세계의 바이오의약품 수탁 제조 시장 : 제품, 공급원, 서비스, 사업 규모, 치료 용도별 예측(2025-2030년)

The Biopharmaceuticals Contract Manufacturing Market was valued at USD 18.27 billion in 2023, expected to reach USD 19.16 billion in 2024, and is projected to grow at a CAGR of 5.14%, to USD 25.95 billion by 2030.

Biopharmaceuticals contract manufacturing involves outsourcing the production of biopharmaceuticals to specialized companies that have the infrastructure and expertise to manufacture complex biological products. This model is necessary due to the high cost and complexity of building and maintaining manufacturing facilities that comply with stringent regulatory standards. Applications include the production of monoclonal antibodies, vaccines, gene and cell therapies, and recombinant proteins, with end-use spanning pharmaceutical companies, hospitals, and research institutions. The market exhibits significant growth factors, including the increasing prevalence of chronic diseases, the rising demand for biologics and biosimilars, advancements in manufacturing technology, and strategic partnerships between biopharma companies and contract manufacturers. Additionally, the shift towards personalized medicine and increased investment in healthcare infrastructure present lucrative opportunities. Companies can leverage these by expanding capacities, embracing digital technologies for process optimization, and engaging in mergers and acquisitions to enhance capabilities. However, challenges such as high operational costs, complex regulatory landscapes, and supply chain disruptions may hinder market growth. Moreover, maintaining product quality and ensuring scalability while meeting diverse client requirements remain key concerns. Innovation areas include exploring single-use technologies, process automation, and sustainable manufacturing practices. Companies should focus on building strong relationships with regulatory bodies and investing in state-of-the-art infrastructure to mitigate risks and maintain competitive advantage. Research into novel drug delivery systems and optimization of upstream and downstream processes could drive further growth. The market is primarily competitive, with a few key players holding substantial market share while numerous smaller companies strive to innovate and expand. Overall, the biopharmaceuticals contract manufacturing market offers substantial growth prospects, yet requires a strategic approach to navigate challenges effectively and capitalize on emerging opportunities.

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

The Biopharmaceuticals 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
  • Growing prevalence of chronic diseases
  • Increasing number of CMOs and rising investments in advanced manufacturing technologies
  • Rising outsourcing by biopharmaceutical companies
• Market Restraints
  • High price of setting up a production facility for biopharmaceuticals
• Market Opportunities
  • Increasing investments in biopharmaceutical R&D and manufacturing
  • Growing emphasis on personalized medicine globally
• Market Challenges
  • Stringent regulatory requirements for CMOs

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

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

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

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

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

A strategic analysis of the Biopharmaceuticals 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 Biopharmaceuticals Contract Manufacturing Market, highlighting leading vendors and their innovative profiles. These include 3P Biopharmaceuticals, AbbVie, Inc., Aenova Group GmbH, AGC Biologics, Ajinomoto Co., Inc., Aurobindo Pharma Limited, Boehringer Ingelheim International GmbH, Cambrex Corporation, Catalent, Inc., Celonic AG, FUJIFILM Diosynth Biotechnologies, INCOG BioPharma Services, Inc., JRS PHARMA GmbH + Co. KG, KBI Biopharma Inc, Lonza AG, Merck KGaA, Pressure BioSciences, Inc. by Emergent Health Corp., ProBioGen AG, Rentschler Biopharma SE, Samsung Biologics, Thermo Fisher Scientific Inc., Toyobo Co., Ltd., and WuXi Biologics, Inc..

