporation
• 7. DHL International GmbH
• 8. Eurofins Scientific (Ireland) Limited
• 9. Evotec SE
• 10. GenScript Biotech Corporation
• 11. Hitachi Ltd.
• 12. Icon PLC
• 13. IQVIA HOLDINGS, INC.
• 14. Laboratory Corporation of America Holdings
• 15. Lachman Consultant Services, Inc.
• 16. McKesson Corporation by Aurelius Group
• 17. Parexel International Corporation
• 18. The Quantic Group
• 19. WuXi AppTec Co., Ltd.