생물제제 수탁개발제조기관 시장 : 유형별, 제품별, 적응증별, 서비스별, 최종사용자별 - 세계 예측(2025-2030년)

The Biologics Contract Development & Manufacturing Organization Market was valued at USD 9.88 billion in 2023, expected to reach USD 10.59 billion in 2024, and is projected to grow at a CAGR of 7.44%, to USD 16.35 billion by 2030.

The Biologics Contract Development and Manufacturing Organization (CDMO) market is pivotal in the biopharmaceutical industry, providing essential services such as cell culture development, production processes, and analytical testing. The necessity of biologics CDMOs arises from their ability to offer specialized resources and expertise to pharmaceutical companies, which may lack in-house capabilities. This market serves applications related to monoclonal antibodies, vaccines, recombinant proteins, and gene therapies, catering to a wide array of therapeutic areas including oncology, infectious diseases, and chronic conditions. End-use providers range from large pharmaceutical firms to small biotech startups, leveraging CDMO capabilities to accelerate drug development and bring products to market faster.

Key growth drivers include the escalating demand for biologics due to their precision and efficacy in treating complex diseases, technological advancements in bioprocessing, and the increasing trend towards outsourcing to reduce operational costs and enhance focus on core competencies. Recent opportunities lie in personalized medicine, where CDMOs can tap into the burgeoning field of tailored therapies, and in the adoption of single-use technology, which offers flexibility and cost-effectiveness in production. Companies could capitalize on these trends by investing in advanced bioprocessing technologies and expanding service offerings to include integrated development solutions.

However, challenges persist, such as stringent regulatory requirements, which necessitate high compliance costs and can delay time-to-market. Market growth is also constrained by capacity bottlenecks stemming from the rapid increase in biologics production demand, which can impact production timelines. Innovation and research should focus on addressing these limitations by enhancing manufacturing scalability and efficiency, such as through the development of continuous bioprocessing technologies. Additionally, improving collaborations with technology developers and investing in digital transformations like data analytics and AI-driven insights can foster business growth. The nature of this market is competitive yet ripe with collaboration potential, necessitating a balance between strategic partnership and technological innovation to maintain a competitive edge.

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

The Biologics Contract Development & Manufacturing Organization 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
  • Rising demand for cell and gene therapies for targeted treatment
  • Growing adoption of single-use technologies in upstream and downstream processing
  • Increasing focus on developing novel biotherapeutics
• Market Restraints
  • Concern regarding product quality and high costs associated with biologics products manufacturing
• Market Opportunities
  • Advancement in bioprocessing technologies enabled efficient large-scale production
  • Growing investment in research and innovation and rising numbers of clinical trials for biologics
• Market Challenges
  • Strict governmental laws and regulations for CDMO organizations

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

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

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

A detailed market share analysis in the Biologics Contract Development & Manufacturing Organization 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 & Manufacturing Organization Market

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

A strategic analysis of the Biologics Contract Development & Manufacturing Organization 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 & Manufacturing Organization 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, 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 & Manufacturing Organization Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Type, market is studied across Mammalian and Non-mammalian.
• Based on Product Type, market is studied across Biologics and Biosimilars. The Biologics is further studied across Antisense & Molecular Therapy, Monoclonal, Recombinant Proteins, and Vaccines.
• Based on Disease Indication, market is studied across Cardiovascular Disorders, Hematological Disorders, Immunological Disorders, and Oncology.
• 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. Rising demand for cell and gene therapies for targeted treatment
    • 5.1.1.2. Growing adoption of single-use technologies in upstream and downstream processing
    • 5.1.1.3. Increasing focus on developing novel biotherapeutics
  • 5.1.2. Restraints
    • 5.1.2.1. Concern regarding product quality and high costs associated with biologics products manufacturing
  • 5.1.3. Opportunities
    • 5.1.3.1. Advancement in bioprocessing technologies enabled efficient large-scale production
    • 5.1.3.2. Growing investment in research and innovation and rising numbers of clinical trials for biologics
  • 5.1.4. Challenges
    • 5.1.4.1. Strict governmental laws and regulations for CDMO organizations
• 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 & Manufacturing Organization Market, by Type

• 6.1. Introduction
• 6.2. Mammalian
• 6.3. Non-mammalian

7. Biologics Contract Development & Manufacturing Organization Market, by Product Type

• 7.1. Introduction
• 7.2. Biologics
  • 7.2.1. Antisense & Molecular Therapy
  • 7.2.2. Monoclonal
  • 7.2.3. Recombinant Proteins
  • 7.2.4. Vaccines
• 7.3. Biosimilars

8. Biologics Contract Development & Manufacturing Organization 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 & Manufacturing Organization Market, by Service Type

• 9.1. Introduction
• 9.2. Cell Line Development
  • 9.2.1. Mammalian
  • 9.2.2. Microbial
• 9.3. Process Development
  • 9.3.1. Downstream
    • 9.3.1.1. Impurity, Isolation, & Identification
    • 9.3.1.2. Pharmaceutical Analysis
    • 9.3.1.3. Physicochemical Characterization
  • 9.3.2. Upstream
    • 9.3.2.1. Mammalian
    • 9.3.2.2. Microbial

10. Biologics Contract Development & Manufacturing Organization Market, by End-User

• 10.1. Introduction
• 10.2. Biopharmaceutical Companies
• 10.3. Research Laboratories

11. Americas Biologics Contract Development & Manufacturing Organization Market

• 11.1. Introduction
• 11.2. Argentina
• 11.3. Brazil
• 11.4. Canada
• 11.5. Mexico
• 11.6. United States

12. Asia-Pacific Biologics Contract Development & Manufacturing Organization Market

• 12.1. Introduction
• 12.2. Australia
• 12.3. China
• 12.4. India
• 12.5. Indonesia
• 12.6. Japan
• 12.7. Malaysia
• 12.8. Philippines
• 12.9. Singapore
• 12.10. South Korea
• 12.11. Taiwan
• 12.12. Thailand
• 12.13. Vietnam

13. Europe, Middle East & Africa Biologics Contract Development & Manufacturing Organization Market

• 13.1. Introduction
• 13.2. Denmark
• 13.3. Egypt
• 13.4. Finland
• 13.5. France
• 13.6. Germany
• 13.7. Israel
• 13.8. Italy
• 13.9. Netherlands
• 13.10. Nigeria
• 13.11. Norway
• 13.12. Poland
• 13.13. Qatar
• 13.14. Russia
• 13.15. Saudi Arabia
• 13.16. South Africa
• 13.17. Spain
• 13.18. Sweden
• 13.19. Switzerland
• 13.20. Turkey
• 13.21. United Arab Emirates
• 13.22. United Kingdom

14. Competitive Landscape

• 14.1. Market Share Analysis, 2023
• 14.2. FPNV Positioning Matrix, 2023
• 14.3. Competitive Scenario Analysis
  • 14.3.1. Biosimilar CDMO Capacity Increased in Samsung Biologics
  • 14.3.2. Catalent expands its biologics services platform
  • 14.3.3. Bionova Scientific, U.S. biologics CDMO of the Asahi Kasei Group, expands manufacturing capacity
• 14.4. 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. JSR Life Sciences, LLC
• 14. Lonza Group AG
• 15. Parexel International Corporation
• 16. ProBioGen AG
• 17. Recipharm AB
• 18. Rentschler Biopharma SE
• 19. Samsung Biologics
• 20. Takeda Pharmaceutical Company Limited
• 21. Thermo Fisher Scientific, Inc.
• 22. Toyobo Co., Ltd.
• 23. WuXi Biologics Inc.