생물제제 수탁 개발 시장 : 공급원, 유형, 적응증, 단계, 서비스 유형, 최종 사용자별 - 세계 전망(2025-2030년)

The Biologics Contract Development Market was valued at USD 6.54 billion in 2023, expected to reach USD 7.30 billion in 2024, and is projected to grow at a CAGR of 11.79%, to USD 14.28 billion by 2030.

Biologics Contract Development encompasses services provided by specialized companies to assist biotechnology and pharmaceutical firms in the development of biological products, including monoclonal antibodies, vaccines, cell therapies, and gene therapies. This sector is increasingly necessary due to the complexity and stringent regulatory requirements associated with biologic drug development. Applications span across various stages, such as cell line development, process optimization, and scale-up production, catering to industries like biopharmaceuticals and biotechnology. The market is buoyed by the rising prevalence of chronic diseases, advancements in biotechnology, and an increasing focus on personalized medicine, driving the demand for sophisticated biologic therapies. Key growth factors include intensifying research and development activities, robust government funding for biologics development, and technological innovations in bioprocessing. Emerging opportunities lie in the adoption of single-use technologies, which enhance process efficiency and reduce cross-contamination, as well as escalating demand for biosimilars in cost-sensitive markets.

However, the landscape is not without challenges. High costs associated with biologics development, limited availability of skilled personnel, and stringent regulatory frameworks can hinder market expansion. Moreover, intellectual property issues and the complexity of scale-up processes pose significant barriers. Innovations such as the integration of artificial intelligence and machine learning for optimizing development processes and reducing time-to-market present promising avenues for business growth. Additionally, exploring novel expression systems and enhancing bioprocess efficiency provide areas for significant research and innovation. The market is characterized by a competitive and fragmented nature, with key players focusing on strategic partnerships, acquisitions, and investments to enhance their service offerings and expand their global footprint. Companies aiming to capitalize on market opportunities should invest in cutting-edge technologies, foster collaborative ventures, and address regulatory challenges proactively to sustain growth and capture emerging trends in the biologics contract development landscape.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Biologics Contract Development Market

The Biologics Contract Development 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 demand for vaccine and biosimilar production
  • Government initiatives encouraging biologics activities
  • Improved operational efficiency and cost saving with biologics CDO
• Market Restraints
  • Communication issues between end-user and CDO
• Market Opportunities
  • Technological advancements in biologics development systems
  • Investments in new biologics contract development services expansion
• Market Challenges
  • Concerns associated with breach of intellectual property

Porter's Five Forces: A Strategic Tool for Navigating the Biologics Contract Development Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Biologics Contract Development 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 Biologics Contract Development Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Biologics Contract Development 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 Biologics Contract Development Market

A detailed market share analysis in the Biologics Contract Development 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 Biologics Contract Development Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Biologics Contract Development 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 Biologics Contract Development Market

A strategic analysis of the Biologics Contract Development 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 Biologics Contract Development Market, highlighting leading vendors and their innovative profiles. These include AbbVie, Inc., Abzena Ltd., Aenova Holding GmbH, AGC Biologics GmbH, Avid Bioservices, Inc., Binex Co. Limited, Boehringer Ingelheim International GmbH, Cambrex Corporation, Catalent, Inc., Emergent BioSolutions, Inc., Fujifilm Holdings Corporation, Icon PLC, JRS PHARMA GmbH & Co. KG, JSR Life Sciences, LLC, Lonza Group AG, Parexel International Corporation, ProBioGen AG, Recipharm AB, Rentschler Biopharma SE, Samsung Biologics, Takeda Pharmaceutical Company Limited, Thermo Fisher Scientific, Inc., Toyobo Co., Ltd., and WuXi Biologics Inc..

Market Segmentation & Coverage

This research report categorizes the Biologics Contract Development Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Source, market is studied across Mammalian and Microbial.
• Based on Type, market is studied across Molecular Therapy, Monoclonal Antibodies, Recombinant Proteins, and Vaccines.
• Based on Disease Indication, market is studied across Cardiovascular Disorders, Hematological Disorders, Immunological Disorders, and Oncology.
• Based on Phase, market is studied across Phase I, Phase II, Phase III, and Preclinical.
• Based on Service Type, market is studied across Cell Line Development and Process Development. The Cell Line Development is further studied across Mammalian and Microbial. The Process Development is further studied across Downstream and Upstream. The Downstream is further studied across Impurity, Isolation, & Identification, Pharmaceutical Analysis, and Physicochemical Characterization. The Upstream is further studied across Mammalian and Microbial.
• Based on End-User, market is studied across Biopharmaceutical Companies and Research Laboratories.
• 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 demand for vaccine and biosimilar production
    • 5.1.1.2. Government initiatives encouraging biologics activities
    • 5.1.1.3. Improved operational efficiency and cost saving with biologics CDO
  • 5.1.2. Restraints
    • 5.1.2.1. Communication issues between end-user and CDO
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological advancements in biologics development systems
    • 5.1.3.2. Investments in new biologics contract development services expansion
  • 5.1.4. Challenges
    • 5.1.4.1. Concerns associated with breach of intellectual property
• 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. Biologics Contract Development Market, by Source