Market Segmentation & Coverage

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

• Based on Product, market is studied across Biologics and Biosimilar. The Biologics is further studied across Monoclonal Antibodies, Recombinant Proteins, and Vaccines.
• Based on Source, market is studied across Mammalian and Non-Mammalian.
• Based on Services, market is studied across Analytical & QC studies, Fill & Finish Operations, Packaging, and Process Development. The Process Development is further studied across Downstream and Upstream.
• Based on Scale of Operation, market is studied across Clinical and Commercial.
• Based on Therapeutic Applications, market is studied across Cardiovascular Diseases, Infectious Disease, Neurology, Oncology, Ophthalmology, and Respiratory Disorder.
• 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. Growing prevalence of chronic diseases
    • 5.1.1.2. Increasing number of CMOs and rising investments in advanced manufacturing technologies
    • 5.1.1.3. Rising outsourcing by biopharmaceutical companies
  • 5.1.2. Restraints
    • 5.1.2.1. High price of setting up a production facility for biopharmaceuticals
  • 5.1.3. Opportunities
    • 5.1.3.1. Increasing investments in biopharmaceutical R&D and manufacturing
    • 5.1.3.2. Growing emphasis on personalized medicine globally
  • 5.1.4. Challenges
    • 5.1.4.1. Stringent regulatory requirements for CMOs
• 5.2. Market Segmentation Analysis
  • 5.2.1. Services: Proliferating utilization of analytical and QC studies critical for meeting regulatory standards
  • 5.2.2. Scale of Operation: Evolving commercial scale of operation for biopharmaceuticals contract manufacturing
• 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. Biopharmaceuticals Contract Manufacturing Market, by Product

• 6.1. Introduction
• 6.2. Biologics
  • 6.2.1. Monoclonal Antibodies
  • 6.2.2. Recombinant Proteins
  • 6.2.3. Vaccines
• 6.3. Biosimilar

7. Biopharmaceuticals Contract Manufacturing Market, by Source

• 7.1. Introduction
• 7.2. Mammalian
• 7.3. Non-Mammalian

8. Biopharmaceuticals Contract Manufacturing Market, by Services

• 8.1. Introduction
• 8.2. Analytical & QC studies
• 8.3. Fill & Finish Operations
• 8.4. Packaging
• 8.5. Process Development
  • 8.5.1. Downstream
  • 8.5.2. Upstream

9. Biopharmaceuticals Contract Manufacturing Market, by Scale of Operation

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

10. Biopharmaceuticals Contract Manufacturing Market, by Therapeutic Applications

• 10.1. Introduction
• 10.2. Cardiovascular Diseases
• 10.3. Infectious Disease
• 10.4. Neurology
• 10.5. Oncology
• 10.6. Ophthalmology
• 10.7. Respiratory Disorder

11. Americas Biopharmaceuticals Contract Manufacturing Market

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

12. Asia-Pacific Biopharmaceuticals Contract Manufacturing 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 Biopharmaceuticals Contract Manufacturing 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. SwiftPharma and PlantForm Corporation target blockbuster cancer drug with new contract manufacturing agreement for plant-made biosimilars
  • 14.3.2. Samsung Biologics Expands Strategic Manufacturing Agreement with Bristol Myers Squibb
  • 14.3.3. Hikma and SK Biopharmaceuticals enter a strategic partnership
• 14.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. 3P Biopharmaceuticals
• 2. AbbVie, Inc.
• 3. Aenova Group GmbH
• 4. AGC Biologics
• 5. Ajinomoto Co., Inc.
• 6. Aurobindo Pharma Limited
• 7. Boehringer Ingelheim International GmbH
• 8. Cambrex Corporation
• 9. Catalent, Inc.
• 10. Celonic AG
• 11. FUJIFILM Diosynth Biotechnologies
• 12. INCOG BioPharma Services, Inc.
• 13. JRS PHARMA GmbH + Co. KG
• 14. KBI Biopharma Inc
• 15. Lonza AG
• 16. Merck KGaA
• 17. Pressure BioSciences, Inc. by Emergent Health Corp.
• 18. ProBioGen AG
• 19. Rentschler Biopharma SE
• 20. Samsung Biologics
• 21. Thermo Fisher Scientific Inc.
• 22. Toyobo Co., Ltd.
• 23. WuXi Biologics, Inc.