생물제제 수탁제조 시장 : 제품, 플랫폼, 치료영역, 사업 규모별 - 세계 예측(2025-2030년)

The Biologics Contract Manufacturing Market was valued at USD 22.82 billion in 2023, expected to reach USD 26.53 billion in 2024, and is projected to grow at a CAGR of 16.74%, to USD 67.44 billion by 2030.

Biologics contract manufacturing encompasses the outsourcing of production processes for biologics-complex molecules such as proteins, nucleic acids, or cells produced through biological processes. This industry is crucial for pharmaceutical and biotech companies seeking to scale production efficiently without significant capital investment in specialized facilities. The application of biologics spans various therapeutic areas, including oncology, vaccines, and autoimmune diseases, catering to both human and veterinary health. Contract manufacturers serve as key partners, offering expertise in areas such as cell culture, fermentation, purification, and analytical testing. The necessity for biologics contract manufacturing arises from the growing demand for biologics, advancements in biotechnology, and the need for flexibility in production to manage costs and capacity issues. Key market growth factors include the rising prevalence of chronic diseases, increasing adoption of personalized medicine, and technological advancements in manufacturing processes, such as single-use systems and continuous manufacturing. Opportunities in the market are tied to the diversification of service offerings, expansion in emerging markets, and collaboration on biosimilar development. However, challenges such as stringent regulatory requirements, high initial investment costs, and the need for highly skilled technical expertise can restrain growth. Furthermore, potential supply chain disruptions and quality control issues present additional hurdles. Innovation areas include the development of advanced cell and gene therapy manufacturing techniques, improvements in process analytical technologies, and sustainable manufacturing processes to minimize environmental impact. The market is dynamic, driven by rapid technological advancements and shifting regulatory landscapes. To capitalize on opportunities, companies should focus on fostering strategic partnerships, investing in technology upgrades, and expanding service portfolios to cover end-to-end solutions. A comprehensive understanding of regulatory requirements and a robust quality management system are crucial to navigating market complexities and achieving sustainable growth.

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

The Biologics Contract Manufacturing 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 biosimilars and vaccine production
  • Ongoing investment activities by CMOs for capacity expansion
  • Key advantages such as cost and time saving offered by contract services
• Market Restraints
  • Changing trade policies between countries
• Market Opportunities
  • Emergence of single-use bioprocessing equipment & solutions
  • Rising demand for cell and gene therapies for targeted treatment
• Market Challenges
  • Concerns over the breach of intellectual property and patents

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

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

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

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

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

A strategic analysis of the Biologics Contract Manufacturing 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 Manufacturing Market, highlighting leading vendors and their innovative profiles. These include AbbVie, Inc., Abzena Ltd., Acino International AG, ADMA Biologics, Inc., AGC Biologics, Ajinomoto Bio-Pharma Services, Avid Bioservices, Inc., Baxter International, Inc, Boehringer Ingelheim Biopharmaceuticals GmbH by ArisGlobal Company, Cambrex Corporation, Catalent, Inc., Emergent BioSolutions, Inc., FUJIFILM Diosynth Biotechnologies U.S.A., Inc. by FUJIFILM Corporation, JSR Life Sciences, LLC by JSR Group, Kemwell Biopharma Pvt. Ltd., Lonza Group Ltd., Midas Pharma GmbH, ProBioGen AG, Recipharm AB, Rentschler Biopharma SE, Samsung Biologics, Thermo Fisher Scientific, Inc., Toyobo Co. Ltd., Wacker Chemie AG, and WuXi Biologics Co., Ltd..

Market Segmentation & Coverage

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

• Based on Product, market is studied across Biosimilar, Insulin, Interferons, Monoclonal Antibodies, Recombinant Hormones, and Vaccines.
• Based on Platform, market is studied across Mammalian and Microbial.
• Based on Therapeutic Area, market is studied across Autoimmune Diseases, Cardiovascular Diseases, Infectious Diseases, Metabolic Diseases, Neurology, Oncology, Ophthalmology, and Respiratory Disorders.
• Based on Scale of Operation, market is studied across Clinical and Commercial.
• 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 biosimilars and vaccine production
    • 5.1.1.2. Ongoing investment activities by CMOs for capacity expansion
    • 5.1.1.3. Key advantages such as cost and time saving offered by contract services
  • 5.1.2. Restraints
    • 5.1.2.1. Changing trade policies between countries
  • 5.1.3. Opportunities
    • 5.1.3.1. Emergence of single-use bioprocessing equipment & solutions
    • 5.1.3.2. Rising demand for cell and gene therapies for targeted treatment
  • 5.1.4. Challenges
    • 5.1.4.1. Concerns over the breach of intellectual property and patents
• 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 Manufacturing Market, by Product

• 6.1. Introduction
• 6.2. Biosimilar
• 6.3. Insulin
• 6.4. Interferons
• 6.5. Monoclonal Antibodies
• 6.6. Recombinant Hormones
• 6.7. Vaccines

7. Biologics Contract Manufacturing Market, by Platform

• 7.1. Introduction
• 7.2. Mammalian
• 7.3. Microbial

8. Biologics Contract Manufacturing Market, by Therapeutic Area

• 8.1. Introduction
• 8.2. Autoimmune Diseases
• 8.3. Cardiovascular Diseases
• 8.4. Infectious Diseases
• 8.5. Metabolic Diseases
• 8.6. Neurology
• 8.7. Oncology
• 8.8. Ophthalmology
• 8.9. Respiratory Disorders

9. Biologics Contract Manufacturing Market, by Scale of Operation

• 9.1. Introduction
• 9.2. Clinical
• 9.3. Commercial

10. Americas Biologics Contract Manufacturing Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Biologics Contract Manufacturing Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Biologics Contract Manufacturing Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. AbbVie, Inc.
• 2. Abzena Ltd.
• 3. Acino International AG
• 4. ADMA Biologics, Inc.
• 5. AGC Biologics
• 6. Ajinomoto Bio-Pharma Services
• 7. Avid Bioservices, Inc.
• 8. Baxter International, Inc
• 9. Boehringer Ingelheim Biopharmaceuticals GmbH by ArisGlobal Company
• 10. Cambrex Corporation
• 11. Catalent, Inc.
• 12. Emergent BioSolutions, Inc.
• 13. FUJIFILM Diosynth Biotechnologies U.S.A., Inc. by FUJIFILM Corporation
• 14. JSR Life Sciences, LLC by JSR Group
• 15. Kemwell Biopharma Pvt. Ltd.
• 16. Lonza Group Ltd.
• 17. Midas Pharma GmbH
• 18. ProBioGen AG
• 19. Recipharm AB
• 20. Rentschler Biopharma SE
• 21. Samsung Biologics
• 22. Thermo Fisher Scientific, Inc.
• 23. Toyobo Co. Ltd.
• 24. Wacker Chemie AG
• 25. WuXi Biologics Co., Ltd.