• 6.1. Introduction
• 6.2. Mammalian
• 6.3. Microbial

7. Biologics Contract Development Market, by Type

• 7.1. Introduction
• 7.2. Molecular Therapy
• 7.3. Monoclonal Antibodies
• 7.4. Recombinant Proteins
• 7.5. Vaccines

8. Biologics Contract Development Market, by Disease Indication

• 8.1. Introduction
• 8.2. Cardiovascular Disorders
• 8.3. Hematological Disorders
• 8.4. Immunological Disorders
• 8.5. Oncology

9. Biologics Contract Development Market, by Phase

• 9.1. Introduction
• 9.2. Phase I
• 9.3. Phase II
• 9.4. Phase III
• 9.5. Preclinical

10. Biologics Contract Development Market, by Service Type

• 10.1. Introduction
• 10.2. Cell Line Development
  • 10.2.1. Mammalian
  • 10.2.2. Microbial
• 10.3. Process Development
  • 10.3.1. Downstream
    • 10.3.1.1. Impurity, Isolation, & Identification
    • 10.3.1.2. Pharmaceutical Analysis
    • 10.3.1.3. Physicochemical Characterization
  • 10.3.2. Upstream
    • 10.3.2.1. Mammalian
    • 10.3.2.2. Microbial

11. Biologics Contract Development Market, by End-User

• 11.1. Introduction
• 11.2. Biopharmaceutical Companies
• 11.3. Research Laboratories

12. Americas Biologics Contract Development Market

• 12.1. Introduction
• 12.2. Argentina
• 12.3. Brazil
• 12.4. Canada
• 12.5. Mexico
• 12.6. United States

13. Asia-Pacific Biologics Contract Development Market

• 13.1. Introduction
• 13.2. Australia
• 13.3. China
• 13.4. India
• 13.5. Indonesia
• 13.6. Japan
• 13.7. Malaysia
• 13.8. Philippines
• 13.9. Singapore
• 13.10. South Korea
• 13.11. Taiwan
• 13.12. Thailand
• 13.13. Vietnam

14. Europe, Middle East & Africa Biologics Contract Development Market

• 14.1. Introduction
• 14.2. Denmark
• 14.3. Egypt
• 14.4. Finland
• 14.5. France
• 14.6. Germany
• 14.7. Israel
• 14.8. Italy
• 14.9. Netherlands
• 14.10. Nigeria
• 14.11. Norway
• 14.12. Poland
• 14.13. Qatar
• 14.14. Russia
• 14.15. Saudi Arabia
• 14.16. South Africa
• 14.17. Spain
• 14.18. Sweden
• 14.19. Switzerland
• 14.20. Turkey
• 14.21. United Arab Emirates
• 14.22. United Kingdom

15. Competitive Landscape

• 15.1. Market Share Analysis, 2023
• 15.2. FPNV Positioning Matrix, 2023
• 15.3. Competitive Scenario Analysis
• 15.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. AbbVie, Inc.
• 2. Abzena Ltd.
• 3. Aenova Holding GmbH
• 4. AGC Biologics GmbH
• 5. Avid Bioservices, Inc.
• 6. Binex Co. Limited
• 7. Boehringer Ingelheim International GmbH
• 8. Cambrex Corporation
• 9. Catalent, Inc.
• 10. Emergent BioSolutions, Inc.
• 11. Fujifilm Holdings Corporation
• 12. Icon PLC
• 13. JRS PHARMA GmbH & Co. KG
• 14. JSR Life Sciences, LLC
• 15. Lonza Group AG
• 16. Parexel International Corporation
• 17. ProBioGen AG
• 18. Recipharm AB
• 19. Rentschler Biopharma SE
• 20. Samsung Biologics
• 21. Takeda Pharmaceutical Company Limited
• 22. Thermo Fisher Scientific, Inc.
• 23. Toyobo Co., Ltd.
• 24. WuXi Biologics Inc.